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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>UNITED STATES</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>SECURITIES AND EXCHANGE COMMISSION</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>WASHINGTON, D.C. 20549</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>FORM <ix:nonNumeric contextRef="c0" name="dei:DocumentType">20-F</ix:nonNumeric></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(Mark One)</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b><ix:nonNumeric contextRef="c0" format="ixt:fixed-false" name="dei:DocumentRegistrationStatement">&#9744;</ix:nonNumeric> REGISTRATION STATEMENT PURSUANT TO SECTION
12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>&#160;</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>OR</b></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b><ix:nonNumeric contextRef="c0" format="ixt:fixed-true" name="dei:DocumentAnnualReport">&#9746;</ix:nonNumeric> ANNUAL REPORT PURSUANT TO SECTION 13
OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>&#160;</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>for the fiscal year ended <ix:nonNumeric contextRef="c0" format="ixt:date-monthname-day-year-en" name="dei:DocumentPeriodEndDate"><ix:nonNumeric contextRef="c0" format="ixt:date-monthname-day-en" name="dei:CurrentFiscalYearEndDate">December 31</ix:nonNumeric>, <ix:nonNumeric contextRef="c0" name="dei:DocumentFiscalYearFocus">2022</ix:nonNumeric></ix:nonNumeric></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>&#160;</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>OR</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>&#160;</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b><ix:nonNumeric contextRef="c0" format="ixt:fixed-false" name="dei:DocumentTransitionReport">&#9744;</ix:nonNumeric> TRANSITION REPORT PURSUANT TO SECTION
13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>OR</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b><ix:nonNumeric contextRef="c0" format="ixt:fixed-false" name="dei:DocumentShellCompanyReport">&#9744;</ix:nonNumeric> SHELL COMPANY REPORT PURSUANT TO SECTION
13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>&#160;</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>Date of event requiring this shell company report:
_________</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>for the transition period from _________ to
_________</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">Commission File Number: <b><span style="-sec-ix-hidden: hidden-fact-0">001- 40996</span></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b><span style="-sec-ix-hidden: hidden-fact-1">MDXHEALTH SA</span></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(Exact name of registrant as specified in its charter)</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><ix:nonNumeric contextRef="c0" format="ixt-sec:countrynameen" name="dei:EntityAddressCountry"><b>Belgium</b></ix:nonNumeric></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(Jurisdiction of incorporation or organization)</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>CAP Business Center</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><ix:nonNumeric contextRef="c0" name="dei:EntityAddressAddressLine1"><b>Zone Industrielle des Hauts-Sarts</b></ix:nonNumeric></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b><ix:nonNumeric contextRef="c0" name="dei:EntityAddressPostalZipCode">4040</ix:nonNumeric> <ix:nonNumeric contextRef="c0" name="dei:EntityAddressCityOrTown">Herstal</ix:nonNumeric>, <ix:nonNumeric contextRef="c0" format="ixt-sec:edgarprovcountryen" name="dei:EntityIncorporationStateCountryCode">Belgium</ix:nonNumeric></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(Address of principal executive offices)</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><ix:nonNumeric contextRef="c1" name="dei:ContactPersonnelName"><b>Michael McGarrity</b></ix:nonNumeric></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>Chief Executive Officer</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>MDxHealth, Inc.</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b><ix:nonNumeric contextRef="c1" name="dei:EntityAddressAddressLine1">15279 Alton Parkway</ix:nonNumeric> &#8212; <ix:nonNumeric contextRef="c1" name="dei:EntityAddressAddressLine2">Suite 100</ix:nonNumeric></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b><ix:nonNumeric contextRef="c1" name="dei:EntityAddressCityOrTown">Irvine</ix:nonNumeric>, <ix:nonNumeric contextRef="c1" name="dei:EntityAddressCountry">CA</ix:nonNumeric> <ix:nonNumeric contextRef="c1" name="dei:EntityAddressPostalZipCode">92618</ix:nonNumeric></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>United States</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b><ix:nonNumeric contextRef="c1" name="dei:CityAreaCode">+1 949</ix:nonNumeric>-<ix:nonNumeric contextRef="c1" name="dei:LocalPhoneNumber">812-6979</ix:nonNumeric></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(Name, Telephone, E-mail and/or Facsimile number
and Address of Company Contact Person)</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>Securities registered or to be registered pursuant to Section 12(b)
of the Act:</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%"> <tr style="vertical-align: bottom"> <td style="width: 32%; border-bottom: black 1.5pt solid; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Title of each class</b></span></td> <td style="width: 2%; text-align: center">&#160;</td> <td style="width: 32%; border-bottom: black 1.5pt solid; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Trading Symbol</b></span></td> <td style="width: 2%; text-align: center">&#160;</td> <td style="width: 32%; border-bottom: black 1.5pt solid; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Name of each exchange on which registered</b></span></td></tr> <tr style="vertical-align: top; background-color: #CCEEFF"> <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>American Depositary Shares, each representing 10 ordinary shares, no nominal value per share</b></span></td> <td style="text-align: center">&#160;</td> <td style="text-align: center"><ix:nonNumeric contextRef="c0" name="dei:TradingSymbol"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>MDXH</b></span></ix:nonNumeric></td> <td style="text-align: center">&#160;</td> <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>The Nasdaq Capital Market </b></span></td></tr> <tr style="vertical-align: top"> <td style="text-align: center"><ix:nonNumeric contextRef="c0" name="dei:Security12bTitle"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Ordinary shares, no par value*</b></span></ix:nonNumeric></td> <td style="text-align: center">&#160;</td> <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>*</b></span></td> <td style="text-align: center">&#160;</td> <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>The <ix:nonNumeric contextRef="c0" format="ixt-sec:exchnameen" name="dei:SecurityExchangeName">Nasdaq</ix:nonNumeric> Capital Market*</b></span></td></tr> </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">*</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Not for trading, but only in connection with the listing of the American Depositary Shares on The Nasdaq Stock Market LLC.</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Securities registered or to be registered pursuant
to Section 12(g) of the Act.</b> None</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Securities for which there is a reporting obligation
pursuant to Section 15(d) of the Act.</b> None</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Indicate the number of outstanding shares of
each of the issuer&#8217;s class of capital or common stock as of the close of the period covered by the annual report.</b> Ordinary shares,
no nominal value per share: 162,880,936 as of December 31, 2022.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Indicate by check mark if the registrant is a
well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes &#9744;&#160;&#160;&#160;<ix:nonNumeric contextRef="c0" name="dei:EntityWellKnownSeasonedIssuer">No</ix:nonNumeric> &#9746;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If this report is an annual or transition report,
indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act
of 1934. Yes &#9744;&#160;&#160;&#160;<ix:nonNumeric contextRef="c0" name="dei:EntityVoluntaryFilers">No</ix:nonNumeric> &#9746;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Note - Checking the box above will not relieve
any registrant required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 from their obligations
under those Sections.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Indicate by check mark whether the registrant
(1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements
for the past 90 days. <ix:nonNumeric contextRef="c0" name="dei:EntityCurrentReportingStatus">Yes</ix:nonNumeric> &#9746;&#160;&#160;&#160;No &#9744;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Indicate by check mark whether the registrant
has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (&#167;232.405
of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). <ix:nonNumeric contextRef="c0" name="dei:EntityInteractiveDataCurrent">Yes</ix:nonNumeric>
&#9746;&#160;&#160;&#160;No &#9744;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Indicate by check mark whether the registrant
is a large accelerated filer, accelerated filer, a non-accelerated filer, or an emerging growth company. See definition of &#8220;large
accelerated filer&#8221;, &#8220;accelerated filer&#8221; and &#8220;emerging growth company&#8221; in Rule 12b-2 of the Exchange Act.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%"> <tr style="vertical-align: top"> <td style="white-space: nowrap; width: 20%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Large accelerated filer</span></td> <td style="white-space: nowrap; width: 37%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9744;</span></td> <td style="white-space: nowrap; width: 25%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Accelerated filer</span></td> <td style="white-space: nowrap; width: 18%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9744;</span></td></tr> <tr style="vertical-align: top"> <td style="white-space: nowrap"><ix:nonNumeric contextRef="c0" format="ixt-sec:entityfilercategoryen" name="dei:EntityFilerCategory"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Non-accelerated filer</span></ix:nonNumeric></td> <td style="white-space: nowrap"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9746;</span></td> <td style="white-space: nowrap"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Emerging Growth Company</span></td> <td style="white-space: nowrap"><ix:nonNumeric contextRef="c0" format="ixt:fixed-true" name="dei:EntityEmergingGrowthCompany"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9746;</span></ix:nonNumeric></td></tr> </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If an emerging growth company that prepares its
financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition
period for complying with any new or revised financial accounting standards&#8224; provided pursuant to Section 13(a) of the Exchange
Act. <ix:nonNumeric contextRef="c0" format="ixt:fixed-false" name="dei:EntityExTransitionPeriod">&#9744;</ix:nonNumeric></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#8224;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The term &#8220;new or revised financial accounting standard&#8221; refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Indicate by check mark whether the registrant
has filed a report on and attestation to its management&#8217;s assessment of the effectiveness of its internal control over financial
reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or
issued its audit report. <ix:nonNumeric contextRef="c0" format="ixt:fixed-false" name="dei:IcfrAuditorAttestationFlag">&#9744;</ix:nonNumeric></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If securities are registered pursuant to Section
12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction
of an error to previously issued financial statements. &#9744;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Indicate by check mark whether any of those error
corrections are restatements that required a recovery analysis of incentive based compensation received by any of the registrant&#8217;s
executive officers during the relevant recovery period pursuant to &#167;240.10D-1(b). &#9744;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Indicate by check mark which basis of accounting
the registrant has used to prepare the financial statements included in this filing:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%"> <tr style="vertical-align: bottom"> <td style="width: 28%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">U.S. GAAP &#9744;</span></td> <td style="width: 44%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><ix:nonNumeric contextRef="c0" name="dei:DocumentAccountingStandard">International Financial Reporting Standards</ix:nonNumeric> as issued by the<br/>
International Accounting Standards Board &#9746;</span></td> <td style="width: 28%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Other &#9744;</span></td></tr> </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If &#8220;Other&#8221; has been checked in response
to the previous question, indicate by check mark which financial statement item the registrant has elected to follow: Item 17 &#9744;&#160;&#160;&#160;Item
18 &#9744;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If this is an annual report, indicate by check
mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes&#160;&#9744;&#160;&#160;&#160;No&#160;<ix:nonNumeric contextRef="c0" format="ixt:fixed-false" name="dei:EntityShellCompany">&#9746;</ix:nonNumeric></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Rule-Page --><div style="margin-top: 0pt; margin-bottom: 0pt; width: 100%"><div style="font-size: 1pt; border-top: Black 1pt solid; border-bottom: Black 2pt solid">&#160;</div></div><!-- Field: /Rule-Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 2; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="margin: 0pt"></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>TABLE OF CONTENTS</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr>
    <td style="vertical-align: top; width: 9%">&#160;</td>
    <td style="vertical-align: top; width: 82%">&#160;</td>
    <td style="border-bottom: black 1.5pt solid; vertical-align: bottom; width: 9%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Page</b></span></td></tr>
  <tr style="background-color: #CCEEFF">
    <td colspan="2" style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><a href="#a_001">INTRODUCTION</a></b></span></td>
    <td style="vertical-align: bottom; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">ii</span></td></tr>
  <tr>
    <td colspan="2" style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><a href="#a_002">SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS</a></b></span></td>
    <td style="vertical-align: bottom; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">iii</span></td></tr>
  <tr style="background-color: #CCEEFF">
    <td colspan="2" style="vertical-align: top">&#160;</td>
    <td style="vertical-align: bottom; text-align: center">&#160;</td></tr>
  <tr>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><a href="#a_003">PART I</a></b></span></td>
    <td style="vertical-align: top">&#160;</td>
    <td style="vertical-align: bottom; text-align: center">1</td></tr>
  <tr style="background-color: #CCEEFF">
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 1.</span></td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#a_004">Identity of Directors, Senior Management and Advisers</a></span></td>
    <td style="vertical-align: bottom; text-align: center">1</td></tr>
  <tr>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 2.</span></td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#a_005">Offer Statistics and Expected Timetable</a></span></td>
    <td style="vertical-align: bottom; text-align: center">1</td></tr>
  <tr style="background-color: #CCEEFF">
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 3.</span></td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#a_006">Key Information</a></span></td>
    <td style="vertical-align: bottom; text-align: center">1</td></tr>
  <tr>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 4.</span></td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#a_007">Information on the Company</a></span></td>
    <td style="vertical-align: bottom; text-align: center">30</td></tr>
  <tr style="background-color: #CCEEFF">
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 4a.</span></td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#a_008">Unresolved Staff Comments</a></span></td>
    <td style="vertical-align: bottom; text-align: center">54</td></tr>
  <tr>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 5.</span></td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#a_009">Operating and Financial Review and Prospects</a></span></td>
    <td style="vertical-align: bottom; text-align: center">54</td></tr>
  <tr style="background-color: #CCEEFF">
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 6.</span></td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#a_010">Directors, Senior Management and Employees</a></span></td>
    <td style="vertical-align: bottom; text-align: center">65</td></tr>
  <tr>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 7.</span></td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#a_011">Major Shareholders and Related Party Transactions</a></span></td>
    <td style="vertical-align: bottom; text-align: center">77</td></tr>
  <tr style="background-color: #CCEEFF">
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 8.</span></td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#a_012">Financial Information</a></span></td>
    <td style="vertical-align: bottom; text-align: center">80</td></tr>
  <tr>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 9.</span></td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#a_013">The Offer and Listing</a></span></td>
    <td style="vertical-align: bottom; text-align: center">81</td></tr>
  <tr style="background-color: #CCEEFF">
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 10.</span></td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#a_014">Additional Information</a></span></td>
    <td style="vertical-align: bottom; text-align: center">82</td></tr>
  <tr>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 11.</span></td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#a_015">Quantitative and Qualitative Disclosures about Market Risk</a></span></td>
    <td style="vertical-align: bottom; text-align: center">92</td></tr>
  <tr style="background-color: #CCEEFF">
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 12.</span></td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#a_016">Description of Securities Other than Equity Securities</a></span></td>
    <td style="vertical-align: bottom; text-align: center">93</td></tr>
  <tr>
    <td style="vertical-align: top">&#160;</td>
    <td style="vertical-align: top">&#160;</td>
    <td style="vertical-align: bottom; text-align: center">&#160;</td></tr>
  <tr style="background-color: #CCEEFF">
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><a href="#a_017">PART II</a></b></span></td>
    <td style="vertical-align: top">&#160;</td>
    <td style="vertical-align: bottom; text-align: center">95</td></tr>
  <tr>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 13.</span></td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#a_018">Defaults, Dividend Arrearages and Delinquencies</a></span></td>
    <td style="vertical-align: bottom; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">95</span></td></tr>
  <tr style="background-color: #CCEEFF">
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 14.</span></td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#a_019">Material Modifications to the Rights of Security Holders and Use of Proceeds</a></span></td>
    <td style="vertical-align: bottom; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">95</span></td></tr>
  <tr>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 15.</span></td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#a_020">Controls and Procedures</a></span></td>
    <td style="vertical-align: bottom; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">95</span></td></tr>
  <tr style="background-color: #CCEEFF">
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 16.</span></td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#a_021">Reserved</a></span></td>
    <td style="vertical-align: bottom; text-align: center">95</td></tr>
  <tr>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 16A.</span></td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#a_022">Audit Committee Financial Expert</a></span></td>
    <td style="vertical-align: bottom; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">96</span></td></tr>
  <tr style="background-color: #CCEEFF">
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 16B.</span></td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#a_023">Code of Ethics</a></span></td>
    <td style="vertical-align: bottom; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">96</span></td></tr>
  <tr>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 16C.</span></td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#a_024">Principal Accountant Fees and Services</a></span></td>
    <td style="vertical-align: bottom; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">96</span></td></tr>
  <tr style="background-color: #CCEEFF">
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 16D.</span></td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#a_025">Exemptions from the Listing Standards for Audit Committees</a></span></td>
    <td style="vertical-align: bottom; text-align: center">96</td></tr>
  <tr>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 16E.</span></td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#a_026">Purchases of Equity Securities by the Issuer and Affiliated Purchasers</a></span></td>
    <td style="vertical-align: bottom; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">96</span></td></tr>
  <tr style="background-color: #CCEEFF">
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 16F.</span></td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#a_027">Change in Registrant&#8217;s Certifying Accountant</a></span></td>
    <td style="vertical-align: bottom; text-align: center">96</td></tr>
  <tr>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 16G.</span></td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#a_028">Corporate Governance</a></span></td>
    <td style="vertical-align: bottom; text-align: center">97</td></tr>
  <tr style="background-color: #CCEEFF">
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 16H.</span></td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#a_029">Mine Safety Disclosure</a></span></td>
    <td style="vertical-align: bottom; text-align: center">98</td></tr>
  <tr>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 16I.</span></td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#a_030">Disclosure Regarding Foreign Jurisdictions That Prevent Inspections</a></span></td>
    <td style="vertical-align: bottom; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">98</span></td></tr>
  <tr style="background-color: #CCEEFF">
    <td style="vertical-align: top">&#160;</td>
    <td style="vertical-align: top">&#160;</td>
    <td style="vertical-align: bottom; text-align: center">&#160;</td></tr>
  <tr>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><a href="#a_031">PART III</a></b></span></td>
    <td style="vertical-align: top">&#160;</td>
    <td style="vertical-align: bottom; text-align: center">99</td></tr>
  <tr style="background-color: #CCEEFF">
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 17.</span></td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#a_032">Financial Statements</a></span></td>
    <td style="vertical-align: bottom; text-align: center">99</td></tr>
  <tr>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 18.</span></td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#a_033">Financial Statements</a></span></td>
    <td style="vertical-align: bottom; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">99</span></td></tr>
  <tr style="background-color: #CCEEFF">
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 19.</span></td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#a_034">Exhibits</a></span></td>
    <td style="vertical-align: bottom; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">99</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: LowerRoman; Name: PageNo -->i<!-- Field: /Sequence --></p></div><div>
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</div><div><a id="a_001"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>INTRODUCTION</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Unless otherwise indicated or the context otherwise
requires, references in this annual report to &#8220;we,&#8221; &#8220;our,&#8221; &#8220;us,&#8221; &#8220;MDxHealth,&#8221; or the &#8220;Company&#8221;
refer to MDxHealth SA and its wholly owned subsidiaries.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We were incorporated on January&#160;10, 2003
as a company with limited liability (<i>naamloze vennootschap/soci&#233;t&#233; anonyme</i>) incorporated and operating under the
laws of Belgium. We are registered with the legal entities register (Li&#232;ge) under enterprise number 0479.292.440. We were publicly
listed on Euronext Brussels in June&#160;2006. In October 2010 the Company&#8217;s name was changed from OncoMethylome Sciences SA to&#160;MDxHealth
SA. We have two directly held, wholly owned subsidiaries: MDxHealth, Inc., a Delaware company incorporated in April 2003, and MDxHealth
B.V., a Dutch company incorporated in September 2015.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our headquarters and principal executive offices
are located at CAP Business Center, Zone Industrielle des Hauts-Sarts, Rue d&#8217;Abhooz&#160;31, 4040 Herstal, Belgium, our telephone
number is +32 4 257 70 21 and our email is info@mdxhealth.com. Our website address is&#160;<i>www.mdxhealth.com</i>. The information contained
on, or accessible through, our website is not incorporated by reference into this annual report, and you should not consider any information
contained in, or that can be accessed through, our website as part of this annual report.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our American Depositary Shares, each representing
10 ordinary shares, began trading on the Nasdaq Capital Market on November 4, 2021. Throughout this annual report, references to ADSs
mean American Depository Shares or ordinary shares represented by ADSs, as the case may be. All references in this annual report to &#8220;$&#8221;
are to U.S. dollars and all references to &#8220;&#8364;&#8221; are to Euros. Solely for the convenience of the reader, certain Euro amounts
herein have been translated into U.S. dollars at the official exchange rate quoted as of December 31, 2022, by the European Central Bank
of &#8364;1.00 to $1.067. These translations should not be considered representations that any such amounts have been, could have been
or could be converted into U.S. dollars at that or any other exchange rate as at that or any other date.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Trademarks and Service Marks</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We own various trademark registrations and applications,
and unregistered trademarks and service marks. &#8220;MDxHealth,&#8221; &#8220;Confirm mdx,&#8221; &#8220;Select mdx,&#8221; &#8220;Resolve
mdx,&#8221; &#8220;Genomic Prostate Score,&#8221; &#8220;GPS,&#8221; &#8220;Monitor mdx,&#8221; the MDxHealth logo and other trademarks
or service marks of MDxHealth SA appearing in this annual report are the property of MDxHealth SA or its subsidiaries. Solely for convenience,
the trademarks, service marks and trade names referred to in this annual report are listed without the &#174; and &#8482; symbols, but
such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable
law, their rights thereto. All other trademarks, trade names and service marks appearing in this annual report are the property of their
respective owners. We do not intend to use or display other companies&#8217; trademarks and trade names to imply any relationship with,
or endorsement or sponsorship of us by, any other companies.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><div><a id="a_002"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">This annual report contains forward-looking statements.
All statements other than statements of historical facts contained in this annual report, including statements regarding our strategy,
future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected
market growth are forward-looking statements. Forward-looking statements give our current expectations or forecasts of future events.
You can find many (but not all) of these statements by looking for words such as &#8220;approximates,&#8221; &#8220;believes,&#8221; &#8220;hopes,&#8221;
&#8220;expects,&#8221; &#8220;anticipates,&#8221; &#8220;estimates,&#8221; &#8220;projects,&#8221; &#8220;intends,&#8221; &#8220;plans,&#8221;
&#8220;would,&#8221; &#8220;should,&#8221; &#8220;could,&#8221; &#8220;may&#8221; or other similar expressions in this annual report.
These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from
our historical experience and our present expectations or projections, including, but not limited to, those identified under Item 3D.
<i>&#8220;Risk Factors</i>&#8221; in this annual report. Actual results may differ materially from those discussed as a result of various
factors, including, but not limited to:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our plans relating to commercializing our products and services (collectively &#8220;solutions&#8221;) and the rate and degree of market acceptance of our solutions;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the size of the market opportunity for our Confirm mdx and Select mdx tests and other future tests and solutions we commercialize or may develop;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our ability to achieve and maintain adequate levels of coverage or reimbursement for our current and future solutions we commercialize or may seek to commercialize;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our plans relating to the further development of solutions;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">existing regulations and regulatory developments in the United States, Europe and other jurisdictions;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">timing, progress and results of our research and development programs;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the period over which we estimate our existing cash will be sufficient to fund our future operating expenses and capital expenditure requirements;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our ability to attract and retain qualified employees and key personnel;</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the scope of protection we are able to establish and maintain for intellectual property rights covering our products solutions and technology;</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in">
    <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#9679;</p>
    <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p>
    <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#9679;</p></td>
    <td>
    <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">cost associated with defending intellectual property
    infringement, product liability and other claims;</p>
    <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p>
    <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">the possibility that the anticipated benefits
from our business acquisitions will not be realized in full or at all or may take longer to realize than expected;</p></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 24px">&#160;</td>
    <td style="width: 24px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the impact on our business, financial condition and results of operations from the ongoing and global COVID-19 pandemic, or any other pandemic, epidemic or outbreak of an infectious disease in the United States or worldwide; and</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">other risks and uncertainties, including those listed under Item 3D. <i>&#8220;Risk Factors</i>.&#8221;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">These statements reflect our views with respect
to future events as of the date of this annual report and are based on assumptions and subject to risks and uncertainties. Given these
uncertainties, you should not place undue reliance on these forward-looking statements. These forward-looking statements represent our
estimates and assumptions only as of the date of this annual report and, except as required by law, we undertake no obligation to update
or review publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of
this annual report. We anticipate that subsequent events and developments will cause our views to change. You should read this annual
report and the documents referenced in this annual report and filed as exhibits to the annual report, completely and with the understanding
that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these
cautionary statements.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>MARKET AND INDUSTRY DATA</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Unless otherwise indicated, information contained
in this annual report concerning our industry and the markets in which we operate, including our general expectations and market opportunity,
is based on information from our own management estimates and research, as well as from industry and general publications, research, surveys
and studies conducted by third parties. Management estimates are derived from publicly available information, our knowledge of our industry
and assumptions based on such information and knowledge, which we believe to be reasonable. Where information has been sourced from third
parties, this information has been accurately reproduced. As far as we are aware and are able to ascertain from information published
by those third parties, no facts have been omitted which would render the reproduced information inaccurate or misleading. The industry
publications and third-party&#160;studies generally state that the information that they contain has been obtained from sources believed
to be reliable, although they do not guarantee the accuracy or completeness of such information. Forecasts and other forward-looking&#160;information
obtained from these sources are subject to the same qualifications and uncertainties as the other forward-looking&#160;statements in this
annual report. See &#8220;<i>Special Note Regarding Forward-Looking&#160;Statements.</i>&#8221; These forecasts and forward-looking&#160;information
are subject to uncertainty and risk due to a variety of factors, including those described under &#8220;<i>Risk Factors.</i>&#8221; These
and other factors could cause results to differ materially from those expressed in our forecasts or estimates or those of independent
third parties.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><div><a id="a_003"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>PART I</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><div><a id="a_004"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT
AND ADVISERS</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Not applicable.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><div><a id="a_005"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE
</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Not applicable.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><div><a id="a_006"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>ITEM 3. KEY INFORMATION </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>A. [Reserved]</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>B. Capitalization and Indebtedness </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Not applicable.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>C. Reasons for the Offer and Use of Proceeds
</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Not applicable.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>D. Risk Factors</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our business and our industry are subject to
significant risks. You should carefully consider the risks and uncertainties described below, together with all of the other information
in this annual report, including our audited consolidated financial statements and related notes. This annual report also includes forward-looking
statements that involve risks and uncertainties. See &#8220;<i>Special Note Regarding Forward-Looking Statements</i>.&#8221; If any of
the following risks are realized, our business, financial condition, operating results and prospects could be materially and adversely
affected.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><span style="text-decoration:underline">Summary of Risk Factors</span></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We have a history of losses and expect to incur net losses in the future and may never achieve profitability.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We might require substantial additional funding to continue our operations and to respond to business needs or take advantage of new business opportunities, which may not be available on acceptable terms, or at all.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our commercial success will depend on the market acceptance and adoption of our current and future tests.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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    <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p>
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    <td>
    <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If the FDA were to begin requiring approval
or clearance of our tests, we could incur substantial costs and time delays associated with meeting requirements for premarket clearance
or approval. The dual listing of our ordinary shares and ADSs following the U.S. offering may adversely affect the liquidity and value
of the ADSs.&#160;</p>
    <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We may engage in acquisitions that are not
    successful and which could disrupt our business, cause dilution to our stockholders and reduce our financial resources.</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><span style="text-decoration:underline">Risks Related to Our Business and Industry</span></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>We have a history of losses and expect to
incur net losses in the future and may never achieve profitability.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We have incurred substantial net losses since
our inception, and there can be no assurance that we will achieve profitability. As of December 31, 2022, we had an accumulated deficit
of $288.3 million and for the year ended December&#160;31, 2022, we had a net loss of $44.0 million and net cash used in operating activities
of $34.1 million. We expect our losses to continue as a result of costs relating to ongoing research and development and for increased
sales and marketing costs for existing and planned solutions. These losses have had, and will continue to have, an adverse effect on our
working capital, total assets, and stockholders&#8217; equity. Even if we achieve significant revenues, we may not become profitable,
and even if we achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Failure
to become and remain consistently profitable could adversely affect the market price of our common stock and could significantly impair
our ability to raise capital or expand our business in accordance with our growth strategy. Historically, we have been able to raise capital
at regular occasions. If we are unable to continue to do this, our ability to operate as a going concern could be seriously compromised.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>We may require substantial additional funding
to continue our operations and to respond to business needs (including repayment of our outstanding debt) or take advantage of new business
opportunities, which may not be available on acceptable terms, or at all.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our capital outlays and operating expenditures
are expected to increase over the next several years as commercial operations expand. We may require additional equity or debt funding
from time to time in case of a shortfall in cash inflows from operations or to respond to business needs (including repayment of our outstanding
debt) or take advantage of new business opportunities, which may not be available at acceptable terms, or at all. For more information
about our cash and cash equivalent position or total liquidity position, see also Item 5B. &#8220;<i>Liquidity and Capital Resources</i>.&#8221;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Additionally, under the terms of the Asset Purchase
Agreement in relation to the acquisition of the Oncotype DX GPS prostate cancer business of Exact Sciences Corporation (&#8220;Exact Sciences&#8221;),
following the closing, an additional aggregate earn-out amount of up to $70 million is to be paid by us to Exact Sciences over the course
of 2024, 2025 and 2026, in an amount equal to a portion of the prior calendar year&#8217;s reported revenues attributable to the Oncotype
DX GPS prostate cancer business, with the maximum earn-out payable in 2024 and 2025 not to exceed $30 million and $40 million, respectively.
At the our option, the earn-out amounts can be settled in cash or through the issuance of additional ADSs (valued in function of a volume
weighted average trading price of our shares at the end of the relevant earn-out period) to Exact Sciences, provided that the aggregate
number of shares representing the ADSs held by Exact Sciences will not exceed more than 5% of our outstanding shares.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If additional funds are raised through the sale
of equity, convertible debt or other equity-linked&#160;securities, our securityholders&#8217; ownership will be diluted. Any equity securities
issued also may provide for rights, preferences or privileges senior to those of holders of ordinary shares. If additional funds are raised
by issuing debt securities, these debt securities would have rights, preferences and privileges senior to those of shareholders, and the
terms of the debt securities issued could impose significant restrictions on our operations.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If adequate funds are not available, we may have
to scale back our operations or limit our research and development activities, which may cause us to grow at a slower pace, or not at
all, and our business could be adversely affected.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Our loan facility contains restrictions
that limit our flexibility in operating our business, and if we fail to comply with the covenants and other obligations under our loan
agreement, the lenders may be able to accelerate amounts owed under the facility and may foreclose upon the assets securing our obligations.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In August&#160;2022, we entered into a $35&#160;million
loan and security agreement with an affiliate of Innovatus Capital Partners, LLC (&#8220;Innovatus&#8221;). Under this agreement, at the
option of the Company, an additional $35&#160;million can be drawn from Innovatus, consisting of a $20&#160;million term B loan and a
$15&#160;million term C loan, which can be drawn in 2024 and 2025 respectively, subject to certain conditions. There can be no assurance
that these conditions will be satisfied and that we will be able to draw any further term loan amounts under this facility.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The loans accrue interest at a floating per annum
rate equal to the sum of (a) the greater of (i) the prime rate published in The Wall Street Journal in the &#8220;Money Rates&#8221; section
or (ii) 4.00%, plus (b) 4.25%, and require interest-only payments for the initial four years. At our election, a portion of the interest
may be payable in-kind by adding an amount equal to 2.25% of the outstanding principal amount to the then outstanding principal balance
on a monthly basis until August 2025. The loans mature in August 2027. The lenders have the right to convert, prior to August 2025, up
to 15% of the outstanding principal amount of the loans into ADSs of the Company at a price per ADS of $11.21.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The loans are secured by substantially all assets
of the Company, including intellectual property related to our Confirm mdx, Select mdx and Genomic Prostate Score (&#8220;GPS&#8221;)
tests. The loan agreement also subjects us to certain affirmative and negative covenants, including limitations on our ability to transfer
or dispose of assets, merge with or acquire other companies, make investments, pay dividends, incur additional indebtedness and liens
and conduct transactions with affiliates. As a result of these covenants, we have certain limitations on the manner in which we can conduct
our business, and we may be restricted from engaging in favorable business activities or financing future operations or capital needs
until our current debt obligations are paid in full or we obtain the consent of Innovatus, which we may not be able to obtain. We cannot
be certain that we will be able to generate sufficient cash flow or revenue to meet the financial covenants or pay the principal and accrued
interest on the debt.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In addition, upon the occurrence of an event of
default or a mandatory prepayment event, Innovatus, among other things, can declare all indebtedness due and payable immediately, which
would adversely impact liquidity and reduce the availability of cash flows to fund working capital needs, capital expenditures and other
general corporate purposes. An event of default or a mandatory prepayment event includes, but is not limited to, our failure to pay any
amount due and payable under the loan agreement, the breach of any representation or warranty in the loan agreement, the breach of any
covenant in the loan agreement (subject to a cure period in some cases), a change of control as defined in the loan agreement, certain
defaults on loan agreements with third parties and insolvency events and proceedings. If an event of default or a mandatory prepayment
event occurs and we are unable to repay amounts due under the loan agreement, Innovatus could foreclose on substantially all of our assets,
including intellectual property. We cannot be certain that future working capital, borrowings or equity financings will be available to
repay or refinance our debt to Innovatus or any other debt we may incur in the future.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Furthermore, we must meet certain covenants in
order to draw down an additional $20 million term B loan and a $15 million term C loan that remain available under the $70 million Innovatus
facility in 2024 and 2025, respectively. The availability of the $20 million term B loan and a $15 million term C loans are intended to
coincide with the anticipated contingent earn-out payment obligations due under the terms of the Asset Purchase Agreement in relation
to the acquisition of the Oncotype DX GPS prostate cancer business of Exact Sciences. If we do not have sufficient working capital to
fund our earn-out payment obligations to Exact Sciences if and when they become due, and we are also unable to meet loan covenants necessary
to draw down one or more of the additional Innovatus term loans, we may be unable to satisfy our contractual obligations to Exact Sciences,
resulting in a material breach under the Asset Purchase Agreement with Exact Sciences as well as an event of default under the loan agreement
with Innovatus, and our business could be adversely affected.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Our acceptance of a Paycheck Protection
Program loan subjects us to a variety of federal regulations and although we may apply for forgiveness of this loan it may not be forgiven.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In April 2020, we qualified for a $2.3&#160;million
loan through the Paycheck Protection Program (the &#8220;PPP&#8221;) of the U.S. Coronavirus Aid, Relief and Economic Security Act (the
&#8220;CARES Act&#8221;), under a loan agreement administered by the U.S. Small Business Administration. By participating in a federal
loan program, we become subject to increased governmental oversight and federal regulatory compliance obligations, including potential
civil and criminal liability for making false claims or statements under the U.S. False Claims Act, 31 USC. &#167; 3729 et seq. (the &#8220;FCA&#8221;).
Liability under the FCA and similar federal statutes can carry significant potential monetary penalties and potential jail time, and can
arise from both &#8220;knowing&#8221; and &#8220;willful&#8221; misstatements. FCA violations will result in a civil penalty per false
claim, of not less than $11,181 and not more than $22,363, plus treble the government&#8217;s actual damages. A person who violates &#167;
3729 will also be held liable for the government&#8217;s costs for bringing a civil action to recover any penalty or damages. If, despite
our good faith belief that we satisfied all eligibility requirements for the PPP loan, we are found to have been ineligible to receive
the PPP loan or in violation of any of the laws or regulations that apply to us in connection with the PPP loan, we may be subject to
penalties, including under the FCA, and could be required to repay the PPP loan. Additionally, a review or audit by the U.S. Small Business
Administration (&#8220;SBA&#8221;) or other government entity in connection with any future forgiveness application (if we chose to apply
for forgiveness) or claims under the False Claims Act could consume significant financial and management resources. Any of these events
could harm our business, results of operations and financial condition.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>We may engage in acquisitions that are not
successful and which could disrupt our business, cause dilution to our stockholders and reduce our financial resources.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In addition to our acquisition of NovioGendix,
a privately held company based in Nijmegen, The Netherlands, in September 2015 and our acquisition of our GPS test from Genomic Health,
Inc., a subsidiary of Exact Sciences, in August 2022, we may enter into other transactions in the future to acquire other businesses,
products or technologies. We may be unable to realize the anticipated benefits of the acquisitions or do so within the anticipated timeframe.
Any acquisitions may not strengthen our competitive position, and these transactions may be viewed negatively by customers or investors.
We could incur losses resulting from undiscovered liabilities of the acquired business that are not covered by the indemnification we
may obtain from the seller. In addition, we may not be able to successfully integrate the acquired personnel, technologies and operations
into our existing business in an effective, timely and non-disruptive&#160;manner. If we are unable to do so, the disruption to our operations
could result in additional costs or could distract management&#8217;s attention from other initiatives.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>The molecular diagnostics industry is highly
competitive and characterized by rapid technological changes and we may be unable to keep pace with our competitors.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The molecular diagnostics field is characterized
by rapid technological changes, frequent new product introductions, changing customer preferences, emerging competition, evolving industry
and regulatory compliance standards, reimbursement uncertainty and price competition. Moreover, the molecular diagnostics field is intensely
competitive both in terms of service and price, and continues to undergo significant consolidation, permitting larger clinical laboratory
service providers to increase cost efficiencies and service levels, resulting in more intense competition.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The market for assessing men at risk for prostate
cancer diagnosis or aggressiveness is large. As a result, this market has attracted competitors, some of which possess substantially greater
financial, selling, logistical and laboratory resources, more experience in dealing with third-party&#160;payors, and greater market penetration,
purchasing power and marketing budgets, as well as more experience in providing diagnostic services. Some companies and institutions are
developing serum-based&#160;tests and diagnostic tests based on the detection of proteins, nucleic acids or the presence of fragments
of mutated genes in the blood that are associated with prostate cancer. These competitors could have technological, financial, reputational,
and market access advantages over us.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Regarding our Confirm mdx for Prostate Cancer
tissue-based&#160;test, several directly competitive products are currently commercially available. In 2014, OPKO Health, Inc., a NYSE
listed company, launched the 4Kscore test, a blood based 4-plex&#160;test which combines the results of the blood test with clinical information
in an algorithm that calculates a patient&#8217;s percent risk for aggressive prostate cancer prior to a biopsy. OPKO is the third largest
clinical laboratory in the United States, with a significantly larger sales and marketing team than we have. The 4Kscore test obtained
FDA marketing approval in December 2021. Offered at a lower price point, the 4Kscore test offers a competitive price advantage over the
Confirm mdx test. The PCA-3&#160;test from Hologic, a urine-based&#160;test, is on the U.S. market as an FDA approved test, which may
be perceived as providing a competitive advantage since the Confirm mdx for Prostate Cancer test is not FDA approved. The PCA-3&#160;test
is intended for the same patient population as Confirm mdx for Prostate Cancer, but our performance has only been established in men who
were already recommended by urologists for repeat biopsy.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Regarding our Select mdx for Prostate Cancer tissue-based&#160;test,
several directly competitive products are currently commercially available. In 2016, ExosomeDx launched the ExoDx (Intelliscore), a urine-based&#160;test
designed to assess whether a patient presenting for an initial biopsy is at greater risk for high-grade&#160;prostate cancer. The ExoDx
test competes directly with Select mdx. In 2018, Bio-Techne&#160;Corporation, a large U.S.-based, diversified life sciences company, acquired
the ExoDx test. Bio-Techne&#160;has greater resources and a significantly larger sales and marketing team than we have. For instance,
based on recent Securities and Exchange Commission (&#8220;SEC&#8221;) filings, Bio-Techne has total assets in excess of $1 billion and a market capitalization exceeding $10 billion. In
addition, the ExoDx test may also provide a competitive advantage since, unlike the Select mdx test, it does not require a prostate massage
as part of its specimen collection procedures. In addition to ExoDx, the 4Kscore test offered by OPKO and the Prostate Health Index test,
or the &#8220;phi score&#8221;, offered by Beckman Coulter, both compete directly with the Select mdx test.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Regarding our GPS tissue-based test, acquired
in August 2022 from Exact Sciences, several directly competitive products are currently commercially available. Myriad Genetics offers
the Prolaris test, a tissue-based genetic test to help identify those men who need treatment versus those who can choose active surveillance.
Additionally, Veracyte offers the Decipher test, a tissue-based genetic test to help identify those men who need treatment versus those
who can choose active surveillance. In addition to directly competitive genomic tests, traditional methods used by pathologists and clinicians
to estimate risk for disease progression also pose competitive threats. Companies combining these traditional methods with artificial
intelligence could potentially emerge as competitors, though most of these technologies are currently in the research stage.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Each of OPKO, Myriad Genetics, and Beckman Coulter
have greater resources and a significantly larger sales and marketing team than we do. Beckman Coulter is owned by Danaher Corporation,
which had total assets in excess of $50 billion based on recent SEC filings and a market capitalization in excess of $150 billion. Myriad
Genetics had total assets in excess of $1 billion based on recent SEC filings and a market capitalization in excess of $1.5 billion. As
a result of these significantly greater resources, these competitors are able to make larger investments into the tests they produce and
the sales and marketing of these tests, which may cause us to lose market share. In addition to competitive products, the Confirm mdx,
Select mdx and GPS tests also face competition from multiparametric MRI (&#8220;mpMRI&#8221;), a clinical diagnostic imaging procedure
available to and used by physicians for many years, which focuses on visual tissue analysis. The mpMRI procedure can visually reveal potential
locations of abnormal and potentially cancerous prostate tissue characteristics that distinguish tumors from healthy tissue. The visual
aspect of diagnostic imaging may feel more accessible and be considered preferable by some physicians over molecular analysis, and there
likely is an economic incentive for some physicians to earn a professional fee from the performance of mpMRI procedures. It may be difficult
to change the methods or behavior of physicians to incorporate our testing solutions into their practices in conjunction with, or instead
of, mpMRI clinical diagnostic imaging procedures. In addition, companies developing or offering capital equipment or point-of-care&#160;kits
to physicians represent another source of potential competition. These devices are used directly by the physicians or their institutions,
which can facilitate adoption.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If we are unable to compete effectively with the
abovementioned competitors and with new technologies and procedures such as mpMRI, we may lose market share, which could in turn adversely
affect our revenues.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Our commercial success will depend on the
market acceptance and adoption of our current and future tests.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Healthcare providers typically take a long time
to adopt new products, testing practices and clinical treatments, partly because of perceived liability risks and the uncertainty of third-party&#160;coverage
and reimbursement. It is critical to the success of our sales efforts that we educate enough patients, clinicians and administrators about
molecular diagnostics testing, in general, as well as about our solutions, and demonstrate their clinical benefits. It is likely that
clinicians may not adopt, and third-party&#160;payors may not cover or adequately reimburse for, our tests unless they determine, based
on published peer-reviewed&#160;journal articles and the experience of other clinicians, that they provide accurate, reliable and cost-effective&#160;information.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">As the healthcare reimbursement system in the
United States evolves to place greater emphasis on comparative effectiveness and outcomes data, we cannot predict whether we will have
sufficient data, or whether the data we have will be presented to the satisfaction of any payors seeking such data, in the process of
determining and maintaining coverage for our diagnostic tests. The administration of clinical and economic utility studies is expensive
and demands significant attention from the management team. Our largest ongoing study, a multicenter U.S. observational study of Confirm
mdx and Select mdx entitled a Prospective Validation of Prostate Biomarkers for Repeat Biopsy (&#8220;PRIORITY&#8221;), has encountered
delays in enrollment and completion as a result of the COVID-19&#160;pandemic. Additionally, we have several smaller post-marketing&#160;clinical
studies ongoing or planned that are primarily intended to support expanded indications for our Confirm mdx, Select mdx and GPS tests.
There can be no assurance that the PRIORITY study or our other clinical studies will be successfully initiated, enrolled or completed.
Also, data collected from these studies may not be positive or consistent with our existing data or may not be statistically significant
or compelling to the medical community. If the results obtained from ongoing or future studies are inconsistent with certain results obtained
from previous studies, adoption of diagnostic services would suffer, and our business would be harmed.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If our tests or the technology underlying our
current or future tests do not receive sufficient favorable exposure in peer-reviewed&#160;publications, the rate of clinician adoption
of our tests and positive reimbursement coverage decisions for our tests could be negatively affected. See &#8220;<i>Risk Factors &#8212;
We face uncertainties over the reimbursement of our tests by third party payors</i>.&#8221; The publication of clinical data in peer-reviewed&#160;journals
is a crucial step in commercializing and obtaining reimbursement for diagnostic tests, and our inability to control when, if ever, our
results are published may delay or limit our ability to derive sufficient revenue from any product that is the subject of a study.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Our financial results are largely dependent
on sales of one test, and we will need to generate sufficient revenues from this and other future solutions to grow our business.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Currently, we rely significantly on the sale of
Confirm mdx tests in the United States for our revenues, with these tests accounting for approximately 59%, 91% and 94% of total revenues
in 2022, 2021 and 2020, respectively. We have materially diversified our revenue through the acquisition of the GPS test, with further
revenue diversification attributable to the launch of an additional precision diagnostic test offering and clinical guideline inclusion
for Select mdx, which facilitates reimbursement. However, sales of Confirm mdx are expected to continue to account for a substantial portion
of total revenues for at least the next several years. If reimbursement for our tests were to be revoked or limited either by CMS or commercial
payors, this could have an immediate impact on our revenues. While we do not believe that revocation of Medicare reimbursement for Confirm
mdx or GPS tests is likely, if this were to occur, the impact could be severe.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"> The commercial success of solutions and our
ability to generate sales will depend on several factors, including:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">acceptance by the medical community;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the number of patients undergoing a prostate biopsy procedure;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">acceptance, endorsement and formal policy approval of favorable reimbursement for the test by Medicare and other third-party&#160;payors;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our ability to successfully market the tests;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the amount and nature of competition from other prostate cancer products and procedures; and</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our ability to establish and maintain commercial distribution, sales force and laboratory testing capabilities.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If we are unable to increase sales and reimbursement
of our current solutions or successfully develop and commercialize other solutions or enhancements, our revenues and our ability to achieve
profitability would be impaired, and the market price of our shares could decline.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>We face uncertainties concerning the coverage
and reimbursement of our solutions by third-party payors.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Successful commercialization of our solutions
depends, in large part, on the availability of coverage and adequate reimbursement from government and private payors. Favorable third-party&#160;payor
coverage and reimbursement are essential to meeting our immediate objectives and long-term&#160;commercial goals. In the United States,
for new diagnostic solutions, each private and government payor decides whether to cover the test, the amount it will reimburse clinical
laboratories or other providers for a covered test, and any specific conditions for coverage and reimbursement. Healthcare providers may
be unlikely to order a specific diagnostic test unless an applicable third-party&#160;payor offers meaningful reimbursement for the test.
Therefore,&#160;adequate coverage and reimbursement is critical to the commercial success of a diagnostic product, and if we are unable
to secure and maintain favorable coverage determinations and reimbursement, this will undermine our ability to earn revenue from our products.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>Medicare</i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Reimbursement for diagnostic tests furnished to
Medicare beneficiaries (typically patients aged 65 or older) is usually based on a fee schedule set by the U.S. Centers for Medicare &amp;
Medicaid Services (&#8220;CMS&#8221;), a division of the U.S. Department of Health and Human Services (&#8220;HHS&#8221;). As a Medicare-enrolled
provider with our primary&#160;laboratory based in California, we bill Noridian Healthcare Solutions (&#8220;Noridian&#8221;), the Medicare
Administrative Contractor (&#8220;MAC&#8221;), for California, and our Select mdx, Confirm mdx, and GPS tests are subject to Noridian&#8217;s
local coverage and reimbursement policies. Noridian participates in the Molecular Diagnostic Services Program (&#8220;MolDX&#8221;), administered
by Palmetto GBA, which handles technical assessments for U.S. laboratories that perform molecular diagnostic testing. The Confirm mdx
test obtained a positive Medicare local coverage determination (&#8220;LCD&#8221;) under the MolDX program in 2014, the GPS test obtained
a positive Medicare coverage LCD in 2015, and the Select mdx test obtained a positive Medicare coverage LCD in April 2023, each of which
provides coverage for Medicare patients throughout the United States.</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Medicare accounted for approximately 43% of MDxHealth&#8217;s
revenues in 2022, compared to 38% in 2021. See Note 4 in the Notes to Consolidated Financial Statements included in Part III for further
detail.&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>&#160;</i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>Commercial payors</i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Obtaining coverage and reimbursement by commercial
payors is a time-consuming&#160;and costly process, without a guaranteed outcome, since each commercial payor makes its own decision with
respect to whether to cover a particular test and, if so, at what rate to reimburse providers for that test. In addition, several payors
and other entities conduct technology assessments of new medical tests and devices and provide the results of these assessments for informational
purposes to other parties. These assessments may be used by third-party&#160;payors and healthcare providers as grounds to deny coverage
for a particular test, or to refuse to use or order a particular test or procedure. Our tests have received initial negative technology
assessments from several of these entities and are likely to receive more negative technology assessments. We continue to work with third-party&#160;payors
to obtain coverage and reimbursement&#160;for our tests and to appeal coverage denial decisions based on existing and ongoing studies,
peer reviewed publications, and support from physician and patient groups. There are no assurances that commercial payors will continue
to issue positive coverage and reimbursement policies and/or contracts and, if issued, that such policies and/or contracts will be maintained
in the future. If our tests are considered on a policy-wide&#160;level by major third-party&#160;payors, whether at our request or on
the payor&#8217;s own initiative, and the payor determines that such tests are ineligible for coverage and reimbursement, our revenue
potential could be adversely impacted.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>Outside the United States</i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Outside of the United States, various coverage,
pricing and reimbursement approvals are required, including through coverage determinations made at the national level under public benefit
programs. We expect that it will take several years to establish broad coverage and reimbursement for our tests with payors in countries
outside of the United States where we commercialize our solutions, and our efforts may not be successful. Even if public or private reimbursement
is obtained, it may cover competing tests, the reimbursement may be conditioned upon local performance of the tests or other requirements
we may encounter difficulties in satisfying. Reimbursement levels outside of the United States may vary considerably from the reimbursement
amounts we receive in the United States.&#160;In addition, because we plan in many circumstances to rely on distributors to obtain reimbursement
for our tests, to the extent the distributor does not have direct reimbursement arrangements with payors, we may not be able to retain
reimbursement coverage in certain countries with a particular payor; further, if our agreement with a particular distributor is terminated
or expires or a distributor fails to pay for other reasons, we could lose reimbursement coverage in that jurisdiction.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; "><b><i>Our business is affected by macroeconomic
conditions.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; ">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; ">Various macroeconomic
factors could adversely affect our business and the results of our operations and financial condition, including changes in inflation,
interest rates, and foreign currency exchange rates and overall economic conditions and uncertainties, including those resulting from
the current and future conditions in the global financial markets. For instance, we experienced inflationary pressures in 2022 and expect
such pressures to continue in 2023. Cost inflation, including increases in raw material prices, labor rates, and transportation costs
may impact our profitability. Our ability to recover these cost increases through price increases is significantly limited by the process
by which we are reimbursed for our products and services by government and private payors. The volatility of the capital markets could
also affect the value of our investments and our ability to liquidate our investments in order to fund our operations.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; ">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; ">Increasing interest rates
and reduced access to capital markets could also adversely affect the ability of our suppliers, distributors, licensors, collaborators,
contract manufacturers and other commercial partners to remain effective business partners or to remain in business. The loss of a critical
business partner, or a failure to perform by a critical business partner, could have a disruptive effect on our business and could adversely
affect our results of operations.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>&#160;</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>The ongoing outbreak of COVID-19, or any
future pandemic, could impact our sales volumes, and our business may experience other adverse effects as a result of COVID-19 or future
pandemics.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; ">The broad and extensive
impact of the COVID-19 pandemic on virtually all aspects of our business and society exacerbated many pre-existing risks to our business
by making them more likely to occur or more impactful when they do occur. Accordingly, you should consider the risks described in this
risk factor in addition to, and not in lieu of, the risks described elsewhere throughout these risk factors.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; ">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; ">The level and nature
of the disruption caused by COVID-19, or any future pandemic, is unpredictable, may be cyclical and long-lasting and may vary from location
to location. To the extent COVID-19 conditions improve, the duration and sustainability of any such improvements will be uncertain and
continuing adverse impacts and/or the degree of improvement may vary dramatically by geography and by product. The actions we take in
response to any improvements in conditions, such as our return-to-office plans, may also vary widely by geography and by business and
will likely be made with incomplete information; pose the risk that such actions may prove to be premature, incorrect or insufficient
and could have a material, adverse impact on our business and results of operations.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; ">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; ">Despite our efforts,
the ultimate impact of COVID-19, or any future pandemic, depends on factors beyond our knowledge or control, including the duration and
severity of the outbreak, third-party actions taken to contain its spread and mitigate its public health effects, and short- and long-term
changes in the behaviors of medical professionals and patients resulting from the pandemic.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; "><b><i>&#160;</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; "><b><i>The ongoing military
action by Russia in Ukraine could have negative impact on the global economy, which could materially adversely affect our business, operations,
operating results and financial condition.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; ">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; ">On February 24, 2022,
Russian forces launched significant military action against Ukraine, and sustained conflict and disruption in the region is possible.
The impact to Ukraine as well as actions taken by other countries, including new and stricter sanctions imposed by Canada, the United
Kingdom, the European Union, the United States, and other countries and companies and organizations against officials, individuals, regions,
and industries in Russia and Ukraine, and actions taken by Russia in response to such sanctions, and each country&#8217;s potential response
to such sanctions, tensions, and military actions could adversely affect the global economy and financial markets and thus could affect
our business, operations, operating results and financial condition as well as the price of our common stock and our ability to raise
additional capital when needed on acceptable terms. The extent and duration of the military action, sanctions and resulting market disruptions
are impossible to predict, but could be substantial. Any such disruptions caused by Russian military action or resulting sanctions may
magnify the impact of other risks described in this annual report on Form 20-F.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>&#160;</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>&#160;</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><span style="text-decoration:underline">Risks Related to Our Intellectual Property</span></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>If we are unable to retain intellectual
property protection in relation to our solutions or if we are required to expend significant resources to protect our intellectual property
position, our competitive position could be undercut. </i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our ability to protect our discoveries, know-how&#160;and
technologies affects our ability to compete and to achieve profitability. We rely on a combination of U.S. and foreign patents and patent
applications, copyrights, trademarks and trademark applications, confidentiality or non-disclosure&#160;agreements, material transfer
agreements, licenses and consulting agreements to protect our intellectual property rights. We also maintain certain company know-how,
algorithms, and technological innovations designed to provide us with a competitive advantage in the marketplace as trade secrets. As
of December&#160;31, 2022, we owned or had exclusive rights to more than 17 patent families related to our molecular technology and cancer-specific&#160;biomarkers.
Specifically, there are 116 granted or pending patent applications in this group comprised of 16&#160;issued or allowed U.S. patents,
7 pending U.S. provisional or non-provisional&#160;applications, 19&#160;pending international patent applications filed under the Patent
Cooperation Treaty (&#8220;PCT&#8221;) and 74 granted or allowed patents in jurisdictions outside the United States, including Japan,
Canada, Israel and the major European countries. Our issued U.S. patents expire at various times between 2024 and 2038. Of these issued
patents, 1 covers intellectual property used in our Confirm mdx test, which expires in 2024, 7 cover intellectual property used in our
Select mdx test, the last of which expires in 2036, and 52 cover intellectual property used in our GPS test, the last of which expires
in 2038. When these patents expire other companies will no longer be prohibited from incorporating the subject intellectual property into
competing tests they may seek to develop.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">While we intend to pursue additional and future
patent applications, it is possible that pending patent applications and any future applications may not result in issued patents. Even
if patents are issued, third parties may independently develop similar or competing technology that avoids our patents. Third&#160;parties
may also assert infringement or other intellectual property claims against us or against our licensors, licensees, suppliers or strategic
partners. Any actions regarding patents could be costly and time-consuming&#160;and could divert the attention of management and key personnel
from other areas of our business. Further, we cannot be certain that the steps we have taken will prevent the misappropriation of our
trade secrets and other confidential information as well as the misuse of our patents and other intellectual property, particularly in
foreign countries with no patent protection.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Although we have licensed and own issued patents
in the United States and foreign countries, we cannot be certain the claims will continue to be considered patentable by the U.S. Patent
and Trademark Office (the &#8220;USPTO&#8221;), U.S. courts patent offices and courts in other jurisdictions. The U.S. Supreme Court,
other federal courts and/or the USPTO, may change the standards of patentability and any such changes could have a negative impact on
our business. For instance, the Federal Circuit has recently ruled on several patent cases, such as&#160;<i>Univ. of Utah Research Found.
v. Ambry Genetics Corp.</i>,&#160;774 F.3d 755 (Fed. Cir. 2014)<i>, Ariosa Diagnostics, Inc. v. Sequenom, Inc.</i>,&#160;788 F.3d 1371
(Fed. Cir. 2015)<i>, Genetic Tech. Ltd. v. Merial LLC, </i>818 F.3d 1369 (Fed. Cir. 2016), and&#160;<i>Cleveland Clinic Found. v. True
Health Diagnostics, </i>859 F.3d 1352 (Fed. Cir. 2017), that some diagnostic method claims are not patent eligible. These decisions have
narrowed the scope of patent protection available in certain circumstances or weakened the rights of patent owners in certain situations.
Some aspects of our technology involve processes that may be subject to this evolving standard and we cannot guarantee that any of our
issued or pending process claims will be patentable as a result of such evolving standards. In addition, this combination of decisions
has created uncertainty as to the value of certain issued patents, in particular in the detection of prostate cancer and other cancers.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>We may be subject to substantial costs and
liabilities, or be prevented from using technologies incorporated in our solutions, as a result of litigation or other proceedings relating
to patent rights.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Third parties may assert infringement or other
intellectual property claims against us or our licensors, licensees, suppliers or strategic partners. We pursue a patent strategy that
we believe provides us with a competitive advantage in the assessment of prostate cancer and is designed to maximize patent protection
against third parties in the United States and, potentially, in certain foreign countries. In order to protect or enforce our patent rights,
we may have to initiate actions against third parties. Any actions regarding patents could be costly and time-consuming&#160;and could
divert the attention of management and key personnel from other areas of our business. Additionally, such actions could result in challenges
to the validity or applicability of our patents. Because the USPTO maintains patent applications in secrecy until a patent application
is published or the patent is issued, we have no way of knowing if others may have filed patent applications covering technologies used
by us or our partners. Additionally, there may be third-party&#160;patents, patent applications and other intellectual property relevant
our technologies that may block or compete with our technologies. Even if third-party&#160;claims are without merit, defending a lawsuit
may result in substantial expense to us and may divert the attention of management and key personnel. In addition, we cannot provide assurance
that we would prevail in any such suits or that the damages or other remedies, if any, awarded against us would not be substantial. Claims
of intellectual property infringement may require us, or our strategic partners, to enter into royalty or license agreements with third
parties that may not be available on acceptable terms, if at all. These claims may also result in injunctions which could prevent us from
further developing and commercializing services or products containing our technologies, which could in turn adversely affect our ability
to earn revenues from these services or products.&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Also, patents and patent applications owned by
us may become the subject of post grant challenges or interference proceedings in the USPTO to determine validity and the priority of
invention, which could result in substantial cost as well as a possible adverse decision as to the validity or priority of invention of
the patent or patent application involved. An adverse decision in an interference proceeding may result in the loss of rights under a
patent or patent application subject to such a proceeding.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Ultimately, the potential weakening of our intellectual
property position as a result of the evolution of case law or otherwise may make us more vulnerable to competition. While we are unable
to quantify the impact of this risk given that our patents remain untested in the courts, the impact could be severe if our competitors
are able to take advantage of any weakening of our intellectual property position.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>We rely on strategic collaborative and license
arrangements with third parties to develop critical intellectual property. We may not be able to successfully establish and maintain such
intellectual property.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The development and commercialization of our products
and services rely, directly or indirectly, upon strategic collaborations and license agreements with third parties. We have a license
agreement with an academic institution pursuant to which we have incorporated licensed technology into our Confirm mdx test and may incorporate
licensed technology into our pipeline products. Our dependence on license, collaboration and other similar agreements with third parties
may subject us to a number of risks. There can be no assurance that any current contractual arrangements between us and third parties
or between our strategic partners and other third parties will be continued on materially similar terms and will not be breached or terminated
early. Any failure to obtain or retain the rights to necessary technologies on acceptable commercial terms could require us to re-configure&#160;our
products and services, which could negatively impact their commercial sale or increase the associated costs, either of which could materially
harm our business and adversely affect our future revenues and ability to achieve sustained profitability.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We expect to continue and expand our reliance
on collaboration and license arrangements. Establishing new strategic collaborations and license arrangements is difficult and time-consuming.
Discussions with potential collaborators or licensors may not lead to the establishment of collaborations on favorable terms, if at all.
To the extent we agree to work exclusively with one collaborator in a given area, our opportunities to collaborate with other entities
could be limited. Potential collaborators or licensors may reject collaborations with us based upon their assessment of our financial,
regulatory or intellectual property position or other factors. Even if we successfully establish new collaborations, these relationships
may never result in the successful commercialization of any product or service. In addition, the success of the projects that require
collaboration with third parties will be dependent on the continued success of such collaborators. There is no guarantee that our collaborators
will continue to be successful and, as a result, we may expend considerable time and resources developing products or services that will
not ultimately be commercialized.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><span style="text-decoration:underline">Risks Related to Our Operations</span></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Billing and collections processing for our
tests is complex and time-consuming, and any delay in transmitting and collecting for claims could adversely impact revenue.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our tests are billed on a fee-for-service&#160;basis
and&#160;paid, for example by hospitals and direct payments from individual patients, and may be reimbursed by third-party&#160;payors,
including Medicare and other governmental payor programs, private insurance plans and managed care organizations. Billing for molecular
diagnostics testing services is complex, time-consuming, and expensive. We are often obligated to bill services in the specific manner
required by each particular third-party&#160;payor. Failure to comply with these complex billing requirements (including complex federal
and state regulations related to billing government health care programs, <i>e.g.</i>, Medicare and Medicaid)&#160;may significantly hinder
our collection and retention efforts, including not only potential write-offs&#160;of doubtful accounts and long collection cycles for
accounts receivable, but also the potential disgorgement of previously paid claims based on third-party&#160;payor program integrity investigations
into billing discrepancies, fraud, waste and abuse. With CMS&#8217;s recent implementation of a comprehensive oversight regime that consolidated
program integrity powers into a single Unified Program Integrity Contractor (&#8220;UPIC&#8221;), audit and investigatory activity into
billing fraud, waste and abuse in the industry has in recent years significantly increased. Responding to requests from a UPIC, or other
auditor, is often time-consuming&#160;and requires dedication of internal, and sometimes external, resources. UPICs also have the authority
to implement Medicare payment suspensions during the pendency of an audit, which could significantly impact cash flows, even where no
improper billing is ultimately found to have occurred. Commercial payors may also engage in audit activity, requiring timely production
of medical documentation in support of billed claims.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Among the potential factors that can complicate
third-party&#160;payor billing are:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">differences between the list price for our tests and the reimbursement rates of payors;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">compliance with complex federal and state regulations related to billing government health care programs, (<i>e.g.,</i>&#160;Medicare and Medicaid);</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">disputes among payors as to which party is responsible for payment;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">differences in coverage among payors and the effect of patient co-payments&#160;or co-insurance;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">differences in information and billing requirements among payors;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">incorrect or missing billing information; and</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the resources required to manage the billing and claims appeals process.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>We face an inherent risk of product liability
claims.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The marketing, sale and use of our tests could
lead to product or professional liability claims against us if someone were to allege that our tests failed to perform as they were designed,
or if someone were to misinterpret test results or improperly rely on them for clinical decisions. Although we maintain product and professional
liability insurance which is deemed to be appropriate and adequate, it may not fully protect us from the financial impact of defending
against product liability or professional liability claims or any judgments, fines or settlement costs arising out of any such claims.
Furthermore, any product liability lawsuit, with or without merit, could increase our insurance rates or prevent us from securing insurance
coverage in the future. Additionally, any product liability lawsuit could harm our reputation, which could impact our results of operations,
or cause collaboration partners to terminate existing agreements and potential partners to seek alternate partners, any of which could
negatively impact our results of operations.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Failure to attract or retain key personnel
or to secure the support of key scientific collaborators could materially adversely impact our business.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our success in implementing our business strategy
depends largely on the skills, experience, and performance of key members of our executive management team and others in key management
positions, including Michael McGarrity, our Chief Executive Officer. The collective efforts of our executive management team are critical
to us as we continue to develop our technologies, tests, and R&amp;D and sales programs. As a result of the difficulty in locating qualified
new management, the loss or incapacity of existing members of our executive management team could adversely affect our operations. If
we were to lose one or more of these key employees, we could experience difficulties in finding qualified successors, competing effectively,
developing our technologies and implementing our business strategy. Our executives have employment agreements; however, the existence
of an employment agreement does not guarantee retention of members of our executive management team. We do not maintain &#8220;key person&#8221;
life insurance on any of our employees.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We have established relationships with leading
key opinion leaders and scientists at important research and academic institutions that we believe are key to establishing tests using
our technologies as a standard of care for cancer assessment and diagnosis. If our collaborators determine that cancer testing using our
technologies are not appropriate options for prostate cancer diagnosis, or superior to available prostate cancer methods, or that alternative
technologies would be more effective in the early diagnosis of prostate cancer, we would encounter significant difficulty establishing
tests using our technologies as a standard of care for prostate cancer diagnosis, which would limit our revenue growth and profitability.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Our results of operations can be adversely
affected by labor shortages, turnover and labor cost increases.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Labor is a significant component of operating
our business. A number of factors may adversely affect the labor force available to us or increase labor costs, including high employment
levels, federal unemployment subsidies, increased wages offered by other employers, vaccine mandates and other government regulations
and our responses thereto. As more employers offer remote work, we may have more difficulty recruiting for jobs that require on-site attendance,
such as certain clinical laboratory and sales roles. Although we have not experienced any material labor shortage to date, we have recently
observed an overall tightening and increasingly competitive labor market. A sustained labor shortage or increased turnover rates within
our employee base, caused by a pandemic or as a result of general macroeconomic factors, could lead to increased costs, such as increased
overtime or financial incentives to meet demand and increased wage rates to attract and retain employees, and could negatively affect
our ability to efficiently operate our clinical laboratories and overall business. If we are unable to hire and retain employees capable
of performing at a high-level, or if mitigation measures we may take to respond to a decrease in labor availability have unintended negative
effects, our business could be adversely affected.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Additionally, the operations of our vendors and
partners could also suffer from labor shortages, turnover and labor cost increases which could result in supply change disruptions and
increases in the costs of the products and services we purchase, each of which could adversely affect our operations.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Our business and reputation will suffer
if we are unable to establish and comply with, stringent quality standards to assure that the highest level of quality is observed in
the performance of our solutions.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Inherent risks are involved in providing and marketing
cancer tests and related services. Patients and healthcare providers rely on us to provide accurate clinical and diagnostic information
that may be used to make critical healthcare decisions. As such, users of our solutions may have a greater sensitivity to errors than
users of some other types of products and services.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Past or future performance or accuracy defects,
incomplete or improper quality and process controls, excessively slow turnaround times, unanticipated uses of our tests or mishandling
of samples or test results (whether by us, patients, healthcare providers, courier delivery services or others) can lead to adverse outcomes
for patients and interruptions to our services. These events could lead to voluntary or legally mandated safety alerts relating to our
tests or our laboratory facilities and could result in the removal of our products and services from the market or the suspension of our
laboratories&#8217; operations. Insufficient quality controls and any resulting negative outcomes could result in significant costs and
litigation, as well as negative publicity that could reduce demand for our tests and payors&#8217; willingness to cover our tests. Even
if we maintain adequate controls and procedures, damaging and costly errors may occur.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Our laboratory facilities may become inoperable
due to natural or man-made disasters or regulatory sanctions.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We currently perform testing services in our laboratory
facilities located in Irvine, California; Plano, Texas; and Nijmegen, The Netherlands and our GPS test is currently performed by Exact
Sciences in its laboratory facility in Redwood City, California. These laboratory facilities could become inoperable due to circumstances
that may be beyond our control, and such inoperability could adversely affect our business and operations. The facilities, equipment and
other business process systems would be costly to replace and could require substantial time to repair or replace.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The facilities may be damaged or destroyed by
natural or man-made&#160;disasters, including earthquakes, wildfires, floods, outbreak of disease (such as the COVID-19&#160;pandemic),
acts of terrorism or other criminal activities and power outages, which may render it difficult or impossible for us to perform our tests
for some period.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The facilities may also be rendered inoperable
because of regulatory sanction. In the United States, we are subject to federal and state laws and regulations regarding the operation
of clinical laboratories. Our U.S. laboratory facilities in Irvine, California and Plano, Texas are certified under CLIA. CLIA and the
laws of California and certain other states, impose certification requirements for clinical laboratories, and establish standards for
quality assurance and quality control, among other things. Clinical laboratories are subject to inspection by regulators, and to sanctions
for failing to comply with applicable requirements. Sanctions available under CLIA include prohibiting a laboratory from running tests,
requiring a laboratory to implement a corrective action plan, and imposing civil monetary penalties. Our U.S. laboratory facilities hold
certificates of accreditation from CMS to perform high-complexity&#160;testing. To renew these certificates, the facilities are subject
to survey and inspection every two years. We also hold a certificate of accreditation from the College of American Pathologists (&#8220;CAP&#8221;),
which sets standards that are higher than those contained in the CLIA regulations. CAP is an independent, non-governmental&#160;organization
of board-certified&#160;pathologists that accredits laboratories nationwide on a voluntary basis. Sanctions for failure to comply with
CAP or CLIA requirements, including proficiency testing violations, may include suspension, revocation, or limitation of a laboratory&#8217;s
CLIA certificate, which is necessary to conduct business, as well as the imposition of significant fines or criminal penalties. In addition,
our U.S. facilities are subject to regulation under state laws and regulations governing laboratory licensure. Two states, one of which
is New York, have enacted state licensure laws that are more stringent than CLIA. Failure to maintain CLIA certification, CAP accreditation,
or required state licenses could have a material adverse effect on the sales of our tests and results of operations. Many states maintain
independent licensure, registration, or certification procedures with which our U.S. facilities must maintain compliance in order to receive
and test samples from that location.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In order to rely on a third party to perform certain
of our tests, we could only use another facility with established state licensure and CLIA accreditation following validation and other
required procedures. We cannot assure you that we would be able to find another CLIA certified facility willing to comply with the required
procedures, that this laboratory would be willing to perform the tests for us on commercially reasonable terms, or that it would be able
to meet our quality or regulatory standards.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Maintaining compliance with the myriad of governmental
requirements is time and resource intensive,&#160;and failure to maintain compliance could result in sanctions.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>We rely on a limited number of third-party
suppliers for services and items used in the production and operation of our testing solutions, and some of those services and items are
supplied from a single source. Disruption of the supply chain, unavailability of third-party services required for the performance of
the tests, modifications of certain items or failure to achieve economies of scale could have a material adverse effect on us.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">To provide our testing services, we are required
to obtain customized components and services that are currently available from a limited number of sources. Most of these components and
services are sourced externally from approximately 40 external suppliers. Many of the consumable supplies and reagents used as raw materials
in our testing process are procured from a limited number of suppliers, some of which are single source. In addition, we rely on a limited
number of suppliers, or in some cases a single supplier (for example, for the automation of our deparaffination steps for our Confirm
mdx test), for certain services and equipment with which we provide testing services. If we have to switch to a replacement supplier for
any of these items that are sub-components&#160;or for certain services required for the performance of our tests, or if we have to commence
our own manufacturing or testing services to satisfy market demand, we may face additional delays. For example, in the past, a supplier
has delivered critical non-conforming&#160;components that failed our acceptance testing, requiring us to audit the supplier and assist
the supplier in improving our internal quality processes. In addition, third party suppliers may be subject to circumstances which impact
their ability to supply, including enforcement action by regulatory authorities, natural disasters (<i>e.g.</i>, hurricanes, earthquakes,
disease and terrorism), epidemics (<i>e.g.</i>, the COVID-19&#160;pandemic), industrial action (<i>e.g.</i>, strikes), financial difficulties
including insolvency, among a variety of other internal or external factors. Any such supply disruptions could in turn result in service
disruptions for an extended period of time, which could delay completion of our clinical studies or commercialization activities and prevent
us from achieving or maintaining profitability. While we were able to qualify alternative suppliers to address COVID-19&#160;related disruptions,
in the future alternative suppliers may be unavailable, may be unwilling to supply, may not have the necessary regulatory approvals, or
may not have in place an adequate quality management systems.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Exact Sciences currently performs our GPS test
pursuant to a reference laboratory services agreement we entered into with Exact Sciences in connection with our acquisition of the GPS
test. Until we are able to transition performance of the GPS test to our laboratory facilities we will be reliant on this contractual
relationship to generate revenues from this test.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Modifications to a service or items or inclusions
of certain services or items made by a third-party&#160;supplier could require new approvals from the relevant regulatory authorities
before the modified service or item may be used, for example any modifications to the assembly and packaging of items for our testing
services supplied to healthcare providers. While we have not experienced any material supply chain disruptions to date, if we were to
experience such disruptions it could have an immediate impact on revenues, and the impact could be material depending on the length of
the supply disruption.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Failures in our information technology,
telecommunications or other systems could significantly disrupt our operations.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We use information technology and telecommunications
systems across virtually all aspects of our business, including laboratory testing, sales, billing, customer service, logistics and management
of data, including patient information. Our information technology, telecommunications and other systems, are vulnerable to damage and
failure, computer viruses, acts of God and physical or electronic break-ins. Despite the precautionary measures we have taken to prevent
breakdowns in our information technology and telecommunications systems, sustained or repeated system failures that interrupt our ability
to process test orders, deliver test results or perform tests in a timely manner or that cause us to lose patient information could adversely
affect our business, results of operations and financial condition.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Although we maintain cyber liability insurance
which we believe to be appropriate and adequate, the levels and terms of coverage may not be adequate to compensate us for losses that
may arise from any such disruption, failure or security breach. In addition, such insurance may not be available to us in the future on
economically reasonable terms, or at all. Further, insurance may not cover all claims made against us and could have high deductibles
in any event, and defending a suit, regardless of its merit, could be costly and divert management attention.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Security breaches or loss of data may harm
our reputation, expose us to liability and adversely affect our business.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If we experience any security breaches or loss
of data or if we fail to comply with data protection laws and regulations, we could be subject to government enforcement actions (which
could include civil or criminal penalties), private litigation and/or adverse publicity, which could negatively affect our results of
operations and business.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We face four primary risks relative to protecting
sensitive and critical personally identifiable information, intellectual property or other proprietary business information about our
customers, payors, recipients and collaboration partners, including test results: (1) loss of access risk, (2) inappropriate disclosure
or access risk, (3) inappropriate modification risk, and (4) the risk of being unable to identify and audit controls over the first three
risks. While we devote significant resources to protecting such information, the measures we introduce may not be sufficient to guard
against security breaches, the loss or misappropriation of data, privacy violations or the failure to implement satisfactory remedial
measures, which could in turn disrupt operations and lead to reputational damage, regulatory penalties and other material financial losses.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Furthermore, we are subject to privacy and data
security laws and regulations at the state, federal and international level. In the United States, numerous federal and state laws and
regulations, including state data breach notification laws, state health information privacy laws, and federal and state consumer protection
laws (<i>e.g.</i>, section 5 of the Federal Trade Commission Act), govern the collection, use, disclosure, and protection of health-related&#160;and
other personal information. Failure to comply with data protection laws and regulations could result in (1) government enforcement actions
and potential liability thereunder (potentially including civil and/or criminal penalties), (2) private litigation, and/or (3) adverse
publicity that could negatively affect our operations and/or business. In addition, we obtain health information from third parties (<i>e.g.</i>,
healthcare providers) and are subject to privacy and security requirements under the Health Insurance Portability and Accountability Act
(&#8220;HIPAA&#8221;), as amended by the Health Information Technology for Economic and Clinical Health Act (&#8220;HITECH&#8221;). These
laws contain significant fines and other penalties for wrongful use or disclosure of protected data. For example, HIPAA violations can
result in civil and criminal penalties.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>We expect to make significant investments
to research and develop new tests, which may not be successful.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We are seeking to improve the performance of our
existing solutions and to develop a pipeline for future products and services. For example, in August 2022, we announced our acquisition
of the GPS test from Exact Sciences. In addition, we are currently developing an additional product, Monitor mdx, as a non-invasive test
to risk stratifies patients for continued active surveillance versus intervention. We also recently developed and launched non-invasive
urine test that identifies and quantifies infectious bacteria and their antibiotics susceptibility to help ensure patients receive the
correct diagnosis and treatment as quickly as possible.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Developing new or improved diagnostic tests is
a speculative and risky endeavor. Candidate products and services that may initially show promise may fail to achieve the desired results
in larger clinical validation&#160;studies or may not achieve acceptable levels of clinical accuracy. Results from early studies or trials
are not necessarily predictive of future clinical validation or clinical trial results, and interim results of a validation study or trial
are not necessarily indicative of final results. From time to time, we may publicly disclose then-available&#160;data from clinical validation
studies before completion, and the results and related findings and conclusions may be subject to change following the final analysis
of the data related to the particular study. As a result, such data should be viewed with caution until the final data are available.
Additionally, such data from clinical trials are subject to the risk that one or more of the clinical outcomes may materially change as
patient enrollment and/or follow-up&#160;continues, and more patient data become available. Significant differences between initial or
interim data and final data from either our clinical validation studies or clinical trials could significantly alter our plans to proceed
with additional studies or trials, and harm our reputation and business prospects. If we determine that any of our current or future development
programs is unlikely to succeed, we may abandon it without any return on our investment into the program. We may need to raise additional
capital to bring any new products or services to market, which may not be available on acceptable terms, if at all.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Our research and development efforts will
be hindered if we are not able to obtain samples, contract with third parties for access to samples or complete timely enrollment in future
clinical trials.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Access to human sample types, such as blood, tissue,
stool, or urine is necessary for our research and product development. Acquiring samples from individuals with clinical diagnoses or associated
clinical outcomes through purchase or clinical studies is necessary. Lack of available samples can delay development timelines and increase
costs of development. Generally, the agreements under which we gain access to human samples are non-exclusive. Other companies may compete
with us for access. Additionally, the process of negotiating access to samples can be lengthy and it may involve numerous parties and
approval levels to resolve complex issues such as usage rights, institutional review board approval and patient informed consent, privacy
rights, publication rights, intellectual property ownership and research parameters. If we are not able to negotiate access to clinical
samples with research institutions, hospitals, clinical partners, pharmaceutical companies, or companies developing therapeutics on a
timely basis, or at all, or if other laboratories or our competitors secure access to these samples before us, our ability to research,
develop and commercialize future products will be limited or delayed. Finally, we may not be able to conduct or complete clinical trials
on a timely basis if we are not able to enroll sufficient numbers of patients in such trials, and our failure to do so could have an adverse
effect on our research and development and product commercialization efforts.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><span style="text-decoration:underline">Risks Related to Regulation of Our Business</span></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Failure to comply with governmental payor
regulations could result in us being excluded from participation in Medicare, Medicaid or other governmental payor programs, which would
adversely affect our business.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Failure to comply with applicable Medicare, Medicaid
and other governmental payor rules could result in us being excluded from participation in one or more governmental payor programs, returning
funds already paid, civil monetary penalties, criminal penalties and/or limitations on the operational function of our laboratories. Additionally,
with the recent implementation by CMS of a comprehensive oversight regime that consolidates program integrity powers into a single UPIC,
audit and investigatory activity into potential billing fraud, waste and abuse in the industry has increased. These changes have adversely
affected and may in the future adversely affect coverage and reimbursement for laboratory services, including the molecular diagnostics
testing services we provide. If we were unable to receive reimbursement under a governmental payor program, this would have a severe impact
on our revenues, given the importance of reimbursement under these programs in our revenue base.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>We conduct business in a heavily regulated
industry, and changes in, or violations of, applicable regulations may, directly or indirectly, adversely affect our operational results
and financial condition, which could harm our business.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our business operations and activities may be
subject to a range of local, state, federal, and international healthcare laws and regulations, including investigatory and program integrity
audits and other oversight federal and state health care programs. These laws and regulations currently include, among others:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">CLIA (which requires laboratories to obtain certification from the federal government) and state&#160;laboratory licensure laws;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Federal Trade Commission standards regarding advertising and business practices;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">FDA laws and regulations;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">HIPAA (which imposes comprehensive federal standards with respect to the privacy and security of protected health information, and requirements for the use of certain standardized electronic transactions), and the amendments to HIPAA under HITECH (which strengthened and expanded HIPAA privacy and security compliance requirements, increased penalties for violators, extended enforcement authority to state attorneys general and imposed requirements for breach notification);</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">state laws regulating genetic testing and the privacy protection of genetic test results, as well as state laws protecting the privacy and security of health information and personal data and mandating reporting of breaches to affected individuals and state regulators;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the federal Anti-Kickback&#160;Statute (which prohibits knowingly and willfully offering, paying, soliciting, receiving, or providing remuneration, directly or indirectly, to induce either the referral of an individual, or the furnishing, arranging for, or recommending of an item or service that is reimbursable, in whole or in part, by a federal health care program) and parallel state anti-kickback&#160;laws (which contain similar prohibitions on remuneration between referral sources, although these state laws are not always limited in application to items or services reimbursable by federal or state health care programs);</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the federal False Claims Act (which imposes liability on any person or entity that, among other things, knowingly presents, or causes to be presented, a false or fraudulent claim for payment to the federal government or the improper retention of identified overpayments or other financial obligations to the federal government) and parallel state false claims acts (which contain similar prohibition on presenting false or fraudulent claims, although these state may extend to items or services by any third-party&#160;payor, including commercial insurers);</span></td></tr>
  </table><div>
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  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the federal Civil Monetary Penalties Law, which prohibits, among other things, the offering or transferring of remuneration to a Medicare or state health care program (<i>e.g.</i>,&#160;Medicaid) beneficiary if the person knows or should know it is likely to influence the beneficiary&#8217;s selection of a particular provider, practitioner, or supplier of services reimbursable by Medicare or a state health care program, unless an exception applies;</span></td></tr>
  </table><div>
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  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the federal physician self-referral&#160;law, commonly known as the &#8220;Stark Law,&#8221; which prohibits a physician from making a referral to an entity for certain &#8220;designated health services&#8221; (&#8220;DHS&#8221;) payable by Medicare if the physician, or an immediate family member of the physician, has a financial relationship with that entity, unless an exception applies. The Stark Law further prohibits the entity from billing the Medicare program for DHS furnished pursuant to a prohibited referral. In addition, the Stark Law, through the addition of section 1903(s) to the Social Security Act, prohibits the federal government from making federal financial participation payments to state Medicaid programs for DHS furnished as a result of a referral that would violate the Stark Law if Medicare &#8220;covered the service to the same extent and under the same conditions&#8221; as the state Medicaid Program. The U.S. Department of Justice (&#8220;DOJ&#8221;) and several state agencies have successfully argued that Section 1903(s) expands the Stark Law to Medicaid-covered&#160;claims, even absent a separate state self-referral&#160;law prohibiting the same conduct;</span></td></tr>
  </table><div>
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  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">other federal and state fraud and abuse laws, including (i) the state anti-kickback&#160;laws described above, (ii) the state physician self-referral&#160;laws, and&#160;(iii) the state false claims acts described above;</span></td></tr>
  </table><div>
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  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Section 216 of the Protecting Access to Medicare Act of 2014, which requires applicable laboratories to report commercial payor data in a timely and accurate manner beginning in 2017 and every three years thereafter (and in some cases annually);</span></td></tr>
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  <tr style="vertical-align: top">
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    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Federal and state laws that impose reporting and other compliance-related&#160;requirements; and</span></td></tr>
  </table><div>
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">similar foreign laws and regulations that apply to us in the countries in which we operate.</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In addition, in October 2018, the Eliminating
Kickbacks in Recovery Act of 2018 (&#8220;EKRA&#8221;), was enacted by the U.S. Congress as part of the Substance Use-Disorder&#160;Prevention
that Promotes Opioid Recovery and Treatment for Patients and Communities Act. EKRA is an all-payor&#160;anti-kickback&#160;law that makes
it a criminal offense to pay any remuneration to induce referrals to, or in exchange for, patients using the services of a recovery home,
a substance use clinical treatment facility, or laboratory. Although it appears that EKRA was intended to reach patient brokering and
similar arrangements to induce patronage of substance use recovery and treatment, the language in EKRA is broadly written. Further, certain
of EKRA&#8217;s exceptions, such as the exception applicable to relationships with employees that effectively prohibits incentive compensation,
are inconsistent with the federal anti-kickback&#160;statute and regulations, which permit payment of employee incentive compensation,
a practice that is common in the industry. Significantly, EKRA permits the U.S. Department of Justice to issue regulations clarifying
EKRA&#8217;s exceptions or adding additional exceptions, but such regulations have not yet been issued. Laboratory industry stakeholders
are reportedly seeking clarification regarding EKRA&#8217;s scope and/or amendments to its language.</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our business practices, in operating a U.S. clinical
laboratory, may face heightened scrutiny from U.S. government enforcement agencies such as the DOJ, the HHS Office of Inspector General
(&#8220;OIG&#8221;), and CMS. The OIG has issued fraud alerts in recent years that identify certain arrangements between clinical laboratories
and referring physicians as implicating the&#160;federal Anti-Kickback&#160;Statute. The OIG has stated that it is particularly concerned
about these types of arrangements because the choice of laboratory, as well as the decision to order laboratory tests, typically are made
or strongly influenced by the physician, with little or no input from the patient. Moreover, the provision of payments or other items
of value by a clinical laboratory to a referring physician could be prohibited under the Stark Law, unless the arrangement meets all criteria
of an applicable exception. The government has actively enforced these laws against clinical laboratories in recent years.</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">These U.S. laws and regulations are complex and
are subject to interpretation by the U.S. courts and government agencies. Our failure to comply with such laws and regulations could lead
to significant civil or criminal penalties, exclusion from participation in state and federal health care programs, individual imprisonment,
disgorgement of profits, contractual damages, reputational harm, diminished profits and future earnings, additional reporting or oversight
obligations if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance&#160;with
the law, curtailment or restructuring of our operations, or prohibitions or restrictions on our laboratories&#8217; ability to provide
or receive payment for our services, any of which could adversely affect our ability to operate our business and pursue our strategy.
Even where we are able to successfully defend against any such claims, any potential audit, enforcement action, or litigation would involve
substantial internal and external resources, detract from our executives&#8217; day to day responsibilities, and result in legal expenditures,
all of which could materially adversely affect our results of operations. While we believe that we are in material compliance with all
applicable laws and regulations, there remains a risk that one or more government agencies could take a contrary position, or that a private
party could file suit under the qui tam provisions of the federal False Claims Act or a similar state law. Such occurrences, regardless
of their outcome, could damage our reputation and adversely affect important business relationships with third parties, including managed
care organizations, and other private third-party&#160;payors.</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Our employees, independent contractors,
consultants, commercial partners, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory
standards and requirements.</i></b></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We are exposed to the risk of fraud, misconduct,
or other illegal activity by our employees, independent contractors, consultants, commercial partners, and vendors. Misconduct by these
parties could include intentional, reckless and negligent conduct that fails to: comply with the rules and regulations of the CMS, FDA,
and other federal and state government agencies as well as comparable foreign regulatory authorities; provide true, complete and accurate
information to such regulatory authorities; comply with manufacturing and clinical laboratory standards; comply with healthcare fraud
and abuse laws in the United States and similar foreign fraudulent misconduct laws; or report financial information or data accurately
or to disclose unauthorized activities to us. In particular, research, sales, marketing, education, and other business arrangements in
the healthcare industry are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing, and other abusive practices,
as well as off-label&#160;product promotion. These laws and regulations may restrict or prohibit a wide range of pricing, discounting,
educating, marketing and promotion, sales and commission, certain customer incentive programs, and other business arrangements generally.
Activities subject to these laws also involve the improper use of information obtained in the course of participant recruitment for clinical
studies, which could result in regulatory sanctions and cause serious harm to our reputation. We have adopted a code of business conduct
and ethics and provide compliance training to our workforce members upon onboarding and annually thereafter, but it is not always possible
to identify and deter misconduct by employees and third parties, and the precautions we take to detect and prevent this activity may not
be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions
or lawsuits stemming from a failure to be in compliance with such laws. If any such actions are instituted against us, and we are not
successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the
imposition of significant fines or other sanctions. Even if it is later determined after an action is instituted against us that we were
not in violation of these laws, we may be faced with negative publicity, incur significant expenses defending our actions, and have to
divert significant management resources from other matters.</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Our expansion of our business beyond the
United States has resulted in additional regulatory requirements with which we must comply.</i></b></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our expansion of our business outside of the
United States increases the potential of violating foreign laws similar to those described above under &#8220; &#8212; <i>We conduct
business in a heavily regulated industry, and changes in regulations or violations of regulations may, directly or indirectly, adversely
affect our results of operations and financial condition and harm our business</i>.&#8221; In order to market our tests in other countries,
we may be required to obtain regulatory approvals and comply with extensive safety and quality regulations in other countries. The time
required to obtain approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements
may differ. The European Union/European Economic Area requires a CE conformity mark in order to market medical devices. Many other countries
accept CE or FDA clearance or approval, although others, require separate regulatory filings. Further, the advertising and promotion
of our products in the EEA is subject to the laws of individual EEA Member States implementing the EU Medical Devices Directives including
Directive 98/79/EC on Invitro Diagnostic Medical Devices, Directive 2006/114/EC concerning misleading and comparative advertising, and
Directive 2005/29/EC on unfair commercial practices, as well as other EEA Member State laws governing the advertising and promotion of
medical devices. Going forward, CE marking will be pursuant to Regulation 2017/745 (the &#8220;Medical Devices Regulation&#8221;) and
Regulation 2017/746 (the &#8220;Invitro Diagnostic Medical Devices Regulation&#8221;), which were passed by the European Parliament on
April&#160;5, 2017. The Medical Devices Regulation and the Invitro Diagnostic Medical Devices Regulation contain further obligations
for medical devices and invitro diagnostic medical devices with which we will be required to comply as applicable. These new laws are
generally stricter than the requirements previously in place and contain increased evidence requirements for CE marking. They may limit
or restrict the advertising and promotion of our tests to the general public and may impose limitations on promotional activities with
healthcare professionals. The risk of being found in violation of these or other laws and regulations is further increased by the fact
that many have not been fully interpreted by the regulatory authorities or the courts, and their provisions are open to a variety of
interpretations. Any action brought against us for violation of these or other laws or regulations, even in case of successful defense
against it, could result in significant legal expenses and divert management&#8217;s attention from the operation of our business. While
our business is primarily based in the United States, these laws or regulations would not have an immediate material impact on our revenues.
However, in the longer term, our prospects could be seriously harmed.</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>If the FDA were to take the position that
our tests are not within the scope of its policy on enforcement discretion for laboratory-developed tests (&#8220;LDTs&#8221;), or Congress
or FDA were otherwise to begin requiring approval or clearance of our tests, responding to such a development could lead to a halt in
the commercial provision of our tests until we meet the requirements for premarket approval or clearance, enforcement action from FDA,
and we could incur substantial costs and time delays associated with meeting FDA requirements for premarket clearance or approval.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Although we believe we are within the scope of
the FDA&#8217;s policy on enforcement discretion for LDTs, commercial availability of LDTs is subject to uncertainty given the FDA&#8217;s
latitude in interpreting and applying its laws and policies. For example, although the FDA has historically exercised enforcement discretion
over most LDTs, it does not consider tests to be subject to this enforcement discretion if they were or are designed or manufactured completely,
or partly, outside of the laboratory that offers and uses them, or if they are offered &#8220;over-the-counter&#8221; (as opposed to being
available to patients only when prescribed by a health care provider). Even for tests that appear to fall within FDA&#8217;s previously
stated policy on enforcement discretion, the FDA may decide to regulate certain LDTs on a case-by-case&#160;basis at any time.</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Furthermore, the laws and regulations governing
the marketing of diagnostic products are evolving, extremely complex and in many instances, there are no significant regulatory or judicial
interpretations of these laws and regulations. Pursuant to its authority under the federal Food, Drug, and Cosmetic Act (the &#8220;FDCA&#8221;),
the FDA has jurisdiction over medical devices, including in vitro diagnostics and, therefore, potentially our clinical laboratory tests.
Among other things, pursuant to the FDCA and its implementing regulations, the FDA regulates the research, testing, manufacturing, safety,
labeling, storage, recordkeeping, premarket clearance or approval, marketing and promotion, and sales and distribution of medical devices
in the United States to ensure that medical products distributed domestically are safe and effective for their intended uses. Although
the FDA has asserted that it has authority to regulate the development and use of LDTs, such as our and many other laboratories&#8217;
tests, as medical devices, it has generally exercised enforcement discretion and is not otherwise regulating most tests developed and
performed within a single high complexity CLIA-certified&#160;laboratory.</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Even though our tests are commercialized in the
United States as LDTs, they may in the future become subject to more onerous regulation by the FDA. For example, the FDA may disagree
with the assessment that the tests fall within the definition of an LDT and seek to regulate them as medical devices. The FDA has, for
over the past decade, been introducing proposals to end enforcement discretion and to bring LDTs clearly under existing FDA regulatory
frameworks and the U.S. Congress has recently been working on legislation to create an LDT and in vitro diagnostic regulatory framework
that would be separate and distinct from the existing medical device regulatory framework. If the FDA begins to enforce its medical device
requirements for LDTs, or if the FDA disagrees with our assessment that our tests are LDTs, our company and these tests could for the
first time be subject to a variety of regulatory requirements, including registration and listing, medical device reporting, and adherence
to good manufacturing practices under the quality system regulations, and we could be required to obtain premarket clearance or approval
for these existing tests and any new tests we may develop, which may force us to cease or delay marketing our tests until the required
clearance or approval are obtained. The premarket review process for diagnostic products can be lengthy, expensive, time-consuming, and
unpredictable. Further, obtaining premarket clearance or approval may involve, among other things, successfully completing clinical trials.
Clinical trials require significant time and cash resources and are subject to a high degree of risk, including risks of experiencing
delays, failing to complete the trial or obtaining unexpected or negative results. If we are required to obtain premarket clearance or
approval&#160;and/or&#160;conduct premarket clinical trials, development costs could significantly increase, the introduction of any new
tests under development may be delayed, and sales of our tests could be interrupted or stopped. Any of these outcomes could reduce revenues
or increase costs and materially adversely affect our business, prospects, results of operations, or financial condition. Moreover, any
cleared or approved labeling claims may not be consistent with current claims or be adequate to support continued adoption of and reimbursement
for our tests. For instance, if FDA requires our tests to be labeled as investigational, or if the labeling claims the FDA allows are
limited, order levels may decline and reimbursement may be adversely affected. If after commercialization under the LDT framework our
tests are allowed to remain on the market but there is uncertainty about the regulatory status of our tests, including questions that
may be raised if competitors object to our regulatory positioning as an LDT, we may encounter ongoing regulatory and legal challenges
and related costs. Such challenges or related developments (for example if the labeling claims the FDA allows us to make are more limited
than the claims we currently plan to make) may impact our commercialization efforts as orders or reimbursement may be less than anticipated.
As a result, we could experience significantly increased development costs and a delay in generating additional revenue. Until the&#160;FDA
finalizes its regulatory position regarding LDTs, or federal legislation is passed concerning regulation of LDTs, it is unknown how the
FDA may regulate our tests in the future and what testing and data may be required to support any required clearance or approval.</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The requirement of premarket review could negatively
affect our business until such review is completed and regulatory clearance or approval is obtained. The FDA could require that sales
of our tests be halted pending premarket clearance or approval. In December 2018 the FDA Commissioner and the Director of the Center for
Devices and Radiological Health expressed significant concerns regarding disparities between some LDTs and in vitro diagnostics that have
been reviewed and cleared or approved by FDA. If the FDA were to determine that our tests are not within the policy for LDTs for any reason,
including new rules, policies, or guidance, or due to changes in statute, our tests may become subject to FDA requirements, including
premarket review. If required, the regulatory marketing authorization process may involve, among other things, successfully completing
additional clinical trials and&#160;submitting a premarket clearance (510(k)) submission or filing a de novo or premarket approval application
with the FDA. If premarket review and authorization is required by the FDA, we may need to incur additional expenses or require additional
time to seek it, or we may be unable to satisfy FDA standards, and our tests may not be cleared or approved on a timely basis, if at all,
and the labeling claims permitted by the FDA may not be consistent with our currently planned claims or adequate to support adoption of
and reimbursement for our tests. If the FDA requires any form of premarket review, our tests may not be cleared or approved on a timely
basis, if at all. We may also decide voluntarily to pursue FDA premarket review and authorization of our tests if it appears that doing
so would be appropriate.</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In addition, we believe that the sample collection
kits provided by us for collection and transport of specimens from a health care provider to our clinical laboratories are considered
a Class I medical devices subject to the FDA&#8217;s general device controls but exempt from premarket review. However, the FDA could
assert the specimen collection kits are non-exempt&#160;or Class II devices, which would subject them to premarket clearance or approval
processes, which could be time-consuming&#160;and expensive.</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Failure to comply with any applicable FDA requirements
could trigger a range of enforcement actions by the FDA, including warning letters, civil monetary penalties, injunctions, criminal prosecution,
recall or seizure, operating restrictions, partial suspension or total shutdown of operations and denial of or challenges to applications
for clearance or approval, as well as significant adverse publicity.</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Our operating results could be materially
adversely affected by unanticipated changes in tax laws and regulations, adjustments to our tax provisions, exposure to additional tax
liabilities, or forfeiture of our tax assets.</i></b></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We are subject to laws and regulations on tax
levies and other charges or contributions in different countries, including transfer pricing and tax regulations for the compensation
of personnel and third parties. Our tax structure involves several transfers and transfer price determinations between our parent company
and our subsidiaries or other affiliates. Our effective tax rates could be adversely affected by changes in tax laws, treaties and regulations,
both internationally and domestically. An increase of the effective tax rates could have an adverse effect on our business, financial
position, results of operations and cash flows.</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The net operating loss carry forwards of our corporate
subsidiaries may be unavailable to offset future taxable income because of restrictions under U.S. tax law. As of December&#160;31, 2022,
consolidated net tax loss carry forwards amounted to $285.3 million. Our NOLs generated in tax years ending on or prior to December&#160;31,
2017 are only permitted to be carried forward for 20 taxable years under applicable U.S. federal tax law, and therefore could expire unused.
We consider that it is highly likely that we will be unable to use at least a portion of these NOLs, in light of our continued losses.
Under tax legislation commonly referred to as the Tax Cuts and Jobs Act (&#8220;TCJA&#8221;), as modified by the CARES Act, our federal
NOLs generated in tax years ending after December&#160;31, 2017 may be carried forward indefinitely and NOLs arising in taxable years
beginning after December&#160;31, 2017 and before January 1, 2021 may be carried back to each of the five taxable years preceding the
tax year of such loss, but NOLs arising in taxable years beginning after December&#160;31, 2020 may not be carried back. In addition,
under the TCJA, as modified by the CARES Act, for taxable years beginning after December&#160;31, 2020, the deductibility of federal NOLs
generated in taxable years beginning after December&#160;31, 2017 is limited to 80% of current year taxable income. It is uncertain if
and to what extent various states will conform to the TCJA, as modified by the CARES Act.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In addition, under sections 382 and 383 of the
Internal Revenue Code of 1986, as amended, or the Code, if a corporation undergoes an &#8220;ownership change&#8221; (generally defined
as a cumulative change in ownership by &#8220;5-percent&#160;shareholders&#8221; that exceeds 50 percentage points over a rolling three-year&#160;period),
the corporation&#8217;s ability to use its pre-change&#160;NOLs and certain other pre-change&#160;tax attributes to offset post-change&#160;income
and taxes may be limited. Similar rules may apply under state tax laws. Our existing NOLs and other certain tax attributes may be subject
to limitations arising from previous ownership changes. In addition, future changes in our stock ownership, many of which are outside
of our control, could result in an ownership change under Sections 382 and 383 of the Code. We have not conducted any studies to determine
annual limitations, if any, that could result from such changes in the ownership. Our ability to utilize those NOLs and certain other
tax attributes could be limited by an &#8220;ownership change&#8221; as described above and consequently, we may not be able to utilize
a material portion of our NOLs and certain other tax attributes, which could have a material adverse effect on our cash flows and results
of operations by effectively increasing our future tax obligations.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Also under Belgian tax law, certain restrictions
regarding the use of Belgian tax losses carried forward apply and these losses may also be forfeited upon certain changes of control over
Belgian corporate taxpayers. As a COVID-19 measure, some limited tax loss carried back mechanism was introduced in Belgian tax law.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Given that we have historically generated operating
losses, any change in our ability to use NOLs could have a severe impact on us if and when we become profitable. As of December&#160;31,
2022, we had an accumulated deficit of $288.3&#160;million and for the year ended December&#160;31, 2022, we had a net loss of $44.0&#160;million.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Risks Related to Ownership of the ADSs and
Ordinary Shares</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>The trading price of our ordinary shares
and ADSs may be volatile due to factors beyond our control, and purchasers of the ADSs could incur substantial losses.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The market prices of the ADSs and ordinary shares
may be volatile. The stock market in general and the market for biotechnology companies in particular have experienced extreme volatility
that has often been unrelated to the operating performance of particular companies. As a result of this volatility, investors may not
be able to sell their ADSs or shares at or above the price originally paid for the security. The market price for the ADSs or shares may
be influenced by many factors, including:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">actual or anticipated fluctuations in our financial condition and operating results;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the release of new data from our PRIORITY or other clinical trials;</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">actual or anticipated changes in our growth rate relative to our competitors;</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">competition from existing products or new products that may emerge;</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations or capital commitments;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">failure to meet or exceed financial estimates and projections of the investment community or that we provide to the public;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">issuance of new or updated research or reports by securities analysts;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">fluctuations in the valuation of companies perceived by investors to be comparable to us;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">currency fluctuations;</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">additions or departures of key management or scientific personnel;</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">disputes or other developments related to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">changes to coverage policies or reimbursement levels by commercial third-party&#160;payors and government payors and any announcements relating to coverage policies or reimbursement levels;</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">announcement or expectation of additional debt or equity financing efforts;</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">issuances or sales of the ADSs or shares by us, our insiders or our other holders; and</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">general economic and market conditions.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">These and other market and industry factors may
cause the market price and demand for the ADSs or shares to fluctuate substantially, regardless of our actual operating performance, which
may limit or prevent investors from readily selling their ADSs or shares and may otherwise negatively affect the liquidity of the trading
market for ADSs or shares.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Certain of our significant shareholders
may have different interests from us and may be able to control us, including the outcome of shareholder votes.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">As of March 31, 2023, (i) MVM Partners LLP beneficially
owned approximately 16.8% of our ordinary shares and has one representative at the board level (Dr. Eric Bednarski), (ii) Bleichroeder
LP owned approximately 14.3% of our ordinary shares, (iii) Valiance&#160;Asset Management beneficially owned approximately 7.7% of our
ordinary shares and has one representative at&#160;the board level (Jan Pensaert), and (iv) Biovest NV beneficially owned approximately
4.4% of our ordinary shares. In addition, as long as two of MVM Partners LLP&#8217;s funds (MVM V LP and MVM GP (No.5) LP) hold in aggregate
5% of our company&#8217;s outstanding shares, they are entitled to have one observer at the board level (see Item 7B. &#8220;<i>Related
party transactions &#8212; MVM Subscription Agreement</i>&#8221;). As a result, these shareholders will be able to exercise a significant
level of control over all matters requiring stockholder approval, including the election of directors, amendment of our Articles of Association
and approval of certain significant corporate transactions. This control could have the effect of delaying or preventing a change of control
of the Company or changes in management, in each case, which other shareholders might find favorable, and will make the approval of certain
transactions difficult or impossible without the support of these significant shareholders.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>If securities or industry analysts do not
publish research or publish inaccurate or unfavorable research about our business, the price of the ADSs and ordinary shares and their
trading volume could decline.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The trading market for the ADSs and ordinary shares
depends in part on the research and reports that securities or industry analysts publish about us or our business. If no or only limited
securities or industry analysts cover our company, the trading price for the ADSs and ordinary shares could be negatively impacted. If
one or more of the analysts who covers us downgrades our equity securities or publishes inaccurate or unfavorable research about our business,
the price of ADSs would likely decline. If one or more of these analysts ceases coverage of our company or fails to publish reports on
us regularly, or downgrades our securities, demand for ADSs and ordinary shares could decrease, which could cause the price of the ADSs
and ordinary shares or their trading volume to decline.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>We intend to retain all available funds
and any future earnings and, consequently, ADS holders&#8217; ability to achieve a return on their investment will depend on appreciation
in the price of the ADSs.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We have never declared or paid any cash dividends
on our ordinary shares or ADSs, and we intend to retain all available funds and any future earnings to fund the development and expansion
of our business. In addition, our loan agreement with Innovatus limits our ability to pay any such dividends. Therefore, ADS holders are
not likely to receive any dividends on your ADSs for the foreseeable future and the success of an investment in ADSs will depend upon
any future appreciation in their value. Consequently, investors may need to sell all or part of their holdings of ADSs after price appreciation,
which may never occur, as the only way to realize any future gains on their investment. There is no guarantee that the ADSs will appreciate
in value or even maintain the price at which our investors have purchased them. Investors seeking cash dividends should not purchase the
ADSs.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In addition, if we choose to pay dividends in
the future, exchange rate fluctuations may affect the amount of Euros that we are able to distribute, and the amount in U.S. dollars that
our shareholders receive upon the payment of cash dividends or other distributions we declare and pay in euros, if any. Any dividends
will generally be subject to Belgian withholding tax. These factors could harm the value of the ADSs.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Holders of ADSs should be aware that the
rights provided to our ADS holders under Belgian corporate law and our Articles of Association differ in certain respects from the rights
that you would typically enjoy as a shareholder of a U.S. company under applicable U.S. federal and state laws.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We are a Belgian public company with limited liability.
Our corporate affairs are governed by our Articles of Association and by the laws governing companies incorporated in Belgium. The rights
of shareholders and the responsibilities of members of our Board of Directors may be different from the rights and obligations of shareholders
and boards of directors in companies governed by the laws of U.S. jurisdictions. In the performance of its duties, our Board is required
by Belgian law to consider the interests of our company, its shareholders, its employees, and other stakeholders. It is possible that
some of these parties will have interests that are different from, or in addition to, the interests of our shareholders. See Item 10B.
&#8220;<i>Memorandum and Articles of Association.</i>&#8221;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Concentration of ownership of our ordinary
shares (including ordinary shares in the form of ADSs) among our existing executive officers, directors and principal shareholders may
prevent ADS holders from influencing significant corporate decisions.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our executive officers, directors, greater than
three percent shareholders and their affiliates beneficially owned approximately 45.2% of our outstanding ordinary shares as of March 31,
2023. Depending on the level of attendance at our general meetings of shareholders, these shareholders either alone or voting together
as a group will be in a position to determine the outcome of decisions taken at any such general meeting. Any shareholder or group of
shareholders controlling more than 50% of the share capital present and voting at our general meetings of shareholders may control any
shareholder resolution requiring a simple majority, including the appointment of Board members, as well as certain decisions relating
to our capital structure, the approval of certain significant corporate transactions and amendments to our Articles of Association. Among
other consequences, this concentration of ownership may prevent or discourage unsolicited acquisition proposals that you may believe are
in your best interest as one of our shareholders. Some of these persons or entities may have interests different than yours.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Future sales, or the perception of future
sales, of a substantial number of our ordinary shares could adversely affect the price of the ADSs, and actual sales of our equity will
dilute ADS holders.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Future sales of a substantial number of our ADSs
or ordinary shares, or the perception that such sales will occur, could cause a decline in the market price of the ADSs. Approximately
78.9 million ordinary shares (including ordinary shares underlying ADSs) held by our directors, executive officers and certain shareholders
are subject to the lock-up&#160;agreements with terms generally expiring in May 2023. If, after the period during which such lock-up&#160;agreements
restrict sales of the our ordinary shares and ADSs or if the underwriters of our initial public offering of ADSs waive the restrictions
set forth therein (which may occur at any time), one or more of these securityholders sell substantial amounts of ordinary shares or ADSs
in the public market, or the market perceives that such sales may occur, the market price of the ADSs and our ability to raise capital
through an issue of equity securities in the future could be adversely affected.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>If we issue ADSs or ordinary shares in future
financings, shareholders may experience dilution and, as a result, the price of the ADSs may decline.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We may from time-to-time issue additional ordinary
shares at a discount from the trading price of the ADSs. As a result, holders of the ADSs would experience immediate dilution upon the
issuance of any of our ordinary shares at such discount. In addition, as opportunities present themselves, we may enter into financing
or similar arrangements in the future, including the issuance of debt securities, preference shares or shares. If we issue ordinary shares
or other equity or equity-linked&#160;securities, holders of ADSs would experience additional dilution and, as a result, the price or
the ADSs may decline.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>It may be difficult for ADS holders outside
Belgium to serve process on, or enforce foreign judgments against, us or our directors and senior management.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We are a Belgian public limited liability company.
Less than a majority of the members of our Board of Directors and members of our executive management team are residents of the United
States. All or a substantial portion of the assets of such non-resident&#160;persons and most of our assets are located outside the United
States. As a result, it may not be possible for ADS holders to effect service of process upon such persons or on us or to enforce against
them or us a judgment obtained in U.S. courts. Original actions or actions for the enforcement of judgments of U.S. courts relating to
the civil liability provisions of the federal or state securities laws of the United States are not directly enforceable in Belgium.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The United States and Belgium do not currently
have a multilateral or bilateral treaty providing for reciprocal recognition and enforcement of judgments, other than arbitral awards,
in civil and commercial matters. In order for a final judgment for the payment of money rendered by U.S. courts based on civil liability
to produce any effect on Belgian soil, it is accordingly required that this judgment be recognized or be declared enforceable by a Belgian
court in accordance with Articles 22 to 25 of the 2004 Belgian Code of Private International Law. Recognition or enforcement does not
imply a review of the merits of the case and is irrespective of any reciprocity requirement. A U.S. judgment will, however, not be recognized
or declared enforceable in Belgium, unless (in addition to compliance with certain technical provisions) the Belgian courts are satisfied
of the following:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the effect of the enforcement judgment is not manifestly incompatible with Belgian public policy;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the judgment was not rendered in a matter where the parties transferred rights subject to transfer restrictions with the sole purpose of avoiding the application of the law applicable according to Belgian international private law;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the judgment is not subject to further recourse under U.S. law;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the judgment is not incompatible with a judgment rendered in Belgium or with a subsequent judgment rendered abroad that might be recognized in Belgium;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the claim was not filed outside Belgium after the same claim was filed in Belgium, while the claim filed in Belgium is still pending;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the Belgian courts did not have exclusive jurisdiction to rule on the matter;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the U.S. court did not accept its jurisdiction solely on the basis of the presence of the plaintiff or the location of goods not direct linked to the dispute in the United States;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the judgment did not concern the deposit or validity of intellectual property rights when the deposit or registration of those intellectual property rights was requested, done or should have been done in Belgium pursuant to international treaties;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the judgment did not relate to the validity, operation, dissolution, or liquidation of a legal entity that has its main seat in Belgium at the time of the petition of the U.S. court;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the judgment submitted to the Belgian court is authentic under the laws of the state where the judgment was issued; in case of a default judgment, it can be shown that under locally applicable laws the invitation to appear in court was properly served on the defendant; a document can be produced showing that the judgment is, under the rules of the state where it was issued, enforceable and was properly served on the defendant.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In addition to recognition or enforcement, a judgment
by a federal or state court in the United States against us may also serve as evidence in a similar action in a Belgian court if it meets
the conditions required for the authenticity of judgments according to the law of the state where it was rendered. The findings of a federal
or state court in the United States will not, however, be taken into account to the extent they appear incompatible with Belgian public
policy.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Based on the lack of a treaty as described above,
U.S. investors may not be able to enforce against us or members of our Board of Directors or our executive management any judgments obtained
in U.S. courts in civil and commercial matters, including judgments under the U.S. federal securities laws.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>We are an &#8220;emerging growth company&#8221;
and as a result of the reduced disclosure and governance requirements applicable to emerging growth companies, the ADSs may be less attractive
to investors.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We are an &#8220;emerging growth
company&#8221; as defined in the Jumpstart Our Business Startups Act of 2012 (the &#8220;JOBS Act&#8221;). For as long as we continue to be an emerging growth
company, we may take advantage of exemptions from various reporting requirements that are applicable to other public companies that
are not emerging growth companies, including not being required to comply with the auditor attestation requirements of
Section&#160;404 of the Sarbanes-Oxley&#160;Act of 2002 (the &#8220;Sarbanes-Oxley&#160;Act&#8221;),, exemptions from the
requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute
payments not previously approved. We may take advantage of these exemptions until we are no longer an emerging growth company. We
could be an emerging growth company for up to five&#160;years, although circumstances could cause us to lose that status earlier,
including if the aggregate market value of our ordinary shares held by non-affiliates&#160;exceeds $700&#160;million as of the end
of our second fiscal quarter before that time, in which case we would no longer be an emerging growth company as of the following
December 31st (the last day of our fiscal year). We cannot predict if investors will find the ADSs less attractive because we may
rely on these exemptions. If some investors find the ADSs less attractive as a result, there may be a less active trading market for
the ADSs and the price of the ADSs may be more volatile.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>As a foreign private issuer and as permitted
by the listing requirements of Nasdaq, we rely on certain home country corporate governance practices rather than the corporate governance
requirements of Nasdaq.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We qualify as a foreign private issuer and our
ADSs are listed on Nasdaq. In accordance with the listing requirements of Nasdaq, we rely on home country governance requirements and
certain exemptions thereunder rather than relying on the corporate governance requirements of Nasdaq. For example, we are exempt from
certain rules under the Exchange Act that regulate disclosure obligations and procedural requirements related to the solicitation of proxies,
consents or authorizations applicable to a security registered under the Exchange Act, including the U.S. proxy rules under Section&#160;14
of the Exchange Act. In addition, our officers and directors are exempt from the reporting and &#8220;short-swing&#8221; profit recovery
provisions of Section 16 of the Exchange Act and related rules with respect to their purchases and sales of our securities. Moreover,
while we currently publish annual and semi-annual&#160;reports on our website pursuant to the rules of Euronext Brussels and expect to
file such financial reports with the SEC, we are not required to file periodic reports with the SEC as frequently or as promptly as U.S.
public companies. Specifically, we are not required to file quarterly reports on Form 10-Q&#160;or current reports on Form 8-K&#160;that
a domestic company would be required to file under the Exchange Act. Accordingly, there may be less publicly available information concerning
our company than there would be if we were not a foreign private issuer.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: normal 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->24<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In addition, the Listing Rules of the Nasdaq Stock
Market require a majority of the directors of a listed U.S. company to be independent, whereas in Belgium, only three directors need to
be independent. The Listing Rules of the Nasdaq Stock Market further require that each of the nominating, compensation and audit committees
of a listed U.S. company be comprised entirely of independent directors. However, the Belgian Corporate Governance Code recommends only
that a majority of the directors on the nomination committee meet the technical requirements for independence under Belgian corporate
law. At present, our Audit Committee is composed of three independent directors out of three members, whereas our Nomination and Remuneration
Committee is composed of three independent directors out of five members. Our Board of Directors has no plan to change the composition
of our Audit Committee and Nomination and Remuneration Committee, and we intend to follow home country practice to the maximum extent
possible. Therefore, our shareholders may be afforded less protection than they otherwise would have under corporate governance listing
standards applicable to U.S. domestic issuers.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>We may lose our foreign private issuer status
in the future, which could result in significant additional costs and expenses.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">As a foreign private issuer, we are not required
to comply with all the periodic disclosure and current reporting requirements of the Exchange Act and related rules and regulations. The
determination of foreign private issuer status is made annually on the last business day of our most recently completed second fiscal
quarter. Accordingly, we will next make a determination with respect to our foreign private issuer status on June&#160;30, 2023. There
is a risk that we will lose our foreign private issuer status in the future.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We would lose our foreign private issuer status
if, for instance more than 50% of our ordinary shares are owned by U.S. residents or persons and more than 50% of our assets are located
in the United States and we continue to fail to meet additional requirements necessary to maintain our foreign private issuer status.
The regulatory and compliance costs to us under U.S. securities laws as a U.S. domestic issuer may be significantly greater than the costs
we incur as a foreign private issuer. If we are not a foreign private issuer, we will be required to file periodic reports and registration
statements on U.S. domestic issuer forms with the SEC, which are more detailed and extensive in certain respects than the forms available
to a foreign private issuer. We would be required under current SEC rules to prepare our financial statements in accordance with U.S.
GAAP and modify certain of our policies to comply with corporate governance practices associated with U.S. domestic issuers. Such conversion
and modifications would involve additional costs. In addition, we may lose our ability to rely upon exemptions from certain corporate
governance requirements on U.S. stock exchanges that are available to foreign private issuers, which could also increase our costs.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>U.S. holders of ADSs may suffer adverse
tax consequences if we are characterized as a passive foreign investment company, or PFIC.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In general, a non-U.S.&#160;corporation is a PFIC
for U.S. federal income tax purposes for any taxable year in which (i) 50% or more of value of its assets (based on an average of the
quarterly values of the assets during such taxable year) consists of assets that produce, or are held for the production of, passive income,
or (ii)&#160;75% or more of its gross income consists of passive income. A separate determination must be made after the close of each
fiscal year as to whether a non-U.S. corporation is a PFIC for that year. For purposes of the above calculations, a non-U.S.&#160;corporation
that owns, directly or indirectly, at least 25% by value of the shares of another corporation is treated as if it held its proportionate
share of the assets of the other corporation and received directly its proportionate share of the income of the other corporation. Passive
income generally includes dividends, interest, investment gains and certain rents and royalties. Cash is generally a passive asset for
these purposes. The value goodwill is generally treated as an active asset if it is associated with business activities that produce active
income.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If we are a PFIC for any taxable year during which
a U.S. Holder (as defined under Item 10E. &#8220;<i>Taxation</i>&#8221;) holds ADSs, we will continue to be treated as a PFIC with respect
to such U.S. Holder in all succeeding&#160;years during which the U.S. Holder owns the ADSs regardless of whether we continue to meet
the PFIC test described above, unless the U.S. Holder makes a specified election once we cease to be a PFIC. If we are classified as a
PFIC for any taxable year during which a U.S. Holder holds ADSs, the U.S. Holder may be subject to adverse tax consequences regardless
of whether we continue to qualify as a PFIC, including ineligibility for any preferred tax rates on capital gains or on actual or deemed
dividends, interest charges on certain taxes treated as deferred, and additional reporting requirements.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Based on the current estimates, and expected future
composition, of our income and the value of our assets, including goodwill, we do not expect to be a PFIC for our current taxable year.
However, our PFIC status for any taxable year is an annual determination that can be made only after the end of that year and will depend
on the composition of our income and assets and the value of our assets from time to time. The determination of whether we are a PFIC
is fact-intensive&#160;and the applicable law is subject to varying interpretation. There can be no assurance that the U.S.&#160;Internal
Revenue Service, or IRS, will agree with our position or that the IRS will not successfully challenge our position including our classification
of certain income and assets as non-passive&#160;or our valuation of our tangible and intangible assets.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">A U.S. Holder may in certain circumstances mitigate
the adverse tax consequences of the PFIC rules by filing an election to treat the PFIC as a Qualified Electing Fund (&#8220;QEF&#8221;)
or, if shares of the PFIC are &#8220;marketable stock&#8221; for purposes of the PFIC rules, by making a mark-to-market&#160;election
with respect to the shares of the PFIC. However, we do not currently intend to provide the information necessary for U.S. Holders to make
a QEF election if we were treated as a PFIC for any taxable year and prospective investors should assume that a QEF election will not
be available. Furthermore, if a U.S. Holder were to make a mark-to-market&#160;election with respect to its ADSs, the U.S. Holder would
be required to include annually in its U.S. federal taxable income (taxable at ordinary income rates) an amount reflecting any year end
increase in the value of its ADSs. For further discussion of the PFIC rules and the adverse U.S. federal income tax consequences in the
event we are classified as a PFIC, see Item 10E. &#8220;<i>Taxation</i>.&#8221;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The U.S. federal income tax rules relating to
PFICs are very complex. Current and prospective U.S. Holders are strongly urged to consult their own tax advisors with respect to the
impact of PFIC status on the purchase, ownership and disposition of ADSs, the consequences to them of an investment in a PFIC, any elections
available with respect to the ADSs and the IRS information reporting obligations with respect to the purchase, ownership and disposition
of ADSs of a PFIC.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>If a U.S. Holder is treated as owning at
least 10% of our ordinary share capital, such holder may be subject to adverse U.S. federal income tax consequences.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If a U.S. Holder (as defined below under Item
10E. &#8220;<i>Taxation</i>&#8221;) is treated as owning, directly, indirectly or constructively, at least 10% of the value or voting
power of our share capital, such U.S. Holder may be treated as a &#8220;U.S. shareholder&#8221; with respect to each &#8220;controlled
foreign corporation&#8221; in our group, if any. Because our group currently includes at least one U.S. subsidiary, under current law,
any of our current non-U.S. subsidiaries and any future newly formed or acquired non-U.S. subsidiaries will be treated as controlled foreign
corporations, regardless of whether we are treated as a controlled foreign corporation. A U.S. shareholder of a controlled foreign corporation
may be required to annually report and include in its U.S. taxable income its pro rata share of &#8220;Subpart F income,&#8221; &#8220;global
intangible low-taxed&#160;income&#8221; and investments in U.S.&#160;property by controlled foreign corporations, regardless of whether
we make any distributions. An individual that is a U.S. shareholder with respect to a controlled foreign corporation generally would not
be allowed certain tax deductions or foreign tax credits that would be allowed to a U.S. shareholder that is a U.S. corporation. Failure
to comply with controlled foreign corporation reporting obligations may subject a U.S. shareholder to significant monetary penalties.
We cannot provide any assurances that we will furnish to any U.S. shareholder information that may be necessary to comply with the reporting
and tax paying obligations applicable under the controlled foreign corporation rules of the Code. U.S. Holders should consult their tax
advisors regarding the potential application of these rules to their investment in ADSs. See Item 10E. &#8220;<i>Taxation</i>&#8221; for
a more detailed discussion.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>We incur significant costs as a result of
operating as a company that is publicly listed on both Nasdaq in the United States and Euronext Brussels in Belgium, and our management
is required to devote substantial time to new compliance initiatives.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">As a U.S. public company listed on Nasdaq, we
incur legal, accounting, and other expenses that we did not previously incur. We are subject to the reporting requirements of the Exchange
Act, the Sarbanes-Oxley&#160;Act, the Dodd-Frank&#160;Wall Street Reform and Consumer Protection Act, the Nasdaq listing requirements
and other applicable securities rules and regulations. Compliance with these rules and regulations will increase our legal and financial
compliance costs, make some activities more difficult, time consuming or costly and increase demand on our systems and resources, particularly
after we are no longer an &#8220;emerging growth company&#8221; and/or a foreign private issuer. The Exchange Act requires that, as a
public company, we file annual, semi-annual&#160;and current reports with respect to our business, financial condition and result of operations.
However, as a foreign private issuer, we are not required to file quarterly and current reports with respect to our business and results.
We currently make annual and semi-annual&#160;reporting with respect to our listing on Euronext Brussels.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Moreover, these rules and regulations increase
our legal and financial compliance costs and make some activities more time-consuming&#160;and costly. For example, we expect that these
rules and regulations may make it more difficult and more expensive for us to obtain director and officer liability insurance, which in
turn could make it more difficult for us to attract and retain qualified senior management personnel or members for our Board of Directors.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">However, these rules and regulations are often
subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may
evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding
compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Further, being a U.S. listed company and a Belgian
public company with shares admitted to trading on Euronext Brussels impacts the disclosure of information and requires compliance with
two sets of applicable rules. From time to time, this may result in uncertainty regarding compliance matters and result in higher costs
necessitated by legal analysis of dual legal regimes, ongoing revisions to disclosure and adherence to heightened governance practices.
As a result of the enhanced disclosure requirements of the U.S. securities laws, business and financial information that we report is
broadly disseminated and highly visible to investors, which we believe may increase the likelihood of threatened or actual litigation,
including by competitors and other third parties, which could, even if unsuccessful, divert financial resources and the attention of our
management from our operations.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>As a result of being a U.S. public company,
we are subject to regulatory compliance requirements, including Section 404 of the Sarbanes-Oxley Act (&#8220;Section 404&#8221;), and
if we fail to maintain an effective system of internal controls, we may not be able to accurately report our financial results or prevent
fraud.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Pursuant to Section 404, our management is required
to assess and attest to the effectiveness of our internal control over financial reporting in connection with issuing our consolidated
financial statements as of and for each fiscal year. Section 404 also requires an attestation report on the effectiveness of internal
control over financial reporting be provided by our independent registered public accounting firm beginning with our annual report following
the date on which we are no longer an &#8220;emerging growth company&#8221;, which may be up to five fiscal&#160;years from the initial
public offering of our ADSs.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The cost of complying with Section 404 significantly
increases and management&#8217;s attention may be diverted from other business concerns, which could adversely affect our results. We
may need to hire more employees in the future or engage outside consultants to comply with these requirements, which will further increase
expenses. If we fail to comply with the requirements of Section 404 in the required timeframe, we may be subject to sanctions or investigations
by regulatory authorities, including the SEC and Nasdaq. Furthermore, if we are unable to attest to the effectiveness of our internal
control over financial reporting, we could lose investor confidence in the accuracy and completeness of our financial reports, and the
market price of the ADSs could decline. Failure to implement or maintain effective internal control over financial reporting could also
restrict our future access to the capital markets and subject each of us, our directors and our officers to both significant monetary
and criminal liability. In addition, changing laws, regulations and standards relating to corporate governance and public disclosure are
creating uncertainty for public companies, increasing legal and financial compliance costs and making some activities more time consuming.
These laws, regulations and standards are subject to varying interpretations, in many cases due to their lack of specificity, and, as
a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could
result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance
practices. We intend to invest resources to comply with evolving laws, regulations and standards, and this investment may result in increased
general and administrative expense and a diversion of management&#8217;s time and attention from revenue generating activities to compliance
activities. If our efforts to comply with new laws, regulations and standards differ from the activities intended by regulatory or governing
bodies due to ambiguities related to their application and practice, regulatory authorities may initiate legal proceedings against us
and our business, financial position, results and prospects may be adversely affected.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b><i>&#160;</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b><i>If we fail to implement and maintain effective internal controls
over financial reporting, our ability to produce accurate financial statements on a timely basis could be impaired.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We are subject to reporting obligations under
U.S.&#160;securities laws and the Sarbanes-Oxley&#160;Act&#160;of&#160;2002. Section&#160;404 of the Sarbanes-Oxley&#160;Act requires
that we include a report from management on the effectiveness of our internal control over financial reporting in our annual report on
Form&#160;20-F&#160;for the year ended December&#160;31, 2022. If we fail to implement and maintain adequate disclosure controls and procedures,
our management may conclude that our internal control over financial reporting is not effective. This conclusion could adversely impact
the market price of the ADSs due to a loss of investor confidence in the reliability of our reporting processes.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In connection with the preparation of our financial
statements for the nine&#160;months ended September&#160;30, 2022, (the &#8220;Interim Financial Statements&#8221;), we identified a material
weakness in our internal control over financial reporting at September&#160;30, 2022 related to ineffective design and operation of our
interim financial close and reporting controls. More specifically, internal control over financial reporting procedures used in connection
with the preparation of the financial information that we reported in a press release issued on October&#160;27, 2022 failed to identify
a number of cut-off&#160;errors. These cut-off&#160;errors have been corrected in the Interim Financial Statements and do not relate to
our year-end close and reporting controls. A material weakness is a deficiency, or a combination of deficiencies, in internal control
over financial reporting such that there is a reasonable possibility that a material misstatement of a company&#8217;s annual or interim
financial statements will not be prevented or detected on a timely basis. Although we were able to remediate these issues, including engaging
an outside IFRS consulting firm to assist with our interim closing process, these efforts may not be sufficient to avoid similar material
weaknesses in the future. Undetected material weaknesses in our internal controls could lead to financial statement restatements and require
us to incur remediation costs. To the extent we experience additional future material weaknesses, investors could lose confidence in the
accuracy or completeness of our reported financial information, which could have a negative effect on the trading price of the ADSs. Failure
to implement or maintain effective internal control over financial reporting could also restrict our future access to the capital markets
and subject each of us, our directors and our officers to both significant monetary and criminal liability.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We are required to perform system and process
evaluations and testing of our internal controls over financial reporting, to allow our management and our independent public registered
accounting firm to report on the effectiveness of our internal control over financial reporting. In addition, our compliance with Section&#160;404
of the Sarbanes-Oxley&#160;Act will require that we incur substantial accounting expense, expend significant management effort and we
may need to hire additional accounting and financial staff with the appropriate experience and technical accounting knowledge, and compile
the system and process documentation necessary to perform the evaluation needed to comply with Section&#160;404 of the Sarbanes-Oxley&#160;Act.
We may not be able to complete our evaluation, testing and any required remediation in a timely fashion. Any failure to implement required
new or improved controls, or difficulties encountered in their implementation could cause us to fail to meet our reporting obligations.
In addition, any testing by us conducted in connection with Section&#160;404 of the Sarbanes-Oxley&#160;Act, or any subsequent testing
by our independent registered public accounting firm, may reveal additional deficiencies in our internal controls over financial reporting
that are deemed to be material weaknesses or that may require prospective or retroactive changes to our financial statements or identify
other areas for further attention or improvement. We cannot assure you that there will not be additional material weaknesses or significant
deficiencies in our internal control over financial reporting in the future.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>We may be subject to securities litigation,
which is expensive and could divert management&#8217;s attention.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The market price of the ADSs may be volatile and,
in the past, companies that have experienced volatility in the market price of their stock have been subject to securities class action
litigation. We may be the target of this type of litigation in the future. Securities litigation against us could result in substantial
costs and divert our management&#8217;s attention from other business concerns, which could seriously harm our business.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Investors resident in countries other than
Belgium may suffer dilution if they are unable to participate in future preferential subscription rights offerings.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Under Belgian law and our constitutional documents,
shareholders have a waivable and cancellable preferential subscription right to subscribe&#160;<i>pro&#160;rata</i>&#160;to their existing
shareholdings to the issuance, against a contribution in cash, of new shares or other securities entitling the holder thereof to new shares,
unless such rights are limited or cancelled by resolution of our general shareholders&#8217; meeting or, if so authorized by a resolution
of such meeting, our Board of Directors. The exercise of preferential subscription rights by certain shareholders not residing in Belgium
(including those in the United States, Australia, Israel, Canada or Japan as a result of the offering and taking into account the current
shareholding and international network of our current Board of Directors) may be restricted by applicable law, practice or other considerations,
and such shareholders may not be entitled to exercise such rights, unless the rights and shares are registered or qualified for sale under
the relevant legislation or regulatory framework. In particular, we may not be able to establish an exemption from registration in the
United States under the Securities Act of 1933, as amended (the &#8220;Securities Act&#8221;), and we are under no obligation to file
a registration statement with respect to any such preferential subscription rights or underlying securities or to endeavor to have a registration
statement declared effective under the Securities Act. Shareholders in jurisdictions outside Belgium who are not able or not permitted
to exercise their preferential subscription rights in the event of a future preferential subscription rights, equity or other offering
may suffer dilution of their shareholdings.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>ADS holders may not be able to exercise
their right to vote the ordinary shares underlying their ADSs.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">ADS holders do not have the same rights as our
shareholders. For example, ADS holders may not attend shareholders&#8217; meetings or directly exercise the voting rights attaching to
the ordinary shares underlying their ADSs. ADS holders may vote only by instructing the depositary to vote on their behalf. If we request
the depositary to solicit your voting instructions (and we are not required to do so), the depositary will notify you of a shareholders&#8217;
meeting and send or make voting materials available to you. Those materials will describe the matters to be voted on and explain how ADS
holders may instruct the depositary how to vote. For instructions to be valid, they must reach the depositary by a date set by the depositary.
The depositary will try, as far as practical, to vote or to have its agents vote the deposited ordinary shares as instructed by ADS holders.
If we do not request the depositary to solicit ADS holders&#8217; voting instructions, ADS holders can still send voting instructions,
and, in that case, the depositary may try to vote as the ADS holder instructs, but it is not required to do so. Except by instructing
the depositary as described above, ADS holders will not be able to exercise voting rights unless the ADS holder surrenders the ADS holder&#8217;s
ADSs and withdraw the ordinary shares.&#160;However, ADS holders may not know about the meeting enough in advance to withdraw the ordinary
shares. We cannot assure ADS holders that they will receive the voting materials in time to ensure that they can instruct the depositary
to vote their ordinary shares. In addition, the depositary and its agents are not responsible for failing to carry out voting instructions
or for the manner of carrying out voting instructions. This means that ADS holders may not be able to exercise voting rights and there
may be nothing an ADS holder can do if the ADS holder&#8217;s ordinary shares are not voted as the ADS holder requested. In addition,
ADS holders have no right to call a shareholders&#8217; meeting.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Holders of ADSs may be subject to limitations
on the transfer of their ADSs and the withdrawal of the underlying ordinary shares.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">ADSs, which may be evidenced by American Depositary
Receipts, are transferable on the books of the depositary. However, the depositary may close its books at any time or from time to time
when it deems expedient in connection with the performance of its duties. The depositary may refuse to deliver, transfer or register transfers
of ADSs generally when our books or the books of the depositary are closed, or at any time if we or the depositary think it is advisable
to do so because of any requirement of law, government or governmental body, or under any provision of the deposit agreement, or for any
other reason subject to a holder of ADSs&#8217; right to cancel his or her ADSs and withdraw the underlying ordinary shares as specified
in the deposit agreement. Temporary delays in the cancellation of ADSs and withdrawal of the underlying ordinary shares may arise because
the depositary has closed its transfer books or we have closed our transfer books, in connection with voting at a shareholders&#8217;
meeting or we are paying a dividend on our ordinary shares. In addition, a holder of ADSs may not be able to cancel his or her ADSs and
withdraw the underlying ordinary shares when he or she owes money for fees, taxes and similar charges and when it is necessary to prohibit
withdrawals in order to comply with any laws or governmental regulations that apply to ADSs or to the withdrawal of ordinary shares or
other deposited securities. See Item 12D. &#8220;<i>American Depositary Shares</i>.&#8221;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>ADS holders may not be entitled to a jury
trial with respect to claims arising under the deposit agreement, which could result in less favorable outcomes to the plaintiffs in any
such action.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The deposit agreement governing the ADSs representing
our ordinary shares provides that, to the fullest extent permitted by law, ADS holders, including holders who acquire ADSs in the secondary
market, waive the right to a jury trial of any claim they may have against us or the depositary arising out of or relating to our shares,
the ADSs or the deposit agreement, including any claim under the U.S. federal securities laws.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="margin: 0">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If we or the depositary opposed a jury trial
demand based on the waiver, the court would determine whether the waiver was enforceable based on the facts and circumstances of that
case in accordance with the applicable state and federal law. To our knowledge, the enforceability of a contractual pre-dispute&#160;jury
trial waiver in connection with claims arising under the federal securities laws has not been finally adjudicated by the U.S. Supreme
Court. However, we believe that a contractual pre-dispute&#160;jury trial waiver provision is generally enforceable, including under
the laws of the State of New York, which govern the deposit agreement, by a federal or state court in the City of New York, which has
non-exclusive&#160;jurisdiction over matters arising under the deposit agreement. In determining whether to enforce a contractual pre-dispute&#160;jury
trial waiver provision, courts will generally consider whether a party knowingly, intelligently and voluntarily waived the right to a
jury trial. We believe that this is the case with respect to the deposit agreement and the ADSs. It is advisable that you consult legal
counsel regarding the jury waiver provision before entering into the deposit agreement.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If any owners or holders of ADSs bring a claim
against us or the depositary in connection with matters arising under the deposit agreement or the ADSs, including claims under federal
securities laws, such other holder or beneficial owner may not be entitled to a jury trial with respect to such claims, which may have
the effect of limiting and discouraging lawsuits against us and the depositary. If a lawsuit is brought against either or both of us
and the depositary under the deposit agreement, it may be heard only by a judge or justice of the applicable trial court, which would
be conducted according to different civil procedures and may result in different outcomes than a trial by jury would have, including
results that could be less favorable to the plaintiffs in any such action.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Nevertheless, if this jury trial waiver provision
is not permitted by applicable law, an action could proceed under the terms of the deposit agreement with a jury trial. No condition,
stipulation or provision of the deposit agreement or ADSs serves as a waiver by any owner or holder of ADSs or by us or the depositary
of compliance with U.S. federal securities laws and the rules and regulations promulgated thereunder.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Takeover provisions in the national law
of Belgium may make a takeover difficult.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Public takeover bids on our shares and other
voting securities, such as warrants or convertible bonds, if any, are subject to the Belgian Act of April&#160;1, 2007 on public takeover
bids, as amended and implemented by the Belgian Royal Decree of April&#160;27, 2007, or Royal Decree, and to the supervision by the Belgian
Financial Services and Markets Authority, or FSMA. Public takeover bids must be made for all of our voting securities, as well as for
all other securities that entitle the holders thereof to the subscription to, the acquisition of or the conversion into voting securities.
Prior to making a bid, a bidder must issue and disseminate a prospectus, which must be approved by the FSMA. The bidder must also obtain
approval of the relevant competition authorities, where such approval is legally required for the acquisition of our company. The Belgian
Act of April&#160;1, 2007 provides that a mandatory bid will be required to be launched for all of our outstanding shares and securities
giving access to shares if a person, as a result of its own acquisition or the acquisition by persons acting in concert with it or by
persons acting on their account, directly or indirectly holds more than 30% of the voting securities in a company that has its registered
office in Belgium and of which at least part of the voting securities are traded on a regulated market or on a multilateral trading facility
designated by the Royal Decree. The mere fact of exceeding the relevant threshold through the acquisition of one or more shares will
give rise to a mandatory bid, irrespective of whether or not the price paid in the relevant transaction exceeds the current market price.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">There are several provisions of Belgian company
law and certain other provisions of Belgian law, such as the obligation to disclose important shareholdings and merger control, that
may apply to us and which may make an unfriendly tender offer, merger, change in management or other change in control, more difficult.
These provisions could discourage potential takeover attempts that third parties may consider and thus deprive the shareholders of the
opportunity to sell their shares at a premium (which is typically offered in the framework of a takeover bid).</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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</div><div><a id="a_007"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>ITEM 4. INFORMATION ON THE COMPANY</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>A. History and Development of the Company
</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We were incorporated on January&#160;10, 2003
as a company with limited liability (<i>naamloze vennootschap/soci&#233;t&#233; anonyme</i>) incorporated and operating under the
laws of Belgium. We are registered with the legal entities register (Li&#232;ge) under enterprise number 0479.292.440. We were publicly
listed on Euronext Brussels in June&#160;2006. In October 2010 the Company&#8217;s name was changed from OncoMethylome Sciences SA to&#160;MDxHealth
SA. We have two directly held, wholly owned subsidiaries: MDxHealth, Inc., a Delaware company incorporated in April 2003, and MDxHealth
B.V., a Dutch company incorporated in September 2015. Our agent for service of process in the United States is MDxHealth, Inc., which
is located at 15279 Alton Parkway &#8212; Suite 100, Irvine, CA 92618. MDxHealth, Inc.&#8217;s telephone number is +1 949-812-6979.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our headquarters and principal executive offices
are located at CAP Business Center, Zone Industrielle des Hauts-Sarts, Rue d&#8217;Abhooz&#160;31, 4040 Herstal, Belgium, our telephone
number is +32 4 257 70 21 and our email is info@mdxhealth.com. Our website address is&#160;<i>www.mdxhealth.com</i>. The information
contained on, or accessible through, our website is not incorporated by reference into this annual report, and you should not consider
any information contained in, or that can be accessed through, our website as part of this annual report or in deciding whether to purchase
ADSs.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our capital expenditures for the years ended
December 31, 2020, 2021 and 2022 amounted to $540,000, $1.2 million and 2.8 million, respectively. These capital expenditures primarily
consisted of laboratory equipment, information technology equipment, and leasehold improvements. To date, we have expensed all research
and development costs as incurred, as we do not currently meet the conditions to capitalize expenditures on drug development activities,
as provided in IAS&#160;38&#160;<i>Intangible Assets</i>. Our research and development costs for the&#160;years ended December 31, 2020,
2021 and 2022 amounted to $4.5 million, $6.7 million and $7.6 million, respectively. These research and development costs primarily consisted
of expenses incurred in connection with the development of our pipeline products, such as labor costs (including salaries, bonuses, benefits,
and stock-based&#160;compensation), reagents and supplies, clinical studies, outside services, patent expenses, depreciation of laboratory
equipment, facility occupancy and information technology costs. We expect that our research and development expenses will increase in
absolute dollars as we continue to develop additional products, however, we expect that these expenses will decrease as a percentage
of revenue over the long term, though they may fluctuate as a percentage from period to period due to the timing and extent of these
expenses. For the near future, our investments will mainly remain in the United States where our molecular laboratory facility is currently
located.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The SEC maintains a website that contains reports,
proxy and information statements, and other information regarding issuers that file electronically with the SEC at <i>http://www.sec.gov</i>.
We also maintain a website at <i>http://www.mdxhealth.com/</i>. The reference to our website is an inactive textual reference only and
the information contained in, or that can be accessed through, our website or any other website cited in this annual report is not a
part of this annual report.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>B. Business Overview </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Overview</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We are a commercial-stage precision diagnostics
company committed to providing non-invasive, clinically actionable and cost-effective urologic solutions to improve patient care. Our
novel genomic testing solutions combine advanced clinical modeling with genomic data to provide each patient with a personalized risk
profile, which provides more accurate and actionable information than traditional clinical risk factors used by clinicians. Our Select
mdx and Confirm mdx tests address men at risk for undetected prostate cancer, providing physicians with a clear clinical pathway to accurately
identify clinically significant prostate cancer while reducing the use of invasive procedures that are prone to complications. Our GPS
test addresses men newly diagnosed with localized prostate cancer, providing physicians with a clear clinical pathway to make the most
informed treatment decision for their individual disease. Our team&#8217;s collective decades of experience in precision diagnostics
and our portfolio of novel biomarkers for diagnostic, prognostic and predictive molecular assays supports our active pipeline of new
testing solutions for urologic diseases.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Prostate cancer is presently the most common,
and second deadliest, form of cancer in men. The broad adoption of prostate-specific antigen (&#8220;PSA&#8221;) screening in the 1980s
created a paradigm shift in men&#8217;s health, reducing the incidence of metastatic prostate cancers by more than 50%. However, widespread
PSA testing also significantly increased the pool of symptomatic men, resulting in overdiagnosis, overtreatment, serious complications,
and potential anxiety &#8212; triggering a retreat from standardized PSA screening &#8212; culminating with the decision of the U.S.
Preventative Services Task Force&#8217;s (&#8220;USPSTF&#8221;) to recommend against all PSA testing and prostate cancer screening in
2012. Following recommendations from clinicians and patient advocates together with building evidence of an uptick in metastatic prostate
cancer incidence, the USPSTF softened its position in 2017, upgrading PSA screening for middle-aged men. However, the USPSTF&#8217;s
reversal left unresolved the clinical dilemma posed by the estimated pool of over ten million men living with an elevated PSA in the
United States. Approximately 25 million PSA tests are performed each year, and over 15% of these reveal heightened PSA levels &#8212;
leading to an estimated pool of over three million undiagnosed men informed each year of their heightened risk for prostate cancer based
on elevated PSA test results and/or negative biopsy results. Other than repeated invasive needle biopsy procedures, these symptomatic
men and their clinicians have limited tools to manage their cancer risk.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our Select mdx and Confirm mdx testing solutions
directly address this unmet clinical need. Since the commercial launch of Confirm mdx in 2012 and Select mdx in 2016, we have performed
over 200,000 tests ordered by more than 1,000 urologists in the United States. Select mdx for Prostate Cancer (a urine test for men being
considered for their first prostate biopsy) and Confirm mdx for prostate cancer (an epigenetic test for men post-prostate biopsy), are
designed to (i) improve the earlier detection of clinically significant prostate cancer in at-risk men and (ii) reduce the unnecessary
costs and patient anxiety associated with the diagnosis and treatment of the disease. Both tests have been included in the National Comprehensive
Cancer Network (&#8220;NCCN&#8221;) Guidelines for the Early Prostate Cancer Detection. NCCN is a non-profit alliance of the 31 leading
cancer centers in the United States. Both tests have also successfully completed formal technical assessment review for Medicare reimbursement
and have received a positive final local coverage determination (&#8220;LCD&#8221;).</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">While our existing prostate cancer tests, Select
mdx and Confirm mdx, improve the decision for biopsy in at-risk patients, our recently acquired GPS test moves us further into the cancer
management pathway, providing solutions for patients newly diagnosed with localized prostate cancer to make the most informed treatment
decision for their individual disease. Our acquisition of the GPS (formerly Oncotype DX GPS) prostate cancer business in August 2022
from Genomic Health, Inc., a subsidiary of Exact Sciences, has accelerated our plans to build on our leadership in the urologic diagnostic
space.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Currently, most newly diagnosed cases of
prostate cancer remain indolent&#160;&#8212;&#160;slow growing and non-lethal. Patients diagnosed with indolent prostate cancer may be
appropriately managed with observation or active surveillance (&#8220;AS&#8221;), while those with aggressive cancers may benefit
from immediate treatment. Practice-management agencies worldwide have implemented guidelines stressing the importance of discerning
favorable from unfavorable disease features to guide personalized management for patients diagnosed with low- and high-risk prostate
cancer, including among others NCCN, the American Urology Association, American Society for Radiation Oncology, Society of Urologic
Oncology, the American Society of Clinical Oncology, the National Institute for Health and Care Excellence, and the European
Association of Urology (&#8220;EAU&#8221;). The use of AS has increased in recent years, with approximately half of patients newly
diagnosed with localized prostate cancer choosing to avoid immediate intervention or similar treatment.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">GPS is a tissue-based, multi-gene test that has
been clinically validated to predict aggressive cancer at the time of diagnosis, helping to identify those men who need immediate surgery
or radiation therapy versus those who can confidently choose AS. Since its commercial launch in 2013, over 100,000 GPS tests have been
performed, ordered by more than 3,000 urologists in the United States. GPS is able to provide a more precise and accurate assessment
of disease progression, which helps more men avoid the lifelong complications associated with aggressive treatments. In 2015 our GPS
test received a positive Medicare LCD under the MolDX Program, which provides coverage and reimbursement for Medicare beneficiaries throughout
the United&#160;States.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Building from the foundation of our complementary
marketed products, we are committed to sustained growth, with our core management principles defined by a commitment to focus, commercial
execution and operating discipline throughout our organization. While MDxHealth is domiciled and listed as a public company in Belgium,
our primary commercial focus is the United States, where over 95% of our tests are performed and revenues are generated. Our leadership
change in 2019 and coincident organizational and operational discipline implemented throughout the MDxHealth group of companies has further
focused our commitment to U.S.-sourced growth, with our entire executive management team and over 90% of staff based in or reporting
to our U.S. headquarters and laboratories.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We have established a systematic approach to
commercializing our precision diagnostic solutions in our target markets in the United States, focusing on active engagement, education
and market development directed toward health care professionals and their patients. Our commercial team is focused on prioritizing large
and high-volume community urology centers, and on building long-standing relationships with key physicians and practice groups who have
strong connections to the population of men who may be eligible for our solutions. Our ultimate goal is to support physicians using our
tests through all aspects of the patient&#8217;s journey, starting from initial diagnosis through to advanced prostate cancer management.
We also seek to build on our long-term partnerships with key opinion leaders (&#8220;KOLs&#8221;) and patient associations that are oriented
towards the needs of our patients and customers. Our sales and marketing organization is focused on building physician awareness of the
clinical and economic benefits provided by our tests through education of urologists and their clinical staff as well as pathology and
laboratory staff, targeted KOL development and training, and development of tools for our customers to interact with patients and consumers
(doctor-to-consumer education).</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Our Product Portfolio</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="text-align: justify; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Our core commercial tests address a substantial unmet clinical need
in the prostate cancer diagnostic and treatment pathway. According to the American Cancer Society, prostate cancer is the most common,
and second deadliest, form of cancer in males in the United States. Prior to the emergence of precision diagnostic solutions, existing
diagnostic tests were critically flawed, with high false negatives and false positives, leading to costly and invasive diagnostic protocols
and attendant complications.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><p style="text-align: justify; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">To screen at-risk men for prostate cancer, approximately 25 million
PSA tests are performed each year, and over 15% of those reveal heightened levels of PSA. An elevated PSA level can be caused by many
different sources, the majority of which are not cancer. Current clinical guidelines suggest that men with an elevated PSA should be
considered for a prostate biopsy, so that a pathologist can visually inspect the sampled tissue to identify any sign of malignancy. However,
60% of biopsies are negative, not revealing any cancer, and as many as a third of these negative biopsies are false negatives, providing
limited comfort to patients and their physicians that cancer was not missed. The relatively modest sensitivity and specificity of these
current standard-of-care tests and procedures has led to increased patient anxiety, potentially unnecessary, invasive and costly interventions,
and increased complications and hospitalizations.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><p style="text-align: justify; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Our Select mdx test &#8212; which is a noninvasive urine test with
95% Negative Predictive Value (&#8220;NPV&#8221;) for clinically significant prostate cancer &#8212; can be used to help physicians determine
whether a costly, painful and complication-prone needle-core biopsy is advisable when a patient presents with an elevated PSA level or
an abnormal digital rectal exam (&#8220;DRE&#8221;). For those men who proceed to a biopsy procedure, our Confirm mdx test, which measures
biomarker signals in the biopsied tissue, provides additional information to physicians and increases the accuracy of the biopsy, with
a 96% NPV for clinically significant disease.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><p style="text-align: justify; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Upon an initial diagnosis of localized
prostate cancer, our GPS test &#8212; which measures the expression of a panel of genes in prostate cancer tissue to predict the
aggressiveness of the disease &#8212; can help distinguish between aggressive and indolent prostate cancer, which informs treatment
decisions and helps to identify patients who may avoid unnecessary interventions.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><img alt="" src="image_001.jpg"/>&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">To further supplement our prostate cancer menu,
with Resolve mdx we have developed a novel, advanced urinary tract infection (&#8220;UTI&#8221;) test that delivers patient-specific
antimicrobial treatment options within 24-48 hours (standard urine cultures can take up to 5 to 7 days). Developed especially for patients
with recurrent, persistent, and complicated UTIs, Resolve mdx combines precise pathogen identification and resistance gene detection
with a proprietary susceptibility methodology that identifies personalized oral antibiotic options for fast resolution and improved patient
outcomes.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Our Competitive Strengths</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We believe we have the following competitive
strengths, which underpin our commercial execution success and will position us for sustainable growth:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Targeted
                                            Menu Improving Prostate Cancer Diagnosis and Treatment</b>. We offer a menu of tests that
                                            provide clinically actionable results for men at-risk for, as well as men newly diagnosed
                                            with, prostate cancer. Collectively, Select mdx, Confirm mdx and GPS provide urologists with
                                            a clear clinical pathway to accurately identify and appropriately treat prostate cancer while
                                            minimizing the use of aggressive procedures and treatments, improving health outcomes and
                                            significantly lowering costs to the healthcare system.</span></td>
</tr></table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Strong
                                            Commercial Focus and Presence</b>. We aim to increase adoption of our commercial tests by
                                            leveraging our direct sales force in the United States to continue to market and sell to
                                            our urology-focused network. We have significant experience in building effective commercial
                                            teams consisting of sales reps, strategic account managers, and clinical liaisons led by
                                            a management team with a track record of success. In addition, our payor and reimbursement,
                                            revenue cycle management and client services groups provide expert support for our field
                                            sales team as well as our patients and customer base. We believe we can leverage these groups
                                            to explore additional opportunities for growth based on this commercial channel. Outside
                                            the United States, we will continue to evaluate distribution partners to drive adoption in
                                            markets where our menu is best suited.</span></td>
</tr></table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Commercial
                                            Channel Advantage</b>. Building from the launch of our first commercial test in 2012, we
                                            have established MDxHealth as an industry leader in precision diagnostics for prostate cancer
                                            detection and treatment. We intend to take advantage of our established urology and pathology
                                            relationships to support menu expansion and additional growth opportunities as appropriate
                                            and within our focus.</span></td>
</tr></table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Compelling
                                            Reimbursement Strategy</b>. Adoption of our Confirm mdx, Select mdx and GPS tests has been
                                            supported by LCDs issued via the MolDX Program, their inclusion in NCCN and other U.S. and
                                            internationally recognized clinical-practice guidelines, as well as consistent expansion
                                            of coverage by commercial payors. Our Resolve mdx UTI test is currently reimbursed by Medicare
                                            and most private insurance payors, based on nationally recognized Current Procedural Terminology
                                            (&#8220;CPT&#8221;) codes.</span></td>
</tr></table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 39; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: normal 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->33<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Robust
                                            and Reliable Technology</b>. We possess a proprietary know-how and intellectual property
                                            portfolio capable of advancing our precision diagnostics pathway as well as high quality
                                            laboratory operations, including our CAP accredited, CLIA certified and New York State Department
                                            of Health (&#8220;NYSDOH&#8221;) approved molecular laboratory facilities.&#160;&#160;We
                                            also have an extensive library of biomarkers that can be applied in additional urology and
                                            men&#8217;s health diagnostics.</span></td>
</tr></table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Proven
                                            Leadership with Industry Expertise</b>. Our management team members have proven track records
                                            of execution and value creation across medical devices, diagnostics and biotech. We believe
                                            we have built a culture of performance, responsibility and accountability &#8212; from research
                                            and development, to sales and marketing, and operations and management &#8212; and are committed
                                            to building value for all of our stakeholders, including patients, customers, employees and
                                            shareholders.</span></td>
</tr></table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Our Strategy</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our ultimate goal with our core testing solutions
is to take an at-risk patient from prostate cancer screening all the way through the diagnostic and therapeutic pathway of prostate cancer.
As such, we are focused on continuing to drive adoption of our Select mdx, Confirm mdx, and GPS tests and expand our product offerings.
The key elements of our strategy include:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Physician
                                            and Patient Education</b>. One important component of our efforts to successfully penetrate
                                            the urology market and promote clinical adoption of our Select mdx, Confirm mdx, GPS and
                                            Resolve mdx tests is to drive awareness of these tests. We educate physicians and patients
                                            through a variety of channels including by supporting clinical studies for the publication
                                            of peer reviewed journals and abstracts at key scientific conferences, forging relationships
                                            with the leading medical and scientific opinion leaders in urology, developing strategic
                                            partnerships with leading pathology laboratories with large urology client bases and via
                                            public relations and advertising campaigns.</span></td>
</tr></table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Expand
                                            Test Menu</b>. We intend to build on our leadership in the prostate cancer diagnostic space
                                            by expanding our existing menu of tests. We are currently developing a candidate test, Monitor
                                            mdx, for the prostate cancer diagnostic and treatment pathway.&#160;&#160;Monitor mdx is
                                            intended to function as a non-invasive solution that risk stratifies patients for continued
                                            AS versus intervention, while also improving patient compliance with AS protocols.</span></td>
</tr></table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Expand
                                            Reimbursement</b>. An important component of our commercial strategy is to expand reimbursement
                                            for our tests. Our Select mdx, Confirm mdx and GPS tests have been covered by a Medicare
                                            MoIDX LCD since 2023, 2014 and 2015, respectively. Our managed care team continues to pursue
                                            adoption of positive coverage and reimbursement policies and contracts by other payors. We
                                            believe the clinical utility and actionability of our tests, combined with our experience
                                            and knowledge of the complex coverage and reimbursement landscape in the United States, will
                                            enable us to expand coverage and reimbursement among the commercial payor market. We continue
                                            to build upon our successful strategy, supported by governmental and commercial coverage
                                            policies, as a foundation to secure additional contracts from major payors.</span></td>
</tr></table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Market Opportunity</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Among U.S. males, prostate cancer is the most
diagnosed cancer and the second leading cause of cancer death. According to the American Cancer Society, in 2023, over 280,000 men are
expected to be diagnosed with prostate cancer in the United States, with more than 34,000 dying from the disease.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">There are currently significant challenges with
diagnosing and treating prostate cancer in the United States. Approximately 25 million PSA tests are performed each year, and over 15%
of those reveal heightened levels of PSA. Current clinical guidelines suggest that men with an elevated PSA should be considered for
a prostate biopsy, However, approximately 60% of biopsies are negative, not revealing any cancer, and as many as a third of these negative
biopsies are false negatives, providing limited comfort to patients and their physicians that cancer was not missed. For those men whose
biopsies are positive, the majority will harbor indolent cancer, but traditional methods are unable to accurately identify which of these
men might safely avoid invasive and costly interventions. In addition, for patients diagnosed with localized prostate cancer who are
on AS, management of their disease relies on the measurement of PSA levels and DRE results, which can be unreliable and lead to overdiagnosis
and overtreatment.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 40; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: normal 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->34<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The relatively modest sensitivity, specificity
and prognostic ability of current standard-of-care tests and procedures has led to increased patient anxiety, potentially unnecessary,
invasive and costly interventions, and increased complications and hospitalizations. Our suite of commercial products addresses these
issues, presenting a substantial market opportunity. The Company has calculated approximate addressable market opportunities for our
menu of tests, based on the estimated:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">3
                                            million men screened for prostate cancer annually;</span></td>
</tr></table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">500,000
                                            men who undergo prostate biopsies annually;</span></td>
</tr></table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">268,000
                                            men diagnosed prostate cancers annually; and</span></td>
</tr></table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">2
                                            million UTI cases managed by urologists annually.</span></td>
</tr></table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><img alt="" src="image_002.jpg"/>&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">* Resolve mdx test in development
(all figures based on management estimates).</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Commercial Products</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Select mdx for Prostate Cancer Urine Test</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The current standard for prostate cancer
screening is the PSA blood test. Unfortunately, the PSA is not specific to clinically significant prostate cancer &#8212; it is more
of an indicator of prostate health. There are many factors such as benign prostatic hyperplasia, inflammation, prostatitis and a
naturally occurring enlarged prostate that can cause an elevated PSA. In men with an elevated PSA level between 3-10 ng/mL, only
25-40% of biopsies reveal cancer &#8212; and the majority of these identified cancers are indolent. Also, following a prostate
biopsy procedure, around 18% of men suffer complications (blood in urine) and around 3% are hospitalized for infection (sepsis).
Select mdx helps physicians determine if a patient is at higher or lower risk for prostate cancer and which men can safely avoid
biopsy.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 41; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: normal 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->35<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Select mdx is a non-invasive urine test that
measures the expression of two mRNA cancer-related biomarkers (HOXC6 and DLX1) combined with an advanced clinical model incorporating
traditional risk factors. The test provides a personalized risk profile that helps the physician determine whether:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left">&#9679;</td><td style="text-align: justify">The patient may
                                            benefit from a biopsy and early prostate cancer detection; or</td>
</tr></table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left">&#9679;</td><td style="text-align: justify">The patient can
                                            avoid a biopsy and return to routine screening.</td>
</tr></table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Men identified by the test as having a high likelihood
of clinically significant cancer can, upon biopsy, be diagnosed and treated sooner, while men identified at very low risk may avoid biopsy.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The following chart depicts the functioning of
the Select mdx test:&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><img alt="" src="image_003.jpg"/>&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Guidelines Inclusion</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Select mdx has been included in the NCCN Prostate
Cancer Early Detection guidelines since 2020. Select mdx has also been included in the EAU Prostate Cancer guidelines since 2018.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Clinical Validation Studies</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The use of Select mdx as a predictive test to
identify men at low risk for aggressive prostate cancer has been well validated in both scientific and clinical studies.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Results from the clinical validation study for
Select mdx confirmed its superior performance compared to other commonly used biomarker tests and risk calculators. The test&#8217;s
NPV of 95% in the validation study means that if the test identifies a very low risk, the physician and patient can be 95% sure that
a subsequent biopsy will not detect Gleason score &#8805;7 prostate cancer, information that may provide a level of confidence needed to
avoid a biopsy. The test has a very high predictive accuracy (AUC 0.85) for high-grade prostate cancer, which is significantly better
than the Prostate Cancer Prevention Trial Risk Calculator (&#8220;PCPTRC&#8221;) version 2.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">There are twelve published studies assessing
the Select mdx test and which together demonstrate its analytical validity, clinical validity, clinical utility and positive health economic
outcomes. These studies, all of which have been published in peer-reviewed publications, evaluated more than 4,500 patients in the aggregate.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The following is a summary that highlights key
findings from some of these studies.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.5in">&#160;</td>
    <td style="width: 0.25in; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Analytical
    validity</b>. A study published in 2017 illustrated, in an independent laboratory, the performance characteristics and robustness
    of the Select mdx mRNA assay, covering all aspects of analytical method validation including assay sensitivity, specificity, linearity,
    precision, repeatability and reproducibility using pre-specified acceptance criteria.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 42; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: normal 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->36<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.5in">&#160;</td>
    <td style="width: 0.25in; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Clinical
    validity</b>. In a study published in 2019, the Select mdx test demonstrated an NPV of 95%. Urine samples were collected from 1,955
    men from The Netherlands, France and Germany prior to an initial prostate biopsy. Select mdx molecular biomarker results were combined
    with other risk factors in a clinical model optimized to detect International Society of Urological Pathology Grade Group 2 or greater
    prostate cancer in men. Results in the validation cohort were compared with the independent PCPT risk calculator version 2. The full
    validation cohort of 916 men including all prostate specific antigen levels yielded an AUC of 0.85 with 93% sensitivity, 47% specificity
    and 95% negative predictive value. The PCPTRC AUC was 0.76. In the 715-patient validation cohort, limited to subjects with PSA less
    than 10 ng/ml, the AUC was 0.82 with 89% sensitivity, 53% specificity and 95% negative predictive value. The PCPTRC AUC was 0.70.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.5in">&#160;</td>
    <td style="width: 0.25in; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Clinical
    utility</b>. In a 2019 study, Select mdx had a significant impact on initial prostate biopsy decision-making in a U.S. community
    urology setting. Biopsy rates in Select mdx positive men were 5-fold higher than in Select mdx negatives.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.5in">&#160;</td>
    <td style="width: 0.25in; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Health
    economic outcomes</b>. A 2018 study demonstrated that routine use of the Select mdx test to guide biopsy decision making improved
    health outcomes and significantly lowered costs in American men at risk for prostate cancer. Compared to the current standard of
    care, Select mdx implementation would result in an average of 0.045 quality-adjusted life years (&#8220;QALYs&#8221;) gained at a
    cost savings of $1,694 per patient. Assuming approximately 300,000 men are biopsied each year, this translates to an incremental
    14,000 QALYs gained at cost savings of $500,000 annually.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><img alt="" src="image_004.jpg"/>&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Confirm mdx for Prostate Cancer Tissue
Test</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Approximately 30% of men with a cancer-negative
prostate biopsy actually have cancer. Prostate cancer is difficult to diagnose because it is both heterogenous and multi-focal. The standard
of care for diagnosing prostate cancer is a transrectal ultrasound guided biopsy. However, this procedure samples less than 1% of the
entire gland, leaving men at risk for undetected prostate cancer.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Confirm mdx is a well-validated epigenetic test
that guides the detection of occult prostate cancer on a patient&#8217;s previously biopsied negative tissue. The test can help urologists
determine a man&#8217;s risk for harboring clinically significant prostate cancer despite having a cancer-negative biopsy result, and
it has a number of unique features/advantages.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 43; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: normal 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->37<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">For patients with an initial negative biopsy,
few options are currently available to guide an urologist in determining whether or when an additional biopsy procedure is warranted.
Fear of occult (hidden) prostate cancer leads to additional procedures, leading many men to receive multiple follow-up biopsy procedures
to rule out the presence of cancer.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Confirm mdx test addresses prostate biopsy
sampling concerns, helping urologists to:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#8220;Rule-out&#8221;
                                            men from undergoing potentially unnecessary repeat biopsies and screening procedures, helping
                                            to reduce complications, patient anxiety and excessive healthcare expenses associated with
                                            these procedures; and</span></td>
</tr></table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#8220;Rule-in&#8221;
                                            high-risk men with a previous negative biopsy result who may be harboring undetected cancer
                                            (false negative biopsy result) and therefore may benefit from a repeat biopsy and potentially
                                            treatment.</span></td>
</tr></table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">For men with a negative biopsy, independently
published clinical studies have shown that the Confirm mdx test is the most significant, independent predictor of prostate biopsy outcomes
relative to other available clinical factors such as age, PSA and DRE results. Incorporating Confirm mdx into clinical practice can reduce
the number of unnecessary repeat biopsies, yielding clinical and economic value for healthcare providers, patients and payors. Confirm
mdx can aid urologists with patient management decisions regarding the need for follow-up testing and procedures with the identification
of low-risk patients testing negative for DNA hypermethylation.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The use of Confirm mdx for prostate cancer detection
using methylation-specific PCR (&#8220;MSP&#8221;) and cancer-associated epigenetic biomarkers to improve upon histopathology has been
well validated in both scientific and clinical studies. DNA methylation, the most common and useful measure of epigenetic abnormality
testing, is responsible for the silencing of key tumor suppressor genes. DNA methylation biomarkers associated with prostate cancer have
been extensively evaluated.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">GSTP1 is a widely studied and reported epigenetic
biomarker associated with prostate cancer diagnosis, encoding the glutathione S-transferase Pi 1 (GSTP1) protein involved in detoxification,
due to its high sensitivity and specificity. Complementing GSTP1, methylation of the APC and RASSF1 genes is frequently found in prostate
cancer, and these markers have demonstrated a &#8220;field effect&#8221; aiding in the identification of biopsies with false-negative
histopathological results.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The epigenetic field effect is a molecular mechanism
whereby cells adjacent to cancer foci can contain DNA methylation changes, which may be indistinguishable by histopathology, but detectable
by MSP testing. The presence of epigenetic field effects associated with prostate cancer has been widely published and is the basis of
activity for the Confirm mdx assay to aid in the detection of occult prostate cancer on previously biopsied, histopathologically negative
tissue.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 44; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: normal 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->38<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The following image depicts how the Confirm mdx
test identifies false-negative biopsies:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Confirm mdx Field Effect</span></i></p><div>

</div><p style="font: italic 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 8pt; text-align: justify">&#160;</p><div>

</div><p style="font: italic 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 8pt; text-align: justify"></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
<tr style="vertical-align: top; text-align: left">
  <td style="text-align: center; width: 30%; vertical-align: middle"><img alt="" src="image_005.jpg"/></td>
  <td style="text-align: left; width: 70%; vertical-align: bottom"><img alt="" src="image_006.jpg"/>&#160;</td></tr>
</table><div>

</div><p style="font: italic 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 8pt; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Guidelines Inclusion</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Confirm mdx has been included in the NCCN Prostate
Cancer Early Detection guidelines since 2016. Confirm mdx has also been included in the EAU Prostate Cancer guidelines since 2018.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Confirm mdx Clinical Validation Studies</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The use of Confirm mdx for prostate cancer detection
to improve upon histopathology has been well validated in both scientific and clinical studies.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">There are more than 55 published studies on the
genes and technology used in the Confirm mdx test. Among these, studies demonstrating the analytical validity, clinical validity, clinical
utility and positive health economic outcomes of the Confirm mdx test evaluated more than 1,200 patients in the aggregate.</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The following is a summary that highlights key
findings from some of these studies.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.5in">&#160;</td>
    <td style="width: 0.25in; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Analytical
    validity</i></b>. A study published in 2012 illustrated the performance characteristics and robustness of the Confirm mdx multiplex
    DNA methylation assay, covering the analytical method including assay sensitivity, specificity, linearity, precision, repeatability
    and reproducibility using pre-specified acceptance criteria.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.5in">&#160;</td>
    <td style="width: 0.25in; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Clinical
    validity</i></b>. The clinical validity of the Confirm mdx test has been demonstrated in two large, blinded clinical validation studies
    published in 2013 and 2014, yielding a NPV of ~90% for all prostate cancer, which is significantly higher (p &lt; 0.001) than that
    afforded by standard histopathology review, as well as a NPV of 96% for clinically significant prostate cancer. Further, when compared
    to all pertinent risk factors for prostate cancer detection (patient&#8217;s age, serum PSA level, digital rectal exam (DRE), histopathological
    findings on the previous cancer- negative biopsy and the epigenetic assay), Confirm mdx was shown to be the most significant, independent
    predictor for prostate cancer in a repeat biopsy with an odds ratio of 3.24 (and a p-value &lt; 0.001). An additional clinical validity
    study published in 2017 demonstrated that the Confirm mdx test improved the identification of African American men at risk for aggressive
    cancer missed by a prostate biopsy, with accuracy equivalent to prior studies in predominantly Caucasian populations.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.5in">&#160;</td>
    <td style="width: 0.25in; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Clinical
    utility</i></b>. A 2014 study reported on the real-world use of the Confirm mdx assay, demonstrating that the test impacts physician
    behavior. A very low rate of repeat biopsies (4.4%) was observed in the Confirm mdx negative men, as compared to the expected 43%
    rate of repeat biopsy reported in a large population-based randomized trial sponsored by the National Cancer Institute.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.5in">&#160;</td>
    <td style="width: 0.25in; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Health
    economic outcomes</i></b>. In a study published in 2013, a budget impact model developed to evaluate the effect of the Confirm mdx
    assay on healthcare spending demonstrated significant potential healthcare savings associated with the reduction of repeat biopsies
    and complications avoided. Under the study&#8217;s model, utilization of Confirm mdx would bring approximately $500,000 in annual
    savings per 1 million covered patients.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 45; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: normal 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->39<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><img alt="" src="image_007.jpg"/>&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>&#160;</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>GPS Tissue Test</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>&#160;</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Currently, most cases of detected prostate cancer
remain indolent and men with the disease often die from other causes. Patients who have indolent prostate cancer may be appropriately
managed with observation or AS, while those with aggressive cancers may benefit from immediate treatment. The use of AS has increased
in recent years and it is now estimated that up to 50% of clinically low-risk patients choose AS, while the remainder choose some type
of immediate treatment.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The tissue-based GPS test assesses 17 genes in
total &#8212; 12 cancer-related genes representing 4 important biologic pathways (androgen signaling, cellular organization, stromal
response, and proliferation) together with 5 references genes (to control for RNA quantity and quality). The test uses reverse transcription
polymerase chain reaction (&#8220;RT-PCR&#8221;) to measure gene expression in very small amounts of prostate tumor tissue (requiring
as little as 5 ng of RNA). Genetic expression of the 12 cancer-related genes, normalized by the 5 reference genes, is used in an algorithm
to generate a GPS result that ranges from 0 to 100, with higher scores associated with more aggressive disease. The GPS test, in conjunction
with clinical risk factors, is predictive of a finding of adverse pathology (&#8220;AP&#8221;) upon a radical prostatectomy (&#8220;RP&#8221;)
and clinical recurrence following RP, and consequently provides clinicians and patients with information about the likely aggressiveness
of their cancer to help guide initial treatment decisions.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">For patients with NCCN very low- to favorable
intermediate- prostate cancer, the GPS test provides information on the risk of AP to help physicians guide personalized treatment for
patients at the initial decision point. For the unfavorable intermediate- and high-risk groups, the GPS test helps inform decisions on
the intensity of definitive treatment. The patient results report gives the risk of a patient developing metastasis within 10 years, risk
of PCD within 10 years, and risk of tumor aggressiveness based on AP result outlining the clinical characteristics of each NCCN risk group.</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The GPS test is intended for men with clinically
localized prostate cancer who have undergone biopsy within 3 years and have not yet started treatment. Patients with any NCCN risk category
between very low- and high-risk are eligible for GPS testing.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>&#160;</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 46; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: normal 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->40<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><i><span style="text-decoration:underline">Guidelines Inclusion</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><i>&#160;</i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">GPS has been included in the NCCN Prostate Cancer
guidelines since 2019.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><i><span style="text-decoration:underline">Clinical Validation
Studies</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The use of GPS as a predictive test to identify
men at low risk for aggressive prostate cancer has been well validated in both scientific and clinical studies.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The following is a summary that highlights key
findings from clinical studies regarding the GPS test.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left">&#9679;</td><td style="text-align: justify"><b>Clinical validity</b>. In a prospective and retrospective
study on 402 patients published in 2015, the GPS test demonstrated its ability to discriminate prostate cancer aggressiveness in biopsy
tissue despite tumor heterogeneity and multifocality. Further, the test demonstrated its ability to improve prediction of adverse pathology.</td>
</tr></table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left">&#9679;</td><td style="text-align: justify"><b>Clinical utility</b>. Numerous clinical studies have shown
the impact of GPS on treatment recommendations and have demonstrated that generally, use of GPS increases the proportion of men for whom
AS is recommended, when the background AS rates are similar to the national average for these risk groups.</td>
</tr></table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.5in"></td><td style="width: 0.25in; text-align: left">o</td><td style="text-align: justify">In a prospective decision impact study by Badani et al. (2015)
of 158 patients with NCCN very low-, low- and low intermediate-risk disease, the GPS test resulted in a 26% change in recommended treatment
modality or intensity and patients who received GPS testing had a 24% relative increase in AS recommendations.</td>
</tr></table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.5in"></td><td style="width: 0.25in; text-align: left">o</td><td style="text-align: justify">In a chart review study by Dall&#8217;Era et al. (2015) of
211 patients with NCCN very low- or low risk-disease, biological risk predicted by GPS differed from NCCN clinical risk alone in 62 men
(39%). AS use increased by 24% in patients who received the GPS test versus patients who did not receive the GPS test.</td>
</tr></table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.5in"></td><td style="width: 0.25in; text-align: left"><span style="font-size: 10pt">o</span></td><td style="text-align: justify"><span style="font-size: 10pt">In a study by Eure et al. (2017)
of 297 patients, 23% of patients&#8217; risk was restratified. In the NCCN low-risk group, the change in the management plan between
AS and immediate treatment was 28%; 51% of the men who were initially recommended immediate treatment pre-GPS testing switched to AS
post-GPS testing, while 14% of those initially recommended AS switched to immediate treatment post-GPS testing. Among the men who elected
AS, their one-year AS persistence rates remained high at 89%.A fourth study by Lynch et al. (2017) demonstrated utility in a US Department
of Veterans Affairs population, an equal-access healthcare system with high baseline AS rates</span> without t<span style="font-size: 10pt">esting.
The study compared management patterns for men with NCCN very low-, low-, and intermediate-risk PCa with and without molecular profiling.
Overall, use of AS was 12% higher (absolute; relative increase 19%) in GPS-tested versus untested men, with the biggest increases observed
in low-risk patients (90% versus 72% for tested versus untested, respectively) and patients under the age of 60 (75% versus 42% for tested
versus untested, respectively).</span></td>
</tr></table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left">&#9679;</td><td style="text-align: justify"><b>Health economic outcomes</b>. A 2016 publication in Reviews
in Urology presented a comprehensive economic analysis of the GPS test in low-risk prostate cancer patients. Results showed that use
of the GPS test results in a net savings of $2,286 USD per patient &#8212; including the cost of the test &#8212; by decreasing unnecessary
immediate invasive treatments. The study demonstrated that incorporation of the GPS test as part of the treatment decision algorithm
for patients with NCCN very low- and low-risk disease (64% of the study population) led to a 21% net increase in the use of AS. Of these,
treatment patterns and cost for 80 men tested with GPS were compared to 100 patients in the same practice without genomic testing. Based
on a real-world practice setting in the U.S. Northeast with a contemporary patient population and using current treatment cost averages,
these results demonstrated that the use of the GPS test represented a reduction in cost of unnecessary intermediate interventions (by
more than 50%) over a 6-month period. Additional savings can also be expected by removing the cost of management of associated side effects
of treatment such as impotence and incontinence.</td>
</tr></table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>&#160;</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>&#160;</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><b><img alt="" src="image_008.jpg"/>&#160;</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Resolve mdx for Urinary Tract Infection</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>&#160;</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">UTIs affect around 10 million people who seek
medical attention every year. It is estimated that 2-3 million of these cases lead to emergency department visits. UTIs can be complicated
and recurrent, resulting in painful symptoms such as abdominal and rectal pain, frequent urination, burning or pain during urination,
and fatigue. Antibiotic resistance is a significant issue, observed in up to one-third of UTI infections, causing about 2.8 million infections
and 35,000 deaths annually, according to the CDC.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The traditional method of conducting a UTI test,
urine culture, can take up to 3 to 5 days to produce results. Unfortunately, relying solely on culture-based testing may produce equivocal
results of &#8220;mixed flora&#8221; in up to 30% of cases, Often clinicians will rely on empiric therapy to treat UTIs, which can lead
to overuse/misuse of antibiotics. Through the use of Resolve mdx, we help support antibiotic stewardship initiatives, as our test identifies
personalized antibiotic options that would be expected to be more effective against the patient&#8217;s infection.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">To address this unmet clinical need, with Resolve
mdx we developed an advanced urine test that utilizes Polymerase Chain Reaction (&#8220;PCR&#8221;) technology to detect and quantify
both infectious pathogens and resistance genes. Resolve mdx also includes susceptibility testing to identify the antibiotics that may
be best suited to resolve the urinary tract infection. This approach provides prompt and accurate pathogen identification and personalized
antibiotic recommendations. PCR-based testing offers improved sensitivity and specificity in identifying pathogens, addressing the problem
of &#8220;mixed flora&#8221; results associated with traditional testing methods. This increased accuracy provides physicians with clinically
actionable information to guide their decision-making for patient care.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our proprietary Antibiotic Susceptibility Testing
method included with the Resolve mdx test, called ASTX, determines how each pathogen responds to the 26 antibiotics tested. The unique
aspect of ASTX is that it tests whole urine samples, ensuring accurate results and identifying the most effective treatment options for
patients.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>&#160;</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 48; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: normal 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->42<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>&#160;</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 10.9pt 0pt 8pt; text-align: center"><b>Resolve mdx Pathogens Tested,
Resistance Genes and Antibiotics</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 10.9pt 0pt 8pt; text-align: center"><b>&#160;</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><img alt="" src="image_009.jpg"/><b>&#160;</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our goal is to help pinpoint not only the offending
organisms, regardless of how many are identified, but also the most likely oral antibiotics capable of clearing the entire infection.
We estimate the addressable market in the United States for UTI testing at approximately 2 million cases annually, or $1 billion.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Pipeline</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We intend to build on our leadership in the urologic
diagnostic space by expanding our menu of tests beyond Select mdx, Confirm mdx, GPS and Resolve mdx. We are currently developing an additional
product for the prostate cancer diagnostic and treatment pathway. AS is a management approach for prostate cancer that involves closely
monitoring the cancer&#8217;s progression through regular tests and imaging, without immediately initiating active treatment such as
surgery or radiation therapy. Since not all prostate cancers progress the same manner, there is a significant unmet clinical need to
help physicians identify which patients may benefit from AS, distinguishing those at risk for disease progression.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Men on AS are monitored using PSA, MRI and
periodic biopsies to determine if their prostate cancer has progressed and whether definitive treatment is necessary. We are
actively analyzing urine and blood biomarker panels with the goal of developing a non-invasive test for monitoring these patients that we call Monitor mdx.
A testing solution that allows a physician to forego or delay their patient&#8217;s surveillance biopsy would represent a
significant business opportunity with little or no direct competition.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If our development efforts are successful, MDxHealth
would have a full offering of biomarker-based prostate cancer tests from early detection to treatment and management. Select mdx and
Confirm mdx help determine which patients should (or should not) undergo a prostate biopsy, while our GPS test guides the decision to
enter into AS upon an initial diagnosis of prostate cancer. In the AS setting, Monitor mdx would provide methods to identify and monitor
patients who could remain on AS as a treatment option.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Laboratory Operations</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We currently process tests at our 38,000 square
foot, CAP-accredited, CLIA-certified,&#160;and NYSDOH-approved&#160;molecular laboratory and office facility located at our U.S. headquarters
in Irvine, California; through our 7,800 square foot diagnostic facilities in Nijmegen, The Netherlands; and through our smaller, CAP-accredited,
CLIA-certified laboratory facility in Plano, Texas. Our GPS test is currently performed by Exact Sciences in its laboratory facility
in Redwood City, California. Our current clinical reference laboratory has excess processing expansion capacity with incremental increases
in laboratory personnel and equipment, including expansion capacity for laboratory facilities. We believe that we currently have sufficient
capacity to process all of our tests. We may require additional facilities in the future as we expand our business and believe that additional
space, when needed, will be available on commercially reasonable terms.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Sales and Marketing</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our sales approach focuses on the clinical and
economic benefits of our tests as supported by peer-reviewed&#160;literature covering the clinical validation and utility of these tests.
Our sales and marketing team include molecular diagnostic specialists, reimbursement account managers, clinical liaisons and client service
personnel. Sales personnel are primarily field based, client service and marketing personnel are primarily based in our California headquarters.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our sales team is trained to address the clinical,
economic and reimbursement questions associated with selling our tests. Our sales force focuses on educating its primary and secondary
clientele, which consists of urologists and their clinical staff, including nurses, laboratory and pathology personnel, finance administrators
and billing personnel, and secondarily the pathology and laboratory staff who fulfil test requests on behalf of their clinician clients.
Our current urology sales force consists of direct sales representatives, strategic account managers and regional sales managers.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our sales efforts are directed towards increasing
adoption and utilization of our tests in clinical practice. The strategy entails:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">working
with community-based, large group practices and academic urologists to educate them on the clinical and economic benefits provided by
our tests;</span></td>
</tr></table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">nurturing
and strengthening relationships with key thought leaders in urology;</span></td>
</tr></table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">supporting
ongoing collaborations with leading universities and research institutions that have generated clinical validation data supporting our
tests; and</span></td>
</tr></table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">encouraging
ongoing exploration and studies of expanded indications for our tests.</span></td>
</tr></table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Successful penetration of the urology market
and clinical adoption of our tests has been achieved with a multi-faceted&#160;approach to build brand recognition and raise awareness
of the tests. Our efforts and programs include sharing information with leaders in the medical community on a national and regional scale,
supporting clinical studies for the publication of peer reviewed journals and abstracts at key scientific conferences, development of
tools for our customers to interact with patients and consumers (doctor-to-consumer&#160;education), providing support to patient advocacy
groups like Prostate Conditions Education Council, developing strategic partnerships with leading pathology laboratories with large urology
client bases, participation in industry trade shows and the implementation of public relations, media and advertising campaigns.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;<b>Reimbursement</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Reimbursement of our tests by third-party payors
is essential to our commercial success. Payment for our testing services may come from, in some cases:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">third-party&#160;payors
that provide health care coverage to the patient (<i>e.g</i>., commercial health insurance companies or managed care organizations);</span></td>
</tr></table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">federal
health care programs, such as Medicare, state Medicaid programs, the Department of Defense and Veterans Affairs hospitals in the United&#160;States;</span></td>
</tr></table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">other
government agencies or laboratories that order the testing service; and</span></td>
</tr></table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">patients
in cases where the patient has no insurance or coverage benefit, is underinsured or has insurance with cost sharing benefits whereby
the insurance covers a percentage of testing costs, and the patients are responsible for a co-payment, co-insurance&#160;and/or deductible
amount.</span></td>
</tr></table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Reimbursement for diagnostic tests furnished
to Medicare beneficiaries (typically patients aged 65 or older) is typically based on a fee schedule set by CMS, a division of the HHS.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 50; Value: 1 --><div>
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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In 2014, 2015 and 2023, respectively, our Confirm
mdx test, our GPS test and our Select mdx test received positive Medicare LCDs under the MoIDX Program, which provide coverage and reimbursement
for Medicare beneficiaries throughout the United&#160;States. Our Resolve mdx UTI test is currently reimbursed by Medicare and most private
insurance payors, based on nationally recognized CPT codes.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We believe the clinical utility and actionability
of our tests, combined with our experience and knowledge of the complex coverage and reimbursement landscape in the United&#160;States
will enable us to expand coverage and reimbursement of our tests among the commercial payor market. We continue to build upon our successful
strategy, using our Medicare LCD for Confirm mdx, Select mdx and GPS and existing commercial payor contracts as a foundation to secure additional contracts
from major payors.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Where there is a payor policy or contract in
place, we bill in accordance with the terms of that policy or contract. Where there is no payor policy or contract in place, we pursue
third-party&#160;reimbursement on behalf of each patient on a case-by-case basis. Our efforts on behalf of these patients involve a substantial
amount of time and expense, and bills may not be paid for many months, if at all. Furthermore, if a third-party payor denies coverage
after final appeal, it may take a substantial amount of time to collect from the patient, if we are able to collect at all.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Materials Needed for Our Laboratory Services</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In connection with our role as a CLIA-certified&#160;provider
of laboratory services, we assist healthcare providers with certain logistics related to the collection and return of samples for testing.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The processing of testing solutions requires
items and services, the majority of which are sourced from multiple suppliers. Certain of the consumable supplies and reagents used in
our testing process are procured from a limited number of suppliers, some of which are single source. In addition, we rely on a limited
number of suppliers, or in some cases a single supplier (for example, for the automation of our deparaffination steps for the Confirm
mdx test), for certain equipment with which we perform testing services. To date, we have acquired all of our equipment and the majority
of our materials on a purchase order basis, and we generally do not have language included in contracts with our suppliers and manufacturers
that commit them to supply equipment and materials to us.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Competition</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The molecular diagnostics field is characterized
by rapid technological changes, frequent new product introductions, changing customer preferences, emerging competition, evolving industry
standards, reimbursement uncertainty and price competition. Moreover, the molecular diagnostics field is intensely competitive both in
terms of service and price, and continues to undergo significant consolidation, permitting larger clinical laboratory service providers
to increase cost efficiencies and service levels, resulting in more intense competition.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The market for assessing men at risk for prostate
cancer is large. As a result, this market has attracted competitors, some of which possess substantially greater financial, selling,
logistical and laboratory resources, more experience in dealing with third-party&#160;payors, and greater market penetration, purchasing
power and marketing budgets, as well as more experience in providing diagnostic services. Some companies and institutions are developing
liquid biopsy (blood and urine)-based&#160;tests and diagnostic tests based on the detection of proteins, mRNA, nucleic acids or the
presence of fragments of mutated genes that are associated with prostate cancer. These competitors could have technological, financial,
reputational, and market access advantages over us.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In regard to our Select mdx for Prostate Cancer
test, several directly competitive products are currently commercially available. In 2014, OPKO Health, a NYSE listed company, launched
the 4Kscore test, a blood based 4-plex&#160;test which combines the results of the blood test with clinical information in an algorithm
that calculates a patient&#8217;s percent risk for aggressive prostate cancer prior to an initial or repeat biopsy (no previous diagnosis
of prostate cancer). The 4Kscore test received marketing approval from the FDA in December 2021. OPKO Health, a NYSE listed company, operates
one of the largest clinical laboratories in the United&#160;States. The 4Kscore test competes directly with Select mdx. In 2016, ExosomeDx
launched the ExoDx (Intelliscore), a urine-based&#160;test designed to assess whether  patient presenting for an initial or repeat biopsy
is at greater risk for high-grade&#160;prostate cancer. The ExoDx test competes directly with Select mdx. In 2018, Bio-Techne&#160;Corporation,
a large U.S.-based, diversified life sciences company, acquired the ExoDx test. In addition to the ExoDx and the 4Kscore tests, the Prostate
Health Index test (&#8220;phi score&#8221;) offered by Beckman Coulter, competes directly with the Select mdx test. In addition, each
of these tests may also provide a competitive advantage since, unlike the Select mdx test, they do not require a digital rectal procedure
as part of their specimen collection process. Each of Bio-Techne, OPKO Health and Beckman Coulter have greater resources and significantly
larger sales and marketing teams than MDxHealth. As a result of these significantly greater resources, these competitors are able to make
larger investments into the tests they produce and the sales and marketing of these tests, which may cause us to lose market share.</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Regarding our GPS tissue-based test, acquired
in August 2022 from Exact Sciences, several directly competitive products are currently commercially available. Myriad Genetics offers
the Prolaris test, a tissue-based genetic test to help identify those men who need treatment versus those who can choose active surveillance.
Additionally, Veracyte offers the Decipher test, a tissue-based genetic test to help identify those men who need treatment versus those
who can choose active surveillance. In addition to directly competitive genomic tests, traditional methods used by pathologists and clinicians
to estimate risk for disease progression also pose competitive threats. Companies combining these traditional methods with artificial
intelligence could potentially emerge as competitors, though most of these technologies are currently in the research stage.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In regard to our Confirm mdx for Prostate Cancer
test, several competitive products are currently commercially available. Both the 4Kscore test, offered by OPKO Health, and the ExoDx
(Intelliscore) test offered by ExosomeDx, compete with the Confirm mdx test. Offered at a lower price point, both the 4Kscore and ExoDx
tests offer a competitive price advantage over the Confirm mdx test. In addition, both the 4Kscore test and the PCA-3&#160;test from Hologic,
a urine-based&#160;test, are on the U.S. market as FDA-approved tests, which may be perceived as providing a competitive advantage since
the Confirm mdx for Prostate Cancer test is not FDA approved. The PCA-3&#160;test is intended for the same patient population as Confirm
mdx for Prostate Cancer, but its performance has only been established in men who were already recommended by urologists for repeat biopsy.</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In addition to competitive products, the Confirm
mdx, Select mdx and GPS tests also face competition from mpMRI, a clinical diagnostic imaging procedure available to and used by physicians
for many years, which focuses on visual tissue analysis. The mpMRI procedure can visually reveal potential locations of abnormal and
potentially cancerous prostate tissue characteristics that distinguish tumors from healthy tissue. The visual aspect of diagnostic imaging
may feel more accessible and be considered preferable by some physicians over molecular analysis, and there likely is an economic incentive
for some physicians to earn a professional fee from the performance of mpMRI procedures. It may be difficult to change the methods or
behavior of physicians to incorporate our testing solutions into their practices in conjunction with, or instead of, mpMRI clinical diagnostic
imaging procedures. In addition, companies developing or offering capital equipment or point-of-care&#160;kits to physicians represent
another source of potential competition. These devices are used directly by the physicians or their institutions, which can facilitate
adoption.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Intellectual Property</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our intellectual property and its protection are
crucial to the operation of our business. We are committed to developing and protecting our intellectual property and, where appropriate,
filing patent applications or securing licenses to patents to protect our technology. We rely on a combination of patent, copyright, trademark
and other agreements with employees and third parties to establish and protect our proprietary intellectual property rights. We also rely
upon trade secret laws to protect unpatented know-how and continuing technological innovation. However, trade secrets can be difficult
to protect, and do not provide protection against a third party independently discovering or recreating the information for which trade
secret protection is claimed. We seek to protect our proprietary unpatented technology, know how, algorithms and processes, in part, by
entering into confidentiality agreements with our employees, consultants, scientific advisors and contractors and limit access to, and
distribution of, our proprietary information. We also require our officers, employees and consultants to enter into standard agreements
containing provisions requiring confidentiality of proprietary information and assignment to us of all inventions made during the course
of their employment or consulting relationship. We also enter into nondisclosure agreements with our commercial counterparties and limit
access to, and distribution of, our proprietary information. We also seek to preserve the integrity and confidentiality of our data and
trade secrets by maintaining physical security of our premises and physical and electronic security of our information technology systems.</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We believe that our patent portfolio places us
in a competitive position in the realm of molecular cancer diagnostics. We own or hold exclusive rights to a range of issued and pending
patents in multiple countries worldwide covering our epigenetic and molecular tests and associated biomarkers, their methods of use and
any other inventions that are important to the development of our business. Many of our commercially important technology and inventions
are in-licensed&#160;from academic and commercial collaborators. Through our internal R&amp;D programs, together with our academic and
commercial collaborations, we continue to be at the forefront of researching and understanding the link between cancer and methylation
(epigenetics), and how this link can be translated into meaningful clinical molecular diagnostic products and services. We consider patent
protection of the technologies, on which our products are based, to be a key factor to our success.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our intellectual property portfolio is managed
by an in-house&#160;intellectual property team, which works in close collaboration with qualified external patent attorneys both in Europe
and the United&#160;States. As of December 31, 2022, we own or have exclusive rights to more than 17 patent families related to our molecular
technology and cancer-specific&#160;biomarkers. Specifically, there are 116 granted or pending patent applications in this group comprised
of 16 issued or allowed U.S. patents, 7 pending U.S. provisional or non-provisional&#160;applications,&#160;19 pending&#160;international
patent applications filed under the PCT and 74 granted or allowed patents in jurisdictions outside the United&#160;States, including
Japan, Canada, Israel and certain European countries. Our issued U.S. patents expire at various times between 2024 and 2038. Of these
issued patents, 1 covers intellectual property used in our Confirm mdx test, which expires in 2024, 7 cover intellectual property used
in our Select mdx test, the last of which expires in 2036, and 52 cover intellectual property used in our GPS test, the last of which
expires in 2038. When these patents expire other companies will no longer be prohibited from incorporating the subject intellectual property
into competing tests they may seek to develop. Nevertheless, given the significant unpatented proprietary and confidential intellectual
property that we have developed and that is used in our tests, together with the clinical performance characteristics reported in published
clinical studies that are specific to these branded tests, we believe there will be significant barriers to&#160;any competitors&#8217;
ability to use such previously patent-protected&#160;intellectual property to develop competitive&#160;tests.&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In most countries in which we file, our patents
have a life of 20 years from the date of the filing of the nonprovisional application. In the United&#160;States, a patent&#8217;s term
may be lengthened by patent term adjustment, which compensates a patentee for administrative delays by the USPTO in granting a patent,
or may be shortened if a patent is terminally disclaimed over an earlier-expiring&#160;patent. The expected expiration dates listed above
assume that no terminal disclaimers will be filed. A patent term can also be lengthened in certain countries, including the United&#160;States,
under circumstances where there is a delay associated with approval from a governmental regulatory agency.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We may in the future receive notices of claims
of infringement and misappropriation or misuse of other parties&#8217; proprietary rights and may from time to time receive additional
notices. Assertions of misappropriation, infringement or misuse, or actions seeking to establish the validity of our patents could materially
or adversely affect our business, financial condition and results of operations.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Collaboration and License Agreements</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Collaborative research agreements and clinical
research agreements</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We have entered into agreements with universities,
medical centers and external researchers for research and development work and for the validation of our technology and products. These
agreements typically have durations of one to three years. In certain circumstances, we pay fixed fees to the collaborators and in exchange
typically receive access and rights to the results of the work. MDxHealth has collaborated on research and clinical development with
a number of the world&#8217;s leading academic and government cancer research institutes. These important relationships have provided
us with additional resources and expertise for clinical marker validation as well as access to patient samples for testing.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Commercial and intellectual property licensing
agreements</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We have entered into numerous agreements with
universities and companies for in-licensing&#160;intellectual property. These agreements typically require us to pay an up-front&#160;fee,
annual maintenance fees and/or minimum annual royalty fees, legal fees related to the patents, and certain milestone and royalty fees
if the patents are eventually used in a commercialized product. In addition, we must provide the licensor with periodic reports.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In particular, we are party to an Amended and
Restated Exclusive License Agreement with The Johns Hopkins University through which we hold an exclusive license to intellectual property
that is used in our Confirm mdx test. Pursuant to this agreement, we made upfront license fee payments of $10,000 in each of 2004 and
2005, and we are obligated to pay a mid-single-digit&#160;royalty rate on our net sales of Confirm mdx (with minimum annual royalties
of $5,000). Unless earlier terminated in accordance with the agreement, the agreement will remain in effect until the last of the licensed
patents expires in 2024. The agreement contains customary termination provisions which, among other things, permit termination in the
event of material uncured breaches.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In regard to our developed tests, we have entered
into a range of marketing and sales arrangements with commercial entities. These important relationships provide us with additional resources
and infrastructure to expand the geographic reach and awareness of our solutions. Our marketing partners include Ferrer Internacional,
SouthGenetics, LifeLabs, Helix Laboratories, Laboratory Corporation of America (LabCorp), Inform Diagnostics (InformDx) and Poplar Healthcare.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Government Regulations</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Certain of our activities are subject to regulatory
oversight by CMS pursuant to CLIA, as well as agencies in various states, including New York.&#160;We are subject to many other federal,
state and foreign laws, including anti-fraud&#160;and abuse, anti-kickback&#160;and patient privacy. Failure to comply with applicable
requirements can lead to sanctions, including withdrawal of products from the market, recalls, refusal to authorize government contracts,
product seizures, exclusion from participation in federal and state healthcare programs, civil money penalties, injunctions, and criminal
prosecution.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Laboratory Certification, Accreditation,
and Licensing</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We are also subject to&#160;U.S. and state laws
and regulations regarding the operation of clinical laboratories. CLIA requirements and laws of certain states, including those of California,
New York, Maryland, Pennsylvania and Rhode Island, impose certification requirements for clinical laboratories, and establish standards
for quality assurance and quality control, among other things. CLIA provides that a state may adopt different or more stringent regulations
than federal law and permits states to apply for exemption from CLIA if the state&#8217;s laboratory laws are equivalent to or more stringent
than CLIA. For example, the State of New York&#8217;s clinical laboratory regulations, which have received an exemption from CLIA, contain
provisions that are in certain respects more stringent than federal law. Therefore, as long as New York maintains a licensure program
that is CLIA-exempt, we will need to comply with New York&#8217;s clinical laboratory regulations in order to offer our clinical laboratory
products and services in New York.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our U.S. laboratory facilities in Irvine, California
and Plano, Texas are certified under CLIA. Clinical laboratories are subject to inspection by regulators and to sanctions for failing
to comply with applicable requirements. Sanctions available under CLIA and certain state laws include prohibiting a laboratory from running
tests, requiring a laboratory to implement a corrective plan, and imposing civil monetary penalties. If we fail to meet any applicable
requirements of CLIA or state law, that failure could adversely affect any future CMS consideration of our technologies, prevent their
approval entirely, and/or interrupt the commercial sale of any products and services and otherwise cause us to incur significant expense.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">HIPAA and Other Privacy Laws</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Health Insurance Portability and Accountability
Act of 1996, as amended by HIPAA established comprehensive protection for the privacy and security of health information. The HIPAA standards
apply to three types of organizations, or &#8220;Covered Entities&#8221;: (1) health plans, (2) healthcare clearinghouses, and (3) healthcare
providers that conduct certain healthcare transactions electronically. Covered Entities and their business associates must have in place
administrative, physical, and technical standards to guard against the misuse of individually identifiable health information. As a clinical
laboratory that engages in HIPAA-covered&#160;standard transactions, we are a Covered Entity subject to regulation under HIPAA. We have
implemented privacy and security policies and procedures, provided required training to our personnel, and ensure that we enter into
Business Associate Agreements with our vendors who have access to our protected health information. Penalties for violations of HIPAA
include civil money and criminal penalties.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">HIPAA establishes a federal &#8220;floor&#8221;
with respect to privacy, security, and breach notification requirements and does not supersede any state laws insofar as they are broader
or more stringent than HIPAA. Numerous state and certain other federal laws protect the confidentiality of health information and other
personal information, including but not limited to state medical privacy laws, state laws protecting personal information, state data
breach notification laws, state genetic privacy laws, human subjects research laws and federal and state consumer protection laws. These
additional federal and state privacy and security-related&#160;laws may be more restrictive than HIPAA and could impose additional penalties.
For example, the Federal Trade Commission uses its consumer protection authority under Section 5 of the Federal Trade Act to initiate
enforcement actions in response to alleged privacy violations and data breaches. California recently enacted the California Consumer
Privacy Act (&#8220;CCPA&#8221;), which went into effect on January&#160;1, 2020. The CCPA, among other things, creates new data privacy
obligations for covered companies and provides new privacy rights to California residents, including the right to opt out of certain
disclosures of their information. The CCPA also creates a private right of action with statutory damages for certain data breaches, thereby
potentially increasing risks associated with a data breach. California recently amended and expanded the CCPA through another ballot
initiative, the California Privacy Rights Act (&#8220;CPRA&#8221;), passed on November&#160;3, 2020. It remains unclear what, if any,
additional modifications will be made to the CPRA by the California legislature or how it will be interpreted. In addition to California,
other states have strengthened their data security laws and others are indicated their intention to do so as well. Virginia also enacted
a comprehensive data privacy and security law, the Virginia Consumer Data Protection Act, on March&#160;2, 2021, to go into effect on
January&#160;1, 2023. We expect that other states will follow with their own comprehensive data privacy legislation as well. Our activities
must therefore comply with these other applicable privacy laws, which impose further restrictions on the access, use and disclosure of
personal information. Further, we are required to comply with international personal data protection laws and regulations, including
the European Union&#8217;s General Data Protection Regulation (&#8220;GDPR&#8221;). The GDPR is a prescriptive, detailed regulation that
provides extensive powers to public authorities to sanction and stop use of personal data. While companies are afforded some flexibility
in determining how to comply with the GDPR&#8217;s various requirements, the GDPR has and will continue to require significant effort
and expense to ensure compliance.&#160;All of these laws may impact our business and may change periodically, which could adversely affect
our business operations. Our failure to comply with these privacy laws or significant changes in the laws restricting our ability to
obtain stool, tissue, blood, and other patient samples and associated patient information could significantly impact our business and
our future business plans, including potentially a temporary inability to provide tests to patients in the European Union.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">In Vitro Regulation</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Under current law,&#160;<i>in vitro diagnostics</i>&#160;that
the FDA regulates as medical devices must undergo premarket review prior to commercialization, unless the device is exempt from such
review. The particular premarket requirements that must be met to market a medical device in the United States will depend on the classification
of the device under FDA regulations. Medical devices are categorized into one of three classes, based on the degree of risk they present.
Devices that pose the lowest risk are designated as Class I devices; devices that pose moderate risk are designated as Class II devices
and are subject to general controls and special controls; and the devices that pose the highest risk are designated as Class III devices
and are subject to general controls and premarket approval. As a CLIA-certified&#160;laboratory, we offer our Select mdx and Confirm
mdx testing services as LDTs, and we may seek to commercialize future testing services in development as LDTs. LDTs are generally defined
as clinical laboratory tests that are developed and validated by a laboratory for its own use.&#160;Historically, the FDA has exercised
enforcement discretion and not required approvals or clearances for many LDTs (as that term is viewed and defined by the FDA, which is
the subject of interpretation) that are regulated under CLIA, and has not required laboratories that offer LDTs consistent with FDA&#8217;s
interpretation to comply with the FDA requirements for medical devices, such as registration, device listing, quality systems regulations,
premarket clearance or premarket approval, and post-market&#160;controls.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Regulatory jurisdiction over LDTs has historically
been greatly disputed. For many years, the FDA has expressed its position through a range of guidance documents and precedent provided
through enforcement action. The FDA has issued documents outlining its intent, at various times, to require varying levels of heightened
FDA oversight of many laboratory tests that have traditionally been offered as LDTs, including categories that would include our tests.
Additionally, in recent years, Congress has introduced two draft bills: the VALID Act and the VITAL Act of 2021. While we cannot predict
whether the either VALID Act or the VITAL Act as proposed, or any modified version of either act will be enacted into law, it is expected
that some form of the acts will be incorporated into a broader health care legislative package. It is unknown at this time whether legislation
will be enacted impacting LDTs, or whether in the interim the FDA may take a more aggressive enforcement approach toward certain laboratory
testing. Legal, regulatory, and policy developments may materially impact our ability to develop and commercialize testing services as
LDTs, including without limitation our current tests.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Until regulatory requirements suggested by the
FDA or required by any new legislation are phased in, we do not consider our current LDTs to require FDA filings or clearance or approval
before launch and we will continue to follow the CLIA certification and inspection pathway.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If the new requirements are phased in or if we
elect to develop IVDs, our future offerings may require a 510(k) submission or a Premarket Approval (&#8220;PMA&#8221;) application to
the FDA. In a 510(k) submission, the device sponsor must demonstrate that the new device is &#8220;substantially equivalent&#8221; to
a predicate device in terms of intended use, technological characteristics, and performance testing. A 510(k) requires demonstration
of substantial equivalence to another device that is legally marketed in the United&#160;States. Substantial equivalence means that the
new device is at least as safe and effective as the predicate. A device is substantially equivalent if, in comparison to a predicate
it (a)&#160;has the same intended use as the predicate and has the same technological characteristics as the predicate; or (b)&#160;has
the same intended use as the predicate, has different technological characteristics, and the information submitted to the FDA does not
raise new questions of safety and effectiveness, and is demonstrated to be at least as safe and effective as the legally marketed predicate
device.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">A claim of substantial equivalence does not mean
the new and predicate devices must be identical. Substantial equivalence is established with respect to intended use, design, energy
used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility,
standards, and other characteristics. A device may not be marketed in the United States until the submitter receives a letter declaring
the device substantially equivalent. If the FDA determines that a device is not substantially equivalent, the applicant may resubmit
another 510(k) with new data, or request a Class I or II designation through the FDA&#8217;s de novo process that allows a new device
without a valid predicate to be classified into Class&#160;I or II if it meets certain criteria, or file a reclassification petition,
or submit a PMA.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Manufacturers of medical devices must comply
with various regulatory requirements under the FDCA and regulations thereunder, including, but not limited to, quality system regulations,
unless they are exempt, facility registration, product listing, labeling requirements, and certain post-market&#160;surveillance requirements.
Entities that fail to comply with FDA requirements can be liable for criminal or civil penalties, such as recalls, detentions, orders
to cease manufacturing, and restrictions on labeling and promotion, among other potential sanctions.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The regulatory review and approval process for
medical devices can be costly, timely, and uncertain. This process may involve, among other things, successfully completing additional
clinical trials and submitting a premarket clearance notice or filing a premarket approval application with the FDA. If premarket review
is required by the FDA, there can be no assurance that our tests will be cleared or approved on a timely basis, if at all. In addition,
there can be no assurance that the labeling claims cleared or approved by the FDA will be consistent with our current claims or adequate
to support continued adoption of and reimbursement for our products. Ongoing compliance with FDA regulations could increase the cost
of conducting our business, subject us to FDA inspections and other regulatory actions, and potentially subject us to penalties in the
event we fail to comply with such requirements.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Federal and State Fraud and Abuse Laws</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: justify"><b><i>False Claims and Overpayments</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We are subject to numerous federal and state
fraud and abuse laws, including the federal False Claims Act. Many of these fraud and abuse laws are broad in scope, and, at least with
respect to the state laws, neither the courts nor relevant government agencies have extensively interpreted these laws. Prohibitions
under some of these laws include:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the submission
    of false claims or false information to government programs,</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the retention
    of any overpayments received from governmental payors,</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">deceptive
    or fraudulent conduct,</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">excessive
    or unnecessary services or services at excessive prices, and</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">defrauding
    commercial health insurers.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We may be subject to substantial penalties for
violations of these fraud and abuse laws, including denial of payment and refunds or recoupments, suspension of payments from Medicare,
Medicaid or other federal health care programs, and exclusion from participation in federal and state health care programs, as well as
civil monetary and criminal penalties and imprisonment. Numerous federal and state agencies enforce the fraud and abuse laws. In addition,
commercial insurers may also bring private actions. In some circumstances, private whistleblowers are authorized to bring lawsuits on
behalf of the government against providers and are entitled to receive a portion of any final recovery.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In addition, amendments to the FCA impose severe
penalties for the knowing and improper retention of overpayments collected from governmental payors. Within sixty days of identifying
and quantifying an overpayment, a provider is required to notify CMS or the relevant MAC of the overpayment (and the reason for it) and
to return the overpayment; failure to do so may result in a separate basis for liability under the FCA. These amendments could subject
our procedures for identifying and processing payments to greater scrutiny.&#160;Overpayments may occur from time to time in the healthcare
industry without any fraudulent intent. For example, overpayments may result from mistakes in reimbursement claim forms or from improper
processing by governmental payors. We maintain protocols intended to identify any overpayments and to make timely refunds as appropriate.
From time to time, we have identified overpayments and made appropriate refunds to government payors.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">To avoid liability, we must carefully and accurately
code claims for reimbursement, proactively monitor the accuracy and appropriateness of Medicare claims and payments received, diligently
investigate any credible information indicating that we may have received an overpayment, and promptly return any overpayments.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: justify"><b><i>Federal and State &#8220;Self-Referral&#8221;
and &#8220;Anti-Kickback&#8221; Restrictions</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If we or our operations are found to be in violation
of applicable laws and regulations prohibiting improper referrals for healthcare items or services, we may be subject to penalties, including
civil and criminal penalties, damages, fines, exclusion from participation in U.S. federal or state healthcare programs, and the curtailment
or restructuring of our operations.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: justify"><b><i>Anti-Kickback Statute</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The federal Anti-Kickback&#160;Statute prohibits
persons from knowingly and willfully soliciting, receiving, offering, or paying remuneration, directly or indirectly, to induce either
the referral of an individual, or the furnishing, recommending, or arranging for an item or service, for which payment may be made under
a federal health care program, such as the Medicare and Medicaid programs, unless an exception or &#8220;safe harbor&#8221; applies.
The term &#8220;remuneration&#8221; is not defined in the federal Anti-Kickback&#160;Statute and has been broadly interpreted to include
anything of value, including for example, gifts, discounts, the furnishing of supplies or equipment, credit arrangements, payments of
cash, waivers of payment, ownership interests and providing anything at less than its fair market value. Sanctions for violations of
the federal Anti-Kickback&#160;Statute may include imprisonment and other criminal penalties, civil monetary penalties, and exclusion
from participation in federal health care programs. Further, the Affordable Care Act made clear that claims for items or services resulting
from a violation of the federal Anti-Kickback&#160;Statute constitutes a false or fraudulent claim for purposes of the federal civil
FCA. Further, the Affordable Care Act made clear that claims for items or services resulting from a violation of the federal Anti-Kickback&#160;Statute
constitutes a false or fraudulent claim for purposes of the federal civil FCA. Many states have also adopted laws similar to the federal
Anti-Kickback&#160;Statute, some of which are not limited in application to only items or services reimbursable by federal health care
programs, and do not contain identical safe harbors.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In addition to the Anti-Kickback&#160;Statute,
in October 2018, Congress enacted EKRA as a component of the Substance Use-Disorder&#160;Prevention that Promotes Opioid Recovery and
Treatment for Patients and Communities Act. EKRA is an anti-kickback&#160;law similar to the federal Anti-Kickback&#160;Statute that,
subject to several exceptions, makes it a criminal offense to pay any remuneration to induce referrals to, or in exchange for, patients
using the services of a recovery home, a substance use clinical treatment facility, or laboratory. Although it appears that EKRA was
intended to reach patient brokering and similar arrangements to induce patronage of substance use recovery and treatment, the language
in EKRA is broadly written and can apply to laboratory services covered under public or private payor arrangements. That said, an interpretation
of EKRA that prohibits certain incentive compensation payments to sales employees or other forms of remuneration that would otherwise
be permissible under a safe harbor to the federal Anti-Kickback&#160;Statute would directly conflict with the intent of the federal Anti-Kickback&#160;Statute
and regulations and would prohibit a number of practices that are common throughout the industry. Significantly, EKRA permits the DOJ
to issue regulations clarifying EKRA&#8217;s exceptions or adding additional exceptions, but no such regulations or applicable guidance
have yet been issued.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: justify"><b><i>Medicare Physician Self-Referral
Law</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The federal Physician Self-Referral&#160;Law,
commonly referred to as the &#8220;Stark Law&#8221;, prohibits, subject to certain exceptions, physicians from making a referral to an
entity for certain &#8220;designated health services&#8221; (&#8220;DHS&#8221;) payable by Medicare if the physician, or an immediate
family member of the physician, has a direct or indirect financial relationship (including ownership interests and compensation arrangements)
with the entity. The Stark Law also prohibits such an entity from presenting or causing to be presented a claim to Medicare for DHS provided
pursuant to a prohibited referral, and provides that certain collections related to any such claims must be refunded in a timely manner.
The Stark Law is a strict liability statute and therefore, any referrals for Medicare DHS pursuant to a financial relationship that does
not meet an exception will be non-payable and subject to refund to Medicare. In addition, any Medicare &#8220;overpayment&#8221; (that
is, Medicare funds to which a person is not entitled) must be returned within 60 days of identification &#8212; or risk liability under
the FCA&#8217;s &#8220;obligation&#8221; provision. Therefore, claims relating to Stark Law violations must be timely refunded to Medicare
or we would risk liability under the federal FCA. Violations of the Stark Law can also result in civil penalties and federal health care
program exclusions for knowing violations and civil monetary assessments of up to three times the amount claimed. Although the Stark Law
is drafted to apply only to Medicare claims, the DOJ has taken the position that it applies to Medicaid claims under an extension of the
federal FCA and several courts, including courts in Florida and Texas, have agreed. In addition, there are comparable state laws, some
of which apply to all payors (not just Medicare), and do not contain identical exceptions to the Stark Law.</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Compliance with federal fraud and abuse laws
such as the Anti-Kickback&#160;Statute and the Stark Law involve constant monitoring for regulatory changes, agency and court interpretations,
and revisiting of arrangements based on new interpretations or clarifications, all of which will require ongoing compliance costs. In
addition, these laws and their exceptions and safe harbors are complex and clear interpretations are not always available. Despite our
best efforts to comply, we cannot guarantee that a government agency will necessarily agree with our interpretations or that one or more
of our arrangements will not be subject to challenge, nor can we provide any assurance that they will not have an adverse effect on our
business, financial condition, results of operations, and cash flows. Any action against us for violation of these or similar foreign
laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management&#8217;s
attention from the operation of our business.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: justify"><b><i>Sunshine Act</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In 2010, Congress enacted the Physician Payments
Sunshine Act (&#8220;Sunshine Act&#8221;), which aims to promote transparency around financial relationships between physicians, teaching
hospitals and certain life sciences industry manufacturers. The Sunshine Act requires manufacturers of drugs, devices, biologicals, and
medical supplies covered by Medicare, Medicaid, or the Children&#8217;s Health Insurance Program to report annually to CMS any payments
or other transfers of value made to healthcare providers and teaching hospitals, unless an exception applies. Manufacturers must also
disclose to CMS any healthcare provider ownership or investment interests. Some states have similar transparency laws. Although we do
not consider our laboratory services to be covered devices under the Sunshine Act, the laws and regulations are continually evolving
and in the future we could be required to comply with transparency requirements in the future, or we could otherwise be subject to scrutiny
for the nature and amount of our payments and transfers of value in the healthcare industry.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: justify"><b><i>International</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">When marketing our tests outside of the United&#160;States,
we are subject to foreign regulatory requirements governing human clinical testing, export of tissue, marketing approval for our products,
and performance and reporting of tests in each market. These requirements vary by jurisdiction, differ from those in the United&#160;States,
and may require us to perform additional pre-clinical&#160;or clinical testing. In many countries outside of the United&#160;States,
coverage, pricing, and reimbursement approvals are also required in order for our tests to be made available to patients in substantial
volume.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: normal 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->52<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Many countries in which we offer our tests have
anti-kickback&#160;regulations prohibiting providers, as well as medical and in vitro diagnostic device manufacturers, from offering,
paying, soliciting, or receiving remuneration, directly or indirectly, or providing a benefit to a healthcare professional in order to
induce business that is reimbursable under any national healthcare program. In situations involving healthcare providers employed by
public or state-funded&#160;institutions or national healthcare services, violation of the local anti-corruption&#160;or anti-gift&#160;laws
may also constitute a violation of the U.S. Foreign Corrupt Practices Act (&#8220;FCPA&#8221;).</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The FCPA prohibits any U.S. individual, business
entity, or employee of a U.S. business entity from offering or providing, directly or through a third party, including the distributors
we rely on in certain markets, anything of value to a foreign government official with corrupt intent to influence an award or continuation
of business or to gain an unfair advantage, whether or not such conduct violates local laws. In addition, it is illegal for a company
that reports to the SEC to have false or inaccurate books or records or to fail to
maintain a system of internal accounting controls. We are also required to maintain accurate information and control over sales and distributors&#8217;
activities that may fall within the purview of the FCPA, its books and records provisions, and its anti-bribery&#160;provisions.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Other Laws</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: justify"><b><i>Occupational Safety and Health</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In addition to its comprehensive regulation of
health and safety in the workplace in general, the Occupational Safety and Health Administration has established extensive requirements
aimed specifically at laboratories and other healthcare-related&#160;facilities. In addition, because our operations require employees
to use certain hazardous chemicals, we also must comply with regulations on hazard communication and hazardous chemicals in laboratories.
These regulations require us, among other things, to develop written programs and plans, which must address methods for preventing and
mitigating employee exposure, the use of personal protective equipment, and training.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: justify"><b><i>Specimen Transportation</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our commercialization activities subject us to
regulations of the Department of Transportation, the U.S. Postal Service, and the Centers for Disease Control and Prevention that apply
to the surface and air transportation of clinical laboratory specimens.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>C. Organizational Structure </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">MDxHealth SA is a company with limited liability
(<i>naamloze vennootschap/soci&#233;t&#233; anonyme</i>) incorporated and operating under the laws of Belgium.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The following chart shows our organizational
structure as of December 31, 2022:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: bottom">
    <td style="border-bottom: black 1.5pt solid; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Subsidiary
    Name</b></span></td>
    <td style="font-size: 10pt">&#160;</td>
    <td style="border-bottom: black 1.5pt solid; text-align: center; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Jurisdiction
    of Organization</b></span></td>
    <td style="font-size: 10pt">&#160;</td>
    <td style="border-bottom: black 1.5pt solid; text-align: center; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Ownership
    &amp; Voting Interest<br/>
    Held by MDxHealth SA</b></span></td></tr>
  <tr style="background-color: rgb(204,238,255)">
    <td style="vertical-align: top; width: 33%; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">MDxHealth,
    Inc.</span></td>
    <td style="width: 1%; font-size: 10pt">&#160;</td>
    <td style="width: 32%; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Delaware</span></td>
    <td style="width: 1%; font-size: 10pt">&#160;</td>
    <td style="width: 33%; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">100% (held directly)</span></td></tr>
  <tr>
    <td style="vertical-align: top; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">MDxHealth
    BV</span></td>
    <td style="font-size: 10pt">&#160;</td>
    <td style="font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The Netherlands</span></td>
    <td style="font-size: 10pt">&#160;</td>
    <td style="font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">100% (held directly)</span></td></tr>
  <tr style="background-color: rgb(204,238,255)">
    <td style="vertical-align: top; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">MDxHealth
    Servicelab BV</span></td>
    <td style="font-size: 10pt">&#160;</td>
    <td style="font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The Netherlands</span></td>
    <td style="font-size: 10pt">&#160;</td>
    <td style="font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">100% (held through MDxHealth
    BV)</span></td></tr>
  <tr>
    <td style="vertical-align: top; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">MDxHealth
    Research BV</span></td>
    <td style="font-size: 10pt">&#160;</td>
    <td style="font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The Netherlands</span></td>
    <td style="font-size: 10pt">&#160;</td>
    <td style="font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">100% (held through MDxHealth
    BV)</span></td></tr>
  <tr style="background-color: rgb(204,238,255)">
    <td style="vertical-align: top; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Delta
    Laboratories LLC</span></td>
    <td style="font-size: 10pt">&#160;</td>
    <td style="font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Texas</span></td>
    <td style="font-size: 10pt">&#160;</td>
    <td style="font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">100% (held through MDxHealth,
    Inc.)</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>D. Property, Plant and Equipment </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We process our tests, and conduct research and
development, at our 38,000 square foot U.S. headquarters and laboratory facility in Irvine, California pursuant to a lease that is currently
scheduled to expire in 2026. This laboratory facility is certified pursuant to CLIA and accredited by CAP. We also maintain a small laboratory
facility in Plano, Texas. This laboratory facility is certified pursuant to CLIA.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our headquarters is located in the CAP Business
Center, Herstal, Belgium.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We maintain offices and a laboratory facility
located in Nijmegen, The Netherlands, where we process our Select mdx test and conduct research and development at our 7,800 square foot
laboratory and office facility pursuant to a lease that is currently scheduled to expire in 2027.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We believe that our existing facilities are adequate
for our near-term needs, and we believe that suitable additional or alternative office and manufacturing space will be available as required
in the future on commercially reasonable terms.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><div><a id="a_008"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>ITEM 4A. UNRESOLVED STAFF COMMENTS </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Not applicable.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><div><a id="a_009"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>ITEM 5. OPERATING AND FINANCIAL REVIEW AND
PROSPECTS</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>You should read the following discussion of
our operating and financial review and prospects in conjunction with our audited consolidated financial statements and the related notes
thereto included elsewhere in this annual report. In addition to historical information, the following discussion and analysis contains
forward-looking statements that reflect our current plans, estimates, expectations and beliefs and involve risks and uncertainties. Our
actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result
of various factors. Factors that could cause or contribute to these differences include, but are not limited to, those discussed below
and elsewhere in this annual report, particularly in sections titled &#8220;Risk Factors&#8221; and &#8220;Special Note Regarding Forward-Looking
Statements.&#8221;</i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Overview</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We are a commercial-stage precision diagnostics
company committed to providing non-invasive, clinically actionable and cost-effective urologic solutions to improve patient care. Our
novel genomic testing solutions combine advanced clinical modeling with genomic data to provide each patient with a personalized risk
profile, which provides more accurate and actionable information than traditional clinical risk factors used by clinicians. Our Select
mdx and Confirm mdx tests address men at risk for undetected prostate cancer, providing physicians with a clear clinical pathway to accurately
identify clinically significant prostate cancer while reducing the use of invasive procedures that are prone to complications. Our GPS
test addresses men newly diagnosed with localized prostate cancer, providing physicians with a clear clinical pathway to make the most
informed treatment decision for their individual disease. Our team&#8217;s collective decades of experience in precision diagnostics
and our portfolio of novel biomarkers for diagnostic, prognostic and predictive molecular assays supports our active pipeline of new
testing solutions for urologic diseases.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We have experienced net losses and significant
cash used in operating activities since inception in 2003. To date, our primary sources of capital have been public offerings of our
ordinary shares and ADSs and private placements, debt financing agreements, and revenue from the sale of our products. Since inception,
we have raised equity financing of approximately $360 million. As of December 31, 2022, we had cash and cash equivalents of $15.5 million,
long-term loans and borrowings of $34.9 million and an accumulated deficit of $288.3 million. During the years ended December 31, 2020,
2021 and 2022, we generated revenue of $18.5 million, $22.2 million and $37.1 million, respectively, with a net loss of $28.7 million,
$29.0 million and $44.0 million, respectively.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In February 2023, the Company raised $40 million
in gross proceeds by means of a public offering of 10,000,000 ADSs being the equivalent of 100,000,000 new shares at an issue price of
$4.00 per ADS (or approximately &#8364;0.37 per share) through a public offering. In March 2023, the Company received additional gross
proceeds of $3.0 from the underwriters&#8217; exercise of their overallotment option.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Management expects the Company to continue to
incur net losses and have significant cash outflows for at least the next twelve months. While these conditions, among others, could
raise doubt about our ability to continue as a going concern, these consolidated financial statements have been prepared assuming that
the Company will continue as a going concern. This basis of accounting contemplates the recovery of our assets and the satisfaction of
liabilities in the normal course of business. A successful transition to attaining profitable operations is dependent upon achieving
a level of positive cash flows adequate to support the Company&#8217;s cost structure.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Acquisition of Genomic Prostate Score&#174;
(GPS) test (formerly Oncotype DX GPS) from Exact Sciences</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On August 2, 2022, we announced that we have
entered into an agreement with Genomic Health, Inc., a subsidiary of Exact Sciences, to acquire the GPS test from Exact Sciences. We
acquired GPS in order to expand our menu of tests targeted into urology and prostate cancer and in order to position the Company as one
of the leaders in the urology and prostate cancer space with one of the most comprehensive menus of precision diagnostics.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Under the terms of the agreement, we acquired
the GPS prostate cancer business of Exact Sciences for an aggregate purchase price of up to $100 million, of which an amount of $25 million
was paid in cash and an amount of $5 million was settled through the delivery of 691,171 ADSs of the Company, at a price per ADS of $7.23.
Following the closing, which took place on August 2, 2022, an additional aggregate earn-out amount of up to $70 million is to be paid
by us to Exact Sciences over a three year period, commencing in 2024, in tranches equal to a portion of the annual revenues attributable
to the GPS prostate cancer business for the preceding fiscal year; provided, in each instance, that such revenues exceed certain minimum
revenue milestones for such fiscal year.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">At our option, the earn-out amounts can be settled
in cash or through the issuance of additional ADSs of the Company (valued in function of a volume weighted average trading price of the
Company's shares at the end of the relevant earn-out period) to Exact Sciences, provided that the aggregate number of shares representing
the ADSs held by Exact Sciences shall not exceed more than 5% of our outstanding shares. &#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Financial Operations Overview </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Revenues and Other Income</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Revenues</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The majority of our revenue is derived from laboratory
services with revenue recognized at a point in time when control of the services has transferred to the customer. This is generally when
the test results are delivered to the customer. We derive a small amount of additional revenue from license fees, royalties and government
grants.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">A large portion of our revenues are either derived
from Medicare, which has set a fixed price pursuant to a LCD for the Company&#8217;s Confirm mdx and GPS tests, or are established with
reference to the Medicare fixed price level. Therefore, the amount of revenue recognized from Medicare (as well certain contracted commercial
insurance companies) for Confirm mdx and GPS is determined by reference to a fixed price pursuant to the LCD. For reimbursement claims
made to other commercial insurance companies, where there is no certainty of the amount that will be paid for services rendered, the
Company uses historical collection data &#8212; on an individual payor basis &#8212; to estimate its future collection and corresponding
revenues that should be recognized for each of our testing solutions.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We analyze historical collection data on a monthly
basis and make monthly adjustments to our estimates. In accordance with IFRS&#160;15, revenue is recognized where such a variable consideration
is included in the transaction price only to the extent that it is highly probable that the amount of revenue recognized will not be
subject to significant future reversals as a result of subsequent re-estimation. When historical collection data is insufficient to estimate
future collections, recognize revenue on a cash basis, meaning that revenues will not be recognized until actual cash payment is received
from the payor.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Cost of Goods &amp; Services Sold</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Cost of goods sold includes the cost of materials,
labor (including salaries, bonuses, and benefits), transportation, collection kits, and allocated overhead costs associated with processing
samples. Allocated overhead costs include depreciation of laboratory equipment, facility occupancy and information technology costs.
Costs associated with processing samples are expensed when incurred, regardless of the timing of revenue recognition. As such, cost of
goods and related volume does not always trend in the same direction as revenue recognition.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Gross Profit and Gross Margin</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We calculate gross profit as revenue less cost
of goods &amp; services sold, and gross margin as gross profit divided by revenue. Our gross margin has and will continue to be affected
by a variety of factors, primarily average selling prices and ordering volumes. We expect our gross profit to increase in the foreseeable
future as our revenue grows, our average selling price improves&#160;&#8212;&#160;based on broader commercial coverage for our tests&#160;&#8212;&#160;and as
we take advantage of economies of scale as we grow test volume.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Operating Expenses</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: justify"><b><i>Research and Development Expenses</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Research and development expenses consist of
costs incurred for the development of our products. These expenses consist primarily of labor costs (including salaries, bonuses, benefits,
and stock-based&#160;compensation), reagents and supplies, clinical studies, outside services, patent expenses, depreciation of laboratory
equipment, facility occupancy and information technology costs. Research and development expenses also include costs associated with
assay improvements and automation workflow for our current suite of products. We expense our research and development expenses in the
period in which they are incurred, except for those development expenses that qualify for capitalization.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We expect that our research and development expenses
will increase in absolute dollars as we continue to develop additional products, however, we expect that these expenses will decrease
as a percentage of revenue over the long term, though they may fluctuate as a percentage from period to period due to the timing and
extent of these expenses.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: justify"><b><i>Sales and Marketing Expenses</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our sales and marketing expenses are expensed
as incurred and include costs associated with our sales organization, including our direct clinical sales force and sales management,
medical affairs, client services, marketing and managed care, as well as technical lab support and administration. These expenses consist
primarily of labor costs (including salaries, bonuses, benefits, and stock-based&#160;compensation), customer education and promotional
expenses, market analysis expenses, conference fees, travel expenses and allocated overhead costs.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">While there are no immediate plans to grow the
size of our commercial organization, our sales and marketing expenses may increase in absolute dollars as we increase our marketing activities
to drive further awareness and adoption of our products. However, we expect that these expenses will decrease as a percentage of revenue
over the long term, though they may fluctuate as a percentage from period to period due to the timing and extent of these expenses.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: justify"><b><i>General and Administrative Expenses</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our general and administrative expenses include
costs for certain executives, accounting and finance, legal, revenue cycle management, information technology, human resources, and administrative
functions. These expenses consist primarily of labor costs (including salaries, bonuses, benefits, and stock-based&#160;compensation),
professional service fees such as consulting, accounting, legal, general corporate costs, and public-company&#160;costs associated with
our European listing, as well as allocated overhead costs (rent, utilities, insurance, etc.).</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We expect that our general and administrative
expenses will continue to increase in absolute dollars primarily due to increased headcount (some of it related to volume, such as revenue
cycle management) and costs associated with operating as a public company, including expenses related to legal, accounting, regulatory,
tax, maintaining compliance with exchange listing in both Belgium (EURONEXT) and the United States (Nasdaq) and requirements of the SEC,
director and officer insurance and investor relations.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: justify"><b><i>Other Operating Income/Expenses</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Other operating income/expense is comprised of
grant income, fair-value adjustment of loan facility, revaluation of the contingent consideration related to the acquisition of NovioGendix
in 2015, and goodwill impairment, if any. We do not expect the revaluation of the contingent consideration to be a significant source
of income or expense going forward.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: justify"><b><i>Financial Income/Expenses</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Financial income/expense is comprised of fair-value
adjustments related to the GPS contingent consideration, interest income/expense, debt extinguishment expenses, as well as foreign exchange
gain/loss and other financial gain/loss. Interest income consists primarily of interest earned on our deposits. Our interest income has
not been significant to date and we do not expect it to be significant in the future. Our interest expense is primarily related to our
current $35 million long-term&#160;debt facility with Innovatus Capital Partners, which replaced our previous &#8364;9 million debt facility
with Kreos Capital VI (UK) Limited (&#8220;Kreos Capital&#8221;).</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Foreign exchange gains/losses are derived from
our operating in two different currencies&#160;(Euro and U.S. dollar)&#160;for our European and U.S. operations. These gains and losses
are not expected to be significant and we maintain reserves in both currencies to offset extreme fluctuations in the dollar/euro exchange
rate.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Other financial loss is derived from accrued
interest charges on the fair value of the NovioGendix contingent liability.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>A. Operating results </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>Comparison of the years ended as of December
31, 2022 and 2021</i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our results of operations for the years ended
as of December 31, 2022 and 2021 are summarized in the tables below:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><b><i>Revenue</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Revenue increased $14.8 million, or 67% for the
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as an increase in our test volumes for Confirm mdx and Resolve mdx. Excluding revenues from the recently acquired GPS test, total revenue
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 63; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: normal 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->57<!-- Field: /Sequence --></p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">For&#160;the&#160;year&#160;ended&#160;December
31,&#160;2022&#160;and&#160;2021,&#160;Confirm mdx accounted for 59% and 91% of total revenue, respectively. 2022 revenues were comprised
of $21.8 million from Confirm mdx, $9.3 million from GPS, $4.9 million from Resolve mdx, with the remaining revenues from Select mdx
and other.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><b><i>Cost of Goods&#160;&amp;
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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in sales and unit volumes, however, gross margins increased from 47.5% for the year ended December&#160;31, 2021 to 51.9% for the year
ended December&#160;31, 2021, a 440 basis-point&#160;improvement primarily related to our product mix and the addition of GPS to our
product menu.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><b><i>Research and Development
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Research and development expenses increased $0.9&#160;million,
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development expenses as well as expenses associated with our pipeline products.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><b><i>Selling and Marketing
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Selling and marketing expenses increased $8.8
million, or 50%, for the year ended December&#160;31, 2022, compared to the year ended December&#160;31, 2021, primarily due to the additional
field sales personnel associated with the GPS business as well as an increase in amortization expense related to customer lists as part
of the GPS intangible asset.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><b><i>General and Administrative
Expenses</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">General and administrative expense increased
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million of one-time expenses related to the GPS acquisition (included in Professional fees), with the remaining $5.7 million increase
primarily related to higher insurance, professional fees and public company expenses.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><b><i>Other Operating Income,
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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million, or 52% for the year ended December 31, 2022, compared to the year ended December 31, 2021, primarily due to the reduction of
grant income from the U.S. Department of Health and Human Services and the Dutch government NOW grants, partially offset by an increase
in fair-value adjustment related to the acquisition of NovioGendix in 2015.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><b><i>Financial Income/Expense</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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or 184% for the year ended December 31, 2022, compared to the year ended December 31, 2021, primarily due to fair-value adjustment for
the GPS contingent consideration of $2.4 million, interest charges and extinguishment expenses of $1.6 million for the loan facility
with Kreos Capital, and interest charges of $1.6 million related to the Innovatus debt facility.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: normal 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->58<!-- Field: /Sequence --></p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>Comparison of the years ended as of December
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our results of operations for the years ended
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><b><i>Revenue</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Revenue increased $3.8&#160;million, or 20% for
the year ended December 31, 2021, compared to the year ended&#160;December 31, 2020, due an increase in our test volumes and average
selling price.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">For&#160;the&#160;year&#160;ended&#160;December
31,&#160;2021&#160;and&#160;2020,&#160;Confirm mdx accounted for 91% and 94% of total revenue, respectively.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><b><i>Cost of Goods&#160;&amp;
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Cost of revenue increased $1.3&#160;million,
or 12% for the year ended December&#160;31, 2021 compared to the year ended December&#160;31, 2020, primarily as a result of the increase
in unit volumes, however, gross margins increased from 43.6% for the year ended December&#160;31, 2020 to 47.5% for the year ended December&#160;31,
2021, a 390 basis-point&#160;improvement primarily due to the increase in our average selling price.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><b><i>Research and Development
Expenses</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Research and development expenses increased $2.1&#160;million,
or 47% for the year ended December&#160;31, 2021, compared to the year ended December&#160;31, 2020, primarily due to increased expenses
associated with our pipeline products.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><b><i>Selling and Marketing
Expenses</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Selling and marketing expenses increased $1.0
million, or 6%, for the year ended December&#160;31, 2021, compared to the year ended December&#160;31, 2020, primarily due to increased
activity in 2021 versus 2020, which was the first year of the COVID-19 pandemic.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><b><i>General and Administrative
Expenses</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">General and administrative expense increased
$0.2 million, or 1% for the year ended December&#160;31, 2021, compared to the year ended December&#160;31, 2020, primarily due to an
increase in professional fees and insurance expenses associated with our U.S. listing on the Nasdaq Stock Market.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><b><i>Other Operating Income,
net</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Other operating income, net was comprised of
grant income in the U.S. and The Netherlands as well as the revaluation of the contingent consideration related to the acquisition of
NovioGendix in 2015. The increase of $1.0 million for the year ended December&#160;31, 2021 versus the prior year period was primarily
related to $659,000 grant income from the U.S. Department of Health and Human Services as well as a $382,000 grant from the Dutch government
NOW grants.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><b><i>Financial Income/Expense</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Financial income was comprised of interest income
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on lease liabilities. Financial expenses increased by $0.6&#160;million, or 41% primarily related to interest charges recognized on leases
under IFRS 16.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>B. Liquidity and Capital Resources </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We have incurred net losses in each quarter since
our inception. For the years ended December&#160;31, 2022, 2021 and 2020, we incurred a net loss of $44.0 million, $29.0 million and
$28.7&#160;million respectively. We expect to continue to incur significant expenses for the foreseeable future and to incur operating
losses in the near term while we make investments to support our anticipated growth.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">As of December 31, 2022, we have been financed
primarily through net proceeds of approximately $360 million from the sale of our equity securities and long-term&#160;debt facilities.
Our primary source of cash from operations is cash receipts on accounts receivable from our revenue. As of December 31, 2022, we had
cash and cash equivalents of $15.5 million and an accumulated deficit of $288.3 million.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On February 3, 2023, we announced the pricing
of a registered public offering of 10,000,000 ADSs (each representing 10 ordinary shares of the Company without nominal value) at a price
to the public of $4.00 per ADS (equivalent to a price of &#8364;0.364 per share, assuming an exchange rate of &#8364;1 = $1.0988 as published
by the European Central bank on February 2, 2023 and a 10-for-1 ADS to share ratio) for total gross proceeds of $40.0 million before
deducting commissions and estimated offering expenses.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On March 6, 2023, we announced that, in the context
of the above-mentioned offering, the underwriters exercised the option to purchase additional ADSs, on the same terms and conditions
as stated above, in the amount of 750,000 ADSs for gross proceeds of $3.0 million, bringing the aggregate gross proceeds from this transaction
to $43.0 million.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our primary uses of cash are to fund operating
expenses, service debt and acquire equipment. Cash used to fund operating expenses excludes the impact of non-cash&#160;items such as
depreciation and stock-based&#160;compensation and is impacted by the timing of when we pay our operating expenses as reflected in the
change in our outstanding accounts payable and accrued expenses. Debt service primarily consists of interest payments on our outstanding
debt. Acquisitions of property and equipment primarily consist of purchases of laboratory equipment.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On August 2, 2022, we entered into a $70 million
loan and security agreement with Innovatus, which loan also replaced the Company&#8217;s &#8364;9 million debt facility with Kreos Capital.
At closing, an amount of $35 million was drawn, with an additional $35 million remaining available as a $20 million term B loan and a
$15 million term C loan that can be drawn in 2024 and 2025 respectively, subject to certain conditions. The loans are secured by our
assets including intellectual property rights. Remaining proceeds of the loans will be used for working capital purposes and to fund
general business requirements.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The loans accrue interest at a floating per annum
rate equal to the sum of (a) the greater of (i) the prime rate published in The Wall Street Journal in the &#8220;Money Rates&#8221;
section or (ii) 4.00%, plus (b) 4.25%, and require interest-only payments for the initial four years. As contractually agreed, and at
our election, a portion of the interest becomes payable in-kind by adding an amount equal to 2.25% of the outstanding principal amount
to the then outstanding principal balance on a monthly basis until August 2, 2025. The loans mature on August 2, 2027. The lenders shall
have the right to convert, prior to August 2, 2025, up to 15% of the outstanding principal amount of the loans into ADSs of the Company
at a price per ADS equal to $11.21, reflecting a substantial premium to the trading price prior to the announcement of the acquisition.
Amounts converted into ADSs of the Company will be reduced from the principal amount outstanding under the loan. Notable fees payable
to Innovatus consist of a facility fee equal to 1% of the total loan commitment, due on the funding date of the relevant loans, and an
end-of-loan fee equal to 5% of the amount drawn, payable upon final repayment of the relevant loans.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In April 2020, the Company, through our U.S. subsidiary,
MDxHealth Inc., entered into a PPP loan with the SBA in the amount of $2,316,000 as part of the CARES Act. The loan has a term of five
years and carries an interest rate of 1.0% per year. Payments on the loan are deferred for the first eighteen months following disbursement
of the loan, with principal and interest payments beginning on the nineteenth month. Interest on the loan continues to accrue during the
eighteen-month&#160;deferment period. Cash proceeds from the loan were received in July 2020. Of the $2.3 million PPP loan, $1.6 million
and $1.0 million has been recorded as long-term&#160;debt on the company&#8217;s consolidated balance sheet as of December&#160;31, 2021,
and December&#160;31, 2022, respectively.</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Funding Requirements</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">As of December 31, 2022, we had cash and cash
equivalents of $15.5 million. Based on our current business plan, as well as the additional $40.4 million in net proceeds from our February
and March 2023 equity offering, we estimate that our current cash and cash equivalents and our anticipated cash flows generated from
sales of our products, will be sufficient to meet our anticipated cash requirements over at least the next 12&#160;months from the date
of this annual report. To meet our long-term financial needs, we may consider raising additional capital to expand our business, to pursue
strategic investments, to take advantage of financing opportunities or for other reasons. As a result of our expected revenue growth,
we expect our accounts receivable and inventory balances to increase. Any increase in accounts receivable and inventory may not fully
cover corresponding increases in accounts payable and accrued expenses, which could result in greater working capital requirements. We
have based these estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than
we expect.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Until such time, if ever, as we can generate
revenue to support our cost structure, we expect to finance our operations through equity offerings or debt financings, or other capital
resources, including potentially collaborations or licensing arrangements. The sale of equity and convertible debt securities may result
in dilution to our shareholders and the terms of these securities could provide for rights, preferences or privileges senior to those
of our common stock. The terms of debt securities issued or borrowings pursuant to a credit agreement could impose significant restrictions
on our operations. If we raise funds through collaborations and licensing arrangements, we might be required to relinquish significant
rights to our technologies or products or grant licenses on terms that are not favorable to us. Additional capital may not be available
on reasonable terms, or at all.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our ability to generate sufficient revenue to
achieve profitability will be heavily dependent on the successful commercialization of our currently marketed products and our anticipated
future products, as well as obtaining favorable reimbursement. We anticipate that a substantial portion of our capital resources and
efforts in the foreseeable future will be focused on the commercialization of our existing products and the development of future products.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our operating results may fluctuate significantly
from period to period, depending on the timing of our planned development activities, clinical studies, and the growth of our sales and
marketing activities. We expect our expenses will increase substantially for the foreseeable future as we:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">attract,
hire and retain qualified personnel;</span></td>
</tr></table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">continue
to develop additional products and generate any evidence required to support expanded reimbursement of our products;</span></td>
</tr></table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">expand
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</tr></table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">protect
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</tr></table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">invest
in processes, infrastructure to support the growth of our business; and</span></td>
</tr></table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">operate
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</tr></table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 67; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: normal 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->61<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The table below summarizes our cash flows information
for the years ended December 31, 2022 and 2021.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <tr style="vertical-align: bottom">
    <td>&#160;</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom">
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    <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold">&#160;</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="width: 1%; text-align: left">$</td><td style="width: 9%; text-align: right">(34,118</td><td style="width: 1%; text-align: left">)</td><td style="width: 1%">&#160;</td>
    <td style="width: 1%; text-align: left">$</td><td style="width: 9%; text-align: right">(22,548</td><td style="width: 1%; text-align: left">)</td></tr>
  <tr style="vertical-align: bottom; ">
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    <td style="text-align: left">&#160;</td><td style="text-align: right">(29,163</td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(896</td><td style="text-align: left">)</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="text-align: left">&#160;</td><td style="text-align: right">20,841</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">66,509</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
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    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right">(555</td><td style="padding-bottom: 1.5pt; text-align: left">)</td><td style="padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="font-weight: bold; text-align: left; padding-bottom: 4pt; text-indent: -9pt; padding-left: 9pt">Change in cash and cash equivalents</td><td style="font-weight: bold; padding-bottom: 4pt">&#160;</td>
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  </table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Net cash used in operations was $34.1&#160;million
for year ended December 31, 2022, compared to $22.5&#160;million for the year ended December 31, 2021. The increase of cash used in operations
of $11.6&#160;million was primarily due to a higher operating loss as well as negative variation in our working capital.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Net cash from investing activities for the year
ended December 31, 2022, was $29.2&#160;million compared to $0.9 million for the year ended December 31, 2021. The increase in net cash
from investing activities primarily related to the acquisition of the GPS business as well as to purchases of property, plant, and equipment
during 2022.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Net cash from financing activities for year ended
December 31, 2022, was $20.8 million compared to $66.5&#160;million for the year ended December 31, 2021. Cash from financing activities
for the year ended December 31, 2022 were primarily derived from the $35 million debt facility from Innovatus. Cash from financing activities
for the year ended December 31, 2021 were primarily from an equity financing of &#8364;25.0&#160;million ($30.4&#160;million) in gross
proceeds by means of a private placement of 27,777,777 new shares (being approximately 30.63% of the Company&#8217;s outstanding shares
at the time) at an issue price of &#8364;0.90 per share through an accelerated bookbuild offering as well as from an initial public offering
in the United states of 3,750,000 ADSs (representing 37,500,000 ordinary shares, being approximately 32% of the Company&#8217;s outstanding
shares at the time) for gross proceeds of $45.0 million.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Cash Flows</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The table below summarizes our cash flows information
for the years ended December 31, 2021 and 2020.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <tr style="vertical-align: bottom">
    <td>&#160;</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="width: 1%; text-align: left">$</td><td style="width: 9%; text-align: right">(22,548</td><td style="width: 1%; text-align: left">)</td><td style="width: 1%">&#160;</td>
    <td style="width: 1%; text-align: left">$</td><td style="width: 9%; text-align: right">(20,244</td><td style="width: 1%; text-align: left">)</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-align: left; text-indent: -9pt; padding-left: 9pt">Net cash used in investing activities</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(896</td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(537</td><td style="text-align: left">)</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="text-align: left">&#160;</td><td style="text-align: right">66,509</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">14,290</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-align: left; padding-bottom: 1.5pt; text-indent: -9pt; padding-left: 9pt">Effects of exchange rate changes</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right">(520</td><td style="padding-bottom: 1.5pt; text-align: left">)</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right">394</td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="font-weight: bold; text-align: left; padding-bottom: 4pt; text-indent: -9pt; padding-left: 9pt">Change in cash and cash equivalents</td><td style="font-weight: bold; padding-bottom: 4pt">&#160;</td>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Net cash used in operations was $22.5&#160;million
for year ended December 31, 2021, compared to $20.2&#160;million for the year ended December 31, 2020. The increase of cash used in operations
of $2.3&#160;million was primarily due to negative variation in our working capital.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Net cash from investing activities for the year
ended December 31, 2021, was $0.9&#160;million compared to $0.5&#160;million for the year ended December 31, 2020. The increase in net
cash from investing activities related to purchases of property, plant, and equipment during 2021.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Net cash from financing activities for year ended
December 31, 2021, was $66.5&#160;million compared to $14.3&#160;million for the year ended December 31, 2020. Cash from financing activities
for the year ended December 31, 2021 were primarily from an equity financing of &#8364;25.0&#160;million ($30.4&#160;million) in gross
proceeds by means of a private placement of 27,777,777 new shares (being approximately 30.63% of the Company&#8217;s outstanding shares
at the time) at an issue price of &#8364;0.90 per share through an accelerated bookbuild offering as well as from an initial public offering
in the United States of 3,750,000 ADSs (representing 37,500,000 ordinary shares, being approximately 32% of the Company&#8217;s outstanding
shares at the time) for gross proceeds of $45.0 million. Cash&#160;from financing activities for the year ended December 31, 2020, were
primarily from an equity investment in the Company by MVM&#160;V LP and MVM GP (No.5) LP, funds managed by MVM Partners LLP (collectively
&#8220;MVM&#8221;) of $13.7&#160;million as well as proceeds of $2.3&#160;million from the PPP loan with the SBA as part of the CARES
Act.&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 68; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: normal 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->62<!-- Field: /Sequence --></p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Contractual Obligations and Commitments</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our principal obligations consist of a lease
liability, financial debt and trade and other payables. The following table sets out, as of December&#160;31, 2022, our contractual obligations
and commitments due by period:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <tr style="vertical-align: bottom">
    <td>&#160;</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom">
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    <td style="width: 1%; text-align: left">$</td><td style="width: 9%; text-align: right">616</td><td style="width: 1%; text-align: left">&#160;</td><td style="width: 1%">&#160;</td>
    <td style="width: 1%; text-align: left">$</td><td style="width: 9%; text-align: right">989</td><td style="width: 1%; text-align: left">&#160;</td><td style="width: 1%">&#160;</td>
    <td style="width: 1%; text-align: left">$</td><td style="width: 9%; text-align: right">33,925</td><td style="width: 1%; text-align: left">&#160;</td><td style="width: 1%">&#160;</td>
    <td style="width: 1%; text-align: left">$</td><td style="width: 9%; text-align: right">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;0</td><td style="width: 1%; text-align: left">&#160;</td></tr>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  </table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The contractual obligations table does not
include any additional potential contingent payments upon the future achievement by us of specified sales-based&#160;and other
milestones, or royalty payments we may be required to make under license agreements we have entered into pursuant to which we
have&#160;in-licensed&#160;certain intellectual property or under the agreement pursuant to which we acquired the GPS test. See &#8220;<i>Collaboration and License Agreements</i>&#8221; under Item
4B. &#8220;<i>Business Overview</i>&#8221; for additional information. The timing of when these additional payments will actually be
made is uncertain and the payments are contingent upon the completion of future activities.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>C. Research and development, patents and licenses</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our research and development teams utilize our
deep expertise to contribute to the growth of our business. In the years ended December 31, 2020, 2021 and 2022, R&amp;D expenses were
$4.5 million, $6.7 million and $7.6&#160;million, respectively, on research and development. For a discussion of our research and development
activities, see Item 4B. &#8220;<i>Business Overview</i>&#8221; and Item 5A. &#8220;<i>Operating Results</i>.&#8221;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>D. Trend information </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Key Factors and Trends</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Impact of COVID-19 Pandemic</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0; ">The broad and extensive impact of the COVID-19
pandemic on virtually all aspects of our business and society exacerbated many pre-existing risks to our business by making them more
likely to occur or more impactful when they do occur. The level and nature of the disruption caused by COVID-19, or any future pandemic,
is unpredictable, may be cyclical and long-lasting and may vary from location to location. To the extent COVID-19 conditions improve,
the duration and sustainability of any such improvements will be uncertain and continuing adverse impacts and/or the degree of improvement
may vary dramatically by geography and by product. The actions we take in response to any improvements in conditions, such as our return-to-office
plans, may also vary widely by geography and by business and will likely be made with incomplete information; pose the risk that such
actions may prove to be premature, incorrect or insufficient and could have a material, adverse impact on our business and results of
operations.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; ">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Ability to Attract New Ordering Physicians
and Increase Our Penetration with Existing Physicians</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Revenue growth for our products will depend on
our ability to continue to expand our base of ordering physicians, increase our penetration with existing physician customers, and increase
the number of physicians who consistently order our tests. We do not have immediate plans to expand our direct sales force and believe
that we have the ability to increase our base of ordering physicians with our current structure.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Reimbursement for Genomic Testing from
Third-Party Payors</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Successful commercialization of our tests depends,
in large part, on the availability of coverage and adequate reimbursement from government and private payors. Favorable third-party&#160;payor
coverage and reimbursement are essential to meeting the Company&#8217;s immediate objectives and long-term&#160;commercial goals. In
the United States, for new diagnostic solutions, each private and government payor decides whether to cover the test, the amount it will
reimburse for a covered test, and any the specific conditions for reimbursement. Providers may be unlikely to order a specific diagnostic
test unless an applicable third-party&#160;payor offers meaningful reimbursement for the test. Therefore,&#160;adequate coverage and
reimbursement is critical to the commercial success of a diagnostic product, and if the Company is unable to secure and maintain favorable
coverage determinations and reimbursement levels, this will compromise its ability to earn revenues from its products.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><b><i>Medicare</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Reimbursement for diagnostic tests furnished
to Medicare beneficiaries is typically based on a fee schedule set by CMS. As a Medicare-enrolled&#160;laboratory based in California,
the Company bills Noridian, and is subject to applicable Medicare local coverage and reimbursement
policies. Noridian participates in the MolDX, which handles technical assessments for U.S. laboratories that perform molecular diagnostic
testing. In 2014, 2015 and 2023, respectively, our Confirm mdx test, our GPS test and our Select mdx test received a positive Medicare
LCDs under the MoIDX Program, which provide coverage and reimbursement for Medicare beneficiaries throughout the United&#160;States.
Our Resolve mdx UTI test is currently reimbursed by Medicare and most private insurance payors, based on nationally recognized CPT codes.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><b><i>Commercial payors</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Obtaining coverage and reimbursement by commercial
payors is a time-consuming&#160;and costly process, without a guaranteed outcome, since each commercial payor makes its own decision
with respect to whether to cover a particular test, and, if so, at what rate to reimburse providers&#160;for such test. In addition,
several payors and other entities conduct technology assessments of new medical tests and devices and provide the results of these assessments
for informational purposes to other parties. These assessments may be used by third-party&#160;payors and healthcare providers as grounds
to deny coverage for a particular test, or to refuse to use or order a particular test or procedure. The Confirm mdx and Select mdx tests
have received initial negative technology assessments from several of these entities and are likely to receive more negative technology
assessments. The Company continues to work with third-party&#160;payors to obtain coverage for its Confirm mdx and Select mdx tests and
to appeal denial decisions based on existing and ongoing studies, peer reviewed publications, and support from physician and patient
groups. There are no assurances that commercial payors will continue to issue positive coverage and reimbursement policies and/or contracts,
and, if issued, that such policies and/or contracts will be maintained in the future. If the Company&#8217;s tests are considered on
a policy-wide&#160;level by major third-party&#160;payors, whether at the Company&#8217;s request or on their own initiative, and the
tests are determined to be ineligible for coverage and reimbursement by such payors, the Company&#8217;s collection efforts and potential
for revenue growth could be adversely impacted.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Increasing Market Acceptance and Adoption
of our Tests</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Healthcare providers typically take a long time
to adopt new products, testing practices and clinical treatments, partly because of perceived liability risks and the uncertainty of
third-party&#160;coverage and reimbursement. It is critical to the success of our sales efforts that we educate enough patients, clinicians
and administrators about molecular diagnostics testing, in general, as well as about our Confirm mdx and Select mdx tests, and demonstrate
our clinical benefits. It is likely that clinicians may not adopt, and third-party&#160;payors may not cover or adequately reimburse
for, the Company&#8217;s tests unless they determine, based on published peer-reviewed&#160;journal articles and the experience of other
clinicians, that they provide accurate, reliable and cost-effective&#160;information.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: normal 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->64<!-- Field: /Sequence --></p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Menu Expansion</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our lead products address men at risk for developing
prostate cancer, but in addition, we are actively developing testing solutions to help with the management of men diagnosed with prostate
cancer, with the goal to provide our clients with a menu of tools spanning the continuum of prostate cancer diagnosis and care. Our expertise
in precision diagnostics and our portfolio of novel biomarkers for diagnostic, prognostic and predictive molecular assays supports our
active pipeline of new testing solutions for prostate and other urologic diseases. Our pipeline products in active surveillance are still
under development and may or may not make it to market, depending on results of our research and clinical studies. The completion of
these research and development activities is difficult to predict, and the related expenses may vary significantly by quarter. We expect
to increase our research and development expense during this time. We may also take advantage of our strong commercial channel into urology
to introduce complimentary tests outside of our current pipeline products.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">While these factors may present significant opportunities
for us, they also pose significant risks and challenges that we must address. See Item 3D. &#8220;<i>Risk Factors</i>&#8221; for more
information.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>E. Critical Accounting Estimates </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Critical Accounting Policies and Estimates</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Refer to Note 2.4 to our consolidated financial
statements found elsewhere in this annual report, for a discussion on the critical accounting policies, estimates, assumptions, and judgments
that we believe to have the most significant impact on our consolidated financial statements.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><div><a id="a_010"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>A. Directors and Senior Management</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Our Board of Directors</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The following table sets forth certain information
relating to our Board of Directors as of December 31, 2022.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: bottom">
    <td style="border-bottom: black 1.5pt solid; text-align: left; width: 24%; vertical-align: bottom"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Name</b></span></td>
    <td style="vertical-align: bottom; width: 1%; text-align: left">&#160;</td>
    <td style="border-bottom: black 1.5pt solid; vertical-align: bottom; width: 9%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Age</b></span></td>
    <td style="vertical-align: bottom; width: 1%; text-align: left">&#160;</td>
    <td style="border-bottom: black 1.5pt solid; vertical-align: bottom; width: 52%; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Position(s)</b></span></td>
    <td style="vertical-align: bottom; width: 1%; text-align: left">&#160;</td>
    <td style="border-bottom: black 1.5pt solid; vertical-align: bottom; width: 12%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Term</b></span></td>
    </tr>
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
    <td style="text-align: left; vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Koen Hoffman<sup>(1)</sup></span></td>
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    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">54</span></td>
    <td style="text-align: justify">&#160;</td>
    <td style="text-align: left; vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Independent Non-Executive Director (Chairperson of
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    <td style="text-align: justify">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Until 2024</span></td>
    </tr>
  <tr style="vertical-align: top; ">
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    <td style="text-align: justify">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">60</span></td>
    <td style="text-align: justify">&#160;</td>
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    <td style="text-align: justify">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Until 2023<sup>(2)</sup></span></td>
    </tr>
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
    <td style="text-align: left; vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Jan Pensaert<sup>(3)</sup></span></td>
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    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">51</span></td>
    <td style="text-align: justify">&#160;</td>
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    <td style="text-align: justify">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Until 2024</span></td>
    </tr>
  <tr style="vertical-align: top; ">
    <td style="text-align: left; vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Dr. Lieve Verplancke<sup>(4)</sup></span></td>
    <td style="text-align: justify">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">63</span></td>
    <td style="text-align: justify">&#160;</td>
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  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
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  <tr style="vertical-align: top">
    <td>&#160;</td>
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  <tr style="vertical-align: top">
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Director is up for reelection
    to a new mandate on May&#160;&#160;2023 at our shareholder meeting.</span></td></tr>
  <tr style="vertical-align: top">
    <td>&#160;</td>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
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  <tr style="vertical-align: top">
    <td>&#160;</td>
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
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  <tr style="vertical-align: top">
    <td>&#160;</td>
    <td style="text-align: justify">&#160;</td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><sup>(5)</sup></span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Acting through Hilde Windels
    BV.</span></td></tr>
  <tr style="vertical-align: top">
    <td>&#160;</td>
    <td style="text-align: justify">&#160;</td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><sup>(6)</sup></span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Acting through Regine Slagmulder
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Unless otherwise stated, the address for our
directors is CAP Business Center, Zone Industrielle des Hauts-Sarts, Rue d&#8217;Abhooz&#160;31, 4040 Herstal, Belgium.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our Board of Directors has determined that five
out of eight of the members of the Board are independent under Belgian law and the Nasdaq Stock Market listing requirements.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Except for our employment agreement with Michael
K. McGarrity, our Executive Director and Chief Executive Officer, as described in &#8220;Item 7B. <i>Related Party Transactions</i>,&#8221;
there are no service contracts between us and any of our directors providing for benefits upon termination of employment.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
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  <tr style="vertical-align: top">
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  <tr style="vertical-align: top">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Country
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    <td colspan="7"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Belgium
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  <tr style="vertical-align: top">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Foreign
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  <tr style="vertical-align: top">
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    <td colspan="7"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Yes
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    <td colspan="7" style="background-color: White"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">8
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  <tr style="vertical-align: top; ">
    <td style="text-align: center; vertical-align: bottom">&#160;</td>
    <td style="vertical-align: bottom; text-align: center">&#160;</td>
    <td>&#160;</td>
    <td style="vertical-align: bottom; text-align: center">&#160;</td>
    <td>&#160;</td>
    <td style="vertical-align: bottom; text-align: center">&#160;</td>
    <td>&#160;</td>
    <td style="vertical-align: bottom; text-align: center">&#160;</td></tr>
  <tr style="vertical-align: top; ">
    <td style="padding-bottom: 1.5pt; text-align: center; width: 55%; vertical-align: bottom">&#160;</td>
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    <td style="border-bottom: Black 1.5pt solid; vertical-align: bottom; text-align: center; width: 15%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Did
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  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
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    I: Gender Identity </b></span></td></tr>
  <tr style="vertical-align: top; ">
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    <td>&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">5</span></td>
    <td>&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">-</span></td>
    <td>&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">-</span></td></tr>
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    <td style="text-align: center">&#160;</td>
    <td style="text-align: center">&#160;</td>
    <td style="text-align: center">&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">-</span></td>
    <td style="text-align: center">&#160;</td>
    <td style="text-align: center">&#160;</td></tr>
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
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    <td style="text-align: center">&#160;</td>
    <td style="text-align: center">&#160;</td>
    <td style="text-align: center">&#160;</td>
    <td style="text-align: center">&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">-</span></td>
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  <tr style="vertical-align: top; ">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Did
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    <td style="text-align: center">&#160;</td>
    <td style="text-align: center">&#160;</td>
    <td style="text-align: center">&#160;</td>
    <td style="text-align: center">&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">-</span></td>
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    <td style="text-align: center">&#160;</td></tr>
</table><div>

</div><p style="margin: 0">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top; ">
    <td colspan="8" style="border-bottom: Black 1.5pt solid; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>(as
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  <tr style="vertical-align: top; ">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Country
    of Principal Executive Offices: </span></td>
    <td colspan="7"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Belgium
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  <tr style="vertical-align: top; ">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Foreign
    Private Issuer </span></td>
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  <tr style="vertical-align: top; ">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Disclosure
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  <tr style="vertical-align: top; ">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Total
    Number of Directors </span></td>
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    <td style="text-align: center; vertical-align: bottom; width: 55%">&#160;</td>
    <td style="vertical-align: bottom; text-align: center; width: 9%">&#160;</td>
    <td style="width: 1%">&#160;</td>
    <td style="vertical-align: bottom; text-align: center; width: 9%">&#160;</td>
    <td style="width: 1%">&#160;</td>
    <td style="vertical-align: bottom; text-align: center; width: 9%">&#160;</td>
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    <td style="vertical-align: bottom; text-align: center; width: 15%">&#160;</td></tr>
  <tr style="vertical-align: top; ">
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  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: top; ">
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    <td style="text-align: center">&#160;</td>
    <td style="text-align: center">&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">-</span></td>
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    <td style="text-align: center">&#160;</td></tr>
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    <td style="text-align: center">&#160;</td>
    <td style="text-align: center">&#160;</td>
    <td style="text-align: center">&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">-</span></td>
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    <td style="text-align: center">&#160;</td>
    <td style="text-align: center">&#160;</td>
    <td style="text-align: center">&#160;</td>
    <td style="text-align: center">&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">-</span></td>
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    <td style="text-align: center">&#160;</td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The following sets forth the biographical information
of the members of our board of directors:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Koen Hoffman</i></b>, Chairperson of our
Board of Directors, obtained a Master in Applied Economics and an MBA at Vlerick Business School. Between 1992 and July 2016, he was
active at KBC Group in which he started his career in the corporate finance department and later became the CEO of KBC Securities as
from October 2012. Since August 2016, he is the CEO of Value Square asset management. Mr Koen Hoffman serves also as board member at
Fagron (Chair),Greenyard (chair), Mithra Pharmaceuticals and SnowWorld. </p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Michael K. McGarrity</i></b>, Chief Executive
Officer and Executive Director of our Company, has more than 25 years of experience in the healthcare industry with a unique combination
of device, diagnostics and biotechnology experience. Michael was most recently the CEO of Sterilis Medical. Prior to Sterilis Michael
was the CEO of Nanosphere (Nasdaq: NSPH), a nanotechnology-based molecular diagnostics company, where he engineered an operational and
strategic turnaround that resulted in its successful sale to Luminex (Nasdaq: LMNX) in 2016. Prior to Nanosphere, McGarrity spent 13
years at Stryker Corporation (NYSE: SYK). Mr.&#160;McGarrity holds a BA from the University of Notre Dame.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Jan Pensaert</i></b>, Non-Independent&#160;Non-Executive&#160;Director
of our Company, is the Founding Managing Partner of Valiance. He brings over 20 years of experience in growth investing. He leads the
Investment Committee for the Valiance Funds and is responsible for all aspects of the Funds&#8217; investment processes. Jan currently
serves on the Board of several Valiance entities funds and portfolio companies including MDxHealth, JenaValve, NeoSync and 4Tech. Prior
to founding Valiance, Jan was CEO of La Fayette, where during his tenure the La Fayette Funds increased in AUM from USD 750 million to
USD 5.5 billion. Before that, he was responsible for the Permal Group&#8217;s European-based investment management and research activities,
and prior to that he worked at Lazard in Corporate Finance M&amp;A. Jan holds a BA in Business Economics from Gent University in Belgium,
and a Masters in Banking &amp; Finance from the University of Aix-Marseille, France.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Dr. Lieve Verplancke&#160;</i></b>MD, Independent
Non-Executive&#160;Director of our Company, a Belgian national, began her career in 1984 with The Beecham Group (now part of GlaxoSmithKline),
and has since held key management positions with Merck &amp; Co., as well as Bristol-Myers Squibb, where she served as Managing Director,
leading their Belgian/GDL subsidiary, until 2012. Ms. Verplancke also serves as a Board Member for Brussels-based Europe Hospitals; the
Imelda Hospital in Bonheiden; and the Euronext fund, Quest for Growth and Materialise. She is also the Founder and Managing Director
of Qaly@Beersel, an elderly care center in Belgium. In addition to being a medical doctor (MD&#8211;KULeuven University), Ms. Verplancke
holds a postgraduate degree in Economics and an MBA from the University of Antwerp. She has also completed courses at INSEAD, CEDEP,
Columbia University and the Vlerick Business School, and is a certified Executive Coach (PCC). &#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Hilde Windels</i></b>, Independent Non-Executive&#160;Director
of our Company, is the CEO of immunodiagnostic company Antelope Dx BV and has 20 years of experience in the biotechnology sector with
a track record of building and structuring organizations, fundraising, M&amp;A, public capital markets and corporate strategies. At Biocartis,
she was CEO ad interim and Deputy CEO from September 2015 until September 2017 and CFO from 2011 until September 2015. Previously, Mrs.
Windels worked as independent CFO for several private biotech companies and from 1999 to 2008 she was CFO of Devgen. Currently, Mrs.
Windels serves as a board member at Erytech and Celyad. In the past, she also served on the boards of Devgen, Biocartis, Ablynx, VIB
and FlandersBio. Mrs. Windels holds a Masters in Economics (commercial engineer) from the University of Leuven, Belgium.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Dr. Regine Slagmulder</i></b>, Independent
Non-Executive&#160;Director of our Company, is a partner and full professor in management accounting &amp; control at Vlerick Business
School and a visiting professor of accounting &amp; control at INSEAD. Previously, she worked as a strategy practice consultant at McKinsey
&amp; Company. She also previously worked as a professor of management accounting at INSEAD and at the University of Tilburg. She serves
as an independent director and member of the audit committee on the board of the investment company Quest for Growth (since 2011) and
as an independent director and chair of the audit committee of Ekopak (since 2021), both listed on Euronext. Dr. Slagmulder graduated
in civil electrotechnical engineering and industrial management from the University of Gent, after which she received a management doctorate
at Vlerick Business School. As part of her research activities, she was a research fellow attached to INSEAD, Boston University (USA)
and the P. Drucker Graduate Management Center at Claremont University (USA). She is an INSEAD certified director (IDP-C). &#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Dr. Eric Bednarski</i></b>, Non-Independent&#160;Non-Executive&#160;Director
of our Company,<b><i>&#160;</i></b>currently serves as a Partner of MVM Partners LLP. Before joining MVM in 2008, he was a Partner at
Advent Healthcare Ventures and a Principal at Advent International Corporation. Prior to Advent, he was a Director in the Corporate Finance
Group of Silicon Valley Bank. Dr. Bednarski has a B.S. degree in Neural Science from Brown University and a Ph.D. in Biological Sciences
from the University of California, Irvine.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Donnie (Don) M. Hardison</i></b>, Independent
Non-Executive&#160;Director of our Company, currently is the sole proprietor of DMH Consulting, a management consulting firm that he
founded and previously operated from April 2016 to January 2017. He was most recently the President and Chief Executive Officer, and
served on the board of directors, of Biotheranostics, Inc., a molecular diagnostic company focused on oncology, from February 2017 until
it was acquired by Hologic, Inc. in February 2021. From April 2010 to March 2016, Mr. Hardison was the President and Chief Executive
Officer of Good Start Genetics, a molecular genetic testing and information company. For more than 20 years prior to that, Mr. Hardison
held various executive and senior management positions at companies including Laboratory Corporation of America (LabCorp) a clinical
laboratory company, Exact Sciences Corporation, a molecular diagnostics company, OnTarget, Inc., a sales and marketing consulting company,
Quest Diagnostics Inc., a clinical laboratory company, SmithKline Beecham Corporation, a pharmaceutical company, and others. He served
on the board of directors of Exact Sciences Corporation (Nasdaq: EXAS) from May 2000, through its initial public offering in February
2001, until August 2007. Mr. Hardison received his Bachelor of Arts degree, in political science, from the University of North Carolina,
Chapel Hill. &#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Our Executive Management</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The following table sets forth certain information
relating to our executive management as of December 31, 2022.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: bottom">
    <td style="border-bottom: black 1.5pt solid; width: 25%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Name</b></span></td>
    <td style="width: 1%; text-align: justify">&#160;</td>
    <td style="border-bottom: black 1.5pt solid; width: 10%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Age</b></span></td>
    <td style="width: 1%; text-align: justify">&#160;</td>
    <td style="border-bottom: black 1.5pt solid; width: 63%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Position(s)</b></span></td></tr>
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Michael K. McGarrity</span></td>
    <td style="text-align: justify">&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">60</span></td>
    <td style="text-align: justify">&#160;</td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Chief Executive Officer and Executive Director</span></td></tr>
  <tr style="vertical-align: top; ">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">John Bellano</span></td>
    <td style="text-align: justify">&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">54</span></td>
    <td style="text-align: justify">&#160;</td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Chief Commercial Officer</span></td></tr>
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Ron Kalfus</span></td>
    <td style="text-align: justify">&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">48</span></td>
    <td style="text-align: justify">&#160;</td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Chief Financial Officer</span></td></tr>
  <tr style="vertical-align: top; ">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Joseph Sollee</span></td>
    <td style="text-align: justify">&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">58</span></td>
    <td style="text-align: justify">&#160;</td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Executive Vice President of Corporate Development and
    General Counsel</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Unless otherwise stated, the address for our
executive management is CAP Business Center, Zone Industrielle des Hauts-Sarts, Rue d&#8217;Abhooz&#160;31, 4040 Herstal, Belgium.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The following is the biographical information
of those members of our executive management who do not also serve on our Board of Directors:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>John Bellano</i></b>, our Chief Commercial
Officer, joined MDxHealth in June 2019. He has more than 25 years of experience in the healthcare industry. Mr.&#160;Bellano started
his career in pharmaceuticals and transitioned to molecular diagnostics where he has spent the past 20 years of his career, most recently
as Chief Commercial Officer of Sterilis Solutions. Prior to Sterilis Solutions he served as the commercial leader for pharmacogenomic
companies Assurex Health and AltheaDx. Mr.&#160;Bellano holds a degree from Allentown&#160;College.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Ron Kalfus</i></b>, our Chief Financial
Officer, joined MDxHealth in July 2019. He has over 20 years of leadership experience in both public and private companies within diagnostics/biotech
and other sectors, and brings extensive knowledge in financial operations and management. Mr.&#160;Kalfus joined MDxHealth from Rosetta
Genomics, where he helped lead efforts to reposition the company for commercial success with its oncology diagnostic products. Prior
to Rosetta, Mr.&#160;Kalfus served as the CFO and Treasurer of MabCure, a Belgium-based&#160;publicly-traded&#160;biotechnology start
up in the field of early cancer detection using antibodies. Mr.&#160;Kalfus holds a MS in Accounting from Fairleigh Dickinson University
and a BBA in Finance from the University of Georgia and is a CPA licensed in New Jersey.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Joseph Sollee</i></b>, our Executive Vice
President of Corporate Development and General Counsel, has provided legal counsel to MDxHealth since its inception in 2003, and in April
2008 joined our management team. Prior to joining the Company, Mr.&#160;Sollee served as Special Counsel with the law firm of Kennedy
Covington (now K&amp;L Gates), where he led the Life Sciences Practice Group. Mr.&#160;Sollee has more than 20 years of experience in
the life sciences industry, and has held senior legal and management positions at Triangle Pharmaceuticals and TherapyEdge. In addition,
he has practiced as a corporate attorney in the Washington&#160;D.C. legal firm Swidler&#160;&amp; Berlin and in investment banking at
Smith Barney in New York. Mr.&#160;Sollee received a Juris Doctorate in Law (JD) and a Master&#8217;s degree in International &amp; Comparative
Law (LLM) from Duke University, a BA degree from Harvard University, and has been certified into the legal bars of New York, Washington
D.C. and North Carolina.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Family Relationships</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">There are no family relationships among any of
the members of our executive management and/or our Board of Directors.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>B. Compensation</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Compensation of Our Directors and Executive
Management</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our current remuneration policy is based on meritocracy
and a sense of ownership and is designed to reward performance in order to motivate members of the Board of Directors and the executive
management of the Company in order to deliver increased shareholder value through superior business results.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We have prepared and submitted a remuneration
policy in accordance article 7:89/1 of the Belgian Companies and Associations Code to the general shareholders&#8217; meeting of the
Company, which approved said remuneration policy on May&#160;27, 2021. Upon every material change to the remuneration policy and in any
case at least every four years, the remuneration policy will be submitted to the general shareholders&#8217; meeting for approval. The
shareholders&#8217; vote on the remuneration policy is binding.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Compensation of Our Board of Directors</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Upon recommendation and proposal of the Nomination
and Remuneration Committee, our Board of Directors determines the remuneration of the directors to be proposed to the general shareholders&#8217;
meeting.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Pursuant to Belgian law, the general shareholders&#8217;
meeting approves the remuneration of the directors, including inter alia, each time as relevant:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 24px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">a.</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">in relation to the remuneration
    of executive and non-executive&#160;directors, the exemption from the rule that share based awards can only vest after a period of
    at least three years as of the grant of the awards (article 7:91, first subsection of the Belgian Companies and Associations Code);</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 24px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">b.</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">in relation to the remuneration
    of executive directors, the exemption from the rule that (unless the variable remuneration is less than a quarter of the annual remuneration)
    at least one quarter of the variable remuneration must be based on performance criteria that have been determined in advance and
    that can be measured objectively over a period of at least two years and that at least another quarter of the variable remuneration
    must be based on performance criteria that have been determined in advance and that can be measured objectively over a period of
    at least three years (article 7:91, second to fourth subsection of the Belgian Companies and Associations Code);</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 24px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">c.</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">in relation to the remuneration
    of non-executive&#160;directors, any variable part of the remuneration (independent directors can never receive a variable remuneration)
    (Article 7:92, fourth and fifth subsection of the Belgian Companies and Associations Code); and</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 24px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">d.</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">any provisions of service
    agreements to be entered into with executive directors providing for severance payments exceeding twelve months&#8217; remuneration
    and if the severance payments exceed eighteen months&#8217; remuneration, only with the prior recommendation of the Nomination and
    Remuneration Committee (article 7:92, first subsection of the Belgian Companies and Associations Code).</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Notwithstanding points (a) and (b) above, pursuant
to our Articles of Association, our Board of Directors is explicitly authorized to deviate from the provisions of article 7:91 of the
Belgian Companies and Associations Code.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The level and structure of the remuneration of
the members of the Board of Directors are determined based on their general and specific responsibilities and market practice. Our shareholders
approved the following annual remuneration and compensation of the members of the Board of Directors:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <tr style="vertical-align: bottom">
    <td style="text-align: center">&#160;</td><td style="text-align: center; font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
    <td colspan="6" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">Compensation</td><td style="text-align: center; padding-bottom: 1.5pt; font-weight: bold">&#160;</td></tr>
  <tr style="vertical-align: bottom">
    <td style="text-align: center">&#160;</td><td style="text-align: center; font-weight: bold; font-style: italic; padding-bottom: 1.5pt">&#160;</td>
    <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; font-style: italic; text-align: center">(in EUR)</td><td style="text-align: center; padding-bottom: 1.5pt; font-weight: bold; font-style: italic">&#160;</td><td style="text-align: center; font-weight: bold; font-style: italic; padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
    <td style="text-align: left; text-indent: -9pt; padding-left: 9pt">Additional fee for a Member Nomination and Remuneration Committee
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    <td style="text-align: left">&#160;</td><td style="text-align: right">5,500</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  </table><div>


</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The abovementioned remuneration can be reduced&#160;<i>pro
rata temporis</i>&#160;depending on the duration of the mandate, chairpersonship or membership of a director during a given year. The
abovementioned amounts are exclusive of VAT and similar charges.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Directors are not entitled to any kind of performance
cash bonus or other kind of variable remuneration.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Mr.&#160;McGarrity, our Chief Executive Officer,
Executive Director and a member of our Board of Directors, does not receive any<i>&#160;</i>compensation for his service as a director.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Additionally, directors are not entitled to any
kind of compensation when their mandate ends.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 75; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: normal 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->69<!-- Field: /Sequence --></p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">For 2022, the following remuneration or compensation
was due to the directors (excluding Mr.&#160;McGarrity):</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <tr style="vertical-align: bottom">
    <td>&#160;</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
    <td colspan="6" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">Compensation</td><td style="padding-bottom: 1.5pt; font-weight: bold">&#160;</td></tr>
  <tr style="vertical-align: bottom">
    <td>&#160;</td><td style="font-weight: bold; font-style: italic; padding-bottom: 1.5pt">&#160;</td>
    <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; font-style: italic; text-align: center">(in EUR)</td><td style="padding-bottom: 1.5pt; font-weight: bold; font-style: italic">&#160;</td><td style="font-weight: bold; font-style: italic; padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="width: 76%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Koen Hoffman<sup>(1)</sup></span></td><td style="width: 1%">&#160;</td>
    <td style="width: 1%; text-align: left">&#160;</td><td style="width: 9%; text-align: right">102,000</td><td style="width: 1%; text-align: left">&#160;</td><td style="width: 1%">&#160;</td>
    <td style="width: 1%; text-align: left">&#160;</td><td style="width: 9%; text-align: right">107,400</td><td style="width: 1%; text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Jan Pensaert<sup>(2)</sup></span></td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">10,000</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">10,500</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Dr. Lieve Verplancke<sup>(3)</sup></span></td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">52,000</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">54,800</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Hilde Windels<sup>(4)</sup></span></td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">47,000</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">49,500</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Dr. Regine Slagmulder<sup>(5)</sup></span></td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">59,000</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">62,100</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-align: left">Dr. Eric Bednarski</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#8212;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#8212;</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left">Donnie (Don) M. Hardison</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">71,000</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">74,800</td><td style="text-align: left">&#160;</td></tr>
  </table><div>



</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><sup>(1)</sup></span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Acting through Ahok BV.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><sup>(2)</sup></span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Acting through Valiance
    Advisors LLP.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><sup>(3)</sup></span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Acting through Qaly-Co&#160;BV.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><sup>(4)</sup></span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Acting through Hilde Windels
    BV.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><sup>(5)</sup></span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Acting through Regine Slagmulder
    BV.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The table below provides an overview as of December
31, 2022, of the subscription rights, or options, held by the non-executive&#160;directors.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <tr style="vertical-align: bottom; ">
    <td style="text-align: center; padding-bottom: 1.5pt">&#160;</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom; ">
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    <td style="border-bottom: Black 1.5pt solid; width: 15%; font-weight: bold; text-align: center">Option Exercise<br/> Price per<br/>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left; text-indent: -9pt; padding-left: 9pt; vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Koen Hoffman<sup>(1)</sup></span></td><td>&#160;</td>
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    <td style="text-align: center">June 18, 2027<br/> June 20, 2029</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="padding-left: 9pt">&#160;</td><td>&#160;</td>
    <td style="text-align: right">&#160;</td><td>&#160;</td>
    <td style="text-align: right">&#160;</td><td>&#160;</td>
    <td style="text-align: center">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="text-align: center">June 22, 2024<br/> June 22, 2024<br/> June 22, 2024<br/> June 18, 2027<br/> June 18, 2027<br/> June 20,
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  <tr style="vertical-align: bottom; ">
    <td style="text-indent: -9pt; padding-left: 9pt">&#160;</td><td>&#160;</td>
    <td style="text-align: right">&#160;</td><td>&#160;</td>
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    <td style="text-align: center">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="vertical-align: top; text-align: left; text-indent: -9pt; padding-left: 9pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Dr.
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    <td style="text-align: right">10,000<br/> 10,000<br/> 10,000</td><td>&#160;</td>
    <td style="text-align: right">4.97<br/> 4.97<br/> 1.28</td><td>&#160;</td>
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    <td style="text-indent: -9pt; padding-left: 9pt">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left; text-indent: -9pt; padding-left: 9pt; vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Hilde
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  <tr style="vertical-align: bottom; ">
    <td style="text-indent: -9pt; padding-left: 9pt">&#160;</td><td>&#160;</td>
    <td style="text-align: right">&#160;</td><td>&#160;</td>
    <td style="text-align: right">&#160;</td><td>&#160;</td>
    <td style="text-align: center">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="vertical-align: top; text-align: left; text-indent: -9pt; padding-left: 9pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Dr.
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    <td style="text-align: right">&#160;</td><td>&#160;</td>
    <td style="text-align: center">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-indent: -9pt; padding-left: 9pt">&#160;</td><td>&#160;</td>
    <td style="text-align: right">&#160;</td><td>&#160;</td>
    <td style="text-align: right">&#160;</td><td>&#160;</td>
    <td style="text-align: center">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="text-align: right">&#160;</td><td>&#160;</td>
    <td style="text-align: center">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-indent: -9pt; padding-left: 9pt">&#160;</td><td>&#160;</td>
    <td style="text-align: right">&#160;</td><td>&#160;</td>
    <td style="text-align: right">&#160;</td><td>&#160;</td>
    <td style="text-align: center">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="text-align: right">None</td><td>&#160;</td>
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    <td style="text-align: center">&#160;</td></tr>
  </table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0in; margin-bottom: 0in; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><sup>(1)</sup></span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Acting
                                            through Ahok BV.</span></td>
</tr></table><div>

</div><p style="margin: 0">&#160;</p><div>

</div><p style="margin: 0"></p><div>

</div><!-- Field: Page; Sequence: 76; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: normal 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->70<!-- Field: /Sequence --></p></div><div>
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    </div><!-- Field: /Page --><div>

</div><p style="margin: 0">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0in; margin-bottom: 0in; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><sup>(2)</sup></span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Acting
                                            through Valiance Advisors LLP.</span></td>
</tr></table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0in; margin-bottom: 0in; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><sup>(3)</sup></span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Acting
                                            through Qaly-Co&#160;BV.</span></td>
</tr></table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0in; margin-bottom: 0in; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><sup>(4)</sup></span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Acting
                                            through Hilde Windels BV.</span></td>
</tr></table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0in; margin-bottom: 0in; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><sup>(5)</sup></span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Acting
                                            through Regine Slagmulder BV.</span></td>
</tr></table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Compensation of Our Executive Management</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The remuneration of the Chief Executive Officer
and the other members of our executive management is based on recommendations made by our Nomination and Remuneration Committee. The
Chief Executive Officer can, and will in principle be invited to, participate in an advisory capacity to the meetings of the committee
when it deals with the remuneration of other executive managers.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The remuneration of our executive management
is determined by our Board of Directors, in accordance with the current remuneration policy pursuant to Article 7:89/1 Belgian Companies
and Associations Code, as approved by the general shareholders&#8217; meeting of May 27, 2021.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">As an exception to the foregoing rule, Belgian
law provides that the general shareholders&#8217; meeting must approve, as relevant:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">a.</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">in relation to the remuneration
    of members of the executive management and other executives, an exemption from the rule that share-based&#160;awards can only vest
    after a period of at least three years as of the grant of the awards (article 7:121, last subsection&#160;<i>juncto</i>&#160;article
    7:91, first subsection of the Belgian Companies and Associations Code);</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">b.</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">in relation to the remuneration
    of members of the executive management and other executives, an exemption from the rule that (unless the variable remuneration is
    less than a quarter of the annual remuneration) at least one quarter of the variable remuneration must be based on performance criteria
    that have been determined in advance and that can be measured objectively over a period of at least two years and that at least another
    quarter of the variable remuneration must be based on performance criteria that have been determined in advance and that can be measured
    objectively over a period of at least three years (article 7:121, last subsection&#160;<i>juncto</i>&#160;article 7:91, second to
    fourth subsection of the Belgian Companies and Associations Code); and</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">c.</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">any service agreements
    to be entered into with members of the executive management and other executives (as the case may be) providing for severance payments
    exceeding twelve months&#8217; remuneration (or, subject to a motivated opinion by the remuneration committee, eighteen months&#8217;
    remuneration) (article 7:121, last subsection&#160;<i>juncto</i>&#160;article 7:92, first subsection of the Belgian Companies and
    Associations Code).</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Notwithstanding points (a) and (b) above, our
Board of Directors has been explicitly authorized in the Articles of Association to deviate from the provisions of Article 7:91 of the
Belgian Companies and Associations.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Each member of the executive management is entitled
to a basic fixed remuneration designed to fit responsibilities, relevant experience and competences, in line with market rates for equivalent
positions. The majority of the annual remuneration is a fixed compensation amount. There is no minimum or maximum variable bonus.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Chief Executive Officer has a fixed remuneration,
a fixed bonus and variable bonus linked to the performance of the Company and to his capacity to manage remuneration costs.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The other management team members receive a fixed
remuneration plus a variable bonus that is linked to their personal achievements (<i>i.e.</i>, experience, know-how, education, skills,
responsibilities, and performance) and the achievements of the Company. The remuneration is closely linked to performance.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Bonuses, if any, are linked to identifiable objectives
and to special projects and are set and measured on a calendar-year&#160;basis. Non-performers&#160;are not retained in the Company.
The performance objectives of the management team members are primarily evaluated with regard to the following criteria: (i) respect
of the board-approved&#160;annual budget, and (ii) meeting measurable operational targets. The various objectives and their weighting
may differ for the individual managers.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 77; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: normal 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->71<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Nomination and Remuneration Committee of
the Board of Directors meets annually to review the performance of the executive managers, to compare the actual measurable results to
the objectives that were pre-defined&#160;by the committee, and to establish the measurable objectives for the ensuing calendar year.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Each member of the executive management is in
principle entitled to receive share options or subscription rights.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Each member of the executive management who is
a salaried employee may be entitled to a number of fringe benefits, which may include participating in a defined contribution pension
or retirement scheme, disability insurance, a company car, a mobile telephone, internet access and/or a laptop computer according to
general Company policy, and other collective benefits (such as hospitalization insurance and meal vouchers). Executive members who are
engaged on the basis of a services contract do not receive fringe benefits, except that they may be provided with a mobile phone and
laptop computer according to general Company policy, and they qualify for reimbursement of expenses incurred while carrying out their
professional responsibilities.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Executive managers of the Company that are employed
under employee contracts are entitled to enroll in defined-contribution&#160;type pension plans (such as 401(k) plans in the United States).
Executive managers of the Company that are engaged on the basis of a service agreement are not entitled to any pension plans or pension
plan contributions from the Company.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Furthermore, the Company has entered into indemnification
arrangements with the members of the executive management and has implemented directors&#8217; and officers&#8217; insurance coverage
in order to cover liability they may incur in the exercise of their mandates.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Mr.&#160;McGarrity is remunerated on the basis
of his executive management position. As CEO, Mr.&#160;McGarrity is entitled to a gross annual base salary of $535,000, which will be
reviewed by the Board of Directors (or the Nomination and Remuneration Committee) on an annual basis, and an annual bonus of up to 50%
of the then applicable base salary. In connection with his hiring as CEO in February 2019, Mr.&#160;McGarrity also received a one-time&#160;grant
of 1,500,000 subscription rights (employee share options) and a one-time&#160;signing bonus in the gross amount of $85,000. Furthermore,
Mr.&#160;McGarrity is entitled to the reimbursement of expenses, and he and his dependents are eligible to participate in all group health,
medical, dental, disability and insurance plans, incentive, savings and retirement plans, and other employee benefits that are established
by the Company for its executives.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Excluding the value of subscription rights (employee
share options), the remuneration and benefits provided to Mr.&#160;McGarrity in 2022 were composed of the following:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <tr style="vertical-align: bottom">
    <td>&#160;</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
    <td colspan="6" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">Compensation</td><td style="padding-bottom: 1.5pt; font-weight: bold">&#160;</td></tr>
  <tr style="vertical-align: bottom">
    <td>&#160;</td><td style="font-weight: bold; font-style: italic; padding-bottom: 1.5pt">&#160;</td>
    <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; font-style: italic; text-align: center">(in EUR)</td><td style="padding-bottom: 1.5pt; font-weight: bold; font-style: italic">&#160;</td><td style="font-weight: bold; font-style: italic; padding-bottom: 1.5pt">&#160;</td>
    <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; font-style: italic; text-align: center">(in USD)</td><td style="padding-bottom: 1.5pt; font-weight: bold; font-style: italic">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="width: 76%; text-align: left; text-indent: -9pt; padding-left: 9pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Fixed
    gross remuneration<sup>(1)</sup></span></td><td style="width: 1%">&#160;</td>
    <td style="width: 1%; text-align: left">&#160;</td><td style="width: 9%; text-align: right">420,102</td><td style="width: 1%; text-align: left">&#160;</td><td style="width: 1%">&#160;</td>
    <td style="width: 1%; text-align: left">&#160;</td><td style="width: 9%; text-align: right">442,576</td><td style="width: 1%; text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-align: left; text-indent: -9pt; padding-left: 9pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Supplementary
    paid compensation<sup>(2)</sup>&#160;(gross)</span></td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">47,461</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">50,000</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left; text-indent: -9pt; padding-left: 9pt">Pension benefits</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">15,577</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">16,411</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="padding-bottom: 1.5pt; text-indent: -9pt; padding-left: 9pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Other
    benefits<sup>(3)</sup></span></td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right">50,256</td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right">52,945</td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="font-weight: bold; padding-bottom: 4pt; text-indent: -9pt; padding-left: 9pt">Total</td><td style="font-weight: bold; padding-bottom: 4pt">&#160;</td>
    <td style="border-bottom: Black 4pt double; font-weight: bold; text-align: left">&#160;</td><td style="border-bottom: Black 4pt double; font-weight: bold; text-align: right">533,396</td><td style="padding-bottom: 4pt; font-weight: bold; text-align: left">&#160;</td><td style="font-weight: bold; padding-bottom: 4pt">&#160;</td>
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  </table><div>


</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><sup>(1)</sup></span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Total cost to the Company,
    including employer social security contributions and vacation pay accrual.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><sup>(2)</sup></span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Excludes value of 1,000,000
    subscription rights (employee share options) already created, issued, and accepted in 2022 under the Company&#8217;s 2022 Share Option
    Plan.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><sup>(3)</sup></span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Includes Company-paid&#160;and
    other similar benefits, such as the employer&#8217;s payroll taxes, meal tickets and health insurances. Excludes reimbursement of
    normal professional expenses such as telephone and Company travel expenses.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 78; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: normal 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->72<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The 2022 combined remuneration package of the
other executive management team members in office in 2022 (excluding the CEO)&#8212;<i>i</i>.<i>e</i>., John Bellano, Joseph Sollee and
Ron Kalfus&#8212;including employer taxes, was &#8364;1,190,210 composed of the following:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-size: 8pt">&#160;</span></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <tr style="vertical-align: bottom">
    <td>&#160;</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom">
    <td>&#160;</td><td style="font-weight: bold; font-style: italic; padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="width: 76%; text-align: left; text-indent: -9pt; padding-left: 9pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Fixed
    gross remuneration<sup>(1)</sup></span></td><td style="width: 1%">&#160;</td>
    <td style="width: 1%; text-align: left">&#160;</td><td style="width: 9%; text-align: right">931,897</td><td style="width: 1%; text-align: left">&#160;</td><td style="width: 1%">&#160;</td>
    <td style="width: 1%; text-align: left">&#160;</td><td style="width: 9%; text-align: right">981,754</td><td style="width: 1%; text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-align: left; text-indent: -9pt; padding-left: 9pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Bonuses
    paid and awarded&#160;<sup>(2)</sup>&#160;(gross)</span></td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">71,653</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">75,486</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="text-align: left">&#160;</td><td style="text-align: right">35,439</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">37,336</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="padding-bottom: 1.5pt; text-indent: -9pt; padding-left: 9pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Other
    benefits<sup>(3)</sup></span></td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right">157,456</td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right">165,880</td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="font-weight: bold; padding-bottom: 4pt; text-indent: -9pt; padding-left: 9pt">Total</td><td style="font-weight: bold; padding-bottom: 4pt">&#160;</td>
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    <td style="border-bottom: Black 4pt double; font-weight: bold; text-align: left">&#160;</td><td style="border-bottom: Black 4pt double; font-weight: bold; text-align: right">1,260,456</td><td style="padding-bottom: 4pt; font-weight: bold; text-align: left">&#160;</td></tr>
  </table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-size: 8pt">&#160;</span></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><sup>(1)</sup></span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Includes employer taxes
    and vacation pay accrual. Excludes VAT.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-size: 8pt">&#160;</span></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><sup>(2)</sup></span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Excludes value of subscription
    rights (employee share options) already created, issued, and accepted in 2022 by certain other executive managers under the Company&#8217;s
    2022 Share Option Plan.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-size: 8pt">&#160;</span></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><sup>(3)</sup></span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Includes for some individuals
    a Company car, meal vouchers, and other similar benefits. Excludes reimbursement of normal professional expenses such as telephone
    and Company travel expenses.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-size: 8pt">&#160;</span></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The total remuneration and benefits paid to the
executive management team members (including the Chief Executive Officer) in 2022 and 2021 was &#8364;1,729,842 ($1,822,389) and &#8364;1,526,037
($1,814,834) (gross amount, excluding VAT and share based compensation), respectively. In the aforementioned figures, the service fees
of the managers hired on the basis of a service agreement are included with the salaries of the other management team members.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-size: 8pt">&#160;</span></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The primary performance objectives for the bonuses
of the above management team members in 2022 were the following:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-size: 8pt">&#160;</span></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">respect of the board-approved&#160;annual
    budget, with a focus on cash-flow&#160;management; and</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-size: 8pt">&#160;</span></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">meeting measurable operational
    targets, including total revenues, unit volumes for the Confirm mdx test, revenues
attributable to the Company&#8217;s UTI testing solution, and achievement of Medicare reimbursement for the Select mdx test.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-size: 8pt">&#160;</span></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Each of these foregoing targets was based on minimum percentage attainment
of defined, objective outcomes for the full calendar year, with the revenue, cash flow and unit volume targets tied to items that are
reviewed by the Company&#8217;s independent auditors in the ordinary course. Additionally, each performance target was assigned a pre-defined
weighting as a percentage of the bonus eligibility applicable to each member of executive management, with the CEO being treated consistently
with other members of the executive management team.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-size: 8pt">&#160;</span></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The table below provides an overview as of
December 31, 2022, of the subscription rights (employee share options) held by the members of the executive management team. The
options with an expiration date of May 25, 2032 we granted in 2022.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-size: 8pt">&#160;</span></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <tr style="vertical-align: bottom">
    <td style="padding-bottom: 1.5pt; text-indent: -9pt; padding-left: 9pt">&#160;</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="text-align: right">1,500,000 <br/>450,000 <br/>1,000,000<br/>
1,000,000</td><td>&#160;</td>
    <td style="text-align: right">1.49 <br/>0.80 <br/>1.375<br/>
0.684</td><td>&#160;</td>
    <td style="text-align: center">June 18, 2027 <br/>June 20, 2029 <br/>May 26, 2031 <br/>May 25, 2032</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-indent: -9pt; padding-left: 9pt"><span style="font-size: 7pt">&#160;</span></td><td><span style="font-size: 7pt">&#160;</span></td>
    <td style="text-align: right"><span style="font-size: 7pt">&#160;</span></td><td><span style="font-size: 7pt">&#160;</span></td>
    <td style="text-align: right"><span style="font-size: 7pt">&#160;</span></td><td><span style="font-size: 7pt">&#160;</span></td>
    <td style="text-align: center"><span style="font-size: 7pt">&#160;</span></td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="text-align: right">200,000 <br/>347,000 <br/>400,000<br/>
400,000</td><td>&#160;</td>
    <td style="text-align: right">1.24 <br/>0.80 <br/>1.375<br/>
0.684</td><td>&#160;</td>
    <td style="text-align: center">June 20, 2029 <br/>June 20, 2029 <br/>May 26, 2031 <br/>May 25, 2032</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-indent: -9pt; padding-left: 9pt"><span style="font-size: 7pt">&#160;</span></td><td><span style="font-size: 7pt">&#160;</span></td>
    <td style="text-align: right"><span style="font-size: 7pt">&#160;</span></td><td><span style="font-size: 7pt">&#160;</span></td>
    <td style="text-align: right"><span style="font-size: 7pt">&#160;</span></td><td><span style="font-size: 7pt">&#160;</span></td>
    <td style="text-align: center"><span style="font-size: 7pt">&#160;</span></td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="text-align: right">40,000 <br/>40,000 <br/>40,000 <br/>230,000 <br/>98,000 <br/>350,000<br/>
400,000</td><td>&#160;</td>
    <td style="text-align: right">4.49 <br/>3.78 <br/>5.35 <br/>1.24 <br/>0.80 <br/>1.375<br/>
0.684</td><td>&#160;</td>
    <td style="text-align: center">June 22, 2024 <br/>June 22, 2024 <br/>June 22, 2024 <br/>June 20, 2029 <br/>June 20, 2029 <br/>May 26, 2031 <br/>May 25, 2032</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-indent: -9pt; padding-left: 9pt"><span style="font-size: 7pt">&#160;</span></td><td><span style="font-size: 7pt">&#160;</span></td>
    <td style="text-align: right"><span style="font-size: 7pt">&#160;</span></td><td><span style="font-size: 7pt">&#160;</span></td>
    <td style="text-align: right"><span style="font-size: 7pt">&#160;</span></td><td><span style="font-size: 7pt">&#160;</span></td>
    <td style="text-align: center"><span style="font-size: 7pt">&#160;</span></td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="text-align: right">400,000 <br/>288,000 <br/>450,000<br/>
400,000</td><td>&#160;</td>
    <td style="text-align: right">1.24 <br/>0.80 <br/>1.375<br/>
0.684</td><td>&#160;</td>
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  </table><div>


</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-size: 7pt">&#160;</span></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 79; Value: 1 --><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>C. Board Practices </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The following table sets forth certain information
relating to our Board of Directors as of December 31, 2022.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: bottom">
    <td style="border-bottom: black 1.5pt solid"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Name</b></span></td>
    <td>&#160;</td>
    <td style="border-bottom: black 1.5pt solid; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Age</b></span></td>
    <td>&#160;</td>
    <td style="border-bottom: black 1.5pt solid; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Position(s)</b></span></td>
    <td>&#160;</td>
    <td style="border-bottom: black 1.5pt solid; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Year
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    Appointment</b></span></td>
    <td>&#160;</td>
    <td style="border-bottom: black 1.5pt solid; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Current
    Term<br/>
    Expiration Year</b></span></td>
    <td>&#160;</td></tr>
  <tr style="background-color: rgb(204,238,255)">
    <td style="vertical-align: top; width: 25%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Koen Hoffman<sup>(1)</sup></span></td>
    <td style="vertical-align: bottom; width: 1%">&#160;</td>
    <td style="vertical-align: top; width: 10%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">54</span></td>
    <td style="vertical-align: bottom; width: 1%">&#160;</td>
    <td style="vertical-align: top; width: 37%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Independent
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    <td style="vertical-align: bottom; width: 1%">&#160;</td>
    <td style="vertical-align: top; width: 12%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">2018</span></td>
    <td style="vertical-align: bottom; width: 1%">&#160;</td>
    <td style="vertical-align: top; width: 11%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">2024</span></td>
    <td style="vertical-align: bottom; width: 1%">&#160;</td></tr>
  <tr>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Michael K. McGarrity</span></td>
    <td style="vertical-align: bottom">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">60</span></td>
    <td style="vertical-align: bottom">&#160;</td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Executive Director (Chief
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    <td style="vertical-align: bottom">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">2019</span></td>
    <td style="vertical-align: bottom">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">2023<sup>(2)</sup></span></td>
    <td style="vertical-align: bottom">&#160;</td></tr>
  <tr style="background-color: rgb(204,238,255)">
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Jan Pensaert<sup>(3)</sup></span></td>
    <td style="vertical-align: bottom">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">51</span></td>
    <td style="vertical-align: bottom">&#160;</td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Non-Executive Director</span></td>
    <td style="vertical-align: bottom">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">2014</span></td>
    <td style="vertical-align: bottom">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">2024</span></td>
    <td style="vertical-align: bottom">&#160;</td></tr>
  <tr>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Dr. Lieve Verplancke<sup>(4)</sup></span></td>
    <td style="vertical-align: bottom">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">63</span></td>
    <td style="vertical-align: bottom">&#160;</td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Independent Non-Executive
    Director</span></td>
    <td style="vertical-align: bottom">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">2017</span></td>
    <td style="vertical-align: bottom">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">2024</span></td>
    <td style="vertical-align: bottom">&#160;</td></tr>
  <tr style="background-color: rgb(204,238,255)">
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Hilde Windels<sup>(5)</sup></span></td>
    <td style="vertical-align: bottom">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">57</span></td>
    <td style="vertical-align: bottom">&#160;</td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Independent Non-Executive
    Director</span></td>
    <td style="vertical-align: bottom">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">2017</span></td>
    <td style="vertical-align: bottom">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">2023<sup>(2)</sup></span></td>
    <td style="vertical-align: bottom">&#160;</td></tr>
  <tr>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Dr. Regine Slagmulder<sup>(6)</sup></span></td>
    <td style="vertical-align: bottom">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">56</span></td>
    <td style="vertical-align: bottom">&#160;</td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Independent Non-Executive
    Director</span></td>
    <td style="vertical-align: bottom">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">2020</span></td>
    <td style="vertical-align: bottom">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">2023<sup>(2)</sup></span></td>
    <td style="vertical-align: bottom">&#160;</td></tr>
  <tr style="background-color: rgb(204,238,255)">
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Dr. Eric Bednarski</span></td>
    <td style="vertical-align: bottom">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">51</span></td>
    <td style="vertical-align: bottom">&#160;</td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Non-Executive Director</span></td>
    <td style="vertical-align: bottom">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">2020</span></td>
    <td style="vertical-align: bottom">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">2023<sup>(2)</sup></span></td>
    <td style="vertical-align: bottom">&#160;</td></tr>
  <tr>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Donnie (Don) M. Hardison</span></td>
    <td style="vertical-align: bottom">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">72</span></td>
    <td style="vertical-align: bottom">&#160;</td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Independent Non-Executive
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    <td style="vertical-align: bottom">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">2021</span></td>
    <td style="vertical-align: bottom">&#160;</td>
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    <td style="vertical-align: bottom">&#160;</td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
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  <tr style="vertical-align: top">
    <td>&#160;</td>
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Director is up for reelection
    to a new mandate in May 2023 at our shareholder meeting.</span></td></tr>
  <tr style="vertical-align: top">
    <td>&#160;</td>
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  <tr style="vertical-align: top">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><sup>(5)</sup></span></td>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><sup>(6)</sup></span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Acting through Regine Slagmulder
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Unless otherwise stated, the address for
our directors is CAP Business Center, Zone Industrielle des Hauts-Sarts, Rue d&#8217;Abhooz&#160;31, 4040 Herstal, Belgium.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Committees of our Board of Directors</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our Board of Directors is assisted by a number
of specialized committees in order to advise the board in respect of decisions to be taken, to give comfort to the Board of Directors
that certain issues have been adequately addressed and, if necessary, to bring specific issues to the attention of the Board of Directors.
The decision-making&#160;remains the collegial responsibility of the Board of Directors.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our Board of Directors has established, in its
midst and under its responsibility, two board committees which are responsible for assisting the Board of Directors and making recommendations
in specific fields: an Audit Committee (in accordance with article 7:99 of the Belgian Companies and Associations Code and provision&#160;4.10
and following of the Belgian Corporate Governance Code) and a Remuneration and Nomination Committee (in accordance with article 7:100
of the Belgian Companies and Associations Code and provision&#160;4.17 and following of the Belgian Corporate Governance Code). The terms
of reference of these board committees are primarily set out in the Corporate Governance Charter of the Company.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 80; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: normal 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->74<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Audit Committee</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">As of the date of this annual report, our Audit
Committee consists of three directors: Regine Slagmulder, Lieve Verplancke, and Hilde Windels.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">According to the Belgian Companies and Associations
Code, all members of the Audit Committee must be non-executive&#160;directors, and at least one member must be independent within the
meaning of article 7:87 of the Belgian Companies and Associations Code and provision 3.5 of the Belgian Corporate Governance Code. Our
Board of Directors has determined that all members of our Audit Committee are independent under Rule 10A-3&#160;of the Exchange Act,
the applicable listing standards of Nasdaq, and the Belgian Companies and Associations Code and the Belgian Corporate Governance Code.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The members of the Audit Committee must have
a collective expertise relating to the activities of the Company, and at least one member of the Audit Committee must have the necessary
competence in accounting and auditing, including qualifying as an &#8220;audit committee financial expert&#8221; as defined under the
Exchange Act. Our Board of Directors has determined that the members of the Audit Committee satisfy the competency requirement, and our
Board of Directors has further determined that Regine Slagmulder and Hilde Windels each qualifies as an &#8220;audit committee financial
expert&#8221; as defined under the Exchange Act.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Audit Committee will be governed by a charter
that complies with Nasdaq listing rules and the Belgian Corporate Governance Code.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Without prejudice to the legal responsibilities
of the Board of Directors, the Audit Committee has the following roles:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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    Directors of the result of the audit of the financial statements and the manner in which the audit has contributed to the integrity
    of the financial reporting and the role that the Audit Committee has played in that process;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">to monitor the financial
    reporting process, and to make recommendations or proposals to ensure the integrity of the process;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">to monitor the effectiveness
    of our Company&#8217;s internal control and risk management systems, and our Company&#8217;s internal audit process and its effectiveness;</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">to monitor the audit of
    the annual statutory and consolidated financial statements, including the follow-up&#160;questions and recommendations by the statutory
    auditor and, as the case may be, the auditor responsible for the audit of the consolidated financial statements;</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">to assess and monitor the
    independence of the statutory auditor, in particular with respect to the appropriateness of the provision of additional services
    to the Company. More specifically, the Audit Committee analyzes, together with the statutory auditor, the threats for the statutory
    auditor&#8217;s independence and the security measures taken to limit these threats, when the total amount of fees exceeds the criteria
    specified in article 4 &#167; 3 of Regulation (EU) No 537/2014; and</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">to make recommendations
    to our Board of Directors on the selection, appointment and remuneration of our Company&#8217;s statutory auditor in accordance with
    article 16 &#167; 2 of Regulation&#160;(EU) No 537/2014.</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Audit Committee shall meet whenever it deems
it necessary for the proper performance of its duties and at least four regularly scheduled meetings each year. The Audit Committee regularly
reports to our Board of Directors on the exercise of its missions, and at least once a year prior to the approval of the annual financial
statements and annual report by the Board of Directors on the operations, findings and recommendations of the Audit Committee. The members
of the Audit Committee shall have unrestricted access to the offices and all information and papers kept by the company and its subsidiaries.
Each member of the Audit Committee may ask the executive management or any other staff member of the Company or its subsidiaries to submit
the information that he or she deems useful, appropriate or necessary to perform his or her tasks within the framework of the Audit Committee.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 81; Value: 1 --><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Without prejudice to the statutory provisions
which determine that the statutory auditor must address reports or warnings to our corporate bodies, the statutory auditor must discuss,
at the request of the statutory auditor, or at the request of the Audit Committee or of our Board of Directors, with the Audit Committee
or with the Board of Directors, essential issues which are brought to light in the exercise of the statutory audit of the financial statements,
which are included in the additional statement to the Audit Committee, as well as any meaningful shortcomings discovered in our internal
financial control system.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Nomination and Remuneration Committee</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">According to article 7:100 &#167; 4 of the Belgian
Companies and Associations Code, our Company would meet the size criteria in order to operate without a separate remuneration committee,
but we have chosen to continue operating with a separate Nomination and Remuneration Committee.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">As of the date of this annual report, our Nomination
and Remuneration Committee consists of five directors: Eric Bednarski, Don Hardison, Koen Hoffman, Jan Pensaert, and Lieve Verplancke.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In line with the Belgian Companies and Associations
Code and the Belgian Corporate Governance Code (i)&#160;all members of the Nomination and Remuneration Committee are non-executive&#160;directors,
(ii) the Nomination and Remuneration Committee consists of a majority of independent directors, and (iii) the Nomination and Remuneration
Committee is chaired by the Chairperson of our Board of Directors or another non-executive&#160;director appointed by the committee,
it being understood that the Chair of the Board of Directors should not chair the committee when dealing with the designation of his
successor. Our Board of Directors has determined that three members of our Nomination and Remuneration Committee are independent under
the applicable listing standards of Nasdaq, the applicable rules of the Belgian Companies and Association Code and the Belgian Corporate
Governance Code.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Pursuant to the Belgian Companies and Associations
Code, a remuneration committee must have the necessary expertise in terms of remuneration policy. Our Board of Directors has determined
that the members of the Nomination and Remuneration Committee satisfy this requirement.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The role of the Nomination and Remuneration Committee
is to make recommendations to the Board of Directors with regard to the appointment and remuneration of directors and members of the
executive management and, in particular, to:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
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    nominate, for the approval of the Board of Directors, candidates to fill vacancies in the Board of Directors and executive management
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    made by relevant parties, including management and shareholders;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
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    of other members of the executive management;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">draft appointment procedures
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">ensure that the appointment
    and re-election&#160;process is organized objectively and professionally;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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    size and composition of the Board of Directors and make recommendations to the Board of Directors with regard to any changes;</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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    of Directors on the remuneration policy for directors and members of the executive management and the persons responsible for the
    day-to-day&#160;management of the Company, as well as, where appropriate, on the resulting proposals to be submitted by the Board
    of Directors to the shareholders&#8217; meeting;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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    in the form of share options or other financial instruments, and arrangements on early termination, and where applicable, on the
    resulting proposals to be submitted by the Board of Directors to the shareholders&#8217; meeting;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Pursuant to the Belgian Companies and Associations
Code, the Chief Executive Officer participates in the meetings of the Nomination and Remuneration Committee in an advisory capacity each
time the remuneration of another member of the executive management is being discussed.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 82; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: normal 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->76<!-- Field: /Sequence --></p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>D. Employees</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">As of December 31, 2022, we had 258 employees,
252 of whom are employed on a full-time basis. Of these employees, 244 are located in the United States and 14 in Europe. None of our
employees is covered by a collective bargaining agreement, and we believe our relationship with our employees is good.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our human capital resources objectives include,
as applicable, identifying, recruiting, retaining, incentivizing and integrating our existing and new employees, advisors and consultants.
The principal purposes of our equity incentive plans are to attract, retain and reward personnel through the granting of stock-based
compensation awards, in order to increase stockholder value and the success of our company by motivating such individuals to perform
to the best of their abilities and achieve our objectives.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>E. Share Ownership </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">For information regarding the share ownership
of our supervisory and executive board members, see Item 6B. &#8220;<i>Compensation</i>&#8221; and Item 7A. &#8220;<i>Major Shareholders</i>.&#8221;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>F. Disclosure of a registrant&#8217;s action
to recover erroneously awarded compensation</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>&#160;</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Not applicable.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><div><a id="a_011"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>A. Major Shareholders</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Except as specifically noted, the following table
sets forth information with respect to the beneficial ownership of our ordinary shares as of March 31, 2023:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">all of our supervisory
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">As of March 31, 2023, there were four record
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">All of the ordinary shares have the same voting
rights and no major shareholders of the Company have different voting rights.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Beneficial ownership is determined according
to the rules of the SEC and generally means that a person has beneficial ownership of a security if he, she or it possesses sole or shared
voting or investment power of that security, including ordinary shares that can be acquired within 60 days of March 31, 2023. Ordinary
shares subject to derivative securities currently exercisable or exercisable within 60 days of March 31, 2023 are deemed to be outstanding
for computing the percentage ownership of the person holding these securities and the percentage ownership of any group of which the
holder is a member, but are not deemed outstanding for computing the percentage of any other person.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; ">The percentage ownership
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; ">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Except as indicated by the footnotes below, we
believe, based on the information furnished to us, that the persons named in the table below have sole voting and investment power with
respect to all ordinary shares shown that they beneficially own, subject to community property laws where applicable. The information
does not necessarily indicate beneficial ownership for any other purpose, including for purposes of Sections 13(d) and 13(g) of the Exchange
Act.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Except as otherwise indicated in the table below,
addresses of the directors, members of the executive management team and named beneficial owners are in care of MDxHealth SA, CAP Business
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 83; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: normal 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->77<!-- Field: /Sequence --></p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <tr style="vertical-align: bottom">
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  <tr style="vertical-align: bottom">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">*</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#8239;Less than one percent.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><sup>(1)</sup></span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Includes 44,585,295 shares
    held by MVM V LP and 919,289 shares held by MVM GP (No. 5) (collectively, the &#8220;MVM Entities&#8221;). The Company has been informed
    that voting and investment power over the shares held by the MVM Entities is exercised jointly by three or more natural persons and
    voting and disposition decisions require the approval of a majority of such persons. Accordingly, no single natural person has voting
    or dispositive power over such shares. The MVM Entities are party to the MVM Subscription Agreement, providing for certain rights
    to appoint a member of our Board of Directors. See Item 7B. &#8220;<i>Related party transactions &#8212; MVM Subscription Agreement.</i>&#8221;
    This information has been obtained from Schedule 13D/A filed by the MVM Entities with the SEC on February 28, 2023.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 24px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><sup>(2)</sup></span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Includes 20,342,162 shares
    held by 21 April Fund Ltd., a Cayman Islands company for which Bleichroeder LP acts as investment adviser. This information has been
    obtained from Schedule 13G/A filed by Bleichroeder Entities with the SEC on February 14, 2023.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 24px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><sup>(3)</sup></span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Includes 12,339,297&#160;shares
    held by TopMDx Ltd. and 8,591,797 shares held by Valiance Life Sciences Growth Investments SICAV-SIF (collectively, the &#8220;Valiance&#160;Entities&#8221;).
    The Company has been informed that voting and investment power over the shares held by the Valiance Entities is exercised jointly
    by three or more natural persons and voting and disposition decisions require the approval of a majority of such persons. Accordingly,
    no single natural person has voting or dispositive power over such shares. This information has been obtained from Schedule 13D/A
    filed by the Valiance Entities with the SEC on April 14, 2023.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 24px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><sup>(4)</sup></span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Consists of shares held
    by Biovest NV (&#8220;Biovest&#8221;). RMM, S.A. (&#8220;RMM&#8221; and together with Biovest, the &#8220;Biovest Entities&#8221;)
    is the sole owner of Biovest and pursuant to an understanding with Biovest, decisions relating to the voting and dispositive power
    of the shares are shared between Biovest and the RMM&#8217;s Board of Directors (the &#8220;RMM Board&#8221;). Voting and investment
    power over the shares managed by the RMM Board is exercised jointly by more than three natural persons and voting and disposition
    decisions require the approval of a majority of such persons. Accordingly, no single natural person has a controlling decision and
    no individual director of the RMM should be deemed to be a beneficial owner of the shares. This information has been obtained from
    Schedule 13G/A filed by the Biovest Entities with the SEC on March 17, 2023.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 24px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><sup>(5)</sup></span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Reflects shares acquirable
    upon the exercise of warrants, which are described above in Item 6.B. &#8220;<i>Compensation</i>.&#8221;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: normal 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->78<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">From December 31, 2019 to December 31, 2022,
the only significant changes related to the beneficial owners listed in the above table of which we have been notified of through
Shareholder Transparency Declarations in accordance with Article 14 of the Belgian Act of May 2, 2007 on the disclosure of important
participations in issuers of which shares are admitted to trading on a regulated market and regarding miscellaneous provisions (the
&#8220;Declarations&#8221; and each a &#8220;Declaration&#8221;) are listed below:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td style="text-align: justify">November 22, 2021 Declaration: MDxHealth
                                            was notified that the number of shares with respect to which Bleichroeder LP can exercise
                                            voting rights actively crossed above the threshold of 15% of the outstanding shares and voting
                                            rights of MDxHealth on November 19, 2021.</td></tr></table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td style="text-align: justify">November 15, 2021 Declaration: MDxHealth
                                            was notified that the number of shares with respect to which Bleichroeder LP can exercise
                                            voting rights actively crossed above the threshold of 10% of the outstanding shares and voting
                                            rights of MDxHealth on November 4, 2021.</td></tr></table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td style="text-align: justify">February 3, 2021 Declaration: Biovest
                                            NV notified MDxHealth that the number of shares with respect to which Biovest NV can exercise
                                            voting rights passively crossed below the threshold of 10% of the outstanding shares and
                                            voting rights of MDxHealth on January 26, 2021.</td></tr></table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td style="text-align: justify">May 25, 2020 Declaration: Valiance
                                            Asset Management Limited notified MDxHealth that the aggregate number of shares with respect
                                            to which Valiance Asset Management Limited can exercise voting rights passively crossed below
                                            the threshold of 15% of the outstanding shares and voting rights of MDxHealth. MVM Partners
                                            LLP notified MDxHealth that the aggregate number of shares with respect to which MVM Partners
                                            LLP can exercise voting rights actively crossed above the threshold of 20% of the outstanding
                                            shares and voting rights of MDxHealth.</td></tr></table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>B. Related Party Transactions </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Agreements with the Members of the Board of
Directors and the Executive Management</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Each non-executive director exercises his/her
mandate as a self-employed worker. According to our Articles of Association, the term of a directors&#8217; mandate cannot exceed four
years, but may be renewed. The directors&#8217; mandates may be terminated ad nutum (at any time) without any form of compensation. There
is no specific agreement between us and non-executive directors which waives or restrains this right of the Company to terminate ad nutum
(at any time) the mandates of the directors.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Currently, all the members of the executive management
are engaged on the basis of an employment agreement. The employment agreements are for an indefinite term. The employment agreements
include, where appropriate, non-competition undertakings, as well as confidentiality and intellectual property transfer undertakings
(which are intended to obtain maximum protection of our interests, under applicable laws and subject to the employee&#8217;s agreement).</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We hired Mr. Michael K.
    McGarrity, acting in the role of Chief Executive Officer, effective as of February 18, 2019. The executive employment agreement with
    Mr. McGarrity provides that if we terminate the employment agreement without cause or if Mr. McGarrity resigns for good reason, Mr.
    McGarrity shall be eligible to receive as severance an amount equal to twelve months of base salary in effect at the time of the
    separation. In addition, we have the right, exercisable at any time, to terminate the executive employment agreement with immediate
    effect for cause (as defined in the employment agreement) by providing written notice.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Acting under the direction
    of the Board of Directors, we hired Mr.&#160;Ron Kalfus, acting in the role of Chief Financial Officer, effective as of July&#160;22,
    2019. The executive employment agreement with Mr.&#160;Kalfus provides that if we terminate the employment agreement without cause
    or if Mr.&#160;Kalfus resigns for good reason, Mr.&#160;Kalfus shall be eligible to receive as severance an amount equal to six months
    of base salary in effect at the time of the separation, which amount will increase to twelve months of base salary for a termination
    that occurs after July&#160;22, 2020. In addition, we have has the right, exercisable at any time, to terminate the executive employment
    agreement with immediate effect for cause (as defined in the employment agreement) by providing written notice.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Acting under the direction
    of the Board of Directors, we hired Mr.&#160;John Bellano, acting in the role of Chief Commercial Officer, effective as of June&#160;19,
    2019. The executive employment agreement with Mr.&#160;Bellano provides that if we terminate the employment agreement without cause
    or if Mr.&#160;Bellano resigns for good reason, Mr.&#160;Bellano shall be eligible to receive as severance an amount equal to six
    months of base salary in effect at the time of the separation, which amount will increase to twelve months of base salary for a termination
    that occurs after June&#160;19, 2020. In addition, we have the right, exercisable at any time, to terminate the executive employment
    agreement with immediate effect for cause (as defined in the employment agreement) by providing written notice.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The executive employment
    contract with Mr.&#160;Joe Sollee dates from before the entry into force of the Belgian Act of April&#160;6, 2010 on corporate governance
    in public and listed companies and is in conformity with common employment law. The contract with Mr.&#160;Sollee provides that if
    his employment is terminated for a reason other than serious misconduct or if Mr.&#160;Sollee resigns for good reason, he will be
    entitled to severance pay of nine months gross remuneration and benefits. In addition, we have the right, exercisable at any time,
    to terminate the executive employment agreement with immediate effect for cause (as defined in the employment agreement) by providing
    written notice.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: normal 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->79<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Options Granted to Our Board Directors and
Executive Management</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We have granted subscription rights, or options,
to certain members of our Board of Directors and executive management. For more information regarding the options granted to our Board
of Directors and executive management. See Item 6B. &#8220;<i>Compensation</i>.&#8221;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>MVM Subscription Agreement</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">As part of an investment by MVM V LP and MVM GP
(No. 5) LP, or collectively MVM, into our share capital, our company entered in April 2020 into a subscription agreement with MVM, or
the Subscription Agreement. Pursuant to the Subscription Agreement, MVM is entitled to have one observer at the Board of Directors of
our Company for as long as MVM holds in aggregate 5% of our company&#8217;s outstanding shares. At the date of this annual report, the
observer of MVM at our Board of Directors is Dr. Kyle Dempsey. In addition, we agreed that MVM could propose to our 2020 general shareholders&#8217;
meeting to appoint Dr. Eric Bednarski as director of the Company. Our general shareholders&#8217; meeting held on July&#160;30, 2020 approved
the appointment of Dr.&#160;Eric Bednarski as a director for a term of three years, up to and including the closing of our annual general
shareholders&#8217; meeting to be held on May 25, 2023.</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Offering Purchases</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Pursuant to our February 2023 follow-on public
offering of ADSs in the United States, (1) the Bleichroeder Entities (as defined above under &#8220;A. <i>Major Shareholders</i>&#8221;)
purchased 1,500,000 ADSs representing 15,000,000 ordinary shares for an aggregate purchase price of $6,000,000, (2) the MVM Entities
(as defined above under &#8220;A. <i>Major Shareholders</i>&#8221;) purchased 1,000,000 ADSs representing 10,000,000 ordinary shares
for an aggregate purchase price of $4,000,000, and (3) the Valiance Entities (as defined above under &#8220;A. <i>Major Shareholders</i>&#8221;)
acquired and 190,408 ADSs representing 1,904,080 ordinary shares for an aggregate purchase price of $761,632.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>C. Interests of Experts and Counsel </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Not applicable.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><div><a id="a_012"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>ITEM 8. FINANCIAL INFORMATION </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>A. Consolidated Statements and Other Financial
Information</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>Consolidated Financial Statements</i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our audited consolidated financial statements
are appended at the end of this annual report starting at page F-1, and form a part hereof.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>Legal Proceedings</i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We are not a party to any pending material legal
proceedings.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We signed a sale and purchase agreement on September
18, 2015 (the &#8220;Purchase Agreement&#8221;) pursuant to which we acquired all shares and voting interests of NovioGendix, an entity
incorporated in The Netherlands. Under the terms of the Purchase Agreement, in addition to the consideration paid at closing, we committed
to pay up to $3.3 million to the prior owners of NovioGendix (the &#8220;Sellers&#8221;) subject to meeting certain milestones, payable
in six milestone payments. As of December 31, 2021, we had made $1.1 million of these milestone payments. As of December 31, 2021, we
recorded $1.6 million of contingent liabilities related to this contingent consideration. In June 2021, we received a notice of dispute
from the Sellers claiming that approximately $880,000 of the remaining $2.2 million of milestone payments had been earned and we were
in breach of the Purchase Agreement for not having timely paid such milestone payments to the Sellers. In September 2021, pursuant to
the Purchase Agreement, representatives of the Company met with representatives of the Sellers to discuss these matters. During this
meeting the Company&#8217;s representatives informed the representatives of the Seller that the Company disagrees with the Sellers that
any such payments have been earned and are payable by the Company. Following this meeting, the Sellers requested further information
from the Company and indicated if these matters are not resolved to Sellers&#8217; satisfaction, they may take further action to enforce
their rights by instituting arbitration proceedings, in accordance with the terms of the Purchase Agreement, before the Netherlands Arbitration
Institute.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>&#160;</i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>&#160;</i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>Dividend Policy</i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We have never declared or paid any cash dividends
on our ordinary shares. We do not anticipate paying cash dividends on our equity securities in the foreseeable future and intend to retain
all available funds and any future earnings for use in the operation and expansion of our business. All of the ordinary shares offered
by this annual report will have the same dividend rights as all of our other outstanding ordinary shares. In general, distributions of
dividends proposed by our Board of Directors require the approval of our shareholders at a meeting of shareholders with a simple majority
vote, although our Board of Directors may declare interim dividends without shareholder approval, subject to the terms and conditions
of the Belgian Code of Companies and Associations, or CCA. See Item 10B. &#8220;<i>Memorandum and Articles of Association</i>.&#8221;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our ability to distribute dividends is subject
to availability of sufficient distributable profits as defined under Belgian law on the basis of our stand-alone statutory accounts prepared
in accordance with Belgian GAAP. In particular, dividends can only be distributed if following the declaration and issuance of the dividends
the amount of our net assets on the date of the closing of the last financial year as follows from the statutory non-consolidated financial
statements (<i>i.e.</i>, summarized, the amount of the assets as shown in the balance sheet, decreased with provisions and liabilities,
all in accordance with Belgian accounting rules), and, save in exceptional cases, to be mentioned and justified in the notes to the annual
accounts, decreased with the non-amortized costs of incorporation and extension and the non-amortized costs for research and development,
does not fall below the amount of the paid-up capital (or, if higher, the issued capital), increased with the amount of non-distributable
reserves (which include, as the case may be, the unamortized part of any revaluation surpluses).</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In addition, pursuant to Belgian law and our
Articles of Association, we must allocate an amount of 5% of our Belgian GAAP annual net profit to a legal reserve in its stand-alone
statutory accounts, until the legal reserve amounts to 10% of our share capital. Our legal reserve currently does not meet this requirement
nor will it meet the requirement at the time of the closing. Accordingly, 5% of our Belgian GAAP annual net profit during future years
will need to be allocated to the legal reserve, further limiting our ability to pay out dividends to its shareholders.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">For information regarding the Belgian withholding
tax applicable to dividends and related U.S. reimbursement procedures, see Item 9E. &#8220;<i>Taxation &#8212; Material Belgian Tax Consequences.</i>&#8221;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>B. Significant Changes</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>&#160;</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">None.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><div><a id="a_013"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>ITEM 9. THE OFFER AND LISTING </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>A. Offer and Listing Details </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our ADSs have been listed on Nasdaq Capital Market
under the symbol &#8220;MDXH&#8221; since November 4, 2021. Prior to that date, there was no public trading market for out ADSs. Our
ordinary shares have been trading on the regulated market of Euronext in Brussels under the symbol &#8220;MDXH&#8221; since June 2006.
Prior to that date, there was no public trading market for our ADSs or our ordinary shares. No significant trading suspensions have occurred
in the prior three years.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>B. Plan of Distribution </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Not applicable.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>C. Markets </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">For information regarding the stock exchanges
and regulated markets on which our ADSs and ordinary share are listed, see Item 9A. &#8220;<i>Offer and Listing Details.</i>&#8221;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>D. Selling Shareholders </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Not applicable.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>E. Dilution </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Not applicable.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>F. Expenses of the Issuer </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Not applicable.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 87; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: normal 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->81<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><div><a id="a_014"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>ITEM 10. ADDITIONAL INFORMATION</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>A. Share Capital </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Not applicable.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>B. Memorandum and Articles of Association
</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The information set forth in the final
prospectus dated November 3, 2021 as part of our Registration Statement on Form F-1 (File No. 333-260213), declared effective by the
SEC on November 3, 2021, under the headings &#8220;<i>Description of Share Capital and Articles of Association &#8212; Articles of
Association and Other Share Information</i>&#8221; is incorporated herein by reference.&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>C. Material Contracts </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">For information on our material contracts entered
into during the two years immediately preceding the date of the filing of this annual report, please refer to Item 4B. <i>Business Overview</i>&#8221;
and Item 7B. &#8220;<i>Related Party Transactions</i>&#8221; of this annual report.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>D. Exchange Controls </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">There are no Belgian exchange control regulations
that impose limitations on our ability to make, or the amount of, cash payments to residents of the United States.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We are in principle under an obligation to report
to the National Bank of Belgium certain cross-border payments, transfers of funds, investments and other transactions in accordance with
applicable balance-of-payments statistical reporting obligations. Where a cross-border transaction is carried out by a Belgian credit
institution on our behalf, the credit institution will in certain circumstances be responsible for the reporting obligations.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>E. Taxation</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The discussion below is for general information
only and is not, and should not be interpreted to be, tax advice to any holder of the ADSs. Each holder or prospective holder of the
ADSs is urged to consult his, her or its own tax advisor.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Material U.S. Federal Income Tax Consequences</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">General</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The following is a discussion of the material
U.S. federal income tax consequences to&#160;U.S. Holders and Non-U.S. Holders, both as defined below, of the ownership and disposition
of the ADSs as of the date of this report. This discussion is based on the provisions of the Internal Revenue Code of 1986, as amended,
or the &#8220;Code,&#8221; the applicable U.S. Treasury regulations promulgated and proposed thereunder, judicial decisions and current
administrative rulings and guidance, all of which are subject to change, possibly on a retroactive basis. This discussion applies to
you only if you acquire the ADSs and hold such ADSs as a capital asset within the meaning of Section&#160;1221 of the Code (generally,
held for investment). The U.S. Internal Revenue Service, or the &#8220;IRS,&#8221; may challenge the tax consequences described below,
and we have not requested, nor will we request, a ruling from the IRS or an opinion of counsel with respect to the U.S. federal income
tax consequences of acquiring, holding or disposing of the ADSs. This discussion does not purport to deal with all aspects of U.S. federal
income taxation that may be relevant to the ownership of the ADSs. In particular, the discussion does not address tax consequences that
depend upon an investor&#8217;s particular tax circumstances nor does it cover any state, local or foreign law, the possible application
of the U.S. federal estate or gift tax laws. You are urged to consult your own tax advisor regarding the application of the U.S. federal
income tax laws to your particular situation as well as any state, local, foreign and U.S. federal estate and gift tax consequences resulting
from the ownership and disposition of the ADSs. In addition, this discussion does not take into account special U.S. federal income tax
rules that apply to particular categories of holders of the ADSs, including, without limitation, the following:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">dealers, brokers or traders
    in securities electing to use a mark-to-market&#160;method of accounting;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">banks, thrifts or other
    financial institutions;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 88; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: normal 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->82<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">individual retirement or
    tax-deferred&#160;accounts;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">insurance companies;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">tax-exempt&#160;organizations;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">regulated investment companies
    or real estate investment trusts;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">persons holding the ADSs
    as part of a hedging, straddle or conversion transaction for U.S. federal income tax purposes;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">persons required for U.S.
    federal income tax purposes to conform the timing of income accruals to their financial statements under Section&#160;451 of the
    Code;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">persons whose functional
    currency for U. S. federal income tax purposes is not the U.S. dollar;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">persons subject to the
    alternative minimum tax;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">persons that own, or are
    treated as owning, 10% or more, by voting power or value, of our outstanding common stock (including common stock represented by
    ADSs);</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">certain former U.S. citizens
    and residents who have expatriated; or</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">persons receiving the ADSs
    pursuant to the exercise of employee stock options or otherwise as compensation.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">U.S. Holders</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">For purposes of the discussion below, you are
a &#8220;U.S. Holder&#8221; if you are a beneficial owner of the ADSs that is:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">an individual United States
    citizen or resident alien of the United States (as specifically defined for United States federal income tax purposes);</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">a corporation, or other
    entity treated as a corporation for U.S. federal income tax purposes, created or organized in or under the laws of the United States,
    any state thereof or the District of Columbia;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">an estate whose income
    is subject to United States federal income tax regardless of its source; or</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">a trust (x) if a U.S. court
    can exercise primary supervision over the trust&#8217;s administration and one or more U.S. persons are authorized to control all
    substantial decisions of the trust or (y)&#160;that, if it was in existence on August&#160;20, 1996, was treated as a U.S. person
    prior to that date and has a valid election in effect under applicable United States Treasury regulations to be treated as a U.S.&#160;person.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If a partnership (including any entity or arrangement
treated as a partnership for U.S. federal income tax purposes) holds the ADSs, the tax treatment of a partner in such partnership will
generally depend upon the status of the partner and upon the activities of the partnership. If you are a partnership holding the ADSs
or a partner in such partnership, you should consult your tax advisor with respect to the U.S. federal income tax consequences of the
ownership and disposition of the ADSs by the partnership.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: justify"><b><i>General</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In general, a U.S. Holder of the ADSs will be
treated as owning the underlying shares represented by those ADSs for U.S. federal income tax purposes. Accordingly, no gain or loss
will be recognized if a U.S. Holder exchanges ADSs for the underlying shares represented by those ADSs. The&#160;U.S. Department of the
Treasury has expressed concern that parties to whom ADSs are released before shares are delivered to the Depositary (&#8220;pre-release&#8221;),
or intermediaries in the chain of ownership between holders and the issuer of the security underlying the ADSs, may be taking actions
that are inconsistent with the claiming of foreign tax credits by holders of ADSs. These actions would also be inconsistent with the
claiming of the preferential rate of tax, described below, applicable to dividends received by certain non-corporate&#160;U.S. Holders.
Accordingly, the creditability of Belgian taxes, and the availability of the preferential tax rate for dividends received by certain
non-corporate&#160;U.S. Holders, each as described below, could be affected by actions taken by such parties or intermediaries.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: justify"><b><i>Distributions</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Subject to the &#8220;passive foreign investment
company&#8221;, or PFIC, rules discussed below, the amount of any cash distribution (other than in liquidation) that you receive with
respect to the ADSs including the amount of any Belgian taxes actually withheld therefrom (described below in &#8220;&#8212; <i>Material
Belgian Tax Consequences</i>&#8221;) generally will be taxed to a U.S. Holder as dividend income to the extent such distribution does
not exceed our current or accumulated earnings and profits, or E&amp;P, as calculated for U.S. federal income tax purposes. Such income
will be includable in your gross income as ordinary income on the date of receipt by the Depositary. Dividends received by individuals
and certain other non-corporate&#160;U.S. Holders from &#8220;qualified foreign corporations&#8221; are taxed at the rate of either 0
percent, 15 percent or 20 percent, depending upon the particular taxpayer&#8217;s U.S. federal income tax bracket; provided that the
recipient-shareholder&#160;has held his or her shares as a beneficial owner for more than 60 days during the 121-day&#160;period beginning
on the date which is 60 days before the shares&#8217; ex-dividend&#160;date. A foreign corporation is a &#8220;qualified foreign corporation&#8221;
if the stock with respect to which it pays dividends is traded on an established securities market in the United States, provided that
the foreign corporation is not a PFIC.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The ADSs are traded on an established securities
market in the United States, although we cannot guarantee that the ADSs will be so traded in the future. If we are not a PFIC and we
are treated as a qualified foreign corporation, dividends we pay with respect to the ADSs would be eligible for the reduced rates of
taxation described in this paragraph. We do not expect to be treated as a PFIC for our current taxable year. However, our PFIC status
for any taxable year is an annual determination that can be made only after the end of that year and will depend on the composition of
our income and assets and the value of our assets from time to time. No assurance can be given that the IRS will not disagree and seek
to treat us as a PFIC. If we are a PFIC with respect to a particular U.S. Holder, dividends received from us would be taxed at regular
ordinary income tax rates and certain other rules will apply. See &#8220;<i>Passive Foreign Investment Company (PFIC)</i>,&#8221; below.
Holders of Company ADSs should consult their own tax advisors regarding the availability of a reduced dividend tax rate in light of their
own particular circumstances.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">To the extent any distribution exceeds our E&amp;P,
the distribution will first be treated as a tax-free&#160;return of capital to the extent of your adjusted tax basis in the ADSs and
will be applied against and reduce such basis on a dollar-for-dollar&#160;basis (thereby increasing the amount of gain and decreasing
the amount of loss recognized on a subsequent disposition of such ADSs). To the extent that such distribution exceeds your adjusted tax
basis, the distribution will be taxed as gain recognized on a sale or exchange of ADSs. However, because we do not maintain calculations
of our E&amp;P under&#160;U.S. federal income tax principles, it is expected that distributions will generally be reported to U.S. Holders
as dividends. Because we are not a U.S.&#160;corporation, no dividends-received&#160;deduction will be allowed to corporations with respect
to dividends paid by us.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">For U.S. foreign tax credit limitation purposes,
dividends received on ADSs will be treated as foreign source income and will generally constitute &#8220;passive category income,&#8221;
or in the case of certain holders, &#8220;general category income.&#8221; You may be eligible, subject to a number of complex limitations,
to claim a foreign tax credit in respect of Belgian taxes actually withheld on dividends paid on ADSs. A U.S. Holder who does not elect
to claim a foreign tax credit for foreign tax withheld may instead claim a deduction, for U.S. federal income tax purposes, in respect
of such withholding, but only for a year in which such U.S. Holder elects to do so for all creditable foreign income taxes. However,
if we are a &#8220;U.S.-owned&#160;foreign corporation,&#8221; solely for foreign tax credit purposes, a portion of the dividends allocable
to our U.S. source earnings and profits may be re-characterized&#160;as U.S. source. A &#8220;U.S.-owned&#160;foreign corporation&#8221;
is any foreign corporation in which U.S. persons own, directly or indirectly, 50% or more (by vote or by value) of the stock. In general,
U.S.-owned&#160;foreign corporations with less than 10% of earnings and profits attributable to sources within the United States are
excepted from these rules. Although we don&#8217;t believe we are currently a &#8220;U.S.-owned&#160;foreign corporation,&#8221; we may
become one in the future. In such case, if 10% or more of our earnings and profits are attributable to sources within the United States,
a portion of the dividends paid on the ADSs allocable to our U.S. source earnings and profits will be treated as U.S. source, and, as
such, a U.S. Holder may not offset any foreign tax withheld as a credit against U.S. federal income tax imposed on that portion of dividends.
The rules governing U.S. foreign tax credits are complex, and we recommend that you consult your tax advisor regarding the applicability
of such rules to you.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><b><i>Sale, Exchange or Other
Disposition of ADSs</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Subject to the PFIC rules discussed below, generally,
in connection with the sale, exchange or other disposition of ADSs:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">you will recognize capital
    gain or loss equal to the difference (if any) between the amount realized on such sale, exchange or other disposition and your adjusted
    tax basis in such ADSs;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">such gain or loss will
    be long-term&#160;capital gain or loss if your holding period for such ADSs is more than one year at the time of the sale or other
    disposition;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: normal 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->84<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">such gain or loss will
    generally be treated as U.S. source for U.S. foreign tax credit purposes; and</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">your ability to deduct
    capital losses is subject to limitations.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Long-term&#160;capital gains recognized by individuals
and certain other non-corporate&#160;taxpayers are taxed at preferential rates. If the consideration received upon the sale or other
taxable disposition of ADSs is paid in foreign currency, the amount realized will be the U.S. dollar value of the payment received, translated
at the spot rate of exchange on the date of taxable disposition. If ADSs are treated as traded on an established securities market, a
cash basis U.S. Holder and an accrual basis U.S. Holder who has made a special election (which must be applied consistently from year
to year and cannot be changed without the consent of the IRS) will determine U.S. dollar value of the amount realized in foreign currency
by translating the amount received at the spot rate of exchange on the settlement date of the sale. An accrual basis United States Holder
that does not make the special election will recognize exchange gain or loss to the extent attributable to the difference between the
exchange rates on the sale date and the settlement date, and such exchange gain or loss generally will constitute ordinary income or
loss.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><b><i>Passive Foreign Investment
Company (PFIC)</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In general, a non-U.S. corporation is a PFIC
for U.S. federal income tax purposes for any taxable year in which (i) 50% or more of value of its assets (based on an average of the
quarterly values of the assets during such taxable year) consists of assets that produce, or are held for the production of, passive
income, or (ii)&#160;75% or more of its gross income consists of passive income. A separate determination must be made after the close
of each fiscal year as to whether a non-U.S. corporation is a PFIC for that year. For purposes of the above calculations, a non-U.S.
corporation that owns, directly or indirectly, at least 25% by value of the shares of another corporation is treated as if it held its
proportionate share of the assets of the other corporation and received directly its proportionate share of the income of the other corporation.
Passive income generally includes dividends, interest, investment gains and certain rents and royalties. Cash is generally a passive
asset for these purposes. The value goodwill is generally treated as an active asset if it is associated with business activities that
produce active income.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Based on the current estimates, and expected
future composition, of our income and the value of our assets, including goodwill, we do not expect to be a PFIC for our current taxable
year. However, our PFIC status for any taxable year is an annual determination that can be made only after the end of that year and will
depend on the composition of our income and assets and the value of our assets from time to time. The determination of whether we are
a PFIC is fact-intensive&#160;and the applicable law is subject to varying interpretation. There can be no assurance that the IRS will
agree with our position or that the IRS will not successfully challenge our position including our classification of certain income and
assets as non-passive&#160;or our valuation of our tangible and intangible assets.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If we are treated as a PFIC, gain realized on
the sale, exchange or other disposition of your ADSs would in general not be treated as capital gain. Instead, such gain would be allocated
ratably over your holding period for the ADSs. The amounts allocated to the taxable year of the sale, exchange or other disposition and
to any year before we became a PFIC would be taxed as ordinary income. The amount allocated to each other taxable year would be subject
to tax at the highest rate in effect for such year, together with an interest charge on the tax attributable to each such year. If we
are a PFIC for any year during a U.S. Holder&#8217;s holding period for ADSs, we generally will continue to be treated as a PFIC with
respect to such U.S.&#160;Holder for all succeeding years during which such U.S. Holder owns the ADSs. Dividends received from ADSs will
not be eligible for the special tax rates applicable to qualified dividend income for certain non-corporate&#160;U.S. Holder if we were
treated as a PFIC with respect to the U.S. Holder, either in the taxable year of the distribution or the preceding taxable year, but
instead will be taxable at rates applicable to ordinary income. Further, any distribution in respect of ADSs in excess of 125 percent
of the average annual distributions on ADSs received by a U.S. Holder during the preceding three years or such U.S. Holder&#8217;s holding
period, whichever is shorter, would be allocated ratably over the U.S. Holder&#8217;s holding period for ADSs and subject to taxation
as described with respect to sales, exchanges or other dispositions above. Certain elections may be available that would result in alternative
treatments such as mark-to-market&#160;treatment of the ADSs.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><b><i>3.8% Medicare Tax on
&#8220;Net Investment Income&#8221;</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Certain U.S. Holders that are individuals, estates,
and certain trusts are subject to a 3.8% tax on all or a portion of their &#8220;net investment income,&#8221; which may include any
gain realized or amounts received with respect to their ADSs, to the extent of their net investment income that, when added to other
modified adjusted gross income, exceeds $200,000 for a single taxpayer (or a qualifying head of household), $250,000 for married taxpayers
filing a joint return (or a qualifying widower), or $125,000 for a married taxpayer filing a separate return. U.S. Holders should consult
their own tax advisors with respect to the applicability of the net investment income tax.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><b><i>Information Reporting
and Backup Withholding</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Except in the case of corporations or other exempt
holders, amounts received by a U.S. Holder in connection with distributions, if any, paid by Company with respect to ADSs and proceeds
from the sale, exchange or other disposition of ADSs may be subject to U.S. information reporting requirements and backup withholding
unless the U.S. Holder provides an accurate taxpayer identification number and complies with certain certification procedures or otherwise
establishes an exemption from backup withholding. Backup withholding is not an additional tax and amounts withheld may be allowed as
a credit against the U.S. Holder&#8217;s U.S. federal income tax liability and may entitle the U.S. Holder to a refund, provided that
certain required information is timely furnished to the IRS.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">U.S. Holders who are individuals (and under proposed
regulations, certain entities) and who own &#8220;specified foreign financial assets&#8221; with an aggregate value in excess of $50,000
on the last day of the tax year (or more than $75,000 at any time during the tax year) are generally required to file an information
statement along with their tax returns, currently on IRS Form 8938, with respect to such assets, subject to certain exceptions (including
an exception for shares held in custodial accounts maintained with a U.S. financial institution) &#8220;Specified foreign financial assets&#8221;
include securities issued by a non-U.S. issuer (which would include ADSs) that are not held in accounts maintained by financial institutions.
Higher reporting thresholds apply to certain individuals living abroad and to certain married individuals. Individuals who fail to report
the required information could be subject to substantial penalties, and such individuals should consult their own tax advisors concerning
the application of these rules to their investment in ADSs.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">TAX MATTERS CAN BE COMPLICATED. THE FOREGOING
DISCUSSION OF MATERIAL U.S.&#160;FEDERAL INCOME TAX CONSEQUENCES IS NOT INTENDED TO BE A COMPLETE ANALYSIS OR DESCRIPTION OF ALL U.S.
FEDERAL INCOME TAX CONSEQUENCES OF THE OWNERSHIP AND DISPOSITION OF ADSS. IN ADDITION, THE DISCUSSION DOES NOT ADDRESS TAX CONSEQUENCES
THAT DEPEND UPON INDIVIDUAL CIRCUMSTANCES. THIS DISCUSSION DOES NOT ADDRESS ANY U.S. FEDERAL TAX CONSEQUENCES OTHER THAN INCOME TAX OR
ANY FOREIGN, STATE OR LOCAL TAX CONSIDERATIONS, NOR ANY TAX CONSEQUENCES OF ANY TRANSACTION OTHER THAN THE OWNERSHIP AND DISPOSITION
OF ADSS. ACCORDINGLY, YOU ARE STRONGLY URGED TO CONSULT YOUR OWN TAX ADVISOR TO DETERMINE THE PARTICULAR U.S. FEDERAL, STATE, LOCAL,
OR FOREIGN INCOME OR OTHER TAX CONSEQUENCES OF THE OWNERSHIP AND DISPOSITION OF ADSS TO YOU.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Non-United States Holders</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">For purposes of this discussion, if you are not
a U.S.&#160;Holder (as defined above), you are a &#8220;Non-U.S. Holder&#8221;.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><b><i>Distributions on the
ADSs</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">You generally will not be subject to U.S. federal
income tax or withholding on distributions made on the ADSs unless:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">you conduct a trade or
    business in the U.S., and</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the distributions are effectively
    connected with the conduct of that trade or business (or, under certain income tax treaties, such distributions are attributable
    to a permanent establishment that you maintain in the United States).</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If you meet the two tests above, you generally
will be subject to tax in respect of such distributions in the same manner as a U.S. Holder, as described above. In addition, any effectively
connected distributions received by a non-U.S. corporation may also, under certain circumstances, be subject to an additional &#8220;branch
profits tax&#8221; at a 30-percent&#160;rate or such lower rate as may be provided by an applicable income tax treaty.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><b><i>Sale, Exchange or Other
Disposition of the ADSs</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Generally, you will not be subject to U.S. federal
income tax or withholding in respect of gain recognized on a sale, exchange or other disposition of the ADSs unless:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">your gain is effectively
    connected with a trade or business that you conduct in the United States (or, under certain income tax treaties, such gain is attributable
    to a permanent establishment that you maintain in the United States), or</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">you are an individual Non-U.S.
    Holder and are present in the United States for at least 183 days in the taxable year of the sale, exchange or other disposition,
    and certain other conditions exist.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 92; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: normal 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->86<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If you meet either of the two tests above, you
will be subject to tax in respect of any gain effectively connected with your conduct of a trade or business in the United States generally
in the same manner as a U.S. Holder, as described above. Effectively connected gains realized by a non-U.S. corporation may also, under
certain circumstances, be subject to an additional &#8220;branch profits tax&#8221; at a rate of 30-percent&#160;or such lower rate as
may be provided by an applicable income tax treaty.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><b><i>Backup Withholding
and Information Reporting</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Payments, including distributions and proceeds
from sales, exchanges or other dispositions in respect of the ADSs that are made in the United States or by a U.S.-related&#160;financial
intermediary will be subject to U.S.&#160;information reporting rules. In addition, such payments may be subject to U.S. federal backup
withholding. You will not be subject to backup withholding provided that:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">you are a corporation or
    other exempt recipient, or</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">you provide your correct
    U.S. federal taxpayer identification number and certify, under penalties of perjury, that you are not subject to backup withholding.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Amounts withheld under the backup withholding
rules may be credited against your U.S. federal income tax, and you may obtain a refund of any excess amounts withheld under the backup
withholding rules by filing the appropriate claim for refund with the IRS in a timely manner.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><b><i>FATCA</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Foreign Account Tax Compliance Act (or &#8220;FATCA&#8221;)
generally imposes a U.S. federal withholding tax of 30% on dividends on the ADSs paid to a &#8220;foreign financial institution&#8221;
(as specially defined under these rules), unless such institution enters into an agreement with the U.S. government to withhold on certain
payments and to collect and provide to the U.S. tax authorities substantial information regarding the U.S. account holders of such institution
(which includes certain equity and debt holders of such institution, as well as certain account holders that are foreign entities with
U.S. owners) or otherwise establishes an exemption. FATCA also generally imposes a U.S. federal withholding tax of 30% on dividends on
the ADSs paid to a&#160;&#8221;non-financial&#160;foreign entity&#8221; (as specially defined under these rules) unless such entity provides
the withholding agent with a certification identifying certain substantial direct and indirect&#160;U.S. owners of the entity, certifies
that there are none or otherwise establishes an exemption. The withholding obligations under FATCA generally apply to payments of dividends
(including constructive dividends) on the ADSs. Under certain circumstances, a&#160;Non-U.S.&#160;Holder might be eligible for refunds
or credits of such taxes. An intergovernmental agreement between the United States and an applicable foreign country may modify the requirements
described in this paragraph.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Additionally, FATCA may impose a 30% withholding
tax on payments of gross proceeds from the sale, exchange or redemption of property that gives rise to U.S.-source&#160;dividends or
interest, including the ADSs. The IRS recently issued Proposed Treasury Regulations that eliminate withholding on payments of gross proceeds.
Pursuant to the Proposed Treasury Regulations, the issuer and any withholding agent may (but are not required to) rely on this proposed
change to FATCA withholding until the final regulations are issued. Non-U.S.&#160;Holders are encouraged to consult with their own tax
advisors regarding the possible application of FATCA to their ownership of the ADSs.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Material Belgian Tax Consequences</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">General</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The following paragraphs are a summary of material
Belgian tax consequences of the ownership of ADSs by an investor. The summary is based on laws, treaties and regulatory interpretations
in effect in Belgium on the date of this document, all of which are subject to change, including changes that could have retroactive
effect.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The summary only discusses Belgian tax aspects
which are relevant to U.S. holders of ADSs (&#8220;Holders&#8221;). This summary does not address Belgian tax aspects which are relevant
to persons who are residents in Belgium or engaged in a trade or business in Belgium through a permanent establishment or a fixed base
in Belgium. This summary does not purport to be a description of all of the tax consequences of the ownership of ADSs and does not take
into account the specific circumstances of any particular investor, some of which may be subject to special rules, or the tax laws of
any country other than Belgium. This summary does not describe the tax treatment of investors that are subject to special rules, such
as banks, insurance companies, collective investment undertakings, dealers in securities or currencies, persons that hold, or will hold,
ADSs in a position in a straddle, share-repurchase&#160;transaction, conversion transactions, synthetic security or other integrated
financial transactions. Investors should consult their own advisers regarding the tax consequences of an investment in ADSs in the light
of their particular circumstances, including the effect of any state, local or other national laws, treaties and regulatory interpretation
thereof.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 93; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: normal 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->87<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In addition to the assumptions mentioned above,
it is also assumed in this discussion that for purposes of the domestic Belgian tax legislation, the owners of ADSs will be treated as
the owners of the ordinary shares represented by such ADSs. However, the assumption has not been confirmed by or verified with the Belgian
Tax Administration.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">For the purposes of this summary, ADSs or ordinary
shares means ordinary shares represented by ADSs. Both terms are used interchangeably.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Dividend Withholding Tax</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">As a general rule, under current Belgian law,
a withholding tax of 30% is levied on the gross amount of dividends paid on or attributed to the ordinary shares represented by the ADSs,
subject to such relief as may be available under applicable domestic or tax treaty provisions. Dividends subject to the dividend withholding
tax include all benefits attributed to the ordinary shares represented by the ADSs, irrespective of their form. A reimbursement of fiscal
capital made in accordance with the Belgian Companies and Associations Code is partly considered to be a distribution of the existing
taxed reserves (irrespective whether incorporated into the capital or not) and/or the tax-free&#160;reserves incorporated into the capital.
The proportion is determined on the basis of the ratio between certain taxed reserves and tax-free&#160;reserves incorporated into the
capital on the one hand and, on the other hand, the aggregate of such reserves and the fiscal capital. In principle, fiscal capital includes
paid-up&#160;statutory share capital, and subject to certain conditions, the paid-up&#160;issue premiums and the cash amounts subscribed
to at the time of the issue of profit sharing certificates.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In case of a redemption by us of own shares represented
by ADSs, the redemption distribution (after deduction of the portion of fiscal capital represented by the redeemed shares) will be treated
as a dividend which in certain circumstances may be subject to a withholding tax of 30%, subject to such relief as may be available under
applicable domestic or tax treaty provisions. In case of a liquidation of our Company, any amounts distributed in excess of the fiscal
capital will be subject to a 30% withholding tax, subject to such relief as may be available under applicable domestic or tax treaty
provisions.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">For non-residents, the dividend withholding tax
will be the only tax on dividends in Belgium, unless the non-resident&#160;holds ADSs in connection with a business conducted in Belgium,
through a fixed base in Belgium or a Belgian permanent establishment.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Relief of Belgian Dividend Withholding
Tax</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Under the Belgium-United&#160;States Tax Treaty
(the &#8220;Treaty&#8221;), there is a reduced Belgian withholding tax rate of 15% on dividends paid by us to a U.S. resident which beneficially
owns the dividends and is entitled to claim the benefits of the Treaty under the limitation of benefits article included in the Treaty,
(a &#8220;Qualifying Holder&#8221;). If such Qualifying Holder is a company that owns directly at least 10% of our voting stock, the
Belgian withholding tax rate is further reduced to 5%. No withholding tax is however applicable if the Qualifying Holder, is: (i)&#160;a
company that is a resident of the United&#160;States that has owned directly ADSs representing at least 10% of our capital for a 12-month&#160;period
ending on the date the dividend is declared, or (ii)&#160;a pension fund that is a resident of the United&#160;States, provided that
such dividends are not derived from the carrying on of a business by the pension fund or through an associated enterprise.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Under the normal procedure, we or our paying
agent must withhold the full Belgian withholding tax (without taking into account the Treaty rate). Qualifying Holders may make a claim
for reimbursement for amounts withheld in excess of the rate defined by the Treaty. The reimbursement form (Form&#160;276 Div-Aut.) may
be obtained from the KMO Centrum Specifieke Materies, Team&#160;6, Kruidtuinlaan&#160;50, PO 3429, 1000 Brussels, Belgium or online on
the website of the Belgian tax authorities. Qualifying Holders may also, subject to certain conditions, obtain the reduced Treaty rate
at source. Qualifying Holders should deliver a duly completed Form&#160;276 Div-Aut. no later than ten days after the date on which the
dividend is paid or attributed. U.S. holders should consult their own tax advisors as to whether they qualify for reduction in withholding
tax upon payment or attribution of dividends, and as to the procedural requirements for obtaining a reduced withholding tax upon the
payment of dividends or for making claims for reimbursement.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: normal 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->88<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Withholding tax is also not applicable, pursuant
to Belgian domestic tax law, on dividends paid to certain U.S. pension funds provided that the U.S. pension fund (i)&#160;qualifies as
a non-resident&#160;saver for Belgian withholding tax purposes (<i>i.e.</i>, it has a separate legal personality and fiscal residence
outside of Belgium and without a permanent establishment or fixed base in Belgium), (ii)&#160;has a corporate purpose that consists solely
in managing and investing funds collected in order to pay legal or complementary pensions, (iii)&#160;has activity that is limited to
the investment of funds collected in the exercise of its statutory purpose, without any profit making activity and (iv)&#160;is exempt
from income taxes in the United&#160;States. Furthermore, such pension fund may not contractually be obligated to redistribute the dividends
to any beneficial owner of such dividends for whom it would manage the ADSs nor obligated to pay a manufactured dividend with respect
to the ADSs under a securities borrowing transaction (save in certain particular cases as described in Belgian law) and subject to certain
procedural formalities. A pension fund not holding the shares &#8212; which give rise to dividends &#8212; for an uninterrupted period
of 60 days in full ownership amounts to a rebuttable presumption that the arrangement or series of arrangements which are connected to
the dividend distributions, are not genuine. The withholding tax exemption will in such case be rejected, unless counterproof is provided
by the OFP that the arrangement or series of arrangements are genuine.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Under Belgian domestic tax law, a withholding
tax exemption is available to dividends paid to a non-resident&#160;corporate shareholder (located in a Member State of the European
Union or in a country with which Belgium has entered in a double tax treaty including sufficient information exchange provisions) provided
that (i)&#160;at the date of payment or attribution of the dividend it holds a participation in our company representing at least 10%
of our share capital, (ii)&#160;this holding is held or will be held in full ownership for an uninterrupted period of at least one year,
(iii)&#160;this non-resident&#160;corporate shareholder is tax resident of the country where it is established according to the tax laws
of and the bilateral tax treaties established by such country, (iv)&#160;this non-resident&#160;corporate shareholder is subject to a
corporate income tax regime similar to Belgian corporate income tax regime without benefitting from a tax regime that derogates from
the ordinary tax regime and (v)&#160;its legal form is (similar to one of the legal forms) listed in the annex of the E.U. directive
dated July&#160;23, 1990 (90/435/EC) as amended by the directive of December 22,&#160;2003 (2003/123/EC). This reduced withholding tax
will apply provided that certain procedural formalities are complied with.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Finally, a withholding tax exemption is available,
pursuant to Belgian domestic tax law, to dividends paid to a non-resident&#160;corporate shareholder (located in the European Economic
Area or in a country with which Belgium has entered in a double tax treaty including sufficient information exchange provisions) to the
extent that at the date of payment or attribution of the dividend it holds a participation in our company representing less than 10%
of our share capital but the acquisition value of which is at least &#8364;2.5&#160;million and provided that certain other conditions
are met, <i>i.e.</i>, that (i)&#160;this holding is held or will be held in full ownership for an uninterrupted period of at least one
year (ii)&#160;this non-resident&#160;corporate shareholder is subject to a corporate income tax regime similar to Belgian corporate
income tax regime without benefitting from a tax regime that derogates from the ordinary tax regime, and (iii)&#160;its legal form is
(similar to one of the legal forms) listed in the annex I, part A, of the E.U. directive dated November 30,&#160;2011 (2011/96/EU) as
amended by the directive of July&#160;8, 2014 (2014/86/EU). This reduced withholding tax will apply only if and to the extent that the
ordinary Belgian withholding tax cannot be credited or reimbursed to the non-resident&#160;corporate shareholder referred to above and
subject to certain procedural formalities.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Capital Gains and Losses</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Pursuant to the Treaty, capital gains and/or
losses realized by a Qualifying Holder from the sale, exchange or other disposition of ADSs do not fall within the scope of application
of Belgian domestic tax law.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Capital gains realized on ADSs by a corporate
Holder which is not entitled to claim the benefits of the Treaty under the limitation of benefits article included in the Treaty are
generally not subject to taxation in Belgium unless the corporate Holder is acting through a Belgian permanent establishment or a fixed
place in Belgium to which the ADSs are effectively connected. Capital losses are not deductible.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Private individual Holders who are not entitled
to claim the benefits of the Treaty under the limitation of benefits article included in the Treaty and which are holding ADSs as a private
investment will, as a rule, not be subject to tax on any capital gains arising out of a disposal of ADSs. Losses will, as a rule, not
be deductible in Belgium.However, if the gain realized by such individual Holders on ADSs is deemed to be realized outside the scope
of the normal management of such individual&#8217;s private estate and the capital gain is obtained or received in Belgium, the gain
will in principle be taxable at 33%. The Official Commentary to the ITC 1992 stipulates that occasional transactions on a stock exchange
regarding ADSs should not be considered as transactions realized outside the scope of normal management of one&#8217;s own private estate.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Capital gains realized by such individual Holders
on the disposal of ADSs for consideration, outside the exercise of a professional activity, to a non-resident&#160;company (or a body
constituted in a similar legal form), to a foreign state (or one of its political subdivisions or local authorities) or to a non-resident&#160;legal
entity who is established outside the European Economic Area, are in principle taxable at a rate of 16.5% if, at any time during the
five years preceding the sale, such individual Holders has owned directly or indirectly, alone or with his/her spouse or with certain
relatives, a substantial shareholding in us (that is, a shareholding of more than 25% of our shares).</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Capital gains realized by a Holder upon the redemption
of ADSs or upon our liquidation will generally be taxable as a dividend. See section &#8220;<i>Dividend Withholding Tax</i>.&#8221;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Estate and Gift Tax</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">There is no Belgian estate tax on the transfer
of ADSs upon the death of a Belgian non-resident.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Donations of ADSs made in Belgium may or may
not be subject to gift tax in Belgium depending on the modalities under which the donation is carried out.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Belgian Tax on Stock Exchange Transactions</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">A tax on stock exchange transactions (<i>taxe
sur les op&#233;rations de bourse/taks op de beursverrichtingen</i>) is generally levied on the purchase and the sale and on any other
acquisition and transfer for consideration of existing ADSs on the secondary market carried out by a Belgian resident investor through
a professional intermediary if (i)&#160;executed in Belgium through a professional intermediary, or (ii)&#160;deemed to be executed in
Belgium, which is the case if the order is directly or indirectly made to a professional intermediary established outside of Belgium,
either by private individuals having their usual residence in Belgium, or legal entities for the account of their seat or establishment
in Belgium.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The applicable rate amounts to 0.35% of the consideration
paid but with a cap of &#8364;1,600 per transaction and per party. The tax is due separately from each party to any such transaction,
<i>i.e.</i>, the seller (transferor) and the purchaser (transferee), both collected by the professional intermediary.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">However, if the intermediary is established outside
of Belgium, the tax will in principle be due by the ordering private individual or legal entity, unless that individual or entity can
demonstrate that the tax has already been paid. Professional intermediaries established outside of Belgium can, subject to certain conditions
and formalities, appoint a Belgian representative for tax purposes, which will be liable for the tax on stock exchange transactions in
respect of the transactions executed through the professional intermediary.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Belgian non-residents&#160;who purchase or otherwise
acquire or transfer, for consideration, ADSs in Belgium for their own account through a professional intermediary may be exempt from
the tax on stock exchange transactions if they deliver a sworn affidavit to the intermediary in Belgium confirming their non-resident&#160;status.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">No stock exchange tax is payable by: (i)&#160;professional
intermediaries described in Article&#160;2, 9&#176; and 10&#176; of the Belgian Act of August&#160;2, 2002 acting for their own account,
(ii)&#160;insurance companies described in Article&#160;2, &#167;1 of the Belgian Act of 9 July&#160;1975 acting for their own account,
(iii)&#160;professional retirement institutions referred to in Article&#160;2, 1&#176; of the Belgian Act of October&#160;27, 2006 relating
to the control of professional retirement institutions acting for their own account, (iv)&#160;collective investment institutions acting
for their own account, or (v)&#160;regulated real estate companies (for the stock exchange tax only).</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">No stock exchange tax will thus be due by Holders
on the subscription, purchase or sale of ADSs, if the Holders are acting for their own account. In order to benefit from this exemption,
the Holders must file with the professional intermediary in Belgium a sworn affidavit evidencing that they are non-residents&#160;for
Belgian tax purposes.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Belgian Annual Tax on Securities Accounts</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Pursuant to the Belgian Act of February&#160;17,
2021 introducing a new annual tax on securities accounts due on securities accounts held through an intermediary if the average value
of the taxable financial instruments held on this securities account exceeds &#8364;1&#160;million during a reference period of 12 consecutive
months. This new annual tax on securities accounts is introduced because the previous tax on securities accounts was annulled by the
Belgian Constitutional Court.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The annual tax on securities accounts is due
irrespective of whether the holder of a securities account is a physical person or a legal entity. If the holder of a securities account
is a Belgian resident, the annual tax on securities accounts will be applicable both to securities accounts held in Belgium as well as
securities accounts held abroad. For non-residents, only securities accounts held in Belgium fall in scope of the annual tax on securities
accounts. A double tax treaty could prevent Belgium to levy the annual tax on securities accounts.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Certain exemptions exist to mitigate the impact
of the annual tax on securities accounts on the financial sector. As such, securities accounts held by certain financial undertakings
are exempt.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">All securities held on a securities account are
targeted, such as shares, bonds, participations in investment funds and investment companies, but also derived products, such as index
trackers, turbos, real estate certificates and cash. The rate of the annual tax on securities accounts amounts to 0.15% on securities
accounts of which the average value exceeds &#8364;1&#160;million during a reference period of 12 consecutive months. In order to avoid
that the payment of the tax would result in a decrease of the average value below the &#8364;1&#160;million threshold, the rate is limited
to 10% of the difference between the taxable base and &#8364;1&#160;million in those cases. The reference period is a subsequent period
of 12&#160;months starting on October 1 and ending September 30 of the subsequent year or (i)&#160;any earlier date when the account
is closed; or (ii)&#160;the moment when the account holder becomes a resident of a state with which Belgium has concluded a tax treaty
and the tax treaty allocates the taxing rights to the other state. The average value is calculated by taking the average of the securities
accounts values on December&#160;31, March&#160;31, June 30 and September 30.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The tax must be declared and paid by the Belgian
resident intermediary with whom the securities account is held. If a securities account is held with a non-resident&#160;intermediary,
the holder of the securities account itself is responsible for the declaration and the payment of the annual tax on securities accounts.
Alternatively, the foreign intermediary could also voluntarily appoint a recognized responsible representative in Belgium to declare
and pay the tax.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In case of non-declaration, late, inaccurate
or incomplete declaration, as well as non-payment&#160;or late payment, a penalty varying from 10% to 200% of the tax due can be imposed.
Every holder of the securities account is jointly and severally liable to pay these penalties. The Act furthermore includes a general
anti-abuse&#160;provision pursuant to which the following is not allowed: (i)&#160;distributing taxable financial instruments over different
securities accounts to avoid the threshold of &#8364;1&#160;million for an individual account, (ii)&#160;converting taxable financial
instruments into nominative securities (the latter are out of scope of the tax); (iii)&#160;transferring a securities account to a foreign
legal entity which then transfers the securities to a foreign securities account, etc. In the aforementioned circumstances, there is
a refutable presumption that abuse exists. However, the Act also includes situations in which there is an irrefutable presumption of
abuse (specific anti-abuse provisions). As such, the following transactions taking place as of October&#160;30, 2020 onwards will be
considered to constitute abuse: (i)&#160;splitting of a securities account into multiple securities accounts held by the same intermediary;
and (ii)&#160;the conversion of taxable financial instruments held in a securities account to nominal financial instruments. However,
in its judgment of October 27, 2022, the Belgian Constitutional Court annulled the specific anti-abuse provisions as well as the retroactive
effect up to October 30, 2020 of the general anti-abuse provision. As a result, only the general anti-abuse provision can still be validly
applied and, moreover, only as of February 26, 2021.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Prospective Holders should consult their own
tax advisors as to whether they are subject to the new annual tax on securities accounts.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i><span style="text-decoration:underline">Proposed Financial Transactions Tax</span></i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On February&#160;14, 2013, the European Commission
published a proposal for a Directive for a common financial transactions tax (&#8220;FTT&#8221;) in Belgium, Germany, Greece, Spain,
France, Italy, Austria, Portugal, Slovenia, Estonia and Slovakia (collectively, the &#8220;Participating Member States&#8221;). On December&#160;8,
2015, Estonia declared that it will no longer support the FTT.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The proposed FTT has a very broad scope and could,
if introduced in its current form, apply to certain dealings in ADSs in certain circumstances. The FTT could apply in certain circumstances
to persons both within and outside of the Participating Member States. Generally, it would apply to certain dealings in ADSs where at
least one party is a financial institution, and at least one party is established in a Participating Member State.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">A financial institution may be, or be deemed
to be, &#8220;established&#8221; in a Participating Member State in a broad range of circumstances, including by transacting with a person
established in a Participating Member State.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Currently, the proposed FTT remains subject to
further negotiations between the Participating Member States (excluding Estonia). It may therefore be adjusted prior to any implementation,
of which the timing and fate remains unclear. Moreover, additional E.U. Member States could decide to participate or drop out of the
negotiations. Prospective Holders of ADSs are advised to seek their own professional advice in relation to the FTT.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>F. Dividends and Paying Agents </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Not applicable.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>G. Statement by Experts</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Not applicable.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>H. Documents on Display </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We are subject to the information reporting requirements
of the Exchange Act applicable to foreign private issuers and under those requirements file reports with the SEC. Those reports may be
inspected without charge at the locations described below. As a foreign private issuer, we are exempt from the rules under the Exchange
Act related to the furnishing and content of proxy statements, and our supervisory and executive board members and principal shareholders
are exempt from the reporting and short-swing profit recovery provisions contained in Section 16 of the Exchange Act. In addition, we
are not required under the Exchange Act to file periodic reports and financial statements with the SEC as frequently or as promptly as
United States companies whose securities are registered under the Exchange Act. Nevertheless, we file with the SEC an annual report containing
financial statements that have been examined and reported on, with and opinion expressed by an independent registered public accounting
firm, and we submit quarterly interim consolidated financial data to the SEC under cover of the SEC&#8217;s Form 6-K.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We maintain a corporate website at <i>www.mdxhealth.com</i>.
We intend to post our annual report on our website promptly following it being filed with the SEC. Information contained on, or that
can be accessed through, our website does not constitute a part of this annual report. We have included our website address in this annual
report solely as an inactive textual reference.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The SEC maintains a website (<i>http://www.sec.gov</i>)
that contains reports, proxy and information statements and other information regarding registrants, such as MDxHealth, that file electronically
with the SEC.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">With respect to references made in this annual
report to any contract or other document of MDxHealth, such references are not necessarily complete and you should refer to the exhibits
attached or incorporated by reference to this annual report for copies of the actual contract or document.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>I. Subsidiary Information </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Not applicable.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>J. Annual Report to Security Holders</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If we are required to provide an annual report
to security holders in response to the requirements of Form 6-K, we will submit the annual report to security holders in electronic format
in accordance with the EDGAR Filer Manual.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><div><a id="a_015"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURES
ABOUT MARKET RISK </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Credit Risk</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Credit risk arises from cash and cash equivalents,
short-term bank deposits, as well as credit exposure to collaboration partners. Credit risk refers to the risks that counterparty will
default on its contractual obligations resulting in financial loss to the Group.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">At the end of 2022, the Company operated with
more than 1,000 different customers, systematically reducing credit risk compared to prior periods.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In the U.S. healthcare system, and particularly
within the molecular diagnostic CLIA-laboratory industry, where there are rapid technological advances in diagnostic services, companies
provide services to healthcare professionals and their patients, while being reimbursed from commercial and governmental insurance systems.
Often these services are provided out-of-network and without supplier contracts. As a result, there is reimbursement risk, separate from
credit risk that is characterized by uncertainty in reimbursement value, delays in payment, and ultimately non-payment. This impacts
the Company&#8217;s revenue recognition and cash collections.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In addition to reimbursement risk associated
with commercial third-party payors, credit risk may also arise from amounts due directly from patients. In many cases, payors will cover
the entire cost of testing. For example, for tests that fall under the Clinical Laboratory Fee Schedule, there is no co-payment, co-insurance
or deductible for patients covered under traditional Medicare. However, patients covered by commercial insurance companies may be responsible
for a co-payment, co-insurance, and/or deductible depending on the health insurance plan and individual patient benefit. Credit risk
exists for those patients who cannot meet their co-payment or deductible portions.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Customers&#8217; compliance with agreed credit
terms is regularly and closely monitored. Trade accounts receivable amounted to $9.4 million as of December 31, 2022, and no allowance
for expected credit loss was recorded. The Company applies the simplified approach to providing for expected credit losses (&#8220;ECL&#8221;)
prescribed by IFRS 9, which requires the use of the lifetime expected loss provision for all trade receivables. No ECL has been recorded
for other financial assets carried at amortized cost as there is no related credit risk.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The credit risk on cash and cash equivalents
of $15.5 million is limited given that the counterparties are banks with high credit scores attributed by international rating agencies.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Interest Rate Risk</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our cash consists of cash in readily available
checking accounts and money market accounts. As a result, the fair value of our portfolio is relatively insensitive to interest rate
changes. Our long-term debt bears interest at a fixed rate and therefore has no exposure to changes in interest rates.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Foreign Currency</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our European operations, including all sales
and expenses, are denominated in Euros. At the end of each reporting period, these assets and liabilities are converted to U.S. dollars
at the then-applicable foreign exchange rate. As a result, our business is affected by fluctuations in exchange rates between the U.S.
dollar and foreign currencies. We enter into limited foreign currency hedging transactions to mitigate our exposure to foreign currency
exchange risks. Exchange rate fluctuations may adversely affect our expenses, results of operations, financial position and cash flows.
However, to date, these fluctuations have not been significant and a movement of 10% in U.S. dollar to the Euro exchange rate would not
have a material effect on our results of operations.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;&#160;</p><div>

</div><div><a id="a_016"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>ITEM 12. DESCRIPTION OF SECURITIES OTHER THAN
EQUITY SECURITIES</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>A. Debt Securities </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Not applicable.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>B. Warrants and Rights </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Not applicable.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>C. Other Securities </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Not applicable.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>D. American Depositary Shares</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Bank of New York Mellon, as depositary, registers
and delivers American Depositary Shares, or ADSs. Each ADS represent ten ordinary shares (or a right to receive ten ordinary shares)
deposited with ING Belgium SA/NV, as custodian for the depositary in Belgium. Each ADS also represents any other securities, cash or
other property that may be held by the depositary. The deposited ordinary shares together with any other securities, cash or other property
held by the depositary are referred to as the deposited securities. The depositary&#8217;s office at which the ADSs will be administered
and its principal executive office are located at 240 Greenwich Street, New York, New York 10286.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">A deposit agreement among us, the depositary
and the ADS holders sets out the ADS holder rights as well as the rights and obligations of the depositary. New York law governs the
deposit agreement and the ADSs. A copy of the Agreement is incorporated by reference as an exhibit to this annual report.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">For additional information on our ADSs, please
refer to Exhibit 2.3 &#8220;Description of Securities registered under Section 12 of the Exchange Act&#8221; of this annual report.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Fees and Expenses</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="border-bottom: Black 1.5pt solid; width: 52%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Persons depositing or withdrawing
    ordinary shares&#160;or <br/>
ADS holders must pay:</b></span></td>
    <td style="border-bottom: Black 1.5pt solid; width: 2%">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; width: 5%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="vertical-align: bottom; border-bottom: Black 1.5pt solid; text-align: center; width: 41%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>For:</b></span></td></tr>
  <tr style="vertical-align: top">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">$5.00 (or less) per 100 ADSs (or portion of 100 ADSs)</span></td>
    <td>&#160;</td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Issuance of ADSs, including issuances resulting from
    a distribution of ordinary shares or rights or other property</span></td></tr>
  <tr style="vertical-align: top">
    <td>&#160;</td>
    <td>&#160;</td>
    <td>&#160;</td>
    <td>&#160;</td></tr>
  <tr style="vertical-align: top">
    <td style="border-bottom: Black 1.5pt solid"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="border-bottom: Black 1.5pt solid">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="border-bottom: Black 1.5pt solid"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Cancellation of ADSs for the purpose of withdrawal,
    including if the deposit agreement terminates</span></td></tr>
  <tr style="vertical-align: top">
    <td style="border-bottom: Black 1.5pt solid"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">$.05 (or less) per ADS</span></td>
    <td style="border-bottom: Black 1.5pt solid">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="border-bottom: Black 1.5pt solid"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Any cash distribution to ADS holders</span></td></tr>
  <tr style="vertical-align: top">
    <td style="border-bottom: Black 1.5pt solid"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">A fee equivalent to the fee that would be payable if
    securities distributed to you had been ordinary shares and the ordinary shares had been deposited for issuance of ADSs</span></td>
    <td style="border-bottom: Black 1.5pt solid">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="border-bottom: Black 1.5pt solid"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Distribution of securities distributed to holders of
    deposited securities (including rights) that are distributed by the depositary to ADS holders</span></td></tr>
  <tr style="vertical-align: top">
    <td style="border-bottom: Black 1.5pt solid"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">$.05 (or less) per ADS per calendar year</span></td>
    <td style="border-bottom: Black 1.5pt solid">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="border-bottom: Black 1.5pt solid"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Depositary services</span></td></tr>
  <tr style="vertical-align: top">
    <td style="border-bottom: Black 1.5pt solid"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Registration or transfer fees</span></td>
    <td style="border-bottom: Black 1.5pt solid">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="border-bottom: Black 1.5pt solid"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Transfer and registration of ordinary shares on our
    share register to or from the name of the depositary or its agent when you deposit or withdraw ordinary shares</span></td></tr>
  <tr style="vertical-align: top">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Expenses of the depositary</span></td>
    <td>&#160;</td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Cable (including SWIFT) and facsimile transmissions
    (when expressly provided in the deposit agreement)</span></td></tr>
  <tr style="vertical-align: top">
    <td style="border-bottom: Black 1.5pt solid"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="border-bottom: Black 1.5pt solid">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="border-bottom: Black 1.5pt solid"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Converting foreign currency to U.S. dollars</span></td></tr>
  <tr style="vertical-align: top">
    <td style="border-bottom: Black 1.5pt solid"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Taxes and other governmental charges the depositary
    or the custodian has to pay on any ADSs or ordinary shares underlying ADSs, such as stock transfer taxes, stamp duty or withholding
    taxes</span></td>
    <td style="border-bottom: Black 1.5pt solid">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="border-bottom: Black 1.5pt solid"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As necessary</span></td></tr>
  <tr style="vertical-align: top">
    <td style="border-bottom: Black 1.5pt solid"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Any charges incurred by the depositary or its agents
    for servicing the deposited securities</span></td>
    <td style="border-bottom: Black 1.5pt solid">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="border-bottom: Black 1.5pt solid"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As necessary</span></td></tr>
  </table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>



</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The depositary collects its fees for delivery
and surrender of ADSs directly from investors depositing ordinary shares or surrendering ADSs for the purpose of withdrawal or from intermediaries
acting for them. The depositary collects fees for making distributions to investors by deducting those fees from the amounts distributed
or by selling a portion of distributable property to pay the fees. The depositary may collect its annual fee for depositary services
by deduction from cash distributions or by directly billing investors or by charging the book-entry&#160;system accounts of participants
acting for them. The depositary may collect any of its fees by deduction from any cash distribution payable (or by selling a portion
of securities or other property distributable) to ADS holders that are obligated to pay those fees. The depositary may generally refuse
to provide fee attracting services until its fees for those services are paid.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">From time to time, the depositary may make payments
to us to reimburse us for costs and expenses generally arising out of establishment and maintenance of the ADS program, waive fees and
expenses for services provided to us by the depositary or share revenue from the fees collected from ADS holders. In performing its duties
under the deposit agreement, the depositary may use brokers, dealers, foreign currency dealers or other service providers that are owned
by or affiliated with the depositary and that may earn or share fees, spreads or commissions.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The depositary may convert currency itself or
through any of its affiliates, or the custodian or we may convert currency and pay U.S. dollars to the depositary. Where the depositary
converts currency itself or through any of its affiliates, the depositary acts as principal for its own account and not as agent, advisor,
broker or fiduciary on behalf of any other person and earns revenue, including, without limitation, transaction spreads, that it will
retain for its own account. The revenue is based on, among other things, the difference between the exchange rate assigned to the currency
conversion made under the deposit agreement and the rate that the depositary or its affiliate receives when buying or selling foreign
currency for its own account. The depositary makes no representation that the exchange rate used or obtained by it or its affiliate in
any currency conversion under the deposit agreement will be the most favorable rate that could be obtained at the time or that the method
by which that rate will be determined will be the most favorable to ADS holders, subject to the depositary&#8217;s obligation to act
without negligence or bad faith. The methodology used to determine exchange rates used in currency conversions made by the depositary
is available upon request. Where the custodian converts currency, the custodian has no obligation to obtain the most favorable rate that
could be obtained at the time or to ensure that the method by which that rate will be determined will be the most favorable to ADS holders,
and the depositary makes no representation that the rate is the most favorable rate and will not be liable for any direct or indirect
losses associated with the rate. In certain instances, the depositary may receive dividends or other distributions from us in U.S. dollars
that represent the proceeds of a conversion of foreign currency or translation from foreign currency at a rate that was obtained or determined
by us and, in such cases, the depositary will not engage in, or be responsible for, any foreign currency transactions and neither it
nor we make any representation that the rate obtained or determined by us is the most favorable rate and neither it nor we will be liable
for any direct or indirect losses associated with the rate.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></p><div>

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    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: normal 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->94<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><div><a id="a_017"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>PART II </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><div><a id="a_018"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>ITEM 13. DEFAULTS, DIVIDENDS ARREARAGES AND
DELINQUENCIES</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Not applicable.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><div><a id="a_019"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS
OF SECURITY HOLDERS AND USE OF PROCEEDS</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Not applicable.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><div><a id="a_020"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>ITEM 15. CONTROLS AND PROCEDURES</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Disclosure Controls and Procedures</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We are responsible for maintaining disclosure
controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Disclosure controls and procedures are controls
and other procedures designed to ensure that the information required to be disclosed by us in the reports that we file or submit under
the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC&#8217;s rules and forms.
Our management, with the participation of our Chief Executive Officer (principal executive officer) and our Chief Financial Officer (principal
financial officer), has evaluated the effectiveness of our disclosure controls and procedures, as of the end of the period covered by
this annual report on Form 20-F. Based on the foregoing, our Chief Executive Officer (principal executive officer) and Chief Financial
Officer (principal financial officer) concluded that, as of December 31, 2022, our disclosure controls and procedures were effective.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Management&#8217;s Annual Report on Internal
Control over Financial Reporting</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our management is responsible for establishing
and maintaining adequate internal control over our financial reporting (as such term is defined in Rule 13a-15(f) and 15d-15(f) under
the Exchange Act). Our management, with the participation of the Chief Executive Officer and the Chief Financial Officer, conducted an
assessment of the effectiveness of our internal control over financial reporting as of December 31, 2022 based on the criteria set forth
in &#8220;Internal Control &#8212; Integrated Framework (2013)&#8221; issued by the Committee of Sponsoring Organizations of the Treadway
Commission. Based on this assessment, our management concluded that, as of December 31, 2022, our internal control over financial reporting
was effective.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Attestation Report of the Registered Public
Accounting Firm</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">This annual report does not include an attestation report of the company&#8217;s
registered public accounting firm due to a transition period established by rules of the SEC for newly public companies, and because MDxHealth
is an emerging growth company under the JOBS Act.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Changes in Control over Financial Reporting</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">There has been no change in our internal control
over financial reporting during the year ended December 31, 2022 that has materially affected, or is reasonably likely to materially
affect, our internal control over financial reporting.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In January 2023, in connection with the preparation
of our financial statements for the nine months ended September 30, 2022, (the &#8220;Interim Financial Statements&#8221;), we identified
a material weakness in our internal control over financial reporting at September 30, 2022 related to ineffective design and operation
of our interim financial close and reporting controls. More specifically, internal control over financial reporting procedures used in
connection with the preparation of the financial information that we reported in a press release issued on October 27, 2022 failed to
identify a number of cut-off errors. These cut-off errors have been corrected in the Interim Financial Statements and do not relate to
our year-end close and reporting controls. A material weakness is a deficiency, or a combination of deficiencies, in internal control
over financial reporting such that there is a reasonable possibility that a material misstatement of a company&#8217;s annual or interim
financial statements will not be prevented or detected on a timely basis. Although we were able to remediate these issues, including
engaging an outside IFRS consulting firm to assist with our interim closing process, these efforts may not be sufficient to avoid similar
material weaknesses in the future.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><div><a id="a_021"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>ITEM 16. [RESERVED] </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Not applicable.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><div><a id="a_022"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>ITEM 16A. AUDIT COMMITTEE FINANCIAL EXPERT
</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Currently, our Audit Committee consists of three
directors: Regine Slagmulder, Lieve Verplancke and Hilde Windels. The members of the Audit Committee must have a collective expertise
relating to the activities of the Company, and at least one member of the Audit Committee must have the necessary competence in accounting
and auditing, including qualifying as an &#8220;audit committee financial expert&#8221; as defined under the Exchange Act. Our Board
of Directors has determined that Regine Slagmulder and Hilde Windels each qualify as an &#8220;audit committee financial expert,&#8221;
as defined by SEC rules and regulations. Regine Slagmulder, Lieve Verplancke, and Hilde Windels are independent under Belgian law and
the Nasdaq Stock Market listing requirements.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><div><a id="a_023"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>ITEM 16B. CODE OF ETHICS </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We have adopted a Code of Business Conduct and
Ethics that is applicable to all of our, and our subsidiaries&#8217;, directors, officers and employees. The Code of Business Conduct
and Ethics is available on our website at <i>www.mdxhealth.com</i>. Our Board is responsible for overseeing the Code of Business Conduct
and Ethics. Any waiver of the Code of Business Conduct and Ethics for our directors or executive officers (including our principal financial
officers) may be made only by the Board and will be disclosed to the public as required by law or under applicable listing rules. Waivers
of the Code of Business Conduct and Ethics for other employees may be made only by our Chief Executive Officer or Compliance Officer
and will be reported to our Audit Committee. All amendments to Code of Business Conduct and Ethics Code must be approved by the Board
or a committee thereof and, if applicable, shall be promptly disclosed to the public as required by law or under applicable listing rules.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><div><a id="a_024"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>ITEM 16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">BDO R&#233;viseurs d&#8217;Entreprises SRL,
has served as our independent registered public accounting firm for 2022 and 2021. Our accountants billed the following fees to us for
professional services in each of those fiscal years:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <tr style="vertical-align: bottom">
    <td>&#160;</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
    <td colspan="6" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">Year ended December&#160;31,</td><td style="padding-bottom: 1.5pt; font-weight: bold">&#160;</td></tr>
  <tr style="vertical-align: bottom">
    <td>&#160;</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
    <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2021</td><td style="padding-bottom: 1.5pt; font-weight: bold">&#160;</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
    <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="width: 76%; text-align: left">Audit fees for statutory and consolidated financials</td><td style="width: 1%">&#160;</td>
    <td style="width: 1%; text-align: left">$</td><td style="width: 9%; text-align: right">182,125</td><td style="width: 1%; text-align: left">&#160;</td><td style="width: 1%">&#160;</td>
    <td style="width: 1%; text-align: left">$</td><td style="width: 9%; text-align: right">238,500</td><td style="width: 1%; text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-align: left">Other audit fees</td><td>&#160;</td>
    <td style="text-align: left">$</td><td style="text-align: right">183,652</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">$</td><td style="text-align: right">191,455</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left">Audit-related and other fees</td><td>&#160;</td>
    <td style="text-align: left">$</td><td style="text-align: right">16,569</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">$</td><td style="text-align: right">41,811</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-align: left; padding-bottom: 1.5pt">Tax Fees</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left">$</td><td style="border-bottom: Black 1.5pt solid; text-align: right">&#8212;</td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left">$</td><td style="border-bottom: Black 1.5pt solid; text-align: right">&#8212;</td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="font-weight: bold; padding-bottom: 4pt">Total</td><td style="padding-bottom: 4pt">&#160;</td>
    <td style="border-bottom: Black 4pt double; text-align: left">$</td><td style="border-bottom: Black 4pt double; text-align: right">382,346</td><td style="padding-bottom: 4pt; text-align: left">&#160;</td><td style="padding-bottom: 4pt">&#160;</td>
    <td style="border-bottom: Black 4pt double; text-align: left">$</td><td style="border-bottom: Black 4pt double; text-align: right">471,766</td><td style="padding-bottom: 4pt; text-align: left">&#160;</td></tr>
  </table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#8220;Audit Fees&#8221; are the aggregate fees
billed for the audit of our annual financial statements.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#8220;Other Audit Fees&#8221; are mainly the
aggregate fees billed in the relation with the Company&#8217;s initial public offering (in 2021) and follow on public offering and capital
raise process (in 2022).</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#8220;Audit-Related Fees&#8221; are the aggregate
fees billed for assurance and related services that are reasonably related to the performance of the audit and are not reported under
Audit Fees. This category also includes services that generally the independent accountant provides, such as consents and assistance with
and review of documents filed with the SEC, as well as the aggregate fees billed for statutory audit services as requested by the Belgian
Company Code.&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#8220;Tax Fees&#8221; are the aggregate fees
billed for professional services rendered by the principal accountant for tax compliance, tax advice and tax planning related services.</p><div>



</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Audit and Non-Audit Services Pre-Approval Policy</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Audit Committee&#8217;s policy is to pre-approve
all audit and permissible non-audit services to be performed by the independent registered public accounting firm. These services may
include audit services, audit-related services, tax services and other services. All such services provided in fiscal 2022 were pre-approved
by the Audit Committee. The Audit Committee has delegated pre-approval authority to its chairman when necessary due to timing considerations.
Any services pre-approved by such chairman must be reported to the full Audit Committee at its next scheduled meeting.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><div><a id="a_025"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>ITEM 16D. EXEMPTIONS FROM THE LISTING STANDARDS
FOR AUDIT COMMITTEES </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Not applicable.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><div><a id="a_026"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>ITEM 16E. PURCHASES OF EQUITY SECURITIES BY
THE ISSUER AND AFFILIATED PURCHASERS </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Not applicable.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><div><a id="a_027"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>ITEM 16F. CHANGE IN REGISTRANT&#8217;S CERTIFYING
ACCOUNTANT </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Not applicable.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><div><a id="a_028"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>ITEM 16G. CORPORATE GOVERNANCE</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Differences between Our Corporate Governance
Practices and the Listing Rules of the Nasdaq Stock Market</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The listing rules of the Nasdaq Stock Market
include certain accommodations in relation to corporate governance requirements that allow foreign private issuers, to follow &#8220;home
country&#8221; corporate governance practices in lieu of the otherwise applicable corporate governance standards of the Nasdaq Stock
Market. The application of such exceptions requires that we disclose each instance of non-compliance&#160;with the Nasdaq Stock Market
listing rules that we do not follow and describe the Belgian corporate governance practices that we do follow in lieu of the relevant
Nasdaq Stock Market corporate governance standard.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We intend to continue to follow Belgian corporate
governance practices in lieu of the corporate governance requirements of the Nasdaq Stock Market in respect of the following:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Quorum at Shareholder
    Meetings</i>. Nasdaq Stock Market Listing Rule 5620(c) requires that for any meeting of shareholders, the quorum must be no less
    than 33.33% of the outstanding shares of common voting stock. There is no general quorum requirement under Belgian law for ordinary
    meetings of shareholders, except in relation to decisions regarding certain matters. See Item 10B. &#8220;<i>Memorandum and Articles
    of Association</i>&#8221; and information set forth in the final prospectus dated November 3, 2021 as part of our Registration Statement
    on Form F-1 (File No. 333-260213), declared effective by the SEC on November 3, 2021, under the headings &#8220;<i>Description of
    Share Capital and Articles of Association &#8212; Articles of Association and Other Share Information &#8212; Description of the
    Rights and Benefits Attached to Our Shares &#8212; Quorum and majorities</i>.&#8221;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Nomination and Remuneration
    Committee</i>. Nasdaq Stock Market Listing Rule 5605(d)(2) requires that compensation of officers must be determined by, or recommended
    to, the Board of Directors for determination, either by a majority of the independent directors, or a compensation committee comprised
    solely of independent directors. Nasdaq Stock Market Listing Rule 5605(e) requires that director nominees be selected, or recommended
    for selection, either by a majority of the independent directors or a nominations committee comprised solely of independent directors.
    Under Belgian law, we are not subject to any such requirements. In particular, we are not required by Belgian law to set up any compensation
    or nominations committees within our Board of Directors, and are therefore not subject to any Belgian legal requirements as to the
    composition of such committees. However, our Articles of Association provide that our Board of Directors may form committees from
    among its members. Accordingly, our Board of Directors has set up and appointed a Nomination and Remuneration Committee. Pursuant
    to article 7:100 of the Belgian Companies and Associations Code, only a majority of the members of the remuneration committee should
    in principle meet the independence criteria referred to in article 7:87 of the Belgian Companies and Associations Code and set out
    in provision 3.5 of the Belgian Corporate Governance Code. Pursuant to provision 4.19 of the Belgian Corporate Governance Code, only
    a majority of the members of the remuneration committee must qualify as independent.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Charters</i>. Nasdaq
    Stock Market Listing Rules 5605(c)(1), (d)(1) and (e)(2) require that each committee of the Board of Directors must have a formal
    written charter. Pursuant to the Belgian Corporate Governance Code, our Board of Directors has drawn up a corporate governance charter
    including, amongst others, the internal rules of our committees.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Independent Director
    Majority</i>. Nasdaq Stock Market Listing Rules 5605(b)(1) and (2) require that a majority of the Board of Directors must be comprised
    of independent directors and that independent directors must have regularly scheduled meetings at which only independent directors
    are present. We are not required under Belgian law to have a majority of independent directors on our Board of Directors. However,
    our Articles of Association provide that our Board of Directors must be comprised of at least three directors, of which, pursuant
    to our corporate governance charter and provision 3.4 of the Belgian Corporate Governance Code, at least three directors must be
    independent directors under Belgian law. Furthermore, in line with the provisions of the Belgian Companies and Associations Code
    and the Belgian Corporate Governance Code, the Nomination and Remuneration Committee should consist of a majority of independent
    directors, and the Audit Committee should have at least one independent director among its members</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: normal 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->97<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 24px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Meetings of Independent Directors</i>. Nasdaq Stock Market Listing Rule 5605(b)(2) requires that independent directors must have regularly scheduled meetings at which only independent directors are present. We do not intend to require our independent directors to meet separately from the full Board of Directors on a regular basis or at all, although the Board of Directors is supportive of its independent members voluntarily arranging to meet separately from the other members of our Board of Directors when and if they wish to do so.</span></td></tr>
  <tr style="vertical-align: top">
    <td>&#160;</td>
    <td>&#160;</td>
    <td style="text-align: justify">&#160;</td></tr>
  <tr style="vertical-align: top">
    <td>&#160;</td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Stockholder Approval of Certain Share Issuances. </i>Nasdaq Stock Market Listing Rule&#160;5635(a) requires shareholder approval prior to the issuance of securities in connection with the acquisition of the stock or assets of another company if (1)(A) the common stock has or will have upon issuance voting power equal to or in excess of 20% of the voting power outstanding before the issuance of stock or securities convertible into or exercisable for common stock or (B) the number of shares of common stock to be issued is or will be equal to or in excess of 20% of the number of shares of common stock outstanding before the issuance of the stock or securities; or (2) any director, officer or Substantial Shareholder (as defined in the Nasdaq rules) has a 5% or greater interest (or all such parties have a 10% or greater interest in the aggregate) in the Company or assets to be acquired or in the consideration to be paid in the transaction or series of transactions and the transaction or series of transactions results in an increase in the outstanding common shares or voting power of 5% or more. However, as permitted by Belgian law, we do not need prior stockholder approval to issue shares of authorized stock.</span></td></tr>
  </table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 24px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Stockholder Approval of
    Equity Compensation Arrangements</i>. Nasdaq Stock Market Listing Rule&#160;5635(c) requires shareholder approval when a plan or
    other equity compensation arrangement is established or materially amended. Under Belgian law the establishment or amendment of
    equity compensation arrangements does not require a prior approval by the general shareholders&#8217; meeting. However, pursuant to
    Belgian law our shareholders must decide any issuance of new equity, as a general matter. As mentioned in the final prospectus dated
    November 3, 2021 as part of our Registration Statement on Form F-1 (File No. 333-260213), declared effective by the SEC on November
    3, 2021, under the headings &#8220;<i>Description of Share Capital and Articles of Association &#8212; Articles of Association and
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    the so-called&#160;authorized capital. By virtue of a resolution of our extraordinary general shareholders&#8217; meeting of
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    framework of the authorized capital. Furthermore, the compensation of director mandates is subject to an approval by the general
    shareholders&#8217; meeting. See also Item 6B. &#8220;<i>Management &#8212; Compensation of Our Directors and Executive
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  </table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><div><a id="a_029"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>ITEM 16H. MINE SAFETY DISCLOSURE </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Not applicable.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><div><a id="a_030"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>ITEM 16I. DISCLOSURE REGARDING FOREIGN JURISDICTIONS
THAT PREVENT INSPECTIONS </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Not applicable.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 104; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: normal 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->98<!-- Field: /Sequence --></p></div><div>
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    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><div><a id="a_031"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>PART III</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><div><a id="a_032"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>ITEM 17. FINANCIAL STATEMENTS </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Not applicable.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><div><a id="a_033"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>ITEM 18. FINANCIAL STATEMENTS </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">See pages F-1 through F-45 of this annual report.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><div><a id="a_034"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>ITEM 19. EXHIBITS </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>Exhibit Index </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The following exhibits are filed as part of this
annual report:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: bottom">
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    <td style="border-bottom: black 1.5pt solid; width: 44%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Description of Exhibit</b></span></td>
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    <td style="border-bottom: black 1.5pt solid; width: 9%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Form</b></span></td>
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    <td style="border-bottom: black 1.5pt solid; width: 9%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>File No.</b></span></td>
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    <td style="border-bottom: black 1.5pt solid; width: 9%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Filed Herewith</b></span></td>
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  <tr style="background-color: rgb(204,238,255)">
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    <td style="vertical-align: top">&#160;</td>
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    <td style="vertical-align: top">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">6-K</span></td>
    <td style="vertical-align: top; text-align: center">&#160;</td>
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    <td style="vertical-align: top; text-align: center">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">March 8, 2023</span></td>
    <td style="vertical-align: top; text-align: center">&#160;</td>
    <td style="vertical-align: bottom; text-align: center">&#160;</td>
    <td style="vertical-align: top">&#160;</td></tr>
  <tr>
    <td style="vertical-align: top; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">1.2</span></td>
    <td style="vertical-align: top">&#160;</td>
    <td style="vertical-align: top; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="http://www.sec.gov/Archives/edgar/data/1872529/000121390021052578/ff12021ex3-2_mdxhealthsa.htm">Corporate Governance Charter of MDxHealth SA (English Translation)</a></span></td>
    <td style="vertical-align: top">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-1</span></td>
    <td style="vertical-align: top; text-align: center">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">333-260213</span></td>
    <td style="vertical-align: top; text-align: center">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">October 13, 2021</span></td>
    <td style="vertical-align: top; text-align: center">&#160;</td>
    <td style="vertical-align: bottom; text-align: center">&#160;</td>
    <td style="vertical-align: top">&#160;</td></tr>
  <tr style="background-color: rgb(204,238,255)">
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    <td style="vertical-align: top">&#160;</td>
    <td style="vertical-align: top; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="http://www.sec.gov/Archives/edgar/data/1872529/000121390021054912/ff12021ex4-1_mdxhealthsa.htm">Form of Deposit Agreement</a></span></td>
    <td style="vertical-align: top">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-1/A</span></td>
    <td style="vertical-align: top; text-align: center">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">333-260213</span></td>
    <td style="vertical-align: top; text-align: center">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">October 28, 2021</span></td>
    <td style="vertical-align: top; text-align: center">&#160;</td>
    <td style="vertical-align: bottom; text-align: center">&#160;</td>
    <td style="vertical-align: top">&#160;</td></tr>
  <tr>
    <td style="vertical-align: top; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">2.2</span></td>
    <td style="vertical-align: top">&#160;</td>
    <td style="vertical-align: top; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="http://www.sec.gov/Archives/edgar/data/1872529/000121390021054912/ff12021ex4-2_mdxhealthsa.htm">Form of American Depositary Receipt</a></span></td>
    <td style="vertical-align: top">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-1/A</span></td>
    <td style="vertical-align: top; text-align: center">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">333-260213</span></td>
    <td style="vertical-align: top; text-align: center">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">October 28, 2021</span></td>
    <td style="vertical-align: top; text-align: center">&#160;</td>
    <td style="vertical-align: bottom; text-align: center">&#160;</td>
    <td style="vertical-align: top">&#160;</td></tr>
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">2.3</span></td>
    <td>&#160;</td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="f20f2022ex2-3_mdxhealthsa.htm">Description of Securities registered under Section 12 of the Exchange Act</a></span></td>
    <td>&#160;</td>
    <td style="text-align: center">&#160;</td>
    <td style="text-align: center">&#160;</td>
    <td style="text-align: center">&#160;</td>
    <td style="text-align: center">&#160;</td>
    <td style="text-align: center">&#160;</td>
    <td style="text-align: center">&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">X</span></td>
    <td>&#160;</td></tr>
  <tr>
    <td style="vertical-align: top; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4.1</span></td>
    <td style="vertical-align: top">&#160;</td>
    <td style="vertical-align: top; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="http://www.sec.gov/Archives/edgar/data/1872529/000121390021052578/ff12021ex10-1_mdxhealthsa.htm">March 2012 Stock Option Plan (English Translation)*</a></span></td>
    <td style="vertical-align: top">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-1</span></td>
    <td style="vertical-align: top; text-align: center">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">333-260213</span></td>
    <td style="vertical-align: top; text-align: center">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">October 13, 2021</span></td>
    <td style="vertical-align: top; text-align: center">&#160;</td>
    <td style="vertical-align: bottom; text-align: center">&#160;</td>
    <td style="vertical-align: top">&#160;</td></tr>
  <tr style="background-color: rgb(204,238,255)">
    <td style="vertical-align: top; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4.2</span></td>
    <td style="vertical-align: top">&#160;</td>
    <td style="vertical-align: top; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="http://www.sec.gov/Archives/edgar/data/1872529/000121390021052578/ff12021ex10-2_mdxhealthsa.htm">May 2012 Stock Option Plan (English Translation)*</a></span></td>
    <td style="vertical-align: top">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-1</span></td>
    <td style="vertical-align: top; text-align: center">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">333-260213</span></td>
    <td style="vertical-align: top; text-align: center">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">October 13, 2021</span></td>
    <td style="vertical-align: top; text-align: center">&#160;</td>
    <td style="vertical-align: bottom; text-align: center">&#160;</td>
    <td style="vertical-align: top">&#160;</td></tr>
  <tr>
    <td style="vertical-align: top; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4.3</span></td>
    <td style="vertical-align: top">&#160;</td>
    <td style="vertical-align: top; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="http://www.sec.gov/Archives/edgar/data/1872529/000121390021052578/ff12021ex10-3_mdxhealthsa.htm">May 2014 Stock Option Plan (English Translation)*</a></span></td>
    <td style="vertical-align: top">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-1</span></td>
    <td style="vertical-align: top; text-align: center">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">333-260213</span></td>
    <td style="vertical-align: top; text-align: center">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">October 13, 2021</span></td>
    <td style="vertical-align: top; text-align: center">&#160;</td>
    <td style="vertical-align: bottom; text-align: center">&#160;</td>
    <td style="vertical-align: top">&#160;</td></tr>
  <tr style="background-color: rgb(204,238,255)">
    <td style="vertical-align: top; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4.4</span></td>
    <td style="vertical-align: top">&#160;</td>
    <td style="vertical-align: top; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="http://www.sec.gov/Archives/edgar/data/1872529/000121390021052578/ff12021ex10-4_mdxhealthsa.htm">May 2017 Stock Option Plan (English Translation)*</a></span></td>
    <td style="vertical-align: top">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-1</span></td>
    <td style="vertical-align: top; text-align: center">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">333-260213</span></td>
    <td style="vertical-align: top; text-align: center">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">October 13, 2021</span></td>
    <td style="vertical-align: top; text-align: center">&#160;</td>
    <td style="vertical-align: bottom; text-align: center">&#160;</td>
    <td style="vertical-align: top">&#160;</td></tr>
  <tr>
    <td style="vertical-align: top; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4.5</span></td>
    <td style="vertical-align: top">&#160;</td>
    <td style="vertical-align: top; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="http://www.sec.gov/Archives/edgar/data/1872529/000121390021052578/ff12021ex10-5_mdxhealthsa.htm">2019 Stock Option Plan (English Translation)*</a></span></td>
    <td style="vertical-align: top">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-1</span></td>
    <td style="vertical-align: top; text-align: center">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">333-260213</span></td>
    <td style="vertical-align: top; text-align: center">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">October 13, 2021</span></td>
    <td style="vertical-align: top; text-align: center">&#160;</td>
    <td style="vertical-align: bottom; text-align: center">&#160;</td>
    <td style="vertical-align: top">&#160;</td></tr>
  <tr style="background-color: rgb(204,238,255)">
    <td style="vertical-align: top; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4.6</span></td>
    <td style="vertical-align: top">&#160;</td>
    <td style="vertical-align: top; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="http://www.sec.gov/Archives/edgar/data/1872529/000121390021052578/ff12021ex10-6_mdxhealthsa.htm">2021 Share Option Plan (English Translation)*</a></span></td>
    <td style="vertical-align: top">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-1</span></td>
    <td style="vertical-align: top; text-align: center">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">333-260213</span></td>
    <td style="vertical-align: top; text-align: center">&#160;</td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">October 13, 2021</span></td>
    <td style="vertical-align: top; text-align: center">&#160;</td>
    <td style="vertical-align: bottom; text-align: center">&#160;</td>
    <td style="vertical-align: top">&#160;</td></tr>
  <tr>
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    <td style="vertical-align: top">&#160;</td>
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    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">333-260213</span></td>
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    <td style="vertical-align: top; text-align: center">&#160;</td>
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    <td style="vertical-align: top; text-align: center">&#160;</td>
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    <td style="text-align: center; width: 1%">&#160;</td>
    <td style="text-align: center; width: 9%">&#160;</td>
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    <td style="text-align: center">&#160;</td>
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    <td style="text-align: center">&#160;</td>
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    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">October 13, 2021</span></td>
    <td style="text-align: center">&#160;</td>
    <td style="text-align: center">&#160;</td>
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    <td style="text-align: center">&#160;</td>
    <td style="text-align: center">&#160;</td>
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</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0in; margin-bottom: 0in; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">*</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Indicates
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0in; margin-bottom: 0in; width: 100%"><tr style="vertical-align: top; text-align: justify">
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confidential portions of this Exhibit were omitted by means of marking such portions with brackets (&#8220;[***]&#8221;) because the
identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.</span></td>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></p><div>

</div><!-- Field: Page; Sequence: 106; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: normal 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->100<!-- Field: /Sequence --></p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>SIGNATURES</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The registrant hereby certifies that it meets
all of the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned to sign this annual report
on its behalf.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td>&#160;</td>
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  <tr>
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    <td colspan="2">&#160;</td></tr>
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    <td style="vertical-align: top; width: 4%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">By: </span></td>
    <td style="vertical-align: top; width: 36%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Michael McGarrity</span></td></tr>
  <tr>
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    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Chief Executive Officer</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Date: April 25, 2023</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 107; Value: 1 --><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>MDxHealth SA</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>INDEX TO THE CONSOLIDATED FINANCIAL STATEMENTS</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="width: 1%; text-align: justify; text-underline-color: #000000">&#160;</td>
    <td style="border-bottom: black 1.5pt solid; width: 8%; text-align: center; text-underline-color: #000000"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Page</b></span></td></tr>
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    <td style="text-align: justify; text-underline-color: #000000"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Audited
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    <td style="text-align: center; text-underline-color: #000000">&#160;</td></tr>
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    <td style="text-align: center; text-underline-color: #000000"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-3</span></td></tr>
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    <td style="text-align: center; text-underline-color: #000000"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-4</span></td></tr>
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    <td style="padding-left: 0.125in; text-underline-color: #000000; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#f_004">Consolidated Statement of Financial Position</a></span></td>
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    <td style="text-align: center; text-underline-color: #000000"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-5</span></td></tr>
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    <td style="text-align: center; text-underline-color: #000000"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-6</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>


</div><!-- Field: Page; Sequence: 108; Options: NewSection --><div>
    </div><div style="border-bottom: Black 1.5pt solid; margin-top: 12pt; margin-bottom: 6pt"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->1<!-- Field: /Sequence --></p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><div><a id="f_001"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">Report of Independent Registered Public Accounting
Firm</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Shareholders and Board of Directors</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">MDxHealth SA</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Herstal, Belgium</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Opinion on the Consolidated Financial Statements</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We have audited the accompanying consolidated
statements of financial position of MDxHealth SA (the &#8220;Company&#8221;) as of December 31, 2022 and 2021, the related consolidated
statements of profit or loss, comprehensive income, changes in equity, and cash flows for each of the three years in the period ended
December 31, 2022, and the related notes (collectively referred to as the &#8220;consolidated financial statements&#8221;). In our opinion,
the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31,
2022 and 2021, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2022<b>,
</b>in conformity with the International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board
(IASB).</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Basis for Opinion</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">These consolidated financial statements are the
responsibility of the Company&#8217;s management. Our responsibility is to express an opinion on the Company&#8217;s consolidated financial
statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United
States) (&#8220;PCAOB&#8221;) and are required to be independent with respect to the Company in accordance with the U.S. federal securities
laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We conducted our audits in accordance with the
standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated
financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were
we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an
understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the
Company&#8217;s internal control over financial reporting. Accordingly, we express no such opinion.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our audits included performing procedures to
assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures
that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the
consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made
by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide
a reasonable basis for our opinion.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We have served as the Company&#8217;s auditor since
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">April 25, 2023</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>


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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><i>&#160;</i></p><div>

</div><div><a id="f_002"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>Consolidated statement of profit or loss</i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>&#160;</i></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <tr style="vertical-align: bottom">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></p><div>

</div><!-- Field: Page; Sequence: 110 --><div>
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</div><div><a id="f_003"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><i>Consolidated statement of comprehensive income</i></p><div>



</div><p style="margin: 0">&#160;</p><div>


</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <tr style="vertical-align: bottom">
    <td style="border-bottom: Black 1.5pt solid; font-weight: bold; font-style: italic; font-variant: small-caps">Thousands of $ <br/>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="padding-left: 0.125in; text-indent: -0.125in; font-weight: bold; text-align: left">&#160;</td><td>&#160;</td>
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    <td style="font-weight: bold; text-align: left">&#160;</td><td style="font-weight: bold; text-align: right">&#160;</td><td style="font-weight: bold; text-align: left">&#160;</td><td style="font-weight: bold">&#160;</td>
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    <td style="text-align: left">&#160;</td><td style="text-align: right"></td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding-bottom: 4pt; padding-left: 0.125in; text-indent: -0.125in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Total
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</div><p style="margin: 0">&#160;</p><div>

</div><p style="margin: 0"></p><div>

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    </div><div style="border-bottom: Black 1.5pt solid; margin-top: 12pt; margin-bottom: 6pt"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->4<!-- Field: /Sequence --></p></div><div>
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</div><div><a id="f_004"></a></div><p style="margin: 0"><i>Consolidated statement of financial position</i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>&#160;</i></b></span></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <tr style="vertical-align: bottom">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
    <td>&#160;</td><td>&#160;</td>
    <td style="text-align: center">&#160;</td><td style="text-align: center">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="font-weight: bold">EQUITY</td><td>&#160;</td>
    <td style="text-align: center">&#160;</td><td style="text-align: center">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
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    <td style="text-align: center">&#160;</td><td style="text-align: center">22</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left">Issuance premium</td><td>&#160;</td>
    <td style="text-align: center">&#160;</td><td style="text-align: center">22</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c2" decimals="-3" format="ixt:num-dot-decimal" name="tmdx:IssuancePremium" scale="3" unitRef="usd">153,177</ix:nonFraction></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c5" decimals="-3" format="ixt:num-dot-decimal" name="tmdx:IssuancePremium" scale="3" unitRef="usd">153,177</ix:nonFraction></td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-align: left">Accumulated deficit</td><td>&#160;</td>
    <td style="text-align: center">&#160;</td><td style="text-align: center">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="text-align: center">&#160;</td><td style="text-align: center">24</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; ">
    <td style="padding-bottom: 1.5pt; text-align: left">Translation reserve</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="padding-bottom: 1.5pt; text-align: center">&#160;</td><td style="padding-bottom: 1.5pt; text-align: center">&#160;</td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right">(<ix:nonFraction contextRef="c2" decimals="-3" format="ixt:num-dot-decimal" name="tmdx:TranslationReserve" scale="3" sign="-" unitRef="usd">444</ix:nonFraction></td><td style="padding-bottom: 1.5pt; text-align: left">)</td><td style="padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding-bottom: 4pt; font-weight: bold; text-align: left">Total equity</td><td style="padding-bottom: 4pt">&#160;</td>
    <td style="padding-bottom: 4pt; text-align: center">&#160;</td><td style="padding-bottom: 4pt; text-align: center">&#160;</td><td style="padding-bottom: 4pt; text-align: left">&#160;</td><td style="padding-bottom: 4pt; font-weight: bold">&#160;</td>
    <td style="border-bottom: Black 4pt double; font-weight: bold; text-align: left">&#160;</td><td style="border-bottom: Black 4pt double; font-weight: bold; text-align: right"><ix:nonFraction contextRef="c2" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:Equity" scale="3" unitRef="usd">9,315</ix:nonFraction></td><td style="padding-bottom: 4pt; font-weight: bold; text-align: left">&#160;</td><td style="padding-bottom: 4pt; font-weight: bold">&#160;</td>
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  <tr style="vertical-align: bottom; ">
    <td>&#160;</td><td>&#160;</td>
    <td style="text-align: center">&#160;</td><td style="text-align: center">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="font-weight: bold">LIABILITIES</td><td>&#160;</td>
    <td style="text-align: center">&#160;</td><td style="text-align: center">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
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    <td style="text-align: center">&#160;</td><td style="text-align: center">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="text-align: center">&#160;</td><td style="text-align: center">16/19</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; ">
    <td style="text-align: left">Lease liabilities</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; ">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><i>&#160;</i></p><div>

</div><div><a id="f_005"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>Consolidated statement of changes in equity</i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>&#160;</i></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
    <td style="padding-left: 0.125in; text-indent: -0.125in">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; ">
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    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding-left: 0.125in; text-indent: -0.125in; text-align: left">Deduction of transaction costs</td><td>&#160;</td>
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    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-11">&#160;</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; ">
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    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right">&#160;</td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right"><div style="-sec-ix-hidden: hidden-fact-12">&#160;</div></td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right">&#160;</td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
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    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right">&#160;</td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding-bottom: 1.5pt; padding-left: 0.125in; text-indent: -0.125in; font-weight: bold">Balance at December 31, 2020</td><td style="padding-bottom: 1.5pt; font-weight: bold">&#160;</td>
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    <td style="padding-bottom: 1.5pt; font-weight: bold; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: right">(<ix:nonFraction contextRef="c16" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:Equity" scale="3" sign="-" unitRef="usd">215,300</ix:nonFraction></td><td style="padding-bottom: 1.5pt; font-weight: bold; text-align: left">)</td><td style="padding-bottom: 1.5pt; font-weight: bold">&#160;</td>
    <td style="padding-bottom: 1.5pt; font-weight: bold; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: right"><ix:nonFraction contextRef="c17" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:Equity" scale="3" unitRef="usd">9,385</ix:nonFraction></td><td style="padding-bottom: 1.5pt; font-weight: bold; text-align: left">&#160;</td><td style="padding-bottom: 1.5pt; font-weight: bold">&#160;</td>
    <td style="padding-bottom: 1.5pt; font-weight: bold; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: right">(<ix:nonFraction contextRef="c18" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:Equity" scale="3" sign="-" unitRef="usd">1,301</ix:nonFraction></td><td style="padding-bottom: 1.5pt; font-weight: bold; text-align: left">)</td><td style="padding-bottom: 1.5pt; font-weight: bold">&#160;</td>
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  <tr style="vertical-align: bottom; ">
    <td style="padding-left: 0.125in; text-indent: -0.125in">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding-left: 0.125in; text-indent: -0.125in; font-weight: bold">Balance at January 1, 2021</td><td style="font-weight: bold">&#160;</td>
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  <tr style="vertical-align: bottom; ">
    <td style="padding-left: 0.125in; text-indent: -0.125in; text-align: left">Loss for the year</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c20" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:ProfitLoss" scale="3" sign="-" unitRef="usd">29,002</ix:nonFraction></td><td style="text-align: left">)</td><td>&#160;</td>
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    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c3" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:ProfitLoss" scale="3" sign="-" unitRef="usd">29,002</ix:nonFraction></td><td style="text-align: left">)</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding-left: 0.125in; text-indent: -0.125in; text-align: left">Other comprehensive income</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-14">&#160;</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-15">&#160;</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding-left: 0.125in; text-indent: -0.125in">&#160;</td><td>&#160;</td>
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    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; ">
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    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-19">&#160;</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right"><div style="-sec-ix-hidden: hidden-fact-20">&#160;</div></td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right">&#160;</td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
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    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right">&#160;</td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding-left: 0.125in; text-indent: -0.125in">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding-left: 0.125in; text-indent: -0.125in; text-align: left">Loss for the year</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c28" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:ProfitLoss" scale="3" sign="-" unitRef="usd">44,044</ix:nonFraction></td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:ProfitLoss" scale="3" sign="-" unitRef="usd">44,044</ix:nonFraction></td><td style="text-align: left">)</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="padding-left: 0.125in; text-indent: -0.125in; text-align: left">Other comprehensive income</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding-left: 0.125in; text-indent: -0.125in; font-weight: bold; text-align: left">Total comprehensive income for the year</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td style="font-weight: bold">&#160;</td>
    <td style="font-weight: bold; text-align: left">&#160;</td><td style="font-weight: bold; text-align: right">(<ix:nonFraction contextRef="c28" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:ComprehensiveIncome" scale="3" sign="-" unitRef="usd">44,044</ix:nonFraction></td><td style="font-weight: bold; text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td style="font-weight: bold">&#160;</td>
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  <tr style="vertical-align: bottom; ">
    <td style="padding-left: 0.125in; text-indent: -0.125in">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding-left: 0.125in; text-indent: -0.125in; font-weight: bold; text-align: left">Transactions with owners in their capacity as owners:</td><td>&#160;</td>
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    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; ">
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  </table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>&#160;</i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></p><div>

</div><!-- Field: Page; Sequence: 113 --><div>
    </div><div style="border-bottom: Black 1.5pt solid; margin-top: 12pt; margin-bottom: 6pt"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->6<!-- Field: /Sequence --></p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><div><a id="f_006"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left"><i>Consolidated statement of cash flow</i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>&#160;</i></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <tr style="vertical-align: bottom">
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of $<br/>
For the years ended December 31</i></b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"></p></td><td style="padding-bottom: 1.5pt; text-align: center; font-weight: bold; font-style: italic; font-variant: small-caps">&#160;</td>
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  <tr style="vertical-align: bottom">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="font-weight: bold; text-align: left">Net cash outflow from operating activities</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; ">
    <td style="font-weight: bold; text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: center">&#160;</td><td style="text-align: center">&#160;</td><td style="text-align: left">&#160;</td><td style="font-weight: bold">&#160;</td>
    <td style="font-weight: bold; text-align: left">&#160;</td><td style="font-weight: bold; text-align: right">&#160;</td><td style="font-weight: bold; text-align: left">&#160;</td><td style="font-weight: bold">&#160;</td>
    <td style="font-weight: bold; text-align: left">&#160;</td><td style="font-weight: bold; text-align: right">&#160;</td><td style="font-weight: bold; text-align: left">&#160;</td><td style="font-weight: bold">&#160;</td>
    <td style="font-weight: bold; text-align: left">&#160;</td><td style="font-weight: bold; text-align: right">&#160;</td><td style="font-weight: bold; text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left"><b>CASH FLOWS FROM INVESTING ACTIVITIES</b></td><td>&#160;</td>
    <td style="text-align: center">&#160;</td><td style="text-align: center">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-align: left">Purchase of property, plant and equipment</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left">Acquisition and generation of intangible assets</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; ">
    <td style="padding-bottom: 1.5pt; text-align: left">Acquisition of Genomic Prostate Score Business</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="padding-bottom: 1.5pt; text-align: center">&#160;</td><td style="padding-bottom: 1.5pt; text-align: center">11</td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right">(<ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:CashFlowsUsedInObtainingControlOfSubsidiariesOrOtherBusinessesClassifiedAsInvestingActivities" scale="3" unitRef="usd">25,000</ix:nonFraction></td><td style="padding-bottom: 1.5pt; text-align: left">)</td><td style="padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="font-weight: bold; text-align: left">Net cash outflow from investing activities</td><td>&#160;</td>
    <td style="text-align: center">&#160;</td><td style="text-align: center">&#160;</td><td style="text-align: left">&#160;</td><td style="font-weight: bold">&#160;</td>
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  <tr style="vertical-align: bottom; ">
    <td style="font-weight: bold; text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: center">&#160;</td><td style="text-align: center">&#160;</td><td style="text-align: left">&#160;</td><td style="font-weight: bold">&#160;</td>
    <td style="font-weight: bold; text-align: left">&#160;</td><td style="font-weight: bold; text-align: right">&#160;</td><td style="font-weight: bold; text-align: left">&#160;</td><td style="font-weight: bold">&#160;</td>
    <td style="font-weight: bold; text-align: left">&#160;</td><td style="font-weight: bold; text-align: right">&#160;</td><td style="font-weight: bold; text-align: left">&#160;</td><td style="font-weight: bold">&#160;</td>
    <td style="font-weight: bold; text-align: left">&#160;</td><td style="font-weight: bold; text-align: right">&#160;</td><td style="font-weight: bold; text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left"><b>CASH FLOWS FROM FINANCING ACTIVITIES</b></td><td>&#160;</td>
    <td style="text-align: center">&#160;</td><td style="text-align: center">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-align: left">Proceeds from issuance of shares (net of transaction costs)</td><td>&#160;</td>
    <td style="text-align: center">&#160;</td><td style="text-align: center">22</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left">Proceeds from loan obligation</td><td>&#160;</td>
    <td style="text-align: center">&#160;</td><td style="text-align: center">16</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:ProceedsFromBorrowingsClassifiedAsFinancingActivities" scale="3" unitRef="usd">34,291</ix:nonFraction></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c3" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:ProceedsFromBorrowingsClassifiedAsFinancingActivities" scale="3" unitRef="usd">0</ix:nonFraction></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:ProceedsFromBorrowingsClassifiedAsFinancingActivities" scale="3" unitRef="usd">2,316</ix:nonFraction></td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-align: left">Repayment of loan obligation and debt extinguishment costs</td><td>&#160;</td>
    <td style="text-align: center">&#160;</td><td style="text-align: center">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="tmdx:PaymentOfLongtermDebt" scale="3" unitRef="usd">10,805</ix:nonFraction></td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c3" decimals="-3" format="ixt:num-dot-decimal" name="tmdx:PaymentOfLongtermDebt" scale="3" unitRef="usd">0</ix:nonFraction></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="tmdx:PaymentOfLongtermDebt" scale="3" unitRef="usd">0</ix:nonFraction></td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left">Payment of lease liability</td><td>&#160;</td>
    <td style="text-align: center">&#160;</td><td style="text-align: center">16</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:PaymentsOfLeaseLiabilitiesClassifiedAsFinancingActivities" scale="3" unitRef="usd">1,358</ix:nonFraction></td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c3" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:PaymentsOfLeaseLiabilitiesClassifiedAsFinancingActivities" scale="3" unitRef="usd">1,057</ix:nonFraction></td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:PaymentsOfLeaseLiabilitiesClassifiedAsFinancingActivities" scale="3" unitRef="usd">831</ix:nonFraction></td><td style="text-align: left">)</td></tr>
  <tr style="vertical-align: bottom; ">
    <td>Payment of interest</td><td>&#160;</td>
    <td style="text-align: center">&#160;</td><td style="text-align: center">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="tmdx:PaymentOfInterest" scale="3" sign="-" unitRef="usd">1,412</ix:nonFraction></td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c3" decimals="-3" format="ixt:num-dot-decimal" name="tmdx:PaymentOfInterest" scale="3" sign="-" unitRef="usd">1,011</ix:nonFraction></td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="tmdx:PaymentOfInterest" scale="3" sign="-" unitRef="usd">1,070</ix:nonFraction></td><td style="text-align: left">)</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding-bottom: 1.5pt; text-align: left">Interests received</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="padding-bottom: 1.5pt; text-align: center">&#160;</td><td style="padding-bottom: 1.5pt; text-align: center">8</td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right"><ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="tmdx:InterestsReceived" scale="3" unitRef="usd">125</ix:nonFraction></td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right"><ix:nonFraction contextRef="c3" decimals="-3" format="ixt:num-dot-decimal" name="tmdx:InterestsReceived" scale="3" unitRef="usd">11</ix:nonFraction></td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="padding-bottom: 1.5pt; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right"><ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="tmdx:InterestsReceived" scale="3" unitRef="usd">0</ix:nonFraction></td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="font-weight: bold; text-align: left">Net cash inflow from financing activities</td><td>&#160;</td>
    <td style="text-align: center">&#160;</td><td style="text-align: center">&#160;</td><td style="text-align: left">&#160;</td><td style="font-weight: bold">&#160;</td>
    <td style="font-weight: bold; text-align: left">&#160;</td><td style="font-weight: bold; text-align: right"><ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:CashFlowsFromUsedInFinancingActivities" scale="3" unitRef="usd">20,841</ix:nonFraction></td><td style="font-weight: bold; text-align: left">&#160;</td><td style="font-weight: bold">&#160;</td>
    <td style="font-weight: bold; text-align: left">&#160;</td><td style="font-weight: bold; text-align: right"><ix:nonFraction contextRef="c3" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:CashFlowsFromUsedInFinancingActivities" scale="3" unitRef="usd">66,509</ix:nonFraction></td><td style="font-weight: bold; text-align: left">&#160;</td><td style="font-weight: bold">&#160;</td>
    <td style="font-weight: bold; text-align: left">&#160;</td><td style="font-weight: bold; text-align: right"><ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:CashFlowsFromUsedInFinancingActivities" scale="3" unitRef="usd">14,290</ix:nonFraction></td><td style="font-weight: bold; text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td>&#160;</td><td>&#160;</td>
    <td style="text-align: center">&#160;</td><td style="text-align: center">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; ">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="clear: both; display: block;"><br/></span></p><div>

</div><div><a id="f_007"></a></div><ix:nonNumeric contextRef="c0" continuedAt="tmdx_DisclosureOfStatusAndPrincipalActivitytextBlock-c0_cont_1" escape="true" name="tmdx:DisclosureOfStatusAndPrincipalActivitytextBlock"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>NOTE 1: Status and principal activity</i></b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-transform: uppercase"><b>&#160;</b></span></p></ix:nonNumeric><div>

</div><div>

</div><ix:continuation continuedAt="tmdx_DisclosureOfStatusAndPrincipalActivitytextBlock-c0_cont_2" id="tmdx_DisclosureOfStatusAndPrincipalActivitytextBlock-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">When used in this report, all references to &#8220;MDxHealth&#8221;,
the &#8220;company&#8221;, &#8220;we&#8221;, &#8220;our&#8221; and &#8220;us&#8221; refer to MDxHealth, SA and its subsidiaries. MDxHealth is
a limited liability company domiciled in Belgium, with offices and labs in Belgium, the United States and The Netherlands.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="tmdx_DisclosureOfStatusAndPrincipalActivitytextBlock-c0_cont_3" id="tmdx_DisclosureOfStatusAndPrincipalActivitytextBlock-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">MDxHealth is a commercial-stage precision diagnostics
company committed to providing non-invasive, clinically actionable and cost-effective urologic solutions to improve patient care. The
Company&#8217;s novel prostate cancer genomic testing solutions combine advanced clinical modeling with genomic data to provide each
patient with a personalized cancer risk profile, which provides more accurate and actionable information than standard risk factors (e.g.,
PSA, DRE, age) used by clinicians.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="tmdx_DisclosureOfStatusAndPrincipalActivitytextBlock-c0_cont_4" id="tmdx_DisclosureOfStatusAndPrincipalActivitytextBlock-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Company&#8217;s Select mdx and Confirm mdx
solutions address men at risk for developing prostate cancer, providing physicians with a clear clinical pathway to accurately identify
clinically significant prostate cancer while minimizing the use of invasive procedures that are prone to complications. The Company&#8217;s
Genomic Prostate Score (GPS) solution addresses men newly diagnosed with early-stage prostate cancer, providing physicians with a clear
clinical pathway to make the most informed treatment decision for their individual disease, including active surveillance. The Company&#8217;s
collective decades of experience in precision diagnostics and its portfolio of novel biomarkers for diagnostic, prognostic and predictive
molecular assays supports its active pipeline of new testing solutions for prostate and other urologic diseases.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="tmdx_DisclosureOfStatusAndPrincipalActivitytextBlock-c0_cont_5" id="tmdx_DisclosureOfStatusAndPrincipalActivitytextBlock-c0_cont_4"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">MDxHealth offers its laboratory solutions from
its state-of-the-art, <ix:nonFraction contextRef="c2" decimals="0" format="ixt:num-dot-decimal" name="tmdx:CollegeOfAmericanPathologists" scale="0" unitRef="sqft">13,448</ix:nonFraction> square feet, College of American Pathologists (CAP)-accredited and Clinical Laboratory Improvement Amendments
of 1988 (&#8220;CLIA&#8221;) certified, molecular laboratory facility located at its U.S. headquarters in Irvine, California as well
as a CLIA-certified lab in Plano, Texas. MDxHealth also operates a molecular laboratory facility, MDxHealth B.V., located in Nijmegen,
the Netherlands. This site is ISO 13485:2016 certified and operates a management quality system with the following scope: The design
and development, manufacture, service laboratory activities and client services of in vitro diagnostic test kits, in vitro diagnostic
reagents used for molecular diagnostic detection of oncological diseases.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation id="tmdx_DisclosureOfStatusAndPrincipalActivitytextBlock-c0_cont_5"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Company is headquartered in Belgium. The
parent company, MDxHealth SA, has its registered and corporate office in Cap Business Center, Rue d&#8217;Abhooz 31, 4040 Herstal, Belgium.
MDxHealth, Inc., the Company&#8217;s U.S. subsidiary, is located at 15279 Alton Parkway, Suite 100, Irvine, CA 92618, United States.
MDxHealth B.V., the Company&#8217;s Dutch subsidiary, is located at Transistorweg 5, 6534 Nijmegen, The Netherlands.</p></ix:continuation><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:nonNumeric contextRef="c0" continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_1" escape="true" name="ifrs-full:DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>NOTE 2: Summary of Significant Accounting
Policies</i></b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>&#160;</i></b></span></p></ix:nonNumeric><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_2" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>2.1.
<ix:nonNumeric contextRef="c0" continuedAt="tmdx_DescriptionOfAccountingPolicyForBasisOfPreparationAndStatementOfComplianceTextBlock-c0_cont_1" escape="true" name="tmdx:DescriptionOfAccountingPolicyForBasisOfPreparationAndStatementOfComplianceTextBlock">Basis of preparation and statement of compliance</ix:nonNumeric></i></b></span></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="text-underline-style: double">&#160;</span></p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_3" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_2"><ix:continuation continuedAt="tmdx_DescriptionOfAccountingPolicyForBasisOfPreparationAndStatementOfComplianceTextBlock-c0_cont_2" id="tmdx_DescriptionOfAccountingPolicyForBasisOfPreparationAndStatementOfComplianceTextBlock-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">MDxHealth&#8217;s consolidated financial statements have been prepared
in accordance with the International Financial Reporting Standards (IFRS) and interpretations issued by the IFRS Interpretation Committee
(IFRS-IC) applicable to companies reported under IFRS. The financial statements comply with IFRS as issued by the International Accounting
Standards Board (IASB), collectively &#8220;IFRS&#8221;. Additionally, the financial statements are also prepared in accordance with IFRS
as endorsed by the European Union (&#8220;EU-IFRS&#8221;).</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_4" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_3"><ix:continuation id="tmdx_DescriptionOfAccountingPolicyForBasisOfPreparationAndStatementOfComplianceTextBlock-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The principal accounting policies applied in
the preparation of the consolidated financial statements are set out below. These policies have been consistently applied to all the
years presented, unless otherwise stated. The functional and presentation currency is the U.S. Dollar and all amounts are presented in
thousands of U.S. Dollars ($), rounded to the nearest thousand, unless otherwise indicated.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_5" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_4"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>2.2.
<ix:nonNumeric contextRef="c0" continuedAt="tmdx_DescriptionOfAccountingPolicyForConsolidationTextBlock-c0_cont_1" escape="true" name="tmdx:DescriptionOfAccountingPolicyForConsolidationTextBlock">Basis of consolidation</ix:nonNumeric></i></b></span></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-transform: uppercase"><b><i>&#160;</i></b></span></p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_6" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_5"><ix:continuation continuedAt="tmdx_DescriptionOfAccountingPolicyForConsolidationTextBlock-c0_cont_2" id="tmdx_DescriptionOfAccountingPolicyForConsolidationTextBlock-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The consolidated financial statements incorporate
the financial statements of MDxHealth SA (Belgium) and its wholly-owned subsidiaries, including MDxHealth Inc. (United States), and MDxHealth
BV (The Netherlands) for each fiscal year ending on December 31.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_7" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_6"><ix:continuation continuedAt="tmdx_DescriptionOfAccountingPolicyForConsolidationTextBlock-c0_cont_3" id="tmdx_DescriptionOfAccountingPolicyForConsolidationTextBlock-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Subsidiaries are all entities over which the
Company has control. The Company controls an entity when the Company is exposed to, or has rights to, variable returns from its involvement
with the entity and has the ability to affect those returns through its power to direct the activities of the entity. Subsidiaries are
fully consolidated from the date on which control is transferred to the Company. The acquisition method of accounting is used to account
for business combinations by the Company.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_8" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_7"><ix:continuation id="tmdx_DescriptionOfAccountingPolicyForConsolidationTextBlock-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">All intercompany balances, profits and transactions are eliminated
upon consolidation.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></p><div>

</div><!-- Field: Page; Sequence: 115 --><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_9" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_8"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>2.3.
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_10" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_9"><ix:continuation continuedAt="tmdx_DescriptionOfAccountingPolicyForGoingConcernTextBlock-c0_cont_2" id="tmdx_DescriptionOfAccountingPolicyForGoingConcernTextBlock-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Company has experienced net losses and significant
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a net loss of $<ix:nonFraction contextRef="c0" decimals="-5" format="ixt:num-dot-decimal" name="tmdx:NetLoss" scale="6" unitRef="usd">44.0</ix:nonFraction> million, and net cash used in operating activities of $<ix:nonFraction contextRef="c0" decimals="-5" format="ixt:num-dot-decimal" name="tmdx:NetCashUsedInOperatingActivities" scale="6" unitRef="usd">34.1</ix:nonFraction> million. Management expects the Company to continue to
incur net losses and have significant cash outflows for at least the next twelve months. While these conditions, among others, could
raise doubt about its ability to continue as a going concern, these consolidated financial statements have been prepared assuming that
the Company will continue as a going concern. This basis of accounting contemplates the recovery of its assets and the satisfaction of
liabilities in the normal course of business. A successful transition to attaining profitable operations is dependent upon achieving
a level of positive cash flows adequate to support the Company&#8217;s cost structure.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_11" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_10"><ix:continuation continuedAt="tmdx_DescriptionOfAccountingPolicyForGoingConcernTextBlock-c0_cont_3" id="tmdx_DescriptionOfAccountingPolicyForGoingConcernTextBlock-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">As of December 31, 2022, the Company had cash and cash equivalents of
$<ix:nonFraction contextRef="c2" decimals="-5" format="ixt:num-dot-decimal" name="tmdx:CashEquivalent" scale="6" unitRef="usd">15.5</ix:nonFraction> million. In February 2023, the Company raised $<ix:nonFraction contextRef="c36" decimals="-6" format="ixt:num-dot-decimal" name="tmdx:GrossProceeds" scale="6" unitRef="usd">40</ix:nonFraction> million in gross proceeds by means of a public offering of <ix:nonFraction contextRef="c37" decimals="0" format="ixt:num-dot-decimal" name="tmdx:PublicOffering" scale="0" unitRef="usd">10,000,000</ix:nonFraction> American
Depository Shares (ADSs) being the equivalent of <ix:nonFraction contextRef="c37" decimals="0" format="ixt:num-dot-decimal" name="tmdx:DepositoryShares" scale="0" unitRef="shares">100,000,000</ix:nonFraction> new shares (approximately <ix:nonFraction contextRef="c37" decimals="2" format="ixt:num-dot-decimal" name="tmdx:PercentageOfOutstandingShares" scale="-2" unitRef="pure">38</ix:nonFraction>% of the Company&#8217;s outstanding shares)
at an issue price of $<ix:nonFraction contextRef="c37" decimals="2" format="ixt:num-dot-decimal" name="tmdx:issuePrice" scale="0" unitRef="usdPershares">4.00</ix:nonFraction> per ADS (or approximately &#8364;<ix:nonFraction contextRef="c37" decimals="2" format="ixt:num-dot-decimal" name="tmdx:PricePerShare" scale="0" unitRef="eurPershares">0.37</ix:nonFraction> per share) through a public offering. In March 2023, the Company received
additional gross proceeds of $<ix:nonFraction contextRef="c38" decimals="-5" format="ixt:num-dot-decimal" name="tmdx:GrossProceeds" scale="6" unitRef="usd">3.0</ix:nonFraction> million from the underwriters&#8217; exercise of their overallotment option (for further details of
this transaction, refer to Note 27 Subsequent Events). Taking into account the above financial situation and on the basis of the most
recent business plan, the Company believes that it has sufficient cash to be able to continue its operations for at least the next twelve
months from the date of issuance of these financial statements, and accordingly has prepared the consolidated financial statements assuming
that it will continue as a going concern. This assessment is based on forecasts and projections within management&#8217;s most recent
business plan as well as the Company&#8217;s expected ability to realize cost reductions should these forecasts and projections not be
met.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-variant: small-caps"><b><i>&#160;</i></b></span></p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_12" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_11"><ix:continuation continuedAt="tmdx_DescriptionOfAccountingPolicyForGoingConcernTextBlock-c0_cont_4" id="tmdx_DescriptionOfAccountingPolicyForGoingConcernTextBlock-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-variant: small-caps"><b><i>COVID-19 and Macroeconomic
Factors</i></b></span></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_13" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_12"><ix:continuation continuedAt="tmdx_DescriptionOfAccountingPolicyForGoingConcernTextBlock-c0_cont_5" id="tmdx_DescriptionOfAccountingPolicyForGoingConcernTextBlock-c0_cont_4"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Company does not believe that COVID-19 or the Ukraine war has an
impact on the Company&#8217;s ability to continue as a going concern. The Company does not have business relationships with Russia or
Ukraine. There is no direct or indirect impact of the conflict on the day-to-day business of the Company. The Company is not materially
impacted by inflation, supply disruption or cyber-attacks due to the current geopolitical conflict.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_14" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_13"><ix:continuation id="tmdx_DescriptionOfAccountingPolicyForGoingConcernTextBlock-c0_cont_5"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">With regards to climate-related matters, the
Company is not impacted in a material way by extreme weather conditions.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>&#160;</i></b></span></p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_15" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_14"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>2.4.
<ix:nonNumeric contextRef="c0" continuedAt="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_1" escape="true" name="tmdx:UseOfEstimatesPolicyTextBlock">Use of estimates and judgments</ix:nonNumeric></i></b></span></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_16" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_15"><ix:continuation continuedAt="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_2" id="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Management makes certain critical accounting estimates and management
judgments when applying the Company&#8217;s accounting policies, which affect the reported amounts of assets and liabilities, the disclosure
of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenue and expenses during
the reporting period. Estimates and judgments are continuously evaluated based on historical experience and other factors, including expectations
of future events, which are believed to be reasonable under the circumstances. In the future, actual experience may differ from these
estimates and assumptions.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_17" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_16"><ix:continuation continuedAt="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_3" id="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The areas where assumptions and estimation uncertainties
in the financial statements have potentially the most significant effect in 2022, are listed below:</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>&#160;</b></p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_18" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_17"><ix:continuation continuedAt="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_4" id="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>Business combination (see Note 3)</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_19" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_18"><ix:continuation continuedAt="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_5" id="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_4"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On August 2, 2022, the Company announced it has entered into an agreement
with Genomic Health, Inc., a subsidiary of Exact Sciences Corporation (&#8220;Exact Sciences&#8221;), to acquire the Genomic Prostate
Score&#174; (GPS) test (formerly Oncotype DX GPS) from Exact Sciences. The company accounted for this acquisition under the acquisition
method of accounting and treated it as a business combination in accordance with IFRS. The purchase price was allocated based on the estimated
fair value of net assets acquired and liabilities assumed at the date of the acquisition. Following the closing, an additional aggregate
earn-out amount of up to $<ix:nonFraction contextRef="c39" decimals="-6" format="ixt:num-dot-decimal" name="tmdx:AggregateEarnoutAmount" scale="6" unitRef="usd">70</ix:nonFraction> million is to be paid by MDxHealth to Exact Sciences upon achievement of certain revenue milestones related
to fiscal years 2023 through 2025. The fair value of this contingent consideration at the acquisition date of August 2, 2022, was assessed
at $<ix:nonFraction contextRef="c40" decimals="-5" format="ixt:num-dot-decimal" name="ifrs-full:NetDebt" scale="6" unitRef="usd">50.5</ix:nonFraction> million, based on a probability-weighted estimate of the net present value expected to become payable, as further detailed in
Note 3. Subsequent fair value adjustments to this contingent consideration classified as financial liability are recognized through the
statement of profit or loss.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>&#160;</b></p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_20" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_19"><ix:continuation continuedAt="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_6" id="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_5"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>Revenue recognition (see Note 4):</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_21" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_20"><ix:continuation continuedAt="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_7" id="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_6"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">As further described in Note 2.7 (paragraph &#8220;Determining
the Transaction Price&#8221;), the Company analyzes historical collection data on a quarterly basis and makes adjustments to its estimates.
In accordance with IFRS&#160;15, revenue is recognized where such a variable consideration is included in the transaction price only
to the extent that it is highly probable that the amount of revenue recognized will not be subject to significant future reversals as
a result of subsequent re-estimation.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>&#160;</b></p></ix:continuation></ix:continuation><div>

</div><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>&#160;</b></p><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_22" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_21"><ix:continuation continuedAt="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_8" id="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_7"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>Deferred income tax (see Note 9)</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_23" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_22"><ix:continuation continuedAt="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_9" id="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_8"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Management estimates unused tax credits and tax
losses to the extent that it is probable that taxable profit will be available against which the tax credits and tax losses can be utilized.
On December&#160;31, 2022, the Company had a consolidated net tax loss carried forward amounting to $<ix:nonFraction contextRef="c0" decimals="-5" format="ixt:num-dot-decimal" name="tmdx:CarriedForwardAmount" scale="6" unitRef="usd">285.3</ix:nonFraction> million (2021: $<ix:nonFraction contextRef="c3" decimals="-5" format="ixt:num-dot-decimal" name="ifrs-full:OtherComprehensiveIncomeNetOfTaxChangeInValueOfForwardElementsOfForwardContracts" scale="6" unitRef="usd">258.5</ix:nonFraction> million),
implying a potential deferred tax asset of $<ix:nonFraction contextRef="c0" decimals="-5" format="ixt:num-dot-decimal" name="ifrs-full:IncreaseDecreaseInDeferredTaxLiabilityAsset" scale="6" unitRef="usd">71.3</ix:nonFraction> million (2021: $<ix:nonFraction contextRef="c3" decimals="-5" format="ixt:num-dot-decimal" name="ifrs-full:OtherComprehensiveIncomeNetOfTaxChangeInValueOfForwardElementsOfForwardContractsThatHedgeTimeperiodRelatedHedgedItems" scale="6" unitRef="usd">64.6</ix:nonFraction> million). No deferred tax assets have been recognized as of December&#160;31,
2022.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>&#160;</b></p></ix:continuation></ix:continuation><div>
</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_24" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_23"><ix:continuation continuedAt="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_10" id="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_9"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>Impairment Testing (see Note 3, 10 and 11)</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>&#160;</b></p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_25" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_24"><ix:continuation continuedAt="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_11" id="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_10"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Company has recorded Goodwill of $<ix:nonFraction contextRef="c0" decimals="-5" format="ixt:num-dot-decimal" name="tmdx:GoodwillAmount" scale="6" unitRef="usd">35.9</ix:nonFraction> million
as part of the GPS business combination (explained above), which is subject to annual impairment testing. The Company has performed an
impairment test as of December 31, 2022, at the level of the entire company which is in line with the level at which management monitors
its profitability. All the Company&#8217;s cash-generating units (CGUs) are expected to benefit from the synergies of the business combination.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_26" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_25"><ix:continuation continuedAt="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_12" id="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_11"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The impairment testing is based on a discounted
cash flow (DCF) model, with cash flows for the next <ix:nonNumeric contextRef="c0" format="ixt-sec:durwordsen" name="tmdx:ImpairmentTerm">five years</ix:nonNumeric> derived from the internal budgets and a residual value that assumes a
perpetual growth rate of <ix:nonFraction contextRef="c0" decimals="2" format="ixt:num-dot-decimal" name="tmdx:perpetualGrowthRate" scale="-2" unitRef="pure">2</ix:nonFraction>%. The value in use is sensitive to the discount rate used for the DCF model as well as the expected future
cash-inflows and the growth rate used for extrapolation purposes.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_27" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_26"><ix:continuation continuedAt="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_13" id="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_12"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Key underlying estimates are considered to be estimated cashflows and
the weighted-average cost of capital (WACC) and are further described in Note 10.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>&#160;</b></p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_28" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_27"><ix:continuation continuedAt="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_14" id="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_13"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>Share-Based Payments (see Note 24)</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_29" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_28"><ix:continuation continuedAt="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_15" id="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_14"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Management estimates the fair value of the equity-settled&#160;share-based&#160;payment
transactions by using the Black-Scholes&#160;option valuation model:</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: justify; text-indent: -0.25in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_30" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_29"><ix:continuation continuedAt="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_16" id="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_15"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left">&#9679;</td><td style="text-align: justify">The dividend return is estimated by reference to the historical
dividend payment of the Company; currently, this is estimated to be zero as no dividends have been paid since inception</td>
</tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: justify; text-indent: -0.25in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_31" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_30"><ix:continuation continuedAt="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_17" id="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_16"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left">&#9679;</td><td style="text-align: justify">The expected volatility was determined using the average
volatility of the stock over the last two years at the date of grant</td>
</tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: justify; text-indent: -0.25in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_32" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_31"><ix:continuation continuedAt="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_18" id="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_17"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left">&#9679;</td><td style="text-align: justify">Risk-free&#160;interest rate is based on the interest rate
applicable for the <ix:nonNumeric contextRef="c0" format="ixt-sec:duryear" name="tmdx:InterestRate">10</ix:nonNumeric>-year Belgian government bond at the grant date</td>
</tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>&#160;</b></p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_33" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_32"><ix:continuation continuedAt="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_19" id="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_18"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>Going Concern (note 2.3)</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_34" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_33"><ix:continuation continuedAt="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_20" id="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_19"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Management needs to make significant judgements
whether the Company will have sufficient liquidity to continue operations during the next twelve months. Refer to Note 2.3 for management
assessment.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_35" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_34"><ix:continuation continuedAt="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_21" id="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_20"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Financial liabilities (note 16)</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>&#160;</b></p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_36" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_35"><ix:continuation continuedAt="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_22" id="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_21"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Other financial liabilities are accounted for
at fair value through the statement of profit or loss and include the following:</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_37" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_36"><ix:continuation continuedAt="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_23" id="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_22"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">The fair value of the contingent consideration payable to Exact Sciences
(for the GPS acquisition) and to NovioGendix, which are presented in the yearend statement of financial position under &#8220;other non-current
financial liabilities&#8221; and &#8220;other current financial liabilities&#8221; are based on an estimated outcome of the conditional
purchase price/contingent payments arising from contractual obligations (level 3 input). These are initially recognized as part of the
purchase price and then subsequently measured for fair valued. Any changes to fair value are recorded through &#8220;other operating income&#8221;
in the statement of profit or loss.</span></td>
</tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_38" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_37"><ix:continuation continuedAt="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_24" id="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_23"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.75in"></td><td style="width: 0.25in; text-align: left">o</td><td style="text-align: justify">The fair value of the contingent consideration payable with regard to
the GPS acquisition is based on a probability-weighted average estimate based on multiple scenarios varying in timing and amount of earn-out
payment. This probability-weighted estimate is then discounted to its net present value taking into account the expected time when the
earn-out would become payable in 2024, 2025 and 2026. This contingent consideration was initially recorded along with the purchase price
allocation of this business combination as detailed in Note 3. Fair value at December 31, 2022, was estimated at $<ix:nonFraction contextRef="c2" decimals="-5" format="ixt:num-dot-decimal" name="ifrs-full:EstimatedFinancialEffectOfContingentLiabilities" scale="6" unitRef="usd">52.9</ix:nonFraction> million resulting
in a fair value adjustment expense of $<ix:nonFraction contextRef="c0" decimals="-5" format="ixt:num-dot-decimal" name="ifrs-full:AdjustmentsForGainsLossesOnFairValueAdjustmentInvestmentProperty" scale="6" unitRef="usd">2.4</ix:nonFraction> million. The Company used a discount rate of <ix:nonFraction contextRef="c2" decimals="4" format="ixt:num-dot-decimal" name="tmdx:DiscountRatePercentage" scale="-2" unitRef="pure">14.95</ix:nonFraction>%.</td>
</tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_39" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_38"><ix:continuation continuedAt="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_25" id="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_24"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.75in"></td><td style="width: 0.25in; text-align: left">o</td><td style="text-align: justify">For NovioGendix, fair value adjustments gain for the year
ended December 31, 2022, totaled $<ix:nonFraction contextRef="c41" decimals="0" format="ixt:num-dot-decimal" name="tmdx:TotalCost" scale="0" unitRef="usd">632,000</ix:nonFraction> and the Company used a discount rate of <ix:nonFraction contextRef="c42" decimals="4" format="ixt:num-dot-decimal" name="tmdx:DiscountRatePercentage" scale="-2" unitRef="pure">12.16</ix:nonFraction>%.</td>
</tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_40" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_39"><ix:continuation continuedAt="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_26" id="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_25"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">The
fair value of the derivative financial liabilities related to the initial Kreos drawdown fee of &#8364;<ix:nonFraction contextRef="c2" decimals="0" format="ixt:num-dot-decimal" name="ifrs-full:RedesignatedFinancialLiabilityAtFairValueThroughProfitOrLoss" scale="0" unitRef="eur">630,000</ix:nonFraction> is based upon the evolution
of the share price of MDxHealth as well as the estimated probabilities that either payment at <ix:nonFraction contextRef="c2" decimals="0" format="ixt:num-dot-decimal" name="ifrs-full:RedesignatedFinancialLiabilityAtFairValueThroughProfitOrLoss" scale="0" unitRef="usd">150</ix:nonFraction>%, or conversion into shares, will be
requested by Kreos. Whereas share price of MDxHealth can be considered as a level 1 input, the other variable, being the probability
assessment of possible scenarios should be considered as level 3 input. The fair value of the liability for the year ended December 31,
2022, is estimated at $<ix:nonFraction contextRef="c0" decimals="0" format="ixt:num-dot-decimal" name="tmdx:EstimatedAmount" scale="0" unitRef="usd">891,000</ix:nonFraction>.</span></td>
</tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 35.45pt; text-align: justify; text-indent: 0.55pt">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_41" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_40"><ix:continuation id="tmdx_UseOfEstimatesPolicyTextBlock-c0_cont_26"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 35.45pt; text-align: justify; text-indent: 0.55pt">The fair value
of the derivative financial liabilities related to the Innovatus derivative call option (as detailed in Note 16) was performed using
a binomial pricing model which takes into account several factors including the expected evolution in price of an ADS and are considered
as level 3 input. The fair value of the liability for the year ended December 31, 2022, is estimated at $<ix:nonFraction contextRef="c0" decimals="-5" format="ixt:num-dot-decimal" name="tmdx:EstimatedValue" scale="6" unitRef="usd">0.9</ix:nonFraction> million.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 35.45pt; text-align: justify; text-indent: 0.55pt">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

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    </div><div style="border-bottom: Black 1.5pt solid; margin-top: 12pt; margin-bottom: 6pt"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->10<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 35.45pt; text-align: justify; text-indent: 0.55pt">&#160;</p><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_42" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_41"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>2.5.
<ix:nonNumeric contextRef="c0" continuedAt="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_1" escape="true" name="tmdx:NewStandardsInterpretationsAndAmendmentsPolicyTextBlock">New Standards, Interpretations and Amendments </ix:nonNumeric></i></b></span></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_43" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_42"><ix:continuation continuedAt="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_2" id="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>2.5.1. New Standards, Interpretations and Amendments adopted by
the Company</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>&#160;</b></p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_44" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_43"><ix:continuation continuedAt="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_3" id="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The accounting policies have been consistently
applied by the Company and are consistent with those used in previous years.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_45" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_44"><ix:continuation continuedAt="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_4" id="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In the current financial year, the following
amendments to standards went into effect for the financial year beginning January 1, 2022, and have been endorsed by the European Union.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_46" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_45"><ix:continuation continuedAt="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_5" id="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_4"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">Amendments
to IFRS 3 Business Combinations; IAS 16 Property, Plant and Equipment; IAS 37 Provisions, Contingent Liabilities and Contingent Assets
as well as Annual Improvements (effective 1 January 2022). The package of amendments includes narrow-scope amendments to three Standards
as well as the Board&#8217;s Annual Improvements, which are changes that clarify the wording or correct minor consequences, oversights
or conflicts between requirements in the Standards.</span></td>
</tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-align: justify; text-indent: -0.25in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_47" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_46"><ix:continuation continuedAt="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_6" id="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_5"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.75in"></td><td style="width: 0.25in">o</td><td style="text-align: justify">Amendments to IFRS 3 Business Combinations
                                            update a reference in IFRS 3 to the Conceptual Framework for Financial Reporting without
                                            changing the accounting requirements for business combinations.</td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-align: justify; text-indent: -0.25in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_48" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_47"><ix:continuation continuedAt="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_7" id="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_6"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.75in"></td><td style="width: 0.25in">o</td><td style="text-align: justify">Amendments to IAS 16 Property, Plant and Equipment prohibit a company
from deducting from the cost of property, plant and equipment amounts received from selling items produced while the company is preparing
the asset for its intended use. Instead, a company will recognize such sales proceeds and related cost in profit or loss.</td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-align: justify; text-indent: -0.25in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_49" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_48"><ix:continuation continuedAt="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_8" id="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_7"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.75in"></td><td style="width: 0.25in">o</td><td style="text-align: justify">Amendments to IAS 37 Provisions, Contingent
                                            Liabilities and Contingent Assets specify which costs a company includes when assessing whether
                                            a contract will be loss-making.</td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-align: justify; text-indent: -0.25in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_50" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_49"><ix:continuation continuedAt="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_9" id="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_8"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.75in"></td><td style="width: 0.25in">o</td><td style="text-align: justify">Annual Improvements 2018-2020 make minor
                                            amendments to IFRS 1 First-time Adoption of International Financial Reporting Standards,
                                            IFRS 9 Financial Instruments, IAS 41 Agriculture and the Illustrative Examples accompanying
                                            IFRS 16 Leases.</td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_51" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_50"><ix:continuation continuedAt="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_10" id="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_9"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">This adoption has not had any material impact
on the disclosures or on the amounts reported in these financial statements.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_52" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_51"><ix:continuation continuedAt="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_11" id="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_10"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>2.5.2. Standards and Interpretations issued
but not yet effective in the current period</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_53" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_52"><ix:continuation continuedAt="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_12" id="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_11"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Certain new accounting standards and amendments
to standards have been published, but were not mandatory for December 31, 2022 reporting period.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_54" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_53"><ix:continuation continuedAt="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_13" id="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_12"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The following new standard and amendments have
been issued and endorsed by the European Union, but are not mandatory for the financial year beginning January 1, 2022:</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify; text-indent: -0.25in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_55" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_54"><ix:continuation continuedAt="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_14" id="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_13"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">Amendments
                                            to IAS 1 Presentation of Financial Statements and IFRS Practice Statement 2: Disclosure of
                                            Accounting policies (effective January 1, 2023). The amendments aim to improve accounting
                                            policy disclosures and to help users of the financial statements to distinguish between changes
                                            in accounting estimates and changes in accounting policies. The IAS 1 amendment requires
                                            companies to disclose their material accounting policy information rather than their significant
                                            accounting policies. Further, the amendment to IAS 1 clarifies that immaterial accounting
                                            policy information need not be disclosed. To support this amendment, the Board also amended
                                            IFRS Practice Statement 2, &#8216;Making Materiality Judgements&#8217;, to provide guidance
                                            on how to apply the concept of materiality to accounting policy disclosures. The amendments
                                            are effective for annual reporting periods beginning on or after January 1, 2023. Earlier
                                            application is permitted (subject to any local endorsement process).</span></td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify; text-indent: -0.25in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_56" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_55"><ix:continuation continuedAt="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_15" id="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_14"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">Amendments
                                            to IAS 8 Accounting policies, Changes in Accounting Estimates and Errors: Definition of Accounting
                                            Estimates (effective January 1, 2023). The amendment to IAS 8, &#8216;Accounting Policies,
                                            Changes in Accounting Estimates and Errors&#8217;, clarifies how companies should distinguish
                                            changes in accounting policies from changes in accounting estimates. The amendments are effective
                                            for annual reporting periods beginning on or after January 1, 2023. Earlier application is
                                            permitted (subject to any local endorsement process).</span></td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify; text-indent: -0.25in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_57" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_56"><ix:continuation continuedAt="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_16" id="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_15"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">Amendments
                                            to IAS 12 Income Taxes: Deferred Tax related to Assets and Liabilities arising from a Single
                                            Transaction (effective January 1, 2023). The amendments clarify how companies account for
                                            deferred tax on transactions such as leases and decommissioning obligations. The main change
                                            in the amendments is an exemption from the initial recognition exemption of IAS 12.15(b)
                                            and IAS 12.24. Accordingly, the initial recognition exemption does not apply to transactions
                                            in which equal amounts of deductible and taxable temporary differences arise on initial recognition.
                                            The amendments are effective for annual reporting periods beginning on or after January 1,
                                            2023 and early adoption is permitted.</span></td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 118 --><div>
    </div><div style="border-bottom: Black 1.5pt solid; margin-top: 12pt; margin-bottom: 6pt"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->11<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_58" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_57"><ix:continuation continuedAt="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_17" id="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_16"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">No amendments to standards that are issued but
not yet effective are considered to materially affect the Company&#8217;s accounting policies or any of the disclosures when applied
for the first time.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_59" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_58"><ix:continuation continuedAt="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_18" id="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_17"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The following amendments have been issued, but
are not mandatory for the financial year beginning January 1, 2022, and have not been endorsed by the European Union:</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify; text-indent: -0.25in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_60" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_59"><ix:continuation continuedAt="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_19" id="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_18"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">Amendments
to IAS 1 &#8216;Presentation of Financial Statements: Classification of Liabilities as current or non-current&#8217; (effective January
1, 2024), affect only the presentation of liabilities in the statement of financial position &#8212; not the amount or timing of recognition
of any asset, liability income or expenses, or the information that entities disclose about those items. The amendments:</span></td>
</tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-align: justify; text-indent: -0.25in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_61" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_60"><ix:continuation continuedAt="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_20" id="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_19"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.75in"></td><td style="width: 0.25in">o</td><td style="text-align: justify">clarify that the classification of liabilities
                                            as current or non-current should be based on rights that are in existence at the end of the
                                            reporting period and align the wording in all affected paragraphs to refer to the &#8220;right&#8221;
                                            to defer settlement by at least twelve months and make explicit that only rights in place
                                            &#8220;at the end of the reporting period&#8221; should affect the classification of a liability;</td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-align: justify; text-indent: -0.25in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_62" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_61"><ix:continuation continuedAt="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_21" id="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_20"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.75in"></td><td style="width: 0.25in">o</td><td style="text-align: justify">clarify that classification is unaffected
                                            by expectations about whether an entity will exercise its right to defer settlement of a
                                            liability; and make clear that settlement refers to the transfer to the counterparty of cash,
                                            equity instruments, other assets or services; and</td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-align: justify; text-indent: -0.25in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_63" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_62"><ix:continuation continuedAt="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_22" id="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_21"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.75in"></td><td style="width: 0.25in">o</td><td style="text-align: justify">clarify how conditions with which an entity
                                            must comply within 12 months after the reporting period, such as covenants, affect the corresponding
                                            liability&#8217;s classification.</td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify; text-indent: -0.25in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_64" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_63"><ix:continuation continuedAt="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_23" id="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_22"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left">&#9679;</td><td style="text-align: justify"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Amendments to IFRS 16 Leases: Lease Liability in a Sale and Leaseback
(effective January 1, 2024). The amendments explain how an entity accounts for a sale and leaseback after the date of the transaction,
specifically where some or all the lease payments are variable lease payments that do not depend on an index or rate. They state that,
in subsequently measuring the lease liability, the seller-lessee determines &#8216;lease payments&#8217; and &#8216;revised lease payments&#8217;
in a way that does not result in the seller-lessee recognizing any amount of the gain or loss that relates to the right of use it retains.
Any gains and losses relating to the full or partial termination of a lease continue to be recognized when they occur as these relate
to the right of use terminated and not the right of use retained.</p></td>
</tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_65" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_64"><ix:continuation id="tmdx_NewStandardsInterpretationsAndAmendmentsPolicyTextBlock-c0_cont_23"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Company will make an impact analysis in view
of the application of the amendment of IAS 1 on its consolidated financial statements.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>&#160;</i></b></span></p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_66" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_65"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>2.6.
<ix:nonNumeric contextRef="c0" continuedAt="_DescriptionOfAccountingPolicyForForeignCurrencyTranslationExplanatory-c0_cont_1" escape="true" name="ifrs-full:DescriptionOfAccountingPolicyForForeignCurrencyTranslationExplanatory">Foreign currency translation</ix:nonNumeric></i></b></span></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-transform: uppercase"><b><i>&#160;</i></b></span></p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_67" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_66"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForForeignCurrencyTranslationExplanatory-c0_cont_2" id="_DescriptionOfAccountingPolicyForForeignCurrencyTranslationExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>Functional and presentation currency</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_68" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_67"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForForeignCurrencyTranslationExplanatory-c0_cont_3" id="_DescriptionOfAccountingPolicyForForeignCurrencyTranslationExplanatory-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Items included in the financial statements of
each of the Company&#8217;s entities are measured using the currency of the primary economic environment in which the entity operates
(the functional currency). The Company&#8217;s functional and presentation currency is the U.S. dollar based on the continuing development
of the commercial activities in the U.S. market.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_69" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_68"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForForeignCurrencyTranslationExplanatory-c0_cont_4" id="_DescriptionOfAccountingPolicyForForeignCurrencyTranslationExplanatory-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Foreign currency transactions are translated into the functional currency
using the exchange rates at the date of the transactions. Foreign exchange gains and losses resulting from the settlement of such transactions
and from the translation of monetary assets and liabilities denominated in foreign currencies at year-end exchange rates are generally
recognized in profit or loss.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_70" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_69"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForForeignCurrencyTranslationExplanatory-c0_cont_5" id="_DescriptionOfAccountingPolicyForForeignCurrencyTranslationExplanatory-c0_cont_4"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The results and financial positions of foreign
operations that have a functional currency different from the presentation currency are translated into the presentation currency as
follows:</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify; text-indent: -0.25in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_71" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_70"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForForeignCurrencyTranslationExplanatory-c0_cont_6" id="_DescriptionOfAccountingPolicyForForeignCurrencyTranslationExplanatory-c0_cont_5"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">Assets
and liabilities for each statement of financial position presented are translated at the closing rate at the date of that balance sheet</span></td>
</tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify; text-indent: -0.25in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_72" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_71"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForForeignCurrencyTranslationExplanatory-c0_cont_7" id="_DescriptionOfAccountingPolicyForForeignCurrencyTranslationExplanatory-c0_cont_6"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">Income
and expenses for each statement of profit or loss and statement of comprehensive income are translated at average exchange rates</span></td>
</tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify; text-indent: -0.25in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_73" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_72"><ix:continuation id="_DescriptionOfAccountingPolicyForForeignCurrencyTranslationExplanatory-c0_cont_7"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">All
resulting exchange differences are recognized in other comprehensive income</span></td>
</tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>&#160;</i></b></span></p></ix:continuation></ix:continuation><div>

</div><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>&#160;</i></b></span></p><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_74" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_73"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>2.7.
<ix:nonNumeric contextRef="c0" continuedAt="_DescriptionOfAccountingPolicyForRecognitionOfRevenue-c0_cont_1" escape="true" name="ifrs-full:DescriptionOfAccountingPolicyForRecognitionOfRevenue">Revenue recognition</ix:nonNumeric></i></b></span></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-transform: uppercase"><b><i>&#160;</i></b></span></p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_75" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_74"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForRecognitionOfRevenue-c0_cont_2" id="_DescriptionOfAccountingPolicyForRecognitionOfRevenue-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Performance obligations and timing of revenue
recognition </b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_76" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_75"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForRecognitionOfRevenue-c0_cont_3" id="_DescriptionOfAccountingPolicyForRecognitionOfRevenue-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The majority of the Company&#8217;s revenue is
derived from laboratory services with revenue recognized at a point in time when control of the services has transferred to the customer.
This is generally when the test results are delivered to the customer.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_77" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_76"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForRecognitionOfRevenue-c0_cont_4" id="_DescriptionOfAccountingPolicyForRecognitionOfRevenue-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Minor other Company&#8217;s revenue is derived
from license fees and royalties:</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_78" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_77"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForRecognitionOfRevenue-c0_cont_5" id="_DescriptionOfAccountingPolicyForRecognitionOfRevenue-c0_cont_4"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">License
fees are recognized when the Company has fulfilled all conditions and obligations. If the Company has continuing performance obligations
towards the fees, the fee will be recognized on a straight-line basis over the contractual performance period.</span></td>
</tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_79" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_78"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForRecognitionOfRevenue-c0_cont_6" id="_DescriptionOfAccountingPolicyForRecognitionOfRevenue-c0_cont_5"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">Royalties
are recognized as revenue once the amounts due can be reliably estimated based on the sale of the underlying products and services and
when the collection of the royalties can be reasonably assured.</span></td>
</tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_80" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_79"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForRecognitionOfRevenue-c0_cont_7" id="_DescriptionOfAccountingPolicyForRecognitionOfRevenue-c0_cont_6"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">License up-front (signature fees) and non-refundable
fees for access to prior research results and databases are recognized when earned, if the Company has no continuing performance obligations
and all conditions and obligations are fulfilled. If the Company has continuing performance obligations towards the fees, the fee will
be recognized on a straight-line basis over the contractual performance period.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_81" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_80"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForRecognitionOfRevenue-c0_cont_8" id="_DescriptionOfAccountingPolicyForRecognitionOfRevenue-c0_cont_7"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Royalties are generated from the sales by third
parties of products or services which incorporate the Company&#8217;s proprietary technology. Royalties are recognized as revenue once
the amounts due can be reliably estimated based on the sale of the underlying products and services and when the collection of the royalties
can be reasonably assured.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_82" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_81"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForRecognitionOfRevenue-c0_cont_9" id="_DescriptionOfAccountingPolicyForRecognitionOfRevenue-c0_cont_8"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Determining the transaction price </b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_83" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_82"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForRecognitionOfRevenue-c0_cont_10" id="_DescriptionOfAccountingPolicyForRecognitionOfRevenue-c0_cont_9"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">A large portion of the Company&#8217;s revenues
are derived from Medicare, which reimburses the Company for tests performed on its insured patients. Medicare has set a fixed price (via
a Local Coverage Determination or &#8220;LCD&#8221;) for the Company&#8217;s Confirm mdx and GPS tests. Therefore, the amount of revenue
recognized from Medicare for these tests is determined by reference to the LCD pricing.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_84" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_83"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForRecognitionOfRevenue-c0_cont_11" id="_DescriptionOfAccountingPolicyForRecognitionOfRevenue-c0_cont_10"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">For other patients insured by commercial insurance
companies where there is no certainty of the amount that will be paid for services rendered, the Company uses historical collection data
&#8211; on an individual payor basis &#8211; to estimate its future collection and corresponding revenues that should be recognized for
each type of test.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_85" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_84"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForRecognitionOfRevenue-c0_cont_12" id="_DescriptionOfAccountingPolicyForRecognitionOfRevenue-c0_cont_11"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Company analyzes historical collection data
on a monthly basis and makes monthly adjustments to its estimates. In accordance with IFRS 15, revenue is recognized where such a variable
consideration is included in the transaction price only to the extent that it is highly probable that the amount of revenue recognized
will not be subject to significant future reversals as a result of subsequent re-estimation.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_86" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_85"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForRecognitionOfRevenue-c0_cont_13" id="_DescriptionOfAccountingPolicyForRecognitionOfRevenue-c0_cont_12"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">When historical collection data is insufficient
to estimate future collections, the Company defaults to cash basis, meaning that revenues will not be recognized until actual cash payment
is received from the payor.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_87" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_86"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForRecognitionOfRevenue-c0_cont_14" id="_DescriptionOfAccountingPolicyForRecognitionOfRevenue-c0_cont_13"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Total revenue in any given year includes amounts
related to tests performed in previous years that relate to:</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_88" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_87"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForRecognitionOfRevenue-c0_cont_15" id="_DescriptionOfAccountingPolicyForRecognitionOfRevenue-c0_cont_14"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">revenue
                                            from transactions in previous years that did not previously meet the revenue recognition
                                            criteria;</span></td></tr><tr style="vertical-align: top">
<td>&#160;</td><td>&#160;</td><td style="text-align: justify">&#160;</td></tr>
                                                                      </table></ix:continuation></ix:continuation><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_89" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_88"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForRecognitionOfRevenue-c0_cont_16" id="_DescriptionOfAccountingPolicyForRecognitionOfRevenue-c0_cont_15"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">differences
                                            between the revenue recognized in previous years and the actual amount received; and</span></td></tr><tr style="vertical-align: top">
<td>&#160;</td><td>&#160;</td><td style="text-align: justify">&#160;</td></tr>
                                                                                                                                                 </table></ix:continuation></ix:continuation><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_90" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_89"><ix:continuation id="_DescriptionOfAccountingPolicyForRecognitionOfRevenue-c0_cont_16"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">reversals
                                            of revenue relating to balances that are outstanding for more than 9 months.</span></td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_91" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_90"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>2.8.
<ix:nonNumeric contextRef="c0" continuedAt="tmdx_SegmentInformationPolicyTextBlock-c0_cont_1" escape="true" name="tmdx:SegmentInformationPolicyTextBlock">Segment information</ix:nonNumeric></i></b></span></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-transform: uppercase">&#160;</span></p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_92" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_91"><ix:continuation continuedAt="tmdx_SegmentInformationPolicyTextBlock-c0_cont_2" id="tmdx_SegmentInformationPolicyTextBlock-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Information for the Company&#8217;s operating
segments has been determined by reference to the information used by the chief operating decision maker (&#8220;CODM&#8221;) of the Company
to review the performance of the Company and in making decisions on allocation of resources, the nature of the activities and the management
structure and accountabilities. The Company&#8217;s CEO has been identified as the chief operating decision maker in accordance with
his designated responsibility for the allocation of resources to operating segments and assessing their performance through periodic
reporting. The CODM periodically reviews the Company&#8217;s performance based on information at a company level.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_93" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_92"><ix:continuation id="tmdx_SegmentInformationPolicyTextBlock-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Company monitors the profitability of the
group as a whole given revenues are generated from clinical laboratory service testing and does accordingly not distinguish different
business segments.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 120 --><div>
    </div><div style="border-bottom: Black 1.5pt solid; margin-top: 12pt; margin-bottom: 6pt"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->13<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_94" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_93"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>2.9.
<ix:nonNumeric contextRef="c0" continuedAt="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_1" escape="true" name="ifrs-full:DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory">intangible assets</ix:nonNumeric></i></b></span></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-transform: uppercase"><b><i>&#160;</i></b></span></p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_95" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_94"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_2" id="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-decoration:underline">Initial measurement: </span></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_96" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_95"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_3" id="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>Externally acquired</i></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_97" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_96"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_4" id="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Intangible assets are recognized on business combinations if they
are separable from the acquired entity or give rise to other contractual/legal rights. The amounts ascribed to such intangibles are determined
using appropriate valuation techniques.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_98" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_97"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_5" id="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_4"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Intangible assets are recognized on the business combinations of NovioGendix
in 2015 (Select mdx) and GPS in 2022 and include:</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_99" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_98"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_6" id="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_5"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td><span style="font-family: Times New Roman, Times, Serif">Externally
                                            acquired intellectual property, including patents, technology and related IP; and</span></td></tr><tr style="vertical-align: top">
<td>&#160;</td><td>&#160;</td><td>&#160;</td></tr>
                                                                                                                                              </table></ix:continuation></ix:continuation><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_100" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_99"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_7" id="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_6"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td><span style="font-family: Times New Roman, Times, Serif">Customers</span></td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_101" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_100"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_8" id="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_7"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">All were valued through application of the relief from royalty method,
except for the customers which were valued on the basis of multi-period excess earnings method.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_102" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_101"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_9" id="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_8"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Externally acquired intangible assets also include patents and software
licenses which are initially recognized at cost.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_103" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_102"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_10" id="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_9"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>Internally generated intangible assets (development
costs)</i></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-transform: uppercase"><b><i>&#160;</i></b></span></p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_104" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_103"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_11" id="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_10"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Development costs are capitalized when the following can be demonstrated:</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_105" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_104"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_12" id="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_11"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td><span style="font-family: Times New Roman, Times, Serif">It
                                            is technically feasible to develop the product for it to be sold;</span></td></tr><tr style="vertical-align: top">
<td>&#160;</td><td>&#160;</td><td>&#160;</td></tr>
                                                                                                                              </table></ix:continuation></ix:continuation><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_106" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_105"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_13" id="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_12"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td><span style="font-family: Times New Roman, Times, Serif">Adequate
                                            resources are available to complete the development;</span></td></tr><tr style="vertical-align: top">
<td>&#160;</td><td>&#160;</td><td>&#160;</td></tr>
                                                                                                                 </table></ix:continuation></ix:continuation><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_107" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_106"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_14" id="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_13"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td><span style="font-family: Times New Roman, Times, Serif">There
                                            is an intention to complete and sell the product;</span></td></tr><tr style="vertical-align: top">
<td>&#160;</td><td>&#160;</td><td>&#160;</td></tr>
                                                                                                              </table></ix:continuation></ix:continuation><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_108" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_107"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_15" id="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_14"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td><span style="font-family: Times New Roman, Times, Serif">The
                                            Company is able to sell the product;</span></td></tr><tr style="vertical-align: top">
<td>&#160;</td><td>&#160;</td><td>&#160;</td></tr>
                                                                                                 </table></ix:continuation></ix:continuation><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_109" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_108"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_16" id="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_15"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td><span style="font-family: Times New Roman, Times, Serif">Sale
                                            of the product will generate future economic benefits; and</span></td></tr><tr style="vertical-align: top">
<td>&#160;</td><td>&#160;</td><td>&#160;</td></tr>
                                                                                                                       </table></ix:continuation></ix:continuation><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_110" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_109"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_17" id="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_16"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td><span style="font-family: Times New Roman, Times, Serif">Expenditures
                                            on the project can be measured reliably.</span></td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_111" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_110"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_18" id="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_17"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Internally generated intangible assets relate to Confirm mdx, Select
mdx, Resolve mdx and GPS.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_112" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_111"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_19" id="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_18"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-decoration:underline">Subsequent measurement</span></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_113" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_112"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_20" id="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_19"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Intangible assets are carried at their cost less
any accumulated amortization and any accumulated impairment losses amortized on a straight-line basis over their estimated useful lives
on the following basis:</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_114" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_113"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_21" id="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_20"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">Patents
                                            &amp; software: shorter of (a) 5 years; or (b) the software license period / patent life</span></td></tr><tr style="vertical-align: top">
<td>&#160;</td><td>&#160;</td><td style="text-align: justify">&#160;</td></tr>
                                                                                                                                                     </table></ix:continuation></ix:continuation><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_115" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_114"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_22" id="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_21"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">Intellectual property: <ix:nonNumeric contextRef="c43" format="ixt-sec:duryear" name="tmdx:IntellectualProperty">10</ix:nonNumeric>-<ix:nonNumeric contextRef="c44" format="ixt-sec:duryear" name="tmdx:IntellectualProperty">15</ix:nonNumeric> years </span></td></tr><tr style="vertical-align: top">
<td>&#160;</td><td>&#160;</td><td style="text-align: justify">&#160;</td></tr> </table></ix:continuation></ix:continuation><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_116" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_115"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_23" id="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_22"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">Customers: <ix:nonNumeric contextRef="c0" format="ixt-sec:duryear" name="tmdx:Customers">6.5</ix:nonNumeric> years </span></td></tr><tr style="vertical-align: top">
<td>&#160;</td><td>&#160;</td><td style="text-align: justify">&#160;</td></tr> </table></ix:continuation></ix:continuation><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_117" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_116"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_24" id="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_23"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">Capitalized development costs: <ix:nonNumeric contextRef="c0" format="ixt-sec:duryear" name="tmdx:CapitalizedDevelopmentCosts">5</ix:nonNumeric> years </span></td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_118" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_117"><ix:continuation id="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_24"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Amortization over the asset&#8217;s useful life shall begin when the
asset is available for use.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_119" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_118"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>2.10.
<ix:nonNumeric contextRef="c0" continuedAt="_DescriptionOfAccountingPolicyForPropertyPlantAndEquipmentExplanatory-c0_cont_1" escape="true" name="ifrs-full:DescriptionOfAccountingPolicyForPropertyPlantAndEquipmentExplanatory">Property, plant and equipment</ix:nonNumeric></i></b></span></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-transform: uppercase"><b><i>&#160;</i></b></span></p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_120" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_119"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForPropertyPlantAndEquipmentExplanatory-c0_cont_2" id="_DescriptionOfAccountingPolicyForPropertyPlantAndEquipmentExplanatory-c0_cont_1"><ix:nonNumeric contextRef="c0" continuedAt="tmdx_EstimatedUsefulLifeDescription-c0_cont_1" name="tmdx:EstimatedUsefulLifeDescription"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Property, plant and equipment are stated at historical
cost less accumulated depreciation and impairment. Repair and maintenance costs are charged to the income statement as incurred. Gains
and losses on the disposal of property, plant and equipment are included in other income or expenses. Depreciation is charged to write
off the cost or valuation of assets over their useful lives, using the straight-line method, on the following basis:</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:nonNumeric></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_121" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_120"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForPropertyPlantAndEquipmentExplanatory-c0_cont_3" id="_DescriptionOfAccountingPolicyForPropertyPlantAndEquipmentExplanatory-c0_cont_2"><ix:continuation continuedAt="tmdx_EstimatedUsefulLifeDescription-c0_cont_2" id="tmdx_EstimatedUsefulLifeDescription-c0_cont_1"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">Equipment:
                                            5 years</span></td></tr><tr style="vertical-align: top">
<td>&#160;</td><td>&#160;</td><td style="text-align: justify">&#160;</td></tr>
                                                                    </table></ix:continuation></ix:continuation></ix:continuation><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_122" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_121"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForPropertyPlantAndEquipmentExplanatory-c0_cont_4" id="_DescriptionOfAccountingPolicyForPropertyPlantAndEquipmentExplanatory-c0_cont_3"><ix:continuation continuedAt="tmdx_EstimatedUsefulLifeDescription-c0_cont_3" id="tmdx_EstimatedUsefulLifeDescription-c0_cont_2"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">IT
                                            hardware and software: 3 years</span></td></tr></table><p style="margin: 0">&#160;</p></ix:continuation></ix:continuation></ix:continuation><div>

</div><div>

</div><p style="margin: 0"></p><div>

</div><!-- Field: Page; Sequence: 121 --><div>
    </div><div style="border-bottom: Black 1.5pt solid; margin-top: 12pt; margin-bottom: 6pt"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->14<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
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</div><p style="margin: 0">&#160;</p><div>


</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_123" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_122"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForPropertyPlantAndEquipmentExplanatory-c0_cont_5" id="_DescriptionOfAccountingPolicyForPropertyPlantAndEquipmentExplanatory-c0_cont_4"><ix:continuation continuedAt="tmdx_EstimatedUsefulLifeDescription-c0_cont_4" id="tmdx_EstimatedUsefulLifeDescription-c0_cont_3"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">Furniture:
                                            5 years</span></td></tr><tr style="vertical-align: top">
<td>&#160;</td><td>&#160;</td><td style="text-align: justify">&#160;</td></tr>
                                                                    </table></ix:continuation></ix:continuation></ix:continuation><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_124" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_123"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForPropertyPlantAndEquipmentExplanatory-c0_cont_6" id="_DescriptionOfAccountingPolicyForPropertyPlantAndEquipmentExplanatory-c0_cont_5"><ix:continuation continuedAt="tmdx_EstimatedUsefulLifeDescription-c0_cont_5" id="tmdx_EstimatedUsefulLifeDescription-c0_cont_4"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">Vehicles:
                                            5 years</span></td></tr><tr style="vertical-align: top">
<td>&#160;</td><td>&#160;</td><td style="text-align: justify">&#160;</td></tr>
                                                                    </table></ix:continuation></ix:continuation></ix:continuation><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_125" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_124"><ix:continuation id="_DescriptionOfAccountingPolicyForPropertyPlantAndEquipmentExplanatory-c0_cont_6"><ix:continuation id="tmdx_EstimatedUsefulLifeDescription-c0_cont_5"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">Leasehold
                                            improvements: in line with the non-cancellable lease period of the related lease</span></td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>&#160;</b></p></ix:continuation></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_126" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_125"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>2.11.
<ix:nonNumeric contextRef="c0" continuedAt="tmdx_RightofuseAssetsAndLiabilitiesPolicyTextBlock-c0_cont_1" escape="true" name="tmdx:RightofuseAssetsAndLiabilitiesPolicyTextBlock">Right-of-use assets and liabilities</ix:nonNumeric></i></b></span></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>&#160;</b></p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_127" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_126"><ix:continuation continuedAt="tmdx_RightofuseAssetsAndLiabilitiesPolicyTextBlock-c0_cont_2" id="tmdx_RightofuseAssetsAndLiabilitiesPolicyTextBlock-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>Right-of-use assets:</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_128" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_127"><ix:continuation continuedAt="tmdx_RightofuseAssetsAndLiabilitiesPolicyTextBlock-c0_cont_3" id="tmdx_RightofuseAssetsAndLiabilitiesPolicyTextBlock-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Company recognizes right-of-use assets at
the commencement date of the lease (i.e., the date the underlying asset is available for use). Right-of-use assets are measured at cost,
less any accumulated depreciation and impairment losses, and adjusted for any remeasurement of lease liabilities. The cost of right-of-use
assets includes the amount of lease liabilities recognized, initial direct costs incurred, and lease payments made at or before the commencement
date less any lease incentives received. Unless the Company is reasonably certain to obtain ownership of the leased asset at the end
of the lease term, the recognized right-of-use assets are depreciated on a straight-line basis over the shorter of its estimated useful
life and the lease term. Depreciation periods range between <ix:nonNumeric contextRef="c43" format="ixt-sec:duryear" name="tmdx:DepreciationPeriodsRange">3</ix:nonNumeric> and <ix:nonNumeric contextRef="c44" format="ixt-sec:duryear" name="tmdx:DepreciationPeriodsRange">6</ix:nonNumeric> years. Right-of-use assets are subject to impairment.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_129" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_128"><ix:continuation continuedAt="tmdx_RightofuseAssetsAndLiabilitiesPolicyTextBlock-c0_cont_4" id="tmdx_RightofuseAssetsAndLiabilitiesPolicyTextBlock-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Lease liabilities: </b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_130" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_129"><ix:continuation continuedAt="tmdx_RightofuseAssetsAndLiabilitiesPolicyTextBlock-c0_cont_5" id="tmdx_RightofuseAssetsAndLiabilitiesPolicyTextBlock-c0_cont_4"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">At the commencement date of the lease, the Company
recognizes lease liabilities measured at the present value of lease payments to be made over the lease term. The lease payments include
fixed payments (including in substance fixed payments) less any lease incentives receivable, variable lease payments that depend on an
index or a rate, and amounts expected to be paid under residual value guarantees. The lease payments also include the exercise price
of a purchase option reasonably certain to be exercised by the Company and payments of penalties for terminating a lease, if the lease
term reflects the Company exercising the option to terminate. The variable lease payments that do not depend on an index or a rate are
recognized as expense in the period on which the event or condition that triggers the payment occurs. In calculating the present value
of lease payments, the Company uses the incremental borrowing rate at the lease commencement date which is in the following ranges:</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_131" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_130"><ix:continuation continuedAt="tmdx_RightofuseAssetsAndLiabilitiesPolicyTextBlock-c0_cont_6" id="tmdx_RightofuseAssetsAndLiabilitiesPolicyTextBlock-c0_cont_5"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td><span style="font-family: Times New Roman, Times, Serif">Buildings: <ix:nonFraction contextRef="c43" decimals="2" format="ixt:num-dot-decimal" name="tmdx:PercentageOfBuildings" scale="-2" unitRef="pure">10</ix:nonFraction>% and <ix:nonFraction contextRef="c44" decimals="2" format="ixt:num-dot-decimal" name="tmdx:PercentageOfBuildings" scale="-2" unitRef="pure">11</ix:nonFraction>%</span></td></tr><tr style="vertical-align: top">
<td>&#160;</td><td>&#160;</td><td>&#160;</td></tr> </table></ix:continuation></ix:continuation><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_132" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_131"><ix:continuation continuedAt="tmdx_RightofuseAssetsAndLiabilitiesPolicyTextBlock-c0_cont_7" id="tmdx_RightofuseAssetsAndLiabilitiesPolicyTextBlock-c0_cont_6"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td><span style="font-family: Times New Roman, Times, Serif">Vehicles: <ix:nonFraction contextRef="c43" decimals="3" format="ixt:num-dot-decimal" name="tmdx:PercentageOfVehicles" scale="-2" unitRef="pure">2.5</ix:nonFraction>% and <ix:nonFraction contextRef="c44" decimals="4" format="ixt:num-dot-decimal" name="tmdx:PercentageOfVehicles" scale="-2" unitRef="pure">3.75</ix:nonFraction>%</span></td></tr><tr style="vertical-align: top">
<td>&#160;</td><td>&#160;</td><td>&#160;</td></tr> </table></ix:continuation></ix:continuation><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_133" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_132"><ix:continuation continuedAt="tmdx_RightofuseAssetsAndLiabilitiesPolicyTextBlock-c0_cont_8" id="tmdx_RightofuseAssetsAndLiabilitiesPolicyTextBlock-c0_cont_7"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td><span style="font-family: Times New Roman, Times, Serif">Materials: <ix:nonFraction contextRef="c43" decimals="2" format="ixt:num-dot-decimal" name="tmdx:PercentageOfMaterials" scale="-2" unitRef="pure">5</ix:nonFraction>% and <ix:nonFraction contextRef="c44" decimals="2" format="ixt:num-dot-decimal" name="tmdx:PercentageOfMaterials" scale="-2" unitRef="pure">6</ix:nonFraction>%</span></td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_134" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_133"><ix:continuation continuedAt="tmdx_RightofuseAssetsAndLiabilitiesPolicyTextBlock-c0_cont_9" id="tmdx_RightofuseAssetsAndLiabilitiesPolicyTextBlock-c0_cont_8"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">After the commencement date, the amount of lease
liabilities is increased to reflect the accretion of interest and reduced for the lease payments made. In addition, the carrying amount
of lease liabilities is remeasured if there is a modification, a change in the lease term, a change in the in-substance fixed lease payments
or a change in the assessment to purchase the underlying asset.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_135" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_134"><ix:continuation continuedAt="tmdx_RightofuseAssetsAndLiabilitiesPolicyTextBlock-c0_cont_10" id="tmdx_RightofuseAssetsAndLiabilitiesPolicyTextBlock-c0_cont_9"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Short-term leases and leases of low-value
assets: </b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_136" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_135"><ix:continuation id="tmdx_RightofuseAssetsAndLiabilitiesPolicyTextBlock-c0_cont_10"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Company applies the short-term lease recognition
exemption to its short-term leases of machinery and equipment (i.e., those leases that have a lease term of 12 months or less from the
commencement date and do not contain a purchase option). It also applies the lease of low-value assets recognition exemption to leases
of office equipment that are considered of low value (i.e., below $<ix:nonFraction contextRef="c2" decimals="0" format="ixt:num-dot-decimal" name="ifrs-full:OfficeEquipment" scale="0" unitRef="usd">5,000</ix:nonFraction>). Lease payments on short-term leases and low-value assets are
recognized in the consolidated statement of profit or loss as incurred.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_137" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_136"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>2.12.
<ix:nonNumeric contextRef="c0" continuedAt="_DescriptionOfAccountingPolicyForImpairmentOfNonfinancialAssetsExplanatory-c0_cont_1" escape="true" name="ifrs-full:DescriptionOfAccountingPolicyForImpairmentOfNonfinancialAssetsExplanatory">Impairment of assets</ix:nonNumeric></i></b></span></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-transform: uppercase"><b><i>&#160;</i></b></span></p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_138" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_137"><ix:continuation id="_DescriptionOfAccountingPolicyForImpairmentOfNonfinancialAssetsExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Goodwill and intangible assets that have an indefinite useful life
are not subject to amortization and are tested annually for impairment, or more frequently if events or changes in circumstances indicate
that they might be impaired. Other assets are tested for impairment whenever events or changes in circumstances indicate that the carrying
amount may not be recoverable. An impairment loss is recognized for the amount by which the asset&#8217;s carrying amount exceeds its
recoverable amount. The recoverable amount is the higher of an asset&#8217;s fair value less costs of disposal and value in use. The Company
monitors its Goodwill at consolidated Company level which is the level of the Company of cash-generating units (CGUs) benefiting from
the synergies. Non-financial assets other than Goodwill that suffered an impairment are reviewed for possible reversal of the impairment
at the end of each reporting period.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_139" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_138"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>2.13.
<ix:nonNumeric contextRef="c0" continuedAt="_DescriptionOfAccountingPolicyForMeasuringInventories-c0_cont_1" escape="true" name="ifrs-full:DescriptionOfAccountingPolicyForMeasuringInventories">Inventories</ix:nonNumeric></i></b></span></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-transform: uppercase"><b><i>&#160;</i></b></span></p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_140" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_139"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForMeasuringInventories-c0_cont_2" id="_DescriptionOfAccountingPolicyForMeasuringInventories-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Inventories are initially recognized at cost,
and subsequently at the lower of cost and net realizable value. Cost comprises merely purchase costs, as the inventory consists solely
of raw materials. Raw materials are not ordinarily interchangeable, and they are as such accounted for using the specific identification
of their individual cost.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_141" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_140"><ix:continuation id="_DescriptionOfAccountingPolicyForMeasuringInventories-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Company does not account for work in progress
and finished products.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>&#160;</b></p></ix:continuation></ix:continuation><div>

</div><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 122 --><div>
    </div><div style="border-bottom: Black 1.5pt solid; margin-top: 12pt; margin-bottom: 6pt"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->15<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>&#160;</b></p><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_142" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_141"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>2.14.
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_143" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_142"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForGovernmentGrants-c0_cont_2" id="_DescriptionOfAccountingPolicyForGovernmentGrants-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">A government grant is only recorded as a receivable
when (i) the grant has been approved by the granting party, (ii) the amounts are measurable, and (iii) the Company believes it will meet
the conditions necessary to be able to receive/use the grant.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_144" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_143"><ix:continuation id="_DescriptionOfAccountingPolicyForGovernmentGrants-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Government grants are recognized as other operating
income over the life of the grant as the required or planned activities are performed and the related costs are incurred, and when there
is reasonable assurance that the Company will comply with the conditions of the grant.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_145" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_144"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>2.15.
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_146" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_145"><ix:continuation id="_DescriptionOfAccountingPolicyForRestrictedCashAndCashEquivalentsExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Cash and cash equivalents are carried on the
consolidated statement of financial position at nominal value. For the purposes of the cash flow statements, cash and cash equivalents
comprise cash on hand, deposits held on call with banks, other short-term highly liquid investments and bank overdrafts. Bank overdrafts,
if any, are included in borrowings included in current liabilities.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_147" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_146"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>2.16.
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_148" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_147"><ix:continuation continuedAt="tmdx_DescriptionOfAccountingPolicyForTaxationtextBlock-c0_cont_2" id="tmdx_DescriptionOfAccountingPolicyForTaxationtextBlock-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Current tax assets and liabilities for the current
period are measured at the amount expected to be recovered from or paid to the taxation authorities. The tax rates and tax laws used
to compute the amount are those that are enacted or substantively enacted, at the reporting date.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_149" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_148"><ix:continuation continuedAt="tmdx_DescriptionOfAccountingPolicyForTaxationtextBlock-c0_cont_3" id="tmdx_DescriptionOfAccountingPolicyForTaxationtextBlock-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Deferred income tax is provided in full using
the &#8220;balance sheet liability method&#8221;, on temporary differences between the carrying amount of assets and liabilities for
financial reporting purposes and the amounts used for taxation purposes.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_150" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_149"><ix:continuation continuedAt="tmdx_DescriptionOfAccountingPolicyForTaxationtextBlock-c0_cont_4" id="tmdx_DescriptionOfAccountingPolicyForTaxationtextBlock-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Deferred tax liabilities are recognized for all
taxable differences. Deferred tax assets are recognized for all deductible temporary differences, carry forward of unused tax credits
and unused tax losses, to the extent that it is probable that taxable profit will be available against which the deductible temporary
differences, and the carry forward of unused tax credits and unused tax losses can be utilized.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_151" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_150"><ix:continuation continuedAt="tmdx_DescriptionOfAccountingPolicyForTaxationtextBlock-c0_cont_5" id="tmdx_DescriptionOfAccountingPolicyForTaxationtextBlock-c0_cont_4"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The carrying amount of deferred tax assets is
reviewed at each reporting date and reduced to the extent that it is no longer probable that sufficient taxable profit will be available
to allow all or part of the deferred tax asset to be utilized. Unrecognized deferred tax assets are reassessed at each reporting date
and are recognized to the extent that it has become probable that future taxable profits will allow the deferred tax asset to be recovered.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_152" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_151"><ix:continuation continuedAt="tmdx_DescriptionOfAccountingPolicyForTaxationtextBlock-c0_cont_6" id="tmdx_DescriptionOfAccountingPolicyForTaxationtextBlock-c0_cont_5"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Deferred tax assets and liabilities are measured
at the tax rates that are expected to apply in the year when the asset is realized or the liability is settled, based on tax rates (and
tax laws) that have been enacted or substantively enacted at the reporting date.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_153" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_152"><ix:continuation id="tmdx_DescriptionOfAccountingPolicyForTaxationtextBlock-c0_cont_6"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Deferred tax assets and deferred tax liabilities
are offset, if a legally enforceable right exists to set off current tax assets against current income tax liabilities and the deferred
taxes relate to the same taxable entity and the same taxation authority.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_154" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_153"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>2.17.
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_155" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_154"><ix:continuation id="tmdx_DescriptionOfAccountingPolicyForShareCapitalPolicyTextBlock-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Ordinary shares are classified as equity. Incremental
costs directly attributable to the issue of new shares or options are shown in equity as a deduction, net of tax, from the proceeds.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_156" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_155"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>2.18.
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_157" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_156"><ix:continuation continuedAt="tmdx_DescriptionOfAccountingPolicyForFinancialAssets-c0_cont_2" id="tmdx_DescriptionOfAccountingPolicyForFinancialAssets-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The financial assets consist mainly of trade
receivables and other current assets (deposits).</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_158" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_157"><ix:continuation continuedAt="tmdx_DescriptionOfAccountingPolicyForFinancialAssets-c0_cont_3" id="tmdx_DescriptionOfAccountingPolicyForFinancialAssets-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-decoration:underline">Classification and measurement on initial
recognition</span></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_159" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_158"><ix:continuation continuedAt="tmdx_DescriptionOfAccountingPolicyForFinancialAssets-c0_cont_4" id="tmdx_DescriptionOfAccountingPolicyForFinancialAssets-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The classification of financial assets at initial
recognition depends on the financial asset&#8217;s contractual cash flow characteristics and the Company&#8217;s business model for managing
them.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_160" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_159"><ix:continuation continuedAt="tmdx_DescriptionOfAccountingPolicyForFinancialAssets-c0_cont_5" id="tmdx_DescriptionOfAccountingPolicyForFinancialAssets-c0_cont_4"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The company initially measures a financial asset
at its fair value plus, in the case of a financial asset not at fair value through profit or loss, transaction costs.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_161" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_160"><ix:continuation continuedAt="tmdx_DescriptionOfAccountingPolicyForFinancialAssets-c0_cont_6" id="tmdx_DescriptionOfAccountingPolicyForFinancialAssets-c0_cont_5"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">For both trade receivables that do not contain a significant financing
component, and trade receivables for which the collection is expected in less than <ix:nonNumeric contextRef="c0" format="ixt-sec:durwordsen" name="tmdx:TradeReceivable">one year</ix:nonNumeric>, the Company has applied the simplified approach
to providing for expected credit losses (ECL) prescribed by IFRS 9, which requires the use of the lifetime expected loss provision for
all trade receivables.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 123 --><div>
    </div><div style="border-bottom: Black 1.5pt solid; margin-top: 12pt; margin-bottom: 6pt"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->16<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_162" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_161"><ix:continuation continuedAt="tmdx_DescriptionOfAccountingPolicyForFinancialAssets-c0_cont_7" id="tmdx_DescriptionOfAccountingPolicyForFinancialAssets-c0_cont_6"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Trade receivables do not carry any interest and
are recognized initially at fair value and subsequently measured at amortized cost using the effective interest method, less provision
for impairment based on expected credit losses, where applicable.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_163" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_162"><ix:continuation continuedAt="tmdx_DescriptionOfAccountingPolicyForFinancialAssets-c0_cont_8" id="tmdx_DescriptionOfAccountingPolicyForFinancialAssets-c0_cont_7"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-decoration:underline">Subsequent measurement</span></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_164" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_163"><ix:continuation id="tmdx_DescriptionOfAccountingPolicyForFinancialAssets-c0_cont_8"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">After initial recognition, trade receivables
and some other current assets as listed in Note 14 are measured at amortized cost using the effective interest method, less provision
for impairment based on expected credit losses.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_165" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_164"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>2.19.
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_166" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_165"><ix:continuation continuedAt="tmdx_DescriptionOfAccountingPolicyForFinancialLiabilitiesTextBlock-c0_cont_2" id="tmdx_DescriptionOfAccountingPolicyForFinancialLiabilitiesTextBlock-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The financial liabilities consist mainly of loans
and borrowings, lease liabilities, trade and other payables and other financial liabilities that include derivative financial liabilities
and contingent consideration related to business combinations.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_167" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_166"><ix:continuation continuedAt="tmdx_DescriptionOfAccountingPolicyForFinancialLiabilitiesTextBlock-c0_cont_3" id="tmdx_DescriptionOfAccountingPolicyForFinancialLiabilitiesTextBlock-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-decoration:underline">Measurement on initial recognition</span></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_168" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_167"><ix:continuation continuedAt="tmdx_DescriptionOfAccountingPolicyForFinancialLiabilitiesTextBlock-c0_cont_4" id="tmdx_DescriptionOfAccountingPolicyForFinancialLiabilitiesTextBlock-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">At initial recognition, financial liabilities
are measured at fair value less transaction costs unless the financial liability is carried at fair value through the statement of profit
or loss, in which case the transaction costs are immediately recognized in the statement of profit or loss. The best estimate of the
fair value at initial recognition is usually the transaction price, represented by the fair value of the consideration given or received
in exchange for the financial instrument. Any difference between the fair value estimated by the entity and the transaction price (&#8220;day
one gain or loss&#8221;) is recognized:</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_169" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_168"><ix:continuation continuedAt="tmdx_DescriptionOfAccountingPolicyForFinancialLiabilitiesTextBlock-c0_cont_5" id="tmdx_DescriptionOfAccountingPolicyForFinancialLiabilitiesTextBlock-c0_cont_4"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">in
                                            the statement of profit or loss if the estimate is evidenced by a quoted price in an active
                                            market; and</span></td></tr><tr style="vertical-align: top">
<td>&#160;</td><td>&#160;</td><td style="text-align: justify">&#160;</td></tr>
                                                                        </table></ix:continuation></ix:continuation><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_170" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_169"><ix:continuation continuedAt="tmdx_DescriptionOfAccountingPolicyForFinancialLiabilitiesTextBlock-c0_cont_6" id="tmdx_DescriptionOfAccountingPolicyForFinancialLiabilitiesTextBlock-c0_cont_5"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">deferred
                                            as an adjustment to the carrying amount of the financial instrument in all other cases. </span></td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_171" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_170"><ix:continuation continuedAt="tmdx_DescriptionOfAccountingPolicyForFinancialLiabilitiesTextBlock-c0_cont_7" id="tmdx_DescriptionOfAccountingPolicyForFinancialLiabilitiesTextBlock-c0_cont_6"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The fair value of the contingent consideration
payable at the date of acquisition is computed as the sum of the probability-weighted fair values of the purchase prices, as follows:</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_172" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_171"><ix:continuation continuedAt="tmdx_DescriptionOfAccountingPolicyForFinancialLiabilitiesTextBlock-c0_cont_8" id="tmdx_DescriptionOfAccountingPolicyForFinancialLiabilitiesTextBlock-c0_cont_7"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif"><b>GPS</b>:
                                            the liability recognized reflects a probability-weighted estimate at the current net present
                                            value at the date of acquisition, which is expected to become payable.</span></td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_173" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_172"><ix:continuation continuedAt="tmdx_DescriptionOfAccountingPolicyForFinancialLiabilitiesTextBlock-c0_cont_9" id="tmdx_DescriptionOfAccountingPolicyForFinancialLiabilitiesTextBlock-c0_cont_8"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif"><b>Noviogendix</b>:
                                            each of the potential product development paths. The fair value of each path is in turn computed
                                            as the sum of the survival probability discounted to present values of the contingent payments
                                            in each such path, including the milestone and commercialization payments. Any other financial
                                            liability included in the consideration payable for a business combination is recorded at
                                            fair value at the date of acquisition. </span></td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_174" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_173"><ix:continuation continuedAt="tmdx_DescriptionOfAccountingPolicyForFinancialLiabilitiesTextBlock-c0_cont_10" id="tmdx_DescriptionOfAccountingPolicyForFinancialLiabilitiesTextBlock-c0_cont_9"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The derivative financial instrument related to
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for a period up to August 2, 2025, is accounted for at fair value with a portion of the transaction costs allocated to the embedded derivative
being expensed as incurred. The embedded derivative will be measured as an American call option using a binomial tree option pricing
model with changes to fair value being recorded in the statement of profit or loss under Financial expenses, net, as described further
in Note 16.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_175" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_174"><ix:continuation continuedAt="tmdx_DescriptionOfAccountingPolicyForFinancialLiabilitiesTextBlock-c0_cont_11" id="tmdx_DescriptionOfAccountingPolicyForFinancialLiabilitiesTextBlock-c0_cont_10"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The derivative financial instrument related to
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each of the possible outcomes further described in Note 16.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_176" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_175"><ix:continuation continuedAt="tmdx_DescriptionOfAccountingPolicyForFinancialLiabilitiesTextBlock-c0_cont_12" id="tmdx_DescriptionOfAccountingPolicyForFinancialLiabilitiesTextBlock-c0_cont_11"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="text-decoration:underline">Subsequent measurement</span></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_177" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_176"><ix:continuation id="tmdx_DescriptionOfAccountingPolicyForFinancialLiabilitiesTextBlock-c0_cont_12"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">After initial recognition, loans and borrowings,
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and derivative financial liabilities are measured at fair value are reviewed at each reporting period, with any changes in fair value
recorded in the statement of profit and loss.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_178" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_177"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>2.20.
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_179" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_178"><ix:continuation id="tmdx_DescriptionOfAccountingPolicyForRetirementBenefitSchemesAndEmployeeSavingsSchemesTextBlock-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Payments to defined contribution employee savings
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With respect to Belgian pension plans and as explained in Note 23, the Company has considered the potential impact of the employer&#8217;s
legal obligation to guarantee a minimum return on the Belgian pension plans and that this was assessed not to be significant.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_180" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_179"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>2.21.
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_181" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_180"><ix:continuation continuedAt="tmdx_DescriptionOfAccountingPolicyForSharesBasedCompensationPlansForPersonnelDirectorsAndBusinessAssociatesTextBlock-c0_cont_2" id="tmdx_DescriptionOfAccountingPolicyForSharesBasedCompensationPlansForPersonnelDirectorsAndBusinessAssociatesTextBlock-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Company grants stock options in accordance
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The cost of the services rendered is measured at the fair value of the granted options and recognized as an expense in the statement
of profit or loss. The corresponding credit is recorded directly into equity.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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equity.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>&#160;</i></b></p><div>

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</div><div>

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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfContingentLiabilitiesInBusinessCombinationExplanatory-c0_cont_3" id="_DisclosureOfContingentLiabilitiesInBusinessCombinationExplanatory-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On August 2, 2022, the Company announced it has
entered into an agreement with Genomic Health, Inc., a subsidiary of Exact Sciences Corporation (&#8220;Exact Sciences&#8221;), to acquire
the GPS test from Exact Sciences. MDxHealth acquired GPS in order to expand its menu of tests targeted into urology and prostate cancer
and in order to position the Company as one of the leaders in the urology and prostate cancer space with one of the most comprehensive
menus of precision diagnostics.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfContingentLiabilitiesInBusinessCombinationExplanatory-c0_cont_4" id="_DisclosureOfContingentLiabilitiesInBusinessCombinationExplanatory-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Under the terms of the agreement, the Company
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equal to a portion of the annual revenues attributable to the GPS prostate cancer business for the preceding fiscal year; provided, in
each instance, that such revenues exceed certain minimum revenue milestones for such fiscal year.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

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can be settled in cash or through the issuance of additional ADSs of the Company (valued in function of a volume weighted average trading
price of the Company&#8217;s shares at the end of the relevant earn-out period) to Exact Sciences, provided that the aggregate number of shares
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</div><div>

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method of accounting and is being treated as a business combination in accordance with IFRS given that there are inputs from the intellectual
property and customers acquired, a substantive process, consisting of a workforce that was hired from Exact Sciences, which allows the
Company to generate outputs as from day 1 of the acquisition. The purchase price was allocated based on the estimated fair value of net
assets acquired and liabilities assumed at the date of the acquisition.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfContingentLiabilitiesInBusinessCombinationExplanatory-c0_cont_8" id="_DisclosureOfContingentLiabilitiesInBusinessCombinationExplanatory-c0_cont_7"><ix:nonNumeric contextRef="c0" escape="true" name="tmdx:DisclosureOfAcquisitionConsiderationtable"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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</div><div>

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</div><div>

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</div><div>

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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfContingentLiabilitiesInBusinessCombinationExplanatory-c0_cont_12" id="_DisclosureOfContingentLiabilitiesInBusinessCombinationExplanatory-c0_cont_11"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">We have performed a fair value analysis of the business combination,
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfContingentLiabilitiesInBusinessCombinationExplanatory-c0_cont_13" id="_DisclosureOfContingentLiabilitiesInBusinessCombinationExplanatory-c0_cont_12"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The accounting for the business combination resulted
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</div><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfContingentLiabilitiesInBusinessCombinationExplanatory-c0_cont_15" id="_DisclosureOfContingentLiabilitiesInBusinessCombinationExplanatory-c0_cont_14"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The net deferred tax asset resulting from this
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</div><div>

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</div><div>

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</div><div>

</div><ix:continuation id="_DisclosureOfContingentLiabilitiesInBusinessCombinationExplanatory-c0_cont_17"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Company financed the acquisition in part through a $<ix:nonFraction contextRef="c2" decimals="-6" format="ixt:num-dot-decimal" name="ifrs-full:LoansAndReceivables" scale="6" unitRef="usd">35</ix:nonFraction> million
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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</div><div>

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</div><div>

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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfProductsAndServicesExplanatory-c0_cont_4" id="_DisclosureOfProductsAndServicesExplanatory-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Revenues related to services are recognized at
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</div><div>

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</div><div>

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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfProductsAndServicesExplanatory-c0_cont_7" id="_DisclosureOfProductsAndServicesExplanatory-c0_cont_6"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><i><span style="text-decoration:underline">Medicare</span></i></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfProductsAndServicesExplanatory-c0_cont_8" id="_DisclosureOfProductsAndServicesExplanatory-c0_cont_7"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Reimbursement for diagnostic tests furnished to Medicare beneficiaries
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(&#8220;CMS&#8221;), a division of the U.S. Department of Health and Human Services (&#8220;HHS&#8221;). As a Medicare-enrolled service
provider, the Company bills the regional Medicare Administrative Contractor (&#8220;MAC&#8221;) for CMS that covers the region where the
testing service is performed by the Company. The Confirm mdx test obtained a positive Medicare local coverage determination (&#8220;LCD&#8221;)
in 2014, and the GPS test obtained a positive Medicare coverage LCD in 2015, each of which provides coverage for Medicare patients throughout
the United States.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfProductsAndServicesExplanatory-c0_cont_9" id="_DisclosureOfProductsAndServicesExplanatory-c0_cont_8"><p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0">In July 2022, a foundational LCD covering the indication for the Select
mdx test became effective under the Molecular Diagnostic Services Program (&#8220;MolDX&#8221;), administered by Palmetto GBA, which handles
technical assessments for U.S. laboratories that perform molecular diagnostic testing. Under the foundational LCD process recently implemented
by MolDX, all tests within an LCD-covered indication must submit a technical assessment (&#8220;TA&#8221;) for review and consideration.
A technical assessment requesting coverage for Select mdx has been submitted and the Company is engaged in an interactive review process
with MolDX. Based on the Company&#8217;s most recent communications with MolDX, a final coverage decision is not expected until mid-year
2023. A final determination with respect to Medicare coverage and reimbursement of the Select mdx test therefore remains pending, and
there can be no assurance that such coverage and reimbursement will be granted or, if granted, that it will be maintained.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfProductsAndServicesExplanatory-c0_cont_10" id="_DisclosureOfProductsAndServicesExplanatory-c0_cont_9"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In 2022, Medicare represented the only payer generating over <ix:nonFraction contextRef="c0" decimals="2" format="ixt:num-dot-decimal" name="tmdx:CustomerGeneratingOver" scale="-2" unitRef="pure">10</ix:nonFraction>% of
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfProductsAndServicesExplanatory-c0_cont_11" id="_DisclosureOfProductsAndServicesExplanatory-c0_cont_10"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">At the end of 2022, <ix:nonNumeric contextRef="c0" name="tmdx:ConcludedAgreementsDescription">the Company had concluded
agreements with 129 commercial payors for Confirm mdx (2021: 119; 2020: 107) and 62 commercial payors for Select mdx (2021: 54; 2020:
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</div><div>

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</div><ix:continuation continuedAt="_DisclosureOfProductsAndServicesExplanatory-c0_cont_12" id="_DisclosureOfProductsAndServicesExplanatory-c0_cont_11"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>Segment revenue</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfProductsAndServicesExplanatory-c0_cont_13" id="_DisclosureOfProductsAndServicesExplanatory-c0_cont_12"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Company does not distinguish different business
segments since most revenues are generated from clinical laboratory service testing, or the out-licensing of the Company&#8217;s patented
DNA methylation platform and biomarkers. However, the Company does distinguish different geographical operating segments based on revenue
since the revenues are generated both in United States of America and Europe.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfProductsAndServicesExplanatory-c0_cont_14" id="_DisclosureOfProductsAndServicesExplanatory-c0_cont_13"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In 2022, <ix:nonNumeric contextRef="c0" name="tmdx:SegmentRevenueDescription">the Company earned 99.8% (2021: 98.6%;
2020: 97.9%) of its revenue from external customers from its clinical laboratory testing services and out-licensing of intellectual property.
In 2022, the clinical laboratory testing in the U.S. CLIA laboratory represented 99% of the Company&#8217;s revenue (2021: 97%; 2020:
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfProductsAndServicesExplanatory-c0_cont_15" id="_DisclosureOfProductsAndServicesExplanatory-c0_cont_14"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The amount of its revenue from external customers
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfProductsAndServicesExplanatory-c0_cont_16" id="_DisclosureOfProductsAndServicesExplanatory-c0_cont_15"><ix:nonNumeric contextRef="c0" escape="true" name="ifrs-full:DisclosureOfOperatingSegmentsExplanatory"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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  <tr style="vertical-align: bottom; ">
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfProductsAndServicesExplanatory-c0_cont_17" id="_DisclosureOfProductsAndServicesExplanatory-c0_cont_16"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">At the end of 2022, <ix:nonFraction contextRef="c0" decimals="2" format="ixt:num-dot-decimal" name="tmdx:NoncurrentAsset" scale="-2" unitRef="pure">93</ix:nonFraction>% of the non-current assets
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfProductsAndServicesExplanatory-c0_cont_18" id="_DisclosureOfProductsAndServicesExplanatory-c0_cont_17"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>Cost
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfProductsAndServicesExplanatory-c0_cont_19" id="_DisclosureOfProductsAndServicesExplanatory-c0_cont_18"><ix:nonNumeric contextRef="c0" escape="true" name="tmdx:ScheduleOfCostOfGoodsServicesSoldTableTextBlock"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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</div><div>

</div><ix:continuation id="_DisclosureOfProductsAndServicesExplanatory-c0_cont_19"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The costs of goods &amp; services sold include
the costs associated with providing testing services to third parties and include the cost of materials, labor (including salaries, bonuses,
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include depreciation of laboratory equipment, facility occupancy and information technology costs. Costs associated with processing samples
are expensed when incurred, regardless of the timing of revenue recognition.</p></ix:continuation><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:nonNumeric contextRef="c0" continuedAt="_DisclosureOfExpensesByNatureExplanatory-c0_cont_1" escape="true" name="ifrs-full:DisclosureOfExpensesByNatureExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>NOTE 5: Nature of expenses</i></b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-transform: uppercase"><b>&#160;</b></span></p></ix:nonNumeric><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfExpensesByNatureExplanatory-c0_cont_2" id="_DisclosureOfExpensesByNatureExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>Research
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfExpensesByNatureExplanatory-c0_cont_3" id="_DisclosureOfExpensesByNatureExplanatory-c0_cont_2"><ix:nonNumeric contextRef="c0" escape="true" name="tmdx:ScheduleOfResearchAndDevelopmentExpensesTableTextBlock"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfExpensesByNatureExplanatory-c0_cont_4" id="_DisclosureOfExpensesByNatureExplanatory-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Research and development expenses consist of
costs incurred for the development and improvement of our products. These expenses consist primarily of labor costs (including salaries,
bonuses, benefits, and stock-based compensation), reagents and supplies, clinical studies, outside services, patent expenses, depreciation
of laboratory equipment, facility occupancy and information technology costs. Research and development expenses also include costs associated
with assay improvements and automation workflow for our current suite of products. The Company expenses its research and development
expenses in the period in which they are incurred, except for those development expenses that qualify for capitalization (refer to Note
11).</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>&#160;</i></b></span></p><div>

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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfExpensesByNatureExplanatory-c0_cont_6" id="_DisclosureOfExpensesByNatureExplanatory-c0_cont_5"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">A change in presentation for clinical validation
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</div><div>

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</div><div>

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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfExpensesByNatureExplanatory-c0_cont_9" id="_DisclosureOfExpensesByNatureExplanatory-c0_cont_8"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Company&#8217;s sales and marketing expenses
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfExpensesByNatureExplanatory-c0_cont_10" id="_DisclosureOfExpensesByNatureExplanatory-c0_cont_9"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">For the year ended December 31, 2022, selling
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfExpensesByNatureExplanatory-c0_cont_11" id="_DisclosureOfExpensesByNatureExplanatory-c0_cont_10"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">For the year ended December 31, 2021, selling
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</div><div>

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</div><div>

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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding-bottom: 1.5pt; text-align: left">Other expenses</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="padding-bottom: 1.5pt; text-align: left">&#160;</td><td style="padding-bottom: 1.5pt; text-align: right">&#160;</td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom; ">
    <td style="padding-bottom: 4pt; font-weight: bold; text-align: left">Total general and administrative expenses</td><td style="padding-bottom: 4pt">&#160;</td>
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  </table></ix:nonNumeric></ix:continuation><div>

</div><ix:continuation continuedAt="_DisclosureOfExpensesByNatureExplanatory-c0_cont_14" id="_DisclosureOfExpensesByNatureExplanatory-c0_cont_13"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><br/>
General and administrative expenses include costs for certain executives, accounting and finance, legal, revenue cycle management, information
technology, human resources, and administrative functions. These expenses consist primarily of labor costs (including salaries, bonuses,
benefits, and stock-based compensation), professional service fees such as consulting, accounting, legal, general corporate costs, and
public-company costs associated with the Company&#8217;s listing, as well as allocated overhead costs (rent, utilities, insurance, etc.).</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfExpensesByNatureExplanatory-c0_cont_15" id="_DisclosureOfExpensesByNatureExplanatory-c0_cont_14"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">General and administrative expenses increased
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with the remaining $<ix:nonFraction contextRef="c74" decimals="-5" format="ixt:num-dot-decimal" name="ifrs-full:ProfessionalFeesExpense" scale="6" unitRef="usd">5.7</ix:nonFraction> million increase primarily related to higher insurance, professional fees and public company expenses.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation id="_DisclosureOfExpensesByNatureExplanatory-c0_cont_15"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">General and administrative expense increased
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with our U.S. listing on the Nasdaq Stock Market.</p></ix:continuation><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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    </div><div style="border-bottom: Black 1.5pt solid; margin-top: 12pt; margin-bottom: 6pt"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->21<!-- Field: /Sequence --></p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:nonNumeric contextRef="c0" continuedAt="_DisclosureOfFinanceIncomeExpenseExplanatory-c0_cont_1" escape="true" name="ifrs-full:DisclosureOfFinanceIncomeExpenseExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>NOTE 6: Personnel costs</i></b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:nonNumeric><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinanceIncomeExpenseExplanatory-c0_cont_2" id="_DisclosureOfFinanceIncomeExpenseExplanatory-c0_cont_1"><ix:nonNumeric contextRef="c0" escape="true" name="tmdx:ScheduleOfPersonnelCostsTableTextBlock"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <tr style="vertical-align: bottom">
    <td style="border-bottom: Black 1.5pt solid; font-weight: bold; font-style: italic; font-variant: small-caps">Thousands of $<br/> For the years ended December 31</td><td style="padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom">
    <td>The number of employees at the end of the year was:</td><td>&#160;</td>
    <td colspan="2">&#160;</td><td>&#160;</td><td>&#160;</td>
    <td colspan="2">&#160;</td><td>&#160;</td><td>&#160;</td>
    <td colspan="2" style="text-align: right">&#160;</td><td>&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="width: 64%; text-align: left">Laboratory operations</td><td style="width: 1%">&#160;</td>
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  <tr style="vertical-align: bottom; ">
    <td style="text-align: left">R&amp;D staff</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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</div><div>

</div><ix:continuation id="_DisclosureOfFinanceIncomeExpenseExplanatory-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0">The personnel numbers in the table reflect year-end numbers, with 42 sales and marketing employees hired in August 2022 as part of the
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>&#160;</i></p><div>

</div><ix:nonNumeric contextRef="c0" continuedAt="_DisclosureOfOtherOperatingIncomeExpenseExplanatory-c0_cont_1" escape="true" name="ifrs-full:DisclosureOfOtherOperatingIncomeExpenseExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>NOTE 7: Other operating income, net</i></b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>&#160;</i></p></ix:nonNumeric><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfOtherOperatingIncomeExpenseExplanatory-c0_cont_2" id="_DisclosureOfOtherOperatingIncomeExpenseExplanatory-c0_cont_1"><ix:nonNumeric contextRef="c0" continuedAt="tmdx_ScheduleOfOtherOperatingIncomeExpensesNetTextBlock-c0_cont_1" escape="true" name="tmdx:ScheduleOfOtherOperatingIncomeExpensesNetTextBlock"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfOtherOperatingIncomeExpenseExplanatory-c0_cont_3" id="_DisclosureOfOtherOperatingIncomeExpenseExplanatory-c0_cont_2"><ix:continuation id="tmdx_ScheduleOfOtherOperatingIncomeExpensesNetTextBlock-c0_cont_1"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%"> <tr style="vertical-align: top"> <td style="width: 24px; text-underline-color: #000000"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">1)</span></td> <td style="text-align: justify; text-underline-color: #000000"><ix:footnote id="ix_0_footnote" xml:lang="en-US"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>2020 grant income of $<ix:nonFraction contextRef="c75" decimals="0" format="ixt:num-dot-decimal" name="tmdx:GrantIncome" scale="0" unitRef="usd">88,000</ix:nonFraction> is classified under &#8220;Royalties and other revenues&#8221;</i></span></ix:footnote></td></tr> </table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>
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</div><div>

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</div><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b><i>&#160;</i></b></p><div>

</div><ix:nonNumeric contextRef="c0" continuedAt="_DisclosureOfFinanceIncomeExplanatory-c0_cont_1" escape="true" name="ifrs-full:DisclosureOfFinanceIncomeExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>NOTE 8: Finance expenses, net</i></b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:nonNumeric><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinanceIncomeExplanatory-c0_cont_2" id="_DisclosureOfFinanceIncomeExplanatory-c0_cont_1"><ix:nonNumeric contextRef="c0" escape="true" name="tmdx:ScheduleOfFinanceIncomeExpensesTableTextBlock"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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</div><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-transform: uppercase"><b>&#160;</b></span>&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 129 --><div>
    </div><div style="border-bottom: Black 1.5pt solid; margin-top: 12pt; margin-bottom: 6pt"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->22<!-- Field: /Sequence --></p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:continuation continuedAt="_DisclosureOfFinanceIncomeExplanatory-c0_cont_3" id="_DisclosureOfFinanceIncomeExplanatory-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">For the year ended December 31, 2022, financial expenses, net, were primarily comprised of fair value adjustments for the GPS contingent
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for the loan facility with Kreos Capital (as further detailed in Note 16), and interest charges of $<ix:nonFraction contextRef="c0" decimals="-5" format="ixt:num-dot-decimal" name="tmdx:InterestChargesAndExtinguishmentExpenses" scale="6" unitRef="usd">1.6</ix:nonFraction> million related to the Innovatus
debt facility.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation id="_DisclosureOfFinanceIncomeExplanatory-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Other financial expenses relate to bank costs
incurred during the year.</p></ix:continuation><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:nonNumeric contextRef="c0" continuedAt="_DisclosureOfIncomeTaxExplanatory-c0_cont_1" escape="true" name="ifrs-full:DisclosureOfIncomeTaxExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>NOTE 9: Income Tax</i></b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:nonNumeric><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfIncomeTaxExplanatory-c0_cont_2" id="_DisclosureOfIncomeTaxExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">No income taxes were payable in view of the losses
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million) at a tax rate of <ix:nonFraction contextRef="c0" decimals="2" format="ixt:num-dot-decimal" name="ifrs-full:ApplicableTaxRate" scale="-2" unitRef="pure">25</ix:nonFraction>%.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfIncomeTaxExplanatory-c0_cont_3" id="_DisclosureOfIncomeTaxExplanatory-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The tax losses related to MDxHealth SA in Belgium
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a period of 6 years. As of 2022, tax losses related to MDxHealth BV in the Netherlands are available for carry forward indefinitely.
The tax losses of MDxHealth Inc., related to the years beginning on or after January 1, 2018, are available for carry forward indefinitely.
Tax losses related to the years before January 1, 2018, can be carried forward to a period of 20 years.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfIncomeTaxExplanatory-c0_cont_4" id="_DisclosureOfIncomeTaxExplanatory-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">The Company has no notional interest deduction to offset future taxable
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfIncomeTaxExplanatory-c0_cont_5" id="_DisclosureOfIncomeTaxExplanatory-c0_cont_4"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Tax credits (investment deductions) amounted to $<ix:nonFraction contextRef="c0" decimals="0" format="ixt:num-dot-decimal" name="ifrs-full:IncomeTaxRelatingToChangesInFairValueOfFinancialLiabilityAttributableToChangeInCreditRiskOfLiabilityOfOtherComprehensiveIncome" scale="0" unitRef="usd">402,000</ix:nonFraction> in 2022,
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfIncomeTaxExplanatory-c0_cont_6" id="_DisclosureOfIncomeTaxExplanatory-c0_cont_5"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">It is uncertain if the Company will have taxable
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in 2022, 2021, and 2020. The tax reconciliation and the impact of the unrecognized deferred tax assets is as follows:</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>&#160;</i></b></span></p></ix:continuation><div>

</div><div>

</div><ix:continuation id="_DisclosureOfIncomeTaxExplanatory-c0_cont_6"><ix:nonNumeric contextRef="c0" escape="true" name="tmdx:ScheduleOfTaxReconciliationAndImpactOfUnrecognizedDeferredTaxAssetsTableTextBlock"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:nonNumeric contextRef="c0" continuedAt="_DisclosureOfGoodwillExplanatory-c0_cont_1" escape="true" name="ifrs-full:DisclosureOfGoodwillExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>NOTE 10: Goodwill</i></b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:nonNumeric><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfGoodwillExplanatory-c0_cont_2" id="_DisclosureOfGoodwillExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On August 2, 2022, the Company acquired the GPS
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfGoodwillExplanatory-c0_cont_3" id="_DisclosureOfGoodwillExplanatory-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Company is required to test Goodwill for
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfGoodwillExplanatory-c0_cont_4" id="_DisclosureOfGoodwillExplanatory-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The company monitors its Goodwill at the consolidated
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</div><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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</div><p style="font: 8pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:continuation continuedAt="_DisclosureOfGoodwillExplanatory-c0_cont_5" id="_DisclosureOfGoodwillExplanatory-c0_cont_4"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The amount by which the CGU&#8217;s recoverable
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfGoodwillExplanatory-c0_cont_6" id="_DisclosureOfGoodwillExplanatory-c0_cont_5"><ix:nonNumeric contextRef="c0" escape="true" name="ifrs-full:DisclosureOfDetailedInformationAboutIntangibleAssetsExplanatory"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfGoodwillExplanatory-c0_cont_7" id="_DisclosureOfGoodwillExplanatory-c0_cont_6"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The assumptions used are as follows:</p><p style="font: 8pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfGoodwillExplanatory-c0_cont_8" id="_DisclosureOfGoodwillExplanatory-c0_cont_7"><ix:nonNumeric contextRef="c0" escape="true" name="ifrs-full:DisclosureOfSensitivityAnalysisForActuarialAssumptionsExplanatory"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfGoodwillExplanatory-c0_cont_9" id="_DisclosureOfGoodwillExplanatory-c0_cont_8"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The discount rate is based on comparable companies
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfGoodwillExplanatory-c0_cont_10" id="_DisclosureOfGoodwillExplanatory-c0_cont_9"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Company&#8217;s impairment review is sensitive
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfGoodwillExplanatory-c0_cont_11" id="_DisclosureOfGoodwillExplanatory-c0_cont_10"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">An increase of <ix:nonFraction contextRef="c2" decimals="2" format="ixt:num-dot-decimal" name="ifrs-full:PercentageOfReasonablyPossibleIncreaseInUnobservableInputAssets" scale="-2" unitRef="pure">1</ix:nonFraction>% in the discount rate would cause
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the recoverable amount.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation id="_DisclosureOfGoodwillExplanatory-c0_cont_11"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Based on the above information, management concluded
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</div><p style="font: 8pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:nonNumeric contextRef="c0" continuedAt="_DisclosureOfIntangibleAssetsExplanatory-c0_cont_1" escape="true" name="ifrs-full:DisclosureOfIntangibleAssetsExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>NOTE 11: Intangible assets</i></b></p><p style="font: 8pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>&#160;</i></b></p></ix:nonNumeric><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfIntangibleAssetsExplanatory-c0_cont_2" id="_DisclosureOfIntangibleAssetsExplanatory-c0_cont_1"><ix:nonNumeric contextRef="c0" escape="true" name="ifrs-full:DisclosureOfDetailedInformationAboutPropertyPlantAndEquipmentExplanatory"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <tr style="vertical-align: bottom">
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    <td style="text-align: center; vertical-align: bottom"><span style="font-family: Times New Roman, Times, Serif; font-variant: small-caps"><b><i>&#160;</i></b></span></td>
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    <td style="text-align: center; font-weight: bold; font-style: italic; font-variant: small-caps; vertical-align: bottom"><span style="font-family: Times New Roman, Times, Serif; font-variant: small-caps"><b><i>&#160;</i></b></span></td>
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    <td style="text-align: center; vertical-align: bottom"><span style="font-family: Times New Roman, Times, Serif; font-variant: small-caps"><b><i>&#160;</i></b></span></td>
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    <td style="text-align: center; vertical-align: bottom"><span style="font-family: Times New Roman, Times, Serif; font-variant: small-caps"><b><i>&#160;</i></b></span></td>
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    <td colspan="2">&#160;</td>
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    <td style="padding-bottom: 1.5pt">&#160;</td>
    <td colspan="2">&#160;</td>
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    <td style="padding-bottom: 1.5pt">&#160;</td>
    <td colspan="2">&#160;</td>
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    <td style="padding-bottom: 1.5pt">&#160;</td>
    <td colspan="2">&#160;</td>
    <td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="padding-bottom: 1.5pt">&#160;</td>
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    <td style="border-bottom: Black 1.5pt solid; width: 1%; font-weight: bold; text-align: left">&#160;</td>
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    <td style="width: 1%; padding-bottom: 1.5pt; font-weight: bold; text-align: left">&#160;</td>
    <td style="width: 1%; font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; width: 1%; font-weight: bold; text-align: left">&#160;</td>
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    <td style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: left">&#160;</td>
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    <td style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: left">&#160;</td>
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    <td style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: left">&#160;</td>
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    <td style="font-weight: bold">&#160;</td>
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    <td>&#160;</td>
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    <td>&#160;</td>
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    <td style="text-align: right">&#160;</td>
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    <td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
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    <td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
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    <td style="padding-left: 0.125in; text-indent: -0.125in; text-align: left; vertical-align: top">&#160;</td>
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    <td style="text-align: left">&#160;</td>
    <td style="text-align: right">&#160;</td>
    <td style="text-align: left">&#160;</td>
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    <td style="text-align: left">&#160;</td>
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    <td style="text-align: right">&#160;</td>
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    <td style="text-align: left">&#160;</td>
    <td style="text-align: right">&#160;</td>
    <td style="text-align: left">&#160;</td>
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  <tr style="vertical-align: bottom; ">
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    <td style="padding-bottom: 1.5pt; text-align: left">&#160;</td>
    <td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: right"><div style="-sec-ix-hidden: hidden-fact-46">&#160;</div></td>
    <td style="padding-bottom: 1.5pt; text-align: left">&#160;</td>
    <td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: right"><div style="-sec-ix-hidden: hidden-fact-47">&#160;</div></td>
    <td style="padding-bottom: 1.5pt; text-align: left">&#160;</td>
    <td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: right"><div style="-sec-ix-hidden: hidden-fact-48">&#160;</div></td>
    <td style="padding-bottom: 1.5pt; text-align: left">&#160;</td>
    <td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: right"><div style="-sec-ix-hidden: hidden-fact-49">&#160;</div></td>
    <td style="padding-bottom: 1.5pt; text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: left">&#160;</td>
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    <td style="padding-bottom: 1.5pt; font-weight: bold; text-align: left">&#160;</td>
    <td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: left">&#160;</td>
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    <td style="padding-bottom: 1.5pt; font-weight: bold; text-align: left">&#160;</td>
    <td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: left">&#160;</td>
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    <td style="padding-bottom: 1.5pt; font-weight: bold; text-align: left">&#160;</td>
    <td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: left">&#160;</td>
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    <td style="padding-bottom: 1.5pt; font-weight: bold; text-align: left">&#160;</td>
    <td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: left">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: right"><ix:nonFraction contextRef="c2" decimals="-3" format="ixt:num-dot-decimal" name="tmdx:GrossValueEndingBalance" scale="3" unitRef="usd">64,888</ix:nonFraction></td>
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    <td style="font-weight: bold">&#160;</td>
    <td style="font-weight: bold; text-align: left">&#160;</td>
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    <td style="font-weight: bold">&#160;</td>
    <td style="font-weight: bold; text-align: left">&#160;</td>
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    <td style="font-weight: bold; text-align: left">&#160;</td>
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    <td style="font-weight: bold; text-align: left">&#160;</td>
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    <td style="font-weight: bold">&#160;</td>
    <td style="font-weight: bold; text-align: left">&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td>&#160;</td>
    <td style="text-align: left">&#160;</td>
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    <td style="text-align: left">&#160;</td>
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    <td>&#160;</td>
    <td style="text-align: left">&#160;</td>
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    <td>&#160;</td>
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    <td style="text-align: right">&#160;</td>
    <td style="text-align: left">&#160;</td>
    <td>&#160;</td>
    <td style="text-align: left">&#160;</td>
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    <td>&#160;</td>
    <td style="text-align: left">&#160;</td>
    <td style="text-align: right">&#160;</td>
    <td style="text-align: left">&#160;</td>
    <td>&#160;</td>
    <td style="text-align: left">&#160;</td>
    <td style="text-align: right">&#160;</td>
    <td style="text-align: left">&#160;</td>
    <td>&#160;</td>
    <td style="text-align: left">&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td>&#160;</td>
    <td style="text-align: left">&#160;</td>
    <td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-51">&#160;</div></td>
    <td style="text-align: left">&#160;</td>
    <td>&#160;</td>
    <td style="text-align: left">&#160;</td>
    <td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-52">&#160;</div></td>
    <td style="text-align: left">&#160;</td>
    <td>&#160;</td>
    <td style="text-align: left">&#160;</td>
    <td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-53">&#160;</div></td>
    <td style="text-align: left">&#160;</td>
    <td>&#160;</td>
    <td style="text-align: left">&#160;</td>
    <td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-54">&#160;</div></td>
    <td style="text-align: left">&#160;</td>
    <td>&#160;</td>
    <td style="text-align: left">&#160;</td>
    <td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-55">&#160;</div></td>
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    <td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: left">&#160;</td>
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    <td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: left">&#160;</td>
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    <td style="padding-bottom: 1.5pt; font-weight: bold; text-align: left">)</td>
    <td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: left">&#160;</td>
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    <td style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: left">&#160;</td>
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    <td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: left">&#160;</td>
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  </table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></p></ix:nonNumeric></ix:continuation><div>


</div><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></p><div>

</div><!-- Field: Page; Sequence: 131 --><div>
    </div><div style="border-bottom: Black 1.5pt solid; margin-top: 12pt; margin-bottom: 6pt"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->24<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><ix:continuation continuedAt="_DisclosureOfIntangibleAssetsExplanatory-c0_cont_3" id="_DisclosureOfIntangibleAssetsExplanatory-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0">Amortization of intangible assets is
included in research &amp; development expenses and in selling and marketing expenses in the statement of profit and loss.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfIntangibleAssetsExplanatory-c0_cont_4" id="_DisclosureOfIntangibleAssetsExplanatory-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The externally acquired intangible asset includes
technology acquired in the business combination with NovioGendix in 2015 and with the acquisition of the GPS test in August 2022, and
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfIntangibleAssetsExplanatory-c0_cont_5" id="_DisclosureOfIntangibleAssetsExplanatory-c0_cont_4"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Customer relationships includes customers acquired
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</div><div>

</div><ix:continuation id="_DisclosureOfIntangibleAssetsExplanatory-c0_cont_5"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The internally-developed intangible assets relate
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assay in-house and our Resolve mdx assay. The estimated remaining amortization period amounts to <ix:nonNumeric contextRef="c103" format="ixt-sec:duryear" name="ifrs-full:UsefulLifeMeasuredAsPeriodOfTimeIntangibleAssetsOtherThanGoodwill">1.2</ix:nonNumeric> years for Confirm mdx and Select
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Resolve mdx development expenses.</p></ix:continuation><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:nonNumeric contextRef="c0" continuedAt="_DisclosureOfPropertyPlantAndEquipmentExplanatory-c0_cont_1" escape="true" name="ifrs-full:DisclosureOfPropertyPlantAndEquipmentExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b><i>NOTE 12: Property, plant and equipment and right of-use assets</i></b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:nonNumeric><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfPropertyPlantAndEquipmentExplanatory-c0_cont_2" id="_DisclosureOfPropertyPlantAndEquipmentExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="text-decoration:underline">Property, plant and equipment</span></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>&#160;</i></p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfPropertyPlantAndEquipmentExplanatory-c0_cont_3" id="_DisclosureOfPropertyPlantAndEquipmentExplanatory-c0_cont_2"><ix:nonNumeric contextRef="c0" escape="true" name="tmdx:ScheduleOfAdditionalRightOfUseAssetsTableTextBlock"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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    <td style="padding-left: 0.125in; text-indent: -0.125in; font-weight: bold">&#160;</td><td style="font-weight: bold">&#160;</td>
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    <td style="font-weight: bold; text-align: left">&#160;</td><td style="font-weight: bold; text-align: right">&#160;</td><td style="font-weight: bold; text-align: left">&#160;</td><td style="font-weight: bold">&#160;</td>
    <td style="font-weight: bold; text-align: left">&#160;</td><td style="font-weight: bold; text-align: right">&#160;</td><td style="font-weight: bold; text-align: left">&#160;</td><td style="font-weight: bold">&#160;</td>
    <td style="font-weight: bold; text-align: left">&#160;</td><td style="font-weight: bold; text-align: right">&#160;</td><td style="font-weight: bold; text-align: left">&#160;</td><td style="font-weight: bold">&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfPropertyPlantAndEquipmentExplanatory-c0_cont_4" id="_DisclosureOfPropertyPlantAndEquipmentExplanatory-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">During 2022, the Company acquired $<ix:nonFraction contextRef="c0" decimals="-2" format="ixt:num-dot-decimal" name="ifrs-full:DepreciationPropertyPlantAndEquipment" scale="3" unitRef="usd">1.7</ix:nonFraction> million
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</div><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

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</div><div>

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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-indent: -9pt; padding-left: 9pt">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; ">
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    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right">&#160;</td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom; ">
    <td style="font-weight: bold; padding-bottom: 1.5pt; text-indent: -9pt; padding-left: 9pt">Gross value on December 31, 2022</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-indent: -9pt; padding-left: 9pt">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
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    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfPropertyPlantAndEquipmentExplanatory-c0_cont_7" id="_DisclosureOfPropertyPlantAndEquipmentExplanatory-c0_cont_6"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In December 2019, the Company entered into a lease
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space.&#160;Under the terms of the Plano lease, the lease will automatically renew for successive 12-month periods after the end of the
original term of the agreement.&#160;Under the terms of the lease agreements mentioned, the rental payments escalate through the term
of each agreement and the Company is subject to additional charges for common area maintenance and other costs.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfPropertyPlantAndEquipmentExplanatory-c0_cont_8" id="_DisclosureOfPropertyPlantAndEquipmentExplanatory-c0_cont_7"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In October 2022, the company renewed its lease
agreement for a term of 60 months for its facilities in Nijmegen, The Netherlands.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfPropertyPlantAndEquipmentExplanatory-c0_cont_9" id="_DisclosureOfPropertyPlantAndEquipmentExplanatory-c0_cont_8"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The new lease agreements from 2022 represent
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfPropertyPlantAndEquipmentExplanatory-c0_cont_10" id="_DisclosureOfPropertyPlantAndEquipmentExplanatory-c0_cont_9"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The following amounts related to leases are recognized
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</div><div>

</div><ix:continuation id="_DisclosureOfPropertyPlantAndEquipmentExplanatory-c0_cont_10"><ix:nonNumeric contextRef="c0" escape="true" name="tmdx:ScheduleOfLeaseRecognizedTableTextBlock"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <tr style="vertical-align: bottom">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
    <td style="text-align: left">Interest expense on lease liabilities</td><td>&#160;</td>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><ix:nonNumeric contextRef="c0" continuedAt="_DisclosureOfInventoriesExplanatory-c0_cont_1" escape="true" name="ifrs-full:DisclosureOfInventoriesExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>NOTE 13: Inventories</i></b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:nonNumeric><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfInventoriesExplanatory-c0_cont_2" id="_DisclosureOfInventoriesExplanatory-c0_cont_1"><ix:nonNumeric contextRef="c0" escape="true" name="tmdx:InventoriesTableTextBlock"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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</div><div>

</div><ix:continuation id="_DisclosureOfInventoriesExplanatory-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Inventories are recognized at the lower of cost
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:nonNumeric contextRef="c0" continuedAt="_DisclosureOfTradeAndOtherReceivablesExplanatory-c0_cont_1" escape="true" name="ifrs-full:DisclosureOfTradeAndOtherReceivablesExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>NOTE 14: Trade and other receivables</i></b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-transform: uppercase"><b>&#160;</b></span></p></ix:nonNumeric><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfTradeAndOtherReceivablesExplanatory-c0_cont_2" id="_DisclosureOfTradeAndOtherReceivablesExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>Trade
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfTradeAndOtherReceivablesExplanatory-c0_cont_3" id="_DisclosureOfTradeAndOtherReceivablesExplanatory-c0_cont_2"><ix:nonNumeric contextRef="c0" escape="true" name="tmdx:ScheduleOfTradeReceivablesTableTextBlock"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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  </table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:nonNumeric></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfTradeAndOtherReceivablesExplanatory-c0_cont_4" id="_DisclosureOfTradeAndOtherReceivablesExplanatory-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Trade receivables mainly consist of claims due
from our patients&#8217; insurance companies related to our diagnostic tests.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfTradeAndOtherReceivablesExplanatory-c0_cont_5" id="_DisclosureOfTradeAndOtherReceivablesExplanatory-c0_cont_4"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Considering the Company&#8217;s revenue recognition
methodology further described in Note 2.7, total accounts receivable balance could be presented in relation with the claim date of each
sample as follows:</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfTradeAndOtherReceivablesExplanatory-c0_cont_6" id="_DisclosureOfTradeAndOtherReceivablesExplanatory-c0_cont_5"><ix:nonNumeric contextRef="c0" continuedAt="tmdx_ScheduleOfTotalAccountsReceivableBalanceWithTheClaimDateTableTextBlock-c0_cont_1" escape="true" name="tmdx:ScheduleOfTotalAccountsReceivableBalanceWithTheClaimDateTableTextBlock"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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  <tr style="vertical-align: bottom; ">
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    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td style="font-weight: bold">&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right">&#160;</td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom; ">
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfTradeAndOtherReceivablesExplanatory-c0_cont_7" id="_DisclosureOfTradeAndOtherReceivablesExplanatory-c0_cont_6"><ix:continuation id="tmdx_ScheduleOfTotalAccountsReceivableBalanceWithTheClaimDateTableTextBlock-c0_cont_1"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfTradeAndOtherReceivablesExplanatory-c0_cont_8" id="_DisclosureOfTradeAndOtherReceivablesExplanatory-c0_cont_7"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-variant: small-caps"><b><i>Prepaid expenses and
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfTradeAndOtherReceivablesExplanatory-c0_cont_9" id="_DisclosureOfTradeAndOtherReceivablesExplanatory-c0_cont_8"><ix:nonNumeric contextRef="c0" escape="true" name="tmdx:ScheduleOfPrepaidExpensesAndOtherCurrentAssetsTableTextBlock"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  </table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:nonNumeric></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfTradeAndOtherReceivablesExplanatory-c0_cont_10" id="_DisclosureOfTradeAndOtherReceivablesExplanatory-c0_cont_9"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Prepaid expenses mainly consist of prepaid insurance
premiums and prepaid maintenance contracts.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation id="_DisclosureOfTradeAndOtherReceivablesExplanatory-c0_cont_10"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">All financial assets carried at amortized cost
are shown net of expected credit losses.</p></ix:continuation><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfRestrictedCashAndCashEquivalentsExplanatory-c0_cont_2" id="_DisclosureOfRestrictedCashAndCashEquivalentsExplanatory-c0_cont_1"><ix:nonNumeric contextRef="c0" escape="true" name="tmdx:ScheduleOfCashAndCashEquivalentTableTextBlock"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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  <tr style="vertical-align: bottom; ">
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  </table></ix:nonNumeric></ix:continuation><div>

</div><ix:continuation continuedAt="_DisclosureOfRestrictedCashAndCashEquivalentsExplanatory-c0_cont_3" id="_DisclosureOfRestrictedCashAndCashEquivalentsExplanatory-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><br/>
The bank balances and cash held by the Company and short-term bank deposits have an original maturity of less than 3 months. The carrying
amount of these assets approximates their fair value.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation id="_DisclosureOfRestrictedCashAndCashEquivalentsExplanatory-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">The Company had no restricted cash in 2022 and 2021.</p></ix:continuation><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></p><div>

</div><!-- Field: Page; Sequence: 134 --><div>
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    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><ix:nonNumeric contextRef="c0" continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_1" escape="true" name="tmdx:LoansBorrowingsAndLeaseLiabilitiesTextBlock"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>NOTE 16: Loans, Borrowings, Leases obligations
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</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_2" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Loans, Borrowings &amp; Lease liabilities</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>&#160;</b></p></ix:continuation><div>

</div><div>

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</div><div>

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</div><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Rule-Page --><div style="margin-top: 0pt; margin-bottom: 0pt; width: 25%"><div style="border-top: Black 1.5pt solid; font-size: 1pt">&#160;</div></div><!-- Field: /Rule-Page --><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_5" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_4"><ix:continuation id="tmdx_LoansBorrowingsLeaseLiabilitiesTableTextBlock-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">(*) <ix:footnote id="ix_1_footnote" xml:lang="en-US">the evolution in the right of use assets
is further disclosed in note 12.</ix:footnote></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_6" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_5"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Innovatus debt facility</i></b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>&#160;</i></p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_7" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_6"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On August 2, 2022, the Company entered into a
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subject to certain conditions. The loans are secured by assets of the Group including intellectual property rights. Remaining proceeds
of the loans will be used for working capital purposes and to fund general business requirements.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_8" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_7"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><ix:nonNumeric contextRef="c0" name="tmdx:DescriptionOfLoanAccrueInterest">The loans accrue interest at a floating per annum
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section or (ii) 4.00%, plus (b) 4.25%, and require interest-only payments for the initial four years.</ix:nonNumeric> As contractually agreed, and at
the election of the Company, a portion of the interest becomes payable in-kind by adding an amount equal to <ix:nonFraction contextRef="c0" decimals="4" format="ixt:num-dot-decimal" name="tmdx:PercentageOfOutstandingPrincipalAmount" scale="-2" unitRef="pure">2.25</ix:nonFraction>% of the outstanding
principal amount to the then outstanding principal balance on a monthly basis until August 2, 2025. The loans mature on August 2, 2027.
The lenders shall have the right to convert, prior to August 2, 2025, up to <ix:nonFraction contextRef="c209" decimals="2" format="ixt:num-dot-decimal" name="tmdx:PercentageOfOutstandingPrincipalAmount" scale="-2" unitRef="pure">15</ix:nonFraction>% of the outstanding principal amount of the loans into
ADSs of the Company at a price per ADS equal to $<ix:nonFraction contextRef="c0" decimals="2" format="ixt:num-dot-decimal" name="tmdx:loanPrice" scale="0" unitRef="usdPershares">11.21</ix:nonFraction>, reflecting a substantial premium to the trading price prior to the announcement
of the acquisition. Amounts converted into ADSs of the Company will be reduced from the principal amount outstanding under the loan.
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relevant loans, and an end-of-loan fee equal to <ix:nonFraction contextRef="c0" decimals="2" format="ixt:num-dot-decimal" name="tmdx:EndOfLoanFee" scale="-2" unitRef="pure">5</ix:nonFraction>% of the amount drawn, payable upon final repayment of the relevant loans.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_9" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_8"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Security has been granted over all assets (including IP rights) owned
by the Company and MDxHealth, Inc. The loan agreement contains customary financial covenants and general affirmative and negative covenants,
including limitations on our ability to transfer or dispose of assets, change our business, merge with or acquire other companies, incur
additional indebtedness and liens, make investments, pay dividends and conduct transactions with affiliates.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_10" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_9"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Innovatus debt facility has been accounted
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</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_11" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_10"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The embedded derivative is not considered to
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</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_12" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_11"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">The
host financial liability is recognized at amortized cost applying the effective interest rate method and has been accounted for as non-current
loans and borrowings;</span></td>
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</div><div>

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<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">The
embedded derivative convertible (American) call option is recognized at fair value using a binomial tree option pricing model whereby
the fair value is based on the actual stock price and the estimated volatility of the Company&#8217;s ADS on Nasdaq since the Company&#8217;s
IPO on November 4, 2021, and through the valuation date. The volatility measured on August 2, 2022, which was the closing date of the
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be recognized through the statement of profit or loss. The derivative financial instrument has been accounted for as other current financial
liabilities.</span></td>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify; text-indent: -0.25in">&#160;</p><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_14" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_13"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Kreos debt facility</i></b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_15" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_14"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">As part of the new debt facility with Innovatus,
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facility.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_16" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_15"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The repayment did not include the derivative
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</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_17" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_16"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The financial results largely related to the
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interest method, which allocates interests and expenses at a constant rate over the term of the instrument. The debt extinguishment costs
incurred amounted to $<ix:nonFraction contextRef="c0" decimals="-5" format="ixt:num-dot-decimal" name="tmdx:IncurredAmount" scale="6" unitRef="usd">1.8</ix:nonFraction> million and are included in the statement of profit or loss under Financial expenses.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_18" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_17"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">During 2019, the Company entered into a loan
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the first 12 months of interest-only payments followed by 36 months of principal and interest payments. On October 20, 2020, MDxHealth
and Kreos Capital executed an amendment to the 2019 loan facility, extending the interest-only period from 12 months to 18 months. As
a result of this amendment, repayment of principal was extended by 6 months, from November 2020 to May 2021. As part of the amendment,
the Company agreed to increase the end-of-loan fee by &#8364;<ix:nonFraction contextRef="c0" decimals="0" format="ixt:num-dot-decimal" name="tmdx:EndofloanFee" scale="0" unitRef="eur">67,500</ix:nonFraction> (approx. $<ix:nonFraction contextRef="c0" decimals="0" format="ixt:num-dot-decimal" name="tmdx:EndofloanFee" scale="0" unitRef="usd">80,000</ix:nonFraction>) as well as to provide for &#8364;<ix:nonFraction contextRef="c2" decimals="0" format="ixt:num-dot-decimal" name="ifrs-full:NetDebt" scale="0" unitRef="eur">180,000</ix:nonFraction> of the &#8364;<ix:nonFraction contextRef="c2" decimals="-6" format="ixt:num-dot-decimal" name="ifrs-full:BankDebtInstrumentsHeld" scale="6" unitRef="eur">9</ix:nonFraction>
million loan to be convertible into shares of MDxHealth at a <ix:nonFraction contextRef="c2" decimals="2" format="ixt:num-dot-decimal" name="tmdx:PercentageOfPrincipalAmountOfTheInitialConvertibleLoan" scale="-2" unitRef="pure">25</ix:nonFraction>% premium to the 30-day volume weighted average price immediately prior
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</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_19" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_18"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In April 2021, MDxHealth and Kreos Capital executed
a second amendment to the loan facility, extending the interest-only period from 18 months to 27 months. As a result of this amendment,
repayment of principal was extended from May 2021 to February 2022. As part of the amendment, the Company agreed to increase the end-of-loan
fee by an additional &#8364;<ix:nonFraction contextRef="c3" decimals="0" format="ixt:num-dot-decimal" name="tmdx:LoanProcessingFees" scale="0" unitRef="eur">67,500</ix:nonFraction> (approx. $<ix:nonFraction contextRef="c3" decimals="0" format="ixt:num-dot-decimal" name="tmdx:LoanProcessingFees" scale="0" unitRef="usd">80,000</ix:nonFraction>) as well as to provide for an additional &#8364;<ix:nonFraction contextRef="c5" decimals="0" format="ixt:num-dot-decimal" name="ifrs-full:NetDebt" scale="0" unitRef="eur">202,500</ix:nonFraction> of the &#8364;<ix:nonFraction contextRef="c5" decimals="-6" format="ixt:num-dot-decimal" name="ifrs-full:BankDebtInstrumentsHeld" scale="6" unitRef="eur">9</ix:nonFraction> million loan
to be convertible into shares of MDxHealth at a <ix:nonFraction contextRef="c5" decimals="2" format="ixt:num-dot-decimal" name="tmdx:PercentageOfPrincipalAmountOfTheInitialConvertibleLoan" scale="-2" unitRef="pure">25</ix:nonFraction>% premium to the 30-day volume weighted average price 10 days prior to signing the
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</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_20" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_19"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The convertible part of the loan, representing
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were recognized at their amortized cost.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_21" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_20"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In addition, the second amendment provided for
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in new equity financing. Following the completion of the Company&#8217;s Initial Public Offering of ADSs in the United States on November
8, 2021, whereby the Company received gross proceeds of $<ix:nonFraction contextRef="c212" decimals="-6" format="ixt:num-dot-decimal" name="ifrs-full:GrossLoanCommitments" scale="6" unitRef="usd">45</ix:nonFraction> million in new equity financing, Kreos granted a six-month extension of the
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</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_22" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_21"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In addition, as the loan facility is contracted
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which allocates interests and expenses at a constant rate over the term of the instrument.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_23" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_22"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 1.15pt 0pt 0; text-align: justify">On April 20, 2020, the Company, through
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Administration (SBA) in the amount of $<ix:nonFraction contextRef="c127" decimals="0" format="ixt:num-dot-decimal" name="tmdx:SmallBusinessAdministration" scale="0" unitRef="usd">2,316,000</ix:nonFraction> as part of the U.S Coronavirus Aid, Relief, and Economic Security (CARES) Act. The loan
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following disbursement of the loan, with principal and interest payments beginning on the nineteenth month. Interest on the loan continues
to accrue during the eighteen-month deferment period. Cash proceeds from the loan were received in July 2020. As of December 31, 2022,
the outstanding amount on the PPP loan was $<ix:nonFraction contextRef="c0" decimals="-5" format="ixt:num-dot-decimal" name="tmdx:OutstandingAmount" scale="6" unitRef="usd">1.6</ix:nonFraction> million.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_24" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_23"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In addition to the contracted loans, the Company
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</div><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_26" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_25"><ix:nonNumeric contextRef="c0" escape="true" name="tmdx:ScheduleOfMaturityOfLoansAndBorrowingsTableTextBlock"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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    <td colspan="2" style="text-align: right">&#160;</td><td>&#160;</td><td>&#160;</td>
    <td colspan="2" style="text-align: right">&#160;</td><td>&#160;</td></tr>
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</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_27" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_26"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>Note: all figures shown in this table are
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</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_28" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_27"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Other financial liabilities </b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

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</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_30" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_29"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><i>GPS Contingent consideration</i></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_31" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_30"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">As part of the acquisition of the GPS business
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achievement of certain revenue milestones related to fiscal years 2023 through 2025, with the maximum earn-out payable in relation to
2023 and 2024 not to exceed $<ix:nonFraction contextRef="c215" decimals="-6" format="ixt:num-dot-decimal" name="tmdx:EarnoutPayable" scale="6" unitRef="usd">30</ix:nonFraction> million and $<ix:nonFraction contextRef="c216" decimals="-6" format="ixt:num-dot-decimal" name="tmdx:EarnoutPayable" scale="6" unitRef="usd">40</ix:nonFraction> million, respectively. The liability recognized reflects a probability-weighted estimate
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</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_32" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_31"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>Innovatus embedded derivative convertible
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</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_33" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_32"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The embedded derivative convertible (American)
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2022.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_34" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_33"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>Kreos derivative financial instrument (&#8220;initial
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</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_35" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_34"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">As of December 31, 2022, the derivative financial
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</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_36" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_35"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">a
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</tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 21.3pt; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_37" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_36"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">Upon
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</tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_38" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_37"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">In
lieu of converting the Initial Convertible Loan, Kreos Capital may instead cancel the convertible loan at any time (but before the Expiration
Date) after the earlier to occur of (i) a repayment or prepayment in full of the loan, and (ii) sale of the entire issued share capital
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</tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_39" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_38"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The fair value of the financial derivative related
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</div><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_40" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_39"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>Other financial liabilities</i></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_41" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_40"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Other financial liabilities include the contingent consideration related
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is valued at fair value through the statement of profit or loss. The fair value of this contingent consideration is reviewed on a periodic
basis. The fair value is based on a risk-adjusted future cash flows of different scenarios discounted using an interest rate of <ix:nonFraction contextRef="c2" decimals="4" format="ixt:num-dot-decimal" name="ifrs-full:BorrowingsInterestRate" scale="-2" unitRef="pure">12.16</ix:nonFraction>%.
The structure of the possible scenarios and the probability assigned to each scenario is reassessed by management at every reporting period
and requires judgement from management about the outcome and probability of the different scenarios (refer to Note 26 for further details).</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_42" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_41"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">A reconciliation of cash and non-cash movements
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</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_43" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_42"><ix:nonNumeric contextRef="c0" continuedAt="tmdx_ScheduleOfCashAndNoncashMovementsOfLoansAndBorrowingsTableTextBlock-c0_cont_1" escape="true" name="tmdx:ScheduleOfCashAndNoncashMovementsOfLoansAndBorrowingsTableTextBlock"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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  <tr style="vertical-align: bottom; ">
    <td style="padding-left: 0.125in; text-indent: -0.125in; font-weight: bold; text-align: left">Cash movements</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
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    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding-left: 0.125in; text-indent: -0.125in; font-weight: bold; text-align: left">Non-cash movements</td><td>&#160;</td>
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    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
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    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding-left: 0.125in; text-indent: -0.125in"><span style="font-size: 10pt">Reclassification<sup>2</sup></span></td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; ">
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</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_44" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_43"><ix:continuation continuedAt="tmdx_ScheduleOfCashAndNoncashMovementsOfLoansAndBorrowingsTableTextBlock-c0_cont_2" id="tmdx_ScheduleOfCashAndNoncashMovementsOfLoansAndBorrowingsTableTextBlock-c0_cont_1"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt"><tr style="vertical-align: top">
<td style="width: 18pt">1)</td><td><ix:footnote id="ix_2_footnote" xml:lang="en-US">The amount includes interest paid on loans and borrowings</ix:footnote></td></tr><tr style="vertical-align: top">
<td>&#160;</td><td>&#160;</td></tr> </table></ix:continuation></ix:continuation><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_45" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_44"><ix:continuation id="tmdx_ScheduleOfCashAndNoncashMovementsOfLoansAndBorrowingsTableTextBlock-c0_cont_2"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0pt; margin-bottom: 0pt"><tr style="vertical-align: top">
<td style="width: 18pt">2)</td><td><ix:footnote id="ix_3_footnote" xml:lang="en-US">Reclassification of the fair value of the derivative financial liability of the initial drawdown fee to be presented separately</ix:footnote></td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_46" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_45"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Fair value adjustments recognized during 2022
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</div><div>

</div><ix:continuation continuedAt="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_47" id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_46"><ix:nonNumeric contextRef="c0" escape="true" name="tmdx:ScheduleOfFairValueAdjustmentsRecognizedTableTextBlock"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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    <td style="text-align: justify">Increase of GPS contingent consideration</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding-bottom: 4pt; font-weight: bold; text-align: justify">Total fair value adjustment</td><td style="padding-bottom: 4pt; font-weight: bold">&#160;</td>
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</div><div>

</div><ix:continuation id="tmdx_LoansBorrowingsAndLeaseLiabilitiesTextBlock-c0_cont_47"><ix:nonNumeric contextRef="c0" escape="true" name="tmdx:ScheduleOfLeaseLiabilitiesTableTextBlock"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="width: 76%; font-weight: bold; text-align: left">Opening balance</td><td style="width: 1%; font-weight: bold">&#160;</td>
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  </table></ix:nonNumeric></ix:continuation><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 32.2pt">&#160;</p><div>

</div><ix:nonNumeric contextRef="c0" continuedAt="tmdx_ContractualObligationsTextBlock-c0_cont_1" escape="true" name="tmdx:ContractualObligationsTextBlock"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b><i>NOTE 17: Contractual obligations</i></b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-transform: uppercase"><b>&#160;</b></span></p></ix:nonNumeric><div>

</div><div>

</div><ix:continuation continuedAt="tmdx_ContractualObligationsTextBlock-c0_cont_2" id="tmdx_ContractualObligationsTextBlock-c0_cont_1"><ix:nonNumeric contextRef="c0" escape="true" name="tmdx:ScheduleOfContractualObligationsTableTextBlock"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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  <tr style="vertical-align: bottom">
    <td style="font-weight: bold">Outstanding commitments for future minimum rent payments, which fall due as follows:</td><td>&#160;</td>
    <td colspan="2">&#160;</td><td>&#160;</td><td>&#160;</td>
    <td colspan="2">&#160;</td><td>&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  </table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:nonNumeric></ix:continuation><div>

</div><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></p><div>

</div><ix:continuation continuedAt="tmdx_ContractualObligationsTextBlock-c0_cont_3" id="tmdx_ContractualObligationsTextBlock-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">For 2022 and 2021, we refer to note 12 and 16
for the lease liabilities subsequent adoption and application of IFRS 16.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 138 --><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:continuation id="tmdx_ContractualObligationsTextBlock-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Outstanding commitments for future minimum rent
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These lease contracts can be terminated early with certain indemnity fees. All figures shown assume that the lease contracts will not
be terminated early.</p></ix:continuation><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:nonNumeric contextRef="c0" continuedAt="_DisclosureOfTradeAndOtherPayablesExplanatory-c0_cont_1" escape="true" name="ifrs-full:DisclosureOfTradeAndOtherPayablesExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>NOTE 18: Trade and other payables</i></b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-transform: uppercase"><b>&#160;</b></span></p></ix:nonNumeric><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfTradeAndOtherPayablesExplanatory-c0_cont_2" id="_DisclosureOfTradeAndOtherPayablesExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>Trade
accounts payable</i></b></span></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>&#160;</i></b></span></p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfTradeAndOtherPayablesExplanatory-c0_cont_3" id="_DisclosureOfTradeAndOtherPayablesExplanatory-c0_cont_2"><ix:nonNumeric contextRef="c0" escape="true" name="tmdx:ScheduleOfTradeAccountsPayableTableTextBlock"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <tr style="vertical-align: bottom">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right"><ix:nonFraction contextRef="c2" decimals="-3" format="ixt:num-dot-decimal" name="tmdx:AccrualsForInvoicesToBeReceived" scale="3" unitRef="usd">5,117</ix:nonFraction></td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  </table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-transform: uppercase"><b><i>&#160;</i></b></span></p></ix:nonNumeric></ix:continuation><div>


</div><div>

</div><ix:continuation continuedAt="_DisclosureOfTradeAndOtherPayablesExplanatory-c0_cont_4" id="_DisclosureOfTradeAndOtherPayablesExplanatory-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>Other
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</div><div>

</div><ix:continuation id="_DisclosureOfTradeAndOtherPayablesExplanatory-c0_cont_4"><ix:nonNumeric contextRef="c0" escape="true" name="tmdx:ScheduleOfOtherCurrentLiabilitiesTableTextBlock"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <tr style="vertical-align: bottom">
    <td style="border-bottom: Black 1.5pt solid; text-align: justify"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-variant: small-caps"><b><i>Thousands
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  </table></ix:nonNumeric></ix:continuation><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><ix:nonNumeric contextRef="c0" continuedAt="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_1" escape="true" name="ifrs-full:DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>NOTE 19: Financial instruments and fair
value</i></b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>&#160;</i></p></ix:nonNumeric><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_2" id="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The table shows the Company&#8217;s significant financial assets and
liabilities.&#160;All financial assets and liabilities are carried at amortized cost with the exception of the contingent considerations
in relation to acquisitions and derivative financial instruments reported at fair value through the statement of profit or loss.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_3" id="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">All financial assets and liabilities are considered
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_4" id="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_3"><ix:nonNumeric contextRef="c0" escape="true" name="tmdx:ScheduleOfAssetsAndLiabilitiesAreConsideredToHaveCarryingAmountstTableTextBlock"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <tr style="vertical-align: bottom">
    <td style="border-bottom: Black 1.5pt solid; font-weight: bold; font-style: italic; font-variant: small-caps">Thousands of $<br/> For The Years ended December 31</td><td style="padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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</div><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></p><div>

</div><!-- Field: Page; Sequence: 139 --><div>
    </div><div style="border-bottom: Black 1.5pt solid; margin-top: 12pt; margin-bottom: 6pt"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->32<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_5" id="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_4"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>Recognized fair value measurements &#8211; valuation technique
and principal inputs</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>&#160;</b></p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_6" id="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_5"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The fair value of the financial instruments has
been determined on the basis of the following methods and assumptions:</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_7" id="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_6"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">The
carrying value of the cash and cash equivalents, the trade receivables, other current assets and the trade payables approximate their
fair value due to their short-term character;</span></td>
</tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_8" id="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_7"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">The
fair value of loans and borrowings applying the Effective Interest Rate method approximates their carrying value (level 2).</span></td>
</tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_9" id="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_8"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.75in"></td><td style="width: 0.25in">o</td><td style="text-align: justify"><b>Innovatus debt facility</b>: the host financial liability was obtained with a variable interest rate based upon the Prime Rate (with a floor of <ix:nonFraction contextRef="c228" decimals="2" format="ixt:num-dot-decimal" name="tmdx:VariableInterestRate" scale="-2" unitRef="pure">4</ix:nonFraction>% and a margin of <ix:nonFraction contextRef="c0" decimals="4" format="ixt:num-dot-decimal" name="tmdx:VariableInterestRate" scale="-2" unitRef="pure">4.25</ix:nonFraction>%)</td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_10" id="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_9"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.75in"></td><td style="width: 0.25in">o</td><td style="text-align: justify"><b>Paycheck Protection Program (PPP)</b>: applying a market rate would not result in a materially different fair value which carries an interest rate of <ix:nonFraction contextRef="c229" decimals="2" format="ixt:num-dot-decimal" name="tmdx:InterestRatePercentage" scale="-2" unitRef="pure">1</ix:nonFraction>% and was obtained as part of the U.S Coronavirus Aid, Relief, and Economic Security (CARES) Act.</td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_11" id="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_10"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.75in"></td><td style="width: 0.25in">o</td><td style="text-align: justify"><b>Kreos debt facility</b>: the Kreos loan was obtained at the end of 2019 with a nominal fixed interest rate of <ix:nonFraction contextRef="c230" decimals="3" format="ixt:num-dot-decimal" name="tmdx:InterestRatePercentage" scale="-2" unitRef="pure">9.5</ix:nonFraction>%, however, the carrying value is considered to approximate their fair value considering:</td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_12" id="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_11"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 1.25in"></td><td style="width: 0.25in">&#9632;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">Additional
                                            contractually agreed advance and post payments agreed upon with Kreos that have been integrated
                                            in the effective interest rate method;&#160; </span></td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1.5in; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_13" id="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_12"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 1.25in"></td><td style="width: 0.25in">&#9632;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">During
                                            2020 and 2021, the Company and Kreos negotiated modification to the original agreement resulting
                                            in additional consecutive interest-only periods. As compensation for these modifications,
                                            part of the loan amounts became convertible as described in Note 16, however the Company
                                            and Kreos agreed to maintain nominal fixed interest rate in line with the initial agreement.</span></td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_14" id="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_13"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 1.25in"></td><td style="width: 0.25in">&#9632;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">Given
                                            repayment of the Kreos facility during 2022, no fair value assessment was performed as of
                                            December 31, 2022</span></td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_15" id="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_14"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">Leases
                                            are measured at the present value of the remaining lease payments, using a discount rate
                                            based on the incremental borrowing rate at the commencement date of these leases. Their fair
                                            value approximates their carrying value.</span></td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_16" id="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_15"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td style="text-align: justify"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><ix:nonNumeric contextRef="c0" continuedAt="tmdx_NovioGendixGPSDescription-c0_cont_1" name="tmdx:NovioGendixGPSDescription">The fair value of contingent consideration payable to NovioGendix (presented
in the yearend statement of financial position under &#8220;other non-current financial liabilities&#8221; and &#8220;other current financial
liabilities&#8221;) and Exact Sciences is based on an estimated outcome of the conditional purchase price/contingent payments arising
from contractual obligations (level 3). This is initially recognized as part of the purchase price and subsequently fair valued with changes
recorded through other operating income in the statement of profit or loss.</ix:nonNumeric></p></td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_17" id="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_16"><ix:continuation continuedAt="tmdx_NovioGendixGPSDescription-c0_cont_2" id="tmdx_NovioGendixGPSDescription-c0_cont_1"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.75in"></td><td style="width: 0.25in">o</td><td style="text-align: justify"><b>NovioGendix</b>: the Company used a discount rate of 12.16%. A net positive fair value
measurement of $435,000 was recognized in the 2022 consolidated financial statements, of which $632,000 in operating income and $197,000
in financial expense.</td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_18" id="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_17"><ix:continuation id="tmdx_NovioGendixGPSDescription-c0_cont_2"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.75in"></td><td style="width: 0.25in">o</td><td style="text-align: justify"><b>GPS</b>: The fair value of the contingent consideration payable to Exact Sciences
is based on a probability-weighted average estimate based on multiple scenarios varying in timing and amount of earn-out payment. This
probably-weighted estimate is then discounted to its net present value taking into account expected time when earn-out would become payable
in 2024, 2025 and 2026. This contingent consideration was initially recorded along with the purchase price allocation of this business
combination as explained in Note 3. A fair-value adjustments resulting in a financial charge of $ 2.4 million has been recorded as of
December 31, 2022. The Company used a discount rate of 14.95%</td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_19" id="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_18"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">The fair value of the derivative financial liabilities related to the initial Kreos drawdown fee of &#8364;<ix:nonFraction contextRef="c2" decimals="0" format="ixt:num-dot-decimal" name="ifrs-full:DerivativeFinancialLiabilities" scale="0" unitRef="eur">630,000</ix:nonFraction> ($<ix:nonFraction contextRef="c2" decimals="0" format="ixt:num-dot-decimal" name="ifrs-full:DerivativeFinancialLiabilities" scale="0" sign="-" unitRef="usd">672,000</ix:nonFraction>) is based upon the evolution of the share price of MDxHealth as well as the estimated probabilities that either payment at <ix:nonFraction contextRef="c0" decimals="2" format="ixt:num-dot-decimal" name="tmdx:SharePriceConversionPercentage" scale="-2" unitRef="pure">150</ix:nonFraction>% or conversion will be requested by Kreos. Whereas share price of MDxHealth can be considered as a level 1 input, the other variable, being the probability assessment of possible scenarios should be considered as level 3 input. The fair value of the liability is estimated at $<ix:nonFraction contextRef="c231" decimals="0" format="ixt:num-dot-decimal" name="ifrs-full:IssuesFairValueMeasurementAssets" scale="0" unitRef="usd">891,000</ix:nonFraction> for the year ended December 31, 2022.</span></td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_20" id="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_19"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">The fair value of the derivative financial liabilities related to the Innovatus derivative call option (as detailed in Note 16) was performed using a binomial pricing model which takes into account several factors including the expected evolution in price of an ADS and are considered as level 3 input. The fair value of the liability is estimated at $<ix:nonFraction contextRef="c0" decimals="0" format="ixt:num-dot-decimal" name="ifrs-full:IssuesFairValueMeasurementAssets" scale="0" unitRef="usd">910,000</ix:nonFraction> for the year ended December 31, 2022. </span></td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_21" id="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_20"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">Financial
                                            instruments are evaluated based on the mark-to-market report and the unrealized gains (loss)
                                            are recognized through the statement of profit or loss.</span></td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 28.35pt; text-align: justify; text-indent: -21.25pt">&#160;</p></ix:continuation><div>

</div><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 28.35pt; text-align: justify; text-indent: -21.25pt"></p><div>

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    </div><div style="border-bottom: Black 1.5pt solid; margin-top: 12pt; margin-bottom: 6pt"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->33<!-- Field: /Sequence --></p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 28.35pt; text-align: justify; text-indent: -21.25pt">&#160;</p><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_22" id="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_21"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>Fair value hierarchy:</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_23" id="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_22"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Company uses the following hierarchy for
determining and disclosing the fair value of financial instruments by valuation technique:</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify; text-indent: -0.25in">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_24" id="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_23"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif"><b>Level
                                            1</b>: quoted prices in active markets for identical assets and liabilities;</span></td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify; text-indent: -0.25in">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_25" id="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_24"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif"><b>Level
                                            2</b>: other techniques for which all inputs which have a significant effect on the recorded
                                            fair value are observable, either directly or indirectly; and</span></td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify; text-indent: -0.25in">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_26" id="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_25"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif"><b>Level
                                            3</b>: techniques which use inputs that have a significant effect on the recorded fair value
                                            that are not based on observable market data. </span></td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_27" id="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_26"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">No financial assets or financial liabilities
have been reclassified between the valuation categories during the year.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_28" id="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_27"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">A reconciliation of cash and non-cash movements
of level 3 financial liabilities is presented below:</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_29" id="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_28"><ix:nonNumeric contextRef="c0" continuedAt="tmdx_ScheduleOfReconciliationOfCashAndNoncashMovementsTableTextBlock-c0_cont_1" escape="true" name="tmdx:ScheduleOfReconciliationOfCashAndNoncashMovementsTableTextBlock"><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
  <tr style="vertical-align: bottom">
    <td style="font-weight: bold; font-style: italic; font-variant: small-caps; border-bottom: Black 1.5pt solid">Thousands of $</td><td style="font-weight: bold; font-style: italic; font-variant: small-caps; padding-bottom: 1.5pt">&#160;</td>
    <td colspan="6" style="font-weight: bold; font-style: italic; font-variant: small-caps; text-align: center; border-bottom: Black 1.5pt solid">Financial Derivative Instruments (Kreos and Innovatus)</td><td style="padding-bottom: 1.5pt; font-weight: bold; font-style: italic; font-variant: small-caps">&#160;</td><td style="font-weight: bold; font-style: italic; font-variant: small-caps; padding-bottom: 1.5pt">&#160;</td>
    <td colspan="6" style="font-weight: bold; font-style: italic; font-variant: small-caps; text-align: center; border-bottom: Black 1.5pt solid">Contingent Consideration (NovioGendix and GPS)</td><td style="padding-bottom: 1.5pt; font-weight: bold; font-style: italic; font-variant: small-caps">&#160;</td></tr>
  <tr style="vertical-align: bottom">
    <td style="font-weight: bold; font-style: italic; font-variant: small-caps; text-align: justify; border-bottom: Black 1.5pt solid">For the years ended December 31</td><td style="font-weight: bold; font-style: italic; font-variant: small-caps; padding-bottom: 1.5pt">&#160;</td>
    <td colspan="2" style="font-weight: bold; font-style: italic; font-variant: small-caps; text-align: center; border-bottom: Black 1.5pt solid">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold; font-style: italic; font-variant: small-caps">&#160;</td><td style="font-weight: bold; font-style: italic; font-variant: small-caps; padding-bottom: 1.5pt">&#160;</td>
    <td colspan="2" style="font-weight: bold; font-style: italic; font-variant: small-caps; text-align: center; border-bottom: Black 1.5pt solid">2021</td><td style="padding-bottom: 1.5pt; font-weight: bold; font-style: italic; font-variant: small-caps">&#160;</td><td style="font-weight: bold; font-style: italic; font-variant: small-caps; padding-bottom: 1.5pt">&#160;</td>
    <td colspan="2" style="font-weight: bold; font-style: italic; font-variant: small-caps; text-align: center; border-bottom: Black 1.5pt solid">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold; font-style: italic; font-variant: small-caps">&#160;</td><td style="font-weight: bold; font-style: italic; font-variant: small-caps; padding-bottom: 1.5pt">&#160;</td>
    <td colspan="2" style="font-weight: bold; font-style: italic; font-variant: small-caps; text-align: center; border-bottom: Black 1.5pt solid">2021</td><td style="padding-bottom: 1.5pt; font-weight: bold; font-style: italic; font-variant: small-caps">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="width: 52%; font-weight: bold; text-align: left">Beginning balance</td><td style="width: 1%; font-weight: bold">&#160;</td>
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    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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</div><div>

</div><ix:continuation id="_DisclosureOfFinancialInstrumentsDesignatedAtFairValueThroughProfitOrLossExplanatory-c0_cont_29"><ix:continuation id="tmdx_ScheduleOfReconciliationOfCashAndNoncashMovementsTableTextBlock-c0_cont_1"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in; text-align: left">1)</td><td style="text-align: justify"><ix:footnote id="ix_4_footnote" xml:lang="en-US">Reclassification of the fair value of the derivative financial
liability of the initial drawdown fee to be presented separately</ix:footnote></td>
</tr></table></ix:continuation></ix:continuation><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.25in">&#160;</p><div>

</div><ix:nonNumeric contextRef="c0" continuedAt="_DisclosureOfEarningsPerShareExplanatory-c0_cont_1" escape="true" name="ifrs-full:DisclosureOfEarningsPerShareExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>NOTE 20: Loss per share</i></b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-transform: uppercase"><b>&#160;</b></span></p></ix:nonNumeric><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfEarningsPerShareExplanatory-c0_cont_2" id="_DisclosureOfEarningsPerShareExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The basic loss per share is calculated by dividing
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfEarningsPerShareExplanatory-c0_cont_3" id="_DisclosureOfEarningsPerShareExplanatory-c0_cont_2"><ix:nonNumeric contextRef="c0" continuedAt="_EarningsPerShareExplanatory-c0_cont_1" escape="true" name="ifrs-full:EarningsPerShareExplanatory"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfEarningsPerShareExplanatory-c0_cont_4" id="_DisclosureOfEarningsPerShareExplanatory-c0_cont_3"><ix:continuation id="_EarningsPerShareExplanatory-c0_cont_1"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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</div><div>

</div><ix:continuation id="_DisclosureOfEarningsPerShareExplanatory-c0_cont_4"><p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-right: 0; margin-bottom: 0pt; text-align: justify">At December 31, 2022, 2021, and 2020, the Company had potential dilutive
shares in the form of warrants, contingent considerations and convertible loans (see Note 16 for further details). Diluted loss per share
considers the impact of potentially dilutive securities except in periods in which there is a loss because the inclusion of the potential
common shares would have an anti-dilutive effect.</p></ix:continuation><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_2" id="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>Capital
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_3" id="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Capital is comprised of equity attributable to
shareholders, borrowings, and cash and cash equivalents. The Company aims to maintain a strong capital base in order to maintain investor
and creditor confidence and to sustain the future development of the business. The Company&#8217;s objectives when managing capital are
to maintain sufficient liquidity to meet its working capital requirements, fund capital investment and purchases, and safeguard its ability
to continue operating as a going concern. The Company monitors capital regularly to ensure that the statutory capital requirements are
met and may propose capital increases at shareholders&#8217; meetings to ensure the necessary capital remains intact.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_4" id="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>Credit
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_5" id="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_4"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Credit risk arises from cash and cash equivalents,
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default on its contractual obligations resulting in financial loss to the Company.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_6" id="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_5"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">At the end of 2022, the Company operated with
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_7" id="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_6"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In the U.S. healthcare system, and particularly
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provide services to healthcare professionals and their patients, while being reimbursed from commercial and governmental insurance systems.
Often these services are provided out of network and without supplier contracts. As a result, there is reimbursement risk, separate from
credit risk that is characterized by uncertainty in reimbursement value, delays in payment, and ultimately non-payment. This impacts
the Company&#8217;s revenue recognition and cash collections.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_8" id="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_7"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In addition to reimbursement risk associated
with commercial third-party payors, credit risk may also arise from amounts due directly from patients. In many cases, payors will cover
the entire cost of testing. For example, for tests that fall under the Clinical Laboratory Fee Schedule, there is no co-payment, co-insurance
or deductible for patients covered under traditional Medicare. However, patients covered by commercial insurance companies may be responsible
for a co-payment, co-insurance, and/or deductible depending on the health insurance plan and individual patient benefit. Credit risk
exists for those patients who cannot meet their co-payment or deductible portions.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_9" id="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_8"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Customer&#8217;s compliance with agreed credit
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for expected credit loss was recorded. No ECL has been recorded for other financial assets carried at amortized cost as there is no related
credit risk.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_10" id="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_9"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The credit risk on cash and cash equivalents
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_11" id="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_10"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>Interest
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</div><div>

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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_13" id="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_12"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In addition, on April 20, 2020, the Company,
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_14" id="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_13"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>Currency
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_15" id="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_14"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The functional currency changed from the EURO
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_16" id="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_15"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">As of December 31, 2022, cash deposits in EURO
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</div><div>

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</div><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-transform: uppercase"><b><i>&#160;</i></b></span></p><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_18" id="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_17"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>Liquidity
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_19" id="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_18"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Company manages liquidity risk by maintaining
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</div><div>

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    <td colspan="2">&#160;</td><td>&#160;</td><td>&#160;</td>
    <td colspan="2">&#160;</td><td>&#160;</td><td>&#160;</td>
    <td colspan="2">&#160;</td><td>&#160;</td><td>&#160;</td>
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_21" id="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_20"><ix:continuation id="tmdx_ScheduleOfMaturityAnalysisForFinancialAssetsAndLiabilitiesTableTextBlock-c0_cont_1"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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  </table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><i>&#160;</i></p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_22" id="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_21"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><i>Note: Except for carrying amount, all figures shown in this table
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_23" id="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_22"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Company is also committed to a potential
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_24" id="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_23"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">&#8364;<ix:nonFraction contextRef="c242" decimals="0" format="ixt:num-dot-decimal" name="ifrs-full:DerivativeFinancialLiabilities" scale="0" unitRef="eur">945,000</ix:nonFraction>
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Note 16).</span></td>
</tr><tr style="vertical-align: top; text-align: justify">
<td>&#160;</td><td style="text-align: left">&#160;</td><td style="text-align: justify">&#160;</td></tr> </table></ix:continuation><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_25" id="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_24"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_26" id="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_25"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>Other
risks</i></b></span></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-transform: uppercase"><b><i>&#160;</i></b></span></p></ix:continuation><div>

</div><div>

</div><ix:continuation id="_DisclosureOfFinancialRiskManagementExplanatory-c0_cont_26"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Company subscribes to certain insurance policies
to cover matters such as (i) fire, theft, and other damage to its assets, (ii) product and liability insurance and clinical trial insurance,
and (iii) D&amp;O insurance. To date, no significant claims have been made under these insurance policies and there is no guarantee that
the insurances will cover all damages if they should ever occur.</p></ix:continuation><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:nonNumeric contextRef="c0" continuedAt="_DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory-c0_cont_1" escape="true" name="ifrs-full:DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>NOTE 22: Share capital and reserves</i></b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-transform: uppercase"><b>&#160;</b></span></p></ix:nonNumeric><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory-c0_cont_2" id="_DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">At December 31, 2022, the Company&#8217;s share
capital was represented by the following number of shares (units). Only one class of shares (common shares) exists and they have no par
value.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory-c0_cont_3" id="_DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory-c0_cont_2"><ix:nonNumeric contextRef="c0" escape="true" name="tmdx:ScheduleOfShareCapitalNumberOfSharesTableTextBlock"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory-c0_cont_4" id="_DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On January 21, 2021, the company announced the
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</div><div>

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</div><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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</div><div>

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  <tr style="vertical-align: bottom; ">
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</div><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; text-align: left; margin-top: 0pt; margin-bottom: 0pt"></p><div>

</div><!-- Field: Rule-Page --><div style="margin-top: 0pt; margin-bottom: 0pt; width: 25%"><div style="border-top: Black 1.5pt solid; font-size: 1pt">&#160;</div></div><!-- Field: /Rule-Page --><div>

</div><ix:continuation continuedAt="_DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory-c0_cont_8" id="_DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory-c0_cont_7"><ix:continuation id="tmdx_ScheduleOfShareCapitalAndIssuancePremiumIncreasedTableTextBlock-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; text-align: left; margin-top: 0pt; margin-bottom: 0pt"><i>(*) <ix:footnote id="ix_5_footnote" xml:lang="en-US">net of expenses</ix:footnote></i></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;&#160;</p></ix:continuation></ix:continuation><div>



</div><div>

</div><ix:continuation continuedAt="_DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory-c0_cont_9" id="_DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory-c0_cont_8"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">The capital stock and the issuance premium amounted to the following:</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory-c0_cont_10" id="_DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory-c0_cont_9"><ix:nonNumeric contextRef="c0" escape="true" name="tmdx:ScheduleOfCapitalStockAndTheIssuancePremiumTableTextBlock"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory-c0_cont_11" id="_DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory-c0_cont_10"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">The history of the Share Capital can be found in &#8220;General Information;
Capital and Shares&#8221;.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-variant: small-caps"><b><i>&#160;</i></b></span></p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory-c0_cont_12" id="_DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory-c0_cont_11"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">By virtue of the resolution of the extraordinary general shareholders&#8217;
meeting of the Company held on May 27, 2021, which entered into force on June 1, 2021, the board of directors of the Company has been
granted certain powers to increase the Company&#8217;s share capital in the framework of the authorized capital. The powers under the
authorized capital have been set out in article 6 of the Company&#8217;s articles of association.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory-c0_cont_13" id="_DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory-c0_cont_12"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Pursuant to the authorization granted by the extraordinary general
shareholders&#8217; meeting, the board of directors was authorized to increase the share capital of the Company on one or several occasions
by a maximum aggregate amount of EUR <ix:nonFraction contextRef="c267" decimals="2" format="ixt:num-dot-decimal" name="tmdx:AggregateAmount" scale="0" unitRef="eur">90,132,067.69</ix:nonFraction> (excluding issue premium, as the case may be) for a period of <ix:nonNumeric contextRef="c267" name="tmdx:SeveralOccasionsPeriod">5 years</ix:nonNumeric> as from June
1, 2021.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory-c0_cont_14" id="_DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory-c0_cont_13"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><ix:nonNumeric contextRef="c267" name="tmdx:DescriptionOfDirectors">The board of directors has used its powers under the authorized capital
on (i) November 8, 2021, by issuing 37,500,000 new shares (3,750,000 ADSs) for an aggregate amount of &#8364;28,530,000.00 (excluding issue
premium), and (ii) August 11, 2022, by issuing 6,911,710 new shares (691,171 ADSs) for an aggregate amount of &#8364;4,877,097.50. Moreover,
subsequent to the balance sheet date (and as described further in Note 27), the board of directors has used its powers under the authorized
capital at the occasion of the February 2023 capital increase.</ix:nonNumeric> As a result, the board of directors therefore still has the authority under
the authorized capital to increase the Company&#8217;s share capital with an aggregate amount of &#8364;16,792,505.80 (excluding issue
premium, as the case may be).</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory-c0_cont_15" id="_DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory-c0_cont_14"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; ">In addition to the outstanding shares of
the Company:</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify; text-indent: -0.25in">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory-c0_cont_16" id="_DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory-c0_cont_15"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left"><ix:nonNumeric contextRef="c0" continuedAt="tmdx_DescriptionOfSharesOutstanding-c0_cont_1" name="tmdx:DescriptionOfSharesOutstanding">&#9679;</ix:nonNumeric></td><td style="text-align: justify"><ix:continuation continuedAt="tmdx_DescriptionOfSharesOutstanding-c0_cont_2" id="tmdx_DescriptionOfSharesOutstanding-c0_cont_1"><span style="font-family: Times New Roman, Times, Serif">a
total of 13,895,280 subscription rights of the Company have been created, of which 12,257,780 subscription rights have been granted as
of December 31, 2022, which entitles their holders (assuming all subscription rights are granted and exercised) to subscribe to a total
of 12,257,780 new shares with voting rights (see Note 24 for further details). The remaining 1,637,500 subscription rights have not yet
been granted and are currently still managed by the Company&#8217;s board of directors;</span></ix:continuation></td>
</tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory-c0_cont_17" id="_DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory-c0_cont_16"><ix:continuation continuedAt="tmdx_DescriptionOfSharesOutstanding-c0_cont_3" id="tmdx_DescriptionOfSharesOutstanding-c0_cont_2"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">under
                                            the loan agreement entered into by the Company and Kreos Capital in July&#160;2021, a drawdown
                                            fee equal to 7% of the amounts drawn down under the loan agreement (being EUR&#160;630,000
                                            in aggregate) remains outstanding as a payable due by the Company (without accruing interest),
                                            and is convertible into ordinary shares with voting rights by means of a contribution in
                                            kind of the payable by Kreos Capital to the share capital of the Company at a price of &#8364;0.85
                                            per share (see Note 24 for further details); and,</span></td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 144 --><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify">&#160;</p><div>

</div><ix:continuation id="_DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory-c0_cont_17"><ix:continuation id="tmdx_DescriptionOfSharesOutstanding-c0_cont_3"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.25in"></td><td style="width: 0.25in">&#9679;</td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">under
                                            the loan and security agreement entered into by the Company and Innovatus Capital Partners
                                            in August 2022, Innovatus has the right to convert, prior to August&#160;2, 2025, up to 15%
                                            of the outstanding principal amount of the loans (by means of a contribution in kind of the
                                            relevant payables due by the Company under the loans) into American Depositary Shares (&#8220;ADSs&#8221;)&#160;of
                                            the Company (each representing 10 ordinary shares of the Company) at a conversion price per&#160;ADS&#160;equal
                                            to $11.21 (i.e., $1.121 per share on the basis of the ratio of 1 ADS per 10 shares) (see
                                            note 16 for further details).</span></td></tr></table></ix:continuation></ix:continuation><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify; text-indent: -0.25in"><span style="font-variant: small-caps"><b><i>&#160;</i></b></span></p><div>

</div><ix:nonNumeric contextRef="c0" continuedAt="tmdx_RetirementBenefitSchemesTextBlock-c0_cont_1" escape="true" name="tmdx:RetirementBenefitSchemesTextBlock"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>NOTE 23: Retirement benefit plans</i></b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-transform: uppercase">&#160;</span></p></ix:nonNumeric><div>

</div><div>

</div><ix:continuation continuedAt="tmdx_RetirementBenefitSchemesTextBlock-c0_cont_2" id="tmdx_RetirementBenefitSchemesTextBlock-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Company operates defined contribution plans
for all its qualifying employees. The assets of these plans are held separately from those of the Company in designated funds.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="tmdx_RetirementBenefitSchemesTextBlock-c0_cont_3" id="tmdx_RetirementBenefitSchemesTextBlock-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">A total cost of $<ix:nonFraction contextRef="c0" decimals="0" format="ixt:num-dot-decimal" name="tmdx:TotalCost" scale="0" unitRef="usd">724,000</ix:nonFraction> in 2022 (2021: $<ix:nonFraction contextRef="c3" decimals="0" format="ixt:num-dot-decimal" name="tmdx:TotalCost" scale="0" unitRef="usd">594,000</ix:nonFraction>)
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</div><div>

</div><ix:continuation continuedAt="tmdx_RetirementBenefitSchemesTextBlock-c0_cont_4" id="tmdx_RetirementBenefitSchemesTextBlock-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The employees of the Company in Belgium are members
of a state-managed retirement benefit plan operated by the government (<i>i.e.</i>, legal pension) and are members of a bank-operated
private pension plan. The Company is required to contribute a specified percentage of payroll costs to the retirement benefit plan to
fund the benefits. The obligation of the Company with respect to the retirement benefit plan is to make the specified contributions.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation id="tmdx_RetirementBenefitSchemesTextBlock-c0_cont_4"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Because the Company must guarantee the statutory
minimum return on these plans, not all actuarial and investment risks relating to these plans are transferred to the insurance company
or pension fund managing the plans. The Company has considered the potential impact of the employer&#8217;s obligation to guarantee a
minimum return and that this was assessed not to be significant.</p></ix:continuation><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>&#160;</i></b></p><div>

</div><ix:nonNumeric contextRef="c0" continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_1" escape="true" name="ifrs-full:DisclosureOfSharebasedPaymentArrangementsExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>NOTE 24: Share-based payments</i></b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-transform: uppercase"><b>&#160;</b></span></p></ix:nonNumeric><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_2" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">This section provides an overview of the outstanding
warrants as of December 31, 2022. The warrants were created within the context of stock-based incentive plans for employees, directors
and consultants of the Company.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_3" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Company has created several pools of warrants under stock option
plans for grant to eligible employees, Directors, and consultants. On March 15, 2012 (<ix:nonFraction contextRef="c271" decimals="0" format="ixt:num-dot-decimal" name="tmdx:WarrantsUnderStockOptionPlansForGrantToEmployees" scale="0" unitRef="usd">195,000</ix:nonFraction>), June 15, 2012 (<ix:nonFraction contextRef="c272" decimals="0" format="ixt:num-dot-decimal" name="tmdx:WarrantsUnderStockOptionPlansForGrantToDirectors" scale="0" unitRef="usd">700,000</ix:nonFraction>), June 23, 2014
(<ix:nonFraction contextRef="c273" decimals="0" format="ixt:num-dot-decimal" name="tmdx:WarrantsUnderStockOptionPlansForGrantToConsultants" scale="0" unitRef="usd">1,500,000</ix:nonFraction>), June 19, 2017 (<ix:nonFraction contextRef="c274" decimals="0" format="ixt:num-dot-decimal" name="tmdx:WarrantsUnderStockOptionPlansForGrantToEmployees" scale="0" unitRef="usd">2,500,000</ix:nonFraction>), June 21, 2019 (<ix:nonFraction contextRef="c275" decimals="0" format="ixt:num-dot-decimal" name="tmdx:WarrantsUnderStockOptionPlansForGrantToDirectors" scale="0" unitRef="usd">3,000,000</ix:nonFraction>), May 27, 2021 (<ix:nonFraction contextRef="c276" decimals="0" format="ixt:num-dot-decimal" name="tmdx:WarrantsUnderStockOptionPlansForGrantToConsultants" scale="0" sign="-" unitRef="usd">3,600,000</ix:nonFraction>) and May 25, 2022 (<ix:nonFraction contextRef="c277" decimals="0" format="ixt:num-dot-decimal" name="tmdx:WarrantsUnderStockOptionPlansForGrantToConsultants" scale="0" sign="-" unitRef="usd">5,000,000</ix:nonFraction>). <ix:nonNumeric contextRef="c0" name="tmdx:WarrantsDescription">In aggregate
17,310,800 warrants were issued, subject to warrants being granted to and accepted by the beneficiaries. 18,150 of these warrants never
allocated have become null and void, resulting in a remaining and outstanding 17,296,650 warrants, (i) 2,840,397 warrants were terminated
or lapsed, (ii) 577,123 warrants were exercised, (iii) 12,257,780 warrants were granted but not yet exercised, and (iv) 1,637,500 warrants
were not yet granted by the Company. For the year 2022, 590,345 warrants (2021: 304,968) were terminated or lapsed, no warrants were exercised,
and 2,127,021 warrants (2021: 795,250) were vested. As a result, as at December 31, 2022, there are 12,257,780 warrants outstanding, entitling
their holders to subscribe to 12,257,780 shares of the Company.</ix:nonNumeric></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_4" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_3"><ix:nonNumeric contextRef="c0" escape="true" name="ifrs-full:DisclosureOfNumberAndWeightedAverageExercisePricesOfShareOptionsExplanatory"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <tr style="vertical-align: bottom">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  </table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:nonNumeric></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_5" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_4"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The warrants are granted to employees (mainly),
consultants or directors of the Company and its subsidiaries. Each warrant entitles its holders to subscribe to one new share of the
Company at a subscription price determined by the board of directors, within the limits decided upon at the occasion of their issuance.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_6" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_5"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The warrants issued have generally a term of
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</div><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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rule which are, if applicable, specified in the relevant stock option plans. The warrants granted under the June 23, 2014 Stock Option
Plan to directors all vest on the date of the annual meeting that takes place in the calendar year following the calendar year in which
they were granted, provided that the mandate of the relevant director has not ended or been terminated. The warrants granted under the
June 23, 2014 Stock Option Plan to beneficiaries who are not directors all vest in instalments of <ix:nonFraction contextRef="c0" decimals="2" format="ixt:num-dot-decimal" name="tmdx:VestInInstalmentPercentage" scale="-2" unitRef="pure">25</ix:nonFraction>% per year, the first tranche of
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granted under the June 21, 2019 Stock Option Plan, the May 27, 2021 Stock Option Plan and under the May 25, 2022 Stock Option Plan to
specific beneficiaries (Directors and Management Team) may adopt a manual vesting procedure under certain conditions or a particular
vesting period over 3 years.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_8" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_7"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The table below presents the outstanding warrants
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_9" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_8"><ix:nonNumeric contextRef="c0" escape="true" name="tmdx:ScheduleOfOutstandingWarrantsAndTheirExercisePriceTableTextBlock"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <tr style="vertical-align: bottom">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left">Granted in 2022</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; ">
    <td>Outstanding 31 December 2022</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td>Exercisable at 31 December 2022</td><td>&#160;</td>
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_10" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_9"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The following table provides an overview of the outstanding potential
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_11" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_10"><ix:nonNumeric contextRef="c0" escape="true" name="tmdx:ScheduleOfTheOutstandingPotentialSharesFromWarrantsPerPersonnelCategoryTableTextBlock"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_12" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_11"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The share-based compensation expense recognized
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_13" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_12"><ix:nonNumeric contextRef="c0" escape="true" name="tmdx:DisclosureOfSharebasedCompensationExpenseRecognizedInTheStatementOfComprehensiveIncomeExplanatory"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_14" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_13"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Cumulated Share-based compensation amount
is part of the Total Shareholders&#8217; Equity on the Consolidated statement of financial position. This amount is presented on the
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_15" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_14"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The weighted average exercise price of all outstanding
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</div><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></p><div>

</div><!-- Field: Page; Sequence: 146 --><div>
    </div><div style="border-bottom: Black 1.5pt solid; margin-top: 12pt; margin-bottom: 6pt"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->39<!-- Field: /Sequence --></p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_16" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_15"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The fair value of each warrant is estimated on
the date of grant using the Black-Scholes methodology with the following assumptions:</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_17" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_16"><ix:nonNumeric contextRef="c0" escape="true" name="ifrs-full:DisclosureOfIndirectMeasurementOfFairValueOfGoodsOrServicesReceivedShareOptionsGrantedDuringPeriodExplanatory"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">24-Jul-19</span></td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; ">
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    <td style="text-align: left">&#8364;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-145">0,80</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">30-Jul-20</span></td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; ">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">01-Oct-20</span></td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">01-Jun-21</span></td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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</div><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 147 --><div>
    </div><div style="border-bottom: Black 1.5pt solid; margin-top: 12pt; margin-bottom: 6pt"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->40<!-- Field: /Sequence --></p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_18" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_17"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">The above inputs for the Black-Scholes model have been determined
based on the following:</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_19" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_18"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
dividend return is estimated by reference to the historical dividend payment of the Company. Currently, this is estimated to be zero
as no dividends have been paid since inception.</span></td>
</tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>
</div><div>

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<td style="width: 0.25in"></td><td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
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</div><div>

</div><ix:continuation id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_20"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
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</tr></table></ix:continuation><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;&#160;</p><div>

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</div><div>

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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfRelatedPartyExplanatory-c0_cont_3" id="_DisclosureOfRelatedPartyExplanatory-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>Remuneration
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</div><div>

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</div><div>

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</div><div>

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</div><div>

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</div><div>

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</div><div>

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</div><div>

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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfRelatedPartyExplanatory-c0_cont_11" id="_DisclosureOfRelatedPartyExplanatory-c0_cont_10"><p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0">The following table sets forth the number of warrants that were exercised,
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfRelatedPartyExplanatory-c0_cont_12" id="_DisclosureOfRelatedPartyExplanatory-c0_cont_11"><ix:nonNumeric contextRef="c0" escape="true" name="tmdx:DisclosureOfWarrantsTableTextBlock"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <tr style="vertical-align: bottom">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfRelatedPartyExplanatory-c0_cont_13" id="_DisclosureOfRelatedPartyExplanatory-c0_cont_12"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">No loans, quasi-loans or other guarantees are
outstanding with members of the executive management team.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:continuation continuedAt="_DisclosureOfRelatedPartyExplanatory-c0_cont_14" id="_DisclosureOfRelatedPartyExplanatory-c0_cont_13"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>Remuneration
of the Board</i></b></span></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-transform: uppercase"><b><i>&#160;</i></b></span></p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfRelatedPartyExplanatory-c0_cont_15" id="_DisclosureOfRelatedPartyExplanatory-c0_cont_14"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The total remuneration of the Board of Directors
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compensation and reimbursement of expenses). No advances or credits have been granted to any member of the Board of Directors. None of
the members of the Board of Directors have received any non-monetary remuneration other than warrants as disclosed above.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfRelatedPartyExplanatory-c0_cont_16" id="_DisclosureOfRelatedPartyExplanatory-c0_cont_15"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-variant: small-caps"><b><i>Transactions with Non-Executive
Directors</i></b></span></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfRelatedPartyExplanatory-c0_cont_17" id="_DisclosureOfRelatedPartyExplanatory-c0_cont_16"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Since 2012, the Non-Independent Directors do
not receive a fee payment for attending and preparing for Board meetings or for assisting the Company with Board matters. They receive
reimbursement for expenses directly related to the Board meetings, totaling less than $<ix:nonFraction contextRef="c2" decimals="0" format="ixt:num-dot-decimal" name="ifrs-full:ExpectedReimbursementOtherProvisions" scale="0" unitRef="usd">23,000</ix:nonFraction> in 2022.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfRelatedPartyExplanatory-c0_cont_18" id="_DisclosureOfRelatedPartyExplanatory-c0_cont_17"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Independent Directors receive a fee for attending
and preparing meetings of the Board of Directors and for assisting the Company with Board matters, and they receive reimbursement for
expenses directly related to the Board meetings. In 2022, 2021, and 2020, fees and expense reimbursement in the amount of $<ix:nonFraction contextRef="c0" decimals="0" format="ixt:num-dot-decimal" name="tmdx:ReimbursementForExpenses" scale="0" unitRef="usd">314,000</ix:nonFraction>, $<ix:nonFraction contextRef="c3" decimals="0" format="ixt:num-dot-decimal" name="tmdx:ReimbursementForExpenses" scale="0" unitRef="usd">302,000</ix:nonFraction>,
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</div><div>

</div><ix:continuation id="_DisclosureOfRelatedPartyExplanatory-c0_cont_18"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">No warrants were granted to Non-Executive Directors in 2022 and no
warrants were exercised in 2022.</p></ix:continuation><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><ix:nonNumeric contextRef="c0" continuedAt="_DisclosureOfCommitmentsAndContingentLiabilitiesExplanatory-c0_cont_1" escape="true" name="ifrs-full:DisclosureOfCommitmentsAndContingentLiabilitiesExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>NOTE 26: Significant agreements, commitments
and contingencies</i></b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-transform: uppercase"><b>&#160;</b></span></p></ix:nonNumeric><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfCommitmentsAndContingentLiabilitiesExplanatory-c0_cont_2" id="_DisclosureOfCommitmentsAndContingentLiabilitiesExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>Fair
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfCommitmentsAndContingentLiabilitiesExplanatory-c0_cont_3" id="_DisclosureOfCommitmentsAndContingentLiabilitiesExplanatory-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On September 18, 2015, MDxHealth acquired MDxHealth
BV (former NovioGendix), a Dutch molecular diagnostic research and service company with expertise in the urological oncology. The terms
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the average closing price of the Company&#8217;s shares on Euronext Brussels during a period of 30 days ending on September 17, 2015.
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is contractually required to pay at maturity to the holder of the obligation the amount of maximum $<ix:nonFraction contextRef="c2" decimals="-5" format="ixt:num-dot-decimal" name="ifrs-full:CurrentHeldtomaturityInvestments" scale="6" unitRef="usd">2.2</ix:nonFraction> million. Based on its judgement
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liabilities (current and non-current) as detailed in Note 16.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><ix:continuation continuedAt="_DisclosureOfCommitmentsAndContingentLiabilitiesExplanatory-c0_cont_4" id="_DisclosureOfCommitmentsAndContingentLiabilitiesExplanatory-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">As part of the acquisition of the GPS business
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which has been accounted for under other non-current liabilities as further detailed in Note 3. The liability recognized reflects a probability-weighted
estimate at the current net present value which is expected to become payable. Future fair value adjustments to this contingent consideration
will be recognized in the statement of profit or loss. The value of the contingent liability for GPS is $<ix:nonFraction contextRef="c336" decimals="-5" format="ixt:num-dot-decimal" name="ifrs-full:EstimatedFinancialEffectOfContingentLiabilities" scale="6" unitRef="usd">52.9</ix:nonFraction> million as of December 31,
2022, and was accounted for as other non-current financial liabilities as detailed in Note 16.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>&#160;</i></b></span></p></ix:continuation><div>
</div><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 149 --><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>&#160;</i></b></span></p><div>

</div><ix:continuation continuedAt="_DisclosureOfCommitmentsAndContingentLiabilitiesExplanatory-c0_cont_5" id="_DisclosureOfCommitmentsAndContingentLiabilitiesExplanatory-c0_cont_4"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>Collaborative
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfCommitmentsAndContingentLiabilitiesExplanatory-c0_cont_6" id="_DisclosureOfCommitmentsAndContingentLiabilitiesExplanatory-c0_cont_5"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Company has entered into numerous agreements
with universities, medical centers and external researchers for research and development work and for the validation of the Company&#8217;s
technology and products. These agreements typically have durations of <ix:nonNumeric contextRef="c337" continuedAt="_UsefulLifeMeasuredAsPeriodOfTimeBiologicalAssetsAtCost-c337_cont_1" format="ixt-sec:durwordsen" name="ifrs-full:UsefulLifeMeasuredAsPeriodOfTimeBiologicalAssetsAtCost">one</ix:nonNumeric> to <ix:nonNumeric contextRef="c338" format="ixt-sec:durwordsen" name="ifrs-full:UsefulLifeMeasuredAsPeriodOfTimeBiologicalAssetsAtCost">three<ix:continuation id="_UsefulLifeMeasuredAsPeriodOfTimeBiologicalAssetsAtCost-c337_cont_1"> years</ix:continuation></ix:nonNumeric>. The Company must pay fixed fees to the collaborators
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfCommitmentsAndContingentLiabilitiesExplanatory-c0_cont_7" id="_DisclosureOfCommitmentsAndContingentLiabilitiesExplanatory-c0_cont_6"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">MDxHealth collaborates on research and clinical
development with many of the world&#8217;s leading academic and government cancer research institutes. These important relationships
provide the Company with additional resources and expertise for clinical marker validation as well as access to patient samples for testing.
MDxHealth&#8217;s collaborators include such prestigious institutions as Johns Hopkins University Medical Institutions (US), Duke University
Medical Center (US), Harvard Medical School (US), Cleveland Clinic (US), University of Colorado (US) and University of California at
Los Angeles (US) among others.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfCommitmentsAndContingentLiabilitiesExplanatory-c0_cont_8" id="_DisclosureOfCommitmentsAndContingentLiabilitiesExplanatory-c0_cont_7"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>Intellectual
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfCommitmentsAndContingentLiabilitiesExplanatory-c0_cont_9" id="_DisclosureOfCommitmentsAndContingentLiabilitiesExplanatory-c0_cont_8"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Company has entered into numerous agreements
with universities and companies for in-licensing intellectual property. These agreements typically require the Company to pay an up-front
fee, annual maintenance fees and/or minimum annual royalty fees, legal fees related to the patents, and certain milestone and royalty
fees if the patents are eventually used in a commercialized product. In addition, the Company must provide the licensor with periodic
reports.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfCommitmentsAndContingentLiabilitiesExplanatory-c0_cont_10" id="_DisclosureOfCommitmentsAndContingentLiabilitiesExplanatory-c0_cont_9"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>Commercial
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfCommitmentsAndContingentLiabilitiesExplanatory-c0_cont_11" id="_DisclosureOfCommitmentsAndContingentLiabilitiesExplanatory-c0_cont_10"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Company has entered into numerous partnering
and sub-licensing agreements. With regards to the Company&#8217;s developed tests, the Company has entered into a range of marketing and
sales arrangements with commercial entities. These important relationships provide the Company with additional resources and infrastructure
to expand the geographic reach and awareness of the Company&#8217;s solutions, primarily in relation to the Confirm mdx and Select mdx
tests. MDxHealth&#8217;s marketing partners include, Ferrer Internacional (Spain), Teva Pharmaceuticals (Israel), and SouthGenetics (South
and Central America), LifeLabs (Canada) and, in the US, LabCorp, Miraca Life Sciences, Bostwick Laboratories.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;&#160;</p></ix:continuation><div>
</div><div>

</div><ix:continuation continuedAt="_DisclosureOfCommitmentsAndContingentLiabilitiesExplanatory-c0_cont_12" id="_DisclosureOfCommitmentsAndContingentLiabilitiesExplanatory-c0_cont_11"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In regard to intellectual property that MDxHealth
has developed or improved, MDxHealth has sublicensed certain of its non-core technologies to commercial partners, several of whom have
launched products that generate royalties and other fees. These sublicenses include an exclusive sublicense to Laboratory Corporation
of America (LabCorp) for the MGMT test, which LabCorp began to commercialize in North America in 2008, and an exclusive sublicense to
Vesica Health, Inc. for the Company&#8217;s patented AssureMDx test for the purpose of bladder cancer detection on a worldwide basis.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-transform: uppercase"><b><i>&#160;</i></b></span></p></ix:continuation><div>

</div><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 150 --><div>
    </div><div style="border-bottom: Black 1.5pt solid; margin-top: 12pt; margin-bottom: 6pt"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->43<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-transform: uppercase"><b><i>&#160;</i></b></span></p><div>

</div><ix:continuation continuedAt="_DisclosureOfCommitmentsAndContingentLiabilitiesExplanatory-c0_cont_13" id="_DisclosureOfCommitmentsAndContingentLiabilitiesExplanatory-c0_cont_12"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>Litigation</i></b></span></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation id="_DisclosureOfCommitmentsAndContingentLiabilitiesExplanatory-c0_cont_13"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">As of the date of this document and as far as
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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</div><div>

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assuming an exchange rate of &#8364;1 = $1.0988 as published by the European Central bank on February 2, 2023 and a 10-for-1 ADS to share
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfEventsAfterReportingPeriodExplanatory-c0_cont_3" id="_DisclosureOfEventsAfterReportingPeriodExplanatory-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On March 6, 2023, the Company announced that,
in the context of the above-mentioned offering, the underwriters exercised the option to purchase additional ADSs, on the same terms
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</div><div>

</div><ix:continuation id="_DisclosureOfEventsAfterReportingPeriodExplanatory-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On April 19, 2023, the Company announced that it has received notice
that its Select mdx for Prostate Cancer test has successfully completed the technical assessment process with the Molecular Diagnostics
Services (MolDX) Program developed by Palmetto GBA. Select mdx will be reimbursed throughout the U.S. for Medicare patients who meet coverage
conditions under the foundational Local Coverage Determination (LCD) for Molecular Biomarkers to Risk-Stratify Patients at Increased Risk
for Prostate Cancer.</p></ix:continuation><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:nonNumeric contextRef="c0" continuedAt="_DescriptionOfAccountingPolicyForSubsidiariesExplanatory-c0_cont_1" escape="true" name="ifrs-full:DescriptionOfAccountingPolicyForSubsidiariesExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b><i>NOTE 28: Subsidiaries</i></b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-transform: uppercase"><b><i>&#160;</i></b></span></p></ix:nonNumeric><div>

</div><div>

</div><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForSubsidiariesExplanatory-c0_cont_2" id="_DescriptionOfAccountingPolicyForSubsidiariesExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">The Company has the following two wholly-owned direct subsidiaries:</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation id="_DescriptionOfAccountingPolicyForSubsidiariesExplanatory-c0_cont_2"><ix:nonNumeric contextRef="c0" escape="true" name="tmdx:ScheduleOfWhollyOwnedDirectSubsidiariesTableTextBlock"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
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    <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p></td>
    <td style="padding-bottom: 1.5pt; width: 2%">&#160;</td>
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    <td style="text-underline-color: #000000"><ix:nonNumeric contextRef="c231" format="ixt:date-monthname-day-year-en" name="tmdx:IncorporationDate"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">April 14, 2003</span></ix:nonNumeric></td></tr>
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    <td style="text-underline-color: #000000">&#160;</td>
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    <td style="padding-bottom: 1.5pt">&#160;</td>
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    <td>&#160;</td>
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  <tr style="vertical-align: top">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps">&#160;</span></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><!-- Field: Page; Sequence: 151 --><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-variant: small-caps"><b><i>&#160;</i></b></span></p><div>

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</div><div>

</div><ix:continuation continuedAt="tmdx_PrincipalAuditFeesAndServicesTextBlock-c0_cont_2" id="tmdx_PrincipalAuditFeesAndServicesTextBlock-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">During the past fiscal year, in addition to their
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</div><div>

</div><ix:continuation continuedAt="tmdx_PrincipalAuditFeesAndServicesTextBlock-c0_cont_3" id="tmdx_PrincipalAuditFeesAndServicesTextBlock-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The detail is presented in the table below:</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation id="tmdx_PrincipalAuditFeesAndServicesTextBlock-c0_cont_3"><ix:nonNumeric contextRef="c0" escape="true" name="tmdx:ScheduleOfStatutoryAuditorPerformedAdditionalActivitiesTableTextBlock"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt">F-45</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></p><div>

</div><!-- Field: Rule-Page --><div style="margin-top: 0pt; margin-bottom: 0pt; width: 100%"><div style="border-top: Black 1.5pt solid; font-size: 1pt">&#160;</div></div><!-- Field: /Rule-Page --><div>

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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
20-F
(Mark One)
☐
REGISTRATION STATEMENT PURSUANT TO SECTION
12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934
OR
☒
ANNUAL REPORT PURSUANT TO SECTION 13
OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
for the fiscal year ended
December 31
,
2022
OR
☐
TRANSITION REPORT PURSUANT TO SECTION
13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
OR
☐
SHELL COMPANY REPORT PURSUANT TO SECTION
13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of event requiring this shell company report:
_________
for the transition period from _________ to
_________
Commission File Number:
001- 40996
MDXHEALTH SA
(Exact name of registrant as specified in its charter)
Belgium
(Jurisdiction of incorporation or organization)
CAP Business Center
Zone Industrielle des Hauts-Sarts
4040
Herstal
,
Belgium
(Address of principal executive offices)
Michael McGarrity
Chief Executive Officer
MDxHealth, Inc.
15279 Alton Parkway
—
Suite 100
Irvine
,
CA
92618
United States
+1 949
-
812-6979
(Name, Telephone, E-mail and/or Facsimile number
and Address of Company Contact Person)
Securities registered or to be registered pursuant to Section 12(b)
of the Act:
Title of each class
Trading Symbol
Name of each exchange on which registered
American Depositary Shares, each representing 10 ordinary shares, no nominal value per share
MDXH
The Nasdaq Capital Market
Ordinary shares, no par value*
*
The
Nasdaq
Capital Market*
*
Not for trading, but only in connection with the listing of the American Depositary Shares on The Nasdaq Stock Market LLC.
Securities registered or to be registered pursuant
to Section 12(g) of the Act.
None
Securities for which there is a reporting obligation
pursuant to Section 15(d) of the Act.
None
Indicate the number of outstanding shares of
each of the issuer's class of capital or common stock as of the close of the period covered by the annual report.
Ordinary shares,
no nominal value per share: 162,880,936 as of December 31, 2022.
Indicate by check mark if the registrant is a
well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐
No
☒
If this report is an annual or transition report,
indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act
of 1934. Yes ☐
No
☒
Note - Checking the box above will not relieve
any registrant required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 from their obligations
under those Sections.
Indicate by check mark whether the registrant
(1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements
for the past 90 days.
Yes
☒   No ☐
Indicate by check mark whether the registrant
has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405
of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Yes
☒   No ☐
Indicate by check mark whether the registrant
is a large accelerated filer, accelerated filer, a non-accelerated filer, or an emerging growth company. See definition of "large
accelerated filer", "accelerated filer" and "emerging growth company" in Rule 12b-2 of the Exchange Act.
Large accelerated filer
☐
Accelerated filer
☐
Non-accelerated filer
☒
Emerging Growth Company
☒
If an emerging growth company that prepares its
financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition
period for complying with any new or revised financial accounting standards† provided pursuant to Section 13(a) of the Exchange
Act.
☐
†
The term "new or revised financial accounting standard" refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.
Indicate by check mark whether the registrant
has filed a report on and attestation to its management's assessment of the effectiveness of its internal control over financial
reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or
issued its audit report.
☐
If securities are registered pursuant to Section
12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction
of an error to previously issued financial statements. ☐
Indicate by check mark whether any of those error
corrections are restatements that required a recovery analysis of incentive based compensation received by any of the registrant's
executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark which basis of accounting
the registrant has used to prepare the financial statements included in this filing:
U.S. GAAP ☐
International Financial Reporting Standards
as issued by the
International Accounting Standards Board ☒
Other ☐
If "Other" has been checked in response
to the previous question, indicate by check mark which financial statement item the registrant has elected to follow: Item 17 ☐   Item
18 ☐
If this is an annual report, indicate by check
mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐   No
☒
TABLE OF CONTENTS
Page
INTRODUCTION
ii
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
iii
PART I
1
Item 1.
Identity of Directors, Senior Management and Advisers
1
Item 2.
Offer Statistics and Expected Timetable
1
Item 3.
Key Information
1
Item 4.
Information on the Company
30
Item 4a.
Unresolved Staff Comments
54
Item 5.
Operating and Financial Review and Prospects
54
Item 6.
Directors, Senior Management and Employees
65
Item 7.
Major Shareholders and Related Party Transactions
77
Item 8.
Financial Information
80
Item 9.
The Offer and Listing
81
Item 10.
Additional Information
82
Item 11.
Quantitative and Qualitative Disclosures about Market Risk
92
Item 12.
Description of Securities Other than Equity Securities
93
PART II
95
Item 13.
Defaults, Dividend Arrearages and Delinquencies
95
Item 14.
Material Modifications to the Rights of Security Holders and Use of Proceeds
95
Item 15.
Controls and Procedures
95
Item 16.
Reserved
95
Item 16A.
Audit Committee Financial Expert
96
Item 16B.
Code of Ethics
96
Item 16C.
Principal Accountant Fees and Services
96
Item 16D.
Exemptions from the Listing Standards for Audit Committees
96
Item 16E.
Purchases of Equity Securities by the Issuer and Affiliated Purchasers
96
Item 16F.
Change in Registrant's Certifying Accountant
96
Item 16G.
Corporate Governance
97
Item 16H.
Mine Safety Disclosure
98
Item 16I.
Disclosure Regarding Foreign Jurisdictions That Prevent Inspections
98
PART III
99
Item 17.
Financial Statements
99
Item 18.
Financial Statements
99
Item 19.
Exhibits
99
i
INTRODUCTION
Unless otherwise indicated or the context otherwise
requires, references in this annual report to "we," "our," "us," "MDxHealth," or the "Company"
refer to MDxHealth SA and its wholly owned subsidiaries.
We were incorporated on January 10, 2003
as a company with limited liability (
naamloze vennootschap/société anonyme
) incorporated and operating under the
laws of Belgium. We are registered with the legal entities register (Liège) under enterprise number 0479.292.440. We were publicly
listed on Euronext Brussels in June 2006. In October 2010 the Company's name was changed from OncoMethylome Sciences SA to MDxHealth
SA. We have two directly held, wholly owned subsidiaries: MDxHealth, Inc., a Delaware company incorporated in April 2003, and MDxHealth
B.V., a Dutch company incorporated in September 2015.
Our headquarters and principal executive offices
are located at CAP Business Center, Zone Industrielle des Hauts-Sarts, Rue d'Abhooz 31, 4040 Herstal, Belgium, our telephone
number is +32 4 257 70 21 and our email is info@mdxhealth.com. Our website address is
www.mdxhealth.com
. The information contained
on, or accessible through, our website is not incorporated by reference into this annual report, and you should not consider any information
contained in, or that can be accessed through, our website as part of this annual report.
Our American Depositary Shares, each representing
10 ordinary shares, began trading on the Nasdaq Capital Market on November 4, 2021. Throughout this annual report, references to ADSs
mean American Depository Shares or ordinary shares represented by ADSs, as the case may be. All references in this annual report to "$"
are to U.S. dollars and all references to "€" are to Euros. Solely for the convenience of the reader, certain Euro amounts
herein have been translated into U.S. dollars at the official exchange rate quoted as of December 31, 2022, by the European Central Bank
of €1.00 to $1.067. These translations should not be considered representations that any such amounts have been, could have been
or could be converted into U.S. dollars at that or any other exchange rate as at that or any other date.
Trademarks and Service Marks
We own various trademark registrations and applications,
and unregistered trademarks and service marks. "MDxHealth," "Confirm mdx," "Select mdx," "Resolve
mdx," "Genomic Prostate Score," "GPS," "Monitor mdx," the MDxHealth logo and other trademarks
or service marks of MDxHealth SA appearing in this annual report are the property of MDxHealth SA or its subsidiaries. Solely for convenience,
the trademarks, service marks and trade names referred to in this annual report are listed without the ® and ™ symbols, but
such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable
law, their rights thereto. All other trademarks, trade names and service marks appearing in this annual report are the property of their
respective owners. We do not intend to use or display other companies' trademarks and trade names to imply any relationship with,
or endorsement or sponsorship of us by, any other companies.
ii
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This annual report contains forward-looking statements.
All statements other than statements of historical facts contained in this annual report, including statements regarding our strategy,
future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected
market growth are forward-looking statements. Forward-looking statements give our current expectations or forecasts of future events.
You can find many (but not all) of these statements by looking for words such as "approximates," "believes," "hopes,"
"expects," "anticipates," "estimates," "projects," "intends," "plans,"
"would," "should," "could," "may" or other similar expressions in this annual report.
These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from
our historical experience and our present expectations or projections, including, but not limited to, those identified under Item 3D.
"Risk Factors
" in this annual report. Actual results may differ materially from those discussed as a result of various
factors, including, but not limited to:
●
our plans relating to commercializing our products and services (collectively "solutions") and the rate and degree of market acceptance of our solutions;
●
the size of the market opportunity for our Confirm mdx and Select mdx tests and other future tests and solutions we commercialize or may develop;
●
our ability to achieve and maintain adequate levels of coverage or reimbursement for our current and future solutions we commercialize or may seek to commercialize;
●
our plans relating to the further development of solutions;
●
existing regulations and regulatory developments in the United States, Europe and other jurisdictions;
●
timing, progress and results of our research and development programs;
●
the period over which we estimate our existing cash will be sufficient to fund our future operating expenses and capital expenditure requirements;
●
our ability to attract and retain qualified employees and key personnel;
●
the scope of protection we are able to establish and maintain for intellectual property rights covering our products solutions and technology;
●
our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties;
●
●
cost associated with defending intellectual property
    infringement, product liability and other claims;
the possibility that the anticipated benefits
from our business acquisitions will not be realized in full or at all or may take longer to realize than expected;
●
the impact on our business, financial condition and results of operations from the ongoing and global COVID-19 pandemic, or any other pandemic, epidemic or outbreak of an infectious disease in the United States or worldwide; and
●
other risks and uncertainties, including those listed under Item 3D.
"Risk Factors
."
These statements reflect our views with respect
to future events as of the date of this annual report and are based on assumptions and subject to risks and uncertainties. Given these
uncertainties, you should not place undue reliance on these forward-looking statements. These forward-looking statements represent our
estimates and assumptions only as of the date of this annual report and, except as required by law, we undertake no obligation to update
or review publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of
this annual report. We anticipate that subsequent events and developments will cause our views to change. You should read this annual
report and the documents referenced in this annual report and filed as exhibits to the annual report, completely and with the understanding
that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these
cautionary statements.
iii
MARKET AND INDUSTRY DATA
Unless otherwise indicated, information contained
in this annual report concerning our industry and the markets in which we operate, including our general expectations and market opportunity,
is based on information from our own management estimates and research, as well as from industry and general publications, research, surveys
and studies conducted by third parties. Management estimates are derived from publicly available information, our knowledge of our industry
and assumptions based on such information and knowledge, which we believe to be reasonable. Where information has been sourced from third
parties, this information has been accurately reproduced. As far as we are aware and are able to ascertain from information published
by those third parties, no facts have been omitted which would render the reproduced information inaccurate or misleading. The industry
publications and third-party studies generally state that the information that they contain has been obtained from sources believed
to be reliable, although they do not guarantee the accuracy or completeness of such information. Forecasts and other forward-looking information
obtained from these sources are subject to the same qualifications and uncertainties as the other forward-looking statements in this
annual report. See "
Special Note Regarding Forward-Looking Statements.
" These forecasts and forward-looking information
are subject to uncertainty and risk due to a variety of factors, including those described under "
Risk Factors.
" These
and other factors could cause results to differ materially from those expressed in our forecasts or estimates or those of independent
third parties.
iv
PART I
ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT
AND ADVISERS
Not applicable.
ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE
Not applicable.
ITEM 3. KEY INFORMATION
A. [Reserved]
B. Capitalization and Indebtedness
Not applicable.
C. Reasons for the Offer and Use of Proceeds
Not applicable.
D. Risk Factors
Our business and our industry are subject to
significant risks. You should carefully consider the risks and uncertainties described below, together with all of the other information
in this annual report, including our audited consolidated financial statements and related notes. This annual report also includes forward-looking
statements that involve risks and uncertainties. See "
Special Note Regarding Forward-Looking Statements
." If any of
the following risks are realized, our business, financial condition, operating results and prospects could be materially and adversely
affected.
Summary of Risk Factors
●
We have a history of losses and expect to incur net losses in the future and may never achieve profitability.
●
We might require substantial additional funding to continue our operations and to respond to business needs or take advantage of new business opportunities, which may not be available on acceptable terms, or at all.
●
Our commercial success will depend on the market acceptance and adoption of our current and future tests.
●
We face uncertainties over the reimbursement of our tests by third party payors.
●
Billing and collections processing for our tests is complex and time-consuming, and any delay in transmitting and collecting claims could have an adverse effect on revenue.
●
Our business and reputation will suffer if we are unable to establish and comply with, stringent quality standards to assure that the highest level of quality is observed in the performance of our tests.
●
We expect to make significant investments to research and develop new tests, which may not be successful.
1
●
Failure to comply with governmental payor regulations could result in us being excluded from participation in Medicare, Medicaid or other governmental payor programs, which would adversely affect our business.
●
We conduct business in a heavily regulated industry, and changes in regulations or violations of regulations may, directly or indirectly, adversely affect our results of operations and financial condition and harm our business.
●
If the FDA were to begin requiring approval
or clearance of our tests, we could incur substantial costs and time delays associated with meeting requirements for premarket clearance
or approval. The dual listing of our ordinary shares and ADSs following the U.S. offering may adversely affect the liquidity and value
of the ADSs.
●
We may engage in acquisitions that are not
    successful and which could disrupt our business, cause dilution to our stockholders and reduce our financial resources.
Risks Related to Our Business and Industry
We have a history of losses and expect to
incur net losses in the future and may never achieve profitability.
We have incurred substantial net losses since
our inception, and there can be no assurance that we will achieve profitability. As of December 31, 2022, we had an accumulated deficit
of $288.3 million and for the year ended December 31, 2022, we had a net loss of $44.0 million and net cash used in operating activities
of $34.1 million. We expect our losses to continue as a result of costs relating to ongoing research and development and for increased
sales and marketing costs for existing and planned solutions. These losses have had, and will continue to have, an adverse effect on our
working capital, total assets, and stockholders' equity. Even if we achieve significant revenues, we may not become profitable,
and even if we achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Failure
to become and remain consistently profitable could adversely affect the market price of our common stock and could significantly impair
our ability to raise capital or expand our business in accordance with our growth strategy. Historically, we have been able to raise capital
at regular occasions. If we are unable to continue to do this, our ability to operate as a going concern could be seriously compromised.
We may require substantial additional funding
to continue our operations and to respond to business needs (including repayment of our outstanding debt) or take advantage of new business
opportunities, which may not be available on acceptable terms, or at all.
Our capital outlays and operating expenditures
are expected to increase over the next several years as commercial operations expand. We may require additional equity or debt funding
from time to time in case of a shortfall in cash inflows from operations or to respond to business needs (including repayment of our outstanding
debt) or take advantage of new business opportunities, which may not be available at acceptable terms, or at all. For more information
about our cash and cash equivalent position or total liquidity position, see also Item 5B. "
Liquidity and Capital Resources
."
Additionally, under the terms of the Asset Purchase
Agreement in relation to the acquisition of the Oncotype DX GPS prostate cancer business of Exact Sciences Corporation ("Exact Sciences"),
following the closing, an additional aggregate earn-out amount of up to $70 million is to be paid by us to Exact Sciences over the course
of 2024, 2025 and 2026, in an amount equal to a portion of the prior calendar year's reported revenues attributable to the Oncotype
DX GPS prostate cancer business, with the maximum earn-out payable in 2024 and 2025 not to exceed $30 million and $40 million, respectively.
At the our option, the earn-out amounts can be settled in cash or through the issuance of additional ADSs (valued in function of a volume
weighted average trading price of our shares at the end of the relevant earn-out period) to Exact Sciences, provided that the aggregate
number of shares representing the ADSs held by Exact Sciences will not exceed more than 5% of our outstanding shares.
2
If additional funds are raised through the sale
of equity, convertible debt or other equity-linked securities, our securityholders' ownership will be diluted. Any equity securities
issued also may provide for rights, preferences or privileges senior to those of holders of ordinary shares. If additional funds are raised
by issuing debt securities, these debt securities would have rights, preferences and privileges senior to those of shareholders, and the
terms of the debt securities issued could impose significant restrictions on our operations.
If adequate funds are not available, we may have
to scale back our operations or limit our research and development activities, which may cause us to grow at a slower pace, or not at
all, and our business could be adversely affected.
Our loan facility contains restrictions
that limit our flexibility in operating our business, and if we fail to comply with the covenants and other obligations under our loan
agreement, the lenders may be able to accelerate amounts owed under the facility and may foreclose upon the assets securing our obligations.
In August 2022, we entered into a $35 million
loan and security agreement with an affiliate of Innovatus Capital Partners, LLC ("Innovatus"). Under this agreement, at the
option of the Company, an additional $35 million can be drawn from Innovatus, consisting of a $20 million term B loan and a
$15 million term C loan, which can be drawn in 2024 and 2025 respectively, subject to certain conditions. There can be no assurance
that these conditions will be satisfied and that we will be able to draw any further term loan amounts under this facility.
The loans accrue interest at a floating per annum
rate equal to the sum of (a) the greater of (i) the prime rate published in The Wall Street Journal in the "Money Rates" section
or (ii) 4.00%, plus (b) 4.25%, and require interest-only payments for the initial four years. At our election, a portion of the interest
may be payable in-kind by adding an amount equal to 2.25% of the outstanding principal amount to the then outstanding principal balance
on a monthly basis until August 2025. The loans mature in August 2027. The lenders have the right to convert, prior to August 2025, up
to 15% of the outstanding principal amount of the loans into ADSs of the Company at a price per ADS of $11.21.
The loans are secured by substantially all assets
of the Company, including intellectual property related to our Confirm mdx, Select mdx and Genomic Prostate Score ("GPS")
tests. The loan agreement also subjects us to certain affirmative and negative covenants, including limitations on our ability to transfer
or dispose of assets, merge with or acquire other companies, make investments, pay dividends, incur additional indebtedness and liens
and conduct transactions with affiliates. As a result of these covenants, we have certain limitations on the manner in which we can conduct
our business, and we may be restricted from engaging in favorable business activities or financing future operations or capital needs
until our current debt obligations are paid in full or we obtain the consent of Innovatus, which we may not be able to obtain. We cannot
be certain that we will be able to generate sufficient cash flow or revenue to meet the financial covenants or pay the principal and accrued
interest on the debt.
In addition, upon the occurrence of an event of
default or a mandatory prepayment event, Innovatus, among other things, can declare all indebtedness due and payable immediately, which
would adversely impact liquidity and reduce the availability of cash flows to fund working capital needs, capital expenditures and other
general corporate purposes. An event of default or a mandatory prepayment event includes, but is not limited to, our failure to pay any
amount due and payable under the loan agreement, the breach of any representation or warranty in the loan agreement, the breach of any
covenant in the loan agreement (subject to a cure period in some cases), a change of control as defined in the loan agreement, certain
defaults on loan agreements with third parties and insolvency events and proceedings. If an event of default or a mandatory prepayment
event occurs and we are unable to repay amounts due under the loan agreement, Innovatus could foreclose on substantially all of our assets,
including intellectual property. We cannot be certain that future working capital, borrowings or equity financings will be available to
repay or refinance our debt to Innovatus or any other debt we may incur in the future.
Furthermore, we must meet certain covenants in
order to draw down an additional $20 million term B loan and a $15 million term C loan that remain available under the $70 million Innovatus
facility in 2024 and 2025, respectively. The availability of the $20 million term B loan and a $15 million term C loans are intended to
coincide with the anticipated contingent earn-out payment obligations due under the terms of the Asset Purchase Agreement in relation
to the acquisition of the Oncotype DX GPS prostate cancer business of Exact Sciences. If we do not have sufficient working capital to
fund our earn-out payment obligations to Exact Sciences if and when they become due, and we are also unable to meet loan covenants necessary
to draw down one or more of the additional Innovatus term loans, we may be unable to satisfy our contractual obligations to Exact Sciences,
resulting in a material breach under the Asset Purchase Agreement with Exact Sciences as well as an event of default under the loan agreement
with Innovatus, and our business could be adversely affected.
3
Our acceptance of a Paycheck Protection
Program loan subjects us to a variety of federal regulations and although we may apply for forgiveness of this loan it may not be forgiven.
In April 2020, we qualified for a $2.3 million
loan through the Paycheck Protection Program (the "PPP") of the U.S. Coronavirus Aid, Relief and Economic Security Act (the
"CARES Act"), under a loan agreement administered by the U.S. Small Business Administration. By participating in a federal
loan program, we become subject to increased governmental oversight and federal regulatory compliance obligations, including potential
civil and criminal liability for making false claims or statements under the U.S. False Claims Act, 31 USC. § 3729 et seq. (the "FCA").
Liability under the FCA and similar federal statutes can carry significant potential monetary penalties and potential jail time, and can
arise from both "knowing" and "willful" misstatements. FCA violations will result in a civil penalty per false
claim, of not less than $11,181 and not more than $22,363, plus treble the government's actual damages. A person who violates §
3729 will also be held liable for the government's costs for bringing a civil action to recover any penalty or damages. If, despite
our good faith belief that we satisfied all eligibility requirements for the PPP loan, we are found to have been ineligible to receive
the PPP loan or in violation of any of the laws or regulations that apply to us in connection with the PPP loan, we may be subject to
penalties, including under the FCA, and could be required to repay the PPP loan. Additionally, a review or audit by the U.S. Small Business
Administration ("SBA") or other government entity in connection with any future forgiveness application (if we chose to apply
for forgiveness) or claims under the False Claims Act could consume significant financial and management resources. Any of these events
could harm our business, results of operations and financial condition.
We may engage in acquisitions that are not
successful and which could disrupt our business, cause dilution to our stockholders and reduce our financial resources.
In addition to our acquisition of NovioGendix,
a privately held company based in Nijmegen, The Netherlands, in September 2015 and our acquisition of our GPS test from Genomic Health,
Inc., a subsidiary of Exact Sciences, in August 2022, we may enter into other transactions in the future to acquire other businesses,
products or technologies. We may be unable to realize the anticipated benefits of the acquisitions or do so within the anticipated timeframe.
Any acquisitions may not strengthen our competitive position, and these transactions may be viewed negatively by customers or investors.
We could incur losses resulting from undiscovered liabilities of the acquired business that are not covered by the indemnification we
may obtain from the seller. In addition, we may not be able to successfully integrate the acquired personnel, technologies and operations
into our existing business in an effective, timely and non-disruptive manner. If we are unable to do so, the disruption to our operations
could result in additional costs or could distract management's attention from other initiatives.
The molecular diagnostics industry is highly
competitive and characterized by rapid technological changes and we may be unable to keep pace with our competitors.
The molecular diagnostics field is characterized
by rapid technological changes, frequent new product introductions, changing customer preferences, emerging competition, evolving industry
and regulatory compliance standards, reimbursement uncertainty and price competition. Moreover, the molecular diagnostics field is intensely
competitive both in terms of service and price, and continues to undergo significant consolidation, permitting larger clinical laboratory
service providers to increase cost efficiencies and service levels, resulting in more intense competition.
The market for assessing men at risk for prostate
cancer diagnosis or aggressiveness is large. As a result, this market has attracted competitors, some of which possess substantially greater
financial, selling, logistical and laboratory resources, more experience in dealing with third-party payors, and greater market penetration,
purchasing power and marketing budgets, as well as more experience in providing diagnostic services. Some companies and institutions are
developing serum-based tests and diagnostic tests based on the detection of proteins, nucleic acids or the presence of fragments
of mutated genes in the blood that are associated with prostate cancer. These competitors could have technological, financial, reputational,
and market access advantages over us.
4
Regarding our Confirm mdx for Prostate Cancer
tissue-based test, several directly competitive products are currently commercially available. In 2014, OPKO Health, Inc., a NYSE
listed company, launched the 4Kscore test, a blood based 4-plex test which combines the results of the blood test with clinical information
in an algorithm that calculates a patient's percent risk for aggressive prostate cancer prior to a biopsy. OPKO is the third largest
clinical laboratory in the United States, with a significantly larger sales and marketing team than we have. The 4Kscore test obtained
FDA marketing approval in December 2021. Offered at a lower price point, the 4Kscore test offers a competitive price advantage over the
Confirm mdx test. The PCA-3 test from Hologic, a urine-based test, is on the U.S. market as an FDA approved test, which may
be perceived as providing a competitive advantage since the Confirm mdx for Prostate Cancer test is not FDA approved. The PCA-3 test
is intended for the same patient population as Confirm mdx for Prostate Cancer, but our performance has only been established in men who
were already recommended by urologists for repeat biopsy.
Regarding our Select mdx for Prostate Cancer tissue-based test,
several directly competitive products are currently commercially available. In 2016, ExosomeDx launched the ExoDx (Intelliscore), a urine-based test
designed to assess whether a patient presenting for an initial biopsy is at greater risk for high-grade prostate cancer. The ExoDx
test competes directly with Select mdx. In 2018, Bio-Techne Corporation, a large U.S.-based, diversified life sciences company, acquired
the ExoDx test. Bio-Techne has greater resources and a significantly larger sales and marketing team than we have. For instance,
based on recent Securities and Exchange Commission ("SEC") filings, Bio-Techne has total assets in excess of $1 billion and a market capitalization exceeding $10 billion. In
addition, the ExoDx test may also provide a competitive advantage since, unlike the Select mdx test, it does not require a prostate massage
as part of its specimen collection procedures. In addition to ExoDx, the 4Kscore test offered by OPKO and the Prostate Health Index test,
or the "phi score", offered by Beckman Coulter, both compete directly with the Select mdx test.
Regarding our GPS tissue-based test, acquired
in August 2022 from Exact Sciences, several directly competitive products are currently commercially available. Myriad Genetics offers
the Prolaris test, a tissue-based genetic test to help identify those men who need treatment versus those who can choose active surveillance.
Additionally, Veracyte offers the Decipher test, a tissue-based genetic test to help identify those men who need treatment versus those
who can choose active surveillance. In addition to directly competitive genomic tests, traditional methods used by pathologists and clinicians
to estimate risk for disease progression also pose competitive threats. Companies combining these traditional methods with artificial
intelligence could potentially emerge as competitors, though most of these technologies are currently in the research stage.
Each of OPKO, Myriad Genetics, and Beckman Coulter
have greater resources and a significantly larger sales and marketing team than we do. Beckman Coulter is owned by Danaher Corporation,
which had total assets in excess of $50 billion based on recent SEC filings and a market capitalization in excess of $150 billion. Myriad
Genetics had total assets in excess of $1 billion based on recent SEC filings and a market capitalization in excess of $1.5 billion. As
a result of these significantly greater resources, these competitors are able to make larger investments into the tests they produce and
the sales and marketing of these tests, which may cause us to lose market share. In addition to competitive products, the Confirm mdx,
Select mdx and GPS tests also face competition from multiparametric MRI ("mpMRI"), a clinical diagnostic imaging procedure
available to and used by physicians for many years, which focuses on visual tissue analysis. The mpMRI procedure can visually reveal potential
locations of abnormal and potentially cancerous prostate tissue characteristics that distinguish tumors from healthy tissue. The visual
aspect of diagnostic imaging may feel more accessible and be considered preferable by some physicians over molecular analysis, and there
likely is an economic incentive for some physicians to earn a professional fee from the performance of mpMRI procedures. It may be difficult
to change the methods or behavior of physicians to incorporate our testing solutions into their practices in conjunction with, or instead
of, mpMRI clinical diagnostic imaging procedures. In addition, companies developing or offering capital equipment or point-of-care kits
to physicians represent another source of potential competition. These devices are used directly by the physicians or their institutions,
which can facilitate adoption.
If we are unable to compete effectively with the
abovementioned competitors and with new technologies and procedures such as mpMRI, we may lose market share, which could in turn adversely
affect our revenues.
Our commercial success will depend on the
market acceptance and adoption of our current and future tests.
Healthcare providers typically take a long time
to adopt new products, testing practices and clinical treatments, partly because of perceived liability risks and the uncertainty of third-party coverage
and reimbursement. It is critical to the success of our sales efforts that we educate enough patients, clinicians and administrators about
molecular diagnostics testing, in general, as well as about our solutions, and demonstrate their clinical benefits. It is likely that
clinicians may not adopt, and third-party payors may not cover or adequately reimburse for, our tests unless they determine, based
on published peer-reviewed journal articles and the experience of other clinicians, that they provide accurate, reliable and cost-effective information.
5
As the healthcare reimbursement system in the
United States evolves to place greater emphasis on comparative effectiveness and outcomes data, we cannot predict whether we will have
sufficient data, or whether the data we have will be presented to the satisfaction of any payors seeking such data, in the process of
determining and maintaining coverage for our diagnostic tests. The administration of clinical and economic utility studies is expensive
and demands significant attention from the management team. Our largest ongoing study, a multicenter U.S. observational study of Confirm
mdx and Select mdx entitled a Prospective Validation of Prostate Biomarkers for Repeat Biopsy ("PRIORITY"), has encountered
delays in enrollment and completion as a result of the COVID-19 pandemic. Additionally, we have several smaller post-marketing clinical
studies ongoing or planned that are primarily intended to support expanded indications for our Confirm mdx, Select mdx and GPS tests.
There can be no assurance that the PRIORITY study or our other clinical studies will be successfully initiated, enrolled or completed.
Also, data collected from these studies may not be positive or consistent with our existing data or may not be statistically significant
or compelling to the medical community. If the results obtained from ongoing or future studies are inconsistent with certain results obtained
from previous studies, adoption of diagnostic services would suffer, and our business would be harmed.
If our tests or the technology underlying our
current or future tests do not receive sufficient favorable exposure in peer-reviewed publications, the rate of clinician adoption
of our tests and positive reimbursement coverage decisions for our tests could be negatively affected. See "
Risk Factors —
We face uncertainties over the reimbursement of our tests by third party payors
." The publication of clinical data in peer-reviewed journals
is a crucial step in commercializing and obtaining reimbursement for diagnostic tests, and our inability to control when, if ever, our
results are published may delay or limit our ability to derive sufficient revenue from any product that is the subject of a study.
Our financial results are largely dependent
on sales of one test, and we will need to generate sufficient revenues from this and other future solutions to grow our business.
Currently, we rely significantly on the sale of
Confirm mdx tests in the United States for our revenues, with these tests accounting for approximately 59%, 91% and 94% of total revenues
in 2022, 2021 and 2020, respectively. We have materially diversified our revenue through the acquisition of the GPS test, with further
revenue diversification attributable to the launch of an additional precision diagnostic test offering and clinical guideline inclusion
for Select mdx, which facilitates reimbursement. However, sales of Confirm mdx are expected to continue to account for a substantial portion
of total revenues for at least the next several years. If reimbursement for our tests were to be revoked or limited either by CMS or commercial
payors, this could have an immediate impact on our revenues. While we do not believe that revocation of Medicare reimbursement for Confirm
mdx or GPS tests is likely, if this were to occur, the impact could be severe.
The commercial success of solutions and our
ability to generate sales will depend on several factors, including:
●
acceptance by the medical community;
●
the number of patients undergoing a prostate biopsy procedure;
●
acceptance, endorsement and formal policy approval of favorable reimbursement for the test by Medicare and other third-party payors;
●
our ability to successfully market the tests;
●
the amount and nature of competition from other prostate cancer products and procedures; and
●
our ability to establish and maintain commercial distribution, sales force and laboratory testing capabilities.
6
If we are unable to increase sales and reimbursement
of our current solutions or successfully develop and commercialize other solutions or enhancements, our revenues and our ability to achieve
profitability would be impaired, and the market price of our shares could decline.
We face uncertainties concerning the coverage
and reimbursement of our solutions by third-party payors.
Successful commercialization of our solutions
depends, in large part, on the availability of coverage and adequate reimbursement from government and private payors. Favorable third-party payor
coverage and reimbursement are essential to meeting our immediate objectives and long-term commercial goals. In the United States,
for new diagnostic solutions, each private and government payor decides whether to cover the test, the amount it will reimburse clinical
laboratories or other providers for a covered test, and any specific conditions for coverage and reimbursement. Healthcare providers may
be unlikely to order a specific diagnostic test unless an applicable third-party payor offers meaningful reimbursement for the test.
Therefore, adequate coverage and reimbursement is critical to the commercial success of a diagnostic product, and if we are unable
to secure and maintain favorable coverage determinations and reimbursement, this will undermine our ability to earn revenue from our products.
Medicare
Reimbursement for diagnostic tests furnished to
Medicare beneficiaries (typically patients aged 65 or older) is usually based on a fee schedule set by the U.S. Centers for Medicare &
Medicaid Services ("CMS"), a division of the U.S. Department of Health and Human Services ("HHS"). As a Medicare-enrolled
provider with our primary laboratory based in California, we bill Noridian Healthcare Solutions ("Noridian"), the Medicare
Administrative Contractor ("MAC"), for California, and our Select mdx, Confirm mdx, and GPS tests are subject to Noridian's
local coverage and reimbursement policies. Noridian participates in the Molecular Diagnostic Services Program ("MolDX"), administered
by Palmetto GBA, which handles technical assessments for U.S. laboratories that perform molecular diagnostic testing. The Confirm mdx
test obtained a positive Medicare local coverage determination ("LCD") under the MolDX program in 2014, the GPS test obtained
a positive Medicare coverage LCD in 2015, and the Select mdx test obtained a positive Medicare coverage LCD in April 2023, each of which
provides coverage for Medicare patients throughout the United States.
Medicare accounted for approximately 43% of MDxHealth's
revenues in 2022, compared to 38% in 2021. See Note 4 in the Notes to Consolidated Financial Statements included in Part III for further
detail.
Commercial payors
Obtaining coverage and reimbursement by commercial
payors is a time-consuming and costly process, without a guaranteed outcome, since each commercial payor makes its own decision with
respect to whether to cover a particular test and, if so, at what rate to reimburse providers for that test. In addition, several payors
and other entities conduct technology assessments of new medical tests and devices and provide the results of these assessments for informational
purposes to other parties. These assessments may be used by third-party payors and healthcare providers as grounds to deny coverage
for a particular test, or to refuse to use or order a particular test or procedure. Our tests have received initial negative technology
assessments from several of these entities and are likely to receive more negative technology assessments. We continue to work with third-party payors
to obtain coverage and reimbursement for our tests and to appeal coverage denial decisions based on existing and ongoing studies,
peer reviewed publications, and support from physician and patient groups. There are no assurances that commercial payors will continue
to issue positive coverage and reimbursement policies and/or contracts and, if issued, that such policies and/or contracts will be maintained
in the future. If our tests are considered on a policy-wide level by major third-party payors, whether at our request or on
the payor's own initiative, and the payor determines that such tests are ineligible for coverage and reimbursement, our revenue
potential could be adversely impacted.
Outside the United States
Outside of the United States, various coverage,
pricing and reimbursement approvals are required, including through coverage determinations made at the national level under public benefit
programs. We expect that it will take several years to establish broad coverage and reimbursement for our tests with payors in countries
outside of the United States where we commercialize our solutions, and our efforts may not be successful. Even if public or private reimbursement
is obtained, it may cover competing tests, the reimbursement may be conditioned upon local performance of the tests or other requirements
we may encounter difficulties in satisfying. Reimbursement levels outside of the United States may vary considerably from the reimbursement
amounts we receive in the United States. In addition, because we plan in many circumstances to rely on distributors to obtain reimbursement
for our tests, to the extent the distributor does not have direct reimbursement arrangements with payors, we may not be able to retain
reimbursement coverage in certain countries with a particular payor; further, if our agreement with a particular distributor is terminated
or expires or a distributor fails to pay for other reasons, we could lose reimbursement coverage in that jurisdiction.
7
Our business is affected by macroeconomic
conditions.
Various macroeconomic
factors could adversely affect our business and the results of our operations and financial condition, including changes in inflation,
interest rates, and foreign currency exchange rates and overall economic conditions and uncertainties, including those resulting from
the current and future conditions in the global financial markets. For instance, we experienced inflationary pressures in 2022 and expect
such pressures to continue in 2023. Cost inflation, including increases in raw material prices, labor rates, and transportation costs
may impact our profitability. Our ability to recover these cost increases through price increases is significantly limited by the process
by which we are reimbursed for our products and services by government and private payors. The volatility of the capital markets could
also affect the value of our investments and our ability to liquidate our investments in order to fund our operations.
Increasing interest rates
and reduced access to capital markets could also adversely affect the ability of our suppliers, distributors, licensors, collaborators,
contract manufacturers and other commercial partners to remain effective business partners or to remain in business. The loss of a critical
business partner, or a failure to perform by a critical business partner, could have a disruptive effect on our business and could adversely
affect our results of operations.
The ongoing outbreak of COVID-19, or any
future pandemic, could impact our sales volumes, and our business may experience other adverse effects as a result of COVID-19 or future
pandemics.
The broad and extensive
impact of the COVID-19 pandemic on virtually all aspects of our business and society exacerbated many pre-existing risks to our business
by making them more likely to occur or more impactful when they do occur. Accordingly, you should consider the risks described in this
risk factor in addition to, and not in lieu of, the risks described elsewhere throughout these risk factors.
The level and nature
of the disruption caused by COVID-19, or any future pandemic, is unpredictable, may be cyclical and long-lasting and may vary from location
to location. To the extent COVID-19 conditions improve, the duration and sustainability of any such improvements will be uncertain and
continuing adverse impacts and/or the degree of improvement may vary dramatically by geography and by product. The actions we take in
response to any improvements in conditions, such as our return-to-office plans, may also vary widely by geography and by business and
will likely be made with incomplete information; pose the risk that such actions may prove to be premature, incorrect or insufficient
and could have a material, adverse impact on our business and results of operations.
Despite our efforts,
the ultimate impact of COVID-19, or any future pandemic, depends on factors beyond our knowledge or control, including the duration and
severity of the outbreak, third-party actions taken to contain its spread and mitigate its public health effects, and short- and long-term
changes in the behaviors of medical professionals and patients resulting from the pandemic.
The ongoing military
action by Russia in Ukraine could have negative impact on the global economy, which could materially adversely affect our business, operations,
operating results and financial condition.
On February 24, 2022,
Russian forces launched significant military action against Ukraine, and sustained conflict and disruption in the region is possible.
The impact to Ukraine as well as actions taken by other countries, including new and stricter sanctions imposed by Canada, the United
Kingdom, the European Union, the United States, and other countries and companies and organizations against officials, individuals, regions,
and industries in Russia and Ukraine, and actions taken by Russia in response to such sanctions, and each country's potential response
to such sanctions, tensions, and military actions could adversely affect the global economy and financial markets and thus could affect
our business, operations, operating results and financial condition as well as the price of our common stock and our ability to raise
additional capital when needed on acceptable terms. The extent and duration of the military action, sanctions and resulting market disruptions
are impossible to predict, but could be substantial. Any such disruptions caused by Russian military action or resulting sanctions may
magnify the impact of other risks described in this annual report on Form 20-F.
8
Risks Related to Our Intellectual Property
If we are unable to retain intellectual
property protection in relation to our solutions or if we are required to expend significant resources to protect our intellectual property
position, our competitive position could be undercut.
Our ability to protect our discoveries, know-how and
technologies affects our ability to compete and to achieve profitability. We rely on a combination of U.S. and foreign patents and patent
applications, copyrights, trademarks and trademark applications, confidentiality or non-disclosure agreements, material transfer
agreements, licenses and consulting agreements to protect our intellectual property rights. We also maintain certain company know-how,
algorithms, and technological innovations designed to provide us with a competitive advantage in the marketplace as trade secrets. As
of December 31, 2022, we owned or had exclusive rights to more than 17 patent families related to our molecular technology and cancer-specific biomarkers.
Specifically, there are 116 granted or pending patent applications in this group comprised of 16 issued or allowed U.S. patents,
7 pending U.S. provisional or non-provisional applications, 19 pending international patent applications filed under the Patent
Cooperation Treaty ("PCT") and 74 granted or allowed patents in jurisdictions outside the United States, including Japan,
Canada, Israel and the major European countries. Our issued U.S. patents expire at various times between 2024 and 2038. Of these issued
patents, 1 covers intellectual property used in our Confirm mdx test, which expires in 2024, 7 cover intellectual property used in our
Select mdx test, the last of which expires in 2036, and 52 cover intellectual property used in our GPS test, the last of which expires
in 2038. When these patents expire other companies will no longer be prohibited from incorporating the subject intellectual property into
competing tests they may seek to develop.
While we intend to pursue additional and future
patent applications, it is possible that pending patent applications and any future applications may not result in issued patents. Even
if patents are issued, third parties may independently develop similar or competing technology that avoids our patents. Third parties
may also assert infringement or other intellectual property claims against us or against our licensors, licensees, suppliers or strategic
partners. Any actions regarding patents could be costly and time-consuming and could divert the attention of management and key personnel
from other areas of our business. Further, we cannot be certain that the steps we have taken will prevent the misappropriation of our
trade secrets and other confidential information as well as the misuse of our patents and other intellectual property, particularly in
foreign countries with no patent protection.
Although we have licensed and own issued patents
in the United States and foreign countries, we cannot be certain the claims will continue to be considered patentable by the U.S. Patent
and Trademark Office (the "USPTO"), U.S. courts patent offices and courts in other jurisdictions. The U.S. Supreme Court,
other federal courts and/or the USPTO, may change the standards of patentability and any such changes could have a negative impact on
our business. For instance, the Federal Circuit has recently ruled on several patent cases, such as
Univ. of Utah Research Found.
v. Ambry Genetics Corp.
, 774 F.3d 755 (Fed. Cir. 2014)
, Ariosa Diagnostics, Inc. v. Sequenom, Inc.
, 788 F.3d 1371
(Fed. Cir. 2015)
, Genetic Tech. Ltd. v. Merial LLC,
818 F.3d 1369 (Fed. Cir. 2016), and
Cleveland Clinic Found. v. True
Health Diagnostics,
859 F.3d 1352 (Fed. Cir. 2017), that some diagnostic method claims are not patent eligible. These decisions have
narrowed the scope of patent protection available in certain circumstances or weakened the rights of patent owners in certain situations.
Some aspects of our technology involve processes that may be subject to this evolving standard and we cannot guarantee that any of our
issued or pending process claims will be patentable as a result of such evolving standards. In addition, this combination of decisions
has created uncertainty as to the value of certain issued patents, in particular in the detection of prostate cancer and other cancers.
We may be subject to substantial costs and
liabilities, or be prevented from using technologies incorporated in our solutions, as a result of litigation or other proceedings relating
to patent rights.
Third parties may assert infringement or other
intellectual property claims against us or our licensors, licensees, suppliers or strategic partners. We pursue a patent strategy that
we believe provides us with a competitive advantage in the assessment of prostate cancer and is designed to maximize patent protection
against third parties in the United States and, potentially, in certain foreign countries. In order to protect or enforce our patent rights,
we may have to initiate actions against third parties. Any actions regarding patents could be costly and time-consuming and could
divert the attention of management and key personnel from other areas of our business. Additionally, such actions could result in challenges
to the validity or applicability of our patents. Because the USPTO maintains patent applications in secrecy until a patent application
is published or the patent is issued, we have no way of knowing if others may have filed patent applications covering technologies used
by us or our partners. Additionally, there may be third-party patents, patent applications and other intellectual property relevant
our technologies that may block or compete with our technologies. Even if third-party claims are without merit, defending a lawsuit
may result in substantial expense to us and may divert the attention of management and key personnel. In addition, we cannot provide assurance
that we would prevail in any such suits or that the damages or other remedies, if any, awarded against us would not be substantial. Claims
of intellectual property infringement may require us, or our strategic partners, to enter into royalty or license agreements with third
parties that may not be available on acceptable terms, if at all. These claims may also result in injunctions which could prevent us from
further developing and commercializing services or products containing our technologies, which could in turn adversely affect our ability
to earn revenues from these services or products.
9
Also, patents and patent applications owned by
us may become the subject of post grant challenges or interference proceedings in the USPTO to determine validity and the priority of
invention, which could result in substantial cost as well as a possible adverse decision as to the validity or priority of invention of
the patent or patent application involved. An adverse decision in an interference proceeding may result in the loss of rights under a
patent or patent application subject to such a proceeding.
Ultimately, the potential weakening of our intellectual
property position as a result of the evolution of case law or otherwise may make us more vulnerable to competition. While we are unable
to quantify the impact of this risk given that our patents remain untested in the courts, the impact could be severe if our competitors
are able to take advantage of any weakening of our intellectual property position.
We rely on strategic collaborative and license
arrangements with third parties to develop critical intellectual property. We may not be able to successfully establish and maintain such
intellectual property.
The development and commercialization of our products
and services rely, directly or indirectly, upon strategic collaborations and license agreements with third parties. We have a license
agreement with an academic institution pursuant to which we have incorporated licensed technology into our Confirm mdx test and may incorporate
licensed technology into our pipeline products. Our dependence on license, collaboration and other similar agreements with third parties
may subject us to a number of risks. There can be no assurance that any current contractual arrangements between us and third parties
or between our strategic partners and other third parties will be continued on materially similar terms and will not be breached or terminated
early. Any failure to obtain or retain the rights to necessary technologies on acceptable commercial terms could require us to re-configure our
products and services, which could negatively impact their commercial sale or increase the associated costs, either of which could materially
harm our business and adversely affect our future revenues and ability to achieve sustained profitability.
We expect to continue and expand our reliance
on collaboration and license arrangements. Establishing new strategic collaborations and license arrangements is difficult and time-consuming.
Discussions with potential collaborators or licensors may not lead to the establishment of collaborations on favorable terms, if at all.
To the extent we agree to work exclusively with one collaborator in a given area, our opportunities to collaborate with other entities
could be limited. Potential collaborators or licensors may reject collaborations with us based upon their assessment of our financial,
regulatory or intellectual property position or other factors. Even if we successfully establish new collaborations, these relationships
may never result in the successful commercialization of any product or service. In addition, the success of the projects that require
collaboration with third parties will be dependent on the continued success of such collaborators. There is no guarantee that our collaborators
will continue to be successful and, as a result, we may expend considerable time and resources developing products or services that will
not ultimately be commercialized.
Risks Related to Our Operations
Billing and collections processing for our
tests is complex and time-consuming, and any delay in transmitting and collecting for claims could adversely impact revenue.
Our tests are billed on a fee-for-service basis
and paid, for example by hospitals and direct payments from individual patients, and may be reimbursed by third-party payors,
including Medicare and other governmental payor programs, private insurance plans and managed care organizations. Billing for molecular
diagnostics testing services is complex, time-consuming, and expensive. We are often obligated to bill services in the specific manner
required by each particular third-party payor. Failure to comply with these complex billing requirements (including complex federal
and state regulations related to billing government health care programs,
e.g.
, Medicare and Medicaid) may significantly hinder
our collection and retention efforts, including not only potential write-offs of doubtful accounts and long collection cycles for
accounts receivable, but also the potential disgorgement of previously paid claims based on third-party payor program integrity investigations
into billing discrepancies, fraud, waste and abuse. With CMS's recent implementation of a comprehensive oversight regime that consolidated
program integrity powers into a single Unified Program Integrity Contractor ("UPIC"), audit and investigatory activity into
billing fraud, waste and abuse in the industry has in recent years significantly increased. Responding to requests from a UPIC, or other
auditor, is often time-consuming and requires dedication of internal, and sometimes external, resources. UPICs also have the authority
to implement Medicare payment suspensions during the pendency of an audit, which could significantly impact cash flows, even where no
improper billing is ultimately found to have occurred. Commercial payors may also engage in audit activity, requiring timely production
of medical documentation in support of billed claims.
10
Among the potential factors that can complicate
third-party payor billing are:
●
differences between the list price for our tests and the reimbursement rates of payors;
●
compliance with complex federal and state regulations related to billing government health care programs, (
e.g.,
Medicare and Medicaid);
●
disputes among payors as to which party is responsible for payment;
●
differences in coverage among payors and the effect of patient co-payments or co-insurance;
●
differences in information and billing requirements among payors;
●
incorrect or missing billing information; and
●
the resources required to manage the billing and claims appeals process.
We face an inherent risk of product liability
claims.
The marketing, sale and use of our tests could
lead to product or professional liability claims against us if someone were to allege that our tests failed to perform as they were designed,
or if someone were to misinterpret test results or improperly rely on them for clinical decisions. Although we maintain product and professional
liability insurance which is deemed to be appropriate and adequate, it may not fully protect us from the financial impact of defending
against product liability or professional liability claims or any judgments, fines or settlement costs arising out of any such claims.
Furthermore, any product liability lawsuit, with or without merit, could increase our insurance rates or prevent us from securing insurance
coverage in the future. Additionally, any product liability lawsuit could harm our reputation, which could impact our results of operations,
or cause collaboration partners to terminate existing agreements and potential partners to seek alternate partners, any of which could
negatively impact our results of operations.
Failure to attract or retain key personnel
or to secure the support of key scientific collaborators could materially adversely impact our business.
Our success in implementing our business strategy
depends largely on the skills, experience, and performance of key members of our executive management team and others in key management
positions, including Michael McGarrity, our Chief Executive Officer. The collective efforts of our executive management team are critical
to us as we continue to develop our technologies, tests, and R&D and sales programs. As a result of the difficulty in locating qualified
new management, the loss or incapacity of existing members of our executive management team could adversely affect our operations. If
we were to lose one or more of these key employees, we could experience difficulties in finding qualified successors, competing effectively,
developing our technologies and implementing our business strategy. Our executives have employment agreements; however, the existence
of an employment agreement does not guarantee retention of members of our executive management team. We do not maintain "key person"
life insurance on any of our employees.
We have established relationships with leading
key opinion leaders and scientists at important research and academic institutions that we believe are key to establishing tests using
our technologies as a standard of care for cancer assessment and diagnosis. If our collaborators determine that cancer testing using our
technologies are not appropriate options for prostate cancer diagnosis, or superior to available prostate cancer methods, or that alternative
technologies would be more effective in the early diagnosis of prostate cancer, we would encounter significant difficulty establishing
tests using our technologies as a standard of care for prostate cancer diagnosis, which would limit our revenue growth and profitability.
11
Our results of operations can be adversely
affected by labor shortages, turnover and labor cost increases.
Labor is a significant component of operating
our business. A number of factors may adversely affect the labor force available to us or increase labor costs, including high employment
levels, federal unemployment subsidies, increased wages offered by other employers, vaccine mandates and other government regulations
and our responses thereto. As more employers offer remote work, we may have more difficulty recruiting for jobs that require on-site attendance,
such as certain clinical laboratory and sales roles. Although we have not experienced any material labor shortage to date, we have recently
observed an overall tightening and increasingly competitive labor market. A sustained labor shortage or increased turnover rates within
our employee base, caused by a pandemic or as a result of general macroeconomic factors, could lead to increased costs, such as increased
overtime or financial incentives to meet demand and increased wage rates to attract and retain employees, and could negatively affect
our ability to efficiently operate our clinical laboratories and overall business. If we are unable to hire and retain employees capable
of performing at a high-level, or if mitigation measures we may take to respond to a decrease in labor availability have unintended negative
effects, our business could be adversely affected.
Additionally, the operations of our vendors and
partners could also suffer from labor shortages, turnover and labor cost increases which could result in supply change disruptions and
increases in the costs of the products and services we purchase, each of which could adversely affect our operations.
Our business and reputation will suffer
if we are unable to establish and comply with, stringent quality standards to assure that the highest level of quality is observed in
the performance of our solutions.
Inherent risks are involved in providing and marketing
cancer tests and related services. Patients and healthcare providers rely on us to provide accurate clinical and diagnostic information
that may be used to make critical healthcare decisions. As such, users of our solutions may have a greater sensitivity to errors than
users of some other types of products and services.
Past or future performance or accuracy defects,
incomplete or improper quality and process controls, excessively slow turnaround times, unanticipated uses of our tests or mishandling
of samples or test results (whether by us, patients, healthcare providers, courier delivery services or others) can lead to adverse outcomes
for patients and interruptions to our services. These events could lead to voluntary or legally mandated safety alerts relating to our
tests or our laboratory facilities and could result in the removal of our products and services from the market or the suspension of our
laboratories' operations. Insufficient quality controls and any resulting negative outcomes could result in significant costs and
litigation, as well as negative publicity that could reduce demand for our tests and payors' willingness to cover our tests. Even
if we maintain adequate controls and procedures, damaging and costly errors may occur.
Our laboratory facilities may become inoperable
due to natural or man-made disasters or regulatory sanctions.
We currently perform testing services in our laboratory
facilities located in Irvine, California; Plano, Texas; and Nijmegen, The Netherlands and our GPS test is currently performed by Exact
Sciences in its laboratory facility in Redwood City, California. These laboratory facilities could become inoperable due to circumstances
that may be beyond our control, and such inoperability could adversely affect our business and operations. The facilities, equipment and
other business process systems would be costly to replace and could require substantial time to repair or replace.
The facilities may be damaged or destroyed by
natural or man-made disasters, including earthquakes, wildfires, floods, outbreak of disease (such as the COVID-19 pandemic),
acts of terrorism or other criminal activities and power outages, which may render it difficult or impossible for us to perform our tests
for some period.
12
The facilities may also be rendered inoperable
because of regulatory sanction. In the United States, we are subject to federal and state laws and regulations regarding the operation
of clinical laboratories. Our U.S. laboratory facilities in Irvine, California and Plano, Texas are certified under CLIA. CLIA and the
laws of California and certain other states, impose certification requirements for clinical laboratories, and establish standards for
quality assurance and quality control, among other things. Clinical laboratories are subject to inspection by regulators, and to sanctions
for failing to comply with applicable requirements. Sanctions available under CLIA include prohibiting a laboratory from running tests,
requiring a laboratory to implement a corrective action plan, and imposing civil monetary penalties. Our U.S. laboratory facilities hold
certificates of accreditation from CMS to perform high-complexity testing. To renew these certificates, the facilities are subject
to survey and inspection every two years. We also hold a certificate of accreditation from the College of American Pathologists ("CAP"),
which sets standards that are higher than those contained in the CLIA regulations. CAP is an independent, non-governmental organization
of board-certified pathologists that accredits laboratories nationwide on a voluntary basis. Sanctions for failure to comply with
CAP or CLIA requirements, including proficiency testing violations, may include suspension, revocation, or limitation of a laboratory's
CLIA certificate, which is necessary to conduct business, as well as the imposition of significant fines or criminal penalties. In addition,
our U.S. facilities are subject to regulation under state laws and regulations governing laboratory licensure. Two states, one of which
is New York, have enacted state licensure laws that are more stringent than CLIA. Failure to maintain CLIA certification, CAP accreditation,
or required state licenses could have a material adverse effect on the sales of our tests and results of operations. Many states maintain
independent licensure, registration, or certification procedures with which our U.S. facilities must maintain compliance in order to receive
and test samples from that location.
In order to rely on a third party to perform certain
of our tests, we could only use another facility with established state licensure and CLIA accreditation following validation and other
required procedures. We cannot assure you that we would be able to find another CLIA certified facility willing to comply with the required
procedures, that this laboratory would be willing to perform the tests for us on commercially reasonable terms, or that it would be able
to meet our quality or regulatory standards.
Maintaining compliance with the myriad of governmental
requirements is time and resource intensive, and failure to maintain compliance could result in sanctions.
We rely on a limited number of third-party
suppliers for services and items used in the production and operation of our testing solutions, and some of those services and items are
supplied from a single source. Disruption of the supply chain, unavailability of third-party services required for the performance of
the tests, modifications of certain items or failure to achieve economies of scale could have a material adverse effect on us.
To provide our testing services, we are required
to obtain customized components and services that are currently available from a limited number of sources. Most of these components and
services are sourced externally from approximately 40 external suppliers. Many of the consumable supplies and reagents used as raw materials
in our testing process are procured from a limited number of suppliers, some of which are single source. In addition, we rely on a limited
number of suppliers, or in some cases a single supplier (for example, for the automation of our deparaffination steps for our Confirm
mdx test), for certain services and equipment with which we provide testing services. If we have to switch to a replacement supplier for
any of these items that are sub-components or for certain services required for the performance of our tests, or if we have to commence
our own manufacturing or testing services to satisfy market demand, we may face additional delays. For example, in the past, a supplier
has delivered critical non-conforming components that failed our acceptance testing, requiring us to audit the supplier and assist
the supplier in improving our internal quality processes. In addition, third party suppliers may be subject to circumstances which impact
their ability to supply, including enforcement action by regulatory authorities, natural disasters (
e.g.
, hurricanes, earthquakes,
disease and terrorism), epidemics (
e.g.
, the COVID-19 pandemic), industrial action (
e.g.
, strikes), financial difficulties
including insolvency, among a variety of other internal or external factors. Any such supply disruptions could in turn result in service
disruptions for an extended period of time, which could delay completion of our clinical studies or commercialization activities and prevent
us from achieving or maintaining profitability. While we were able to qualify alternative suppliers to address COVID-19 related disruptions,
in the future alternative suppliers may be unavailable, may be unwilling to supply, may not have the necessary regulatory approvals, or
may not have in place an adequate quality management systems.
Exact Sciences currently performs our GPS test
pursuant to a reference laboratory services agreement we entered into with Exact Sciences in connection with our acquisition of the GPS
test. Until we are able to transition performance of the GPS test to our laboratory facilities we will be reliant on this contractual
relationship to generate revenues from this test.
13
Modifications to a service or items or inclusions
of certain services or items made by a third-party supplier could require new approvals from the relevant regulatory authorities
before the modified service or item may be used, for example any modifications to the assembly and packaging of items for our testing
services supplied to healthcare providers. While we have not experienced any material supply chain disruptions to date, if we were to
experience such disruptions it could have an immediate impact on revenues, and the impact could be material depending on the length of
the supply disruption.
Failures in our information technology,
telecommunications or other systems could significantly disrupt our operations.
We use information technology and telecommunications
systems across virtually all aspects of our business, including laboratory testing, sales, billing, customer service, logistics and management
of data, including patient information. Our information technology, telecommunications and other systems, are vulnerable to damage and
failure, computer viruses, acts of God and physical or electronic break-ins. Despite the precautionary measures we have taken to prevent
breakdowns in our information technology and telecommunications systems, sustained or repeated system failures that interrupt our ability
to process test orders, deliver test results or perform tests in a timely manner or that cause us to lose patient information could adversely
affect our business, results of operations and financial condition.
Although we maintain cyber liability insurance
which we believe to be appropriate and adequate, the levels and terms of coverage may not be adequate to compensate us for losses that
may arise from any such disruption, failure or security breach. In addition, such insurance may not be available to us in the future on
economically reasonable terms, or at all. Further, insurance may not cover all claims made against us and could have high deductibles
in any event, and defending a suit, regardless of its merit, could be costly and divert management attention.
Security breaches or loss of data may harm
our reputation, expose us to liability and adversely affect our business.
If we experience any security breaches or loss
of data or if we fail to comply with data protection laws and regulations, we could be subject to government enforcement actions (which
could include civil or criminal penalties), private litigation and/or adverse publicity, which could negatively affect our results of
operations and business.
We face four primary risks relative to protecting
sensitive and critical personally identifiable information, intellectual property or other proprietary business information about our
customers, payors, recipients and collaboration partners, including test results: (1) loss of access risk, (2) inappropriate disclosure
or access risk, (3) inappropriate modification risk, and (4) the risk of being unable to identify and audit controls over the first three
risks. While we devote significant resources to protecting such information, the measures we introduce may not be sufficient to guard
against security breaches, the loss or misappropriation of data, privacy violations or the failure to implement satisfactory remedial
measures, which could in turn disrupt operations and lead to reputational damage, regulatory penalties and other material financial losses.
Furthermore, we are subject to privacy and data
security laws and regulations at the state, federal and international level. In the United States, numerous federal and state laws and
regulations, including state data breach notification laws, state health information privacy laws, and federal and state consumer protection
laws (
e.g.
, section 5 of the Federal Trade Commission Act), govern the collection, use, disclosure, and protection of health-related and
other personal information. Failure to comply with data protection laws and regulations could result in (1) government enforcement actions
and potential liability thereunder (potentially including civil and/or criminal penalties), (2) private litigation, and/or (3) adverse
publicity that could negatively affect our operations and/or business. In addition, we obtain health information from third parties (
e.g.
,
healthcare providers) and are subject to privacy and security requirements under the Health Insurance Portability and Accountability Act
("HIPAA"), as amended by the Health Information Technology for Economic and Clinical Health Act ("HITECH"). These
laws contain significant fines and other penalties for wrongful use or disclosure of protected data. For example, HIPAA violations can
result in civil and criminal penalties.
14
We expect to make significant investments
to research and develop new tests, which may not be successful.
We are seeking to improve the performance of our
existing solutions and to develop a pipeline for future products and services. For example, in August 2022, we announced our acquisition
of the GPS test from Exact Sciences. In addition, we are currently developing an additional product, Monitor mdx, as a non-invasive test
to risk stratifies patients for continued active surveillance versus intervention. We also recently developed and launched non-invasive
urine test that identifies and quantifies infectious bacteria and their antibiotics susceptibility to help ensure patients receive the
correct diagnosis and treatment as quickly as possible.
Developing new or improved diagnostic tests is
a speculative and risky endeavor. Candidate products and services that may initially show promise may fail to achieve the desired results
in larger clinical validation studies or may not achieve acceptable levels of clinical accuracy. Results from early studies or trials
are not necessarily predictive of future clinical validation or clinical trial results, and interim results of a validation study or trial
are not necessarily indicative of final results. From time to time, we may publicly disclose then-available data from clinical validation
studies before completion, and the results and related findings and conclusions may be subject to change following the final analysis
of the data related to the particular study. As a result, such data should be viewed with caution until the final data are available.
Additionally, such data from clinical trials are subject to the risk that one or more of the clinical outcomes may materially change as
patient enrollment and/or follow-up continues, and more patient data become available. Significant differences between initial or
interim data and final data from either our clinical validation studies or clinical trials could significantly alter our plans to proceed
with additional studies or trials, and harm our reputation and business prospects. If we determine that any of our current or future development
programs is unlikely to succeed, we may abandon it without any return on our investment into the program. We may need to raise additional
capital to bring any new products or services to market, which may not be available on acceptable terms, if at all.
Our research and development efforts will
be hindered if we are not able to obtain samples, contract with third parties for access to samples or complete timely enrollment in future
clinical trials.
Access to human sample types, such as blood, tissue,
stool, or urine is necessary for our research and product development. Acquiring samples from individuals with clinical diagnoses or associated
clinical outcomes through purchase or clinical studies is necessary. Lack of available samples can delay development timelines and increase
costs of development. Generally, the agreements under which we gain access to human samples are non-exclusive. Other companies may compete
with us for access. Additionally, the process of negotiating access to samples can be lengthy and it may involve numerous parties and
approval levels to resolve complex issues such as usage rights, institutional review board approval and patient informed consent, privacy
rights, publication rights, intellectual property ownership and research parameters. If we are not able to negotiate access to clinical
samples with research institutions, hospitals, clinical partners, pharmaceutical companies, or companies developing therapeutics on a
timely basis, or at all, or if other laboratories or our competitors secure access to these samples before us, our ability to research,
develop and commercialize future products will be limited or delayed. Finally, we may not be able to conduct or complete clinical trials
on a timely basis if we are not able to enroll sufficient numbers of patients in such trials, and our failure to do so could have an adverse
effect on our research and development and product commercialization efforts.
Risks Related to Regulation of Our Business
Failure to comply with governmental payor
regulations could result in us being excluded from participation in Medicare, Medicaid or other governmental payor programs, which would
adversely affect our business.
Failure to comply with applicable Medicare, Medicaid
and other governmental payor rules could result in us being excluded from participation in one or more governmental payor programs, returning
funds already paid, civil monetary penalties, criminal penalties and/or limitations on the operational function of our laboratories. Additionally,
with the recent implementation by CMS of a comprehensive oversight regime that consolidates program integrity powers into a single UPIC,
audit and investigatory activity into potential billing fraud, waste and abuse in the industry has increased. These changes have adversely
affected and may in the future adversely affect coverage and reimbursement for laboratory services, including the molecular diagnostics
testing services we provide. If we were unable to receive reimbursement under a governmental payor program, this would have a severe impact
on our revenues, given the importance of reimbursement under these programs in our revenue base.
15
We conduct business in a heavily regulated
industry, and changes in, or violations of, applicable regulations may, directly or indirectly, adversely affect our operational results
and financial condition, which could harm our business.
Our business operations and activities may be
subject to a range of local, state, federal, and international healthcare laws and regulations, including investigatory and program integrity
audits and other oversight federal and state health care programs. These laws and regulations currently include, among others:
●
CLIA (which requires laboratories to obtain certification from the federal government) and state laboratory licensure laws;
●
Federal Trade Commission standards regarding advertising and business practices;
●
FDA laws and regulations;
●
HIPAA (which imposes comprehensive federal standards with respect to the privacy and security of protected health information, and requirements for the use of certain standardized electronic transactions), and the amendments to HIPAA under HITECH (which strengthened and expanded HIPAA privacy and security compliance requirements, increased penalties for violators, extended enforcement authority to state attorneys general and imposed requirements for breach notification);
●
state laws regulating genetic testing and the privacy protection of genetic test results, as well as state laws protecting the privacy and security of health information and personal data and mandating reporting of breaches to affected individuals and state regulators;
●
the federal Anti-Kickback Statute (which prohibits knowingly and willfully offering, paying, soliciting, receiving, or providing remuneration, directly or indirectly, to induce either the referral of an individual, or the furnishing, arranging for, or recommending of an item or service that is reimbursable, in whole or in part, by a federal health care program) and parallel state anti-kickback laws (which contain similar prohibitions on remuneration between referral sources, although these state laws are not always limited in application to items or services reimbursable by federal or state health care programs);
●
the federal False Claims Act (which imposes liability on any person or entity that, among other things, knowingly presents, or causes to be presented, a false or fraudulent claim for payment to the federal government or the improper retention of identified overpayments or other financial obligations to the federal government) and parallel state false claims acts (which contain similar prohibition on presenting false or fraudulent claims, although these state may extend to items or services by any third-party payor, including commercial insurers);
●
the federal Civil Monetary Penalties Law, which prohibits, among other things, the offering or transferring of remuneration to a Medicare or state health care program (
e.g.
, Medicaid) beneficiary if the person knows or should know it is likely to influence the beneficiary's selection of a particular provider, practitioner, or supplier of services reimbursable by Medicare or a state health care program, unless an exception applies;
●
the federal physician self-referral law, commonly known as the "Stark Law," which prohibits a physician from making a referral to an entity for certain "designated health services" ("DHS") payable by Medicare if the physician, or an immediate family member of the physician, has a financial relationship with that entity, unless an exception applies. The Stark Law further prohibits the entity from billing the Medicare program for DHS furnished pursuant to a prohibited referral. In addition, the Stark Law, through the addition of section 1903(s) to the Social Security Act, prohibits the federal government from making federal financial participation payments to state Medicaid programs for DHS furnished as a result of a referral that would violate the Stark Law if Medicare "covered the service to the same extent and under the same conditions" as the state Medicaid Program. The U.S. Department of Justice ("DOJ") and several state agencies have successfully argued that Section 1903(s) expands the Stark Law to Medicaid-covered claims, even absent a separate state self-referral law prohibiting the same conduct;
●
other federal and state fraud and abuse laws, including (i) the state anti-kickback laws described above, (ii) the state physician self-referral laws, and (iii) the state false claims acts described above;
●
Section 216 of the Protecting Access to Medicare Act of 2014, which requires applicable laboratories to report commercial payor data in a timely and accurate manner beginning in 2017 and every three years thereafter (and in some cases annually);
16
●
Federal and state laws that impose reporting and other compliance-related requirements; and
●
similar foreign laws and regulations that apply to us in the countries in which we operate.
In addition, in October 2018, the Eliminating
Kickbacks in Recovery Act of 2018 ("EKRA"), was enacted by the U.S. Congress as part of the Substance Use-Disorder Prevention
that Promotes Opioid Recovery and Treatment for Patients and Communities Act. EKRA is an all-payor anti-kickback law that makes
it a criminal offense to pay any remuneration to induce referrals to, or in exchange for, patients using the services of a recovery home,
a substance use clinical treatment facility, or laboratory. Although it appears that EKRA was intended to reach patient brokering and
similar arrangements to induce patronage of substance use recovery and treatment, the language in EKRA is broadly written. Further, certain
of EKRA's exceptions, such as the exception applicable to relationships with employees that effectively prohibits incentive compensation,
are inconsistent with the federal anti-kickback statute and regulations, which permit payment of employee incentive compensation,
a practice that is common in the industry. Significantly, EKRA permits the U.S. Department of Justice to issue regulations clarifying
EKRA's exceptions or adding additional exceptions, but such regulations have not yet been issued. Laboratory industry stakeholders
are reportedly seeking clarification regarding EKRA's scope and/or amendments to its language.
Our business practices, in operating a U.S. clinical
laboratory, may face heightened scrutiny from U.S. government enforcement agencies such as the DOJ, the HHS Office of Inspector General
("OIG"), and CMS. The OIG has issued fraud alerts in recent years that identify certain arrangements between clinical laboratories
and referring physicians as implicating the federal Anti-Kickback Statute. The OIG has stated that it is particularly concerned
about these types of arrangements because the choice of laboratory, as well as the decision to order laboratory tests, typically are made
or strongly influenced by the physician, with little or no input from the patient. Moreover, the provision of payments or other items
of value by a clinical laboratory to a referring physician could be prohibited under the Stark Law, unless the arrangement meets all criteria
of an applicable exception. The government has actively enforced these laws against clinical laboratories in recent years.
These U.S. laws and regulations are complex and
are subject to interpretation by the U.S. courts and government agencies. Our failure to comply with such laws and regulations could lead
to significant civil or criminal penalties, exclusion from participation in state and federal health care programs, individual imprisonment,
disgorgement of profits, contractual damages, reputational harm, diminished profits and future earnings, additional reporting or oversight
obligations if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with
the law, curtailment or restructuring of our operations, or prohibitions or restrictions on our laboratories' ability to provide
or receive payment for our services, any of which could adversely affect our ability to operate our business and pursue our strategy.
Even where we are able to successfully defend against any such claims, any potential audit, enforcement action, or litigation would involve
substantial internal and external resources, detract from our executives' day to day responsibilities, and result in legal expenditures,
all of which could materially adversely affect our results of operations. While we believe that we are in material compliance with all
applicable laws and regulations, there remains a risk that one or more government agencies could take a contrary position, or that a private
party could file suit under the qui tam provisions of the federal False Claims Act or a similar state law. Such occurrences, regardless
of their outcome, could damage our reputation and adversely affect important business relationships with third parties, including managed
care organizations, and other private third-party payors.
Our employees, independent contractors,
consultants, commercial partners, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory
standards and requirements.
We are exposed to the risk of fraud, misconduct,
or other illegal activity by our employees, independent contractors, consultants, commercial partners, and vendors. Misconduct by these
parties could include intentional, reckless and negligent conduct that fails to: comply with the rules and regulations of the CMS, FDA,
and other federal and state government agencies as well as comparable foreign regulatory authorities; provide true, complete and accurate
information to such regulatory authorities; comply with manufacturing and clinical laboratory standards; comply with healthcare fraud
and abuse laws in the United States and similar foreign fraudulent misconduct laws; or report financial information or data accurately
or to disclose unauthorized activities to us. In particular, research, sales, marketing, education, and other business arrangements in
the healthcare industry are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing, and other abusive practices,
as well as off-label product promotion. These laws and regulations may restrict or prohibit a wide range of pricing, discounting,
educating, marketing and promotion, sales and commission, certain customer incentive programs, and other business arrangements generally.
Activities subject to these laws also involve the improper use of information obtained in the course of participant recruitment for clinical
studies, which could result in regulatory sanctions and cause serious harm to our reputation. We have adopted a code of business conduct
and ethics and provide compliance training to our workforce members upon onboarding and annually thereafter, but it is not always possible
to identify and deter misconduct by employees and third parties, and the precautions we take to detect and prevent this activity may not
be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions
or lawsuits stemming from a failure to be in compliance with such laws. If any such actions are instituted against us, and we are not
successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the
imposition of significant fines or other sanctions. Even if it is later determined after an action is instituted against us that we were
not in violation of these laws, we may be faced with negative publicity, incur significant expenses defending our actions, and have to
divert significant management resources from other matters.
17
Our expansion of our business beyond the
United States has resulted in additional regulatory requirements with which we must comply.
Our expansion of our business outside of the
United States increases the potential of violating foreign laws similar to those described above under " —
We conduct
business in a heavily regulated industry, and changes in regulations or violations of regulations may, directly or indirectly, adversely
affect our results of operations and financial condition and harm our business
." In order to market our tests in other countries,
we may be required to obtain regulatory approvals and comply with extensive safety and quality regulations in other countries. The time
required to obtain approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements
may differ. The European Union/European Economic Area requires a CE conformity mark in order to market medical devices. Many other countries
accept CE or FDA clearance or approval, although others, require separate regulatory filings. Further, the advertising and promotion
of our products in the EEA is subject to the laws of individual EEA Member States implementing the EU Medical Devices Directives including
Directive 98/79/EC on Invitro Diagnostic Medical Devices, Directive 2006/114/EC concerning misleading and comparative advertising, and
Directive 2005/29/EC on unfair commercial practices, as well as other EEA Member State laws governing the advertising and promotion of
medical devices. Going forward, CE marking will be pursuant to Regulation 2017/745 (the "Medical Devices Regulation") and
Regulation 2017/746 (the "Invitro Diagnostic Medical Devices Regulation"), which were passed by the European Parliament on
April 5, 2017. The Medical Devices Regulation and the Invitro Diagnostic Medical Devices Regulation contain further obligations
for medical devices and invitro diagnostic medical devices with which we will be required to comply as applicable. These new laws are
generally stricter than the requirements previously in place and contain increased evidence requirements for CE marking. They may limit
or restrict the advertising and promotion of our tests to the general public and may impose limitations on promotional activities with
healthcare professionals. The risk of being found in violation of these or other laws and regulations is further increased by the fact
that many have not been fully interpreted by the regulatory authorities or the courts, and their provisions are open to a variety of
interpretations. Any action brought against us for violation of these or other laws or regulations, even in case of successful defense
against it, could result in significant legal expenses and divert management's attention from the operation of our business. While
our business is primarily based in the United States, these laws or regulations would not have an immediate material impact on our revenues.
However, in the longer term, our prospects could be seriously harmed.
If the FDA were to take the position that
our tests are not within the scope of its policy on enforcement discretion for laboratory-developed tests ("LDTs"), or Congress
or FDA were otherwise to begin requiring approval or clearance of our tests, responding to such a development could lead to a halt in
the commercial provision of our tests until we meet the requirements for premarket approval or clearance, enforcement action from FDA,
and we could incur substantial costs and time delays associated with meeting FDA requirements for premarket clearance or approval.
Although we believe we are within the scope of
the FDA's policy on enforcement discretion for LDTs, commercial availability of LDTs is subject to uncertainty given the FDA's
latitude in interpreting and applying its laws and policies. For example, although the FDA has historically exercised enforcement discretion
over most LDTs, it does not consider tests to be subject to this enforcement discretion if they were or are designed or manufactured completely,
or partly, outside of the laboratory that offers and uses them, or if they are offered "over-the-counter" (as opposed to being
available to patients only when prescribed by a health care provider). Even for tests that appear to fall within FDA's previously
stated policy on enforcement discretion, the FDA may decide to regulate certain LDTs on a case-by-case basis at any time.
Furthermore, the laws and regulations governing
the marketing of diagnostic products are evolving, extremely complex and in many instances, there are no significant regulatory or judicial
interpretations of these laws and regulations. Pursuant to its authority under the federal Food, Drug, and Cosmetic Act (the "FDCA"),
the FDA has jurisdiction over medical devices, including in vitro diagnostics and, therefore, potentially our clinical laboratory tests.
Among other things, pursuant to the FDCA and its implementing regulations, the FDA regulates the research, testing, manufacturing, safety,
labeling, storage, recordkeeping, premarket clearance or approval, marketing and promotion, and sales and distribution of medical devices
in the United States to ensure that medical products distributed domestically are safe and effective for their intended uses. Although
the FDA has asserted that it has authority to regulate the development and use of LDTs, such as our and many other laboratories'
tests, as medical devices, it has generally exercised enforcement discretion and is not otherwise regulating most tests developed and
performed within a single high complexity CLIA-certified laboratory.
18
Even though our tests are commercialized in the
United States as LDTs, they may in the future become subject to more onerous regulation by the FDA. For example, the FDA may disagree
with the assessment that the tests fall within the definition of an LDT and seek to regulate them as medical devices. The FDA has, for
over the past decade, been introducing proposals to end enforcement discretion and to bring LDTs clearly under existing FDA regulatory
frameworks and the U.S. Congress has recently been working on legislation to create an LDT and in vitro diagnostic regulatory framework
that would be separate and distinct from the existing medical device regulatory framework. If the FDA begins to enforce its medical device
requirements for LDTs, or if the FDA disagrees with our assessment that our tests are LDTs, our company and these tests could for the
first time be subject to a variety of regulatory requirements, including registration and listing, medical device reporting, and adherence
to good manufacturing practices under the quality system regulations, and we could be required to obtain premarket clearance or approval
for these existing tests and any new tests we may develop, which may force us to cease or delay marketing our tests until the required
clearance or approval are obtained. The premarket review process for diagnostic products can be lengthy, expensive, time-consuming, and
unpredictable. Further, obtaining premarket clearance or approval may involve, among other things, successfully completing clinical trials.
Clinical trials require significant time and cash resources and are subject to a high degree of risk, including risks of experiencing
delays, failing to complete the trial or obtaining unexpected or negative results. If we are required to obtain premarket clearance or
approval and/or conduct premarket clinical trials, development costs could significantly increase, the introduction of any new
tests under development may be delayed, and sales of our tests could be interrupted or stopped. Any of these outcomes could reduce revenues
or increase costs and materially adversely affect our business, prospects, results of operations, or financial condition. Moreover, any
cleared or approved labeling claims may not be consistent with current claims or be adequate to support continued adoption of and reimbursement
for our tests. For instance, if FDA requires our tests to be labeled as investigational, or if the labeling claims the FDA allows are
limited, order levels may decline and reimbursement may be adversely affected. If after commercialization under the LDT framework our
tests are allowed to remain on the market but there is uncertainty about the regulatory status of our tests, including questions that
may be raised if competitors object to our regulatory positioning as an LDT, we may encounter ongoing regulatory and legal challenges
and related costs. Such challenges or related developments (for example if the labeling claims the FDA allows us to make are more limited
than the claims we currently plan to make) may impact our commercialization efforts as orders or reimbursement may be less than anticipated.
As a result, we could experience significantly increased development costs and a delay in generating additional revenue. Until the FDA
finalizes its regulatory position regarding LDTs, or federal legislation is passed concerning regulation of LDTs, it is unknown how the
FDA may regulate our tests in the future and what testing and data may be required to support any required clearance or approval.
The requirement of premarket review could negatively
affect our business until such review is completed and regulatory clearance or approval is obtained. The FDA could require that sales
of our tests be halted pending premarket clearance or approval. In December 2018 the FDA Commissioner and the Director of the Center for
Devices and Radiological Health expressed significant concerns regarding disparities between some LDTs and in vitro diagnostics that have
been reviewed and cleared or approved by FDA. If the FDA were to determine that our tests are not within the policy for LDTs for any reason,
including new rules, policies, or guidance, or due to changes in statute, our tests may become subject to FDA requirements, including
premarket review. If required, the regulatory marketing authorization process may involve, among other things, successfully completing
additional clinical trials and submitting a premarket clearance (510(k)) submission or filing a de novo or premarket approval application
with the FDA. If premarket review and authorization is required by the FDA, we may need to incur additional expenses or require additional
time to seek it, or we may be unable to satisfy FDA standards, and our tests may not be cleared or approved on a timely basis, if at all,
and the labeling claims permitted by the FDA may not be consistent with our currently planned claims or adequate to support adoption of
and reimbursement for our tests. If the FDA requires any form of premarket review, our tests may not be cleared or approved on a timely
basis, if at all. We may also decide voluntarily to pursue FDA premarket review and authorization of our tests if it appears that doing
so would be appropriate.
In addition, we believe that the sample collection
kits provided by us for collection and transport of specimens from a health care provider to our clinical laboratories are considered
a Class I medical devices subject to the FDA's general device controls but exempt from premarket review. However, the FDA could
assert the specimen collection kits are non-exempt or Class II devices, which would subject them to premarket clearance or approval
processes, which could be time-consuming and expensive.
Failure to comply with any applicable FDA requirements
could trigger a range of enforcement actions by the FDA, including warning letters, civil monetary penalties, injunctions, criminal prosecution,
recall or seizure, operating restrictions, partial suspension or total shutdown of operations and denial of or challenges to applications
for clearance or approval, as well as significant adverse publicity.
Our operating results could be materially
adversely affected by unanticipated changes in tax laws and regulations, adjustments to our tax provisions, exposure to additional tax
liabilities, or forfeiture of our tax assets.
We are subject to laws and regulations on tax
levies and other charges or contributions in different countries, including transfer pricing and tax regulations for the compensation
of personnel and third parties. Our tax structure involves several transfers and transfer price determinations between our parent company
and our subsidiaries or other affiliates. Our effective tax rates could be adversely affected by changes in tax laws, treaties and regulations,
both internationally and domestically. An increase of the effective tax rates could have an adverse effect on our business, financial
position, results of operations and cash flows.
19
The net operating loss carry forwards of our corporate
subsidiaries may be unavailable to offset future taxable income because of restrictions under U.S. tax law. As of December 31, 2022,
consolidated net tax loss carry forwards amounted to $285.3 million. Our NOLs generated in tax years ending on or prior to December 31,
2017 are only permitted to be carried forward for 20 taxable years under applicable U.S. federal tax law, and therefore could expire unused.
We consider that it is highly likely that we will be unable to use at least a portion of these NOLs, in light of our continued losses.
Under tax legislation commonly referred to as the Tax Cuts and Jobs Act ("TCJA"), as modified by the CARES Act, our federal
NOLs generated in tax years ending after December 31, 2017 may be carried forward indefinitely and NOLs arising in taxable years
beginning after December 31, 2017 and before January 1, 2021 may be carried back to each of the five taxable years preceding the
tax year of such loss, but NOLs arising in taxable years beginning after December 31, 2020 may not be carried back. In addition,
under the TCJA, as modified by the CARES Act, for taxable years beginning after December 31, 2020, the deductibility of federal NOLs
generated in taxable years beginning after December 31, 2017 is limited to 80% of current year taxable income. It is uncertain if
and to what extent various states will conform to the TCJA, as modified by the CARES Act.
In addition, under sections 382 and 383 of the
Internal Revenue Code of 1986, as amended, or the Code, if a corporation undergoes an "ownership change" (generally defined
as a cumulative change in ownership by "5-percent shareholders" that exceeds 50 percentage points over a rolling three-year period),
the corporation's ability to use its pre-change NOLs and certain other pre-change tax attributes to offset post-change income
and taxes may be limited. Similar rules may apply under state tax laws. Our existing NOLs and other certain tax attributes may be subject
to limitations arising from previous ownership changes. In addition, future changes in our stock ownership, many of which are outside
of our control, could result in an ownership change under Sections 382 and 383 of the Code. We have not conducted any studies to determine
annual limitations, if any, that could result from such changes in the ownership. Our ability to utilize those NOLs and certain other
tax attributes could be limited by an "ownership change" as described above and consequently, we may not be able to utilize
a material portion of our NOLs and certain other tax attributes, which could have a material adverse effect on our cash flows and results
of operations by effectively increasing our future tax obligations.
Also under Belgian tax law, certain restrictions
regarding the use of Belgian tax losses carried forward apply and these losses may also be forfeited upon certain changes of control over
Belgian corporate taxpayers. As a COVID-19 measure, some limited tax loss carried back mechanism was introduced in Belgian tax law.
Given that we have historically generated operating
losses, any change in our ability to use NOLs could have a severe impact on us if and when we become profitable. As of December 31,
2022, we had an accumulated deficit of $288.3 million and for the year ended December 31, 2022, we had a net loss of $44.0 million.
Risks Related to Ownership of the ADSs and
Ordinary Shares
The trading price of our ordinary shares
and ADSs may be volatile due to factors beyond our control, and purchasers of the ADSs could incur substantial losses.
The market prices of the ADSs and ordinary shares
may be volatile. The stock market in general and the market for biotechnology companies in particular have experienced extreme volatility
that has often been unrelated to the operating performance of particular companies. As a result of this volatility, investors may not
be able to sell their ADSs or shares at or above the price originally paid for the security. The market price for the ADSs or shares may
be influenced by many factors, including:
●
actual or anticipated fluctuations in our financial condition and operating results;
●
the release of new data from our PRIORITY or other clinical trials;
●
actual or anticipated changes in our growth rate relative to our competitors;
●
competition from existing products or new products that may emerge;
●
announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations or capital commitments;
20
●
failure to meet or exceed financial estimates and projections of the investment community or that we provide to the public;
●
issuance of new or updated research or reports by securities analysts;
●
fluctuations in the valuation of companies perceived by investors to be comparable to us;
●
currency fluctuations;
●
additions or departures of key management or scientific personnel;
●
disputes or other developments related to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;
●
changes to coverage policies or reimbursement levels by commercial third-party payors and government payors and any announcements relating to coverage policies or reimbursement levels;
●
announcement or expectation of additional debt or equity financing efforts;
●
issuances or sales of the ADSs or shares by us, our insiders or our other holders; and
●
general economic and market conditions.
These and other market and industry factors may
cause the market price and demand for the ADSs or shares to fluctuate substantially, regardless of our actual operating performance, which
may limit or prevent investors from readily selling their ADSs or shares and may otherwise negatively affect the liquidity of the trading
market for ADSs or shares.
Certain of our significant shareholders
may have different interests from us and may be able to control us, including the outcome of shareholder votes.
As of March 31, 2023, (i) MVM Partners LLP beneficially
owned approximately 16.8% of our ordinary shares and has one representative at the board level (Dr. Eric Bednarski), (ii) Bleichroeder
LP owned approximately 14.3% of our ordinary shares, (iii) Valiance Asset Management beneficially owned approximately 7.7% of our
ordinary shares and has one representative at the board level (Jan Pensaert), and (iv) Biovest NV beneficially owned approximately
4.4% of our ordinary shares. In addition, as long as two of MVM Partners LLP's funds (MVM V LP and MVM GP (No.5) LP) hold in aggregate
5% of our company's outstanding shares, they are entitled to have one observer at the board level (see Item 7B. "
Related
party transactions — MVM Subscription Agreement
"). As a result, these shareholders will be able to exercise a significant
level of control over all matters requiring stockholder approval, including the election of directors, amendment of our Articles of Association
and approval of certain significant corporate transactions. This control could have the effect of delaying or preventing a change of control
of the Company or changes in management, in each case, which other shareholders might find favorable, and will make the approval of certain
transactions difficult or impossible without the support of these significant shareholders.
If securities or industry analysts do not
publish research or publish inaccurate or unfavorable research about our business, the price of the ADSs and ordinary shares and their
trading volume could decline.
The trading market for the ADSs and ordinary shares
depends in part on the research and reports that securities or industry analysts publish about us or our business. If no or only limited
securities or industry analysts cover our company, the trading price for the ADSs and ordinary shares could be negatively impacted. If
one or more of the analysts who covers us downgrades our equity securities or publishes inaccurate or unfavorable research about our business,
the price of ADSs would likely decline. If one or more of these analysts ceases coverage of our company or fails to publish reports on
us regularly, or downgrades our securities, demand for ADSs and ordinary shares could decrease, which could cause the price of the ADSs
and ordinary shares or their trading volume to decline.
21
We intend to retain all available funds
and any future earnings and, consequently, ADS holders' ability to achieve a return on their investment will depend on appreciation
in the price of the ADSs.
We have never declared or paid any cash dividends
on our ordinary shares or ADSs, and we intend to retain all available funds and any future earnings to fund the development and expansion
of our business. In addition, our loan agreement with Innovatus limits our ability to pay any such dividends. Therefore, ADS holders are
not likely to receive any dividends on your ADSs for the foreseeable future and the success of an investment in ADSs will depend upon
any future appreciation in their value. Consequently, investors may need to sell all or part of their holdings of ADSs after price appreciation,
which may never occur, as the only way to realize any future gains on their investment. There is no guarantee that the ADSs will appreciate
in value or even maintain the price at which our investors have purchased them. Investors seeking cash dividends should not purchase the
ADSs.
In addition, if we choose to pay dividends in
the future, exchange rate fluctuations may affect the amount of Euros that we are able to distribute, and the amount in U.S. dollars that
our shareholders receive upon the payment of cash dividends or other distributions we declare and pay in euros, if any. Any dividends
will generally be subject to Belgian withholding tax. These factors could harm the value of the ADSs.
Holders of ADSs should be aware that the
rights provided to our ADS holders under Belgian corporate law and our Articles of Association differ in certain respects from the rights
that you would typically enjoy as a shareholder of a U.S. company under applicable U.S. federal and state laws.
We are a Belgian public company with limited liability.
Our corporate affairs are governed by our Articles of Association and by the laws governing companies incorporated in Belgium. The rights
of shareholders and the responsibilities of members of our Board of Directors may be different from the rights and obligations of shareholders
and boards of directors in companies governed by the laws of U.S. jurisdictions. In the performance of its duties, our Board is required
by Belgian law to consider the interests of our company, its shareholders, its employees, and other stakeholders. It is possible that
some of these parties will have interests that are different from, or in addition to, the interests of our shareholders. See Item 10B.
"
Memorandum and Articles of Association.
"
Concentration of ownership of our ordinary
shares (including ordinary shares in the form of ADSs) among our existing executive officers, directors and principal shareholders may
prevent ADS holders from influencing significant corporate decisions.
Our executive officers, directors, greater than
three percent shareholders and their affiliates beneficially owned approximately 45.2% of our outstanding ordinary shares as of March 31,
2023. Depending on the level of attendance at our general meetings of shareholders, these shareholders either alone or voting together
as a group will be in a position to determine the outcome of decisions taken at any such general meeting. Any shareholder or group of
shareholders controlling more than 50% of the share capital present and voting at our general meetings of shareholders may control any
shareholder resolution requiring a simple majority, including the appointment of Board members, as well as certain decisions relating
to our capital structure, the approval of certain significant corporate transactions and amendments to our Articles of Association. Among
other consequences, this concentration of ownership may prevent or discourage unsolicited acquisition proposals that you may believe are
in your best interest as one of our shareholders. Some of these persons or entities may have interests different than yours.
Future sales, or the perception of future
sales, of a substantial number of our ordinary shares could adversely affect the price of the ADSs, and actual sales of our equity will
dilute ADS holders.
Future sales of a substantial number of our ADSs
or ordinary shares, or the perception that such sales will occur, could cause a decline in the market price of the ADSs. Approximately
78.9 million ordinary shares (including ordinary shares underlying ADSs) held by our directors, executive officers and certain shareholders
are subject to the lock-up agreements with terms generally expiring in May 2023. If, after the period during which such lock-up agreements
restrict sales of the our ordinary shares and ADSs or if the underwriters of our initial public offering of ADSs waive the restrictions
set forth therein (which may occur at any time), one or more of these securityholders sell substantial amounts of ordinary shares or ADSs
in the public market, or the market perceives that such sales may occur, the market price of the ADSs and our ability to raise capital
through an issue of equity securities in the future could be adversely affected.
22
If we issue ADSs or ordinary shares in future
financings, shareholders may experience dilution and, as a result, the price of the ADSs may decline.
We may from time-to-time issue additional ordinary
shares at a discount from the trading price of the ADSs. As a result, holders of the ADSs would experience immediate dilution upon the
issuance of any of our ordinary shares at such discount. In addition, as opportunities present themselves, we may enter into financing
or similar arrangements in the future, including the issuance of debt securities, preference shares or shares. If we issue ordinary shares
or other equity or equity-linked securities, holders of ADSs would experience additional dilution and, as a result, the price or
the ADSs may decline.
It may be difficult for ADS holders outside
Belgium to serve process on, or enforce foreign judgments against, us or our directors and senior management.
We are a Belgian public limited liability company.
Less than a majority of the members of our Board of Directors and members of our executive management team are residents of the United
States. All or a substantial portion of the assets of such non-resident persons and most of our assets are located outside the United
States. As a result, it may not be possible for ADS holders to effect service of process upon such persons or on us or to enforce against
them or us a judgment obtained in U.S. courts. Original actions or actions for the enforcement of judgments of U.S. courts relating to
the civil liability provisions of the federal or state securities laws of the United States are not directly enforceable in Belgium.
The United States and Belgium do not currently
have a multilateral or bilateral treaty providing for reciprocal recognition and enforcement of judgments, other than arbitral awards,
in civil and commercial matters. In order for a final judgment for the payment of money rendered by U.S. courts based on civil liability
to produce any effect on Belgian soil, it is accordingly required that this judgment be recognized or be declared enforceable by a Belgian
court in accordance with Articles 22 to 25 of the 2004 Belgian Code of Private International Law. Recognition or enforcement does not
imply a review of the merits of the case and is irrespective of any reciprocity requirement. A U.S. judgment will, however, not be recognized
or declared enforceable in Belgium, unless (in addition to compliance with certain technical provisions) the Belgian courts are satisfied
of the following:
●
the effect of the enforcement judgment is not manifestly incompatible with Belgian public policy;
●
the judgment did not violate the rights of the defendant;
●
the judgment was not rendered in a matter where the parties transferred rights subject to transfer restrictions with the sole purpose of avoiding the application of the law applicable according to Belgian international private law;
●
the judgment is not subject to further recourse under U.S. law;
●
the judgment is not incompatible with a judgment rendered in Belgium or with a subsequent judgment rendered abroad that might be recognized in Belgium;
●
the claim was not filed outside Belgium after the same claim was filed in Belgium, while the claim filed in Belgium is still pending;
●
the Belgian courts did not have exclusive jurisdiction to rule on the matter;
●
the U.S. court did not accept its jurisdiction solely on the basis of the presence of the plaintiff or the location of goods not direct linked to the dispute in the United States;
23
●
the judgment did not concern the deposit or validity of intellectual property rights when the deposit or registration of those intellectual property rights was requested, done or should have been done in Belgium pursuant to international treaties;
●
the judgment did not relate to the validity, operation, dissolution, or liquidation of a legal entity that has its main seat in Belgium at the time of the petition of the U.S. court;
●
if the judgment relates to the opening, progress or closure of insolvency proceedings, it is rendered on the basis of the European Insolvency Regulation (EC Regulation No. 1346/2000 of May 29, 2000) or, if not, that (a) a decision in the principal proceedings is taken by a judge in the state where the most important establishment of the debtor was located or (b) a decision in territorial proceedings was taken by a judge in the state where the debtor had another establishment than its most important establishment; and
●
the judgment submitted to the Belgian court is authentic under the laws of the state where the judgment was issued; in case of a default judgment, it can be shown that under locally applicable laws the invitation to appear in court was properly served on the defendant; a document can be produced showing that the judgment is, under the rules of the state where it was issued, enforceable and was properly served on the defendant.
In addition to recognition or enforcement, a judgment
by a federal or state court in the United States against us may also serve as evidence in a similar action in a Belgian court if it meets
the conditions required for the authenticity of judgments according to the law of the state where it was rendered. The findings of a federal
or state court in the United States will not, however, be taken into account to the extent they appear incompatible with Belgian public
policy.
Based on the lack of a treaty as described above,
U.S. investors may not be able to enforce against us or members of our Board of Directors or our executive management any judgments obtained
in U.S. courts in civil and commercial matters, including judgments under the U.S. federal securities laws.
We are an "emerging growth company"
and as a result of the reduced disclosure and governance requirements applicable to emerging growth companies, the ADSs may be less attractive
to investors.
We are an "emerging growth
company" as defined in the Jumpstart Our Business Startups Act of 2012 (the "JOBS Act"). For as long as we continue to be an emerging growth
company, we may take advantage of exemptions from various reporting requirements that are applicable to other public companies that
are not emerging growth companies, including not being required to comply with the auditor attestation requirements of
Section 404 of the Sarbanes-Oxley Act of 2002 (the "Sarbanes-Oxley Act"),, exemptions from the
requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute
payments not previously approved. We may take advantage of these exemptions until we are no longer an emerging growth company. We
could be an emerging growth company for up to five years, although circumstances could cause us to lose that status earlier,
including if the aggregate market value of our ordinary shares held by non-affiliates exceeds $700 million as of the end
of our second fiscal quarter before that time, in which case we would no longer be an emerging growth company as of the following
December 31st (the last day of our fiscal year). We cannot predict if investors will find the ADSs less attractive because we may
rely on these exemptions. If some investors find the ADSs less attractive as a result, there may be a less active trading market for
the ADSs and the price of the ADSs may be more volatile.
As a foreign private issuer and as permitted
by the listing requirements of Nasdaq, we rely on certain home country corporate governance practices rather than the corporate governance
requirements of Nasdaq.
We qualify as a foreign private issuer and our
ADSs are listed on Nasdaq. In accordance with the listing requirements of Nasdaq, we rely on home country governance requirements and
certain exemptions thereunder rather than relying on the corporate governance requirements of Nasdaq. For example, we are exempt from
certain rules under the Exchange Act that regulate disclosure obligations and procedural requirements related to the solicitation of proxies,
consents or authorizations applicable to a security registered under the Exchange Act, including the U.S. proxy rules under Section 14
of the Exchange Act. In addition, our officers and directors are exempt from the reporting and "short-swing" profit recovery
provisions of Section 16 of the Exchange Act and related rules with respect to their purchases and sales of our securities. Moreover,
while we currently publish annual and semi-annual reports on our website pursuant to the rules of Euronext Brussels and expect to
file such financial reports with the SEC, we are not required to file periodic reports with the SEC as frequently or as promptly as U.S.
public companies. Specifically, we are not required to file quarterly reports on Form 10-Q or current reports on Form 8-K that
a domestic company would be required to file under the Exchange Act. Accordingly, there may be less publicly available information concerning
our company than there would be if we were not a foreign private issuer.
24
In addition, the Listing Rules of the Nasdaq Stock
Market require a majority of the directors of a listed U.S. company to be independent, whereas in Belgium, only three directors need to
be independent. The Listing Rules of the Nasdaq Stock Market further require that each of the nominating, compensation and audit committees
of a listed U.S. company be comprised entirely of independent directors. However, the Belgian Corporate Governance Code recommends only
that a majority of the directors on the nomination committee meet the technical requirements for independence under Belgian corporate
law. At present, our Audit Committee is composed of three independent directors out of three members, whereas our Nomination and Remuneration
Committee is composed of three independent directors out of five members. Our Board of Directors has no plan to change the composition
of our Audit Committee and Nomination and Remuneration Committee, and we intend to follow home country practice to the maximum extent
possible. Therefore, our shareholders may be afforded less protection than they otherwise would have under corporate governance listing
standards applicable to U.S. domestic issuers.
We may lose our foreign private issuer status
in the future, which could result in significant additional costs and expenses.
As a foreign private issuer, we are not required
to comply with all the periodic disclosure and current reporting requirements of the Exchange Act and related rules and regulations. The
determination of foreign private issuer status is made annually on the last business day of our most recently completed second fiscal
quarter. Accordingly, we will next make a determination with respect to our foreign private issuer status on June 30, 2023. There
is a risk that we will lose our foreign private issuer status in the future.
We would lose our foreign private issuer status
if, for instance more than 50% of our ordinary shares are owned by U.S. residents or persons and more than 50% of our assets are located
in the United States and we continue to fail to meet additional requirements necessary to maintain our foreign private issuer status.
The regulatory and compliance costs to us under U.S. securities laws as a U.S. domestic issuer may be significantly greater than the costs
we incur as a foreign private issuer. If we are not a foreign private issuer, we will be required to file periodic reports and registration
statements on U.S. domestic issuer forms with the SEC, which are more detailed and extensive in certain respects than the forms available
to a foreign private issuer. We would be required under current SEC rules to prepare our financial statements in accordance with U.S.
GAAP and modify certain of our policies to comply with corporate governance practices associated with U.S. domestic issuers. Such conversion
and modifications would involve additional costs. In addition, we may lose our ability to rely upon exemptions from certain corporate
governance requirements on U.S. stock exchanges that are available to foreign private issuers, which could also increase our costs.
U.S. holders of ADSs may suffer adverse
tax consequences if we are characterized as a passive foreign investment company, or PFIC.
In general, a non-U.S. corporation is a PFIC
for U.S. federal income tax purposes for any taxable year in which (i) 50% or more of value of its assets (based on an average of the
quarterly values of the assets during such taxable year) consists of assets that produce, or are held for the production of, passive income,
or (ii) 75% or more of its gross income consists of passive income. A separate determination must be made after the close of each
fiscal year as to whether a non-U.S. corporation is a PFIC for that year. For purposes of the above calculations, a non-U.S. corporation
that owns, directly or indirectly, at least 25% by value of the shares of another corporation is treated as if it held its proportionate
share of the assets of the other corporation and received directly its proportionate share of the income of the other corporation. Passive
income generally includes dividends, interest, investment gains and certain rents and royalties. Cash is generally a passive asset for
these purposes. The value goodwill is generally treated as an active asset if it is associated with business activities that produce active
income.
If we are a PFIC for any taxable year during which
a U.S. Holder (as defined under Item 10E. "
Taxation
") holds ADSs, we will continue to be treated as a PFIC with respect
to such U.S. Holder in all succeeding years during which the U.S. Holder owns the ADSs regardless of whether we continue to meet
the PFIC test described above, unless the U.S. Holder makes a specified election once we cease to be a PFIC. If we are classified as a
PFIC for any taxable year during which a U.S. Holder holds ADSs, the U.S. Holder may be subject to adverse tax consequences regardless
of whether we continue to qualify as a PFIC, including ineligibility for any preferred tax rates on capital gains or on actual or deemed
dividends, interest charges on certain taxes treated as deferred, and additional reporting requirements.
25
Based on the current estimates, and expected future
composition, of our income and the value of our assets, including goodwill, we do not expect to be a PFIC for our current taxable year.
However, our PFIC status for any taxable year is an annual determination that can be made only after the end of that year and will depend
on the composition of our income and assets and the value of our assets from time to time. The determination of whether we are a PFIC
is fact-intensive and the applicable law is subject to varying interpretation. There can be no assurance that the U.S. Internal
Revenue Service, or IRS, will agree with our position or that the IRS will not successfully challenge our position including our classification
of certain income and assets as non-passive or our valuation of our tangible and intangible assets.
A U.S. Holder may in certain circumstances mitigate
the adverse tax consequences of the PFIC rules by filing an election to treat the PFIC as a Qualified Electing Fund ("QEF")
or, if shares of the PFIC are "marketable stock" for purposes of the PFIC rules, by making a mark-to-market election
with respect to the shares of the PFIC. However, we do not currently intend to provide the information necessary for U.S. Holders to make
a QEF election if we were treated as a PFIC for any taxable year and prospective investors should assume that a QEF election will not
be available. Furthermore, if a U.S. Holder were to make a mark-to-market election with respect to its ADSs, the U.S. Holder would
be required to include annually in its U.S. federal taxable income (taxable at ordinary income rates) an amount reflecting any year end
increase in the value of its ADSs. For further discussion of the PFIC rules and the adverse U.S. federal income tax consequences in the
event we are classified as a PFIC, see Item 10E. "
Taxation
."
The U.S. federal income tax rules relating to
PFICs are very complex. Current and prospective U.S. Holders are strongly urged to consult their own tax advisors with respect to the
impact of PFIC status on the purchase, ownership and disposition of ADSs, the consequences to them of an investment in a PFIC, any elections
available with respect to the ADSs and the IRS information reporting obligations with respect to the purchase, ownership and disposition
of ADSs of a PFIC.
If a U.S. Holder is treated as owning at
least 10% of our ordinary share capital, such holder may be subject to adverse U.S. federal income tax consequences.
If a U.S. Holder (as defined below under Item
10E. "
Taxation
") is treated as owning, directly, indirectly or constructively, at least 10% of the value or voting
power of our share capital, such U.S. Holder may be treated as a "U.S. shareholder" with respect to each "controlled
foreign corporation" in our group, if any. Because our group currently includes at least one U.S. subsidiary, under current law,
any of our current non-U.S. subsidiaries and any future newly formed or acquired non-U.S. subsidiaries will be treated as controlled foreign
corporations, regardless of whether we are treated as a controlled foreign corporation. A U.S. shareholder of a controlled foreign corporation
may be required to annually report and include in its U.S. taxable income its pro rata share of "Subpart F income," "global
intangible low-taxed income" and investments in U.S. property by controlled foreign corporations, regardless of whether
we make any distributions. An individual that is a U.S. shareholder with respect to a controlled foreign corporation generally would not
be allowed certain tax deductions or foreign tax credits that would be allowed to a U.S. shareholder that is a U.S. corporation. Failure
to comply with controlled foreign corporation reporting obligations may subject a U.S. shareholder to significant monetary penalties.
We cannot provide any assurances that we will furnish to any U.S. shareholder information that may be necessary to comply with the reporting
and tax paying obligations applicable under the controlled foreign corporation rules of the Code. U.S. Holders should consult their tax
advisors regarding the potential application of these rules to their investment in ADSs. See Item 10E. "
Taxation
" for
a more detailed discussion.
We incur significant costs as a result of
operating as a company that is publicly listed on both Nasdaq in the United States and Euronext Brussels in Belgium, and our management
is required to devote substantial time to new compliance initiatives.
As a U.S. public company listed on Nasdaq, we
incur legal, accounting, and other expenses that we did not previously incur. We are subject to the reporting requirements of the Exchange
Act, the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the Nasdaq listing requirements
and other applicable securities rules and regulations. Compliance with these rules and regulations will increase our legal and financial
compliance costs, make some activities more difficult, time consuming or costly and increase demand on our systems and resources, particularly
after we are no longer an "emerging growth company" and/or a foreign private issuer. The Exchange Act requires that, as a
public company, we file annual, semi-annual and current reports with respect to our business, financial condition and result of operations.
However, as a foreign private issuer, we are not required to file quarterly and current reports with respect to our business and results.
We currently make annual and semi-annual reporting with respect to our listing on Euronext Brussels.
Moreover, these rules and regulations increase
our legal and financial compliance costs and make some activities more time-consuming and costly. For example, we expect that these
rules and regulations may make it more difficult and more expensive for us to obtain director and officer liability insurance, which in
turn could make it more difficult for us to attract and retain qualified senior management personnel or members for our Board of Directors.
However, these rules and regulations are often
subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may
evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding
compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.
Further, being a U.S. listed company and a Belgian
public company with shares admitted to trading on Euronext Brussels impacts the disclosure of information and requires compliance with
two sets of applicable rules. From time to time, this may result in uncertainty regarding compliance matters and result in higher costs
necessitated by legal analysis of dual legal regimes, ongoing revisions to disclosure and adherence to heightened governance practices.
As a result of the enhanced disclosure requirements of the U.S. securities laws, business and financial information that we report is
broadly disseminated and highly visible to investors, which we believe may increase the likelihood of threatened or actual litigation,
including by competitors and other third parties, which could, even if unsuccessful, divert financial resources and the attention of our
management from our operations.
26
As a result of being a U.S. public company,
we are subject to regulatory compliance requirements, including Section 404 of the Sarbanes-Oxley Act ("Section 404"), and
if we fail to maintain an effective system of internal controls, we may not be able to accurately report our financial results or prevent
fraud.
Pursuant to Section 404, our management is required
to assess and attest to the effectiveness of our internal control over financial reporting in connection with issuing our consolidated
financial statements as of and for each fiscal year. Section 404 also requires an attestation report on the effectiveness of internal
control over financial reporting be provided by our independent registered public accounting firm beginning with our annual report following
the date on which we are no longer an "emerging growth company", which may be up to five fiscal years from the initial
public offering of our ADSs.
The cost of complying with Section 404 significantly
increases and management's attention may be diverted from other business concerns, which could adversely affect our results. We
may need to hire more employees in the future or engage outside consultants to comply with these requirements, which will further increase
expenses. If we fail to comply with the requirements of Section 404 in the required timeframe, we may be subject to sanctions or investigations
by regulatory authorities, including the SEC and Nasdaq. Furthermore, if we are unable to attest to the effectiveness of our internal
control over financial reporting, we could lose investor confidence in the accuracy and completeness of our financial reports, and the
market price of the ADSs could decline. Failure to implement or maintain effective internal control over financial reporting could also
restrict our future access to the capital markets and subject each of us, our directors and our officers to both significant monetary
and criminal liability. In addition, changing laws, regulations and standards relating to corporate governance and public disclosure are
creating uncertainty for public companies, increasing legal and financial compliance costs and making some activities more time consuming.
These laws, regulations and standards are subject to varying interpretations, in many cases due to their lack of specificity, and, as
a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could
result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance
practices. We intend to invest resources to comply with evolving laws, regulations and standards, and this investment may result in increased
general and administrative expense and a diversion of management's time and attention from revenue generating activities to compliance
activities. If our efforts to comply with new laws, regulations and standards differ from the activities intended by regulatory or governing
bodies due to ambiguities related to their application and practice, regulatory authorities may initiate legal proceedings against us
and our business, financial position, results and prospects may be adversely affected.
If we fail to implement and maintain effective internal controls
over financial reporting, our ability to produce accurate financial statements on a timely basis could be impaired.
We are subject to reporting obligations under
U.S. securities laws and the Sarbanes-Oxley Act of 2002. Section 404 of the Sarbanes-Oxley Act requires
that we include a report from management on the effectiveness of our internal control over financial reporting in our annual report on
Form 20-F for the year ended December 31, 2022. If we fail to implement and maintain adequate disclosure controls and procedures,
our management may conclude that our internal control over financial reporting is not effective. This conclusion could adversely impact
the market price of the ADSs due to a loss of investor confidence in the reliability of our reporting processes.
In connection with the preparation of our financial
statements for the nine months ended September 30, 2022, (the "Interim Financial Statements"), we identified a material
weakness in our internal control over financial reporting at September 30, 2022 related to ineffective design and operation of our
interim financial close and reporting controls. More specifically, internal control over financial reporting procedures used in connection
with the preparation of the financial information that we reported in a press release issued on October 27, 2022 failed to identify
a number of cut-off errors. These cut-off errors have been corrected in the Interim Financial Statements and do not relate to
our year-end close and reporting controls. A material weakness is a deficiency, or a combination of deficiencies, in internal control
over financial reporting such that there is a reasonable possibility that a material misstatement of a company's annual or interim
financial statements will not be prevented or detected on a timely basis. Although we were able to remediate these issues, including engaging
an outside IFRS consulting firm to assist with our interim closing process, these efforts may not be sufficient to avoid similar material
weaknesses in the future. Undetected material weaknesses in our internal controls could lead to financial statement restatements and require
us to incur remediation costs. To the extent we experience additional future material weaknesses, investors could lose confidence in the
accuracy or completeness of our reported financial information, which could have a negative effect on the trading price of the ADSs. Failure
to implement or maintain effective internal control over financial reporting could also restrict our future access to the capital markets
and subject each of us, our directors and our officers to both significant monetary and criminal liability.
We are required to perform system and process
evaluations and testing of our internal controls over financial reporting, to allow our management and our independent public registered
accounting firm to report on the effectiveness of our internal control over financial reporting. In addition, our compliance with Section 404
of the Sarbanes-Oxley Act will require that we incur substantial accounting expense, expend significant management effort and we
may need to hire additional accounting and financial staff with the appropriate experience and technical accounting knowledge, and compile
the system and process documentation necessary to perform the evaluation needed to comply with Section 404 of the Sarbanes-Oxley Act.
We may not be able to complete our evaluation, testing and any required remediation in a timely fashion. Any failure to implement required
new or improved controls, or difficulties encountered in their implementation could cause us to fail to meet our reporting obligations.
In addition, any testing by us conducted in connection with Section 404 of the Sarbanes-Oxley Act, or any subsequent testing
by our independent registered public accounting firm, may reveal additional deficiencies in our internal controls over financial reporting
that are deemed to be material weaknesses or that may require prospective or retroactive changes to our financial statements or identify
other areas for further attention or improvement. We cannot assure you that there will not be additional material weaknesses or significant
deficiencies in our internal control over financial reporting in the future.
We may be subject to securities litigation,
which is expensive and could divert management's attention.
The market price of the ADSs may be volatile and,
in the past, companies that have experienced volatility in the market price of their stock have been subject to securities class action
litigation. We may be the target of this type of litigation in the future. Securities litigation against us could result in substantial
costs and divert our management's attention from other business concerns, which could seriously harm our business.
27
Investors resident in countries other than
Belgium may suffer dilution if they are unable to participate in future preferential subscription rights offerings.
Under Belgian law and our constitutional documents,
shareholders have a waivable and cancellable preferential subscription right to subscribe
pro rata
to their existing
shareholdings to the issuance, against a contribution in cash, of new shares or other securities entitling the holder thereof to new shares,
unless such rights are limited or cancelled by resolution of our general shareholders' meeting or, if so authorized by a resolution
of such meeting, our Board of Directors. The exercise of preferential subscription rights by certain shareholders not residing in Belgium
(including those in the United States, Australia, Israel, Canada or Japan as a result of the offering and taking into account the current
shareholding and international network of our current Board of Directors) may be restricted by applicable law, practice or other considerations,
and such shareholders may not be entitled to exercise such rights, unless the rights and shares are registered or qualified for sale under
the relevant legislation or regulatory framework. In particular, we may not be able to establish an exemption from registration in the
United States under the Securities Act of 1933, as amended (the "Securities Act"), and we are under no obligation to file
a registration statement with respect to any such preferential subscription rights or underlying securities or to endeavor to have a registration
statement declared effective under the Securities Act. Shareholders in jurisdictions outside Belgium who are not able or not permitted
to exercise their preferential subscription rights in the event of a future preferential subscription rights, equity or other offering
may suffer dilution of their shareholdings.
ADS holders may not be able to exercise
their right to vote the ordinary shares underlying their ADSs.
ADS holders do not have the same rights as our
shareholders. For example, ADS holders may not attend shareholders' meetings or directly exercise the voting rights attaching to
the ordinary shares underlying their ADSs. ADS holders may vote only by instructing the depositary to vote on their behalf. If we request
the depositary to solicit your voting instructions (and we are not required to do so), the depositary will notify you of a shareholders'
meeting and send or make voting materials available to you. Those materials will describe the matters to be voted on and explain how ADS
holders may instruct the depositary how to vote. For instructions to be valid, they must reach the depositary by a date set by the depositary.
The depositary will try, as far as practical, to vote or to have its agents vote the deposited ordinary shares as instructed by ADS holders.
If we do not request the depositary to solicit ADS holders' voting instructions, ADS holders can still send voting instructions,
and, in that case, the depositary may try to vote as the ADS holder instructs, but it is not required to do so. Except by instructing
the depositary as described above, ADS holders will not be able to exercise voting rights unless the ADS holder surrenders the ADS holder's
ADSs and withdraw the ordinary shares. However, ADS holders may not know about the meeting enough in advance to withdraw the ordinary
shares. We cannot assure ADS holders that they will receive the voting materials in time to ensure that they can instruct the depositary
to vote their ordinary shares. In addition, the depositary and its agents are not responsible for failing to carry out voting instructions
or for the manner of carrying out voting instructions. This means that ADS holders may not be able to exercise voting rights and there
may be nothing an ADS holder can do if the ADS holder's ordinary shares are not voted as the ADS holder requested. In addition,
ADS holders have no right to call a shareholders' meeting.
Holders of ADSs may be subject to limitations
on the transfer of their ADSs and the withdrawal of the underlying ordinary shares.
ADSs, which may be evidenced by American Depositary
Receipts, are transferable on the books of the depositary. However, the depositary may close its books at any time or from time to time
when it deems expedient in connection with the performance of its duties. The depositary may refuse to deliver, transfer or register transfers
of ADSs generally when our books or the books of the depositary are closed, or at any time if we or the depositary think it is advisable
to do so because of any requirement of law, government or governmental body, or under any provision of the deposit agreement, or for any
other reason subject to a holder of ADSs' right to cancel his or her ADSs and withdraw the underlying ordinary shares as specified
in the deposit agreement. Temporary delays in the cancellation of ADSs and withdrawal of the underlying ordinary shares may arise because
the depositary has closed its transfer books or we have closed our transfer books, in connection with voting at a shareholders'
meeting or we are paying a dividend on our ordinary shares. In addition, a holder of ADSs may not be able to cancel his or her ADSs and
withdraw the underlying ordinary shares when he or she owes money for fees, taxes and similar charges and when it is necessary to prohibit
withdrawals in order to comply with any laws or governmental regulations that apply to ADSs or to the withdrawal of ordinary shares or
other deposited securities. See Item 12D. "
American Depositary Shares
."
ADS holders may not be entitled to a jury
trial with respect to claims arising under the deposit agreement, which could result in less favorable outcomes to the plaintiffs in any
such action.
The deposit agreement governing the ADSs representing
our ordinary shares provides that, to the fullest extent permitted by law, ADS holders, including holders who acquire ADSs in the secondary
market, waive the right to a jury trial of any claim they may have against us or the depositary arising out of or relating to our shares,
the ADSs or the deposit agreement, including any claim under the U.S. federal securities laws.
28
If we or the depositary opposed a jury trial
demand based on the waiver, the court would determine whether the waiver was enforceable based on the facts and circumstances of that
case in accordance with the applicable state and federal law. To our knowledge, the enforceability of a contractual pre-dispute jury
trial waiver in connection with claims arising under the federal securities laws has not been finally adjudicated by the U.S. Supreme
Court. However, we believe that a contractual pre-dispute jury trial waiver provision is generally enforceable, including under
the laws of the State of New York, which govern the deposit agreement, by a federal or state court in the City of New York, which has
non-exclusive jurisdiction over matters arising under the deposit agreement. In determining whether to enforce a contractual pre-dispute jury
trial waiver provision, courts will generally consider whether a party knowingly, intelligently and voluntarily waived the right to a
jury trial. We believe that this is the case with respect to the deposit agreement and the ADSs. It is advisable that you consult legal
counsel regarding the jury waiver provision before entering into the deposit agreement.
If any owners or holders of ADSs bring a claim
against us or the depositary in connection with matters arising under the deposit agreement or the ADSs, including claims under federal
securities laws, such other holder or beneficial owner may not be entitled to a jury trial with respect to such claims, which may have
the effect of limiting and discouraging lawsuits against us and the depositary. If a lawsuit is brought against either or both of us
and the depositary under the deposit agreement, it may be heard only by a judge or justice of the applicable trial court, which would
be conducted according to different civil procedures and may result in different outcomes than a trial by jury would have, including
results that could be less favorable to the plaintiffs in any such action.
Nevertheless, if this jury trial waiver provision
is not permitted by applicable law, an action could proceed under the terms of the deposit agreement with a jury trial. No condition,
stipulation or provision of the deposit agreement or ADSs serves as a waiver by any owner or holder of ADSs or by us or the depositary
of compliance with U.S. federal securities laws and the rules and regulations promulgated thereunder.
Takeover provisions in the national law
of Belgium may make a takeover difficult.
Public takeover bids on our shares and other
voting securities, such as warrants or convertible bonds, if any, are subject to the Belgian Act of April 1, 2007 on public takeover
bids, as amended and implemented by the Belgian Royal Decree of April 27, 2007, or Royal Decree, and to the supervision by the Belgian
Financial Services and Markets Authority, or FSMA. Public takeover bids must be made for all of our voting securities, as well as for
all other securities that entitle the holders thereof to the subscription to, the acquisition of or the conversion into voting securities.
Prior to making a bid, a bidder must issue and disseminate a prospectus, which must be approved by the FSMA. The bidder must also obtain
approval of the relevant competition authorities, where such approval is legally required for the acquisition of our company. The Belgian
Act of April 1, 2007 provides that a mandatory bid will be required to be launched for all of our outstanding shares and securities
giving access to shares if a person, as a result of its own acquisition or the acquisition by persons acting in concert with it or by
persons acting on their account, directly or indirectly holds more than 30% of the voting securities in a company that has its registered
office in Belgium and of which at least part of the voting securities are traded on a regulated market or on a multilateral trading facility
designated by the Royal Decree. The mere fact of exceeding the relevant threshold through the acquisition of one or more shares will
give rise to a mandatory bid, irrespective of whether or not the price paid in the relevant transaction exceeds the current market price.
There are several provisions of Belgian company
law and certain other provisions of Belgian law, such as the obligation to disclose important shareholdings and merger control, that
may apply to us and which may make an unfriendly tender offer, merger, change in management or other change in control, more difficult.
These provisions could discourage potential takeover attempts that third parties may consider and thus deprive the shareholders of the
opportunity to sell their shares at a premium (which is typically offered in the framework of a takeover bid).
29
ITEM 4. INFORMATION ON THE COMPANY
A. History and Development of the Company
We were incorporated on January 10, 2003
as a company with limited liability (
naamloze vennootschap/société anonyme
) incorporated and operating under the
laws of Belgium. We are registered with the legal entities register (Liège) under enterprise number 0479.292.440. We were publicly
listed on Euronext Brussels in June 2006. In October 2010 the Company's name was changed from OncoMethylome Sciences SA to MDxHealth
SA. We have two directly held, wholly owned subsidiaries: MDxHealth, Inc., a Delaware company incorporated in April 2003, and MDxHealth
B.V., a Dutch company incorporated in September 2015. Our agent for service of process in the United States is MDxHealth, Inc., which
is located at 15279 Alton Parkway — Suite 100, Irvine, CA 92618. MDxHealth, Inc.'s telephone number is +1 949-812-6979.
Our headquarters and principal executive offices
are located at CAP Business Center, Zone Industrielle des Hauts-Sarts, Rue d'Abhooz 31, 4040 Herstal, Belgium, our telephone
number is +32 4 257 70 21 and our email is info@mdxhealth.com. Our website address is
www.mdxhealth.com
. The information
contained on, or accessible through, our website is not incorporated by reference into this annual report, and you should not consider
any information contained in, or that can be accessed through, our website as part of this annual report or in deciding whether to purchase
ADSs.
Our capital expenditures for the years ended
December 31, 2020, 2021 and 2022 amounted to $540,000, $1.2 million and 2.8 million, respectively. These capital expenditures primarily
consisted of laboratory equipment, information technology equipment, and leasehold improvements. To date, we have expensed all research
and development costs as incurred, as we do not currently meet the conditions to capitalize expenditures on drug development activities,
as provided in IAS 38
Intangible Assets
. Our research and development costs for the years ended December 31, 2020,
2021 and 2022 amounted to $4.5 million, $6.7 million and $7.6 million, respectively. These research and development costs primarily consisted
of expenses incurred in connection with the development of our pipeline products, such as labor costs (including salaries, bonuses, benefits,
and stock-based compensation), reagents and supplies, clinical studies, outside services, patent expenses, depreciation of laboratory
equipment, facility occupancy and information technology costs. We expect that our research and development expenses will increase in
absolute dollars as we continue to develop additional products, however, we expect that these expenses will decrease as a percentage
of revenue over the long term, though they may fluctuate as a percentage from period to period due to the timing and extent of these
expenses. For the near future, our investments will mainly remain in the United States where our molecular laboratory facility is currently
located.
The SEC maintains a website that contains reports,
proxy and information statements, and other information regarding issuers that file electronically with the SEC at
http://www.sec.gov
.
We also maintain a website at
http://www.mdxhealth.com/
. The reference to our website is an inactive textual reference only and
the information contained in, or that can be accessed through, our website or any other website cited in this annual report is not a
part of this annual report.
B. Business Overview
Overview
We are a commercial-stage precision diagnostics
company committed to providing non-invasive, clinically actionable and cost-effective urologic solutions to improve patient care. Our
novel genomic testing solutions combine advanced clinical modeling with genomic data to provide each patient with a personalized risk
profile, which provides more accurate and actionable information than traditional clinical risk factors used by clinicians. Our Select
mdx and Confirm mdx tests address men at risk for undetected prostate cancer, providing physicians with a clear clinical pathway to accurately
identify clinically significant prostate cancer while reducing the use of invasive procedures that are prone to complications. Our GPS
test addresses men newly diagnosed with localized prostate cancer, providing physicians with a clear clinical pathway to make the most
informed treatment decision for their individual disease. Our team's collective decades of experience in precision diagnostics
and our portfolio of novel biomarkers for diagnostic, prognostic and predictive molecular assays supports our active pipeline of new
testing solutions for urologic diseases.
30
Prostate cancer is presently the most common,
and second deadliest, form of cancer in men. The broad adoption of prostate-specific antigen ("PSA") screening in the 1980s
created a paradigm shift in men's health, reducing the incidence of metastatic prostate cancers by more than 50%. However, widespread
PSA testing also significantly increased the pool of symptomatic men, resulting in overdiagnosis, overtreatment, serious complications,
and potential anxiety — triggering a retreat from standardized PSA screening — culminating with the decision of the U.S.
Preventative Services Task Force's ("USPSTF") to recommend against all PSA testing and prostate cancer screening in
2012. Following recommendations from clinicians and patient advocates together with building evidence of an uptick in metastatic prostate
cancer incidence, the USPSTF softened its position in 2017, upgrading PSA screening for middle-aged men. However, the USPSTF's
reversal left unresolved the clinical dilemma posed by the estimated pool of over ten million men living with an elevated PSA in the
United States. Approximately 25 million PSA tests are performed each year, and over 15% of these reveal heightened PSA levels —
leading to an estimated pool of over three million undiagnosed men informed each year of their heightened risk for prostate cancer based
on elevated PSA test results and/or negative biopsy results. Other than repeated invasive needle biopsy procedures, these symptomatic
men and their clinicians have limited tools to manage their cancer risk.
Our Select mdx and Confirm mdx testing solutions
directly address this unmet clinical need. Since the commercial launch of Confirm mdx in 2012 and Select mdx in 2016, we have performed
over 200,000 tests ordered by more than 1,000 urologists in the United States. Select mdx for Prostate Cancer (a urine test for men being
considered for their first prostate biopsy) and Confirm mdx for prostate cancer (an epigenetic test for men post-prostate biopsy), are
designed to (i) improve the earlier detection of clinically significant prostate cancer in at-risk men and (ii) reduce the unnecessary
costs and patient anxiety associated with the diagnosis and treatment of the disease. Both tests have been included in the National Comprehensive
Cancer Network ("NCCN") Guidelines for the Early Prostate Cancer Detection. NCCN is a non-profit alliance of the 31 leading
cancer centers in the United States. Both tests have also successfully completed formal technical assessment review for Medicare reimbursement
and have received a positive final local coverage determination ("LCD").
While our existing prostate cancer tests, Select
mdx and Confirm mdx, improve the decision for biopsy in at-risk patients, our recently acquired GPS test moves us further into the cancer
management pathway, providing solutions for patients newly diagnosed with localized prostate cancer to make the most informed treatment
decision for their individual disease. Our acquisition of the GPS (formerly Oncotype DX GPS) prostate cancer business in August 2022
from Genomic Health, Inc., a subsidiary of Exact Sciences, has accelerated our plans to build on our leadership in the urologic diagnostic
space.
Currently, most newly diagnosed cases of
prostate cancer remain indolent — slow growing and non-lethal. Patients diagnosed with indolent prostate cancer may be
appropriately managed with observation or active surveillance ("AS"), while those with aggressive cancers may benefit
from immediate treatment. Practice-management agencies worldwide have implemented guidelines stressing the importance of discerning
favorable from unfavorable disease features to guide personalized management for patients diagnosed with low- and high-risk prostate
cancer, including among others NCCN, the American Urology Association, American Society for Radiation Oncology, Society of Urologic
Oncology, the American Society of Clinical Oncology, the National Institute for Health and Care Excellence, and the European
Association of Urology ("EAU"). The use of AS has increased in recent years, with approximately half of patients newly
diagnosed with localized prostate cancer choosing to avoid immediate intervention or similar treatment.
GPS is a tissue-based, multi-gene test that has
been clinically validated to predict aggressive cancer at the time of diagnosis, helping to identify those men who need immediate surgery
or radiation therapy versus those who can confidently choose AS. Since its commercial launch in 2013, over 100,000 GPS tests have been
performed, ordered by more than 3,000 urologists in the United States. GPS is able to provide a more precise and accurate assessment
of disease progression, which helps more men avoid the lifelong complications associated with aggressive treatments. In 2015 our GPS
test received a positive Medicare LCD under the MolDX Program, which provides coverage and reimbursement for Medicare beneficiaries throughout
the United States.
31
Building from the foundation of our complementary
marketed products, we are committed to sustained growth, with our core management principles defined by a commitment to focus, commercial
execution and operating discipline throughout our organization. While MDxHealth is domiciled and listed as a public company in Belgium,
our primary commercial focus is the United States, where over 95% of our tests are performed and revenues are generated. Our leadership
change in 2019 and coincident organizational and operational discipline implemented throughout the MDxHealth group of companies has further
focused our commitment to U.S.-sourced growth, with our entire executive management team and over 90% of staff based in or reporting
to our U.S. headquarters and laboratories.
We have established a systematic approach to
commercializing our precision diagnostic solutions in our target markets in the United States, focusing on active engagement, education
and market development directed toward health care professionals and their patients. Our commercial team is focused on prioritizing large
and high-volume community urology centers, and on building long-standing relationships with key physicians and practice groups who have
strong connections to the population of men who may be eligible for our solutions. Our ultimate goal is to support physicians using our
tests through all aspects of the patient's journey, starting from initial diagnosis through to advanced prostate cancer management.
We also seek to build on our long-term partnerships with key opinion leaders ("KOLs") and patient associations that are oriented
towards the needs of our patients and customers. Our sales and marketing organization is focused on building physician awareness of the
clinical and economic benefits provided by our tests through education of urologists and their clinical staff as well as pathology and
laboratory staff, targeted KOL development and training, and development of tools for our customers to interact with patients and consumers
(doctor-to-consumer education).
Our Product Portfolio
Our core commercial tests address a substantial unmet clinical need
in the prostate cancer diagnostic and treatment pathway. According to the American Cancer Society, prostate cancer is the most common,
and second deadliest, form of cancer in males in the United States. Prior to the emergence of precision diagnostic solutions, existing
diagnostic tests were critically flawed, with high false negatives and false positives, leading to costly and invasive diagnostic protocols
and attendant complications.
To screen at-risk men for prostate cancer, approximately 25 million
PSA tests are performed each year, and over 15% of those reveal heightened levels of PSA. An elevated PSA level can be caused by many
different sources, the majority of which are not cancer. Current clinical guidelines suggest that men with an elevated PSA should be
considered for a prostate biopsy, so that a pathologist can visually inspect the sampled tissue to identify any sign of malignancy. However,
60% of biopsies are negative, not revealing any cancer, and as many as a third of these negative biopsies are false negatives, providing
limited comfort to patients and their physicians that cancer was not missed. The relatively modest sensitivity and specificity of these
current standard-of-care tests and procedures has led to increased patient anxiety, potentially unnecessary, invasive and costly interventions,
and increased complications and hospitalizations.
Our Select mdx test — which is a noninvasive urine test with
95% Negative Predictive Value ("NPV") for clinically significant prostate cancer — can be used to help physicians determine
whether a costly, painful and complication-prone needle-core biopsy is advisable when a patient presents with an elevated PSA level or
an abnormal digital rectal exam ("DRE"). For those men who proceed to a biopsy procedure, our Confirm mdx test, which measures
biomarker signals in the biopsied tissue, provides additional information to physicians and increases the accuracy of the biopsy, with
a 96% NPV for clinically significant disease.
Upon an initial diagnosis of localized
prostate cancer, our GPS test — which measures the expression of a panel of genes in prostate cancer tissue to predict the
aggressiveness of the disease — can help distinguish between aggressive and indolent prostate cancer, which informs treatment
decisions and helps to identify patients who may avoid unnecessary interventions.
32
To further supplement our prostate cancer menu,
with Resolve mdx we have developed a novel, advanced urinary tract infection ("UTI") test that delivers patient-specific
antimicrobial treatment options within 24-48 hours (standard urine cultures can take up to 5 to 7 days). Developed especially for patients
with recurrent, persistent, and complicated UTIs, Resolve mdx combines precise pathogen identification and resistance gene detection
with a proprietary susceptibility methodology that identifies personalized oral antibiotic options for fast resolution and improved patient
outcomes.
Our Competitive Strengths
We believe we have the following competitive
strengths, which underpin our commercial execution success and will position us for sustainable growth:
●
Targeted
                                            Menu Improving Prostate Cancer Diagnosis and Treatment
. We offer a menu of tests that
                                            provide clinically actionable results for men at-risk for, as well as men newly diagnosed
                                            with, prostate cancer. Collectively, Select mdx, Confirm mdx and GPS provide urologists with
                                            a clear clinical pathway to accurately identify and appropriately treat prostate cancer while
                                            minimizing the use of aggressive procedures and treatments, improving health outcomes and
                                            significantly lowering costs to the healthcare system.
●
Strong
                                            Commercial Focus and Presence
. We aim to increase adoption of our commercial tests by
                                            leveraging our direct sales force in the United States to continue to market and sell to
                                            our urology-focused network. We have significant experience in building effective commercial
                                            teams consisting of sales reps, strategic account managers, and clinical liaisons led by
                                            a management team with a track record of success. In addition, our payor and reimbursement,
                                            revenue cycle management and client services groups provide expert support for our field
                                            sales team as well as our patients and customer base. We believe we can leverage these groups
                                            to explore additional opportunities for growth based on this commercial channel. Outside
                                            the United States, we will continue to evaluate distribution partners to drive adoption in
                                            markets where our menu is best suited.
●
Commercial
                                            Channel Advantage
. Building from the launch of our first commercial test in 2012, we
                                            have established MDxHealth as an industry leader in precision diagnostics for prostate cancer
                                            detection and treatment. We intend to take advantage of our established urology and pathology
                                            relationships to support menu expansion and additional growth opportunities as appropriate
                                            and within our focus.
●
Compelling
                                            Reimbursement Strategy
. Adoption of our Confirm mdx, Select mdx and GPS tests has been
                                            supported by LCDs issued via the MolDX Program, their inclusion in NCCN and other U.S. and
                                            internationally recognized clinical-practice guidelines, as well as consistent expansion
                                            of coverage by commercial payors. Our Resolve mdx UTI test is currently reimbursed by Medicare
                                            and most private insurance payors, based on nationally recognized Current Procedural Terminology
                                            ("CPT") codes.
33
●
Robust
                                            and Reliable Technology
. We possess a proprietary know-how and intellectual property
                                            portfolio capable of advancing our precision diagnostics pathway as well as high quality
                                            laboratory operations, including our CAP accredited, CLIA certified and New York State Department
                                            of Health ("NYSDOH") approved molecular laboratory facilities.  We
                                            also have an extensive library of biomarkers that can be applied in additional urology and
                                            men's health diagnostics.
●
Proven
                                            Leadership with Industry Expertise
. Our management team members have proven track records
                                            of execution and value creation across medical devices, diagnostics and biotech. We believe
                                            we have built a culture of performance, responsibility and accountability — from research
                                            and development, to sales and marketing, and operations and management — and are committed
                                            to building value for all of our stakeholders, including patients, customers, employees and
                                            shareholders.
Our Strategy
Our ultimate goal with our core testing solutions
is to take an at-risk patient from prostate cancer screening all the way through the diagnostic and therapeutic pathway of prostate cancer.
As such, we are focused on continuing to drive adoption of our Select mdx, Confirm mdx, and GPS tests and expand our product offerings.
The key elements of our strategy include:
●
Physician
                                            and Patient Education
. One important component of our efforts to successfully penetrate
                                            the urology market and promote clinical adoption of our Select mdx, Confirm mdx, GPS and
                                            Resolve mdx tests is to drive awareness of these tests. We educate physicians and patients
                                            through a variety of channels including by supporting clinical studies for the publication
                                            of peer reviewed journals and abstracts at key scientific conferences, forging relationships
                                            with the leading medical and scientific opinion leaders in urology, developing strategic
                                            partnerships with leading pathology laboratories with large urology client bases and via
                                            public relations and advertising campaigns.
●
Expand
                                            Test Menu
. We intend to build on our leadership in the prostate cancer diagnostic space
                                            by expanding our existing menu of tests. We are currently developing a candidate test, Monitor
                                            mdx, for the prostate cancer diagnostic and treatment pathway.  Monitor mdx is
                                            intended to function as a non-invasive solution that risk stratifies patients for continued
                                            AS versus intervention, while also improving patient compliance with AS protocols.
●
Expand
                                            Reimbursement
. An important component of our commercial strategy is to expand reimbursement
                                            for our tests. Our Select mdx, Confirm mdx and GPS tests have been covered by a Medicare
                                            MoIDX LCD since 2023, 2014 and 2015, respectively. Our managed care team continues to pursue
                                            adoption of positive coverage and reimbursement policies and contracts by other payors. We
                                            believe the clinical utility and actionability of our tests, combined with our experience
                                            and knowledge of the complex coverage and reimbursement landscape in the United States, will
                                            enable us to expand coverage and reimbursement among the commercial payor market. We continue
                                            to build upon our successful strategy, supported by governmental and commercial coverage
                                            policies, as a foundation to secure additional contracts from major payors.
Market Opportunity
Among U.S. males, prostate cancer is the most
diagnosed cancer and the second leading cause of cancer death. According to the American Cancer Society, in 2023, over 280,000 men are
expected to be diagnosed with prostate cancer in the United States, with more than 34,000 dying from the disease.
There are currently significant challenges with
diagnosing and treating prostate cancer in the United States. Approximately 25 million PSA tests are performed each year, and over 15%
of those reveal heightened levels of PSA. Current clinical guidelines suggest that men with an elevated PSA should be considered for
a prostate biopsy, However, approximately 60% of biopsies are negative, not revealing any cancer, and as many as a third of these negative
biopsies are false negatives, providing limited comfort to patients and their physicians that cancer was not missed. For those men whose
biopsies are positive, the majority will harbor indolent cancer, but traditional methods are unable to accurately identify which of these
men might safely avoid invasive and costly interventions. In addition, for patients diagnosed with localized prostate cancer who are
on AS, management of their disease relies on the measurement of PSA levels and DRE results, which can be unreliable and lead to overdiagnosis
and overtreatment.
34
The relatively modest sensitivity, specificity
and prognostic ability of current standard-of-care tests and procedures has led to increased patient anxiety, potentially unnecessary,
invasive and costly interventions, and increased complications and hospitalizations. Our suite of commercial products addresses these
issues, presenting a substantial market opportunity. The Company has calculated approximate addressable market opportunities for our
menu of tests, based on the estimated:
●
3
                                            million men screened for prostate cancer annually;
●
500,000
                                            men who undergo prostate biopsies annually;
●
268,000
                                            men diagnosed prostate cancers annually; and
●
2
                                            million UTI cases managed by urologists annually.
* Resolve mdx test in development
(all figures based on management estimates).
Commercial Products
Select mdx for Prostate Cancer Urine Test
The current standard for prostate cancer
screening is the PSA blood test. Unfortunately, the PSA is not specific to clinically significant prostate cancer — it is more
of an indicator of prostate health. There are many factors such as benign prostatic hyperplasia, inflammation, prostatitis and a
naturally occurring enlarged prostate that can cause an elevated PSA. In men with an elevated PSA level between 3-10 ng/mL, only
25-40% of biopsies reveal cancer — and the majority of these identified cancers are indolent. Also, following a prostate
biopsy procedure, around 18% of men suffer complications (blood in urine) and around 3% are hospitalized for infection (sepsis).
Select mdx helps physicians determine if a patient is at higher or lower risk for prostate cancer and which men can safely avoid
biopsy.
35
Select mdx is a non-invasive urine test that
measures the expression of two mRNA cancer-related biomarkers (HOXC6 and DLX1) combined with an advanced clinical model incorporating
traditional risk factors. The test provides a personalized risk profile that helps the physician determine whether:
●
The patient may
                                            benefit from a biopsy and early prostate cancer detection; or
●
The patient can
                                            avoid a biopsy and return to routine screening.
Men identified by the test as having a high likelihood
of clinically significant cancer can, upon biopsy, be diagnosed and treated sooner, while men identified at very low risk may avoid biopsy.
The following chart depicts the functioning of
the Select mdx test:
Guidelines Inclusion
Select mdx has been included in the NCCN Prostate
Cancer Early Detection guidelines since 2020. Select mdx has also been included in the EAU Prostate Cancer guidelines since 2018.
Clinical Validation Studies
The use of Select mdx as a predictive test to
identify men at low risk for aggressive prostate cancer has been well validated in both scientific and clinical studies.
Results from the clinical validation study for
Select mdx confirmed its superior performance compared to other commonly used biomarker tests and risk calculators. The test's
NPV of 95% in the validation study means that if the test identifies a very low risk, the physician and patient can be 95% sure that
a subsequent biopsy will not detect Gleason score ≥7 prostate cancer, information that may provide a level of confidence needed to
avoid a biopsy. The test has a very high predictive accuracy (AUC 0.85) for high-grade prostate cancer, which is significantly better
than the Prostate Cancer Prevention Trial Risk Calculator ("PCPTRC") version 2.
There are twelve published studies assessing
the Select mdx test and which together demonstrate its analytical validity, clinical validity, clinical utility and positive health economic
outcomes. These studies, all of which have been published in peer-reviewed publications, evaluated more than 4,500 patients in the aggregate.
The following is a summary that highlights key
findings from some of these studies.
●
Analytical
    validity
. A study published in 2017 illustrated, in an independent laboratory, the performance characteristics and robustness
    of the Select mdx mRNA assay, covering all aspects of analytical method validation including assay sensitivity, specificity, linearity,
    precision, repeatability and reproducibility using pre-specified acceptance criteria.
36
●
Clinical
    validity
. In a study published in 2019, the Select mdx test demonstrated an NPV of 95%. Urine samples were collected from 1,955
    men from The Netherlands, France and Germany prior to an initial prostate biopsy. Select mdx molecular biomarker results were combined
    with other risk factors in a clinical model optimized to detect International Society of Urological Pathology Grade Group 2 or greater
    prostate cancer in men. Results in the validation cohort were compared with the independent PCPT risk calculator version 2. The full
    validation cohort of 916 men including all prostate specific antigen levels yielded an AUC of 0.85 with 93% sensitivity, 47% specificity
    and 95% negative predictive value. The PCPTRC AUC was 0.76. In the 715-patient validation cohort, limited to subjects with PSA less
    than 10 ng/ml, the AUC was 0.82 with 89% sensitivity, 53% specificity and 95% negative predictive value. The PCPTRC AUC was 0.70.
●
Clinical
    utility
. In a 2019 study, Select mdx had a significant impact on initial prostate biopsy decision-making in a U.S. community
    urology setting. Biopsy rates in Select mdx positive men were 5-fold higher than in Select mdx negatives.
●
Health
    economic outcomes
. A 2018 study demonstrated that routine use of the Select mdx test to guide biopsy decision making improved
    health outcomes and significantly lowered costs in American men at risk for prostate cancer. Compared to the current standard of
    care, Select mdx implementation would result in an average of 0.045 quality-adjusted life years ("QALYs") gained at a
    cost savings of $1,694 per patient. Assuming approximately 300,000 men are biopsied each year, this translates to an incremental
    14,000 QALYs gained at cost savings of $500,000 annually.
Confirm mdx for Prostate Cancer Tissue
Test
Approximately 30% of men with a cancer-negative
prostate biopsy actually have cancer. Prostate cancer is difficult to diagnose because it is both heterogenous and multi-focal. The standard
of care for diagnosing prostate cancer is a transrectal ultrasound guided biopsy. However, this procedure samples less than 1% of the
entire gland, leaving men at risk for undetected prostate cancer.
Confirm mdx is a well-validated epigenetic test
that guides the detection of occult prostate cancer on a patient's previously biopsied negative tissue. The test can help urologists
determine a man's risk for harboring clinically significant prostate cancer despite having a cancer-negative biopsy result, and
it has a number of unique features/advantages.
37
For patients with an initial negative biopsy,
few options are currently available to guide an urologist in determining whether or when an additional biopsy procedure is warranted.
Fear of occult (hidden) prostate cancer leads to additional procedures, leading many men to receive multiple follow-up biopsy procedures
to rule out the presence of cancer.
The Confirm mdx test addresses prostate biopsy
sampling concerns, helping urologists to:
●
"Rule-out"
                                            men from undergoing potentially unnecessary repeat biopsies and screening procedures, helping
                                            to reduce complications, patient anxiety and excessive healthcare expenses associated with
                                            these procedures; and
●
"Rule-in"
                                            high-risk men with a previous negative biopsy result who may be harboring undetected cancer
                                            (false negative biopsy result) and therefore may benefit from a repeat biopsy and potentially
                                            treatment.
For men with a negative biopsy, independently
published clinical studies have shown that the Confirm mdx test is the most significant, independent predictor of prostate biopsy outcomes
relative to other available clinical factors such as age, PSA and DRE results. Incorporating Confirm mdx into clinical practice can reduce
the number of unnecessary repeat biopsies, yielding clinical and economic value for healthcare providers, patients and payors. Confirm
mdx can aid urologists with patient management decisions regarding the need for follow-up testing and procedures with the identification
of low-risk patients testing negative for DNA hypermethylation.
The use of Confirm mdx for prostate cancer detection
using methylation-specific PCR ("MSP") and cancer-associated epigenetic biomarkers to improve upon histopathology has been
well validated in both scientific and clinical studies. DNA methylation, the most common and useful measure of epigenetic abnormality
testing, is responsible for the silencing of key tumor suppressor genes. DNA methylation biomarkers associated with prostate cancer have
been extensively evaluated.
GSTP1 is a widely studied and reported epigenetic
biomarker associated with prostate cancer diagnosis, encoding the glutathione S-transferase Pi 1 (GSTP1) protein involved in detoxification,
due to its high sensitivity and specificity. Complementing GSTP1, methylation of the APC and RASSF1 genes is frequently found in prostate
cancer, and these markers have demonstrated a "field effect" aiding in the identification of biopsies with false-negative
histopathological results.
The epigenetic field effect is a molecular mechanism
whereby cells adjacent to cancer foci can contain DNA methylation changes, which may be indistinguishable by histopathology, but detectable
by MSP testing. The presence of epigenetic field effects associated with prostate cancer has been widely published and is the basis of
activity for the Confirm mdx assay to aid in the detection of occult prostate cancer on previously biopsied, histopathologically negative
tissue.
38
The following image depicts how the Confirm mdx
test identifies false-negative biopsies:
Confirm mdx Field Effect
Guidelines Inclusion
Confirm mdx has been included in the NCCN Prostate
Cancer Early Detection guidelines since 2016. Confirm mdx has also been included in the EAU Prostate Cancer guidelines since 2018.
Confirm mdx Clinical Validation Studies
The use of Confirm mdx for prostate cancer detection
to improve upon histopathology has been well validated in both scientific and clinical studies.
There are more than 55 published studies on the
genes and technology used in the Confirm mdx test. Among these, studies demonstrating the analytical validity, clinical validity, clinical
utility and positive health economic outcomes of the Confirm mdx test evaluated more than 1,200 patients in the aggregate.
The following is a summary that highlights key
findings from some of these studies.
●
Analytical
    validity
. A study published in 2012 illustrated the performance characteristics and robustness of the Confirm mdx multiplex
    DNA methylation assay, covering the analytical method including assay sensitivity, specificity, linearity, precision, repeatability
    and reproducibility using pre-specified acceptance criteria.
●
Clinical
    validity
. The clinical validity of the Confirm mdx test has been demonstrated in two large, blinded clinical validation studies
    published in 2013 and 2014, yielding a NPV of ~90% for all prostate cancer, which is significantly higher (p < 0.001) than that
    afforded by standard histopathology review, as well as a NPV of 96% for clinically significant prostate cancer. Further, when compared
    to all pertinent risk factors for prostate cancer detection (patient's age, serum PSA level, digital rectal exam (DRE), histopathological
    findings on the previous cancer- negative biopsy and the epigenetic assay), Confirm mdx was shown to be the most significant, independent
    predictor for prostate cancer in a repeat biopsy with an odds ratio of 3.24 (and a p-value < 0.001). An additional clinical validity
    study published in 2017 demonstrated that the Confirm mdx test improved the identification of African American men at risk for aggressive
    cancer missed by a prostate biopsy, with accuracy equivalent to prior studies in predominantly Caucasian populations.
●
Clinical
    utility
. A 2014 study reported on the real-world use of the Confirm mdx assay, demonstrating that the test impacts physician
    behavior. A very low rate of repeat biopsies (4.4%) was observed in the Confirm mdx negative men, as compared to the expected 43%
    rate of repeat biopsy reported in a large population-based randomized trial sponsored by the National Cancer Institute.
●
Health
    economic outcomes
. In a study published in 2013, a budget impact model developed to evaluate the effect of the Confirm mdx
    assay on healthcare spending demonstrated significant potential healthcare savings associated with the reduction of repeat biopsies
    and complications avoided. Under the study's model, utilization of Confirm mdx would bring approximately $500,000 in annual
    savings per 1 million covered patients.
39
GPS Tissue Test
Currently, most cases of detected prostate cancer
remain indolent and men with the disease often die from other causes. Patients who have indolent prostate cancer may be appropriately
managed with observation or AS, while those with aggressive cancers may benefit from immediate treatment. The use of AS has increased
in recent years and it is now estimated that up to 50% of clinically low-risk patients choose AS, while the remainder choose some type
of immediate treatment.
The tissue-based GPS test assesses 17 genes in
total — 12 cancer-related genes representing 4 important biologic pathways (androgen signaling, cellular organization, stromal
response, and proliferation) together with 5 references genes (to control for RNA quantity and quality). The test uses reverse transcription
polymerase chain reaction ("RT-PCR") to measure gene expression in very small amounts of prostate tumor tissue (requiring
as little as 5 ng of RNA). Genetic expression of the 12 cancer-related genes, normalized by the 5 reference genes, is used in an algorithm
to generate a GPS result that ranges from 0 to 100, with higher scores associated with more aggressive disease. The GPS test, in conjunction
with clinical risk factors, is predictive of a finding of adverse pathology ("AP") upon a radical prostatectomy ("RP")
and clinical recurrence following RP, and consequently provides clinicians and patients with information about the likely aggressiveness
of their cancer to help guide initial treatment decisions.
For patients with NCCN very low- to favorable
intermediate- prostate cancer, the GPS test provides information on the risk of AP to help physicians guide personalized treatment for
patients at the initial decision point. For the unfavorable intermediate- and high-risk groups, the GPS test helps inform decisions on
the intensity of definitive treatment. The patient results report gives the risk of a patient developing metastasis within 10 years, risk
of PCD within 10 years, and risk of tumor aggressiveness based on AP result outlining the clinical characteristics of each NCCN risk group.
The GPS test is intended for men with clinically
localized prostate cancer who have undergone biopsy within 3 years and have not yet started treatment. Patients with any NCCN risk category
between very low- and high-risk are eligible for GPS testing.
40
Guidelines Inclusion
GPS has been included in the NCCN Prostate Cancer
guidelines since 2019.
Clinical Validation
Studies
The use of GPS as a predictive test to identify
men at low risk for aggressive prostate cancer has been well validated in both scientific and clinical studies.
The following is a summary that highlights key
findings from clinical studies regarding the GPS test.
●
Clinical validity
. In a prospective and retrospective
study on 402 patients published in 2015, the GPS test demonstrated its ability to discriminate prostate cancer aggressiveness in biopsy
tissue despite tumor heterogeneity and multifocality. Further, the test demonstrated its ability to improve prediction of adverse pathology.
●
Clinical utility
. Numerous clinical studies have shown
the impact of GPS on treatment recommendations and have demonstrated that generally, use of GPS increases the proportion of men for whom
AS is recommended, when the background AS rates are similar to the national average for these risk groups.
o
In a prospective decision impact study by Badani et al. (2015)
of 158 patients with NCCN very low-, low- and low intermediate-risk disease, the GPS test resulted in a 26% change in recommended treatment
modality or intensity and patients who received GPS testing had a 24% relative increase in AS recommendations.
o
In a chart review study by Dall'Era et al. (2015) of
211 patients with NCCN very low- or low risk-disease, biological risk predicted by GPS differed from NCCN clinical risk alone in 62 men
(39%). AS use increased by 24% in patients who received the GPS test versus patients who did not receive the GPS test.
o
In a study by Eure et al. (2017)
of 297 patients, 23% of patients' risk was restratified. In the NCCN low-risk group, the change in the management plan between
AS and immediate treatment was 28%; 51% of the men who were initially recommended immediate treatment pre-GPS testing switched to AS
post-GPS testing, while 14% of those initially recommended AS switched to immediate treatment post-GPS testing. Among the men who elected
AS, their one-year AS persistence rates remained high at 89%.A fourth study by Lynch et al. (2017) demonstrated utility in a US Department
of Veterans Affairs population, an equal-access healthcare system with high baseline AS rates
without t
esting.
The study compared management patterns for men with NCCN very low-, low-, and intermediate-risk PCa with and without molecular profiling.
Overall, use of AS was 12% higher (absolute; relative increase 19%) in GPS-tested versus untested men, with the biggest increases observed
in low-risk patients (90% versus 72% for tested versus untested, respectively) and patients under the age of 60 (75% versus 42% for tested
versus untested, respectively).
●
Health economic outcomes
. A 2016 publication in Reviews
in Urology presented a comprehensive economic analysis of the GPS test in low-risk prostate cancer patients. Results showed that use
of the GPS test results in a net savings of $2,286 USD per patient — including the cost of the test — by decreasing unnecessary
immediate invasive treatments. The study demonstrated that incorporation of the GPS test as part of the treatment decision algorithm
for patients with NCCN very low- and low-risk disease (64% of the study population) led to a 21% net increase in the use of AS. Of these,
treatment patterns and cost for 80 men tested with GPS were compared to 100 patients in the same practice without genomic testing. Based
on a real-world practice setting in the U.S. Northeast with a contemporary patient population and using current treatment cost averages,
these results demonstrated that the use of the GPS test represented a reduction in cost of unnecessary intermediate interventions (by
more than 50%) over a 6-month period. Additional savings can also be expected by removing the cost of management of associated side effects
of treatment such as impotence and incontinence.
41
Resolve mdx for Urinary Tract Infection
UTIs affect around 10 million people who seek
medical attention every year. It is estimated that 2-3 million of these cases lead to emergency department visits. UTIs can be complicated
and recurrent, resulting in painful symptoms such as abdominal and rectal pain, frequent urination, burning or pain during urination,
and fatigue. Antibiotic resistance is a significant issue, observed in up to one-third of UTI infections, causing about 2.8 million infections
and 35,000 deaths annually, according to the CDC.
The traditional method of conducting a UTI test,
urine culture, can take up to 3 to 5 days to produce results. Unfortunately, relying solely on culture-based testing may produce equivocal
results of "mixed flora" in up to 30% of cases, Often clinicians will rely on empiric therapy to treat UTIs, which can lead
to overuse/misuse of antibiotics. Through the use of Resolve mdx, we help support antibiotic stewardship initiatives, as our test identifies
personalized antibiotic options that would be expected to be more effective against the patient's infection.
To address this unmet clinical need, with Resolve
mdx we developed an advanced urine test that utilizes Polymerase Chain Reaction ("PCR") technology to detect and quantify
both infectious pathogens and resistance genes. Resolve mdx also includes susceptibility testing to identify the antibiotics that may
be best suited to resolve the urinary tract infection. This approach provides prompt and accurate pathogen identification and personalized
antibiotic recommendations. PCR-based testing offers improved sensitivity and specificity in identifying pathogens, addressing the problem
of "mixed flora" results associated with traditional testing methods. This increased accuracy provides physicians with clinically
actionable information to guide their decision-making for patient care.
Our proprietary Antibiotic Susceptibility Testing
method included with the Resolve mdx test, called ASTX, determines how each pathogen responds to the 26 antibiotics tested. The unique
aspect of ASTX is that it tests whole urine samples, ensuring accurate results and identifying the most effective treatment options for
patients.
42
Resolve mdx Pathogens Tested,
Resistance Genes and Antibiotics
Our goal is to help pinpoint not only the offending
organisms, regardless of how many are identified, but also the most likely oral antibiotics capable of clearing the entire infection.
We estimate the addressable market in the United States for UTI testing at approximately 2 million cases annually, or $1 billion.
Pipeline
We intend to build on our leadership in the urologic
diagnostic space by expanding our menu of tests beyond Select mdx, Confirm mdx, GPS and Resolve mdx. We are currently developing an additional
product for the prostate cancer diagnostic and treatment pathway. AS is a management approach for prostate cancer that involves closely
monitoring the cancer's progression through regular tests and imaging, without immediately initiating active treatment such as
surgery or radiation therapy. Since not all prostate cancers progress the same manner, there is a significant unmet clinical need to
help physicians identify which patients may benefit from AS, distinguishing those at risk for disease progression.
Men on AS are monitored using PSA, MRI and
periodic biopsies to determine if their prostate cancer has progressed and whether definitive treatment is necessary. We are
actively analyzing urine and blood biomarker panels with the goal of developing a non-invasive test for monitoring these patients that we call Monitor mdx.
A testing solution that allows a physician to forego or delay their patient's surveillance biopsy would represent a
significant business opportunity with little or no direct competition.
If our development efforts are successful, MDxHealth
would have a full offering of biomarker-based prostate cancer tests from early detection to treatment and management. Select mdx and
Confirm mdx help determine which patients should (or should not) undergo a prostate biopsy, while our GPS test guides the decision to
enter into AS upon an initial diagnosis of prostate cancer. In the AS setting, Monitor mdx would provide methods to identify and monitor
patients who could remain on AS as a treatment option.
Laboratory Operations
We currently process tests at our 38,000 square
foot, CAP-accredited, CLIA-certified, and NYSDOH-approved molecular laboratory and office facility located at our U.S. headquarters
in Irvine, California; through our 7,800 square foot diagnostic facilities in Nijmegen, The Netherlands; and through our smaller, CAP-accredited,
CLIA-certified laboratory facility in Plano, Texas. Our GPS test is currently performed by Exact Sciences in its laboratory facility
in Redwood City, California. Our current clinical reference laboratory has excess processing expansion capacity with incremental increases
in laboratory personnel and equipment, including expansion capacity for laboratory facilities. We believe that we currently have sufficient
capacity to process all of our tests. We may require additional facilities in the future as we expand our business and believe that additional
space, when needed, will be available on commercially reasonable terms.
43
Sales and Marketing
Our sales approach focuses on the clinical and
economic benefits of our tests as supported by peer-reviewed literature covering the clinical validation and utility of these tests.
Our sales and marketing team include molecular diagnostic specialists, reimbursement account managers, clinical liaisons and client service
personnel. Sales personnel are primarily field based, client service and marketing personnel are primarily based in our California headquarters.
Our sales team is trained to address the clinical,
economic and reimbursement questions associated with selling our tests. Our sales force focuses on educating its primary and secondary
clientele, which consists of urologists and their clinical staff, including nurses, laboratory and pathology personnel, finance administrators
and billing personnel, and secondarily the pathology and laboratory staff who fulfil test requests on behalf of their clinician clients.
Our current urology sales force consists of direct sales representatives, strategic account managers and regional sales managers.
Our sales efforts are directed towards increasing
adoption and utilization of our tests in clinical practice. The strategy entails:
●
working
with community-based, large group practices and academic urologists to educate them on the clinical and economic benefits provided by
our tests;
●
nurturing
and strengthening relationships with key thought leaders in urology;
●
supporting
ongoing collaborations with leading universities and research institutions that have generated clinical validation data supporting our
tests; and
●
encouraging
ongoing exploration and studies of expanded indications for our tests.
Successful penetration of the urology market
and clinical adoption of our tests has been achieved with a multi-faceted approach to build brand recognition and raise awareness
of the tests. Our efforts and programs include sharing information with leaders in the medical community on a national and regional scale,
supporting clinical studies for the publication of peer reviewed journals and abstracts at key scientific conferences, development of
tools for our customers to interact with patients and consumers (doctor-to-consumer education), providing support to patient advocacy
groups like Prostate Conditions Education Council, developing strategic partnerships with leading pathology laboratories with large urology
client bases, participation in industry trade shows and the implementation of public relations, media and advertising campaigns.
Reimbursement
Reimbursement of our tests by third-party payors
is essential to our commercial success. Payment for our testing services may come from, in some cases:
●
third-party payors
that provide health care coverage to the patient (
e.g
., commercial health insurance companies or managed care organizations);
●
federal
health care programs, such as Medicare, state Medicaid programs, the Department of Defense and Veterans Affairs hospitals in the United States;
●
other
government agencies or laboratories that order the testing service; and
●
patients
in cases where the patient has no insurance or coverage benefit, is underinsured or has insurance with cost sharing benefits whereby
the insurance covers a percentage of testing costs, and the patients are responsible for a co-payment, co-insurance and/or deductible
amount.
Reimbursement for diagnostic tests furnished
to Medicare beneficiaries (typically patients aged 65 or older) is typically based on a fee schedule set by CMS, a division of the HHS.
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In 2014, 2015 and 2023, respectively, our Confirm
mdx test, our GPS test and our Select mdx test received positive Medicare LCDs under the MoIDX Program, which provide coverage and reimbursement
for Medicare beneficiaries throughout the United States. Our Resolve mdx UTI test is currently reimbursed by Medicare and most private
insurance payors, based on nationally recognized CPT codes.
We believe the clinical utility and actionability
of our tests, combined with our experience and knowledge of the complex coverage and reimbursement landscape in the United States
will enable us to expand coverage and reimbursement of our tests among the commercial payor market. We continue to build upon our successful
strategy, using our Medicare LCD for Confirm mdx, Select mdx and GPS and existing commercial payor contracts as a foundation to secure additional contracts
from major payors.
Where there is a payor policy or contract in
place, we bill in accordance with the terms of that policy or contract. Where there is no payor policy or contract in place, we pursue
third-party reimbursement on behalf of each patient on a case-by-case basis. Our efforts on behalf of these patients involve a substantial
amount of time and expense, and bills may not be paid for many months, if at all. Furthermore, if a third-party payor denies coverage
after final appeal, it may take a substantial amount of time to collect from the patient, if we are able to collect at all.
Materials Needed for Our Laboratory Services
In connection with our role as a CLIA-certified provider
of laboratory services, we assist healthcare providers with certain logistics related to the collection and return of samples for testing.
The processing of testing solutions requires
items and services, the majority of which are sourced from multiple suppliers. Certain of the consumable supplies and reagents used in
our testing process are procured from a limited number of suppliers, some of which are single source. In addition, we rely on a limited
number of suppliers, or in some cases a single supplier (for example, for the automation of our deparaffination steps for the Confirm
mdx test), for certain equipment with which we perform testing services. To date, we have acquired all of our equipment and the majority
of our materials on a purchase order basis, and we generally do not have language included in contracts with our suppliers and manufacturers
that commit them to supply equipment and materials to us.
Competition
The molecular diagnostics field is characterized
by rapid technological changes, frequent new product introductions, changing customer preferences, emerging competition, evolving industry
standards, reimbursement uncertainty and price competition. Moreover, the molecular diagnostics field is intensely competitive both in
terms of service and price, and continues to undergo significant consolidation, permitting larger clinical laboratory service providers
to increase cost efficiencies and service levels, resulting in more intense competition.
The market for assessing men at risk for prostate
cancer is large. As a result, this market has attracted competitors, some of which possess substantially greater financial, selling,
logistical and laboratory resources, more experience in dealing with third-party payors, and greater market penetration, purchasing
power and marketing budgets, as well as more experience in providing diagnostic services. Some companies and institutions are developing
liquid biopsy (blood and urine)-based tests and diagnostic tests based on the detection of proteins, mRNA, nucleic acids or the
presence of fragments of mutated genes that are associated with prostate cancer. These competitors could have technological, financial,
reputational, and market access advantages over us.
In regard to our Select mdx for Prostate Cancer
test, several directly competitive products are currently commercially available. In 2014, OPKO Health, a NYSE listed company, launched
the 4Kscore test, a blood based 4-plex test which combines the results of the blood test with clinical information in an algorithm
that calculates a patient's percent risk for aggressive prostate cancer prior to an initial or repeat biopsy (no previous diagnosis
of prostate cancer). The 4Kscore test received marketing approval from the FDA in December 2021. OPKO Health, a NYSE listed company, operates
one of the largest clinical laboratories in the United States. The 4Kscore test competes directly with Select mdx. In 2016, ExosomeDx
launched the ExoDx (Intelliscore), a urine-based test designed to assess whether  patient presenting for an initial or repeat biopsy
is at greater risk for high-grade prostate cancer. The ExoDx test competes directly with Select mdx. In 2018, Bio-Techne Corporation,
a large U.S.-based, diversified life sciences company, acquired the ExoDx test. In addition to the ExoDx and the 4Kscore tests, the Prostate
Health Index test ("phi score") offered by Beckman Coulter, competes directly with the Select mdx test. In addition, each
of these tests may also provide a competitive advantage since, unlike the Select mdx test, they do not require a digital rectal procedure
as part of their specimen collection process. Each of Bio-Techne, OPKO Health and Beckman Coulter have greater resources and significantly
larger sales and marketing teams than MDxHealth. As a result of these significantly greater resources, these competitors are able to make
larger investments into the tests they produce and the sales and marketing of these tests, which may cause us to lose market share.
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Regarding our GPS tissue-based test, acquired
in August 2022 from Exact Sciences, several directly competitive products are currently commercially available. Myriad Genetics offers
the Prolaris test, a tissue-based genetic test to help identify those men who need treatment versus those who can choose active surveillance.
Additionally, Veracyte offers the Decipher test, a tissue-based genetic test to help identify those men who need treatment versus those
who can choose active surveillance. In addition to directly competitive genomic tests, traditional methods used by pathologists and clinicians
to estimate risk for disease progression also pose competitive threats. Companies combining these traditional methods with artificial
intelligence could potentially emerge as competitors, though most of these technologies are currently in the research stage.
In regard to our Confirm mdx for Prostate Cancer
test, several competitive products are currently commercially available. Both the 4Kscore test, offered by OPKO Health, and the ExoDx
(Intelliscore) test offered by ExosomeDx, compete with the Confirm mdx test. Offered at a lower price point, both the 4Kscore and ExoDx
tests offer a competitive price advantage over the Confirm mdx test. In addition, both the 4Kscore test and the PCA-3 test from Hologic,
a urine-based test, are on the U.S. market as FDA-approved tests, which may be perceived as providing a competitive advantage since
the Confirm mdx for Prostate Cancer test is not FDA approved. The PCA-3 test is intended for the same patient population as Confirm
mdx for Prostate Cancer, but its performance has only been established in men who were already recommended by urologists for repeat biopsy.
In addition to competitive products, the Confirm
mdx, Select mdx and GPS tests also face competition from mpMRI, a clinical diagnostic imaging procedure available to and used by physicians
for many years, which focuses on visual tissue analysis. The mpMRI procedure can visually reveal potential locations of abnormal and
potentially cancerous prostate tissue characteristics that distinguish tumors from healthy tissue. The visual aspect of diagnostic imaging
may feel more accessible and be considered preferable by some physicians over molecular analysis, and there likely is an economic incentive
for some physicians to earn a professional fee from the performance of mpMRI procedures. It may be difficult to change the methods or
behavior of physicians to incorporate our testing solutions into their practices in conjunction with, or instead of, mpMRI clinical diagnostic
imaging procedures. In addition, companies developing or offering capital equipment or point-of-care kits to physicians represent
another source of potential competition. These devices are used directly by the physicians or their institutions, which can facilitate
adoption.
Intellectual Property
Our intellectual property and its protection are
crucial to the operation of our business. We are committed to developing and protecting our intellectual property and, where appropriate,
filing patent applications or securing licenses to patents to protect our technology. We rely on a combination of patent, copyright, trademark
and other agreements with employees and third parties to establish and protect our proprietary intellectual property rights. We also rely
upon trade secret laws to protect unpatented know-how and continuing technological innovation. However, trade secrets can be difficult
to protect, and do not provide protection against a third party independently discovering or recreating the information for which trade
secret protection is claimed. We seek to protect our proprietary unpatented technology, know how, algorithms and processes, in part, by
entering into confidentiality agreements with our employees, consultants, scientific advisors and contractors and limit access to, and
distribution of, our proprietary information. We also require our officers, employees and consultants to enter into standard agreements
containing provisions requiring confidentiality of proprietary information and assignment to us of all inventions made during the course
of their employment or consulting relationship. We also enter into nondisclosure agreements with our commercial counterparties and limit
access to, and distribution of, our proprietary information. We also seek to preserve the integrity and confidentiality of our data and
trade secrets by maintaining physical security of our premises and physical and electronic security of our information technology systems.
We believe that our patent portfolio places us
in a competitive position in the realm of molecular cancer diagnostics. We own or hold exclusive rights to a range of issued and pending
patents in multiple countries worldwide covering our epigenetic and molecular tests and associated biomarkers, their methods of use and
any other inventions that are important to the development of our business. Many of our commercially important technology and inventions
are in-licensed from academic and commercial collaborators. Through our internal R&D programs, together with our academic and
commercial collaborations, we continue to be at the forefront of researching and understanding the link between cancer and methylation
(epigenetics), and how this link can be translated into meaningful clinical molecular diagnostic products and services. We consider patent
protection of the technologies, on which our products are based, to be a key factor to our success.
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Our intellectual property portfolio is managed
by an in-house intellectual property team, which works in close collaboration with qualified external patent attorneys both in Europe
and the United States. As of December 31, 2022, we own or have exclusive rights to more than 17 patent families related to our molecular
technology and cancer-specific biomarkers. Specifically, there are 116 granted or pending patent applications in this group comprised
of 16 issued or allowed U.S. patents, 7 pending U.S. provisional or non-provisional applications, 19 pending international
patent applications filed under the PCT and 74 granted or allowed patents in jurisdictions outside the United States, including
Japan, Canada, Israel and certain European countries. Our issued U.S. patents expire at various times between 2024 and 2038. Of these
issued patents, 1 covers intellectual property used in our Confirm mdx test, which expires in 2024, 7 cover intellectual property used
in our Select mdx test, the last of which expires in 2036, and 52 cover intellectual property used in our GPS test, the last of which
expires in 2038. When these patents expire other companies will no longer be prohibited from incorporating the subject intellectual property
into competing tests they may seek to develop. Nevertheless, given the significant unpatented proprietary and confidential intellectual
property that we have developed and that is used in our tests, together with the clinical performance characteristics reported in published
clinical studies that are specific to these branded tests, we believe there will be significant barriers to any competitors'
ability to use such previously patent-protected intellectual property to develop competitive tests.
In most countries in which we file, our patents
have a life of 20 years from the date of the filing of the nonprovisional application. In the United States, a patent's term
may be lengthened by patent term adjustment, which compensates a patentee for administrative delays by the USPTO in granting a patent,
or may be shortened if a patent is terminally disclaimed over an earlier-expiring patent. The expected expiration dates listed above
assume that no terminal disclaimers will be filed. A patent term can also be lengthened in certain countries, including the United States,
under circumstances where there is a delay associated with approval from a governmental regulatory agency.
We may in the future receive notices of claims
of infringement and misappropriation or misuse of other parties' proprietary rights and may from time to time receive additional
notices. Assertions of misappropriation, infringement or misuse, or actions seeking to establish the validity of our patents could materially
or adversely affect our business, financial condition and results of operations.
Collaboration and License Agreements
Collaborative research agreements and clinical
research agreements
We have entered into agreements with universities,
medical centers and external researchers for research and development work and for the validation of our technology and products. These
agreements typically have durations of one to three years. In certain circumstances, we pay fixed fees to the collaborators and in exchange
typically receive access and rights to the results of the work. MDxHealth has collaborated on research and clinical development with
a number of the world's leading academic and government cancer research institutes. These important relationships have provided
us with additional resources and expertise for clinical marker validation as well as access to patient samples for testing.
Commercial and intellectual property licensing
agreements
We have entered into numerous agreements with
universities and companies for in-licensing intellectual property. These agreements typically require us to pay an up-front fee,
annual maintenance fees and/or minimum annual royalty fees, legal fees related to the patents, and certain milestone and royalty fees
if the patents are eventually used in a commercialized product. In addition, we must provide the licensor with periodic reports.
In particular, we are party to an Amended and
Restated Exclusive License Agreement with The Johns Hopkins University through which we hold an exclusive license to intellectual property
that is used in our Confirm mdx test. Pursuant to this agreement, we made upfront license fee payments of $10,000 in each of 2004 and
2005, and we are obligated to pay a mid-single-digit royalty rate on our net sales of Confirm mdx (with minimum annual royalties
of $5,000). Unless earlier terminated in accordance with the agreement, the agreement will remain in effect until the last of the licensed
patents expires in 2024. The agreement contains customary termination provisions which, among other things, permit termination in the
event of material uncured breaches.
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In regard to our developed tests, we have entered
into a range of marketing and sales arrangements with commercial entities. These important relationships provide us with additional resources
and infrastructure to expand the geographic reach and awareness of our solutions. Our marketing partners include Ferrer Internacional,
SouthGenetics, LifeLabs, Helix Laboratories, Laboratory Corporation of America (LabCorp), Inform Diagnostics (InformDx) and Poplar Healthcare.
Government Regulations
Certain of our activities are subject to regulatory
oversight by CMS pursuant to CLIA, as well as agencies in various states, including New York. We are subject to many other federal,
state and foreign laws, including anti-fraud and abuse, anti-kickback and patient privacy. Failure to comply with applicable
requirements can lead to sanctions, including withdrawal of products from the market, recalls, refusal to authorize government contracts,
product seizures, exclusion from participation in federal and state healthcare programs, civil money penalties, injunctions, and criminal
prosecution.
Laboratory Certification, Accreditation,
and Licensing
We are also subject to U.S. and state laws
and regulations regarding the operation of clinical laboratories. CLIA requirements and laws of certain states, including those of California,
New York, Maryland, Pennsylvania and Rhode Island, impose certification requirements for clinical laboratories, and establish standards
for quality assurance and quality control, among other things. CLIA provides that a state may adopt different or more stringent regulations
than federal law and permits states to apply for exemption from CLIA if the state's laboratory laws are equivalent to or more stringent
than CLIA. For example, the State of New York's clinical laboratory regulations, which have received an exemption from CLIA, contain
provisions that are in certain respects more stringent than federal law. Therefore, as long as New York maintains a licensure program
that is CLIA-exempt, we will need to comply with New York's clinical laboratory regulations in order to offer our clinical laboratory
products and services in New York.
Our U.S. laboratory facilities in Irvine, California
and Plano, Texas are certified under CLIA. Clinical laboratories are subject to inspection by regulators and to sanctions for failing
to comply with applicable requirements. Sanctions available under CLIA and certain state laws include prohibiting a laboratory from running
tests, requiring a laboratory to implement a corrective plan, and imposing civil monetary penalties. If we fail to meet any applicable
requirements of CLIA or state law, that failure could adversely affect any future CMS consideration of our technologies, prevent their
approval entirely, and/or interrupt the commercial sale of any products and services and otherwise cause us to incur significant expense.
HIPAA and Other Privacy Laws
The Health Insurance Portability and Accountability
Act of 1996, as amended by HIPAA established comprehensive protection for the privacy and security of health information. The HIPAA standards
apply to three types of organizations, or "Covered Entities": (1) health plans, (2) healthcare clearinghouses, and (3) healthcare
providers that conduct certain healthcare transactions electronically. Covered Entities and their business associates must have in place
administrative, physical, and technical standards to guard against the misuse of individually identifiable health information. As a clinical
laboratory that engages in HIPAA-covered standard transactions, we are a Covered Entity subject to regulation under HIPAA. We have
implemented privacy and security policies and procedures, provided required training to our personnel, and ensure that we enter into
Business Associate Agreements with our vendors who have access to our protected health information. Penalties for violations of HIPAA
include civil money and criminal penalties.
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HIPAA establishes a federal "floor"
with respect to privacy, security, and breach notification requirements and does not supersede any state laws insofar as they are broader
or more stringent than HIPAA. Numerous state and certain other federal laws protect the confidentiality of health information and other
personal information, including but not limited to state medical privacy laws, state laws protecting personal information, state data
breach notification laws, state genetic privacy laws, human subjects research laws and federal and state consumer protection laws. These
additional federal and state privacy and security-related laws may be more restrictive than HIPAA and could impose additional penalties.
For example, the Federal Trade Commission uses its consumer protection authority under Section 5 of the Federal Trade Act to initiate
enforcement actions in response to alleged privacy violations and data breaches. California recently enacted the California Consumer
Privacy Act ("CCPA"), which went into effect on January 1, 2020. The CCPA, among other things, creates new data privacy
obligations for covered companies and provides new privacy rights to California residents, including the right to opt out of certain
disclosures of their information. The CCPA also creates a private right of action with statutory damages for certain data breaches, thereby
potentially increasing risks associated with a data breach. California recently amended and expanded the CCPA through another ballot
initiative, the California Privacy Rights Act ("CPRA"), passed on November 3, 2020. It remains unclear what, if any,
additional modifications will be made to the CPRA by the California legislature or how it will be interpreted. In addition to California,
other states have strengthened their data security laws and others are indicated their intention to do so as well. Virginia also enacted
a comprehensive data privacy and security law, the Virginia Consumer Data Protection Act, on March 2, 2021, to go into effect on
January 1, 2023. We expect that other states will follow with their own comprehensive data privacy legislation as well. Our activities
must therefore comply with these other applicable privacy laws, which impose further restrictions on the access, use and disclosure of
personal information. Further, we are required to comply with international personal data protection laws and regulations, including
the European Union's General Data Protection Regulation ("GDPR"). The GDPR is a prescriptive, detailed regulation that
provides extensive powers to public authorities to sanction and stop use of personal data. While companies are afforded some flexibility
in determining how to comply with the GDPR's various requirements, the GDPR has and will continue to require significant effort
and expense to ensure compliance. All of these laws may impact our business and may change periodically, which could adversely affect
our business operations. Our failure to comply with these privacy laws or significant changes in the laws restricting our ability to
obtain stool, tissue, blood, and other patient samples and associated patient information could significantly impact our business and
our future business plans, including potentially a temporary inability to provide tests to patients in the European Union.
In Vitro Regulation
Under current law,
in vitro diagnostics
that
the FDA regulates as medical devices must undergo premarket review prior to commercialization, unless the device is exempt from such
review. The particular premarket requirements that must be met to market a medical device in the United States will depend on the classification
of the device under FDA regulations. Medical devices are categorized into one of three classes, based on the degree of risk they present.
Devices that pose the lowest risk are designated as Class I devices; devices that pose moderate risk are designated as Class II devices
and are subject to general controls and special controls; and the devices that pose the highest risk are designated as Class III devices
and are subject to general controls and premarket approval. As a CLIA-certified laboratory, we offer our Select mdx and Confirm
mdx testing services as LDTs, and we may seek to commercialize future testing services in development as LDTs. LDTs are generally defined
as clinical laboratory tests that are developed and validated by a laboratory for its own use. Historically, the FDA has exercised
enforcement discretion and not required approvals or clearances for many LDTs (as that term is viewed and defined by the FDA, which is
the subject of interpretation) that are regulated under CLIA, and has not required laboratories that offer LDTs consistent with FDA's
interpretation to comply with the FDA requirements for medical devices, such as registration, device listing, quality systems regulations,
premarket clearance or premarket approval, and post-market controls.
Regulatory jurisdiction over LDTs has historically
been greatly disputed. For many years, the FDA has expressed its position through a range of guidance documents and precedent provided
through enforcement action. The FDA has issued documents outlining its intent, at various times, to require varying levels of heightened
FDA oversight of many laboratory tests that have traditionally been offered as LDTs, including categories that would include our tests.
Additionally, in recent years, Congress has introduced two draft bills: the VALID Act and the VITAL Act of 2021. While we cannot predict
whether the either VALID Act or the VITAL Act as proposed, or any modified version of either act will be enacted into law, it is expected
that some form of the acts will be incorporated into a broader health care legislative package. It is unknown at this time whether legislation
will be enacted impacting LDTs, or whether in the interim the FDA may take a more aggressive enforcement approach toward certain laboratory
testing. Legal, regulatory, and policy developments may materially impact our ability to develop and commercialize testing services as
LDTs, including without limitation our current tests.
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Until regulatory requirements suggested by the
FDA or required by any new legislation are phased in, we do not consider our current LDTs to require FDA filings or clearance or approval
before launch and we will continue to follow the CLIA certification and inspection pathway.
If the new requirements are phased in or if we
elect to develop IVDs, our future offerings may require a 510(k) submission or a Premarket Approval ("PMA") application to
the FDA. In a 510(k) submission, the device sponsor must demonstrate that the new device is "substantially equivalent" to
a predicate device in terms of intended use, technological characteristics, and performance testing. A 510(k) requires demonstration
of substantial equivalence to another device that is legally marketed in the United States. Substantial equivalence means that the
new device is at least as safe and effective as the predicate. A device is substantially equivalent if, in comparison to a predicate
it (a) has the same intended use as the predicate and has the same technological characteristics as the predicate; or (b) has
the same intended use as the predicate, has different technological characteristics, and the information submitted to the FDA does not
raise new questions of safety and effectiveness, and is demonstrated to be at least as safe and effective as the legally marketed predicate
device.
A claim of substantial equivalence does not mean
the new and predicate devices must be identical. Substantial equivalence is established with respect to intended use, design, energy
used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility,
standards, and other characteristics. A device may not be marketed in the United States until the submitter receives a letter declaring
the device substantially equivalent. If the FDA determines that a device is not substantially equivalent, the applicant may resubmit
another 510(k) with new data, or request a Class I or II designation through the FDA's de novo process that allows a new device
without a valid predicate to be classified into Class I or II if it meets certain criteria, or file a reclassification petition,
or submit a PMA.
Manufacturers of medical devices must comply
with various regulatory requirements under the FDCA and regulations thereunder, including, but not limited to, quality system regulations,
unless they are exempt, facility registration, product listing, labeling requirements, and certain post-market surveillance requirements.
Entities that fail to comply with FDA requirements can be liable for criminal or civil penalties, such as recalls, detentions, orders
to cease manufacturing, and restrictions on labeling and promotion, among other potential sanctions.
The regulatory review and approval process for
medical devices can be costly, timely, and uncertain. This process may involve, among other things, successfully completing additional
clinical trials and submitting a premarket clearance notice or filing a premarket approval application with the FDA. If premarket review
is required by the FDA, there can be no assurance that our tests will be cleared or approved on a timely basis, if at all. In addition,
there can be no assurance that the labeling claims cleared or approved by the FDA will be consistent with our current claims or adequate
to support continued adoption of and reimbursement for our products. Ongoing compliance with FDA regulations could increase the cost
of conducting our business, subject us to FDA inspections and other regulatory actions, and potentially subject us to penalties in the
event we fail to comply with such requirements.
Federal and State Fraud and Abuse Laws
False Claims and Overpayments
We are subject to numerous federal and state
fraud and abuse laws, including the federal False Claims Act. Many of these fraud and abuse laws are broad in scope, and, at least with
respect to the state laws, neither the courts nor relevant government agencies have extensively interpreted these laws. Prohibitions
under some of these laws include:
●
the submission
    of false claims or false information to government programs,
●
the retention
    of any overpayments received from governmental payors,
●
deceptive
    or fraudulent conduct,
●
excessive
    or unnecessary services or services at excessive prices, and
●
defrauding
    commercial health insurers.
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We may be subject to substantial penalties for
violations of these fraud and abuse laws, including denial of payment and refunds or recoupments, suspension of payments from Medicare,
Medicaid or other federal health care programs, and exclusion from participation in federal and state health care programs, as well as
civil monetary and criminal penalties and imprisonment. Numerous federal and state agencies enforce the fraud and abuse laws. In addition,
commercial insurers may also bring private actions. In some circumstances, private whistleblowers are authorized to bring lawsuits on
behalf of the government against providers and are entitled to receive a portion of any final recovery.
In addition, amendments to the FCA impose severe
penalties for the knowing and improper retention of overpayments collected from governmental payors. Within sixty days of identifying
and quantifying an overpayment, a provider is required to notify CMS or the relevant MAC of the overpayment (and the reason for it) and
to return the overpayment; failure to do so may result in a separate basis for liability under the FCA. These amendments could subject
our procedures for identifying and processing payments to greater scrutiny. Overpayments may occur from time to time in the healthcare
industry without any fraudulent intent. For example, overpayments may result from mistakes in reimbursement claim forms or from improper
processing by governmental payors. We maintain protocols intended to identify any overpayments and to make timely refunds as appropriate.
From time to time, we have identified overpayments and made appropriate refunds to government payors.
To avoid liability, we must carefully and accurately
code claims for reimbursement, proactively monitor the accuracy and appropriateness of Medicare claims and payments received, diligently
investigate any credible information indicating that we may have received an overpayment, and promptly return any overpayments.
Federal and State "Self-Referral"
and "Anti-Kickback" Restrictions
If we or our operations are found to be in violation
of applicable laws and regulations prohibiting improper referrals for healthcare items or services, we may be subject to penalties, including
civil and criminal penalties, damages, fines, exclusion from participation in U.S. federal or state healthcare programs, and the curtailment
or restructuring of our operations.
Anti-Kickback Statute
The federal Anti-Kickback Statute prohibits
persons from knowingly and willfully soliciting, receiving, offering, or paying remuneration, directly or indirectly, to induce either
the referral of an individual, or the furnishing, recommending, or arranging for an item or service, for which payment may be made under
a federal health care program, such as the Medicare and Medicaid programs, unless an exception or "safe harbor" applies.
The term "remuneration" is not defined in the federal Anti-Kickback Statute and has been broadly interpreted to include
anything of value, including for example, gifts, discounts, the furnishing of supplies or equipment, credit arrangements, payments of
cash, waivers of payment, ownership interests and providing anything at less than its fair market value. Sanctions for violations of
the federal Anti-Kickback Statute may include imprisonment and other criminal penalties, civil monetary penalties, and exclusion
from participation in federal health care programs. Further, the Affordable Care Act made clear that claims for items or services resulting
from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil
FCA. Further, the Affordable Care Act made clear that claims for items or services resulting from a violation of the federal Anti-Kickback Statute
constitutes a false or fraudulent claim for purposes of the federal civil FCA. Many states have also adopted laws similar to the federal
Anti-Kickback Statute, some of which are not limited in application to only items or services reimbursable by federal health care
programs, and do not contain identical safe harbors.
In addition to the Anti-Kickback Statute,
in October 2018, Congress enacted EKRA as a component of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and
Treatment for Patients and Communities Act. EKRA is an anti-kickback law similar to the federal Anti-Kickback Statute that,
subject to several exceptions, makes it a criminal offense to pay any remuneration to induce referrals to, or in exchange for, patients
using the services of a recovery home, a substance use clinical treatment facility, or laboratory. Although it appears that EKRA was
intended to reach patient brokering and similar arrangements to induce patronage of substance use recovery and treatment, the language
in EKRA is broadly written and can apply to laboratory services covered under public or private payor arrangements. That said, an interpretation
of EKRA that prohibits certain incentive compensation payments to sales employees or other forms of remuneration that would otherwise
be permissible under a safe harbor to the federal Anti-Kickback Statute would directly conflict with the intent of the federal Anti-Kickback Statute
and regulations and would prohibit a number of practices that are common throughout the industry. Significantly, EKRA permits the DOJ
to issue regulations clarifying EKRA's exceptions or adding additional exceptions, but no such regulations or applicable guidance
have yet been issued.
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Medicare Physician Self-Referral
Law
The federal Physician Self-Referral Law,
commonly referred to as the "Stark Law", prohibits, subject to certain exceptions, physicians from making a referral to an
entity for certain "designated health services" ("DHS") payable by Medicare if the physician, or an immediate
family member of the physician, has a direct or indirect financial relationship (including ownership interests and compensation arrangements)
with the entity. The Stark Law also prohibits such an entity from presenting or causing to be presented a claim to Medicare for DHS provided
pursuant to a prohibited referral, and provides that certain collections related to any such claims must be refunded in a timely manner.
The Stark Law is a strict liability statute and therefore, any referrals for Medicare DHS pursuant to a financial relationship that does
not meet an exception will be non-payable and subject to refund to Medicare. In addition, any Medicare "overpayment" (that
is, Medicare funds to which a person is not entitled) must be returned within 60 days of identification — or risk liability under
the FCA's "obligation" provision. Therefore, claims relating to Stark Law violations must be timely refunded to Medicare
or we would risk liability under the federal FCA. Violations of the Stark Law can also result in civil penalties and federal health care
program exclusions for knowing violations and civil monetary assessments of up to three times the amount claimed. Although the Stark Law
is drafted to apply only to Medicare claims, the DOJ has taken the position that it applies to Medicaid claims under an extension of the
federal FCA and several courts, including courts in Florida and Texas, have agreed. In addition, there are comparable state laws, some
of which apply to all payors (not just Medicare), and do not contain identical exceptions to the Stark Law.
Compliance with federal fraud and abuse laws
such as the Anti-Kickback Statute and the Stark Law involve constant monitoring for regulatory changes, agency and court interpretations,
and revisiting of arrangements based on new interpretations or clarifications, all of which will require ongoing compliance costs. In
addition, these laws and their exceptions and safe harbors are complex and clear interpretations are not always available. Despite our
best efforts to comply, we cannot guarantee that a government agency will necessarily agree with our interpretations or that one or more
of our arrangements will not be subject to challenge, nor can we provide any assurance that they will not have an adverse effect on our
business, financial condition, results of operations, and cash flows. Any action against us for violation of these or similar foreign
laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management's
attention from the operation of our business.
Sunshine Act
In 2010, Congress enacted the Physician Payments
Sunshine Act ("Sunshine Act"), which aims to promote transparency around financial relationships between physicians, teaching
hospitals and certain life sciences industry manufacturers. The Sunshine Act requires manufacturers of drugs, devices, biologicals, and
medical supplies covered by Medicare, Medicaid, or the Children's Health Insurance Program to report annually to CMS any payments
or other transfers of value made to healthcare providers and teaching hospitals, unless an exception applies. Manufacturers must also
disclose to CMS any healthcare provider ownership or investment interests. Some states have similar transparency laws. Although we do
not consider our laboratory services to be covered devices under the Sunshine Act, the laws and regulations are continually evolving
and in the future we could be required to comply with transparency requirements in the future, or we could otherwise be subject to scrutiny
for the nature and amount of our payments and transfers of value in the healthcare industry.
International
When marketing our tests outside of the United States,
we are subject to foreign regulatory requirements governing human clinical testing, export of tissue, marketing approval for our products,
and performance and reporting of tests in each market. These requirements vary by jurisdiction, differ from those in the United States,
and may require us to perform additional pre-clinical or clinical testing. In many countries outside of the United States,
coverage, pricing, and reimbursement approvals are also required in order for our tests to be made available to patients in substantial
volume.
52
Many countries in which we offer our tests have
anti-kickback regulations prohibiting providers, as well as medical and in vitro diagnostic device manufacturers, from offering,
paying, soliciting, or receiving remuneration, directly or indirectly, or providing a benefit to a healthcare professional in order to
induce business that is reimbursable under any national healthcare program. In situations involving healthcare providers employed by
public or state-funded institutions or national healthcare services, violation of the local anti-corruption or anti-gift laws
may also constitute a violation of the U.S. Foreign Corrupt Practices Act ("FCPA").
The FCPA prohibits any U.S. individual, business
entity, or employee of a U.S. business entity from offering or providing, directly or through a third party, including the distributors
we rely on in certain markets, anything of value to a foreign government official with corrupt intent to influence an award or continuation
of business or to gain an unfair advantage, whether or not such conduct violates local laws. In addition, it is illegal for a company
that reports to the SEC to have false or inaccurate books or records or to fail to
maintain a system of internal accounting controls. We are also required to maintain accurate information and control over sales and distributors'
activities that may fall within the purview of the FCPA, its books and records provisions, and its anti-bribery provisions.
Other Laws
Occupational Safety and Health
In addition to its comprehensive regulation of
health and safety in the workplace in general, the Occupational Safety and Health Administration has established extensive requirements
aimed specifically at laboratories and other healthcare-related facilities. In addition, because our operations require employees
to use certain hazardous chemicals, we also must comply with regulations on hazard communication and hazardous chemicals in laboratories.
These regulations require us, among other things, to develop written programs and plans, which must address methods for preventing and
mitigating employee exposure, the use of personal protective equipment, and training.
Specimen Transportation
Our commercialization activities subject us to
regulations of the Department of Transportation, the U.S. Postal Service, and the Centers for Disease Control and Prevention that apply
to the surface and air transportation of clinical laboratory specimens.
C. Organizational Structure
MDxHealth SA is a company with limited liability
(
naamloze vennootschap/société anonyme
) incorporated and operating under the laws of Belgium.
The following chart shows our organizational
structure as of December 31, 2022:
Subsidiary
    Name
Jurisdiction
    of Organization
Ownership
    & Voting Interest
Held by MDxHealth SA
MDxHealth,
    Inc.
Delaware
100% (held directly)
MDxHealth
    BV
The Netherlands
100% (held directly)
MDxHealth
    Servicelab BV
The Netherlands
100% (held through MDxHealth
    BV)
MDxHealth
    Research BV
The Netherlands
100% (held through MDxHealth
    BV)
Delta
    Laboratories LLC
Texas
100% (held through MDxHealth,
    Inc.)
D. Property, Plant and Equipment
We process our tests, and conduct research and
development, at our 38,000 square foot U.S. headquarters and laboratory facility in Irvine, California pursuant to a lease that is currently
scheduled to expire in 2026. This laboratory facility is certified pursuant to CLIA and accredited by CAP. We also maintain a small laboratory
facility in Plano, Texas. This laboratory facility is certified pursuant to CLIA.
53
Our headquarters is located in the CAP Business
Center, Herstal, Belgium.
We maintain offices and a laboratory facility
located in Nijmegen, The Netherlands, where we process our Select mdx test and conduct research and development at our 7,800 square foot
laboratory and office facility pursuant to a lease that is currently scheduled to expire in 2027.
We believe that our existing facilities are adequate
for our near-term needs, and we believe that suitable additional or alternative office and manufacturing space will be available as required
in the future on commercially reasonable terms.
ITEM 4A. UNRESOLVED STAFF COMMENTS
Not applicable.
ITEM 5. OPERATING AND FINANCIAL REVIEW AND
PROSPECTS
You should read the following discussion of
our operating and financial review and prospects in conjunction with our audited consolidated financial statements and the related notes
thereto included elsewhere in this annual report. In addition to historical information, the following discussion and analysis contains
forward-looking statements that reflect our current plans, estimates, expectations and beliefs and involve risks and uncertainties. Our
actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result
of various factors. Factors that could cause or contribute to these differences include, but are not limited to, those discussed below
and elsewhere in this annual report, particularly in sections titled "Risk Factors" and "Special Note Regarding Forward-Looking
Statements."
Overview
We are a commercial-stage precision diagnostics
company committed to providing non-invasive, clinically actionable and cost-effective urologic solutions to improve patient care. Our
novel genomic testing solutions combine advanced clinical modeling with genomic data to provide each patient with a personalized risk
profile, which provides more accurate and actionable information than traditional clinical risk factors used by clinicians. Our Select
mdx and Confirm mdx tests address men at risk for undetected prostate cancer, providing physicians with a clear clinical pathway to accurately
identify clinically significant prostate cancer while reducing the use of invasive procedures that are prone to complications. Our GPS
test addresses men newly diagnosed with localized prostate cancer, providing physicians with a clear clinical pathway to make the most
informed treatment decision for their individual disease. Our team's collective decades of experience in precision diagnostics
and our portfolio of novel biomarkers for diagnostic, prognostic and predictive molecular assays supports our active pipeline of new
testing solutions for urologic diseases.
We have experienced net losses and significant
cash used in operating activities since inception in 2003. To date, our primary sources of capital have been public offerings of our
ordinary shares and ADSs and private placements, debt financing agreements, and revenue from the sale of our products. Since inception,
we have raised equity financing of approximately $360 million. As of December 31, 2022, we had cash and cash equivalents of $15.5 million,
long-term loans and borrowings of $34.9 million and an accumulated deficit of $288.3 million. During the years ended December 31, 2020,
2021 and 2022, we generated revenue of $18.5 million, $22.2 million and $37.1 million, respectively, with a net loss of $28.7 million,
$29.0 million and $44.0 million, respectively.
In February 2023, the Company raised $40 million
in gross proceeds by means of a public offering of 10,000,000 ADSs being the equivalent of 100,000,000 new shares at an issue price of
$4.00 per ADS (or approximately €0.37 per share) through a public offering. In March 2023, the Company received additional gross
proceeds of $3.0 from the underwriters' exercise of their overallotment option.
54
Management expects the Company to continue to
incur net losses and have significant cash outflows for at least the next twelve months. While these conditions, among others, could
raise doubt about our ability to continue as a going concern, these consolidated financial statements have been prepared assuming that
the Company will continue as a going concern. This basis of accounting contemplates the recovery of our assets and the satisfaction of
liabilities in the normal course of business. A successful transition to attaining profitable operations is dependent upon achieving
a level of positive cash flows adequate to support the Company's cost structure.
Acquisition of Genomic Prostate Score®
(GPS) test (formerly Oncotype DX GPS) from Exact Sciences
On August 2, 2022, we announced that we have
entered into an agreement with Genomic Health, Inc., a subsidiary of Exact Sciences, to acquire the GPS test from Exact Sciences. We
acquired GPS in order to expand our menu of tests targeted into urology and prostate cancer and in order to position the Company as one
of the leaders in the urology and prostate cancer space with one of the most comprehensive menus of precision diagnostics.
Under the terms of the agreement, we acquired
the GPS prostate cancer business of Exact Sciences for an aggregate purchase price of up to $100 million, of which an amount of $25 million
was paid in cash and an amount of $5 million was settled through the delivery of 691,171 ADSs of the Company, at a price per ADS of $7.23.
Following the closing, which took place on August 2, 2022, an additional aggregate earn-out amount of up to $70 million is to be paid
by us to Exact Sciences over a three year period, commencing in 2024, in tranches equal to a portion of the annual revenues attributable
to the GPS prostate cancer business for the preceding fiscal year; provided, in each instance, that such revenues exceed certain minimum
revenue milestones for such fiscal year.
At our option, the earn-out amounts can be settled
in cash or through the issuance of additional ADSs of the Company (valued in function of a volume weighted average trading price of the
Company's shares at the end of the relevant earn-out period) to Exact Sciences, provided that the aggregate number of shares representing
the ADSs held by Exact Sciences shall not exceed more than 5% of our outstanding shares.
Financial Operations Overview
Revenues and Other Income
Revenues
The majority of our revenue is derived from laboratory
services with revenue recognized at a point in time when control of the services has transferred to the customer. This is generally when
the test results are delivered to the customer. We derive a small amount of additional revenue from license fees, royalties and government
grants.
A large portion of our revenues are either derived
from Medicare, which has set a fixed price pursuant to a LCD for the Company's Confirm mdx and GPS tests, or are established with
reference to the Medicare fixed price level. Therefore, the amount of revenue recognized from Medicare (as well certain contracted commercial
insurance companies) for Confirm mdx and GPS is determined by reference to a fixed price pursuant to the LCD. For reimbursement claims
made to other commercial insurance companies, where there is no certainty of the amount that will be paid for services rendered, the
Company uses historical collection data — on an individual payor basis — to estimate its future collection and corresponding
revenues that should be recognized for each of our testing solutions.
We analyze historical collection data on a monthly
basis and make monthly adjustments to our estimates. In accordance with IFRS 15, revenue is recognized where such a variable consideration
is included in the transaction price only to the extent that it is highly probable that the amount of revenue recognized will not be
subject to significant future reversals as a result of subsequent re-estimation. When historical collection data is insufficient to estimate
future collections, recognize revenue on a cash basis, meaning that revenues will not be recognized until actual cash payment is received
from the payor.
55
Cost of Goods & Services Sold
Cost of goods sold includes the cost of materials,
labor (including salaries, bonuses, and benefits), transportation, collection kits, and allocated overhead costs associated with processing
samples. Allocated overhead costs include depreciation of laboratory equipment, facility occupancy and information technology costs.
Costs associated with processing samples are expensed when incurred, regardless of the timing of revenue recognition. As such, cost of
goods and related volume does not always trend in the same direction as revenue recognition.
Gross Profit and Gross Margin
We calculate gross profit as revenue less cost
of goods & services sold, and gross margin as gross profit divided by revenue. Our gross margin has and will continue to be affected
by a variety of factors, primarily average selling prices and ordering volumes. We expect our gross profit to increase in the foreseeable
future as our revenue grows, our average selling price improves — based on broader commercial coverage for our tests — and as
we take advantage of economies of scale as we grow test volume.
Operating Expenses
Research and Development Expenses
Research and development expenses consist of
costs incurred for the development of our products. These expenses consist primarily of labor costs (including salaries, bonuses, benefits,
and stock-based compensation), reagents and supplies, clinical studies, outside services, patent expenses, depreciation of laboratory
equipment, facility occupancy and information technology costs. Research and development expenses also include costs associated with
assay improvements and automation workflow for our current suite of products. We expense our research and development expenses in the
period in which they are incurred, except for those development expenses that qualify for capitalization.
We expect that our research and development expenses
will increase in absolute dollars as we continue to develop additional products, however, we expect that these expenses will decrease
as a percentage of revenue over the long term, though they may fluctuate as a percentage from period to period due to the timing and
extent of these expenses.
Sales and Marketing Expenses
Our sales and marketing expenses are expensed
as incurred and include costs associated with our sales organization, including our direct clinical sales force and sales management,
medical affairs, client services, marketing and managed care, as well as technical lab support and administration. These expenses consist
primarily of labor costs (including salaries, bonuses, benefits, and stock-based compensation), customer education and promotional
expenses, market analysis expenses, conference fees, travel expenses and allocated overhead costs.
While there are no immediate plans to grow the
size of our commercial organization, our sales and marketing expenses may increase in absolute dollars as we increase our marketing activities
to drive further awareness and adoption of our products. However, we expect that these expenses will decrease as a percentage of revenue
over the long term, though they may fluctuate as a percentage from period to period due to the timing and extent of these expenses.
General and Administrative Expenses
Our general and administrative expenses include
costs for certain executives, accounting and finance, legal, revenue cycle management, information technology, human resources, and administrative
functions. These expenses consist primarily of labor costs (including salaries, bonuses, benefits, and stock-based compensation),
professional service fees such as consulting, accounting, legal, general corporate costs, and public-company costs associated with
our European listing, as well as allocated overhead costs (rent, utilities, insurance, etc.).
We expect that our general and administrative
expenses will continue to increase in absolute dollars primarily due to increased headcount (some of it related to volume, such as revenue
cycle management) and costs associated with operating as a public company, including expenses related to legal, accounting, regulatory,
tax, maintaining compliance with exchange listing in both Belgium (EURONEXT) and the United States (Nasdaq) and requirements of the SEC,
director and officer insurance and investor relations.
56
Other Operating Income/Expenses
Other operating income/expense is comprised of
grant income, fair-value adjustment of loan facility, revaluation of the contingent consideration related to the acquisition of NovioGendix
in 2015, and goodwill impairment, if any. We do not expect the revaluation of the contingent consideration to be a significant source
of income or expense going forward.
Financial Income/Expenses
Financial income/expense is comprised of fair-value
adjustments related to the GPS contingent consideration, interest income/expense, debt extinguishment expenses, as well as foreign exchange
gain/loss and other financial gain/loss. Interest income consists primarily of interest earned on our deposits. Our interest income has
not been significant to date and we do not expect it to be significant in the future. Our interest expense is primarily related to our
current $35 million long-term debt facility with Innovatus Capital Partners, which replaced our previous €9 million debt facility
with Kreos Capital VI (UK) Limited ("Kreos Capital").
Foreign exchange gains/losses are derived from
our operating in two different currencies (Euro and U.S. dollar) for our European and U.S. operations. These gains and losses
are not expected to be significant and we maintain reserves in both currencies to offset extreme fluctuations in the dollar/euro exchange
rate.
Other financial loss is derived from accrued
interest charges on the fair value of the NovioGendix contingent liability.
A. Operating results
Comparison of the years ended as of December
31, 2022 and 2021
Our results of operations for the years ended
as of December 31, 2022 and 2021 are summarized in the tables below:
Year Ended
December 31,
Year-Over-Year
Change
(in Thousands)
2022
2021
$
%
Services
$
36,965
$
21,937
$
15,028
69
%
Licenses
25
250
(225
)
90
Royalties and other revenues
64
52
12
23
Revenues
37,054
22,239
14,815
67
Cost of goods & services sold
(17,835
)
(11,675
)
(6,160
)
53
Gross Profit
19,219
10,564
8,655
82
Research and development expenses
(7,557
)
(6,673
)
(884
)
13
Selling and marketing expenses
(26,582
)
(17,744
)
(8,838
)
50
General and administrative expenses
(23,539
)
(14,149
)
(9,390
)
66
Other operating income, net
559
1,161
(602
)
(52
)
Operating loss
(37,900
)
(26,841
)
(11,059
)
41
Financial expense, net
(6,144
)
(2,161
)
(3,983
)
184
Loss before income tax
(44,044
)
(29,002
)
(15,042
)
52
Income tax
—
—
—
—
Loss for the year
(44,044
)
(29,002
)
(15,042
)
52
Earnings per share attributable to parent (EPS)
Basic and Diluted,
(0.28
)
(0.24
)
(0.04
)
17
Revenue
Revenue increased $14.8 million, or 67% for the
year ended December 31, 2022, compared to the year ended December 31, 2021, due to both the acquisition of the GPS test as well
as an increase in our test volumes for Confirm mdx and Resolve mdx. Excluding revenues from the recently acquired GPS test, total revenue
for 2022 was $27.7 million, an increase of 25% versus 2021.
57
For the year ended December
31, 2022 and 2021, Confirm mdx accounted for 59% and 91% of total revenue, respectively. 2022 revenues were comprised
of $21.8 million from Confirm mdx, $9.3 million from GPS, $4.9 million from Resolve mdx, with the remaining revenues from Select mdx
and other.
Cost of Goods &
Services Sold
Cost of revenue increased $6.1 million,
or 53% for the year ended December 31, 2022 compared to the year ended December 31, 2021, primarily as a result of the increase
in sales and unit volumes, however, gross margins increased from 47.5% for the year ended December 31, 2021 to 51.9% for the year
ended December 31, 2021, a 440 basis-point improvement primarily related to our product mix and the addition of GPS to our
product menu.
Research and Development
Expenses
Research and development expenses increased $0.9 million,
or 13% for the year ended December 31, 2022, compared to the year ended December 31, 2021, primarily due to increased product
development expenses as well as expenses associated with our pipeline products.
Selling and Marketing
Expenses
Selling and marketing expenses increased $8.8
million, or 50%, for the year ended December 31, 2022, compared to the year ended December 31, 2021, primarily due to the additional
field sales personnel associated with the GPS business as well as an increase in amortization expense related to customer lists as part
of the GPS intangible asset.
General and Administrative
Expenses
General and administrative expense increased
$9.4 million, or 66% for the year ended December 31, 2022, compared to the year ended December 31, 2021, primarily due to $3.7
million of one-time expenses related to the GPS acquisition (included in Professional fees), with the remaining $5.7 million increase
primarily related to higher insurance, professional fees and public company expenses.
Other Operating Income,
net
Other operating income, net, decreased by $0.6
million, or 52% for the year ended December 31, 2022, compared to the year ended December 31, 2021, primarily due to the reduction of
grant income from the U.S. Department of Health and Human Services and the Dutch government NOW grants, partially offset by an increase
in fair-value adjustment related to the acquisition of NovioGendix in 2015.
Financial Income/Expense
Financial expenses, net, increased by $4.0 million,
or 184% for the year ended December 31, 2022, compared to the year ended December 31, 2021, primarily due to fair-value adjustment for
the GPS contingent consideration of $2.4 million, interest charges and extinguishment expenses of $1.6 million for the loan facility
with Kreos Capital, and interest charges of $1.6 million related to the Innovatus debt facility.
58
Comparison of the years ended as of December
31, 2021 and 2020
Our results of operations for the years ended
as of December 31, 2021 and 2020 are summarized in the tables below:
Year Ended
December 31,
Year-Over-Year
Change
(in Thousands)
2021
2020
$
%
Services
$
21,937
$
18,064
$
3,873
21
%
Licenses
250
250
—
—
Royalties and other revenues
52
146
(94
)
(64
)
Revenues
22,239
18,460
3,779
20
Cost of goods & services sold
(11,675
)
(10,416
)
1,259
12
Gross Profit
10,564
8,044
2,520
31
Research and development expenses
(6,673
)
(4,543
)
(2,130
)
47
Selling and marketing expenses
(17,744
)
(16,752
)
(992
)
6
General and administrative expenses
(14,149
)
(13,990
)
(159
)
1
Other operating income, net
1,161
118
1,043
884
Operating loss
(26,841
)
(27,123
)
282
(1
)
Financial income
11
4
7
175
Financial expense
(2,172
)
(1,543
)
(629
)
41
Loss before income tax
(29,002
)
(28,662
)
(340
)
1
Income tax
—
—
—
—
Loss for the year
(29,002
)
(28,662
)
(340
)
1
Earnings per share attributable to parent (EPS)
Basic and Diluted
(0.24
)
(0.34
)
0.1
(29
)
Revenue
Revenue increased $3.8 million, or 20% for
the year ended December 31, 2021, compared to the year ended December 31, 2020, due an increase in our test volumes and average
selling price.
For the year ended December
31, 2021 and 2020, Confirm mdx accounted for 91% and 94% of total revenue, respectively.
Cost of Goods &
Services Sold
Cost of revenue increased $1.3 million,
or 12% for the year ended December 31, 2021 compared to the year ended December 31, 2020, primarily as a result of the increase
in unit volumes, however, gross margins increased from 43.6% for the year ended December 31, 2020 to 47.5% for the year ended December 31,
2021, a 390 basis-point improvement primarily due to the increase in our average selling price.
Research and Development
Expenses
Research and development expenses increased $2.1 million,
or 47% for the year ended December 31, 2021, compared to the year ended December 31, 2020, primarily due to increased expenses
associated with our pipeline products.
Selling and Marketing
Expenses
Selling and marketing expenses increased $1.0
million, or 6%, for the year ended December 31, 2021, compared to the year ended December 31, 2020, primarily due to increased
activity in 2021 versus 2020, which was the first year of the COVID-19 pandemic.
General and Administrative
Expenses
General and administrative expense increased
$0.2 million, or 1% for the year ended December 31, 2021, compared to the year ended December 31, 2020, primarily due to an
increase in professional fees and insurance expenses associated with our U.S. listing on the Nasdaq Stock Market.
Other Operating Income,
net
Other operating income, net was comprised of
grant income in the U.S. and The Netherlands as well as the revaluation of the contingent consideration related to the acquisition of
NovioGendix in 2015. The increase of $1.0 million for the year ended December 31, 2021 versus the prior year period was primarily
related to $659,000 grant income from the U.S. Department of Health and Human Services as well as a $382,000 grant from the Dutch government
NOW grants.
59
Financial Income/Expense
Financial income was comprised of interest income
from deposits. Financial expense is primarily comprised of interest expense on our long-term debt facility as well as interest charges
on lease liabilities. Financial expenses increased by $0.6 million, or 41% primarily related to interest charges recognized on leases
under IFRS 16.
B. Liquidity and Capital Resources
We have incurred net losses in each quarter since
our inception. For the years ended December 31, 2022, 2021 and 2020, we incurred a net loss of $44.0 million, $29.0 million and
$28.7 million respectively. We expect to continue to incur significant expenses for the foreseeable future and to incur operating
losses in the near term while we make investments to support our anticipated growth.
As of December 31, 2022, we have been financed
primarily through net proceeds of approximately $360 million from the sale of our equity securities and long-term debt facilities.
Our primary source of cash from operations is cash receipts on accounts receivable from our revenue. As of December 31, 2022, we had
cash and cash equivalents of $15.5 million and an accumulated deficit of $288.3 million.
On February 3, 2023, we announced the pricing
of a registered public offering of 10,000,000 ADSs (each representing 10 ordinary shares of the Company without nominal value) at a price
to the public of $4.00 per ADS (equivalent to a price of €0.364 per share, assuming an exchange rate of €1 = $1.0988 as published
by the European Central bank on February 2, 2023 and a 10-for-1 ADS to share ratio) for total gross proceeds of $40.0 million before
deducting commissions and estimated offering expenses.
On March 6, 2023, we announced that, in the context
of the above-mentioned offering, the underwriters exercised the option to purchase additional ADSs, on the same terms and conditions
as stated above, in the amount of 750,000 ADSs for gross proceeds of $3.0 million, bringing the aggregate gross proceeds from this transaction
to $43.0 million.
Our primary uses of cash are to fund operating
expenses, service debt and acquire equipment. Cash used to fund operating expenses excludes the impact of non-cash items such as
depreciation and stock-based compensation and is impacted by the timing of when we pay our operating expenses as reflected in the
change in our outstanding accounts payable and accrued expenses. Debt service primarily consists of interest payments on our outstanding
debt. Acquisitions of property and equipment primarily consist of purchases of laboratory equipment.
On August 2, 2022, we entered into a $70 million
loan and security agreement with Innovatus, which loan also replaced the Company's €9 million debt facility with Kreos Capital.
At closing, an amount of $35 million was drawn, with an additional $35 million remaining available as a $20 million term B loan and a
$15 million term C loan that can be drawn in 2024 and 2025 respectively, subject to certain conditions. The loans are secured by our
assets including intellectual property rights. Remaining proceeds of the loans will be used for working capital purposes and to fund
general business requirements.
The loans accrue interest at a floating per annum
rate equal to the sum of (a) the greater of (i) the prime rate published in The Wall Street Journal in the "Money Rates"
section or (ii) 4.00%, plus (b) 4.25%, and require interest-only payments for the initial four years. As contractually agreed, and at
our election, a portion of the interest becomes payable in-kind by adding an amount equal to 2.25% of the outstanding principal amount
to the then outstanding principal balance on a monthly basis until August 2, 2025. The loans mature on August 2, 2027. The lenders shall
have the right to convert, prior to August 2, 2025, up to 15% of the outstanding principal amount of the loans into ADSs of the Company
at a price per ADS equal to $11.21, reflecting a substantial premium to the trading price prior to the announcement of the acquisition.
Amounts converted into ADSs of the Company will be reduced from the principal amount outstanding under the loan. Notable fees payable
to Innovatus consist of a facility fee equal to 1% of the total loan commitment, due on the funding date of the relevant loans, and an
end-of-loan fee equal to 5% of the amount drawn, payable upon final repayment of the relevant loans.
60
In April 2020, the Company, through our U.S. subsidiary,
MDxHealth Inc., entered into a PPP loan with the SBA in the amount of $2,316,000 as part of the CARES Act. The loan has a term of five
years and carries an interest rate of 1.0% per year. Payments on the loan are deferred for the first eighteen months following disbursement
of the loan, with principal and interest payments beginning on the nineteenth month. Interest on the loan continues to accrue during the
eighteen-month deferment period. Cash proceeds from the loan were received in July 2020. Of the $2.3 million PPP loan, $1.6 million
and $1.0 million has been recorded as long-term debt on the company's consolidated balance sheet as of December 31, 2021,
and December 31, 2022, respectively.
Funding Requirements
As of December 31, 2022, we had cash and cash
equivalents of $15.5 million. Based on our current business plan, as well as the additional $40.4 million in net proceeds from our February
and March 2023 equity offering, we estimate that our current cash and cash equivalents and our anticipated cash flows generated from
sales of our products, will be sufficient to meet our anticipated cash requirements over at least the next 12 months from the date
of this annual report. To meet our long-term financial needs, we may consider raising additional capital to expand our business, to pursue
strategic investments, to take advantage of financing opportunities or for other reasons. As a result of our expected revenue growth,
we expect our accounts receivable and inventory balances to increase. Any increase in accounts receivable and inventory may not fully
cover corresponding increases in accounts payable and accrued expenses, which could result in greater working capital requirements. We
have based these estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than
we expect.
Until such time, if ever, as we can generate
revenue to support our cost structure, we expect to finance our operations through equity offerings or debt financings, or other capital
resources, including potentially collaborations or licensing arrangements. The sale of equity and convertible debt securities may result
in dilution to our shareholders and the terms of these securities could provide for rights, preferences or privileges senior to those
of our common stock. The terms of debt securities issued or borrowings pursuant to a credit agreement could impose significant restrictions
on our operations. If we raise funds through collaborations and licensing arrangements, we might be required to relinquish significant
rights to our technologies or products or grant licenses on terms that are not favorable to us. Additional capital may not be available
on reasonable terms, or at all.
Our ability to generate sufficient revenue to
achieve profitability will be heavily dependent on the successful commercialization of our currently marketed products and our anticipated
future products, as well as obtaining favorable reimbursement. We anticipate that a substantial portion of our capital resources and
efforts in the foreseeable future will be focused on the commercialization of our existing products and the development of future products.
Our operating results may fluctuate significantly
from period to period, depending on the timing of our planned development activities, clinical studies, and the growth of our sales and
marketing activities. We expect our expenses will increase substantially for the foreseeable future as we:
●
attract,
hire and retain qualified personnel;
●
continue
to develop additional products and generate any evidence required to support expanded reimbursement of our products;
●
expand
our sales force and territories and increase our marketing activities to drive further awareness and adoption of our products;
●
protect
and defend our intellectual property;
●
invest
in processes, infrastructure to support the growth of our business; and
●
operate
as a dual-listed public company.
61
The table below summarizes our cash flows information
for the years ended December 31, 2022 and 2021.
For the year ended
December 31,
(in Thousands)
2022
2021
Net cash used in operations
$
(34,118
)
$
(22,548
)
Net cash used in investing activities
(29,163
)
(896
)
Net cash from financing activities
20,841
66,509
Effects of exchange rate changes
(555
)
(520
)
Change in cash and cash equivalents
$
(42,995
)
$
(42,545
)
Net cash used in operations was $34.1 million
for year ended December 31, 2022, compared to $22.5 million for the year ended December 31, 2021. The increase of cash used in operations
of $11.6 million was primarily due to a higher operating loss as well as negative variation in our working capital.
Net cash from investing activities for the year
ended December 31, 2022, was $29.2 million compared to $0.9 million for the year ended December 31, 2021. The increase in net cash
from investing activities primarily related to the acquisition of the GPS business as well as to purchases of property, plant, and equipment
during 2022.
Net cash from financing activities for year ended
December 31, 2022, was $20.8 million compared to $66.5 million for the year ended December 31, 2021. Cash from financing activities
for the year ended December 31, 2022 were primarily derived from the $35 million debt facility from Innovatus. Cash from financing activities
for the year ended December 31, 2021 were primarily from an equity financing of €25.0 million ($30.4 million) in gross
proceeds by means of a private placement of 27,777,777 new shares (being approximately 30.63% of the Company's outstanding shares
at the time) at an issue price of €0.90 per share through an accelerated bookbuild offering as well as from an initial public offering
in the United states of 3,750,000 ADSs (representing 37,500,000 ordinary shares, being approximately 32% of the Company's outstanding
shares at the time) for gross proceeds of $45.0 million.
Cash Flows
The table below summarizes our cash flows information
for the years ended December 31, 2021 and 2020.
For the year ended
December 31,
(in Thousands)
2021
2020
Net cash used in operations
$
(22,548
)
$
(20,244
)
Net cash used in investing activities
(896
)
(537
)
Net cash from financing activities
66,509
14,290
Effects of exchange rate changes
(520
)
394
Change in cash and cash equivalents
$
42,545
$
(6,097
)
Net cash used in operations was $22.5 million
for year ended December 31, 2021, compared to $20.2 million for the year ended December 31, 2020. The increase of cash used in operations
of $2.3 million was primarily due to negative variation in our working capital.
Net cash from investing activities for the year
ended December 31, 2021, was $0.9 million compared to $0.5 million for the year ended December 31, 2020. The increase in net
cash from investing activities related to purchases of property, plant, and equipment during 2021.
Net cash from financing activities for year ended
December 31, 2021, was $66.5 million compared to $14.3 million for the year ended December 31, 2020. Cash from financing activities
for the year ended December 31, 2021 were primarily from an equity financing of €25.0 million ($30.4 million) in gross
proceeds by means of a private placement of 27,777,777 new shares (being approximately 30.63% of the Company's outstanding shares
at the time) at an issue price of €0.90 per share through an accelerated bookbuild offering as well as from an initial public offering
in the United States of 3,750,000 ADSs (representing 37,500,000 ordinary shares, being approximately 32% of the Company's outstanding
shares at the time) for gross proceeds of $45.0 million. Cash from financing activities for the year ended December 31, 2020, were
primarily from an equity investment in the Company by MVM V LP and MVM GP (No.5) LP, funds managed by MVM Partners LLP (collectively
"MVM") of $13.7 million as well as proceeds of $2.3 million from the PPP loan with the SBA as part of the CARES
Act.
62
Contractual Obligations and Commitments
Our principal obligations consist of a lease
liability, financial debt and trade and other payables. The following table sets out, as of December 31, 2022, our contractual obligations
and commitments due by period:
Payments Due by Period
(in thousands)
Total
Less than
1 Year
1 – 3
Years
4 – 5
Years
More than
5 Years
Loans and borrowings
$
35,530
$
616
$
989
$
33,925
$
0
Lease liabilities
4,263
1,172
2,128
963
0
Total
$
39,793
$
1,788
$
3,117
$
34,889
$
0
The contractual obligations table does not
include any additional potential contingent payments upon the future achievement by us of specified sales-based and other
milestones, or royalty payments we may be required to make under license agreements we have entered into pursuant to which we
have in-licensed certain intellectual property or under the agreement pursuant to which we acquired the GPS test. See "
Collaboration and License Agreements
" under Item
4B. "
Business Overview
" for additional information. The timing of when these additional payments will actually be
made is uncertain and the payments are contingent upon the completion of future activities.
C. Research and development, patents and licenses
Our research and development teams utilize our
deep expertise to contribute to the growth of our business. In the years ended December 31, 2020, 2021 and 2022, R&D expenses were
$4.5 million, $6.7 million and $7.6 million, respectively, on research and development. For a discussion of our research and development
activities, see Item 4B. "
Business Overview
" and Item 5A. "
Operating Results
."
D. Trend information
Key Factors and Trends
Impact of COVID-19 Pandemic
The broad and extensive impact of the COVID-19
pandemic on virtually all aspects of our business and society exacerbated many pre-existing risks to our business by making them more
likely to occur or more impactful when they do occur. The level and nature of the disruption caused by COVID-19, or any future pandemic,
is unpredictable, may be cyclical and long-lasting and may vary from location to location. To the extent COVID-19 conditions improve,
the duration and sustainability of any such improvements will be uncertain and continuing adverse impacts and/or the degree of improvement
may vary dramatically by geography and by product. The actions we take in response to any improvements in conditions, such as our return-to-office
plans, may also vary widely by geography and by business and will likely be made with incomplete information; pose the risk that such
actions may prove to be premature, incorrect or insufficient and could have a material, adverse impact on our business and results of
operations.
Ability to Attract New Ordering Physicians
and Increase Our Penetration with Existing Physicians
Revenue growth for our products will depend on
our ability to continue to expand our base of ordering physicians, increase our penetration with existing physician customers, and increase
the number of physicians who consistently order our tests. We do not have immediate plans to expand our direct sales force and believe
that we have the ability to increase our base of ordering physicians with our current structure.
63
Reimbursement for Genomic Testing from
Third-Party Payors
Successful commercialization of our tests depends,
in large part, on the availability of coverage and adequate reimbursement from government and private payors. Favorable third-party payor
coverage and reimbursement are essential to meeting the Company's immediate objectives and long-term commercial goals. In
the United States, for new diagnostic solutions, each private and government payor decides whether to cover the test, the amount it will
reimburse for a covered test, and any the specific conditions for reimbursement. Providers may be unlikely to order a specific diagnostic
test unless an applicable third-party payor offers meaningful reimbursement for the test. Therefore, adequate coverage and
reimbursement is critical to the commercial success of a diagnostic product, and if the Company is unable to secure and maintain favorable
coverage determinations and reimbursement levels, this will compromise its ability to earn revenues from its products.
Medicare
Reimbursement for diagnostic tests furnished
to Medicare beneficiaries is typically based on a fee schedule set by CMS. As a Medicare-enrolled laboratory based in California,
the Company bills Noridian, and is subject to applicable Medicare local coverage and reimbursement
policies. Noridian participates in the MolDX, which handles technical assessments for U.S. laboratories that perform molecular diagnostic
testing. In 2014, 2015 and 2023, respectively, our Confirm mdx test, our GPS test and our Select mdx test received a positive Medicare
LCDs under the MoIDX Program, which provide coverage and reimbursement for Medicare beneficiaries throughout the United States.
Our Resolve mdx UTI test is currently reimbursed by Medicare and most private insurance payors, based on nationally recognized CPT codes.
Commercial payors
Obtaining coverage and reimbursement by commercial
payors is a time-consuming and costly process, without a guaranteed outcome, since each commercial payor makes its own decision
with respect to whether to cover a particular test, and, if so, at what rate to reimburse providers for such test. In addition,
several payors and other entities conduct technology assessments of new medical tests and devices and provide the results of these assessments
for informational purposes to other parties. These assessments may be used by third-party payors and healthcare providers as grounds
to deny coverage for a particular test, or to refuse to use or order a particular test or procedure. The Confirm mdx and Select mdx tests
have received initial negative technology assessments from several of these entities and are likely to receive more negative technology
assessments. The Company continues to work with third-party payors to obtain coverage for its Confirm mdx and Select mdx tests and
to appeal denial decisions based on existing and ongoing studies, peer reviewed publications, and support from physician and patient
groups. There are no assurances that commercial payors will continue to issue positive coverage and reimbursement policies and/or contracts,
and, if issued, that such policies and/or contracts will be maintained in the future. If the Company's tests are considered on
a policy-wide level by major third-party payors, whether at the Company's request or on their own initiative, and the
tests are determined to be ineligible for coverage and reimbursement by such payors, the Company's collection efforts and potential
for revenue growth could be adversely impacted.
Increasing Market Acceptance and Adoption
of our Tests
Healthcare providers typically take a long time
to adopt new products, testing practices and clinical treatments, partly because of perceived liability risks and the uncertainty of
third-party coverage and reimbursement. It is critical to the success of our sales efforts that we educate enough patients, clinicians
and administrators about molecular diagnostics testing, in general, as well as about our Confirm mdx and Select mdx tests, and demonstrate
our clinical benefits. It is likely that clinicians may not adopt, and third-party payors may not cover or adequately reimburse
for, the Company's tests unless they determine, based on published peer-reviewed journal articles and the experience of other
clinicians, that they provide accurate, reliable and cost-effective information.
64
Menu Expansion
Our lead products address men at risk for developing
prostate cancer, but in addition, we are actively developing testing solutions to help with the management of men diagnosed with prostate
cancer, with the goal to provide our clients with a menu of tools spanning the continuum of prostate cancer diagnosis and care. Our expertise
in precision diagnostics and our portfolio of novel biomarkers for diagnostic, prognostic and predictive molecular assays supports our
active pipeline of new testing solutions for prostate and other urologic diseases. Our pipeline products in active surveillance are still
under development and may or may not make it to market, depending on results of our research and clinical studies. The completion of
these research and development activities is difficult to predict, and the related expenses may vary significantly by quarter. We expect
to increase our research and development expense during this time. We may also take advantage of our strong commercial channel into urology
to introduce complimentary tests outside of our current pipeline products.
While these factors may present significant opportunities
for us, they also pose significant risks and challenges that we must address. See Item 3D. "
Risk Factors
" for more
information.
E. Critical Accounting Estimates
Critical Accounting Policies and Estimates
Refer to Note 2.4 to our consolidated financial
statements found elsewhere in this annual report, for a discussion on the critical accounting policies, estimates, assumptions, and judgments
that we believe to have the most significant impact on our consolidated financial statements.
ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES
A. Directors and Senior Management
Our Board of Directors
The following table sets forth certain information
relating to our Board of Directors as of December 31, 2022.
Name
Age
Position(s)
Term
Koen Hoffman
(1)
54
Independent Non-Executive Director (Chairperson of
    the Board of Directors)
Until 2024
Michael K. McGarrity
60
Executive Director (Chief Executive Officer)
Until 2023
(2)
Jan Pensaert
(3)
51
Non-Executive Director
Until 2024
Dr. Lieve Verplancke
(4)
63
Independent Non-Executive Director
Until 2024
Hilde Windels
(5)
57
Independent Non-Executive Director
Until 2023
(2)
Dr. Regine Slagmulder
(6)
56
Independent Non-Executive Director
Until 2023
(2)
Dr. Eric Bednarski
51
Non-Executive Director
Until 2023
(2)
Donnie (Don) M. Hardison
72
Independent Non-Executive Director
Until 2023
(2)
(1)
Acting through Ahok BV.
(2)
Director is up for reelection
    to a new mandate on May  2023 at our shareholder meeting.
(3)
Acting through Valiance
    Advisors LLP.
(4)
Acting through Qaly-Co BV.
(5)
Acting through Hilde Windels
    BV.
(6)
Acting through Regine Slagmulder
    BV.
Unless otherwise stated, the address for our
directors is CAP Business Center, Zone Industrielle des Hauts-Sarts, Rue d'Abhooz 31, 4040 Herstal, Belgium.
Our Board of Directors has determined that five
out of eight of the members of the Board are independent under Belgian law and the Nasdaq Stock Market listing requirements.
Except for our employment agreement with Michael
K. McGarrity, our Executive Director and Chief Executive Officer, as described in "Item 7B.
Related Party Transactions
,"
there are no service contracts between us and any of our directors providing for benefits upon termination of employment.
65
Board
    Diversity Matrix
(as
    of November 1, 2022)
Country
    of Principal Executive Offices:
Belgium
Foreign
    Private Issuer
Yes
Disclosure
    Prohibited under Home Country Law
Yes
Total
    Number of Directors
8
Female
Male
Non-Binary
Did
    Not Disclose
Gender
Part
    I: Gender Identity
Directors
3
5
-
-
Part
    II: Demographic Background
Underrepresented Individual in Home Country Jurisdiction
-
LGBTQ+
-
Did
    Not Disclose Demographic Background
-
(as
    of April 25, 2023)
Country
    of Principal Executive Offices:
Belgium
Foreign
    Private Issuer
Yes
Disclosure
    Prohibited under Home Country Law
Yes
Total
    Number of Directors
8
Female
Male
Non-Binary
Did
    Not Disclose
Gender
Part
    I: Gender Identity
Directors
3
5
-
-
Part
    II: Demographic Background
Underrepresented Individual in Home Country Jurisdiction
-
LGBTQ+
-
Did
    Not Disclose Demographic Background
-
The following sets forth the biographical information
of the members of our board of directors:
Koen Hoffman
, Chairperson of our
Board of Directors, obtained a Master in Applied Economics and an MBA at Vlerick Business School. Between 1992 and July 2016, he was
active at KBC Group in which he started his career in the corporate finance department and later became the CEO of KBC Securities as
from October 2012. Since August 2016, he is the CEO of Value Square asset management. Mr Koen Hoffman serves also as board member at
Fagron (Chair),Greenyard (chair), Mithra Pharmaceuticals and SnowWorld.
Michael K. McGarrity
, Chief Executive
Officer and Executive Director of our Company, has more than 25 years of experience in the healthcare industry with a unique combination
of device, diagnostics and biotechnology experience. Michael was most recently the CEO of Sterilis Medical. Prior to Sterilis Michael
was the CEO of Nanosphere (Nasdaq: NSPH), a nanotechnology-based molecular diagnostics company, where he engineered an operational and
strategic turnaround that resulted in its successful sale to Luminex (Nasdaq: LMNX) in 2016. Prior to Nanosphere, McGarrity spent 13
years at Stryker Corporation (NYSE: SYK). Mr. McGarrity holds a BA from the University of Notre Dame.
Jan Pensaert
, Non-Independent Non-Executive Director
of our Company, is the Founding Managing Partner of Valiance. He brings over 20 years of experience in growth investing. He leads the
Investment Committee for the Valiance Funds and is responsible for all aspects of the Funds' investment processes. Jan currently
serves on the Board of several Valiance entities funds and portfolio companies including MDxHealth, JenaValve, NeoSync and 4Tech. Prior
to founding Valiance, Jan was CEO of La Fayette, where during his tenure the La Fayette Funds increased in AUM from USD 750 million to
USD 5.5 billion. Before that, he was responsible for the Permal Group's European-based investment management and research activities,
and prior to that he worked at Lazard in Corporate Finance M&A. Jan holds a BA in Business Economics from Gent University in Belgium,
and a Masters in Banking & Finance from the University of Aix-Marseille, France.
66
Dr. Lieve Verplancke
MD, Independent
Non-Executive Director of our Company, a Belgian national, began her career in 1984 with The Beecham Group (now part of GlaxoSmithKline),
and has since held key management positions with Merck & Co., as well as Bristol-Myers Squibb, where she served as Managing Director,
leading their Belgian/GDL subsidiary, until 2012. Ms. Verplancke also serves as a Board Member for Brussels-based Europe Hospitals; the
Imelda Hospital in Bonheiden; and the Euronext fund, Quest for Growth and Materialise. She is also the Founder and Managing Director
of Qaly@Beersel, an elderly care center in Belgium. In addition to being a medical doctor (MD–KULeuven University), Ms. Verplancke
holds a postgraduate degree in Economics and an MBA from the University of Antwerp. She has also completed courses at INSEAD, CEDEP,
Columbia University and the Vlerick Business School, and is a certified Executive Coach (PCC).
Hilde Windels
, Independent Non-Executive Director
of our Company, is the CEO of immunodiagnostic company Antelope Dx BV and has 20 years of experience in the biotechnology sector with
a track record of building and structuring organizations, fundraising, M&A, public capital markets and corporate strategies. At Biocartis,
she was CEO ad interim and Deputy CEO from September 2015 until September 2017 and CFO from 2011 until September 2015. Previously, Mrs.
Windels worked as independent CFO for several private biotech companies and from 1999 to 2008 she was CFO of Devgen. Currently, Mrs.
Windels serves as a board member at Erytech and Celyad. In the past, she also served on the boards of Devgen, Biocartis, Ablynx, VIB
and FlandersBio. Mrs. Windels holds a Masters in Economics (commercial engineer) from the University of Leuven, Belgium.
Dr. Regine Slagmulder
, Independent
Non-Executive Director of our Company, is a partner and full professor in management accounting & control at Vlerick Business
School and a visiting professor of accounting & control at INSEAD. Previously, she worked as a strategy practice consultant at McKinsey
& Company. She also previously worked as a professor of management accounting at INSEAD and at the University of Tilburg. She serves
as an independent director and member of the audit committee on the board of the investment company Quest for Growth (since 2011) and
as an independent director and chair of the audit committee of Ekopak (since 2021), both listed on Euronext. Dr. Slagmulder graduated
in civil electrotechnical engineering and industrial management from the University of Gent, after which she received a management doctorate
at Vlerick Business School. As part of her research activities, she was a research fellow attached to INSEAD, Boston University (USA)
and the P. Drucker Graduate Management Center at Claremont University (USA). She is an INSEAD certified director (IDP-C).
Dr. Eric Bednarski
, Non-Independent Non-Executive Director
of our Company,
currently serves as a Partner of MVM Partners LLP. Before joining MVM in 2008, he was a Partner at
Advent Healthcare Ventures and a Principal at Advent International Corporation. Prior to Advent, he was a Director in the Corporate Finance
Group of Silicon Valley Bank. Dr. Bednarski has a B.S. degree in Neural Science from Brown University and a Ph.D. in Biological Sciences
from the University of California, Irvine.
Donnie (Don) M. Hardison
, Independent
Non-Executive Director of our Company, currently is the sole proprietor of DMH Consulting, a management consulting firm that he
founded and previously operated from April 2016 to January 2017. He was most recently the President and Chief Executive Officer, and
served on the board of directors, of Biotheranostics, Inc., a molecular diagnostic company focused on oncology, from February 2017 until
it was acquired by Hologic, Inc. in February 2021. From April 2010 to March 2016, Mr. Hardison was the President and Chief Executive
Officer of Good Start Genetics, a molecular genetic testing and information company. For more than 20 years prior to that, Mr. Hardison
held various executive and senior management positions at companies including Laboratory Corporation of America (LabCorp) a clinical
laboratory company, Exact Sciences Corporation, a molecular diagnostics company, OnTarget, Inc., a sales and marketing consulting company,
Quest Diagnostics Inc., a clinical laboratory company, SmithKline Beecham Corporation, a pharmaceutical company, and others. He served
on the board of directors of Exact Sciences Corporation (Nasdaq: EXAS) from May 2000, through its initial public offering in February
2001, until August 2007. Mr. Hardison received his Bachelor of Arts degree, in political science, from the University of North Carolina,
Chapel Hill.
67
Our Executive Management
The following table sets forth certain information
relating to our executive management as of December 31, 2022.
Name
Age
Position(s)
Michael K. McGarrity
60
Chief Executive Officer and Executive Director
John Bellano
54
Chief Commercial Officer
Ron Kalfus
48
Chief Financial Officer
Joseph Sollee
58
Executive Vice President of Corporate Development and
    General Counsel
Unless otherwise stated, the address for our
executive management is CAP Business Center, Zone Industrielle des Hauts-Sarts, Rue d'Abhooz 31, 4040 Herstal, Belgium.
The following is the biographical information
of those members of our executive management who do not also serve on our Board of Directors:
John Bellano
, our Chief Commercial
Officer, joined MDxHealth in June 2019. He has more than 25 years of experience in the healthcare industry. Mr. Bellano started
his career in pharmaceuticals and transitioned to molecular diagnostics where he has spent the past 20 years of his career, most recently
as Chief Commercial Officer of Sterilis Solutions. Prior to Sterilis Solutions he served as the commercial leader for pharmacogenomic
companies Assurex Health and AltheaDx. Mr. Bellano holds a degree from Allentown College.
Ron Kalfus
, our Chief Financial
Officer, joined MDxHealth in July 2019. He has over 20 years of leadership experience in both public and private companies within diagnostics/biotech
and other sectors, and brings extensive knowledge in financial operations and management. Mr. Kalfus joined MDxHealth from Rosetta
Genomics, where he helped lead efforts to reposition the company for commercial success with its oncology diagnostic products. Prior
to Rosetta, Mr. Kalfus served as the CFO and Treasurer of MabCure, a Belgium-based publicly-traded biotechnology start
up in the field of early cancer detection using antibodies. Mr. Kalfus holds a MS in Accounting from Fairleigh Dickinson University
and a BBA in Finance from the University of Georgia and is a CPA licensed in New Jersey.
Joseph Sollee
, our Executive Vice
President of Corporate Development and General Counsel, has provided legal counsel to MDxHealth since its inception in 2003, and in April
2008 joined our management team. Prior to joining the Company, Mr. Sollee served as Special Counsel with the law firm of Kennedy
Covington (now K&L Gates), where he led the Life Sciences Practice Group. Mr. Sollee has more than 20 years of experience in
the life sciences industry, and has held senior legal and management positions at Triangle Pharmaceuticals and TherapyEdge. In addition,
he has practiced as a corporate attorney in the Washington D.C. legal firm Swidler & Berlin and in investment banking at
Smith Barney in New York. Mr. Sollee received a Juris Doctorate in Law (JD) and a Master's degree in International & Comparative
Law (LLM) from Duke University, a BA degree from Harvard University, and has been certified into the legal bars of New York, Washington
D.C. and North Carolina.
Family Relationships
There are no family relationships among any of
the members of our executive management and/or our Board of Directors.
B. Compensation
Compensation of Our Directors and Executive
Management
Our current remuneration policy is based on meritocracy
and a sense of ownership and is designed to reward performance in order to motivate members of the Board of Directors and the executive
management of the Company in order to deliver increased shareholder value through superior business results.
We have prepared and submitted a remuneration
policy in accordance article 7:89/1 of the Belgian Companies and Associations Code to the general shareholders' meeting of the
Company, which approved said remuneration policy on May 27, 2021. Upon every material change to the remuneration policy and in any
case at least every four years, the remuneration policy will be submitted to the general shareholders' meeting for approval. The
shareholders' vote on the remuneration policy is binding.
68
Compensation of Our Board of Directors
Upon recommendation and proposal of the Nomination
and Remuneration Committee, our Board of Directors determines the remuneration of the directors to be proposed to the general shareholders'
meeting.
Pursuant to Belgian law, the general shareholders'
meeting approves the remuneration of the directors, including inter alia, each time as relevant:
a.
in relation to the remuneration
    of executive and non-executive directors, the exemption from the rule that share based awards can only vest after a period of
    at least three years as of the grant of the awards (article 7:91, first subsection of the Belgian Companies and Associations Code);
b.
in relation to the remuneration
    of executive directors, the exemption from the rule that (unless the variable remuneration is less than a quarter of the annual remuneration)
    at least one quarter of the variable remuneration must be based on performance criteria that have been determined in advance and
    that can be measured objectively over a period of at least two years and that at least another quarter of the variable remuneration
    must be based on performance criteria that have been determined in advance and that can be measured objectively over a period of
    at least three years (article 7:91, second to fourth subsection of the Belgian Companies and Associations Code);
c.
in relation to the remuneration
    of non-executive directors, any variable part of the remuneration (independent directors can never receive a variable remuneration)
    (Article 7:92, fourth and fifth subsection of the Belgian Companies and Associations Code); and
d.
any provisions of service
    agreements to be entered into with executive directors providing for severance payments exceeding twelve months' remuneration
    and if the severance payments exceed eighteen months' remuneration, only with the prior recommendation of the Nomination and
    Remuneration Committee (article 7:92, first subsection of the Belgian Companies and Associations Code).
Notwithstanding points (a) and (b) above, pursuant
to our Articles of Association, our Board of Directors is explicitly authorized to deviate from the provisions of article 7:91 of the
Belgian Companies and Associations Code.
The level and structure of the remuneration of
the members of the Board of Directors are determined based on their general and specific responsibilities and market practice. Our shareholders
approved the following annual remuneration and compensation of the members of the Board of Directors:
Compensation
(in EUR)
(in USD)
Chairman – Non-Executive Director
59,500
62,700
Non-Executive Director (including Independent Directors)
35,000
36,900
Additional fee for the Chair of the Audit Committee
17,500
18,400
Additional fee for a Member of the Audit Committee (other than
    the Chair of the Audit Committee)
9,000
9,500
Additional fee for the Chair of the Nomination and Remuneration
    Committee
17,500
18,400
Additional fee for a Member Nomination and Remuneration Committee
    Member (other than the Chair of the Nomination and Remuneration Committee)
5,500
5,800
The abovementioned remuneration can be reduced
pro
rata temporis
depending on the duration of the mandate, chairpersonship or membership of a director during a given year. The
abovementioned amounts are exclusive of VAT and similar charges.
Directors are not entitled to any kind of performance
cash bonus or other kind of variable remuneration.
Mr. McGarrity, our Chief Executive Officer,
Executive Director and a member of our Board of Directors, does not receive any
compensation for his service as a director.
Additionally, directors are not entitled to any
kind of compensation when their mandate ends.
69
For 2022, the following remuneration or compensation
was due to the directors (excluding Mr. McGarrity):
Compensation
(in EUR)
(in USD)
Koen Hoffman
(1)
102,000
107,400
Jan Pensaert
(2)
10,000
10,500
Dr. Lieve Verplancke
(3)
52,000
54,800
Hilde Windels
(4)
47,000
49,500
Dr. Regine Slagmulder
(5)
59,000
62,100
Dr. Eric Bednarski
—
—
Donnie (Don) M. Hardison
71,000
74,800
(1)
Acting through Ahok BV.
(2)
Acting through Valiance
    Advisors LLP.
(3)
Acting through Qaly-Co BV.
(4)
Acting through Hilde Windels
    BV.
(5)
Acting through Regine Slagmulder
    BV.
The table below provides an overview as of December
31, 2022, of the subscription rights, or options, held by the non-executive directors.
Options
Name
Number of
Ordinary Shares
Underlying the
Options
Option Exercise
Price per
Ordinary Share
Underlying the
Options
(in EUR)
Option
Expiration
Date
Koen Hoffman
(1)
10,000
20,000
4.97
1.28
June 18, 2027
June 20, 2029
Jan Pensaert
(2)
4,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
4.13
4.91
4.13
4.97
4.97
1.28
1.28
1.375
0.797
June 22, 2024
June 22, 2024
June 22, 2024
June 18, 2027
June 18, 2027
June 20,
    2029
June 20, 2029
May 26, 2031
May 25, 2032
Dr.
    Lieve Verplancke
(3)
10,000
10,000
10,000
4.97
4.97
1.28
June 18, 2027
June 18, 2027
June 20, 2029
Hilde
    Windels
(4)
10,000
10,000
4.97
1.28
June 18, 2027
June 20, 2029
Dr.
    Regine Slagmulder
(5)
None
Dr. Eric Bednarski
None
Donnie (Don) M. Hardison
None
(1)
Acting
                                            through Ahok BV.
70
(2)
Acting
                                            through Valiance Advisors LLP.
(3)
Acting
                                            through Qaly-Co BV.
(4)
Acting
                                            through Hilde Windels BV.
(5)
Acting
                                            through Regine Slagmulder BV.
Compensation of Our Executive Management
The remuneration of the Chief Executive Officer
and the other members of our executive management is based on recommendations made by our Nomination and Remuneration Committee. The
Chief Executive Officer can, and will in principle be invited to, participate in an advisory capacity to the meetings of the committee
when it deals with the remuneration of other executive managers.
The remuneration of our executive management
is determined by our Board of Directors, in accordance with the current remuneration policy pursuant to Article 7:89/1 Belgian Companies
and Associations Code, as approved by the general shareholders' meeting of May 27, 2021.
As an exception to the foregoing rule, Belgian
law provides that the general shareholders' meeting must approve, as relevant:
a.
in relation to the remuneration
    of members of the executive management and other executives, an exemption from the rule that share-based awards can only vest
    after a period of at least three years as of the grant of the awards (article 7:121, last subsection
juncto
article
    7:91, first subsection of the Belgian Companies and Associations Code);
b.
in relation to the remuneration
    of members of the executive management and other executives, an exemption from the rule that (unless the variable remuneration is
    less than a quarter of the annual remuneration) at least one quarter of the variable remuneration must be based on performance criteria
    that have been determined in advance and that can be measured objectively over a period of at least two years and that at least another
    quarter of the variable remuneration must be based on performance criteria that have been determined in advance and that can be measured
    objectively over a period of at least three years (article 7:121, last subsection
juncto
article 7:91, second to
    fourth subsection of the Belgian Companies and Associations Code); and
c.
any service agreements
    to be entered into with members of the executive management and other executives (as the case may be) providing for severance payments
    exceeding twelve months' remuneration (or, subject to a motivated opinion by the remuneration committee, eighteen months'
    remuneration) (article 7:121, last subsection
juncto
article 7:92, first subsection of the Belgian Companies and
    Associations Code).
Notwithstanding points (a) and (b) above, our
Board of Directors has been explicitly authorized in the Articles of Association to deviate from the provisions of Article 7:91 of the
Belgian Companies and Associations.
Each member of the executive management is entitled
to a basic fixed remuneration designed to fit responsibilities, relevant experience and competences, in line with market rates for equivalent
positions. The majority of the annual remuneration is a fixed compensation amount. There is no minimum or maximum variable bonus.
The Chief Executive Officer has a fixed remuneration,
a fixed bonus and variable bonus linked to the performance of the Company and to his capacity to manage remuneration costs.
The other management team members receive a fixed
remuneration plus a variable bonus that is linked to their personal achievements (
i.e.
, experience, know-how, education, skills,
responsibilities, and performance) and the achievements of the Company. The remuneration is closely linked to performance.
Bonuses, if any, are linked to identifiable objectives
and to special projects and are set and measured on a calendar-year basis. Non-performers are not retained in the Company.
The performance objectives of the management team members are primarily evaluated with regard to the following criteria: (i) respect
of the board-approved annual budget, and (ii) meeting measurable operational targets. The various objectives and their weighting
may differ for the individual managers.
71
The Nomination and Remuneration Committee of
the Board of Directors meets annually to review the performance of the executive managers, to compare the actual measurable results to
the objectives that were pre-defined by the committee, and to establish the measurable objectives for the ensuing calendar year.
Each member of the executive management is in
principle entitled to receive share options or subscription rights.
Each member of the executive management who is
a salaried employee may be entitled to a number of fringe benefits, which may include participating in a defined contribution pension
or retirement scheme, disability insurance, a company car, a mobile telephone, internet access and/or a laptop computer according to
general Company policy, and other collective benefits (such as hospitalization insurance and meal vouchers). Executive members who are
engaged on the basis of a services contract do not receive fringe benefits, except that they may be provided with a mobile phone and
laptop computer according to general Company policy, and they qualify for reimbursement of expenses incurred while carrying out their
professional responsibilities.
Executive managers of the Company that are employed
under employee contracts are entitled to enroll in defined-contribution type pension plans (such as 401(k) plans in the United States).
Executive managers of the Company that are engaged on the basis of a service agreement are not entitled to any pension plans or pension
plan contributions from the Company.
Furthermore, the Company has entered into indemnification
arrangements with the members of the executive management and has implemented directors' and officers' insurance coverage
in order to cover liability they may incur in the exercise of their mandates.
Mr. McGarrity is remunerated on the basis
of his executive management position. As CEO, Mr. McGarrity is entitled to a gross annual base salary of $535,000, which will be
reviewed by the Board of Directors (or the Nomination and Remuneration Committee) on an annual basis, and an annual bonus of up to 50%
of the then applicable base salary. In connection with his hiring as CEO in February 2019, Mr. McGarrity also received a one-time grant
of 1,500,000 subscription rights (employee share options) and a one-time signing bonus in the gross amount of $85,000. Furthermore,
Mr. McGarrity is entitled to the reimbursement of expenses, and he and his dependents are eligible to participate in all group health,
medical, dental, disability and insurance plans, incentive, savings and retirement plans, and other employee benefits that are established
by the Company for its executives.
Excluding the value of subscription rights (employee
share options), the remuneration and benefits provided to Mr. McGarrity in 2022 were composed of the following:
Compensation
(in EUR)
(in USD)
Fixed
    gross remuneration
(1)
420,102
442,576
Supplementary
    paid compensation
(2)
(gross)
47,461
50,000
Pension benefits
15,577
16,411
Other
    benefits
(3)
50,256
52,945
Total
533,396
561,932
(1)
Total cost to the Company,
    including employer social security contributions and vacation pay accrual.
(2)
Excludes value of 1,000,000
    subscription rights (employee share options) already created, issued, and accepted in 2022 under the Company's 2022 Share Option
    Plan.
(3)
Includes Company-paid and
    other similar benefits, such as the employer's payroll taxes, meal tickets and health insurances. Excludes reimbursement of
    normal professional expenses such as telephone and Company travel expenses.
72
The 2022 combined remuneration package of the
other executive management team members in office in 2022 (excluding the CEO)—
i
.
e
., John Bellano, Joseph Sollee and
Ron Kalfus—including employer taxes, was €1,190,210 composed of the following:
Compensation
(in EUR)
(in USD)
Fixed
    gross remuneration
(1)
931,897
981,754
Bonuses
    paid and awarded
(2)
(gross)
71,653
75,486
Pension benefits
35,439
37,336
Other
    benefits
(3)
157,456
165,880
Total
1,196,446
1,260,456
(1)
Includes employer taxes
    and vacation pay accrual. Excludes VAT.
(2)
Excludes value of subscription
    rights (employee share options) already created, issued, and accepted in 2022 by certain other executive managers under the Company's
    2022 Share Option Plan.
(3)
Includes for some individuals
    a Company car, meal vouchers, and other similar benefits. Excludes reimbursement of normal professional expenses such as telephone
    and Company travel expenses.
The total remuneration and benefits paid to the
executive management team members (including the Chief Executive Officer) in 2022 and 2021 was €1,729,842 ($1,822,389) and €1,526,037
($1,814,834) (gross amount, excluding VAT and share based compensation), respectively. In the aforementioned figures, the service fees
of the managers hired on the basis of a service agreement are included with the salaries of the other management team members.
The primary performance objectives for the bonuses
of the above management team members in 2022 were the following:
●
respect of the board-approved annual
    budget, with a focus on cash-flow management; and
●
meeting measurable operational
    targets, including total revenues, unit volumes for the Confirm mdx test, revenues
attributable to the Company's UTI testing solution, and achievement of Medicare reimbursement for the Select mdx test.
Each of these foregoing targets was based on minimum percentage attainment
of defined, objective outcomes for the full calendar year, with the revenue, cash flow and unit volume targets tied to items that are
reviewed by the Company's independent auditors in the ordinary course. Additionally, each performance target was assigned a pre-defined
weighting as a percentage of the bonus eligibility applicable to each member of executive management, with the CEO being treated consistently
with other members of the executive management team.
The table below provides an overview as of
December 31, 2022, of the subscription rights (employee share options) held by the members of the executive management team. The
options with an expiration date of May 25, 2032 we granted in 2022.
Options
Name
Number of
Ordinary Shares
Underlying the
Options
Option Exercise
Price per
Ordinary Share
Underlying the
Options
(in EUR)
Option
Expiration
Date
Michael K. McGarrity
1,500,000
450,000
1,000,000
1,000,000
1.49
0.80
1.375
0.684
June 18, 2027
June 20, 2029
May 26, 2031
May 25, 2032
Ron Kalfus
200,000
347,000
400,000
400,000
1.24
0.80
1.375
0.684
June 20, 2029
June 20, 2029
May 26, 2031
May 25, 2032
Joseph Sollee
40,000
40,000
40,000
230,000
98,000
350,000
400,000
4.49
3.78
5.35
1.24
0.80
1.375
0.684
June 22, 2024
June 22, 2024
June 22, 2024
June 20, 2029
June 20, 2029
May 26, 2031
May 25, 2032
John Bellano
400,000
288,000
450,000
400,000
1.24
0.80
1.375
0.684
June 20, 2029
June 20, 2029
May 26, 2031
May 25, 2032
73
C. Board Practices
The following table sets forth certain information
relating to our Board of Directors as of December 31, 2022.
Name
Age
Position(s)
Year
    of Initial
Appointment
Current
    Term
Expiration Year
Koen Hoffman
(1)
54
Independent
    Non-Executive Director (Chairperson of the Board of Directors)
2018
2024
Michael K. McGarrity
60
Executive Director (Chief
    Executive Officer)
2019
2023
(2)
Jan Pensaert
(3)
51
Non-Executive Director
2014
2024
Dr. Lieve Verplancke
(4)
63
Independent Non-Executive
    Director
2017
2024
Hilde Windels
(5)
57
Independent Non-Executive
    Director
2017
2023
(2)
Dr. Regine Slagmulder
(6)
56
Independent Non-Executive
    Director
2020
2023
(2)
Dr. Eric Bednarski
51
Non-Executive Director
2020
2023
(2)
Donnie (Don) M. Hardison
72
Independent Non-Executive
    Director
2021
2023
(2)
(1)
Acting through Ahok BV.
(2)
Director is up for reelection
    to a new mandate in May 2023 at our shareholder meeting.
(3)
Acting through Valiance
    Advisors LLP.
(4)
Acting through Qaly-Co BV.
(5)
Acting through Hilde Windels
    BV.
(6)
Acting through Regine Slagmulder
    BV.
Unless otherwise stated, the address for
our directors is CAP Business Center, Zone Industrielle des Hauts-Sarts, Rue d'Abhooz 31, 4040 Herstal, Belgium.
Committees of our Board of Directors
Our Board of Directors is assisted by a number
of specialized committees in order to advise the board in respect of decisions to be taken, to give comfort to the Board of Directors
that certain issues have been adequately addressed and, if necessary, to bring specific issues to the attention of the Board of Directors.
The decision-making remains the collegial responsibility of the Board of Directors.
Our Board of Directors has established, in its
midst and under its responsibility, two board committees which are responsible for assisting the Board of Directors and making recommendations
in specific fields: an Audit Committee (in accordance with article 7:99 of the Belgian Companies and Associations Code and provision 4.10
and following of the Belgian Corporate Governance Code) and a Remuneration and Nomination Committee (in accordance with article 7:100
of the Belgian Companies and Associations Code and provision 4.17 and following of the Belgian Corporate Governance Code). The terms
of reference of these board committees are primarily set out in the Corporate Governance Charter of the Company.
74
Audit Committee
As of the date of this annual report, our Audit
Committee consists of three directors: Regine Slagmulder, Lieve Verplancke, and Hilde Windels.
According to the Belgian Companies and Associations
Code, all members of the Audit Committee must be non-executive directors, and at least one member must be independent within the
meaning of article 7:87 of the Belgian Companies and Associations Code and provision 3.5 of the Belgian Corporate Governance Code. Our
Board of Directors has determined that all members of our Audit Committee are independent under Rule 10A-3 of the Exchange Act,
the applicable listing standards of Nasdaq, and the Belgian Companies and Associations Code and the Belgian Corporate Governance Code.
The members of the Audit Committee must have
a collective expertise relating to the activities of the Company, and at least one member of the Audit Committee must have the necessary
competence in accounting and auditing, including qualifying as an "audit committee financial expert" as defined under the
Exchange Act. Our Board of Directors has determined that the members of the Audit Committee satisfy the competency requirement, and our
Board of Directors has further determined that Regine Slagmulder and Hilde Windels each qualifies as an "audit committee financial
expert" as defined under the Exchange Act.
The Audit Committee will be governed by a charter
that complies with Nasdaq listing rules and the Belgian Corporate Governance Code.
Without prejudice to the legal responsibilities
of the Board of Directors, the Audit Committee has the following roles:
●
to inform our Board of
    Directors of the result of the audit of the financial statements and the manner in which the audit has contributed to the integrity
    of the financial reporting and the role that the Audit Committee has played in that process;
●
to monitor the financial
    reporting process, and to make recommendations or proposals to ensure the integrity of the process;
●
to monitor the effectiveness
    of our Company's internal control and risk management systems, and our Company's internal audit process and its effectiveness;
●
to monitor the audit of
    the annual statutory and consolidated financial statements, including the follow-up questions and recommendations by the statutory
    auditor and, as the case may be, the auditor responsible for the audit of the consolidated financial statements;
●
to assess and monitor the
    independence of the statutory auditor, in particular with respect to the appropriateness of the provision of additional services
    to the Company. More specifically, the Audit Committee analyzes, together with the statutory auditor, the threats for the statutory
    auditor's independence and the security measures taken to limit these threats, when the total amount of fees exceeds the criteria
    specified in article 4 § 3 of Regulation (EU) No 537/2014; and
●
to make recommendations
    to our Board of Directors on the selection, appointment and remuneration of our Company's statutory auditor in accordance with
    article 16 § 2 of Regulation (EU) No 537/2014.
The Audit Committee shall meet whenever it deems
it necessary for the proper performance of its duties and at least four regularly scheduled meetings each year. The Audit Committee regularly
reports to our Board of Directors on the exercise of its missions, and at least once a year prior to the approval of the annual financial
statements and annual report by the Board of Directors on the operations, findings and recommendations of the Audit Committee. The members
of the Audit Committee shall have unrestricted access to the offices and all information and papers kept by the company and its subsidiaries.
Each member of the Audit Committee may ask the executive management or any other staff member of the Company or its subsidiaries to submit
the information that he or she deems useful, appropriate or necessary to perform his or her tasks within the framework of the Audit Committee.
75
Without prejudice to the statutory provisions
which determine that the statutory auditor must address reports or warnings to our corporate bodies, the statutory auditor must discuss,
at the request of the statutory auditor, or at the request of the Audit Committee or of our Board of Directors, with the Audit Committee
or with the Board of Directors, essential issues which are brought to light in the exercise of the statutory audit of the financial statements,
which are included in the additional statement to the Audit Committee, as well as any meaningful shortcomings discovered in our internal
financial control system.
Nomination and Remuneration Committee
According to article 7:100 § 4 of the Belgian
Companies and Associations Code, our Company would meet the size criteria in order to operate without a separate remuneration committee,
but we have chosen to continue operating with a separate Nomination and Remuneration Committee.
As of the date of this annual report, our Nomination
and Remuneration Committee consists of five directors: Eric Bednarski, Don Hardison, Koen Hoffman, Jan Pensaert, and Lieve Verplancke.
In line with the Belgian Companies and Associations
Code and the Belgian Corporate Governance Code (i) all members of the Nomination and Remuneration Committee are non-executive directors,
(ii) the Nomination and Remuneration Committee consists of a majority of independent directors, and (iii) the Nomination and Remuneration
Committee is chaired by the Chairperson of our Board of Directors or another non-executive director appointed by the committee,
it being understood that the Chair of the Board of Directors should not chair the committee when dealing with the designation of his
successor. Our Board of Directors has determined that three members of our Nomination and Remuneration Committee are independent under
the applicable listing standards of Nasdaq, the applicable rules of the Belgian Companies and Association Code and the Belgian Corporate
Governance Code.
Pursuant to the Belgian Companies and Associations
Code, a remuneration committee must have the necessary expertise in terms of remuneration policy. Our Board of Directors has determined
that the members of the Nomination and Remuneration Committee satisfy this requirement.
The role of the Nomination and Remuneration Committee
is to make recommendations to the Board of Directors with regard to the appointment and remuneration of directors and members of the
executive management and, in particular, to:
●
identify, recommend and
    nominate, for the approval of the Board of Directors, candidates to fill vacancies in the Board of Directors and executive management
    positions as they arise. In this respect, the Nomination and Remuneration Committee  must consider and advise on proposals
    made by relevant parties, including management and shareholders;
●
advise the Board of Directors
    on any proposal for the appointment of the Chief Executive Officer and on the Chief Executive Officer's proposals for the appointment
    of other members of the executive management;
●
draft appointment procedures
    for members of the Board of Directors and the Chief Executive Officer;
●
ensure that the appointment
    and re-election process is organized objectively and professionally;
●
periodically assess the
    size and composition of the Board of Directors and make recommendations to the Board of Directors with regard to any changes;
●
consider issues related
    to succession planning;
●
make proposals to the Board
    of Directors on the remuneration policy for directors and members of the executive management and the persons responsible for the
    day-to-day management of the Company, as well as, where appropriate, on the resulting proposals to be submitted by the Board
    of Directors to the shareholders' meeting;
●
make proposals to the Board
    of Directors on the individual remuneration of directors and members of the executive management, and the persons responsible for
    the day-to-day management of the company, including variable remuneration and long-term incentives, whether or not share-related,
    in the form of share options or other financial instruments, and arrangements on early termination, and where applicable, on the
    resulting proposals to be submitted by the Board of Directors to the shareholders' meeting;
●
prepare a remuneration
    report to be included by the Board of Directors in the annual Corporate Governance Statement;
●
present and provide explanations
    in relation to the remuneration report at the annual shareholders' meeting; and
●
report regularly to the
    Board of Directors on the exercise of its duties.
Pursuant to the Belgian Companies and Associations
Code, the Chief Executive Officer participates in the meetings of the Nomination and Remuneration Committee in an advisory capacity each
time the remuneration of another member of the executive management is being discussed.
76
D. Employees
As of December 31, 2022, we had 258 employees,
252 of whom are employed on a full-time basis. Of these employees, 244 are located in the United States and 14 in Europe. None of our
employees is covered by a collective bargaining agreement, and we believe our relationship with our employees is good.
Our human capital resources objectives include,
as applicable, identifying, recruiting, retaining, incentivizing and integrating our existing and new employees, advisors and consultants.
The principal purposes of our equity incentive plans are to attract, retain and reward personnel through the granting of stock-based
compensation awards, in order to increase stockholder value and the success of our company by motivating such individuals to perform
to the best of their abilities and achieve our objectives.
E. Share Ownership
For information regarding the share ownership
of our supervisory and executive board members, see Item 6B. "
Compensation
" and Item 7A. "
Major Shareholders
."
F. Disclosure of a registrant's action
to recover erroneously awarded compensation
Not applicable.
ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY
TRANSACTIONS
A. Major Shareholders
Except as specifically noted, the following table
sets forth information with respect to the beneficial ownership of our ordinary shares as of March 31, 2023:
●
each of our directors and
    executive officers;
●
each person known to us
    to beneficially own more than 3% of our ordinary shares; and
●
all of our supervisory
    board members and executive board members as a group.
As of March 31, 2023, there were four record
holders of our ordinary shares, none of who were residents of the United States.
All of the ordinary shares have the same voting
rights and no major shareholders of the Company have different voting rights.
Beneficial ownership is determined according
to the rules of the SEC and generally means that a person has beneficial ownership of a security if he, she or it possesses sole or shared
voting or investment power of that security, including ordinary shares that can be acquired within 60 days of March 31, 2023. Ordinary
shares subject to derivative securities currently exercisable or exercisable within 60 days of March 31, 2023 are deemed to be outstanding
for computing the percentage ownership of the person holding these securities and the percentage ownership of any group of which the
holder is a member, but are not deemed outstanding for computing the percentage of any other person.
The percentage ownership
information shown in the table is based upon 270,380,936 ordinary shares outstanding as of March 31, 2023.
Except as indicated by the footnotes below, we
believe, based on the information furnished to us, that the persons named in the table below have sole voting and investment power with
respect to all ordinary shares shown that they beneficially own, subject to community property laws where applicable. The information
does not necessarily indicate beneficial ownership for any other purpose, including for purposes of Sections 13(d) and 13(g) of the Exchange
Act.
Except as otherwise indicated in the table below,
addresses of the directors, members of the executive management team and named beneficial owners are in care of MDxHealth SA, CAP Business
Center, Zone Industrielle des Hauts-Sarts, Rue d'Abhooz 31, 4040 Herstal, Belgium.
77
Name of beneficial owner
Number of
Ordinary Shares Beneficially
Owned
Percentage of
Ordinary Shares
Beneficially
Owned
3% or Greater Shareholders:
MVM Partners LLP
(1)
45,504,584
16.8
%
Bleichroeder LP
(2)
38,783,330
14.3
%
Valiance Asset Management Limited
(3)
20,931,094
7.7
%
Biovest NV
(4)
11,923,587
4.4
%
Executive Officers and Directors:
Michael K. McGarrity
(5)
2,402,082
*
Ron Kalfus
(5)
666,623
*
Joseph Sollee
(5)
635,999
*
John Bellano
(5)
833,166
*
Koen Hoffman (acting through Ahok BV)
(5)
30,000
*
Jan Pensaert (acting through Valiance Advisors LLP)
(5)
84,000
*
Dr. Lieve Verplancke (acting through Qaly-Co BV)
(5)
30,000
Hilde Windels (acting through Hilde Windels BV)
(5)
20,000
*
Dr. Regine Slagmulder (acting through Regine Slagmulder BV)
590,204
*
Dr. Eric Bednarski
—
*
Donnie (Don) M. Hardison
—
*
All current directors and executive management as a group (11 persons)
5,292,074
1.9
%
*
Less than one percent.
(1)
Includes 44,585,295 shares
    held by MVM V LP and 919,289 shares held by MVM GP (No. 5) (collectively, the "MVM Entities"). The Company has been informed
    that voting and investment power over the shares held by the MVM Entities is exercised jointly by three or more natural persons and
    voting and disposition decisions require the approval of a majority of such persons. Accordingly, no single natural person has voting
    or dispositive power over such shares. The MVM Entities are party to the MVM Subscription Agreement, providing for certain rights
    to appoint a member of our Board of Directors. See Item 7B. "
Related party transactions — MVM Subscription Agreement.
"
    This information has been obtained from Schedule 13D/A filed by the MVM Entities with the SEC on February 28, 2023.
(2)
Includes 20,342,162 shares
    held by 21 April Fund Ltd., a Cayman Islands company for which Bleichroeder LP acts as investment adviser. This information has been
    obtained from Schedule 13G/A filed by Bleichroeder Entities with the SEC on February 14, 2023.
(3)
Includes 12,339,297 shares
    held by TopMDx Ltd. and 8,591,797 shares held by Valiance Life Sciences Growth Investments SICAV-SIF (collectively, the "Valiance Entities").
    The Company has been informed that voting and investment power over the shares held by the Valiance Entities is exercised jointly
    by three or more natural persons and voting and disposition decisions require the approval of a majority of such persons. Accordingly,
    no single natural person has voting or dispositive power over such shares. This information has been obtained from Schedule 13D/A
    filed by the Valiance Entities with the SEC on April 14, 2023.
(4)
Consists of shares held
    by Biovest NV ("Biovest"). RMM, S.A. ("RMM" and together with Biovest, the "Biovest Entities")
    is the sole owner of Biovest and pursuant to an understanding with Biovest, decisions relating to the voting and dispositive power
    of the shares are shared between Biovest and the RMM's Board of Directors (the "RMM Board"). Voting and investment
    power over the shares managed by the RMM Board is exercised jointly by more than three natural persons and voting and disposition
    decisions require the approval of a majority of such persons. Accordingly, no single natural person has a controlling decision and
    no individual director of the RMM should be deemed to be a beneficial owner of the shares. This information has been obtained from
    Schedule 13G/A filed by the Biovest Entities with the SEC on March 17, 2023.
(5)
Reflects shares acquirable
    upon the exercise of warrants, which are described above in Item 6.B. "
Compensation
."
78
From December 31, 2019 to December 31, 2022,
the only significant changes related to the beneficial owners listed in the above table of which we have been notified of through
Shareholder Transparency Declarations in accordance with Article 14 of the Belgian Act of May 2, 2007 on the disclosure of important
participations in issuers of which shares are admitted to trading on a regulated market and regarding miscellaneous provisions (the
"Declarations" and each a "Declaration") are listed below:
●
November 22, 2021 Declaration: MDxHealth
                                            was notified that the number of shares with respect to which Bleichroeder LP can exercise
                                            voting rights actively crossed above the threshold of 15% of the outstanding shares and voting
                                            rights of MDxHealth on November 19, 2021.
●
November 15, 2021 Declaration: MDxHealth
                                            was notified that the number of shares with respect to which Bleichroeder LP can exercise
                                            voting rights actively crossed above the threshold of 10% of the outstanding shares and voting
                                            rights of MDxHealth on November 4, 2021.
●
February 3, 2021 Declaration: Biovest
                                            NV notified MDxHealth that the number of shares with respect to which Biovest NV can exercise
                                            voting rights passively crossed below the threshold of 10% of the outstanding shares and
                                            voting rights of MDxHealth on January 26, 2021.
●
May 25, 2020 Declaration: Valiance
                                            Asset Management Limited notified MDxHealth that the aggregate number of shares with respect
                                            to which Valiance Asset Management Limited can exercise voting rights passively crossed below
                                            the threshold of 15% of the outstanding shares and voting rights of MDxHealth. MVM Partners
                                            LLP notified MDxHealth that the aggregate number of shares with respect to which MVM Partners
                                            LLP can exercise voting rights actively crossed above the threshold of 20% of the outstanding
                                            shares and voting rights of MDxHealth.
B. Related Party Transactions
Agreements with the Members of the Board of
Directors and the Executive Management
Each non-executive director exercises his/her
mandate as a self-employed worker. According to our Articles of Association, the term of a directors' mandate cannot exceed four
years, but may be renewed. The directors' mandates may be terminated ad nutum (at any time) without any form of compensation. There
is no specific agreement between us and non-executive directors which waives or restrains this right of the Company to terminate ad nutum
(at any time) the mandates of the directors.
Currently, all the members of the executive management
are engaged on the basis of an employment agreement. The employment agreements are for an indefinite term. The employment agreements
include, where appropriate, non-competition undertakings, as well as confidentiality and intellectual property transfer undertakings
(which are intended to obtain maximum protection of our interests, under applicable laws and subject to the employee's agreement).
●
We hired Mr. Michael K.
    McGarrity, acting in the role of Chief Executive Officer, effective as of February 18, 2019. The executive employment agreement with
    Mr. McGarrity provides that if we terminate the employment agreement without cause or if Mr. McGarrity resigns for good reason, Mr.
    McGarrity shall be eligible to receive as severance an amount equal to twelve months of base salary in effect at the time of the
    separation. In addition, we have the right, exercisable at any time, to terminate the executive employment agreement with immediate
    effect for cause (as defined in the employment agreement) by providing written notice.
●
Acting under the direction
    of the Board of Directors, we hired Mr. Ron Kalfus, acting in the role of Chief Financial Officer, effective as of July 22,
    2019. The executive employment agreement with Mr. Kalfus provides that if we terminate the employment agreement without cause
    or if Mr. Kalfus resigns for good reason, Mr. Kalfus shall be eligible to receive as severance an amount equal to six months
    of base salary in effect at the time of the separation, which amount will increase to twelve months of base salary for a termination
    that occurs after July 22, 2020. In addition, we have has the right, exercisable at any time, to terminate the executive employment
    agreement with immediate effect for cause (as defined in the employment agreement) by providing written notice.
●
Acting under the direction
    of the Board of Directors, we hired Mr. John Bellano, acting in the role of Chief Commercial Officer, effective as of June 19,
    2019. The executive employment agreement with Mr. Bellano provides that if we terminate the employment agreement without cause
    or if Mr. Bellano resigns for good reason, Mr. Bellano shall be eligible to receive as severance an amount equal to six
    months of base salary in effect at the time of the separation, which amount will increase to twelve months of base salary for a termination
    that occurs after June 19, 2020. In addition, we have the right, exercisable at any time, to terminate the executive employment
    agreement with immediate effect for cause (as defined in the employment agreement) by providing written notice.
●
The executive employment
    contract with Mr. Joe Sollee dates from before the entry into force of the Belgian Act of April 6, 2010 on corporate governance
    in public and listed companies and is in conformity with common employment law. The contract with Mr. Sollee provides that if
    his employment is terminated for a reason other than serious misconduct or if Mr. Sollee resigns for good reason, he will be
    entitled to severance pay of nine months gross remuneration and benefits. In addition, we have the right, exercisable at any time,
    to terminate the executive employment agreement with immediate effect for cause (as defined in the employment agreement) by providing
    written notice.
79
Options Granted to Our Board Directors and
Executive Management
We have granted subscription rights, or options,
to certain members of our Board of Directors and executive management. For more information regarding the options granted to our Board
of Directors and executive management. See Item 6B. "
Compensation
."
MVM Subscription Agreement
As part of an investment by MVM V LP and MVM GP
(No. 5) LP, or collectively MVM, into our share capital, our company entered in April 2020 into a subscription agreement with MVM, or
the Subscription Agreement. Pursuant to the Subscription Agreement, MVM is entitled to have one observer at the Board of Directors of
our Company for as long as MVM holds in aggregate 5% of our company's outstanding shares. At the date of this annual report, the
observer of MVM at our Board of Directors is Dr. Kyle Dempsey. In addition, we agreed that MVM could propose to our 2020 general shareholders'
meeting to appoint Dr. Eric Bednarski as director of the Company. Our general shareholders' meeting held on July 30, 2020 approved
the appointment of Dr. Eric Bednarski as a director for a term of three years, up to and including the closing of our annual general
shareholders' meeting to be held on May 25, 2023.
Offering Purchases
Pursuant to our February 2023 follow-on public
offering of ADSs in the United States, (1) the Bleichroeder Entities (as defined above under "A.
Major Shareholders
")
purchased 1,500,000 ADSs representing 15,000,000 ordinary shares for an aggregate purchase price of $6,000,000, (2) the MVM Entities
(as defined above under "A.
Major Shareholders
") purchased 1,000,000 ADSs representing 10,000,000 ordinary shares
for an aggregate purchase price of $4,000,000, and (3) the Valiance Entities (as defined above under "A.
Major Shareholders
")
acquired and 190,408 ADSs representing 1,904,080 ordinary shares for an aggregate purchase price of $761,632.
C. Interests of Experts and Counsel
Not applicable.
ITEM 8. FINANCIAL INFORMATION
A. Consolidated Statements and Other Financial
Information
Consolidated Financial Statements
Our audited consolidated financial statements
are appended at the end of this annual report starting at page F-1, and form a part hereof.
Legal Proceedings
We are not a party to any pending material legal
proceedings.
We signed a sale and purchase agreement on September
18, 2015 (the "Purchase Agreement") pursuant to which we acquired all shares and voting interests of NovioGendix, an entity
incorporated in The Netherlands. Under the terms of the Purchase Agreement, in addition to the consideration paid at closing, we committed
to pay up to $3.3 million to the prior owners of NovioGendix (the "Sellers") subject to meeting certain milestones, payable
in six milestone payments. As of December 31, 2021, we had made $1.1 million of these milestone payments. As of December 31, 2021, we
recorded $1.6 million of contingent liabilities related to this contingent consideration. In June 2021, we received a notice of dispute
from the Sellers claiming that approximately $880,000 of the remaining $2.2 million of milestone payments had been earned and we were
in breach of the Purchase Agreement for not having timely paid such milestone payments to the Sellers. In September 2021, pursuant to
the Purchase Agreement, representatives of the Company met with representatives of the Sellers to discuss these matters. During this
meeting the Company's representatives informed the representatives of the Seller that the Company disagrees with the Sellers that
any such payments have been earned and are payable by the Company. Following this meeting, the Sellers requested further information
from the Company and indicated if these matters are not resolved to Sellers' satisfaction, they may take further action to enforce
their rights by instituting arbitration proceedings, in accordance with the terms of the Purchase Agreement, before the Netherlands Arbitration
Institute.
80
Dividend Policy
We have never declared or paid any cash dividends
on our ordinary shares. We do not anticipate paying cash dividends on our equity securities in the foreseeable future and intend to retain
all available funds and any future earnings for use in the operation and expansion of our business. All of the ordinary shares offered
by this annual report will have the same dividend rights as all of our other outstanding ordinary shares. In general, distributions of
dividends proposed by our Board of Directors require the approval of our shareholders at a meeting of shareholders with a simple majority
vote, although our Board of Directors may declare interim dividends without shareholder approval, subject to the terms and conditions
of the Belgian Code of Companies and Associations, or CCA. See Item 10B. "
Memorandum and Articles of Association
."
Our ability to distribute dividends is subject
to availability of sufficient distributable profits as defined under Belgian law on the basis of our stand-alone statutory accounts prepared
in accordance with Belgian GAAP. In particular, dividends can only be distributed if following the declaration and issuance of the dividends
the amount of our net assets on the date of the closing of the last financial year as follows from the statutory non-consolidated financial
statements (
i.e.
, summarized, the amount of the assets as shown in the balance sheet, decreased with provisions and liabilities,
all in accordance with Belgian accounting rules), and, save in exceptional cases, to be mentioned and justified in the notes to the annual
accounts, decreased with the non-amortized costs of incorporation and extension and the non-amortized costs for research and development,
does not fall below the amount of the paid-up capital (or, if higher, the issued capital), increased with the amount of non-distributable
reserves (which include, as the case may be, the unamortized part of any revaluation surpluses).
In addition, pursuant to Belgian law and our
Articles of Association, we must allocate an amount of 5% of our Belgian GAAP annual net profit to a legal reserve in its stand-alone
statutory accounts, until the legal reserve amounts to 10% of our share capital. Our legal reserve currently does not meet this requirement
nor will it meet the requirement at the time of the closing. Accordingly, 5% of our Belgian GAAP annual net profit during future years
will need to be allocated to the legal reserve, further limiting our ability to pay out dividends to its shareholders.
For information regarding the Belgian withholding
tax applicable to dividends and related U.S. reimbursement procedures, see Item 9E. "
Taxation — Material Belgian Tax Consequences.
"
B. Significant Changes
None.
ITEM 9. THE OFFER AND LISTING
A. Offer and Listing Details
Our ADSs have been listed on Nasdaq Capital Market
under the symbol "MDXH" since November 4, 2021. Prior to that date, there was no public trading market for out ADSs. Our
ordinary shares have been trading on the regulated market of Euronext in Brussels under the symbol "MDXH" since June 2006.
Prior to that date, there was no public trading market for our ADSs or our ordinary shares. No significant trading suspensions have occurred
in the prior three years.
B. Plan of Distribution
Not applicable.
C. Markets
For information regarding the stock exchanges
and regulated markets on which our ADSs and ordinary share are listed, see Item 9A. "
Offer and Listing Details.
"
D. Selling Shareholders
Not applicable.
E. Dilution
Not applicable.
F. Expenses of the Issuer
Not applicable.
81
ITEM 10. ADDITIONAL INFORMATION
A. Share Capital
Not applicable.
B. Memorandum and Articles of Association
The information set forth in the final
prospectus dated November 3, 2021 as part of our Registration Statement on Form F-1 (File No. 333-260213), declared effective by the
SEC on November 3, 2021, under the headings "
Description of Share Capital and Articles of Association — Articles of
Association and Other Share Information
" is incorporated herein by reference.
C. Material Contracts
For information on our material contracts entered
into during the two years immediately preceding the date of the filing of this annual report, please refer to Item 4B.
Business Overview
"
and Item 7B. "
Related Party Transactions
" of this annual report.
D. Exchange Controls
There are no Belgian exchange control regulations
that impose limitations on our ability to make, or the amount of, cash payments to residents of the United States.
We are in principle under an obligation to report
to the National Bank of Belgium certain cross-border payments, transfers of funds, investments and other transactions in accordance with
applicable balance-of-payments statistical reporting obligations. Where a cross-border transaction is carried out by a Belgian credit
institution on our behalf, the credit institution will in certain circumstances be responsible for the reporting obligations.
E. Taxation
The discussion below is for general information
only and is not, and should not be interpreted to be, tax advice to any holder of the ADSs. Each holder or prospective holder of the
ADSs is urged to consult his, her or its own tax advisor.
Material U.S. Federal Income Tax Consequences
General
The following is a discussion of the material
U.S. federal income tax consequences to U.S. Holders and Non-U.S. Holders, both as defined below, of the ownership and disposition
of the ADSs as of the date of this report. This discussion is based on the provisions of the Internal Revenue Code of 1986, as amended,
or the "Code," the applicable U.S. Treasury regulations promulgated and proposed thereunder, judicial decisions and current
administrative rulings and guidance, all of which are subject to change, possibly on a retroactive basis. This discussion applies to
you only if you acquire the ADSs and hold such ADSs as a capital asset within the meaning of Section 1221 of the Code (generally,
held for investment). The U.S. Internal Revenue Service, or the "IRS," may challenge the tax consequences described below,
and we have not requested, nor will we request, a ruling from the IRS or an opinion of counsel with respect to the U.S. federal income
tax consequences of acquiring, holding or disposing of the ADSs. This discussion does not purport to deal with all aspects of U.S. federal
income taxation that may be relevant to the ownership of the ADSs. In particular, the discussion does not address tax consequences that
depend upon an investor's particular tax circumstances nor does it cover any state, local or foreign law, the possible application
of the U.S. federal estate or gift tax laws. You are urged to consult your own tax advisor regarding the application of the U.S. federal
income tax laws to your particular situation as well as any state, local, foreign and U.S. federal estate and gift tax consequences resulting
from the ownership and disposition of the ADSs. In addition, this discussion does not take into account special U.S. federal income tax
rules that apply to particular categories of holders of the ADSs, including, without limitation, the following:
●
dealers, brokers or traders
    in securities electing to use a mark-to-market method of accounting;
●
banks, thrifts or other
    financial institutions;
82
●
individual retirement or
    tax-deferred accounts;
●
insurance companies;
●
tax-exempt organizations;
●
regulated investment companies
    or real estate investment trusts;
●
persons holding the ADSs
    as part of a hedging, straddle or conversion transaction for U.S. federal income tax purposes;
●
persons required for U.S.
    federal income tax purposes to conform the timing of income accruals to their financial statements under Section 451 of the
    Code;
●
persons whose functional
    currency for U. S. federal income tax purposes is not the U.S. dollar;
●
persons subject to the
    alternative minimum tax;
●
persons that own, or are
    treated as owning, 10% or more, by voting power or value, of our outstanding common stock (including common stock represented by
    ADSs);
●
certain former U.S. citizens
    and residents who have expatriated; or
●
persons receiving the ADSs
    pursuant to the exercise of employee stock options or otherwise as compensation.
U.S. Holders
For purposes of the discussion below, you are
a "U.S. Holder" if you are a beneficial owner of the ADSs that is:
●
an individual United States
    citizen or resident alien of the United States (as specifically defined for United States federal income tax purposes);
●
a corporation, or other
    entity treated as a corporation for U.S. federal income tax purposes, created or organized in or under the laws of the United States,
    any state thereof or the District of Columbia;
●
an estate whose income
    is subject to United States federal income tax regardless of its source; or
●
a trust (x) if a U.S. court
    can exercise primary supervision over the trust's administration and one or more U.S. persons are authorized to control all
    substantial decisions of the trust or (y) that, if it was in existence on August 20, 1996, was treated as a U.S. person
    prior to that date and has a valid election in effect under applicable United States Treasury regulations to be treated as a U.S. person.
If a partnership (including any entity or arrangement
treated as a partnership for U.S. federal income tax purposes) holds the ADSs, the tax treatment of a partner in such partnership will
generally depend upon the status of the partner and upon the activities of the partnership. If you are a partnership holding the ADSs
or a partner in such partnership, you should consult your tax advisor with respect to the U.S. federal income tax consequences of the
ownership and disposition of the ADSs by the partnership.
General
In general, a U.S. Holder of the ADSs will be
treated as owning the underlying shares represented by those ADSs for U.S. federal income tax purposes. Accordingly, no gain or loss
will be recognized if a U.S. Holder exchanges ADSs for the underlying shares represented by those ADSs. The U.S. Department of the
Treasury has expressed concern that parties to whom ADSs are released before shares are delivered to the Depositary ("pre-release"),
or intermediaries in the chain of ownership between holders and the issuer of the security underlying the ADSs, may be taking actions
that are inconsistent with the claiming of foreign tax credits by holders of ADSs. These actions would also be inconsistent with the
claiming of the preferential rate of tax, described below, applicable to dividends received by certain non-corporate U.S. Holders.
Accordingly, the creditability of Belgian taxes, and the availability of the preferential tax rate for dividends received by certain
non-corporate U.S. Holders, each as described below, could be affected by actions taken by such parties or intermediaries.
83
Distributions
Subject to the "passive foreign investment
company", or PFIC, rules discussed below, the amount of any cash distribution (other than in liquidation) that you receive with
respect to the ADSs including the amount of any Belgian taxes actually withheld therefrom (described below in "—
Material
Belgian Tax Consequences
") generally will be taxed to a U.S. Holder as dividend income to the extent such distribution does
not exceed our current or accumulated earnings and profits, or E&P, as calculated for U.S. federal income tax purposes. Such income
will be includable in your gross income as ordinary income on the date of receipt by the Depositary. Dividends received by individuals
and certain other non-corporate U.S. Holders from "qualified foreign corporations" are taxed at the rate of either 0
percent, 15 percent or 20 percent, depending upon the particular taxpayer's U.S. federal income tax bracket; provided that the
recipient-shareholder has held his or her shares as a beneficial owner for more than 60 days during the 121-day period beginning
on the date which is 60 days before the shares' ex-dividend date. A foreign corporation is a "qualified foreign corporation"
if the stock with respect to which it pays dividends is traded on an established securities market in the United States, provided that
the foreign corporation is not a PFIC.
The ADSs are traded on an established securities
market in the United States, although we cannot guarantee that the ADSs will be so traded in the future. If we are not a PFIC and we
are treated as a qualified foreign corporation, dividends we pay with respect to the ADSs would be eligible for the reduced rates of
taxation described in this paragraph. We do not expect to be treated as a PFIC for our current taxable year. However, our PFIC status
for any taxable year is an annual determination that can be made only after the end of that year and will depend on the composition of
our income and assets and the value of our assets from time to time. No assurance can be given that the IRS will not disagree and seek
to treat us as a PFIC. If we are a PFIC with respect to a particular U.S. Holder, dividends received from us would be taxed at regular
ordinary income tax rates and certain other rules will apply. See "
Passive Foreign Investment Company (PFIC)
," below.
Holders of Company ADSs should consult their own tax advisors regarding the availability of a reduced dividend tax rate in light of their
own particular circumstances.
To the extent any distribution exceeds our E&P,
the distribution will first be treated as a tax-free return of capital to the extent of your adjusted tax basis in the ADSs and
will be applied against and reduce such basis on a dollar-for-dollar basis (thereby increasing the amount of gain and decreasing
the amount of loss recognized on a subsequent disposition of such ADSs). To the extent that such distribution exceeds your adjusted tax
basis, the distribution will be taxed as gain recognized on a sale or exchange of ADSs. However, because we do not maintain calculations
of our E&P under U.S. federal income tax principles, it is expected that distributions will generally be reported to U.S. Holders
as dividends. Because we are not a U.S. corporation, no dividends-received deduction will be allowed to corporations with respect
to dividends paid by us.
For U.S. foreign tax credit limitation purposes,
dividends received on ADSs will be treated as foreign source income and will generally constitute "passive category income,"
or in the case of certain holders, "general category income." You may be eligible, subject to a number of complex limitations,
to claim a foreign tax credit in respect of Belgian taxes actually withheld on dividends paid on ADSs. A U.S. Holder who does not elect
to claim a foreign tax credit for foreign tax withheld may instead claim a deduction, for U.S. federal income tax purposes, in respect
of such withholding, but only for a year in which such U.S. Holder elects to do so for all creditable foreign income taxes. However,
if we are a "U.S.-owned foreign corporation," solely for foreign tax credit purposes, a portion of the dividends allocable
to our U.S. source earnings and profits may be re-characterized as U.S. source. A "U.S.-owned foreign corporation"
is any foreign corporation in which U.S. persons own, directly or indirectly, 50% or more (by vote or by value) of the stock. In general,
U.S.-owned foreign corporations with less than 10% of earnings and profits attributable to sources within the United States are
excepted from these rules. Although we don't believe we are currently a "U.S.-owned foreign corporation," we may
become one in the future. In such case, if 10% or more of our earnings and profits are attributable to sources within the United States,
a portion of the dividends paid on the ADSs allocable to our U.S. source earnings and profits will be treated as U.S. source, and, as
such, a U.S. Holder may not offset any foreign tax withheld as a credit against U.S. federal income tax imposed on that portion of dividends.
The rules governing U.S. foreign tax credits are complex, and we recommend that you consult your tax advisor regarding the applicability
of such rules to you.
Sale, Exchange or Other
Disposition of ADSs
Subject to the PFIC rules discussed below, generally,
in connection with the sale, exchange or other disposition of ADSs:
●
you will recognize capital
    gain or loss equal to the difference (if any) between the amount realized on such sale, exchange or other disposition and your adjusted
    tax basis in such ADSs;
●
such gain or loss will
    be long-term capital gain or loss if your holding period for such ADSs is more than one year at the time of the sale or other
    disposition;
84
●
such gain or loss will
    generally be treated as U.S. source for U.S. foreign tax credit purposes; and
●
your ability to deduct
    capital losses is subject to limitations.
Long-term capital gains recognized by individuals
and certain other non-corporate taxpayers are taxed at preferential rates. If the consideration received upon the sale or other
taxable disposition of ADSs is paid in foreign currency, the amount realized will be the U.S. dollar value of the payment received, translated
at the spot rate of exchange on the date of taxable disposition. If ADSs are treated as traded on an established securities market, a
cash basis U.S. Holder and an accrual basis U.S. Holder who has made a special election (which must be applied consistently from year
to year and cannot be changed without the consent of the IRS) will determine U.S. dollar value of the amount realized in foreign currency
by translating the amount received at the spot rate of exchange on the settlement date of the sale. An accrual basis United States Holder
that does not make the special election will recognize exchange gain or loss to the extent attributable to the difference between the
exchange rates on the sale date and the settlement date, and such exchange gain or loss generally will constitute ordinary income or
loss.
Passive Foreign Investment
Company (PFIC)
In general, a non-U.S. corporation is a PFIC
for U.S. federal income tax purposes for any taxable year in which (i) 50% or more of value of its assets (based on an average of the
quarterly values of the assets during such taxable year) consists of assets that produce, or are held for the production of, passive
income, or (ii) 75% or more of its gross income consists of passive income. A separate determination must be made after the close
of each fiscal year as to whether a non-U.S. corporation is a PFIC for that year. For purposes of the above calculations, a non-U.S.
corporation that owns, directly or indirectly, at least 25% by value of the shares of another corporation is treated as if it held its
proportionate share of the assets of the other corporation and received directly its proportionate share of the income of the other corporation.
Passive income generally includes dividends, interest, investment gains and certain rents and royalties. Cash is generally a passive
asset for these purposes. The value goodwill is generally treated as an active asset if it is associated with business activities that
produce active income.
Based on the current estimates, and expected
future composition, of our income and the value of our assets, including goodwill, we do not expect to be a PFIC for our current taxable
year. However, our PFIC status for any taxable year is an annual determination that can be made only after the end of that year and will
depend on the composition of our income and assets and the value of our assets from time to time. The determination of whether we are
a PFIC is fact-intensive and the applicable law is subject to varying interpretation. There can be no assurance that the IRS will
agree with our position or that the IRS will not successfully challenge our position including our classification of certain income and
assets as non-passive or our valuation of our tangible and intangible assets.
If we are treated as a PFIC, gain realized on
the sale, exchange or other disposition of your ADSs would in general not be treated as capital gain. Instead, such gain would be allocated
ratably over your holding period for the ADSs. The amounts allocated to the taxable year of the sale, exchange or other disposition and
to any year before we became a PFIC would be taxed as ordinary income. The amount allocated to each other taxable year would be subject
to tax at the highest rate in effect for such year, together with an interest charge on the tax attributable to each such year. If we
are a PFIC for any year during a U.S. Holder's holding period for ADSs, we generally will continue to be treated as a PFIC with
respect to such U.S. Holder for all succeeding years during which such U.S. Holder owns the ADSs. Dividends received from ADSs will
not be eligible for the special tax rates applicable to qualified dividend income for certain non-corporate U.S. Holder if we were
treated as a PFIC with respect to the U.S. Holder, either in the taxable year of the distribution or the preceding taxable year, but
instead will be taxable at rates applicable to ordinary income. Further, any distribution in respect of ADSs in excess of 125 percent
of the average annual distributions on ADSs received by a U.S. Holder during the preceding three years or such U.S. Holder's holding
period, whichever is shorter, would be allocated ratably over the U.S. Holder's holding period for ADSs and subject to taxation
as described with respect to sales, exchanges or other dispositions above. Certain elections may be available that would result in alternative
treatments such as mark-to-market treatment of the ADSs.
3.8% Medicare Tax on
"Net Investment Income"
Certain U.S. Holders that are individuals, estates,
and certain trusts are subject to a 3.8% tax on all or a portion of their "net investment income," which may include any
gain realized or amounts received with respect to their ADSs, to the extent of their net investment income that, when added to other
modified adjusted gross income, exceeds $200,000 for a single taxpayer (or a qualifying head of household), $250,000 for married taxpayers
filing a joint return (or a qualifying widower), or $125,000 for a married taxpayer filing a separate return. U.S. Holders should consult
their own tax advisors with respect to the applicability of the net investment income tax.
85
Information Reporting
and Backup Withholding
Except in the case of corporations or other exempt
holders, amounts received by a U.S. Holder in connection with distributions, if any, paid by Company with respect to ADSs and proceeds
from the sale, exchange or other disposition of ADSs may be subject to U.S. information reporting requirements and backup withholding
unless the U.S. Holder provides an accurate taxpayer identification number and complies with certain certification procedures or otherwise
establishes an exemption from backup withholding. Backup withholding is not an additional tax and amounts withheld may be allowed as
a credit against the U.S. Holder's U.S. federal income tax liability and may entitle the U.S. Holder to a refund, provided that
certain required information is timely furnished to the IRS.
U.S. Holders who are individuals (and under proposed
regulations, certain entities) and who own "specified foreign financial assets" with an aggregate value in excess of $50,000
on the last day of the tax year (or more than $75,000 at any time during the tax year) are generally required to file an information
statement along with their tax returns, currently on IRS Form 8938, with respect to such assets, subject to certain exceptions (including
an exception for shares held in custodial accounts maintained with a U.S. financial institution) "Specified foreign financial assets"
include securities issued by a non-U.S. issuer (which would include ADSs) that are not held in accounts maintained by financial institutions.
Higher reporting thresholds apply to certain individuals living abroad and to certain married individuals. Individuals who fail to report
the required information could be subject to substantial penalties, and such individuals should consult their own tax advisors concerning
the application of these rules to their investment in ADSs.
TAX MATTERS CAN BE COMPLICATED. THE FOREGOING
DISCUSSION OF MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES IS NOT INTENDED TO BE A COMPLETE ANALYSIS OR DESCRIPTION OF ALL U.S.
FEDERAL INCOME TAX CONSEQUENCES OF THE OWNERSHIP AND DISPOSITION OF ADSS. IN ADDITION, THE DISCUSSION DOES NOT ADDRESS TAX CONSEQUENCES
THAT DEPEND UPON INDIVIDUAL CIRCUMSTANCES. THIS DISCUSSION DOES NOT ADDRESS ANY U.S. FEDERAL TAX CONSEQUENCES OTHER THAN INCOME TAX OR
ANY FOREIGN, STATE OR LOCAL TAX CONSIDERATIONS, NOR ANY TAX CONSEQUENCES OF ANY TRANSACTION OTHER THAN THE OWNERSHIP AND DISPOSITION
OF ADSS. ACCORDINGLY, YOU ARE STRONGLY URGED TO CONSULT YOUR OWN TAX ADVISOR TO DETERMINE THE PARTICULAR U.S. FEDERAL, STATE, LOCAL,
OR FOREIGN INCOME OR OTHER TAX CONSEQUENCES OF THE OWNERSHIP AND DISPOSITION OF ADSS TO YOU.
Non-United States Holders
For purposes of this discussion, if you are not
a U.S. Holder (as defined above), you are a "Non-U.S. Holder".
Distributions on the
ADSs
You generally will not be subject to U.S. federal
income tax or withholding on distributions made on the ADSs unless:
●
you conduct a trade or
    business in the U.S., and
●
the distributions are effectively
    connected with the conduct of that trade or business (or, under certain income tax treaties, such distributions are attributable
    to a permanent establishment that you maintain in the United States).
If you meet the two tests above, you generally
will be subject to tax in respect of such distributions in the same manner as a U.S. Holder, as described above. In addition, any effectively
connected distributions received by a non-U.S. corporation may also, under certain circumstances, be subject to an additional "branch
profits tax" at a 30-percent rate or such lower rate as may be provided by an applicable income tax treaty.
Sale, Exchange or Other
Disposition of the ADSs
Generally, you will not be subject to U.S. federal
income tax or withholding in respect of gain recognized on a sale, exchange or other disposition of the ADSs unless:
●
your gain is effectively
    connected with a trade or business that you conduct in the United States (or, under certain income tax treaties, such gain is attributable
    to a permanent establishment that you maintain in the United States), or
●
you are an individual Non-U.S.
    Holder and are present in the United States for at least 183 days in the taxable year of the sale, exchange or other disposition,
    and certain other conditions exist.
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If you meet either of the two tests above, you
will be subject to tax in respect of any gain effectively connected with your conduct of a trade or business in the United States generally
in the same manner as a U.S. Holder, as described above. Effectively connected gains realized by a non-U.S. corporation may also, under
certain circumstances, be subject to an additional "branch profits tax" at a rate of 30-percent or such lower rate as
may be provided by an applicable income tax treaty.
Backup Withholding
and Information Reporting
Payments, including distributions and proceeds
from sales, exchanges or other dispositions in respect of the ADSs that are made in the United States or by a U.S.-related financial
intermediary will be subject to U.S. information reporting rules. In addition, such payments may be subject to U.S. federal backup
withholding. You will not be subject to backup withholding provided that:
●
you are a corporation or
    other exempt recipient, or
●
you provide your correct
    U.S. federal taxpayer identification number and certify, under penalties of perjury, that you are not subject to backup withholding.
Amounts withheld under the backup withholding
rules may be credited against your U.S. federal income tax, and you may obtain a refund of any excess amounts withheld under the backup
withholding rules by filing the appropriate claim for refund with the IRS in a timely manner.
FATCA
The Foreign Account Tax Compliance Act (or "FATCA")
generally imposes a U.S. federal withholding tax of 30% on dividends on the ADSs paid to a "foreign financial institution"
(as specially defined under these rules), unless such institution enters into an agreement with the U.S. government to withhold on certain
payments and to collect and provide to the U.S. tax authorities substantial information regarding the U.S. account holders of such institution
(which includes certain equity and debt holders of such institution, as well as certain account holders that are foreign entities with
U.S. owners) or otherwise establishes an exemption. FATCA also generally imposes a U.S. federal withholding tax of 30% on dividends on
the ADSs paid to a "non-financial foreign entity" (as specially defined under these rules) unless such entity provides
the withholding agent with a certification identifying certain substantial direct and indirect U.S. owners of the entity, certifies
that there are none or otherwise establishes an exemption. The withholding obligations under FATCA generally apply to payments of dividends
(including constructive dividends) on the ADSs. Under certain circumstances, a Non-U.S. Holder might be eligible for refunds
or credits of such taxes. An intergovernmental agreement between the United States and an applicable foreign country may modify the requirements
described in this paragraph.
Additionally, FATCA may impose a 30% withholding
tax on payments of gross proceeds from the sale, exchange or redemption of property that gives rise to U.S.-source dividends or
interest, including the ADSs. The IRS recently issued Proposed Treasury Regulations that eliminate withholding on payments of gross proceeds.
Pursuant to the Proposed Treasury Regulations, the issuer and any withholding agent may (but are not required to) rely on this proposed
change to FATCA withholding until the final regulations are issued. Non-U.S. Holders are encouraged to consult with their own tax
advisors regarding the possible application of FATCA to their ownership of the ADSs.
Material Belgian Tax Consequences
General
The following paragraphs are a summary of material
Belgian tax consequences of the ownership of ADSs by an investor. The summary is based on laws, treaties and regulatory interpretations
in effect in Belgium on the date of this document, all of which are subject to change, including changes that could have retroactive
effect.
The summary only discusses Belgian tax aspects
which are relevant to U.S. holders of ADSs ("Holders"). This summary does not address Belgian tax aspects which are relevant
to persons who are residents in Belgium or engaged in a trade or business in Belgium through a permanent establishment or a fixed base
in Belgium. This summary does not purport to be a description of all of the tax consequences of the ownership of ADSs and does not take
into account the specific circumstances of any particular investor, some of which may be subject to special rules, or the tax laws of
any country other than Belgium. This summary does not describe the tax treatment of investors that are subject to special rules, such
as banks, insurance companies, collective investment undertakings, dealers in securities or currencies, persons that hold, or will hold,
ADSs in a position in a straddle, share-repurchase transaction, conversion transactions, synthetic security or other integrated
financial transactions. Investors should consult their own advisers regarding the tax consequences of an investment in ADSs in the light
of their particular circumstances, including the effect of any state, local or other national laws, treaties and regulatory interpretation
thereof.
87
In addition to the assumptions mentioned above,
it is also assumed in this discussion that for purposes of the domestic Belgian tax legislation, the owners of ADSs will be treated as
the owners of the ordinary shares represented by such ADSs. However, the assumption has not been confirmed by or verified with the Belgian
Tax Administration.
For the purposes of this summary, ADSs or ordinary
shares means ordinary shares represented by ADSs. Both terms are used interchangeably.
Dividend Withholding Tax
As a general rule, under current Belgian law,
a withholding tax of 30% is levied on the gross amount of dividends paid on or attributed to the ordinary shares represented by the ADSs,
subject to such relief as may be available under applicable domestic or tax treaty provisions. Dividends subject to the dividend withholding
tax include all benefits attributed to the ordinary shares represented by the ADSs, irrespective of their form. A reimbursement of fiscal
capital made in accordance with the Belgian Companies and Associations Code is partly considered to be a distribution of the existing
taxed reserves (irrespective whether incorporated into the capital or not) and/or the tax-free reserves incorporated into the capital.
The proportion is determined on the basis of the ratio between certain taxed reserves and tax-free reserves incorporated into the
capital on the one hand and, on the other hand, the aggregate of such reserves and the fiscal capital. In principle, fiscal capital includes
paid-up statutory share capital, and subject to certain conditions, the paid-up issue premiums and the cash amounts subscribed
to at the time of the issue of profit sharing certificates.
In case of a redemption by us of own shares represented
by ADSs, the redemption distribution (after deduction of the portion of fiscal capital represented by the redeemed shares) will be treated
as a dividend which in certain circumstances may be subject to a withholding tax of 30%, subject to such relief as may be available under
applicable domestic or tax treaty provisions. In case of a liquidation of our Company, any amounts distributed in excess of the fiscal
capital will be subject to a 30% withholding tax, subject to such relief as may be available under applicable domestic or tax treaty
provisions.
For non-residents, the dividend withholding tax
will be the only tax on dividends in Belgium, unless the non-resident holds ADSs in connection with a business conducted in Belgium,
through a fixed base in Belgium or a Belgian permanent establishment.
Relief of Belgian Dividend Withholding
Tax
Under the Belgium-United States Tax Treaty
(the "Treaty"), there is a reduced Belgian withholding tax rate of 15% on dividends paid by us to a U.S. resident which beneficially
owns the dividends and is entitled to claim the benefits of the Treaty under the limitation of benefits article included in the Treaty,
(a "Qualifying Holder"). If such Qualifying Holder is a company that owns directly at least 10% of our voting stock, the
Belgian withholding tax rate is further reduced to 5%. No withholding tax is however applicable if the Qualifying Holder, is: (i) a
company that is a resident of the United States that has owned directly ADSs representing at least 10% of our capital for a 12-month period
ending on the date the dividend is declared, or (ii) a pension fund that is a resident of the United States, provided that
such dividends are not derived from the carrying on of a business by the pension fund or through an associated enterprise.
Under the normal procedure, we or our paying
agent must withhold the full Belgian withholding tax (without taking into account the Treaty rate). Qualifying Holders may make a claim
for reimbursement for amounts withheld in excess of the rate defined by the Treaty. The reimbursement form (Form 276 Div-Aut.) may
be obtained from the KMO Centrum Specifieke Materies, Team 6, Kruidtuinlaan 50, PO 3429, 1000 Brussels, Belgium or online on
the website of the Belgian tax authorities. Qualifying Holders may also, subject to certain conditions, obtain the reduced Treaty rate
at source. Qualifying Holders should deliver a duly completed Form 276 Div-Aut. no later than ten days after the date on which the
dividend is paid or attributed. U.S. holders should consult their own tax advisors as to whether they qualify for reduction in withholding
tax upon payment or attribution of dividends, and as to the procedural requirements for obtaining a reduced withholding tax upon the
payment of dividends or for making claims for reimbursement.
88
Withholding tax is also not applicable, pursuant
to Belgian domestic tax law, on dividends paid to certain U.S. pension funds provided that the U.S. pension fund (i) qualifies as
a non-resident saver for Belgian withholding tax purposes (
i.e.
, it has a separate legal personality and fiscal residence
outside of Belgium and without a permanent establishment or fixed base in Belgium), (ii) has a corporate purpose that consists solely
in managing and investing funds collected in order to pay legal or complementary pensions, (iii) has activity that is limited to
the investment of funds collected in the exercise of its statutory purpose, without any profit making activity and (iv) is exempt
from income taxes in the United States. Furthermore, such pension fund may not contractually be obligated to redistribute the dividends
to any beneficial owner of such dividends for whom it would manage the ADSs nor obligated to pay a manufactured dividend with respect
to the ADSs under a securities borrowing transaction (save in certain particular cases as described in Belgian law) and subject to certain
procedural formalities. A pension fund not holding the shares — which give rise to dividends — for an uninterrupted period
of 60 days in full ownership amounts to a rebuttable presumption that the arrangement or series of arrangements which are connected to
the dividend distributions, are not genuine. The withholding tax exemption will in such case be rejected, unless counterproof is provided
by the OFP that the arrangement or series of arrangements are genuine.
Under Belgian domestic tax law, a withholding
tax exemption is available to dividends paid to a non-resident corporate shareholder (located in a Member State of the European
Union or in a country with which Belgium has entered in a double tax treaty including sufficient information exchange provisions) provided
that (i) at the date of payment or attribution of the dividend it holds a participation in our company representing at least 10%
of our share capital, (ii) this holding is held or will be held in full ownership for an uninterrupted period of at least one year,
(iii) this non-resident corporate shareholder is tax resident of the country where it is established according to the tax laws
of and the bilateral tax treaties established by such country, (iv) this non-resident corporate shareholder is subject to a
corporate income tax regime similar to Belgian corporate income tax regime without benefitting from a tax regime that derogates from
the ordinary tax regime and (v) its legal form is (similar to one of the legal forms) listed in the annex of the E.U. directive
dated July 23, 1990 (90/435/EC) as amended by the directive of December 22, 2003 (2003/123/EC). This reduced withholding tax
will apply provided that certain procedural formalities are complied with.
Finally, a withholding tax exemption is available,
pursuant to Belgian domestic tax law, to dividends paid to a non-resident corporate shareholder (located in the European Economic
Area or in a country with which Belgium has entered in a double tax treaty including sufficient information exchange provisions) to the
extent that at the date of payment or attribution of the dividend it holds a participation in our company representing less than 10%
of our share capital but the acquisition value of which is at least €2.5 million and provided that certain other conditions
are met,
i.e.
, that (i) this holding is held or will be held in full ownership for an uninterrupted period of at least one
year (ii) this non-resident corporate shareholder is subject to a corporate income tax regime similar to Belgian corporate
income tax regime without benefitting from a tax regime that derogates from the ordinary tax regime, and (iii) its legal form is
(similar to one of the legal forms) listed in the annex I, part A, of the E.U. directive dated November 30, 2011 (2011/96/EU) as
amended by the directive of July 8, 2014 (2014/86/EU). This reduced withholding tax will apply only if and to the extent that the
ordinary Belgian withholding tax cannot be credited or reimbursed to the non-resident corporate shareholder referred to above and
subject to certain procedural formalities.
Capital Gains and Losses
Pursuant to the Treaty, capital gains and/or
losses realized by a Qualifying Holder from the sale, exchange or other disposition of ADSs do not fall within the scope of application
of Belgian domestic tax law.
Capital gains realized on ADSs by a corporate
Holder which is not entitled to claim the benefits of the Treaty under the limitation of benefits article included in the Treaty are
generally not subject to taxation in Belgium unless the corporate Holder is acting through a Belgian permanent establishment or a fixed
place in Belgium to which the ADSs are effectively connected. Capital losses are not deductible.
Private individual Holders who are not entitled
to claim the benefits of the Treaty under the limitation of benefits article included in the Treaty and which are holding ADSs as a private
investment will, as a rule, not be subject to tax on any capital gains arising out of a disposal of ADSs. Losses will, as a rule, not
be deductible in Belgium.However, if the gain realized by such individual Holders on ADSs is deemed to be realized outside the scope
of the normal management of such individual's private estate and the capital gain is obtained or received in Belgium, the gain
will in principle be taxable at 33%. The Official Commentary to the ITC 1992 stipulates that occasional transactions on a stock exchange
regarding ADSs should not be considered as transactions realized outside the scope of normal management of one's own private estate.
89
Capital gains realized by such individual Holders
on the disposal of ADSs for consideration, outside the exercise of a professional activity, to a non-resident company (or a body
constituted in a similar legal form), to a foreign state (or one of its political subdivisions or local authorities) or to a non-resident legal
entity who is established outside the European Economic Area, are in principle taxable at a rate of 16.5% if, at any time during the
five years preceding the sale, such individual Holders has owned directly or indirectly, alone or with his/her spouse or with certain
relatives, a substantial shareholding in us (that is, a shareholding of more than 25% of our shares).
Capital gains realized by a Holder upon the redemption
of ADSs or upon our liquidation will generally be taxable as a dividend. See section "
Dividend Withholding Tax
."
Estate and Gift Tax
There is no Belgian estate tax on the transfer
of ADSs upon the death of a Belgian non-resident.
Donations of ADSs made in Belgium may or may
not be subject to gift tax in Belgium depending on the modalities under which the donation is carried out.
Belgian Tax on Stock Exchange Transactions
A tax on stock exchange transactions (
taxe
sur les opérations de bourse/taks op de beursverrichtingen
) is generally levied on the purchase and the sale and on any other
acquisition and transfer for consideration of existing ADSs on the secondary market carried out by a Belgian resident investor through
a professional intermediary if (i) executed in Belgium through a professional intermediary, or (ii) deemed to be executed in
Belgium, which is the case if the order is directly or indirectly made to a professional intermediary established outside of Belgium,
either by private individuals having their usual residence in Belgium, or legal entities for the account of their seat or establishment
in Belgium.
The applicable rate amounts to 0.35% of the consideration
paid but with a cap of €1,600 per transaction and per party. The tax is due separately from each party to any such transaction,
i.e.
, the seller (transferor) and the purchaser (transferee), both collected by the professional intermediary.
However, if the intermediary is established outside
of Belgium, the tax will in principle be due by the ordering private individual or legal entity, unless that individual or entity can
demonstrate that the tax has already been paid. Professional intermediaries established outside of Belgium can, subject to certain conditions
and formalities, appoint a Belgian representative for tax purposes, which will be liable for the tax on stock exchange transactions in
respect of the transactions executed through the professional intermediary.
Belgian non-residents who purchase or otherwise
acquire or transfer, for consideration, ADSs in Belgium for their own account through a professional intermediary may be exempt from
the tax on stock exchange transactions if they deliver a sworn affidavit to the intermediary in Belgium confirming their non-resident status.
No stock exchange tax is payable by: (i) professional
intermediaries described in Article 2, 9° and 10° of the Belgian Act of August 2, 2002 acting for their own account,
(ii) insurance companies described in Article 2, §1 of the Belgian Act of 9 July 1975 acting for their own account,
(iii) professional retirement institutions referred to in Article 2, 1° of the Belgian Act of October 27, 2006 relating
to the control of professional retirement institutions acting for their own account, (iv) collective investment institutions acting
for their own account, or (v) regulated real estate companies (for the stock exchange tax only).
No stock exchange tax will thus be due by Holders
on the subscription, purchase or sale of ADSs, if the Holders are acting for their own account. In order to benefit from this exemption,
the Holders must file with the professional intermediary in Belgium a sworn affidavit evidencing that they are non-residents for
Belgian tax purposes.
Belgian Annual Tax on Securities Accounts
Pursuant to the Belgian Act of February 17,
2021 introducing a new annual tax on securities accounts due on securities accounts held through an intermediary if the average value
of the taxable financial instruments held on this securities account exceeds €1 million during a reference period of 12 consecutive
months. This new annual tax on securities accounts is introduced because the previous tax on securities accounts was annulled by the
Belgian Constitutional Court.
The annual tax on securities accounts is due
irrespective of whether the holder of a securities account is a physical person or a legal entity. If the holder of a securities account
is a Belgian resident, the annual tax on securities accounts will be applicable both to securities accounts held in Belgium as well as
securities accounts held abroad. For non-residents, only securities accounts held in Belgium fall in scope of the annual tax on securities
accounts. A double tax treaty could prevent Belgium to levy the annual tax on securities accounts.
90
Certain exemptions exist to mitigate the impact
of the annual tax on securities accounts on the financial sector. As such, securities accounts held by certain financial undertakings
are exempt.
All securities held on a securities account are
targeted, such as shares, bonds, participations in investment funds and investment companies, but also derived products, such as index
trackers, turbos, real estate certificates and cash. The rate of the annual tax on securities accounts amounts to 0.15% on securities
accounts of which the average value exceeds €1 million during a reference period of 12 consecutive months. In order to avoid
that the payment of the tax would result in a decrease of the average value below the €1 million threshold, the rate is limited
to 10% of the difference between the taxable base and €1 million in those cases. The reference period is a subsequent period
of 12 months starting on October 1 and ending September 30 of the subsequent year or (i) any earlier date when the account
is closed; or (ii) the moment when the account holder becomes a resident of a state with which Belgium has concluded a tax treaty
and the tax treaty allocates the taxing rights to the other state. The average value is calculated by taking the average of the securities
accounts values on December 31, March 31, June 30 and September 30.
The tax must be declared and paid by the Belgian
resident intermediary with whom the securities account is held. If a securities account is held with a non-resident intermediary,
the holder of the securities account itself is responsible for the declaration and the payment of the annual tax on securities accounts.
Alternatively, the foreign intermediary could also voluntarily appoint a recognized responsible representative in Belgium to declare
and pay the tax.
In case of non-declaration, late, inaccurate
or incomplete declaration, as well as non-payment or late payment, a penalty varying from 10% to 200% of the tax due can be imposed.
Every holder of the securities account is jointly and severally liable to pay these penalties. The Act furthermore includes a general
anti-abuse provision pursuant to which the following is not allowed: (i) distributing taxable financial instruments over different
securities accounts to avoid the threshold of €1 million for an individual account, (ii) converting taxable financial
instruments into nominative securities (the latter are out of scope of the tax); (iii) transferring a securities account to a foreign
legal entity which then transfers the securities to a foreign securities account, etc. In the aforementioned circumstances, there is
a refutable presumption that abuse exists. However, the Act also includes situations in which there is an irrefutable presumption of
abuse (specific anti-abuse provisions). As such, the following transactions taking place as of October 30, 2020 onwards will be
considered to constitute abuse: (i) splitting of a securities account into multiple securities accounts held by the same intermediary;
and (ii) the conversion of taxable financial instruments held in a securities account to nominal financial instruments. However,
in its judgment of October 27, 2022, the Belgian Constitutional Court annulled the specific anti-abuse provisions as well as the retroactive
effect up to October 30, 2020 of the general anti-abuse provision. As a result, only the general anti-abuse provision can still be validly
applied and, moreover, only as of February 26, 2021.
Prospective Holders should consult their own
tax advisors as to whether they are subject to the new annual tax on securities accounts.
Proposed Financial Transactions Tax
On February 14, 2013, the European Commission
published a proposal for a Directive for a common financial transactions tax ("FTT") in Belgium, Germany, Greece, Spain,
France, Italy, Austria, Portugal, Slovenia, Estonia and Slovakia (collectively, the "Participating Member States"). On December 8,
2015, Estonia declared that it will no longer support the FTT.
The proposed FTT has a very broad scope and could,
if introduced in its current form, apply to certain dealings in ADSs in certain circumstances. The FTT could apply in certain circumstances
to persons both within and outside of the Participating Member States. Generally, it would apply to certain dealings in ADSs where at
least one party is a financial institution, and at least one party is established in a Participating Member State.
A financial institution may be, or be deemed
to be, "established" in a Participating Member State in a broad range of circumstances, including by transacting with a person
established in a Participating Member State.
Currently, the proposed FTT remains subject to
further negotiations between the Participating Member States (excluding Estonia). It may therefore be adjusted prior to any implementation,
of which the timing and fate remains unclear. Moreover, additional E.U. Member States could decide to participate or drop out of the
negotiations. Prospective Holders of ADSs are advised to seek their own professional advice in relation to the FTT.
F. Dividends and Paying Agents
Not applicable.
91
G. Statement by Experts
Not applicable.
H. Documents on Display
We are subject to the information reporting requirements
of the Exchange Act applicable to foreign private issuers and under those requirements file reports with the SEC. Those reports may be
inspected without charge at the locations described below. As a foreign private issuer, we are exempt from the rules under the Exchange
Act related to the furnishing and content of proxy statements, and our supervisory and executive board members and principal shareholders
are exempt from the reporting and short-swing profit recovery provisions contained in Section 16 of the Exchange Act. In addition, we
are not required under the Exchange Act to file periodic reports and financial statements with the SEC as frequently or as promptly as
United States companies whose securities are registered under the Exchange Act. Nevertheless, we file with the SEC an annual report containing
financial statements that have been examined and reported on, with and opinion expressed by an independent registered public accounting
firm, and we submit quarterly interim consolidated financial data to the SEC under cover of the SEC's Form 6-K.
We maintain a corporate website at
www.mdxhealth.com
.
We intend to post our annual report on our website promptly following it being filed with the SEC. Information contained on, or that
can be accessed through, our website does not constitute a part of this annual report. We have included our website address in this annual
report solely as an inactive textual reference.
The SEC maintains a website (
http://www.sec.gov
)
that contains reports, proxy and information statements and other information regarding registrants, such as MDxHealth, that file electronically
with the SEC.
With respect to references made in this annual
report to any contract or other document of MDxHealth, such references are not necessarily complete and you should refer to the exhibits
attached or incorporated by reference to this annual report for copies of the actual contract or document.
I. Subsidiary Information
Not applicable.
J. Annual Report to Security Holders
If we are required to provide an annual report
to security holders in response to the requirements of Form 6-K, we will submit the annual report to security holders in electronic format
in accordance with the EDGAR Filer Manual.
ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURES
ABOUT MARKET RISK
Credit Risk
Credit risk arises from cash and cash equivalents,
short-term bank deposits, as well as credit exposure to collaboration partners. Credit risk refers to the risks that counterparty will
default on its contractual obligations resulting in financial loss to the Group.
At the end of 2022, the Company operated with
more than 1,000 different customers, systematically reducing credit risk compared to prior periods.
In the U.S. healthcare system, and particularly
within the molecular diagnostic CLIA-laboratory industry, where there are rapid technological advances in diagnostic services, companies
provide services to healthcare professionals and their patients, while being reimbursed from commercial and governmental insurance systems.
Often these services are provided out-of-network and without supplier contracts. As a result, there is reimbursement risk, separate from
credit risk that is characterized by uncertainty in reimbursement value, delays in payment, and ultimately non-payment. This impacts
the Company's revenue recognition and cash collections.
92
In addition to reimbursement risk associated
with commercial third-party payors, credit risk may also arise from amounts due directly from patients. In many cases, payors will cover
the entire cost of testing. For example, for tests that fall under the Clinical Laboratory Fee Schedule, there is no co-payment, co-insurance
or deductible for patients covered under traditional Medicare. However, patients covered by commercial insurance companies may be responsible
for a co-payment, co-insurance, and/or deductible depending on the health insurance plan and individual patient benefit. Credit risk
exists for those patients who cannot meet their co-payment or deductible portions.
Customers' compliance with agreed credit
terms is regularly and closely monitored. Trade accounts receivable amounted to $9.4 million as of December 31, 2022, and no allowance
for expected credit loss was recorded. The Company applies the simplified approach to providing for expected credit losses ("ECL")
prescribed by IFRS 9, which requires the use of the lifetime expected loss provision for all trade receivables. No ECL has been recorded
for other financial assets carried at amortized cost as there is no related credit risk.
The credit risk on cash and cash equivalents
of $15.5 million is limited given that the counterparties are banks with high credit scores attributed by international rating agencies.
Interest Rate Risk
Our cash consists of cash in readily available
checking accounts and money market accounts. As a result, the fair value of our portfolio is relatively insensitive to interest rate
changes. Our long-term debt bears interest at a fixed rate and therefore has no exposure to changes in interest rates.
Foreign Currency
Our European operations, including all sales
and expenses, are denominated in Euros. At the end of each reporting period, these assets and liabilities are converted to U.S. dollars
at the then-applicable foreign exchange rate. As a result, our business is affected by fluctuations in exchange rates between the U.S.
dollar and foreign currencies. We enter into limited foreign currency hedging transactions to mitigate our exposure to foreign currency
exchange risks. Exchange rate fluctuations may adversely affect our expenses, results of operations, financial position and cash flows.
However, to date, these fluctuations have not been significant and a movement of 10% in U.S. dollar to the Euro exchange rate would not
have a material effect on our results of operations.
ITEM 12. DESCRIPTION OF SECURITIES OTHER THAN
EQUITY SECURITIES
A. Debt Securities
Not applicable.
B. Warrants and Rights
Not applicable.
C. Other Securities
Not applicable.
D. American Depositary Shares
The Bank of New York Mellon, as depositary, registers
and delivers American Depositary Shares, or ADSs. Each ADS represent ten ordinary shares (or a right to receive ten ordinary shares)
deposited with ING Belgium SA/NV, as custodian for the depositary in Belgium. Each ADS also represents any other securities, cash or
other property that may be held by the depositary. The deposited ordinary shares together with any other securities, cash or other property
held by the depositary are referred to as the deposited securities. The depositary's office at which the ADSs will be administered
and its principal executive office are located at 240 Greenwich Street, New York, New York 10286.
A deposit agreement among us, the depositary
and the ADS holders sets out the ADS holder rights as well as the rights and obligations of the depositary. New York law governs the
deposit agreement and the ADSs. A copy of the Agreement is incorporated by reference as an exhibit to this annual report.
For additional information on our ADSs, please
refer to Exhibit 2.3 "Description of Securities registered under Section 12 of the Exchange Act" of this annual report.
93
Fees and Expenses
Persons depositing or withdrawing
    ordinary shares or
ADS holders must pay:
For:
$5.00 (or less) per 100 ADSs (or portion of 100 ADSs)
●
Issuance of ADSs, including issuances resulting from
    a distribution of ordinary shares or rights or other property
●
Cancellation of ADSs for the purpose of withdrawal,
    including if the deposit agreement terminates
$.05 (or less) per ADS
●
Any cash distribution to ADS holders
A fee equivalent to the fee that would be payable if
    securities distributed to you had been ordinary shares and the ordinary shares had been deposited for issuance of ADSs
●
Distribution of securities distributed to holders of
    deposited securities (including rights) that are distributed by the depositary to ADS holders
$.05 (or less) per ADS per calendar year
●
Depositary services
Registration or transfer fees
●
Transfer and registration of ordinary shares on our
    share register to or from the name of the depositary or its agent when you deposit or withdraw ordinary shares
Expenses of the depositary
●
Cable (including SWIFT) and facsimile transmissions
    (when expressly provided in the deposit agreement)
●
Converting foreign currency to U.S. dollars
Taxes and other governmental charges the depositary
    or the custodian has to pay on any ADSs or ordinary shares underlying ADSs, such as stock transfer taxes, stamp duty or withholding
    taxes
●
As necessary
Any charges incurred by the depositary or its agents
    for servicing the deposited securities
●
As necessary
The depositary collects its fees for delivery
and surrender of ADSs directly from investors depositing ordinary shares or surrendering ADSs for the purpose of withdrawal or from intermediaries
acting for them. The depositary collects fees for making distributions to investors by deducting those fees from the amounts distributed
or by selling a portion of distributable property to pay the fees. The depositary may collect its annual fee for depositary services
by deduction from cash distributions or by directly billing investors or by charging the book-entry system accounts of participants
acting for them. The depositary may collect any of its fees by deduction from any cash distribution payable (or by selling a portion
of securities or other property distributable) to ADS holders that are obligated to pay those fees. The depositary may generally refuse
to provide fee attracting services until its fees for those services are paid.
From time to time, the depositary may make payments
to us to reimburse us for costs and expenses generally arising out of establishment and maintenance of the ADS program, waive fees and
expenses for services provided to us by the depositary or share revenue from the fees collected from ADS holders. In performing its duties
under the deposit agreement, the depositary may use brokers, dealers, foreign currency dealers or other service providers that are owned
by or affiliated with the depositary and that may earn or share fees, spreads or commissions.
The depositary may convert currency itself or
through any of its affiliates, or the custodian or we may convert currency and pay U.S. dollars to the depositary. Where the depositary
converts currency itself or through any of its affiliates, the depositary acts as principal for its own account and not as agent, advisor,
broker or fiduciary on behalf of any other person and earns revenue, including, without limitation, transaction spreads, that it will
retain for its own account. The revenue is based on, among other things, the difference between the exchange rate assigned to the currency
conversion made under the deposit agreement and the rate that the depositary or its affiliate receives when buying or selling foreign
currency for its own account. The depositary makes no representation that the exchange rate used or obtained by it or its affiliate in
any currency conversion under the deposit agreement will be the most favorable rate that could be obtained at the time or that the method
by which that rate will be determined will be the most favorable to ADS holders, subject to the depositary's obligation to act
without negligence or bad faith. The methodology used to determine exchange rates used in currency conversions made by the depositary
is available upon request. Where the custodian converts currency, the custodian has no obligation to obtain the most favorable rate that
could be obtained at the time or to ensure that the method by which that rate will be determined will be the most favorable to ADS holders,
and the depositary makes no representation that the rate is the most favorable rate and will not be liable for any direct or indirect
losses associated with the rate. In certain instances, the depositary may receive dividends or other distributions from us in U.S. dollars
that represent the proceeds of a conversion of foreign currency or translation from foreign currency at a rate that was obtained or determined
by us and, in such cases, the depositary will not engage in, or be responsible for, any foreign currency transactions and neither it
nor we make any representation that the rate obtained or determined by us is the most favorable rate and neither it nor we will be liable
for any direct or indirect losses associated with the rate.
94
PART II
ITEM 13. DEFAULTS, DIVIDENDS ARREARAGES AND
DELINQUENCIES
Not applicable.
ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS
OF SECURITY HOLDERS AND USE OF PROCEEDS
Not applicable.
ITEM 15. CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
We are responsible for maintaining disclosure
controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Disclosure controls and procedures are controls
and other procedures designed to ensure that the information required to be disclosed by us in the reports that we file or submit under
the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC's rules and forms.
Our management, with the participation of our Chief Executive Officer (principal executive officer) and our Chief Financial Officer (principal
financial officer), has evaluated the effectiveness of our disclosure controls and procedures, as of the end of the period covered by
this annual report on Form 20-F. Based on the foregoing, our Chief Executive Officer (principal executive officer) and Chief Financial
Officer (principal financial officer) concluded that, as of December 31, 2022, our disclosure controls and procedures were effective.
Management's Annual Report on Internal
Control over Financial Reporting
Our management is responsible for establishing
and maintaining adequate internal control over our financial reporting (as such term is defined in Rule 13a-15(f) and 15d-15(f) under
the Exchange Act). Our management, with the participation of the Chief Executive Officer and the Chief Financial Officer, conducted an
assessment of the effectiveness of our internal control over financial reporting as of December 31, 2022 based on the criteria set forth
in "Internal Control — Integrated Framework (2013)" issued by the Committee of Sponsoring Organizations of the Treadway
Commission. Based on this assessment, our management concluded that, as of December 31, 2022, our internal control over financial reporting
was effective.
Attestation Report of the Registered Public
Accounting Firm
This annual report does not include an attestation report of the company's
registered public accounting firm due to a transition period established by rules of the SEC for newly public companies, and because MDxHealth
is an emerging growth company under the JOBS Act.
Changes in Control over Financial Reporting
There has been no change in our internal control
over financial reporting during the year ended December 31, 2022 that has materially affected, or is reasonably likely to materially
affect, our internal control over financial reporting.
In January 2023, in connection with the preparation
of our financial statements for the nine months ended September 30, 2022, (the "Interim Financial Statements"), we identified
a material weakness in our internal control over financial reporting at September 30, 2022 related to ineffective design and operation
of our interim financial close and reporting controls. More specifically, internal control over financial reporting procedures used in
connection with the preparation of the financial information that we reported in a press release issued on October 27, 2022 failed to
identify a number of cut-off errors. These cut-off errors have been corrected in the Interim Financial Statements and do not relate to
our year-end close and reporting controls. A material weakness is a deficiency, or a combination of deficiencies, in internal control
over financial reporting such that there is a reasonable possibility that a material misstatement of a company's annual or interim
financial statements will not be prevented or detected on a timely basis. Although we were able to remediate these issues, including
engaging an outside IFRS consulting firm to assist with our interim closing process, these efforts may not be sufficient to avoid similar
material weaknesses in the future.
ITEM 16. [RESERVED]
Not applicable.
95
ITEM 16A. AUDIT COMMITTEE FINANCIAL EXPERT
Currently, our Audit Committee consists of three
directors: Regine Slagmulder, Lieve Verplancke and Hilde Windels. The members of the Audit Committee must have a collective expertise
relating to the activities of the Company, and at least one member of the Audit Committee must have the necessary competence in accounting
and auditing, including qualifying as an "audit committee financial expert" as defined under the Exchange Act. Our Board
of Directors has determined that Regine Slagmulder and Hilde Windels each qualify as an "audit committee financial expert,"
as defined by SEC rules and regulations. Regine Slagmulder, Lieve Verplancke, and Hilde Windels are independent under Belgian law and
the Nasdaq Stock Market listing requirements.
ITEM 16B. CODE OF ETHICS
We have adopted a Code of Business Conduct and
Ethics that is applicable to all of our, and our subsidiaries', directors, officers and employees. The Code of Business Conduct
and Ethics is available on our website at
www.mdxhealth.com
. Our Board is responsible for overseeing the Code of Business Conduct
and Ethics. Any waiver of the Code of Business Conduct and Ethics for our directors or executive officers (including our principal financial
officers) may be made only by the Board and will be disclosed to the public as required by law or under applicable listing rules. Waivers
of the Code of Business Conduct and Ethics for other employees may be made only by our Chief Executive Officer or Compliance Officer
and will be reported to our Audit Committee. All amendments to Code of Business Conduct and Ethics Code must be approved by the Board
or a committee thereof and, if applicable, shall be promptly disclosed to the public as required by law or under applicable listing rules.
ITEM 16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES
BDO Réviseurs d'Entreprises SRL,
has served as our independent registered public accounting firm for 2022 and 2021. Our accountants billed the following fees to us for
professional services in each of those fiscal years:
Year ended December 31,
2021
2022
Audit fees for statutory and consolidated financials
$
182,125
$
238,500
Other audit fees
$
183,652
$
191,455
Audit-related and other fees
$
16,569
$
41,811
Tax Fees
$
—
$
—
Total
$
382,346
$
471,766
"Audit Fees" are the aggregate fees
billed for the audit of our annual financial statements.
"Other Audit Fees" are mainly the
aggregate fees billed in the relation with the Company's initial public offering (in 2021) and follow on public offering and capital
raise process (in 2022).
"Audit-Related Fees" are the aggregate
fees billed for assurance and related services that are reasonably related to the performance of the audit and are not reported under
Audit Fees. This category also includes services that generally the independent accountant provides, such as consents and assistance with
and review of documents filed with the SEC, as well as the aggregate fees billed for statutory audit services as requested by the Belgian
Company Code.
"Tax Fees" are the aggregate fees
billed for professional services rendered by the principal accountant for tax compliance, tax advice and tax planning related services.
Audit and Non-Audit Services Pre-Approval Policy
The Audit Committee's policy is to pre-approve
all audit and permissible non-audit services to be performed by the independent registered public accounting firm. These services may
include audit services, audit-related services, tax services and other services. All such services provided in fiscal 2022 were pre-approved
by the Audit Committee. The Audit Committee has delegated pre-approval authority to its chairman when necessary due to timing considerations.
Any services pre-approved by such chairman must be reported to the full Audit Committee at its next scheduled meeting.
ITEM 16D. EXEMPTIONS FROM THE LISTING STANDARDS
FOR AUDIT COMMITTEES
Not applicable.
ITEM 16E. PURCHASES OF EQUITY SECURITIES BY
THE ISSUER AND AFFILIATED PURCHASERS
Not applicable.
ITEM 16F. CHANGE IN REGISTRANT'S CERTIFYING
ACCOUNTANT
Not applicable.
96
ITEM 16G. CORPORATE GOVERNANCE
Differences between Our Corporate Governance
Practices and the Listing Rules of the Nasdaq Stock Market
The listing rules of the Nasdaq Stock Market
include certain accommodations in relation to corporate governance requirements that allow foreign private issuers, to follow "home
country" corporate governance practices in lieu of the otherwise applicable corporate governance standards of the Nasdaq Stock
Market. The application of such exceptions requires that we disclose each instance of non-compliance with the Nasdaq Stock Market
listing rules that we do not follow and describe the Belgian corporate governance practices that we do follow in lieu of the relevant
Nasdaq Stock Market corporate governance standard.
We intend to continue to follow Belgian corporate
governance practices in lieu of the corporate governance requirements of the Nasdaq Stock Market in respect of the following:
●
Quorum at Shareholder
    Meetings
. Nasdaq Stock Market Listing Rule 5620(c) requires that for any meeting of shareholders, the quorum must be no less
    than 33.33% of the outstanding shares of common voting stock. There is no general quorum requirement under Belgian law for ordinary
    meetings of shareholders, except in relation to decisions regarding certain matters. See Item 10B. "
Memorandum and Articles
    of Association
" and information set forth in the final prospectus dated November 3, 2021 as part of our Registration Statement
    on Form F-1 (File No. 333-260213), declared effective by the SEC on November 3, 2021, under the headings "
Description of
    Share Capital and Articles of Association — Articles of Association and Other Share Information — Description of the
    Rights and Benefits Attached to Our Shares — Quorum and majorities
."
●
Nomination and Remuneration
    Committee
. Nasdaq Stock Market Listing Rule 5605(d)(2) requires that compensation of officers must be determined by, or recommended
    to, the Board of Directors for determination, either by a majority of the independent directors, or a compensation committee comprised
    solely of independent directors. Nasdaq Stock Market Listing Rule 5605(e) requires that director nominees be selected, or recommended
    for selection, either by a majority of the independent directors or a nominations committee comprised solely of independent directors.
    Under Belgian law, we are not subject to any such requirements. In particular, we are not required by Belgian law to set up any compensation
    or nominations committees within our Board of Directors, and are therefore not subject to any Belgian legal requirements as to the
    composition of such committees. However, our Articles of Association provide that our Board of Directors may form committees from
    among its members. Accordingly, our Board of Directors has set up and appointed a Nomination and Remuneration Committee. Pursuant
    to article 7:100 of the Belgian Companies and Associations Code, only a majority of the members of the remuneration committee should
    in principle meet the independence criteria referred to in article 7:87 of the Belgian Companies and Associations Code and set out
    in provision 3.5 of the Belgian Corporate Governance Code. Pursuant to provision 4.19 of the Belgian Corporate Governance Code, only
    a majority of the members of the remuneration committee must qualify as independent.
●
Charters
. Nasdaq
    Stock Market Listing Rules 5605(c)(1), (d)(1) and (e)(2) require that each committee of the Board of Directors must have a formal
    written charter. Pursuant to the Belgian Corporate Governance Code, our Board of Directors has drawn up a corporate governance charter
    including, amongst others, the internal rules of our committees.
●
Independent Director
    Majority
. Nasdaq Stock Market Listing Rules 5605(b)(1) and (2) require that a majority of the Board of Directors must be comprised
    of independent directors and that independent directors must have regularly scheduled meetings at which only independent directors
    are present. We are not required under Belgian law to have a majority of independent directors on our Board of Directors. However,
    our Articles of Association provide that our Board of Directors must be comprised of at least three directors, of which, pursuant
    to our corporate governance charter and provision 3.4 of the Belgian Corporate Governance Code, at least three directors must be
    independent directors under Belgian law. Furthermore, in line with the provisions of the Belgian Companies and Associations Code
    and the Belgian Corporate Governance Code, the Nomination and Remuneration Committee should consist of a majority of independent
    directors, and the Audit Committee should have at least one independent director among its members
97
●
Meetings of Independent Directors
. Nasdaq Stock Market Listing Rule 5605(b)(2) requires that independent directors must have regularly scheduled meetings at which only independent directors are present. We do not intend to require our independent directors to meet separately from the full Board of Directors on a regular basis or at all, although the Board of Directors is supportive of its independent members voluntarily arranging to meet separately from the other members of our Board of Directors when and if they wish to do so.
●
Stockholder Approval of Certain Share Issuances.
Nasdaq Stock Market Listing Rule 5635(a) requires shareholder approval prior to the issuance of securities in connection with the acquisition of the stock or assets of another company if (1)(A) the common stock has or will have upon issuance voting power equal to or in excess of 20% of the voting power outstanding before the issuance of stock or securities convertible into or exercisable for common stock or (B) the number of shares of common stock to be issued is or will be equal to or in excess of 20% of the number of shares of common stock outstanding before the issuance of the stock or securities; or (2) any director, officer or Substantial Shareholder (as defined in the Nasdaq rules) has a 5% or greater interest (or all such parties have a 10% or greater interest in the aggregate) in the Company or assets to be acquired or in the consideration to be paid in the transaction or series of transactions and the transaction or series of transactions results in an increase in the outstanding common shares or voting power of 5% or more. However, as permitted by Belgian law, we do not need prior stockholder approval to issue shares of authorized stock.
●
Stockholder Approval of
    Equity Compensation Arrangements
. Nasdaq Stock Market Listing Rule 5635(c) requires shareholder approval when a plan or
    other equity compensation arrangement is established or materially amended. Under Belgian law the establishment or amendment of
    equity compensation arrangements does not require a prior approval by the general shareholders' meeting. However, pursuant to
    Belgian law our shareholders must decide any issuance of new equity, as a general matter. As mentioned in the final prospectus dated
    November 3, 2021 as part of our Registration Statement on Form F-1 (File No. 333-260213), declared effective by the SEC on November
    3, 2021, under the headings "
Description of Share Capital and Articles of Association — Articles of Association and
    Other Share Information — Capital increases decided by the board of directors
," the shareholders may also authorize
    the Board of Directors, within certain limits, to issue new equity (including equity compensation arrangements) in the framework of
    the so-called authorized capital. By virtue of a resolution of our extraordinary general shareholders' meeting of
    May 27, 2021, our Board of Directors was authorized to issue equity (including equity compensation arrangements) in the
    framework of the authorized capital. Furthermore, the compensation of director mandates is subject to an approval by the general
    shareholders' meeting. See also Item 6B. "
Management — Compensation of Our Directors and Executive
    Management
." In the future, we intend to keep following Belgian home country rules and practice.
ITEM 16H. MINE SAFETY DISCLOSURE
Not applicable.
ITEM 16I. DISCLOSURE REGARDING FOREIGN JURISDICTIONS
THAT PREVENT INSPECTIONS
Not applicable.
98
PART III
ITEM 17. FINANCIAL STATEMENTS
Not applicable.
ITEM 18. FINANCIAL STATEMENTS
See pages F-1 through F-45 of this annual report.
ITEM 19. EXHIBITS
Exhibit Index
The following exhibits are filed as part of this
annual report:
Exhibit No.
Description of Exhibit
Form
File No.
Filing Date
Filed Herewith
1.1
Articles of Association of MDxHealth SA (English Translation)
6-K
005-93034
March 8, 2023
1.2
Corporate Governance Charter of MDxHealth SA (English Translation)
F-1
333-260213
October 13, 2021
2.1
Form of Deposit Agreement
F-1/A
333-260213
October 28, 2021
2.2
Form of American Depositary Receipt
F-1/A
333-260213
October 28, 2021
2.3
Description of Securities registered under Section 12 of the Exchange Act
X
4.1
March 2012 Stock Option Plan (English Translation)*
F-1
333-260213
October 13, 2021
4.2
May 2012 Stock Option Plan (English Translation)*
F-1
333-260213
October 13, 2021
4.3
May 2014 Stock Option Plan (English Translation)*
F-1
333-260213
October 13, 2021
4.4
May 2017 Stock Option Plan (English Translation)*
F-1
333-260213
October 13, 2021
4.5
2019 Stock Option Plan (English Translation)*
F-1
333-260213
October 13, 2021
4.6
2021 Share Option Plan (English Translation)*
F-1
333-260213
October 13, 2021
4.7
2022 Share Option Plan (English Translation)*
6-K
005-93034
April 28, 2022
4.8
Form of Indemnification Agreement between MDxHealth and each of its officers and directors
F-1
333-260213
October 13, 2021
4.9
Employment Agreement between MDxHealth and Joseph Sollee dated April 14, 2008 and amended January 27, 2014*
F-1
333-260213
October 13, 2021
4.10
Executive Employment Agreement between MDxHealth and Michael K. McGarrity dated February 18, 2019*
F-1
333-260213
October 13, 2021
4.11
Executive Employment Agreement between MDxHealth and John Bellano dated May 21, 2019*
F-1
333-260213
October 13, 2021
4.12
Executive Employment Agreement between MDxHealth and Ron Kalfus dated July 18, 2019*
F-1
333-260213
October 13, 2021
4.13
Amended and Restated License Agreement between The Johns Hopkins University and MDxHealth dated September 1, 2004#
F-1
333-260213
October 13, 2021
4.14
Amendment No. 1 to Restated License Agreement between The Johns Hopkins University and MDxHealth dated April 15, 2005#
F-1
333-260213
October 13, 2021
4.15
Loan and Security Agreement between Innovatus Life Sciences Lending Fund I, LP dated August 2, 2022#
X
4.16
Asset Purchase Agreement between Genomic Health, Inc. and MDxHealth dated August 2, 2022#
X
4.17
Amendment to Asset Purchase Agreement between Genomic Health, Inc. and MDxHealth dated January 1, 2023#
X
4.18
U.S. Small Business Administration Paycheck Protection Program Note, issued by the Company to Customers Bank
F-1/A
333-260213
October 28, 2021
99
4.19
Lease Agreement between Alton Corporate Plaza LLC and MDxHealth dated December 17, 2019
F-1
333-260213
October 13, 2021
4.20
First Amendment to Lease Agreement between Alton Corporate Plaza LLC and MDxHealth dated April 23, 2020
F-1
333-260213
October 13, 2021
4.21
Second Amendment to Lease Agreement between Alton Corporate Plaza LLC and MDxHealth dated March 23, 2021
F-1
333-260213
October 13, 2021
4.22
Subscription Agreement between MDxHealth and MVM V LP and MVM GP (No. 5) LP dated April 24, 2020
F-1
333-260213
October 13, 2021
8.1
List of subsidiaries of the registrant
20-F
005-93034
April 25, 2022
12.1
Certificate of Principal Executive Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
X
12.2
Certification by the Principal Financial Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
X
13.1
Certification by the Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
X
13.2
Certification by the Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
X
15.1
Consent of BDO Réviseurs d'Entreprises SRL, Independent Registered Public Accounting Firm
X
101.INS
Inline XBRL Instance Document
101.SCH
Inline XBRL Taxonomy Extension Schema Document.
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF
Inline XBRL Taxonomy Definition Linkbase Document.
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document.
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document
104
Inline XBRL for the cover page of this Annual Report on Form 20-F (embedded within the Inline XBRL document)
*
Indicates
management compensatory plan, contract or arrangement.
#
Certain
confidential portions of this Exhibit were omitted by means of marking such portions with brackets ("[***]") because the
identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.
100
SIGNATURES
The registrant hereby certifies that it meets
all of the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned to sign this annual report
on its behalf.
MDXHEALTH SA
/s/
    Michael McGarrity
By:
Michael McGarrity
Title:
Chief Executive Officer
Date: April 25, 2023
101
MDxHealth SA
INDEX TO THE CONSOLIDATED FINANCIAL STATEMENTS
Page
Audited
    Consolidated Financial Statements for the Years Ended December 31, 2022 and 2021
Report
    of Independent Registered Public Accounting Firm PCAOB ID #1432
F-2
Consolidated Statement of Profit or Loss
F-3
Consolidated Statement of Comprehensive Income
F-4
Consolidated Statement of Financial Position
F-5
Consolidated Statement of Changes in Equity
F-6
Consolidated Statement of Cash Flow
F-7
Notes to Consolidated Financial Statements
F-8
F-
1
Report of Independent Registered Public Accounting
Firm
Shareholders and Board of Directors
MDxHealth SA
Herstal, Belgium
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated
statements of financial position of MDxHealth SA (the "Company") as of December 31, 2022 and 2021, the related consolidated
statements of profit or loss, comprehensive income, changes in equity, and cash flows for each of the three years in the period ended
December 31, 2022, and the related notes (collectively referred to as the "consolidated financial statements"). In our opinion,
the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31,
2022 and 2021, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2022
,
in conformity with the International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board
(IASB).
Basis for Opinion
These consolidated financial statements are the
responsibility of the Company's management. Our responsibility is to express an opinion on the Company's consolidated financial
statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United
States) ("PCAOB") and are required to be independent with respect to the Company in accordance with the U.S. federal securities
laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the
standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated
financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were
we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an
understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the
Company's internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to
assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures
that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the
consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made
by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide
a reasonable basis for our opinion.
/s/
BDO Réviseurs d'Entreprises
SRL
We have served as the Company's auditor since
2003.
Zaventem, Belgium
April 25, 2023
PCAOB ID #
1432
F-
2
Consolidated statement of profit or loss
Thousands of $ (except per share amounts)
For the years ended December 31
Notes
2022
2021
2020
Services
4
36,965
21,937
18,064
Licenses
4
25
250
250
Royalties and other revenues
4
64
52
146
Revenues
37,054
22,239
18,460
Cost of goods & services sold
4
(
17,835
)
(
11,675
)
(
10,416
)
Gross profit
19,219
10,564
8,044
Research and development expenses
5
(
7,557
)
(
6,673
)
(
4,543
)
Selling and marketing expenses
5
(
26,582
)
(
17,744
)
(
16,752
)
General and administrative expenses
5
(
23,539
)
(
14,149
)
(
13,990
)
Other operating income, net
7
559
1,161
118
Operating loss
(
37,900
)
(
26,841
)
(
27,123
)
Financial expenses, net
8
(
6,144
)
(
2,161
)
(
1,539
)
Loss before income tax
(
44,044
)
(
29,002
)
(
28,662
)
Income tax
9
0
0
0
Loss for the year
(
44,044
)
(
29,002
)
(
28,662
)
Loss per share attributable to parent
Basic and diluted, $
20
(
0.28
)
(
0.24
)
(
0.34
)
F-
3
Consolidated statement of comprehensive income
Thousands of $
For the years ended December 31
Notes
2022
2021
2020
Loss for the year
(
44,044
)
(
29,002
)
(
28,662
)
Other comprehensive income (loss)
Items that will be reclassified to profit or loss:
Exchange differences arising from translation of foreign operations
593
264
(
383
)
Total other comprehensive income (loss)
593
264
(
383
)
Total
comprehensive loss for the year (net of tax)
(
43,451
)
(
28,738
)
(
29,045
)
F-
4
Consolidated statement of financial position
Thousands of $
For the years ended December 31
Notes
2022
2021
ASSETS
Non-current assets
Goodwill
3/10
35,926
0
Intangible assets
11
46,166
3,448
Property, plant and equipment
12
3,791
1,671
Right-of-use assets
12
4,103
3,347
Total non-current assets
89,986
8,466
Current assets
Inventories
13
2,327
1,911
Trade receivables
14/19
9,357
4,582
Prepaid expenses and other current assets
14
1,962
1,615
Cash and cash equivalents
15/19
15,503
58,498
Total current assets
29,149
66,606
TOTAL ASSETS
119,135
75,072
EQUITY
Share capital
22
133,454
128,454
Issuance premium
22
153,177
153,177
Accumulated deficit
(
288,346
)
(
244,302
)
Share-based compensation
24
11,474
10,607
Translation reserve
(
444
)
(
1,037
)
Total equity
9,315
46,899
LIABILITIES
Non-current liabilities
Loans and borrowings
16/19
34,914
7,651
Lease liabilities
16
3,091
2,624
Other non-current financial liabilities
16/19
53,537
1,466
Total non-current liabilities
91,542
11,741
Current liabilities
Loans and borrowings
16/19
616
4,441
Lease liabilities
16
1,172
840
Trade payables
18/19
10,178
7,455
Other current liabilities
18
3,985
2,735
Other current financial liabilities
16/19
2,327
961
Total current liabilities
18,278
16,432
Total liabilities
109,820
28,173
TOTAL EQUITY AND LIABILITIES
119,135
75,072
F-
5
Consolidated statement of changes in equity
Attributable to owners of mdxhealth sa
Thousands of $
(except number of shares)
Number of
shares
Share capital
& issuance premium
Accumulated
Deficit
Share-based
compensation
Translation
reserve
Total
equity
Notes
22
24
Balance at January 1, 2020
70,528,525
199,190
(
186,638
)
8,090
(
918
)
19,724
Loss for the year
(
28,662
)
(
28,662
)
Other comprehensive income
(
383
)
(
383
)
Total comprehensive income for the year
(
28,662
)
(
383
)
(
29,045
)
Transactions with owners in their capacity as owners:
Issuance of shares
20,162,924
14,186
14,186
Deduction of transaction costs
(
311
)
(
311
)
Share-based compensation costs
1,295
1,295
Balance at December 31, 2020
90,691,449
213,065
(
215,300
)
9,385
(
1,301
)
5,849
Balance at January 1, 2021
90,691,449
213,065
(
215,300
)
9,385
(
1,301
)
5,849
Loss for the year
(
29,002
)
(
29,002
)
Other comprehensive income
264
264
Total comprehensive income for the year
(
29,002
)
264
(
28,738
)
Transactions with owners in their capacity as owners:
Issuance of shares
65,277,777
75,339
75,339
Deduction of transaction costs
(
6,773
)
(
6,773
)
Share-based compensation costs
1,222
1,222
Balance at December 31, 2021
155,969,226
281,631
(
244,302
)
10,607
(
1,037
)
46,899
Balance at January 1, 2022
155,969,226
281,631
(
244,302
)
10,607
(
1,037
)
46,899
Loss for the year
(
44,044
)
(
44,044
)
Other comprehensive income
593
593
Total comprehensive income for the year
(
44,044
)
593
(
43,451
)
Transactions with owners in their capacity as owners:
Issuance of shares as part of GPS acquisition
6,911,710
5,000
5,000
Share-based compensation costs
867
867
Balance at December 31, 2022
162,880,936
286,631
(
288,346
)
11,474
(
444
)
9,315
F-
6
Consolidated statement of cash flow
Thousands
of $
For the years ended December 31
Notes
2022
2021
2020
CASH FLOWS FROM OPERATING ACTIVITIES
Operating loss
(
37,900
)
(
26,841
)
(
27,123
)
Depreciation and amortization
11/12
4,909
3,036
3,332
Impairment
11
44
0
273
Share-based compensation
24
867
1,222
1,295
Other non-cash transactions
(
473
)
(
325
)
26
Cash used in operations before working capital changes
(
32,553
)
(
22,908
)
(
22,197
)
Increase (-) / Decrease (+) in inventories
13
(
416
)
413
(
1,132
)
Increase (-) in receivables
14
(
5,122
)
(
1,383
)
2,851
Increase (+) in payables
18/19
3,973
1,330
234
Net cash outflow from operating activities
(
34,118
)
(
22,548
)
(
20,244
)
CASH FLOWS FROM INVESTING ACTIVITIES
Purchase of property, plant and equipment
12
(
2,789
)
(
896
)
(
537
)
Acquisition and generation of intangible assets
11
(
1,374
)
0
0
Acquisition of Genomic Prostate Score Business
11
(
25,000
)
0
0
Net cash outflow from investing activities
(
29,163
)
(
896
)
(
537
)
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from issuance of shares (net of transaction costs)
22
0
68,566
13,875
Proceeds from loan obligation
16
34,291
0
2,316
Repayment of loan obligation and debt extinguishment costs
(
10,805
)
0
0
Payment of lease liability
16
(
1,358
)
(
1,057
)
(
831
)
Payment of interest
(
1,412
)
(
1,011
)
(
1,070
)
Interests received
8
125
11
0
Net cash inflow from financing activities
20,841
66,509
14,290
Net Decrease (-) / increase (+) in cash and cash equivalents
(
42,440
)
43,065
(
6,491
)
Cash and cash equivalents at beginning of the financial year
58,498
15,953
22,050
Effect on exchange rate changes
(
555
)
(
520
)
394
Cash and cash equivalents at end of the financial year
14/18
15,503
58,498
15,953
F-
7
NOTE 1: Status and principal activity
When used in this report, all references to "MDxHealth",
the "company", "we", "our" and "us" refer to MDxHealth, SA and its subsidiaries. MDxHealth is
a limited liability company domiciled in Belgium, with offices and labs in Belgium, the United States and The Netherlands.
MDxHealth is a commercial-stage precision diagnostics
company committed to providing non-invasive, clinically actionable and cost-effective urologic solutions to improve patient care. The
Company's novel prostate cancer genomic testing solutions combine advanced clinical modeling with genomic data to provide each
patient with a personalized cancer risk profile, which provides more accurate and actionable information than standard risk factors (e.g.,
PSA, DRE, age) used by clinicians.
The Company's Select mdx and Confirm mdx
solutions address men at risk for developing prostate cancer, providing physicians with a clear clinical pathway to accurately identify
clinically significant prostate cancer while minimizing the use of invasive procedures that are prone to complications. The Company's
Genomic Prostate Score (GPS) solution addresses men newly diagnosed with early-stage prostate cancer, providing physicians with a clear
clinical pathway to make the most informed treatment decision for their individual disease, including active surveillance. The Company's
collective decades of experience in precision diagnostics and its portfolio of novel biomarkers for diagnostic, prognostic and predictive
molecular assays supports its active pipeline of new testing solutions for prostate and other urologic diseases.
MDxHealth offers its laboratory solutions from
its state-of-the-art,
13,448
square feet, College of American Pathologists (CAP)-accredited and Clinical Laboratory Improvement Amendments
of 1988 ("CLIA") certified, molecular laboratory facility located at its U.S. headquarters in Irvine, California as well
as a CLIA-certified lab in Plano, Texas. MDxHealth also operates a molecular laboratory facility, MDxHealth B.V., located in Nijmegen,
the Netherlands. This site is ISO 13485:2016 certified and operates a management quality system with the following scope: The design
and development, manufacture, service laboratory activities and client services of in vitro diagnostic test kits, in vitro diagnostic
reagents used for molecular diagnostic detection of oncological diseases.
The Company is headquartered in Belgium. The
parent company, MDxHealth SA, has its registered and corporate office in Cap Business Center, Rue d'Abhooz 31, 4040 Herstal, Belgium.
MDxHealth, Inc., the Company's U.S. subsidiary, is located at 15279 Alton Parkway, Suite 100, Irvine, CA 92618, United States.
MDxHealth B.V., the Company's Dutch subsidiary, is located at Transistorweg 5, 6534 Nijmegen, The Netherlands.
NOTE 2: Summary of Significant Accounting
Policies
2.1.
Basis of preparation and statement of compliance
MDxHealth's consolidated financial statements have been prepared
in accordance with the International Financial Reporting Standards (IFRS) and interpretations issued by the IFRS Interpretation Committee
(IFRS-IC) applicable to companies reported under IFRS. The financial statements comply with IFRS as issued by the International Accounting
Standards Board (IASB), collectively "IFRS". Additionally, the financial statements are also prepared in accordance with IFRS
as endorsed by the European Union ("EU-IFRS").
The principal accounting policies applied in
the preparation of the consolidated financial statements are set out below. These policies have been consistently applied to all the
years presented, unless otherwise stated. The functional and presentation currency is the U.S. Dollar and all amounts are presented in
thousands of U.S. Dollars ($), rounded to the nearest thousand, unless otherwise indicated.
2.2.
Basis of consolidation
The consolidated financial statements incorporate
the financial statements of MDxHealth SA (Belgium) and its wholly-owned subsidiaries, including MDxHealth Inc. (United States), and MDxHealth
BV (The Netherlands) for each fiscal year ending on December 31.
Subsidiaries are all entities over which the
Company has control. The Company controls an entity when the Company is exposed to, or has rights to, variable returns from its involvement
with the entity and has the ability to affect those returns through its power to direct the activities of the entity. Subsidiaries are
fully consolidated from the date on which control is transferred to the Company. The acquisition method of accounting is used to account
for business combinations by the Company.
All intercompany balances, profits and transactions are eliminated
upon consolidation.
F-
8
2.3.
Going Concern
The Company has experienced net losses and significant
cash used in operating activities since its inception in 2003, and as of December 31, 2022, had an accumulated deficit of $
288.3
million,
a net loss of $
44.0
million, and net cash used in operating activities of $
34.1
million. Management expects the Company to continue to
incur net losses and have significant cash outflows for at least the next twelve months. While these conditions, among others, could
raise doubt about its ability to continue as a going concern, these consolidated financial statements have been prepared assuming that
the Company will continue as a going concern. This basis of accounting contemplates the recovery of its assets and the satisfaction of
liabilities in the normal course of business. A successful transition to attaining profitable operations is dependent upon achieving
a level of positive cash flows adequate to support the Company's cost structure.
As of December 31, 2022, the Company had cash and cash equivalents of
$
15.5
million. In February 2023, the Company raised $
40
million in gross proceeds by means of a public offering of
10,000,000
American
Depository Shares (ADSs) being the equivalent of
100,000,000
new shares (approximately
38
% of the Company's outstanding shares)
at an issue price of $
4.00
per ADS (or approximately €
0.37
per share) through a public offering. In March 2023, the Company received
additional gross proceeds of $
3.0
million from the underwriters' exercise of their overallotment option (for further details of
this transaction, refer to Note 27 Subsequent Events). Taking into account the above financial situation and on the basis of the most
recent business plan, the Company believes that it has sufficient cash to be able to continue its operations for at least the next twelve
months from the date of issuance of these financial statements, and accordingly has prepared the consolidated financial statements assuming
that it will continue as a going concern. This assessment is based on forecasts and projections within management's most recent
business plan as well as the Company's expected ability to realize cost reductions should these forecasts and projections not be
met.
COVID-19 and Macroeconomic
Factors
The Company does not believe that COVID-19 or the Ukraine war has an
impact on the Company's ability to continue as a going concern. The Company does not have business relationships with Russia or
Ukraine. There is no direct or indirect impact of the conflict on the day-to-day business of the Company. The Company is not materially
impacted by inflation, supply disruption or cyber-attacks due to the current geopolitical conflict.
With regards to climate-related matters, the
Company is not impacted in a material way by extreme weather conditions.
2.4.
Use of estimates and judgments
Management makes certain critical accounting estimates and management
judgments when applying the Company's accounting policies, which affect the reported amounts of assets and liabilities, the disclosure
of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenue and expenses during
the reporting period. Estimates and judgments are continuously evaluated based on historical experience and other factors, including expectations
of future events, which are believed to be reasonable under the circumstances. In the future, actual experience may differ from these
estimates and assumptions.
The areas where assumptions and estimation uncertainties
in the financial statements have potentially the most significant effect in 2022, are listed below:
Business combination (see Note 3)
On August 2, 2022, the Company announced it has entered into an agreement
with Genomic Health, Inc., a subsidiary of Exact Sciences Corporation ("Exact Sciences"), to acquire the Genomic Prostate
Score® (GPS) test (formerly Oncotype DX GPS) from Exact Sciences. The company accounted for this acquisition under the acquisition
method of accounting and treated it as a business combination in accordance with IFRS. The purchase price was allocated based on the estimated
fair value of net assets acquired and liabilities assumed at the date of the acquisition. Following the closing, an additional aggregate
earn-out amount of up to $
70
million is to be paid by MDxHealth to Exact Sciences upon achievement of certain revenue milestones related
to fiscal years 2023 through 2025. The fair value of this contingent consideration at the acquisition date of August 2, 2022, was assessed
at $
50.5
million, based on a probability-weighted estimate of the net present value expected to become payable, as further detailed in
Note 3. Subsequent fair value adjustments to this contingent consideration classified as financial liability are recognized through the
statement of profit or loss.
Revenue recognition (see Note 4):
As further described in Note 2.7 (paragraph "Determining
the Transaction Price"), the Company analyzes historical collection data on a quarterly basis and makes adjustments to its estimates.
In accordance with IFRS 15, revenue is recognized where such a variable consideration is included in the transaction price only
to the extent that it is highly probable that the amount of revenue recognized will not be subject to significant future reversals as
a result of subsequent re-estimation.
F-
9
Deferred income tax (see Note 9)
Management estimates unused tax credits and tax
losses to the extent that it is probable that taxable profit will be available against which the tax credits and tax losses can be utilized.
On December 31, 2022, the Company had a consolidated net tax loss carried forward amounting to $
285.3
million (2021: $
258.5
million),
implying a potential deferred tax asset of $
71.3
million (2021: $
64.6
million). No deferred tax assets have been recognized as of December 31,
2022.
Impairment Testing (see Note 3, 10 and 11)
The Company has recorded Goodwill of $
35.9
million
as part of the GPS business combination (explained above), which is subject to annual impairment testing. The Company has performed an
impairment test as of December 31, 2022, at the level of the entire company which is in line with the level at which management monitors
its profitability. All the Company's cash-generating units (CGUs) are expected to benefit from the synergies of the business combination.
The impairment testing is based on a discounted
cash flow (DCF) model, with cash flows for the next
five years
derived from the internal budgets and a residual value that assumes a
perpetual growth rate of
2
%. The value in use is sensitive to the discount rate used for the DCF model as well as the expected future
cash-inflows and the growth rate used for extrapolation purposes.
Key underlying estimates are considered to be estimated cashflows and
the weighted-average cost of capital (WACC) and are further described in Note 10.
Share-Based Payments (see Note 24)
Management estimates the fair value of the equity-settled share-based payment
transactions by using the Black-Scholes option valuation model:
●
The dividend return is estimated by reference to the historical
dividend payment of the Company; currently, this is estimated to be zero as no dividends have been paid since inception
●
The expected volatility was determined using the average
volatility of the stock over the last two years at the date of grant
●
Risk-free interest rate is based on the interest rate
applicable for the
10
-year Belgian government bond at the grant date
Going Concern (note 2.3)
Management needs to make significant judgements
whether the Company will have sufficient liquidity to continue operations during the next twelve months. Refer to Note 2.3 for management
assessment.
Financial liabilities (note 16)
Other financial liabilities are accounted for
at fair value through the statement of profit or loss and include the following:
●
The fair value of the contingent consideration payable to Exact Sciences
(for the GPS acquisition) and to NovioGendix, which are presented in the yearend statement of financial position under "other non-current
financial liabilities" and "other current financial liabilities" are based on an estimated outcome of the conditional
purchase price/contingent payments arising from contractual obligations (level 3 input). These are initially recognized as part of the
purchase price and then subsequently measured for fair valued. Any changes to fair value are recorded through "other operating income"
in the statement of profit or loss.
o
The fair value of the contingent consideration payable with regard to
the GPS acquisition is based on a probability-weighted average estimate based on multiple scenarios varying in timing and amount of earn-out
payment. This probability-weighted estimate is then discounted to its net present value taking into account the expected time when the
earn-out would become payable in 2024, 2025 and 2026. This contingent consideration was initially recorded along with the purchase price
allocation of this business combination as detailed in Note 3. Fair value at December 31, 2022, was estimated at $
52.9
million resulting
in a fair value adjustment expense of $
2.4
million. The Company used a discount rate of
14.95
%.
o
For NovioGendix, fair value adjustments gain for the year
ended December 31, 2022, totaled $
632,000
and the Company used a discount rate of
12.16
%.
●
The
fair value of the derivative financial liabilities related to the initial Kreos drawdown fee of €
630,000
is based upon the evolution
of the share price of MDxHealth as well as the estimated probabilities that either payment at
150
%, or conversion into shares, will be
requested by Kreos. Whereas share price of MDxHealth can be considered as a level 1 input, the other variable, being the probability
assessment of possible scenarios should be considered as level 3 input. The fair value of the liability for the year ended December 31,
2022, is estimated at $
891,000
.
The fair value
of the derivative financial liabilities related to the Innovatus derivative call option (as detailed in Note 16) was performed using
a binomial pricing model which takes into account several factors including the expected evolution in price of an ADS and are considered
as level 3 input. The fair value of the liability for the year ended December 31, 2022, is estimated at $
0.9
million.
F-
10
2.5.
New Standards, Interpretations and Amendments
2.5.1. New Standards, Interpretations and Amendments adopted by
the Company
The accounting policies have been consistently
applied by the Company and are consistent with those used in previous years.
In the current financial year, the following
amendments to standards went into effect for the financial year beginning January 1, 2022, and have been endorsed by the European Union.
●
Amendments
to IFRS 3 Business Combinations; IAS 16 Property, Plant and Equipment; IAS 37 Provisions, Contingent Liabilities and Contingent Assets
as well as Annual Improvements (effective 1 January 2022). The package of amendments includes narrow-scope amendments to three Standards
as well as the Board's Annual Improvements, which are changes that clarify the wording or correct minor consequences, oversights
or conflicts between requirements in the Standards.
o
Amendments to IFRS 3 Business Combinations
                                            update a reference in IFRS 3 to the Conceptual Framework for Financial Reporting without
                                            changing the accounting requirements for business combinations.
o
Amendments to IAS 16 Property, Plant and Equipment prohibit a company
from deducting from the cost of property, plant and equipment amounts received from selling items produced while the company is preparing
the asset for its intended use. Instead, a company will recognize such sales proceeds and related cost in profit or loss.
o
Amendments to IAS 37 Provisions, Contingent
                                            Liabilities and Contingent Assets specify which costs a company includes when assessing whether
                                            a contract will be loss-making.
o
Annual Improvements 2018-2020 make minor
                                            amendments to IFRS 1 First-time Adoption of International Financial Reporting Standards,
                                            IFRS 9 Financial Instruments, IAS 41 Agriculture and the Illustrative Examples accompanying
                                            IFRS 16 Leases.
This adoption has not had any material impact
on the disclosures or on the amounts reported in these financial statements.
2.5.2. Standards and Interpretations issued
but not yet effective in the current period
Certain new accounting standards and amendments
to standards have been published, but were not mandatory for December 31, 2022 reporting period.
The following new standard and amendments have
been issued and endorsed by the European Union, but are not mandatory for the financial year beginning January 1, 2022:
●
Amendments
                                            to IAS 1 Presentation of Financial Statements and IFRS Practice Statement 2: Disclosure of
                                            Accounting policies (effective January 1, 2023). The amendments aim to improve accounting
                                            policy disclosures and to help users of the financial statements to distinguish between changes
                                            in accounting estimates and changes in accounting policies. The IAS 1 amendment requires
                                            companies to disclose their material accounting policy information rather than their significant
                                            accounting policies. Further, the amendment to IAS 1 clarifies that immaterial accounting
                                            policy information need not be disclosed. To support this amendment, the Board also amended
                                            IFRS Practice Statement 2, 'Making Materiality Judgements', to provide guidance
                                            on how to apply the concept of materiality to accounting policy disclosures. The amendments
                                            are effective for annual reporting periods beginning on or after January 1, 2023. Earlier
                                            application is permitted (subject to any local endorsement process).
●
Amendments
                                            to IAS 8 Accounting policies, Changes in Accounting Estimates and Errors: Definition of Accounting
                                            Estimates (effective January 1, 2023). The amendment to IAS 8, 'Accounting Policies,
                                            Changes in Accounting Estimates and Errors', clarifies how companies should distinguish
                                            changes in accounting policies from changes in accounting estimates. The amendments are effective
                                            for annual reporting periods beginning on or after January 1, 2023. Earlier application is
                                            permitted (subject to any local endorsement process).
●
Amendments
                                            to IAS 12 Income Taxes: Deferred Tax related to Assets and Liabilities arising from a Single
                                            Transaction (effective January 1, 2023). The amendments clarify how companies account for
                                            deferred tax on transactions such as leases and decommissioning obligations. The main change
                                            in the amendments is an exemption from the initial recognition exemption of IAS 12.15(b)
                                            and IAS 12.24. Accordingly, the initial recognition exemption does not apply to transactions
                                            in which equal amounts of deductible and taxable temporary differences arise on initial recognition.
                                            The amendments are effective for annual reporting periods beginning on or after January 1,
                                            2023 and early adoption is permitted.
F-
11
No amendments to standards that are issued but
not yet effective are considered to materially affect the Company's accounting policies or any of the disclosures when applied
for the first time.
The following amendments have been issued, but
are not mandatory for the financial year beginning January 1, 2022, and have not been endorsed by the European Union:
●
Amendments
to IAS 1 'Presentation of Financial Statements: Classification of Liabilities as current or non-current' (effective January
1, 2024), affect only the presentation of liabilities in the statement of financial position — not the amount or timing of recognition
of any asset, liability income or expenses, or the information that entities disclose about those items. The amendments:
o
clarify that the classification of liabilities
                                            as current or non-current should be based on rights that are in existence at the end of the
                                            reporting period and align the wording in all affected paragraphs to refer to the "right"
                                            to defer settlement by at least twelve months and make explicit that only rights in place
                                            "at the end of the reporting period" should affect the classification of a liability;
o
clarify that classification is unaffected
                                            by expectations about whether an entity will exercise its right to defer settlement of a
                                            liability; and make clear that settlement refers to the transfer to the counterparty of cash,
                                            equity instruments, other assets or services; and
o
clarify how conditions with which an entity
                                            must comply within 12 months after the reporting period, such as covenants, affect the corresponding
                                            liability's classification.
●
Amendments to IFRS 16 Leases: Lease Liability in a Sale and Leaseback
(effective January 1, 2024). The amendments explain how an entity accounts for a sale and leaseback after the date of the transaction,
specifically where some or all the lease payments are variable lease payments that do not depend on an index or rate. They state that,
in subsequently measuring the lease liability, the seller-lessee determines 'lease payments' and 'revised lease payments'
in a way that does not result in the seller-lessee recognizing any amount of the gain or loss that relates to the right of use it retains.
Any gains and losses relating to the full or partial termination of a lease continue to be recognized when they occur as these relate
to the right of use terminated and not the right of use retained.
The Company will make an impact analysis in view
of the application of the amendment of IAS 1 on its consolidated financial statements.
2.6.
Foreign currency translation
Functional and presentation currency
Items included in the financial statements of
each of the Company's entities are measured using the currency of the primary economic environment in which the entity operates
(the functional currency). The Company's functional and presentation currency is the U.S. dollar based on the continuing development
of the commercial activities in the U.S. market.
Foreign currency transactions are translated into the functional currency
using the exchange rates at the date of the transactions. Foreign exchange gains and losses resulting from the settlement of such transactions
and from the translation of monetary assets and liabilities denominated in foreign currencies at year-end exchange rates are generally
recognized in profit or loss.
The results and financial positions of foreign
operations that have a functional currency different from the presentation currency are translated into the presentation currency as
follows:
●
Assets
and liabilities for each statement of financial position presented are translated at the closing rate at the date of that balance sheet
●
Income
and expenses for each statement of profit or loss and statement of comprehensive income are translated at average exchange rates
●
All
resulting exchange differences are recognized in other comprehensive income
F-
12
2.7.
Revenue recognition
Performance obligations and timing of revenue
recognition
The majority of the Company's revenue is
derived from laboratory services with revenue recognized at a point in time when control of the services has transferred to the customer.
This is generally when the test results are delivered to the customer.
Minor other Company's revenue is derived
from license fees and royalties:
●
License
fees are recognized when the Company has fulfilled all conditions and obligations. If the Company has continuing performance obligations
towards the fees, the fee will be recognized on a straight-line basis over the contractual performance period.
●
Royalties
are recognized as revenue once the amounts due can be reliably estimated based on the sale of the underlying products and services and
when the collection of the royalties can be reasonably assured.
License up-front (signature fees) and non-refundable
fees for access to prior research results and databases are recognized when earned, if the Company has no continuing performance obligations
and all conditions and obligations are fulfilled. If the Company has continuing performance obligations towards the fees, the fee will
be recognized on a straight-line basis over the contractual performance period.
Royalties are generated from the sales by third
parties of products or services which incorporate the Company's proprietary technology. Royalties are recognized as revenue once
the amounts due can be reliably estimated based on the sale of the underlying products and services and when the collection of the royalties
can be reasonably assured.
Determining the transaction price
A large portion of the Company's revenues
are derived from Medicare, which reimburses the Company for tests performed on its insured patients. Medicare has set a fixed price (via
a Local Coverage Determination or "LCD") for the Company's Confirm mdx and GPS tests. Therefore, the amount of revenue
recognized from Medicare for these tests is determined by reference to the LCD pricing.
For other patients insured by commercial insurance
companies where there is no certainty of the amount that will be paid for services rendered, the Company uses historical collection data
– on an individual payor basis – to estimate its future collection and corresponding revenues that should be recognized for
each type of test.
The Company analyzes historical collection data
on a monthly basis and makes monthly adjustments to its estimates. In accordance with IFRS 15, revenue is recognized where such a variable
consideration is included in the transaction price only to the extent that it is highly probable that the amount of revenue recognized
will not be subject to significant future reversals as a result of subsequent re-estimation.
When historical collection data is insufficient
to estimate future collections, the Company defaults to cash basis, meaning that revenues will not be recognized until actual cash payment
is received from the payor.
Total revenue in any given year includes amounts
related to tests performed in previous years that relate to:
●
revenue
                                            from transactions in previous years that did not previously meet the revenue recognition
                                            criteria;
●
differences
                                            between the revenue recognized in previous years and the actual amount received; and
●
reversals
                                            of revenue relating to balances that are outstanding for more than 9 months.
2.8.
Segment information
Information for the Company's operating
segments has been determined by reference to the information used by the chief operating decision maker ("CODM") of the Company
to review the performance of the Company and in making decisions on allocation of resources, the nature of the activities and the management
structure and accountabilities. The Company's CEO has been identified as the chief operating decision maker in accordance with
his designated responsibility for the allocation of resources to operating segments and assessing their performance through periodic
reporting. The CODM periodically reviews the Company's performance based on information at a company level.
The Company monitors the profitability of the
group as a whole given revenues are generated from clinical laboratory service testing and does accordingly not distinguish different
business segments.
F-
13
2.9.
intangible assets
Initial measurement:
Externally acquired
Intangible assets are recognized on business combinations if they
are separable from the acquired entity or give rise to other contractual/legal rights. The amounts ascribed to such intangibles are determined
using appropriate valuation techniques.
Intangible assets are recognized on the business combinations of NovioGendix
in 2015 (Select mdx) and GPS in 2022 and include:
●
Externally
                                            acquired intellectual property, including patents, technology and related IP; and
●
Customers
All were valued through application of the relief from royalty method,
except for the customers which were valued on the basis of multi-period excess earnings method.
Externally acquired intangible assets also include patents and software
licenses which are initially recognized at cost.
Internally generated intangible assets (development
costs)
Development costs are capitalized when the following can be demonstrated:
●
It
                                            is technically feasible to develop the product for it to be sold;
●
Adequate
                                            resources are available to complete the development;
●
There
                                            is an intention to complete and sell the product;
●
The
                                            Company is able to sell the product;
●
Sale
                                            of the product will generate future economic benefits; and
●
Expenditures
                                            on the project can be measured reliably.
Internally generated intangible assets relate to Confirm mdx, Select
mdx, Resolve mdx and GPS.
Subsequent measurement
Intangible assets are carried at their cost less
any accumulated amortization and any accumulated impairment losses amortized on a straight-line basis over their estimated useful lives
on the following basis:
●
Patents
                                            & software: shorter of (a) 5 years; or (b) the software license period / patent life
●
Intellectual property:
10
-
15
years
●
Customers:
6.5
years
●
Capitalized development costs:
5
years
Amortization over the asset's useful life shall begin when the
asset is available for use.
2.10.
Property, plant and equipment
Property, plant and equipment are stated at historical
cost less accumulated depreciation and impairment. Repair and maintenance costs are charged to the income statement as incurred. Gains
and losses on the disposal of property, plant and equipment are included in other income or expenses. Depreciation is charged to write
off the cost or valuation of assets over their useful lives, using the straight-line method, on the following basis:
●
Equipment:
                                            5 years
●
IT
                                            hardware and software: 3 years
F-
14
●
Furniture:
                                            5 years
●
Vehicles:
                                            5 years
●
Leasehold
                                            improvements: in line with the non-cancellable lease period of the related lease
2.11.
Right-of-use assets and liabilities
Right-of-use assets:
The Company recognizes right-of-use assets at
the commencement date of the lease (i.e., the date the underlying asset is available for use). Right-of-use assets are measured at cost,
less any accumulated depreciation and impairment losses, and adjusted for any remeasurement of lease liabilities. The cost of right-of-use
assets includes the amount of lease liabilities recognized, initial direct costs incurred, and lease payments made at or before the commencement
date less any lease incentives received. Unless the Company is reasonably certain to obtain ownership of the leased asset at the end
of the lease term, the recognized right-of-use assets are depreciated on a straight-line basis over the shorter of its estimated useful
life and the lease term. Depreciation periods range between
3
and
6
years. Right-of-use assets are subject to impairment.
Lease liabilities:
At the commencement date of the lease, the Company
recognizes lease liabilities measured at the present value of lease payments to be made over the lease term. The lease payments include
fixed payments (including in substance fixed payments) less any lease incentives receivable, variable lease payments that depend on an
index or a rate, and amounts expected to be paid under residual value guarantees. The lease payments also include the exercise price
of a purchase option reasonably certain to be exercised by the Company and payments of penalties for terminating a lease, if the lease
term reflects the Company exercising the option to terminate. The variable lease payments that do not depend on an index or a rate are
recognized as expense in the period on which the event or condition that triggers the payment occurs. In calculating the present value
of lease payments, the Company uses the incremental borrowing rate at the lease commencement date which is in the following ranges:
●
Buildings:
10
% and
11
%
●
Vehicles:
2.5
% and
3.75
%
●
Materials:
5
% and
6
%
After the commencement date, the amount of lease
liabilities is increased to reflect the accretion of interest and reduced for the lease payments made. In addition, the carrying amount
of lease liabilities is remeasured if there is a modification, a change in the lease term, a change in the in-substance fixed lease payments
or a change in the assessment to purchase the underlying asset.
Short-term leases and leases of low-value
assets:
The Company applies the short-term lease recognition
exemption to its short-term leases of machinery and equipment (i.e., those leases that have a lease term of 12 months or less from the
commencement date and do not contain a purchase option). It also applies the lease of low-value assets recognition exemption to leases
of office equipment that are considered of low value (i.e., below $
5,000
). Lease payments on short-term leases and low-value assets are
recognized in the consolidated statement of profit or loss as incurred.
2.12.
Impairment of assets
Goodwill and intangible assets that have an indefinite useful life
are not subject to amortization and are tested annually for impairment, or more frequently if events or changes in circumstances indicate
that they might be impaired. Other assets are tested for impairment whenever events or changes in circumstances indicate that the carrying
amount may not be recoverable. An impairment loss is recognized for the amount by which the asset's carrying amount exceeds its
recoverable amount. The recoverable amount is the higher of an asset's fair value less costs of disposal and value in use. The Company
monitors its Goodwill at consolidated Company level which is the level of the Company of cash-generating units (CGUs) benefiting from
the synergies. Non-financial assets other than Goodwill that suffered an impairment are reviewed for possible reversal of the impairment
at the end of each reporting period.
2.13.
Inventories
Inventories are initially recognized at cost,
and subsequently at the lower of cost and net realizable value. Cost comprises merely purchase costs, as the inventory consists solely
of raw materials. Raw materials are not ordinarily interchangeable, and they are as such accounted for using the specific identification
of their individual cost.
The Company does not account for work in progress
and finished products.
F-
15
2.14.
Government Grants
A government grant is only recorded as a receivable
when (i) the grant has been approved by the granting party, (ii) the amounts are measurable, and (iii) the Company believes it will meet
the conditions necessary to be able to receive/use the grant.
Government grants are recognized as other operating
income over the life of the grant as the required or planned activities are performed and the related costs are incurred, and when there
is reasonable assurance that the Company will comply with the conditions of the grant.
2.15.
Cash and cash equivalents
Cash and cash equivalents are carried on the
consolidated statement of financial position at nominal value. For the purposes of the cash flow statements, cash and cash equivalents
comprise cash on hand, deposits held on call with banks, other short-term highly liquid investments and bank overdrafts. Bank overdrafts,
if any, are included in borrowings included in current liabilities.
2.16.
Taxation
Current tax assets and liabilities for the current
period are measured at the amount expected to be recovered from or paid to the taxation authorities. The tax rates and tax laws used
to compute the amount are those that are enacted or substantively enacted, at the reporting date.
Deferred income tax is provided in full using
the "balance sheet liability method", on temporary differences between the carrying amount of assets and liabilities for
financial reporting purposes and the amounts used for taxation purposes.
Deferred tax liabilities are recognized for all
taxable differences. Deferred tax assets are recognized for all deductible temporary differences, carry forward of unused tax credits
and unused tax losses, to the extent that it is probable that taxable profit will be available against which the deductible temporary
differences, and the carry forward of unused tax credits and unused tax losses can be utilized.
The carrying amount of deferred tax assets is
reviewed at each reporting date and reduced to the extent that it is no longer probable that sufficient taxable profit will be available
to allow all or part of the deferred tax asset to be utilized. Unrecognized deferred tax assets are reassessed at each reporting date
and are recognized to the extent that it has become probable that future taxable profits will allow the deferred tax asset to be recovered.
Deferred tax assets and liabilities are measured
at the tax rates that are expected to apply in the year when the asset is realized or the liability is settled, based on tax rates (and
tax laws) that have been enacted or substantively enacted at the reporting date.
Deferred tax assets and deferred tax liabilities
are offset, if a legally enforceable right exists to set off current tax assets against current income tax liabilities and the deferred
taxes relate to the same taxable entity and the same taxation authority.
2.17.
Share Capital
Ordinary shares are classified as equity. Incremental
costs directly attributable to the issue of new shares or options are shown in equity as a deduction, net of tax, from the proceeds.
2.18.
Financial Assets
The financial assets consist mainly of trade
receivables and other current assets (deposits).
Classification and measurement on initial
recognition
The classification of financial assets at initial
recognition depends on the financial asset's contractual cash flow characteristics and the Company's business model for managing
them.
The company initially measures a financial asset
at its fair value plus, in the case of a financial asset not at fair value through profit or loss, transaction costs.
For both trade receivables that do not contain a significant financing
component, and trade receivables for which the collection is expected in less than
one year
, the Company has applied the simplified approach
to providing for expected credit losses (ECL) prescribed by IFRS 9, which requires the use of the lifetime expected loss provision for
all trade receivables.
F-
16
Trade receivables do not carry any interest and
are recognized initially at fair value and subsequently measured at amortized cost using the effective interest method, less provision
for impairment based on expected credit losses, where applicable.
Subsequent measurement
After initial recognition, trade receivables
and some other current assets as listed in Note 14 are measured at amortized cost using the effective interest method, less provision
for impairment based on expected credit losses.
2.19.
Financial Liabilities
The financial liabilities consist mainly of loans
and borrowings, lease liabilities, trade and other payables and other financial liabilities that include derivative financial liabilities
and contingent consideration related to business combinations.
Measurement on initial recognition
At initial recognition, financial liabilities
are measured at fair value less transaction costs unless the financial liability is carried at fair value through the statement of profit
or loss, in which case the transaction costs are immediately recognized in the statement of profit or loss. The best estimate of the
fair value at initial recognition is usually the transaction price, represented by the fair value of the consideration given or received
in exchange for the financial instrument. Any difference between the fair value estimated by the entity and the transaction price ("day
one gain or loss") is recognized:
●
in
                                            the statement of profit or loss if the estimate is evidenced by a quoted price in an active
                                            market; and
●
deferred
                                            as an adjustment to the carrying amount of the financial instrument in all other cases.
The fair value of the contingent consideration
payable at the date of acquisition is computed as the sum of the probability-weighted fair values of the purchase prices, as follows:
●
GPS
:
                                            the liability recognized reflects a probability-weighted estimate at the current net present
                                            value at the date of acquisition, which is expected to become payable.
●
Noviogendix
:
                                            each of the potential product development paths. The fair value of each path is in turn computed
                                            as the sum of the survival probability discounted to present values of the contingent payments
                                            in each such path, including the milestone and commercialization payments. Any other financial
                                            liability included in the consideration payable for a business combination is recorded at
                                            fair value at the date of acquisition.
The derivative financial instrument related to
the Innovatus debt facility option to convert up to
15
% of the outstanding aggregate principal amount into ordinary shares of the Company
for a period up to August 2, 2025, is accounted for at fair value with a portion of the transaction costs allocated to the embedded derivative
being expensed as incurred. The embedded derivative will be measured as an American call option using a binomial tree option pricing
model with changes to fair value being recorded in the statement of profit or loss under Financial expenses, net, as described further
in Note 16.
The derivative financial instrument related to
the initial drawdown fee of the Kreos debt facility, which is either convertible into shares of the Company or repayable in cash at
150
%
at the discretion of Kreos through 2029, is computed as the sum of the probability-weighted values of the fair values associated with
each of the possible outcomes further described in Note 16.
Subsequent measurement
After initial recognition, loans and borrowings,
lease liabilities, trade and other payables, are measured at amortized cost using the effective interest method. Contingent considerations
and derivative financial liabilities are measured at fair value are reviewed at each reporting period, with any changes in fair value
recorded in the statement of profit and loss.
2.20.
Retirement benefit plans and employee savings plans
Payments to defined contribution employee savings
plans are charged as an expense as they fall due. The Company does not offer nor operate any material defined benefit plans for its employees.
With respect to Belgian pension plans and as explained in Note 23, the Company has considered the potential impact of the employer's
legal obligation to guarantee a minimum return on the Belgian pension plans and that this was assessed not to be significant.
2.21.
Share-based compensation plans for personnel, directors and business associates
The Company grants stock options in accordance
with several share-based compensation plans in consideration for services performed by personnel, directors and business associates.
The cost of the services rendered is measured at the fair value of the granted options and recognized as an expense in the statement
of profit or loss. The corresponding credit is recorded directly into equity.
F-
17
The estimate of the number of options which will
ultimately vest is revised at each reporting date. The change in estimate is recorded as an expense with a corresponding correction in
equity.
The received amount, less directly attributable
transaction costs, will be recorded as share capital and share premium when the options are exercised.
NOTE 3: Business combination
Acquisition of Genomic Prostate Score
®
(GPS) test (formerly Oncotype DX GPS) from Exact Sciences
On August 2, 2022, the Company announced it has
entered into an agreement with Genomic Health, Inc., a subsidiary of Exact Sciences Corporation ("Exact Sciences"), to acquire
the GPS test from Exact Sciences. MDxHealth acquired GPS in order to expand its menu of tests targeted into urology and prostate cancer
and in order to position the Company as one of the leaders in the urology and prostate cancer space with one of the most comprehensive
menus of precision diagnostics.
Under the terms of the agreement, the Company
acquired the GPS prostate cancer business of Exact Sciences for an aggregate purchase price of up to $
100
million, of which an amount
of $
25
million was paid in cash and an amount of $
5
million was settled through the delivery of
691,171
American Depositary Shares ("ADSs")
of the Company, at a price per ADS of $
7.23
. Following the closing, which took place on August 2, 2022, an additional aggregate earn-out
amount of up to $
70
million is to be paid by the Company to Exact Sciences over a three year period, commencing in 2024, in tranches
equal to a portion of the annual revenues attributable to the GPS prostate cancer business for the preceding fiscal year; provided, in
each instance, that such revenues exceed certain minimum revenue milestones for such fiscal year.
At the option of MDxHealth, the earn-out amounts
can be settled in cash or through the issuance of additional ADSs of the Company (valued in function of a volume weighted average trading
price of the Company's shares at the end of the relevant earn-out period) to Exact Sciences, provided that the aggregate number of shares
representing the ADSs held by Exact Sciences shall not exceed more than
5
% of the outstanding shares of the MDxHealth.
The Acquisition was accounted for under the acquisition
method of accounting and is being treated as a business combination in accordance with IFRS given that there are inputs from the intellectual
property and customers acquired, a substantive process, consisting of a workforce that was hired from Exact Sciences, which allows the
Company to generate outputs as from day 1 of the acquisition. The purchase price was allocated based on the estimated fair value of net
assets acquired and liabilities assumed at the date of the acquisition.
The acquisition consideration was comprised of (in thousands USD):
Cash
$
25,000
Stock
5,000
GPS Contingent consideration
50,483
Total acquisition consideration
$
80,483
The purchase price in excess of the fair value
of net assets acquired, has been considered as residual Goodwill for an amount of $
35.9
million.
The fair value of the identifiable assets at
the date of acquisition were:
Thousands
    of $
As of December 31, 2022
Carrying
value at
acquisition
date
Fair
value
adjustments
Fair
value at
acquisition
date
Intangible assets IP / Brand
-
36,550
36,550
Intangible assets Customer relationships
-
8,007
8,007
Total identified assets
-
44,557
44,557
Goodwill
-
35,926
35,926
Acquisition price
-
-
80,483
We have performed a fair value analysis of the business combination,
with corresponding adjustments to the intangible assets.
The accounting for the business combination resulted
in fair values at date of acquisition of $
44.6
million for the IP/brand and customer relationships, based on the relief-from-royalty
valuation method, with a royalty rate of
9.56
% and a remaining useful life of
15
years for the IP/Brand and a useful life of
6.5
years
for the customer relationships. The discount rate (post-tax WACC) used for the valuation was set at
14.95
%. The goodwill recognized is
primarily attributable to the trained and knowledgeable workforce and to the expected synergies that will be realized at level of operations,
existing customer base, and sales & marketing.
F-
18
Following the closing, an additional aggregate earn-out amount of up
to $
70
million is to be paid by MDxHealth to Exact Sciences upon achievement of certain revenue milestones related to fiscal years 2023
through 2025. The contingent consideration has been assessed at $
52.9
million for the year ended December 31, 2022. The liability recognized
reflects a probability-weighted estimate at the current net present value at the date of acquisition, which is expected to become payable,
as further detailed in Note 16. Future fair value adjustments to this contingent consideration will be recognized in the statement of
profit or loss.
The net deferred tax asset resulting from this
purchase price allocation was not recognized given insufficient future taxable profits. The recognized goodwill is expected to be fully
tax deductible upon actual payment of the contingent consideration.
The total acquisition-related costs recognized as an expense in General
& administrative expenses were $
3.7
million.
The GPS acquisition has contributed $
9.3
million to the Company's
consolidated revenues for the period ended December 31, 2022. Per the unaudited special purpose financial statements for the GPS business
filed as exhibit 99.1 to Form 6-K on December 19, 2022, the GPS business generated revenues of $
18.5
million for the six-month period
ended June 30, 2022. Revenue information for the month of July 2022 is not available and the Company does not segregate the net result
of the GPS stand-alone business.
The Company financed the acquisition in part through a $
35
million
loan and security agreement with an affiliate of Innovatus Capital Partners, LLC ("Innovatus"), which replaced the Company's
existing €
9
million debt facility with Kreos Capital ("Kreos"). Refer to Note 16 for further details.
NOTE 4: Revenue and Cost of goods &
services sold
Revenue
Thousands
of $
For the years ended December 31
2022
2021
2020
Services
36,965
21,937
18,064
Licenses
25
250
250
Royalties and other revenues
64
52
146
Total revenue
37,054
22,239
18,460
Revenues related to services are recognized at
a point in time while licenses, royalties and other revenues are generally recognized over time as described in Note 2.7.
The Company did not recognize any contract assets
or contracts liabilities.
Total revenue for 2022 was $
37.1
million, an
increase of
67
% as compared to total revenue of $
22.2
million for 2021. Excluding revenues from the recently acquired GPS test, total
revenue for 2022 was $
27.7
million, an increase of
25
% versus 2021. Total revenue of $
22.2
million for 2021 increased of
20
% compared
to total revenue of $
18.5
million for 2020. Revenues from sales of Confirm mdx accounted for
59
%,
91
%, and
94
% of total revenues in 2022,
2021, and 2020, respectively. 2022 revenues were comprised of $
21.8
million from Confirm mdx, $
9.3
million from GPS, $
4.9
million from
Resolve mdx, with the remaining revenues from Select mdx and other.
Medicare
Reimbursement for diagnostic tests furnished to Medicare beneficiaries
(typically patients aged 65 or older) is usually based on a fee schedule set by the U.S. Centers for Medicare & Medicaid Services
("CMS"), a division of the U.S. Department of Health and Human Services ("HHS"). As a Medicare-enrolled service
provider, the Company bills the regional Medicare Administrative Contractor ("MAC") for CMS that covers the region where the
testing service is performed by the Company. The Confirm mdx test obtained a positive Medicare local coverage determination ("LCD")
in 2014, and the GPS test obtained a positive Medicare coverage LCD in 2015, each of which provides coverage for Medicare patients throughout
the United States.
In July 2022, a foundational LCD covering the indication for the Select
mdx test became effective under the Molecular Diagnostic Services Program ("MolDX"), administered by Palmetto GBA, which handles
technical assessments for U.S. laboratories that perform molecular diagnostic testing. Under the foundational LCD process recently implemented
by MolDX, all tests within an LCD-covered indication must submit a technical assessment ("TA") for review and consideration.
A technical assessment requesting coverage for Select mdx has been submitted and the Company is engaged in an interactive review process
with MolDX. Based on the Company's most recent communications with MolDX, a final coverage decision is not expected until mid-year
2023. A final determination with respect to Medicare coverage and reimbursement of the Select mdx test therefore remains pending, and
there can be no assurance that such coverage and reimbursement will be granted or, if granted, that it will be maintained.
In 2022, Medicare represented the only payer generating over
10
% of
the Company's revenues, for a total of $
15.8
million (2021: $
8.5
million; 2020:
8.2
million).
At the end of 2022,
the Company had concluded
agreements with 129 commercial payors for Confirm mdx (2021: 119; 2020: 107) and 62 commercial payors for Select mdx (2021: 54; 2020:
42).
F-
19
Segment revenue
The Company does not distinguish different business
segments since most revenues are generated from clinical laboratory service testing, or the out-licensing of the Company's patented
DNA methylation platform and biomarkers. However, the Company does distinguish different geographical operating segments based on revenue
since the revenues are generated both in United States of America and Europe.
In 2022,
the Company earned 99.8% (2021: 98.6%;
2020: 97.9%) of its revenue from external customers from its clinical laboratory testing services and out-licensing of intellectual property.
In 2022, the clinical laboratory testing in the U.S. CLIA laboratory represented 99% of the Company's revenue (2021: 97%; 2020:
95%), while the out-licensing of intellectual property revenue in Europe represented less than 1% (2021: 1.5%; 2020: 3%).
The amount of its revenue from external customers
broken down by location is shown in the table below:
Thousands of $
For the years ended December 31
2022
2021
2020
United States of America
36,768
21,785
17,760
Europe
277
441
679
Rest of the world
9
13
21
Total segment revenue
37,054
22,239
18,460
At the end of 2022,
93
% of the non-current assets
were located in the US (2021:
38
%; 2020:
40
%) and the remaining
7
% in Europe (2021:
62
%; 2020:
60
%). The increase in non-current assets
located in the U.S. is mainly due to acquired intangible assets in the GPS business combination as detailed in Note 3.
Cost
of goods & services sold
Thousands of $
For the years ended December 31
2022
2021
2020
Cost of goods & services sold
17,835
11,675
10,416
Total cost of goods & services sold
17,835
11,675
10,416
The costs of goods & services sold include
the costs associated with providing testing services to third parties and include the cost of materials, labor (including salaries, bonuses,
and benefits), transportation, collection kits, and allocated overhead costs associated with processing samples. Allocated overhead costs
include depreciation of laboratory equipment, facility occupancy and information technology costs. Costs associated with processing samples
are expensed when incurred, regardless of the timing of revenue recognition.
NOTE 5: Nature of expenses
Research
and development expenses
Thousands
of $
For the years ended December 31
Notes
2022
2021
2020
Personnel costs
6
2,453
1,949
1,277
Depreciation and amortization
11/12
2,272
1,360
1,203
Impairment
11
44
0
273
Lab consumables
713
793
390
Patent expenses
430
577
396
External collaborator fees
783
1,020
874
Clinical validation
584
842
0
Other expenses
278
132
130
Total research and development expenses
7,557
6,673
4,543
Research and development expenses consist of
costs incurred for the development and improvement of our products. These expenses consist primarily of labor costs (including salaries,
bonuses, benefits, and stock-based compensation), reagents and supplies, clinical studies, outside services, patent expenses, depreciation
of laboratory equipment, facility occupancy and information technology costs. Research and development expenses also include costs associated
with assay improvements and automation workflow for our current suite of products. The Company expenses its research and development
expenses in the period in which they are incurred, except for those development expenses that qualify for capitalization (refer to Note
11).
F-
20
Total research and development expenses increased
by
13
% over 2021, primarily due to the amortization expenses related to the acquired IP and brand for the GPS business, as well as an
increase in lab consumables, partially offset by savings in patent expenses, clinical validation, and external collaborator fees.
A change in presentation for clinical validation
expenses has been brought in 2021 to report clinical validation expenses in the amount of $
842,000
under Research and Development, previously
under Selling and Marketing expenses.
Selling
and Marketing expenses
Thousands
of $
For the years ended December 31
Notes
2022
2021
2020
Personnel costs
6
19,070
13,402
12,839
Depreciation and amortization
11/12
1,628
796
603
Professional fees
1,259
523
497
Marketing expenses
2,843
1,761
1,315
Travel expenses
789
340
260
Offices & facilities expenses
356
436
503
Clinical validation
0
0
377
Other expenses
637
486
358
Total selling and marketing expenses
26,582
17,744
16,752
The Company's sales and marketing expenses
are expensed as incurred and include costs associated with its sales organization, including its direct clinical sales force and sales
management, medical affairs, client services, marketing and managed care, as well as technical lab support and administration. These
expenses consist primarily of labor costs (including salaries, bonuses, benefits, and stock-based compensation), customer education and
promotional expenses, market analysis expenses, conference fees, travel expenses and allocated overhead costs.
For the year ended December 31, 2022, selling
and marketing expenses increased by $
8.8
million, or
50
%, compared to 2021, primarily due to an increase in personnel costs and marketing
expenses related to the Company's acquisition of the GPS business as well as an increase in amortization expense related to customer
lists as part of the GPS intangible asset.
For the year ended December 31, 2021, selling
and marketing expenses increased $
1.0
million, or
6
%, compared to 2020, primarily due to increased activity in 2021 versus 2020, which
was the first year of the COVID-19 pandemic.
General
and administrative expenses
Thousands of $
For the years ended December 31
Notes
2022
2021
2020
Personnel costs
6
8,995
9,009
9,209
Depreciation and amortization
11/12
965
880
1,526
Professional fees
7,762
1,678
1,522
Public company expenses
4,025
1,108
584
Offices & facilities expenses
1,142
845
530
Royalties to third parties
47
152
107
Other expenses
603
477
512
Total general and administrative expenses
23,539
14,149
13,990
General and administrative expenses include costs for certain executives, accounting and finance, legal, revenue cycle management, information
technology, human resources, and administrative functions. These expenses consist primarily of labor costs (including salaries, bonuses,
benefits, and stock-based compensation), professional service fees such as consulting, accounting, legal, general corporate costs, and
public-company costs associated with the Company's listing, as well as allocated overhead costs (rent, utilities, insurance, etc.).
General and administrative expenses increased
in 2022 by $
9.4
million, of which $
3.7
million were one-time expenses related to the GPS acquisition (included in Professional fees),
with the remaining $
5.7
million increase primarily related to higher insurance, professional fees and public company expenses.
General and administrative expense increased
in 2021 by $
0.2
million, or
1
% compared to 2020, primarily due to an increase in professional fees and insurance expenses associated
with our U.S. listing on the Nasdaq Stock Market.
F-
21
NOTE 6: Personnel costs
Thousands of $
For the years ended December 31
2022
2021
2020
The number of employees at the end of the year was:
Laboratory operations
67
42
39
R&D staff
19
14
17
S&M staff
101
71
64
G&A staff
71
64
57
Total number of employees
258
191
177
Their aggregate remuneration comprised:
Wages and salaries
23,066
18,150
17,552
Social security costs
1,684
1,257
1,275
Pension costs
724
594
567
Health insurance expenses
3,167
2,324
2,093
Share-based compensation
867
1,222
1,295
Other costs
1,010
813
543
Total personnel costs
30,518
24,360
23,325
The personnel numbers in the table reflect year-end numbers, with 42 sales and marketing employees hired in August 2022 as part of the
GPS acquisition.
NOTE 7: Other operating income, net
Thousands of $
For the years ended December 31
2022
2021
2020
Grant subsidies – The Netherlands
1
5
382
0
Grant subsidies – USA
0
659
0
Fair value adjustments
515
176
118
Other operating income
39
53
0
Other operating expenses
0
(
109
)
0
Total other operating income, net
559
1,161
118
1)
2020 grant income of $
88,000
is classified under "Royalties and other revenues"
Other operating income for the year ended December
31, 2022, primarily consisted of a positive fair value adjustment of $
632,000
of the contingent consideration related to the acquisition
of NovioGendix in 2015, partially offset by a negative fair value adjustment of $
117,000
related to the initial Kreos drawdown derivative
financial instrument.
Other operating income, net, decreased $
602,000
for 2022 compared to 2021, primarily due to reductions in grant income, partially offset by the above-mentioned fair-value adjustments.
The increase of $
1.0
million for 2021 as compared
to 2020 is primarily related to $
659,000
grant income from the U.S. Department of Health and Humas Services as well as a $
382,000
grant
from the Dutch government NOW grants, both considered support for COVID-19 inefficiencies. Management considers there are no pending
conditions left.
NOTE 8: Finance expenses, net
Thousands of $
For the years ended December 31
2022
2021
2020
Interest income
125
11
4
Interest on Kreos loan
(
660
)
(
1,566
)
(
1,205
)
Interest on Innovatus loan
(
1,615
)
0
0
Interest on other loans and leases
(
361
)
(
309
)
(
145
)
Fair value adjustments
(
2,479
)
(
290
)
(
118
)
Kreos loan extinguishment
(
1,047
)
0
0
Other financial expenses
(
107
)
(
7
)
(
75
)
Financial expenses, net
(
6,144
)
(
2,161
)
(
1,539
)
F-
22
For the year ended December 31, 2022, financial expenses, net, were primarily comprised of fair value adjustments for the GPS contingent
consideration of $
2.4
million resulting from changes in net present value, interest charges and extinguishment expenses of $
1.6
million
for the loan facility with Kreos Capital (as further detailed in Note 16), and interest charges of $
1.6
million related to the Innovatus
debt facility.
Other financial expenses relate to bank costs
incurred during the year.
NOTE 9: Income Tax
No income taxes were payable in view of the losses
incurred by the Company. On December 31, 2022, the Company had a consolidated net tax loss carried forward amounting to $
285.3
million
(2021: $
258.5
million; 2020: $
276.1
million), implying a potential deferred tax asset of $
71.3
million (2021: $
64.6
million; 2020: $
69.0
million) at a tax rate of
25
%.
The tax losses related to MDxHealth SA in Belgium
are available for carry forward. Until
2021
, tax losses related to MDxHealth BV in the Netherlands are available for carry forward to
a period of 6 years. As of 2022, tax losses related to MDxHealth BV in the Netherlands are available for carry forward indefinitely.
The tax losses of MDxHealth Inc., related to the years beginning on or after January 1, 2018, are available for carry forward indefinitely.
Tax losses related to the years before January 1, 2018, can be carried forward to a period of 20 years.
The Company has no notional interest deduction to offset future taxable
profits in 2022, 2021, and 2020.
Tax credits (investment deductions) amounted to $
402,000
in 2022,
$
372,000
in 2021, and $
462,000
in 2020.
It is uncertain if the Company will have taxable
profits in the near future to allow all or part of the deferred tax asset to be utilized and as a result, no deferred tax asset was recognized
in 2022, 2021, and 2020. The tax reconciliation and the impact of the unrecognized deferred tax assets is as follows:
Thousands of $
Income Statement
For
the years ended December 31
2022
2021
2020
Loss for the year
(
44,044
)
(
29,002
)
(
28,662
)
Income tax expense
0
0
0
Loss before income tax
(
44,044
)
(
29,002
)
(
28,662
)
Tax using the MDxHealth's domestic tax rate
(
25.00
% in 2022, 2021, and 2020)
11,011
7,251
7,166
Effect of unused tax losses not recognized as deferred tax assets
(
11,011
)
(
7,251
)
(
7,166
)
NOTE 10: Goodwill
On August 2, 2022, the Company acquired the GPS
test from Exact Sciences (refer to Note 3 for further details). The purchase price in excess of the fair value of the net assets acquired
has been considered as residual goodwill for an amount of $
35.9
million.
The Company is required to test Goodwill for
impairment on an annual basis. The recoverable amount is determined based on a value-in-use calculation. The use of this method requires
the estimation of future cash flows and the determination of a discount rate in order to calculate the present value of the cash flows.
The company monitors its Goodwill at the consolidated
company level, which is the level of cash generating units (CGUs) benefiting from the synergies. The recoverable amount of the CGU has
been determined from the value-in-use calculation based on the Company's cash flow projections covering a period of
5
years through
December 31, 2027.
F-
23
The amount by which the CGU's recoverable
value exceeds its carrying value is $
39.8
million. The changes in the carrying value of Goodwill at December 31, 2022, 2021, and 2020
can be presented as follows:
Thousands of $
Goodwill
At January 1, 2020
-
Additions through business combination
-
Impairment
-
Currency translation adjustments
-
Carrying value at December 31, 2020
-
At January 1, 2021
-
Additions through business combination
-
Impairment
-
Currency translation adjustments
-
Carrying value at December 31, 2021
-
At January 1, 2022
-
Additions through business combination
35,926
Impairment
-
Currency translation adjustments
-
Carrying value at December 31, 2022
35,926
The assumptions used are as follows:
Assumptions used
December 31,
2022
Discount rate (post-tax)
14.95
%
Terminal growth rate
2
%
The discount rate is based on comparable companies
in the industry together with company-specific risks. Terminal growth rate is based on management estimates and industry data.
The Company's impairment review is sensitive
to changes in the assumptions used, most notably the discount rate and the terminal growth rate.
An increase of
1
% in the discount rate would cause
the value-in-use of the CGU to reduce by $
12.5
million but would not give rise to an impairment. A
1
% reduction in perpetuity growth rate
would cause the value-in-use of the CGU to decrease by $
8.6
million but would not give rise to an impairment. Based on sensitivity analysis
performed at December 31, 2022 , an increase of the post-tax discount rate by
3.86
% up to
18.81
% would result in the carrying amount exceeding
the recoverable amount.
Based on the above information, management concluded
that there is no Goodwill impairment in 2022.
NOTE 11: Intangible assets
Thousands
    of $
Patents
and
Software
licenses
Internally
developed
intangible
assets
Externally
acquired
Intellectual
property
Customers
TOTAL
Gross value
At January 1, 2021
5,134
9,323
4,500
-
18,957
Gross value at December 31, 2021
5,134
9,323
4,500
-
18,957
Accumulated
    amortization and impairment
At January 1, 2021
(
4,676
)
(
6,810
)
(
2,413
)
-
(
13,899
)
Additions
(
234
)
(
926
)
(
450
)
(
1,610
)
Accumulated amortization and impairment at December 31, 2021
(
4,910
)
(
7,736
)
(
2,863
)
-
(
15,509
)
Net value at December 31, 2021
224
1,587
1,637
-
3,448
Gross value
At January 1, 2022
5,134
9,323
4,500
-
18,957
Additions
1,049
325
1,374
Additions through business combination (Note 3)
36,550
8,007
44,557
Currency translation adjustments
Gross value at December 31, 2022
5,134
10,372
41,375
8,007
64,888
Accumulated
    amortization and impairment
At January 1, 2022
(
4,910
)
(
7,736
)
(
2,863
)
-
(
15,509
)
Additions
(
224
)
(
942
)
(
1,490
)
(
513
)
(
3,169
)
Impairment
(
44
)
(
44
)
Currency translation adjustments
Accumulated
    amortization and impairment at December 31, 2022
(
5,134
)
(
8,722
)
(
4,353
)
(
513
)
(
18,722
)
Net value at December 31, 2022
0
1,650
37,022
7,494
46,166
F-
24
Amortization of intangible assets is
included in research & development expenses and in selling and marketing expenses in the statement of profit and loss.
The externally acquired intangible asset includes
technology acquired in the business combination with NovioGendix in 2015 and with the acquisition of the GPS test in August 2022, and
increased by $
36.6
million in 2022 due to the GPS acquisition. The estimated remaining amortization period amounts to
2.6
years for the
NovioGendix IP and to
14.6
years for the GPS IP.
Customer relationships includes customers acquired
in the GPS acquisition, resulting in the fair value at acquisition date of $
8.0
million. The GPS Customer relationships are amortized
over
6.5
years, the estimated remaining amortization period amounts to
6
years.
The internally-developed intangible assets relate
to the capitalized development expenses for Confirm mdx and Select mdx over the past years as well as for the development of the GPS
assay in-house and our Resolve mdx assay. The estimated remaining amortization period amounts to
1.2
years for Confirm mdx and Select
mdx and
5
years for GPS and
4.3
years for Resolve mdx. In 2022, the Company capitalized $
1.0
million (2021: $
0
; 2020: $
0
) in GPS and
Resolve mdx development expenses.
NOTE 12: Property, plant and equipment and right of-use assets
Property, plant and equipment
Thousands of $
Laboratory equipment
Furniture
IT
equipment
Leasehold
improvements
TOTAL
Gross value
At January 1, 2021
5,359
434
504
666
6,963
Additions
255
131
158
675
1,219
Disposals
(
2
)
(
2
)
Exchange rate difference arising
(
329
)
4
13
(
312
)
Gross value at December 31, 2021
5,285
569
673
1,341
7,868
Accumulated depreciation At
    January 1, 2021
(
4,874
)
(
244
)
(
343
)
(
529
)
(
5,990
)
Additions
(
277
)
(
64
)
(
103
)
(
77
)
(
521
)
Disposals
2
2
Exchange rate difference arising
334
(
7
)
(
15
)
312
Accumulated depreciation at December 31, 2021
(
4,817
)
(
315
)
(
459
)
(
606
)
(
6,197
)
Net value at December 31, 2021
468
254
214
735
1,671
Gross value
At January 1, 2022
5,285
569
673
1,341
7,868
Additions
1,695
104
277
713
2,789
Disposals
(
258
)
(
258
)
Exchange rate difference arising
88
(
4
)
(
5
)
4
83
Gross value at December 31, 2022
7,068
669
687
2,058
10,482
Accumulated depreciation At
    January 1, 2022
(
4,817
)
(
315
)
(
459
)
(
606
)
(
6,197
)
Additions
(
276
)
(
72
)
(
159
)
(
166
)
(
673
)
Disposals
258
258
Exchange rate difference arising
(
91
)
7
3
2
(
79
)
Accumulated depreciation at December 31, 2022
(
5,184
)
(
380
)
(
357
)
(
770
)
(
6,691
)
Net value at December 31, 2022
1,884
289
330
1,288
3,791
During 2022, the Company acquired $
1.7
million
of laboratory equipment and $
713,000
of leasehold improvements. In 2021, the company also acquired $
255,000
of laboratory equipment and
$
675,000
of leasehold improvements. The primary purpose of these acquisitions was to add testing capacity for its new GPS and Resolve
assays.
F-
25
Right of-use assets
Thousands of $
buildings
vehicles
materials
TOTAL
Gross value
Balance at January 1, 2021
3,612
218
897
4,727
Additions
1,518
1,518
Disposals
Gross value at December 31, 2021
5,130
218
897
6,245
Accumulated depreciation
Balance at January 1, 2021
(
1,177
)
(
87
)
(
729
)
(
1,993
)
Additions
(
752
)
(
42
)
(
111
)
(
905
)
Accumulated amortization on December 31, 2021
(
1,929
)
(
129
)
(
840
)
(
2,898
)
Net value at December 31, 2021
3,201
89
57
3,347
Gross value
Balance at January 1, 2022
5,130
218
897
6,245
Additions
1,435
58
334
1,827
Exchange rate differences
(
1
)
(
1
)
Gross value on December 31, 2022
6,565
276
1,230
8,071
Accumulated depreciation
Balance at January 1, 2022
(
1,929
)
(
129
)
(
840
)
(
2,898
)
Additions
(
945
)
(
51
)
(
71
)
(
1,067
)
Exchange rate differences
(
3
)
(
3
)
Accumulated amortization on December 31, 2022
(
2,874
)
(
180
)
(
914
)
(
3,968
)
Net value at December 31, 2022
3,691
96
316
4,103
In December 2019, the Company entered into a lease
agreement (the "Alton lease") for approximately
11,000
square feet of office space in Irvine, California. In April 2020,
the company amended the Alton Lease to add approx.
8,000
additional square feet of adjacent office space. The term of both the Alton
lease and the first amendment is for a period of
6
years, and both commenced in September 2020. In March 2021, the Company amended the
Alton lease for a second time, in order to renew for an additional
5
years its existing
13,000
square foot laboratory space which was
previously part of a separate lease. The commencement date for the second Alton lease amendment was October 2021. Under the terms
of the Alton Lease Agreement, the Company has an option to extend the Alton Lease for a period of
5
years. In October of 2021, the
company entered into a 35-month lease agreement for
6,000
additional office space adjacent to the laboratory. In June 2022, the company
entered into a 36-month lease agreement (the "Plano lease") for approximately
3,000
square feet of lab space in Plano, Texas
with an effective date of June 2022. The Plano lease was amended in November 2022 to add approximately
1,500
square feet of office
space. Under the terms of the Plano lease, the lease will automatically renew for successive 12-month periods after the end of the
original term of the agreement. Under the terms of the lease agreements mentioned, the rental payments escalate through the term
of each agreement and the Company is subject to additional charges for common area maintenance and other costs.
In October 2022, the company renewed its lease
agreement for a term of 60 months for its facilities in Nijmegen, The Netherlands.
The new lease agreements from 2022 represent
an additional right of use assets of a total value of $
1.8
million.
The following amounts related to leases are recognized
in the statement of profit or loss:
Thousands of $
2022
2021
2020
Depreciation expense
1,067
905
771
Interest expense on lease liabilities
314
229
93
NOTE 13: Inventories
Thousands
of $
For the years ended December 31
2022
2021
Raw materials and consumables
2,327
1,911
Total Inventories
2,327
1,911
Inventories are recognized at the lower of cost
or net realizable value. Inventories recognized as an expense during the year ended December 31, 2022, amounted to $
3.6
million (2021:
$
3.2
million; 2020: $
3.0
million). These were included in cost of sales and services.
F-
26
NOTE 14: Trade and other receivables
Trade
receivables
Thousands
of $
For the years ended December 31
2022
2021
Trade receivables
9,357
4,582
Total trade receivables
9,357
4,582
Trade receivables mainly consist of claims due
from our patients' insurance companies related to our diagnostic tests.
Considering the Company's revenue recognition
methodology further described in Note 2.7, total accounts receivable balance could be presented in relation with the claim date of each
sample as follows:
A/R by claim date
Months
Thousands of $
For the years ended December
    31, 2022
1-3
months
4-6
months
7-12
months
Not due
Total
Confirm mdx
1,865
821
765
3,451
Select mdx
134
101
78
25
338
Resolve mdx
1,966
458
158
2,582
GPS
1,907
895
2,802
Other
163
21
184
Total Trade Receivables
6,035
2,275
1,001
46
9,357
A/R by claim date
Months
Thousands of $
For the years ended December 31, 2021
1-3
months
4-6
months
7-12
months
Not due
Total
Confirm mdx
1,644
746
1,256
3,646
Select mdx
151
203
206
33
593
Other
321
22
343
Total Trade Receivables
2,116
949
1,462
55
4,582
Prepaid expenses and
other current assets
Thousands
of $
For the years ended December 31
2022
2021
Prepayments
1,710
1,022
Deposits
101
89
Recoverable VAT
97
246
Grants to be received
54
235
Other
0
23
Total prepaid expenses and other current assets
1,962
1,615
Prepaid expenses mainly consist of prepaid insurance
premiums and prepaid maintenance contracts.
All financial assets carried at amortized cost
are shown net of expected credit losses.
NOTE 15: Cash and cash equivalents
Thousands
of $
For the years ended December 31
2022
2021
Cash and cash equivalents
15,503
58,498
Total cash and cash equivalents
15,503
58,498
The bank balances and cash held by the Company and short-term bank deposits have an original maturity of less than 3 months. The carrying
amount of these assets approximates their fair value.
The Company had no restricted cash in 2022 and 2021.
F-
27
NOTE 16: Loans, Borrowings, Leases obligations
and other financial liabilities
Loans, Borrowings & Lease liabilities
Thousands
of $
For the years ended December 31
2022
2021
Non-current loans and borrowings
Loans
34,914
7,651
Lease liabilities (*)
3,091
2,624
Total non-current loans and borrowings
38,005
10,275
Thousands of $
For the years ended December 31
2022
2021
Current loans and borrowings
Loans
616
4,441
Lease liabilities
1,172
840
Total current loans and borrowings
1,788
5,281
(*)
the evolution in the right of use assets
is further disclosed in note 12.
Innovatus debt facility
On August 2, 2022, the Company entered into a
$
70
million loan and security agreement with Innovatus Life Sciences Lending Fund I, LP ("Innovatus"), which loan also replaced
the Company's €
9
million debt facility with Kreos Capital. At closing, an amount of $
35
million was drawn, with an additional
$
35
million remaining available as a $
20
million term B loan and a $
15
million term C loan that can be drawn in 2024 and 2025 respectively,
subject to certain conditions. The loans are secured by assets of the Group including intellectual property rights. Remaining proceeds
of the loans will be used for working capital purposes and to fund general business requirements.
The loans accrue interest at a floating per annum
rate equal to the sum of (a) the greater of (i) the prime rate published in The Wall Street Journal in the "Money Rates"
section or (ii) 4.00%, plus (b) 4.25%, and require interest-only payments for the initial four years.
As contractually agreed, and at
the election of the Company, a portion of the interest becomes payable in-kind by adding an amount equal to
2.25
% of the outstanding
principal amount to the then outstanding principal balance on a monthly basis until August 2, 2025. The loans mature on August 2, 2027.
The lenders shall have the right to convert, prior to August 2, 2025, up to
15
% of the outstanding principal amount of the loans into
ADSs of the Company at a price per ADS equal to $
11.21
, reflecting a substantial premium to the trading price prior to the announcement
of the acquisition. Amounts converted into ADSs of the Company will be reduced from the principal amount outstanding under the loan.
Notable fees payable to Innovatus consist of a facility fee equal to
1
% of the total loan commitment, due on the funding date of the
relevant loans, and an end-of-loan fee equal to
5
% of the amount drawn, payable upon final repayment of the relevant loans.
Security has been granted over all assets (including IP rights) owned
by the Company and MDxHealth, Inc. The loan agreement contains customary financial covenants and general affirmative and negative covenants,
including limitations on our ability to transfer or dispose of assets, change our business, merge with or acquire other companies, incur
additional indebtedness and liens, make investments, pay dividends and conduct transactions with affiliates.
The Innovatus debt facility has been accounted
for as a hybrid financial instrument which includes a host financial liability as well as an embedded derivative financial instrument
being an equity conversion call option at a fixed rate of up to
15
% of the aggregate outstanding principal amount through August 2, 2025.
The embedded derivative is not considered to
be closely related to the host financial liability given the differences in economics and risks, and as such both are accounted for separately:
●
The
host financial liability is recognized at amortized cost applying the effective interest rate method and has been accounted for as non-current
loans and borrowings;
●
The
embedded derivative convertible (American) call option is recognized at fair value using a binomial tree option pricing model whereby
the fair value is based on the actual stock price and the estimated volatility of the Company's ADS on Nasdaq since the Company's
IPO on November 4, 2021, and through the valuation date. The volatility measured on August 2, 2022, which was the closing date of the
Innovatus debt facility, was
62.85
% and at December 31, 2022 was
64.82
%. Any changes to the fair value of the embedded derivative will
be recognized through the statement of profit or loss. The derivative financial instrument has been accounted for as other current financial
liabilities.
F-
28
Kreos debt facility
As part of the new debt facility with Innovatus,
the Company's debt facility with Kreos for an outstanding principal amount of €
9
million has been fully repaid in cash during
September 2022, for a total amount of $
10.8
million. This repayment included the two convertible loans of €
180,000
($
185,364
) and
€
202,500
($
208,535
) that were not converted by Kreos and that were entered into as part of amendments to the original Kreos debt
facility.
The repayment did not include the derivative
financial liability for the initial Kreos drawdown fee which had an estimated fair value on December 31, 2022, of $
891,000
and is included
in Other financial liabilities as a separate financial instrument valued at fair-value through statement of profit or loss. This financial
liability is payable upon demand in cash, or convertible into the Company's common stock, upon election by Kreos.
The financial results largely related to the
interest charges for the loan facility with Kreos Capital for a total of $
206,000
. The amortized cost is calculated using the effective
interest method, which allocates interests and expenses at a constant rate over the term of the instrument. The debt extinguishment costs
incurred amounted to $
1.8
million and are included in the statement of profit or loss under Financial expenses.
During 2019, the Company entered into a loan
facility with Kreos Capital in the amount of €
9.0
million, or approximately $
10.2
million. The loan had a term of
four years
with
the first 12 months of interest-only payments followed by 36 months of principal and interest payments. On October 20, 2020, MDxHealth
and Kreos Capital executed an amendment to the 2019 loan facility, extending the interest-only period from 12 months to 18 months. As
a result of this amendment, repayment of principal was extended by 6 months, from November 2020 to May 2021. As part of the amendment,
the Company agreed to increase the end-of-loan fee by €
67,500
(approx. $
80,000
) as well as to provide for €
180,000
of the €
9
million loan to be convertible into shares of MDxHealth at a
25
% premium to the 30-day volume weighted average price immediately prior
to signing the amendment. If exercised, this amount was to be reduced from the principal amount due under the loan agreement.
In April 2021, MDxHealth and Kreos Capital executed
a second amendment to the loan facility, extending the interest-only period from 18 months to 27 months. As a result of this amendment,
repayment of principal was extended from May 2021 to February 2022. As part of the amendment, the Company agreed to increase the end-of-loan
fee by an additional €
67,500
(approx. $
80,000
) as well as to provide for an additional €
202,500
of the €
9
million loan
to be convertible into shares of MDxHealth at a
25
% premium to the 30-day volume weighted average price 10 days prior to signing the
amendment.
The convertible part of the loan, representing
the first discretionary convertible loan of €
180,000
($
203,868
) and the second discretionary convertible loan of €
202,500
($
229,352
)
were recognized at their amortized cost.
In addition, the second amendment provided for
a further six-month extension of the interest-only period if the Company would receive gross proceeds for a minimum amount of $
30
million
in new equity financing. Following the completion of the Company's Initial Public Offering of ADSs in the United States on November
8, 2021, whereby the Company received gross proceeds of $
45
million in new equity financing, Kreos granted a six-month extension of the
interest-only period through July 2022.
In addition, as the loan facility is contracted
in Euro, the foreign exchange rate impacts the carrying amount. The amortized cost is calculated using the effective interest method,
which allocates interests and expenses at a constant rate over the term of the instrument.
On April 20, 2020, the Company, through
its U.S. subsidiary, MDxHealth Inc., has entered into a "Paycheck Protection Program" (PPP) loan with the U.S. Small Business
Administration (SBA) in the amount of $
2,316,000
as part of the U.S Coronavirus Aid, Relief, and Economic Security (CARES) Act. The loan
has a term of five years and carries an interest rate of
1.0
% per year. Payments on the loan are deferred for the first eighteen months
following disbursement of the loan, with principal and interest payments beginning on the nineteenth month. Interest on the loan continues
to accrue during the eighteen-month deferment period. Cash proceeds from the loan were received in July 2020. As of December 31, 2022,
the outstanding amount on the PPP loan was $
1.6
million.
In addition to the contracted loans, the Company
has several lease obligations. The leases have terms of 3 to 5 years.
F-
29
Maturity of loans and borrowings are as follows
at the balance sheet date:
Thousands
of $
For the years ended December 31
2022
2021
Loans
Within one year
630
4,780
Years two to five
38,439
9,283
Leases
Within one year
1,551
1,127
Years two to five
2,330
3,094
Note: all figures shown in this table are
undiscounted and reflect future cash payments (capital and interests)
Other financial liabilities
Thousands
of $
For the years ended December 31
2022
2021
Other financial liabilities
Other non-current
financial liabilities
53,537
1,466
Other current financial liabilities
2,327
961
Total other financial liabilities
55,864
2,427
GPS Contingent consideration
As part of the acquisition of the GPS business
from Exact Sciences in August 2022, an aggregate earn-out amount of up to $
70
million is to be paid by MDxHealth to Exact Sciences upon
achievement of certain revenue milestones related to fiscal years 2023 through 2025, with the maximum earn-out payable in relation to
2023 and 2024 not to exceed $
30
million and $
40
million, respectively. The liability recognized reflects a probability-weighted estimate
at the current net present value which is expected to become payable. Future fair value adjustments to this contingent consideration will be recognized in the statement of profit or loss. The value of the contingent liability for GPS including the fair value
adjustment accounted for under other non-current financial liabilities is $
52.9
million as of December 31, 2022.
Innovatus embedded derivative convertible
call option
The embedded derivative convertible (American)
call option is recognized at fair value within the other non-current financial liabilities and amounts to $
910,000
as at December 31,
2022.
Kreos derivative financial instrument ("initial
drawdown fee")
As of December 31, 2022, the derivative financial
liability of the convertible initial drawdown fee payable to Kreos remains outstanding as follows:
●
a
drawdown fee of €
630,000
($
713,538
) is due to Kreos Capital which was not payable in cash but remained outstanding as a "convertible
loan" (the "Initial Convertible Loan").
●
Upon
the Expiration Date, the convertible loan will convert automatically into ordinary shares at €
0.85
per share.
●
In
lieu of converting the Initial Convertible Loan, Kreos Capital may instead cancel the convertible loan at any time (but before the Expiration
Date) after the earlier to occur of (i) a repayment or prepayment in full of the loan, and (ii) sale of the entire issued share capital
of MDxHealth. In such case, Kreos Capital will be paid an amount equal to
150
% of the principal amount of the Initial Convertible Loan.
The fair value of the financial derivative related
to the initial drawdown fee of the Kreos loan is computed as the sum of the probability-weighted values of the fair values associated
with each of the possible outcomes and amounts to $
891,000
as of December 31, 2022. The derivative financial instrument is accounted
for within other current financial liabilities.
F-
30
Other financial liabilities
Other financial liabilities include the contingent consideration related
to the acquisition of NovioGendix in 2015 and amounts to $1.2 million of which $
526,000
was considered as current. The contingent consideration
is valued at fair value through the statement of profit or loss. The fair value of this contingent consideration is reviewed on a periodic
basis. The fair value is based on a risk-adjusted future cash flows of different scenarios discounted using an interest rate of
12.16
%.
The structure of the possible scenarios and the probability assigned to each scenario is reassessed by management at every reporting period
and requires judgement from management about the outcome and probability of the different scenarios (refer to Note 26 for further details).
A reconciliation of cash and non-cash movements
of loans and borrowings, lease liabilities and other financial liabilities is presented below:
Thousands of $
Loans and
borrowings
Other financial
liabilities
For the years ended December 31
2022
2021
2022
2021
Beginning balance
12,092
13,097
2,427
1,599
Cash movements
Loans and borrowings repaid
1
(Kreos / PPP)
(
10,805
)
Loans and borrowings received (Innovatus)
34,291
Non-cash movements
GPS Contingent Consideration
50,483
Reclassification
2
(
773
)
773
Recognition of Innovatus embedded derivative convertible call option
(
1,026
)
1,026
Kreos effective interest rate adjustment and extinguishment costs
1,328
536
194
Innovatus - effective interest rate adjustment
660
Foreign exchange rate impact / other
(
1,010
)
(
768
)
(
35
)
(
59
)
Fair value changes through profit and loss
1,963
(
80
)
Ending balance
35,530
12,092
55,864
2,427
1)
The amount includes interest paid on loans and borrowings
2)
Reclassification of the fair value of the derivative financial liability of the initial drawdown fee to be presented separately
Fair value adjustments recognized during 2022
for other financial liabilities relate to:
Thousands of $
For the years ended December 31
2022
Decrease of contingent consideration Noviogendix
(
632
)
Increase of Kreos derivative financial instrument ("initial drawdown fee")
116
Increase of GPS contingent consideration
2,398
Decrease of Innovatus embedded derivative convertible call option
(
116
)
Total fair value adjustment
1,766
Thousands
    of $
Lease
    liabilities
For
                                            the years ended December 31
2022
2021
Opening balance
3,464
2,774
Cash movements
Repayment of lease liabilities
(
1,358
)
(
1,057
)
Non-cash movements
Interest accretion
314
229
New leases
1,843
1,518
Closing balance
4,263
3,464
NOTE 17: Contractual obligations
Thousands of $
For The Years ended December 31
2022
2021
Outstanding commitments for future minimum rent payments, which fall due as follows:
Less than one year
156
215
Years 2-5
60
39
Total contractual obligations
216
254
For 2022 and 2021, we refer to note 12 and 16
for the lease liabilities subsequent adoption and application of IFRS 16.
F-
31
Outstanding commitments for future minimum rent
payments include rental fees related to leased facilities, and equipment for assets with a value below $
5,000
or with short-term duration.
These lease contracts can be terminated early with certain indemnity fees. All figures shown assume that the lease contracts will not
be terminated early.
NOTE 18: Trade and other payables
Trade
accounts payable
Thousands of $
For The Years ended December 31
2022
2021
Trade accounts payable
5,061
3,192
Accruals for invoices to be received
5,117
4,263
Total trade accounts payable
10,178
7,455
Other
current liabilities
Thousands
of $
For The Years ended December 31
2022
2021
Payroll
3,932
2,703
Other accruals
53
32
Total other current liabilities
3,985
2,735
NOTE 19: Financial instruments and fair
value
The table shows the Company's significant financial assets and
liabilities. All financial assets and liabilities are carried at amortized cost with the exception of the contingent considerations
in relation to acquisitions and derivative financial instruments reported at fair value through the statement of profit or loss.
All financial assets and liabilities are considered
to have carrying amounts that do not materially differ from their fair value.
Thousands of $
For The Years ended December 31
2022
2021
Fair value hierarchy
Assets
At amortized cost
Trade receivables
9,357
4,582
Cash and cash equivalents
15,503
58,498
Total financial assets
24,860
63,080
Liabilities
At fair value:
Other financial liabilities
- GPS contingent consideration
52,881
Level 3
- NovioGendix contingent consideration
1,182
1,617
Level 3
- Innovatus derivative instrument
910
Level 3
- Kreos derivative instrument
891
810
Level 3
Subtotal financial liabilities at fair value
55,864
2,427
At amortized cost:
Loans and borrowings
35,530
12,092
Level 2
Lease liabilities
4,263
3,464
Trade payables
10,178
7,455
Subtotal financial liabilities at amortized cost
49,971
23,011
Total financial liabilities
105,835
25,438
F-
32
Recognized fair value measurements – valuation technique
and principal inputs
The fair value of the financial instruments has
been determined on the basis of the following methods and assumptions:
●
The
carrying value of the cash and cash equivalents, the trade receivables, other current assets and the trade payables approximate their
fair value due to their short-term character;
●
The
fair value of loans and borrowings applying the Effective Interest Rate method approximates their carrying value (level 2).
o
Innovatus debt facility
: the host financial liability was obtained with a variable interest rate based upon the Prime Rate (with a floor of
4
% and a margin of
4.25
%)
o
Paycheck Protection Program (PPP)
: applying a market rate would not result in a materially different fair value which carries an interest rate of
1
% and was obtained as part of the U.S Coronavirus Aid, Relief, and Economic Security (CARES) Act.
o
Kreos debt facility
: the Kreos loan was obtained at the end of 2019 with a nominal fixed interest rate of
9.5
%, however, the carrying value is considered to approximate their fair value considering:
■
Additional
                                            contractually agreed advance and post payments agreed upon with Kreos that have been integrated
                                            in the effective interest rate method;
■
During
                                            2020 and 2021, the Company and Kreos negotiated modification to the original agreement resulting
                                            in additional consecutive interest-only periods. As compensation for these modifications,
                                            part of the loan amounts became convertible as described in Note 16, however the Company
                                            and Kreos agreed to maintain nominal fixed interest rate in line with the initial agreement.
■
Given
                                            repayment of the Kreos facility during 2022, no fair value assessment was performed as of
                                            December 31, 2022
●
Leases
                                            are measured at the present value of the remaining lease payments, using a discount rate
                                            based on the incremental borrowing rate at the commencement date of these leases. Their fair
                                            value approximates their carrying value.
●
The fair value of contingent consideration payable to NovioGendix (presented
in the yearend statement of financial position under "other non-current financial liabilities" and "other current financial
liabilities") and Exact Sciences is based on an estimated outcome of the conditional purchase price/contingent payments arising
from contractual obligations (level 3). This is initially recognized as part of the purchase price and subsequently fair valued with changes
recorded through other operating income in the statement of profit or loss.
o
NovioGendix
: the Company used a discount rate of 12.16%. A net positive fair value
measurement of $435,000 was recognized in the 2022 consolidated financial statements, of which $632,000 in operating income and $197,000
in financial expense.
o
GPS
: The fair value of the contingent consideration payable to Exact Sciences
is based on a probability-weighted average estimate based on multiple scenarios varying in timing and amount of earn-out payment. This
probably-weighted estimate is then discounted to its net present value taking into account expected time when earn-out would become payable
in 2024, 2025 and 2026. This contingent consideration was initially recorded along with the purchase price allocation of this business
combination as explained in Note 3. A fair-value adjustments resulting in a financial charge of $ 2.4 million has been recorded as of
December 31, 2022. The Company used a discount rate of 14.95%
●
The fair value of the derivative financial liabilities related to the initial Kreos drawdown fee of €
630,000
($
672,000
) is based upon the evolution of the share price of MDxHealth as well as the estimated probabilities that either payment at
150
% or conversion will be requested by Kreos. Whereas share price of MDxHealth can be considered as a level 1 input, the other variable, being the probability assessment of possible scenarios should be considered as level 3 input. The fair value of the liability is estimated at $
891,000
for the year ended December 31, 2022.
●
The fair value of the derivative financial liabilities related to the Innovatus derivative call option (as detailed in Note 16) was performed using a binomial pricing model which takes into account several factors including the expected evolution in price of an ADS and are considered as level 3 input. The fair value of the liability is estimated at $
910,000
for the year ended December 31, 2022.
●
Financial
                                            instruments are evaluated based on the mark-to-market report and the unrealized gains (loss)
                                            are recognized through the statement of profit or loss.
F-
33
Fair value hierarchy:
The Company uses the following hierarchy for
determining and disclosing the fair value of financial instruments by valuation technique:
●
Level
                                            1
: quoted prices in active markets for identical assets and liabilities;
●
Level
                                            2
: other techniques for which all inputs which have a significant effect on the recorded
                                            fair value are observable, either directly or indirectly; and
●
Level
                                            3
: techniques which use inputs that have a significant effect on the recorded fair value
                                            that are not based on observable market data.
No financial assets or financial liabilities
have been reclassified between the valuation categories during the year.
A reconciliation of cash and non-cash movements
of level 3 financial liabilities is presented below:
Thousands of $
Financial Derivative Instruments (Kreos and Innovatus)
Contingent Consideration (NovioGendix and GPS)
For the years ended December 31
2022
2021
2022
2021
Beginning balance
810
0
1,617
1,599
Cash movements
Loans and borrowings repaid
Non-cash movements
GPS contingent consideration
50,483
Innovatus embedded derivative convertible call option
1,026
Reclassification
1
773
Effective interest rate adjustment
Foreign exchange rate impact / other movements
(
35
)
(
59
)
Fair value changes through profit and loss
96
1,963
18
Ending balance
1,801
810
54,063
1,617
1)
Reclassification of the fair value of the derivative financial
liability of the initial drawdown fee to be presented separately
NOTE 20: Loss per share
The basic loss per share is calculated by dividing
the net result attributable to shareholders by the weighted average number of shares outstanding during the year.
Years
ended December 31
2022
2021
2020
Loss for the year, in thousands of $
(
44,044
)
(
29,002
)
(
28,662
)
Basic and diluted loss per share, in $
(
0.28
)
(
0.24
)
(
0.34
)
Weighted
average number of shares
2022
2021
2020
Weighted average number of shares for basic and diluted loss per share
158,658,165
121,935,741
83,199,215
At December 31, 2022, 2021, and 2020, the Company had potential dilutive
shares in the form of warrants, contingent considerations and convertible loans (see Note 16 for further details). Diluted loss per share
considers the impact of potentially dilutive securities except in periods in which there is a loss because the inclusion of the potential
common shares would have an anti-dilutive effect.
NOTE 21: Financial Risk Management
Capital
management
Capital is comprised of equity attributable to
shareholders, borrowings, and cash and cash equivalents. The Company aims to maintain a strong capital base in order to maintain investor
and creditor confidence and to sustain the future development of the business. The Company's objectives when managing capital are
to maintain sufficient liquidity to meet its working capital requirements, fund capital investment and purchases, and safeguard its ability
to continue operating as a going concern. The Company monitors capital regularly to ensure that the statutory capital requirements are
met and may propose capital increases at shareholders' meetings to ensure the necessary capital remains intact.
F-
34
Credit
risk
Credit risk arises from cash and cash equivalents,
short-term bank deposits, as well as credit exposure to collaboration partners. Credit risk refers to the risks that counterparty will
default on its contractual obligations resulting in financial loss to the Company.
At the end of 2022, the Company operated with
more than
1,000
different customers, systematically reducing credit risk compared to prior periods.
In the U.S. healthcare system, and particularly
within the molecular diagnostic CLIA laboratory industry, where there are rapid technological advances in diagnostic services, companies
provide services to healthcare professionals and their patients, while being reimbursed from commercial and governmental insurance systems.
Often these services are provided out of network and without supplier contracts. As a result, there is reimbursement risk, separate from
credit risk that is characterized by uncertainty in reimbursement value, delays in payment, and ultimately non-payment. This impacts
the Company's revenue recognition and cash collections.
In addition to reimbursement risk associated
with commercial third-party payors, credit risk may also arise from amounts due directly from patients. In many cases, payors will cover
the entire cost of testing. For example, for tests that fall under the Clinical Laboratory Fee Schedule, there is no co-payment, co-insurance
or deductible for patients covered under traditional Medicare. However, patients covered by commercial insurance companies may be responsible
for a co-payment, co-insurance, and/or deductible depending on the health insurance plan and individual patient benefit. Credit risk
exists for those patients who cannot meet their co-payment or deductible portions.
Customer's compliance with agreed credit
terms is regularly and closely monitored. Trade accounts receivable amounted to $
9.4
million as of December 31, 2022, and no allowance
for expected credit loss was recorded. No ECL has been recorded for other financial assets carried at amortized cost as there is no related
credit risk.
The credit risk on cash and cash equivalents
of $
15.5
million is limited given that the counterparties are banks with high credit scores attributed by international rating agencies.
The Company had no exposure to Silicon Valley Bank, Silvergate Bank, or Credit Suisse.
Interest
risk
During 2022, the Company entered into a
60
-month
loan with Innovatus for a total amount of $
35
million (refer to Note 16 for further details). The loan accrues interest at a floating
per annum rate equal to the sum of (a) the greater of (i) the Prime rate published in The Wall Street Journal in the "Money Rates"
section or (ii)
4.00
%, plus (b)
4.25
%, and require interest-only payments for the initial four years. For every increase of
0.25
% in
the Prime rate, the Company's interest expense increases by approximately $
90,000
per year.
In addition, on April 20, 2020, the Company,
through its U.S. subsidiary, MDxHealth Inc., has entered into a "Paycheck Protection Program" (PPP) loan with the U.S. Small
Business Administration (SBA) in the amount of $
2,316,000
as part of the U.S Coronavirus Aid, Relief, and Economic Security (CARES) Act.
The amortized cost is calculated using the effective interest method, which allocates interests and expenses at a constant rate over
the term of the instrument; the effective interest rate for the loan is
1.00
%. Considering the fixed interest rate, the Company is not
exposed to interest risk, thus did not perform any sensitivity analysis.
Currency
risk
The functional currency changed from the EURO
to the U.S. Dollar as of July 1, 2014. Consequently, the currency risk is concentrated on European operations.
As of December 31, 2022, cash deposits in EURO
amounted to €
1.1
million.
The Company performed a sensitivity analysis
of an increase/decrease of exchange rate on operations of
10
%. The exposure of operations to the currency risk is immaterial given the
limited size of the European operations and contribution to revenues versus the Company as a whole.
F-
35
Liquidity
risk
The Company manages liquidity risk by maintaining
adequate reserves and by continuously monitoring forecast and actual cash flows and matching the maturity profiles of financial assets
and liabilities. At the date of this report, the Company has
2
loan agreements with banks and state institutions, and
11
leases (see
Notes 12 and 16).
For the years ended December 31, 2022
Thousands of $
Less than
1 year
between 1
and 2
years
between 3
and 5
years
Total
contractual
cash
flows
Carrying
amount
Non derivatives
Trade payables
10,178
10,178
10,178
Loans
630
630
37,809
39,069
35,530
Lease liabilities
1,324
915
2,179
4,418
4,263
Total
12,132
1,545
39,988
53,665
49,971
For the years ended December 31, 2021
Thousands of $
Less than
1 year
between 1
and 2
years
between 3
and 5
years
Total
contractual
cash flows
Carrying
amount
Non derivatives
Trade payables
7,455
7,455
7,455
Loans
4,780
8,200
1,083
14,063
12,092
Lease liabilities
1,127
915
2,179
4,221
3,464
Total
13,362
9,115
3,262
25,739
23,011
Note: Except for carrying amount, all figures shown in this table
are undiscounted and reflect future cash payments
The Company is also committed to a potential
additional cash out of:
●
€
945,000
($
1.0
million) if Kreos requests payment in cash of the derivative financial liabilities related to the initial Kreos drawdown fee (see
Note 16).
●
an aggregate earn-out amount of up to $
70
million that could become payable in cash by MDxHealth to Exact Sciences upon achievement of certain revenue milestones related to fiscal years 2023 through 2025 and payable during 2024 through 2026.
Other
risks
The Company subscribes to certain insurance policies
to cover matters such as (i) fire, theft, and other damage to its assets, (ii) product and liability insurance and clinical trial insurance,
and (iii) D&O insurance. To date, no significant claims have been made under these insurance policies and there is no guarantee that
the insurances will cover all damages if they should ever occur.
NOTE 22: Share capital and reserves
At December 31, 2022, the Company's share
capital was represented by the following number of shares (units). Only one class of shares (common shares) exists and they have no par
value.
For
the Years ended December 31
2022
2021
Common shares
162,880,936
155,969,226
Total outstanding shares
162,880,936
155,969,226
On January 21, 2021, the company announced the
successful pricing of its capital increase with the offering of new ordinary shares. The Company raised €
25.0
million ($
30.4
million) in
gross proceeds by means of a private placement of
27,777,777
new shares at an issue price of €
0.90
per share through an accelerated
bookbuild offering. As a result of the issuance of new shares, the Company's share capital increased from €
68,998,734.95
to
€
90,132,067.69
and its issued and outstanding shares increased from
90,691,449
to
118,469,226
ordinary shares.
On November 8, 2021, the Company announced that
completion of a capital increase by means of an initial public offering in the United States of
3,750,000
ADSs at an issue price of $
12
per ADS, resulting in gross proceeds of $
45.0
million. As a result of this capital increase, its share capital has increased from €
90,132,067.69
to €
118,662,067.69
and the number of issued and outstanding shares has increased from
118,469,226
to
155,969,226
ordinary shares,
through the issuance of a total of
37,500,000
new shares.
F-
36
On August 11, 2022, to settle a portion of the
purchase price for the acquisition by the Company of the GPS test from Genomic Health, Inc. (a subsidiary of Exact Sciences Corporation)
announced on August 2, 2022, the Company issued
691,171
American Depositary Shares, or "ADSs" (each representing 10 ordinary
shares of the Company with no nominal value per share), at a price per ADS of $
7.23
, totaling $
5
million. As a result, the Company's
share capital has increased from €
118,662,067.69
to €
123,539,165.19
and the number of issued and outstanding shares has increased
from
155,969,226
to
162,880,936
ordinary shares.
Thousands of $
Thousands of €
For the Years ended December 31
Share
Capital
Issuance
Premium
Share
Capital
Issuance
Premium
As of January 1, 2021
76,716
136,349
62,214
112,078
January 2021 – Issuance of
27,777,777
shares (*)
23,632
4,693
19,473
3,867
November 2021 – Issuance of
37,500,000
shares (*)
28,106
12,135
24,412
10,536
As of December 31, 2021
128,454
153,177
106,099
126,481
August 2022 – Issuance of
6,911,710
shares (*)
5,000
4,876
As of December 31, 2022
133,454
153,177
110,975
126,481
(*)
net of expenses
The capital stock and the issuance premium amounted to the following:
Thousands of $
Thousands of €
For the Years ended December 31
2022
2021
2022
2021
Share Capital as per statutory accounts
148,419
143,419
123,539
118,662
Capital increase costs
(
14,965
)
(
14,965
)
(
12,564
)
(
12,564
)
Share capital under IFRS
133,454
128,454
110,975
106,098
Issuance premium
153,177
153,177
126,481
126,481
Share capital and issuance premium
286,631
281,631
237,456
232,579
The history of the Share Capital can be found in "General Information;
Capital and Shares".
By virtue of the resolution of the extraordinary general shareholders'
meeting of the Company held on May 27, 2021, which entered into force on June 1, 2021, the board of directors of the Company has been
granted certain powers to increase the Company's share capital in the framework of the authorized capital. The powers under the
authorized capital have been set out in article 6 of the Company's articles of association.
Pursuant to the authorization granted by the extraordinary general
shareholders' meeting, the board of directors was authorized to increase the share capital of the Company on one or several occasions
by a maximum aggregate amount of EUR
90,132,067.69
(excluding issue premium, as the case may be) for a period of
5 years
as from June
1, 2021.
The board of directors has used its powers under the authorized capital
on (i) November 8, 2021, by issuing 37,500,000 new shares (3,750,000 ADSs) for an aggregate amount of €28,530,000.00 (excluding issue
premium), and (ii) August 11, 2022, by issuing 6,911,710 new shares (691,171 ADSs) for an aggregate amount of €4,877,097.50. Moreover,
subsequent to the balance sheet date (and as described further in Note 27), the board of directors has used its powers under the authorized
capital at the occasion of the February 2023 capital increase.
As a result, the board of directors therefore still has the authority under
the authorized capital to increase the Company's share capital with an aggregate amount of €16,792,505.80 (excluding issue
premium, as the case may be).
In addition to the outstanding shares of
the Company:
●
a
total of 13,895,280 subscription rights of the Company have been created, of which 12,257,780 subscription rights have been granted as
of December 31, 2022, which entitles their holders (assuming all subscription rights are granted and exercised) to subscribe to a total
of 12,257,780 new shares with voting rights (see Note 24 for further details). The remaining 1,637,500 subscription rights have not yet
been granted and are currently still managed by the Company's board of directors;
●
under
                                            the loan agreement entered into by the Company and Kreos Capital in July 2021, a drawdown
                                            fee equal to 7% of the amounts drawn down under the loan agreement (being EUR 630,000
                                            in aggregate) remains outstanding as a payable due by the Company (without accruing interest),
                                            and is convertible into ordinary shares with voting rights by means of a contribution in
                                            kind of the payable by Kreos Capital to the share capital of the Company at a price of €0.85
                                            per share (see Note 24 for further details); and,
F-
37
●
under
                                            the loan and security agreement entered into by the Company and Innovatus Capital Partners
                                            in August 2022, Innovatus has the right to convert, prior to August 2, 2025, up to 15%
                                            of the outstanding principal amount of the loans (by means of a contribution in kind of the
                                            relevant payables due by the Company under the loans) into American Depositary Shares ("ADSs") of
                                            the Company (each representing 10 ordinary shares of the Company) at a conversion price per ADS equal
                                            to $11.21 (i.e., $1.121 per share on the basis of the ratio of 1 ADS per 10 shares) (see
                                            note 16 for further details).
NOTE 23: Retirement benefit plans
The Company operates defined contribution plans
for all its qualifying employees. The assets of these plans are held separately from those of the Company in designated funds.
A total cost of $
724,000
in 2022 (2021: $
594,000
)
represents contributions payable to these plans by the Company at rates specified in the rules of the plans.
The employees of the Company in Belgium are members
of a state-managed retirement benefit plan operated by the government (
i.e.
, legal pension) and are members of a bank-operated
private pension plan. The Company is required to contribute a specified percentage of payroll costs to the retirement benefit plan to
fund the benefits. The obligation of the Company with respect to the retirement benefit plan is to make the specified contributions.
Because the Company must guarantee the statutory
minimum return on these plans, not all actuarial and investment risks relating to these plans are transferred to the insurance company
or pension fund managing the plans. The Company has considered the potential impact of the employer's obligation to guarantee a
minimum return and that this was assessed not to be significant.
NOTE 24: Share-based payments
This section provides an overview of the outstanding
warrants as of December 31, 2022. The warrants were created within the context of stock-based incentive plans for employees, directors
and consultants of the Company.
The Company has created several pools of warrants under stock option
plans for grant to eligible employees, Directors, and consultants. On March 15, 2012 (
195,000
), June 15, 2012 (
700,000
), June 23, 2014
(
1,500,000
), June 19, 2017 (
2,500,000
), June 21, 2019 (
3,000,000
), May 27, 2021 (
3,600,000
) and May 25, 2022 (
5,000,000
).
In aggregate
17,310,800 warrants were issued, subject to warrants being granted to and accepted by the beneficiaries. 18,150 of these warrants never
allocated have become null and void, resulting in a remaining and outstanding 17,296,650 warrants, (i) 2,840,397 warrants were terminated
or lapsed, (ii) 577,123 warrants were exercised, (iii) 12,257,780 warrants were granted but not yet exercised, and (iv) 1,637,500 warrants
were not yet granted by the Company. For the year 2022, 590,345 warrants (2021: 304,968) were terminated or lapsed, no warrants were exercised,
and 2,127,021 warrants (2021: 795,250) were vested. As a result, as at December 31, 2022, there are 12,257,780 warrants outstanding, entitling
their holders to subscribe to 12,257,780 shares of the Company.
Number of potential shares from outstanding warrants
2022
2021
As of January 1
8,917,625
5,766,093
Number of warrants cancelled/forfeited during the year
(
590,345
)
(
304,968
)
Number of warrants granted during the year
3,930,500
3,456,500
As of December 31
12,257,780
8,917,625
The warrants are granted to employees (mainly),
consultants or directors of the Company and its subsidiaries. Each warrant entitles its holders to subscribe to one new share of the
Company at a subscription price determined by the board of directors, within the limits decided upon at the occasion of their issuance.
The warrants issued have generally a term of
ten years
as of issuance. Upon expiration of their term, the warrants become null and void.
F-
38
In general, the warrants vest in cumulative tranches
of
25
% per year, provided that the beneficiary has provided at least one year of service. However, there are certain exceptions to this
rule which are, if applicable, specified in the relevant stock option plans. The warrants granted under the June 23, 2014 Stock Option
Plan to directors all vest on the date of the annual meeting that takes place in the calendar year following the calendar year in which
they were granted, provided that the mandate of the relevant director has not ended or been terminated. The warrants granted under the
June 23, 2014 Stock Option Plan to beneficiaries who are not directors all vest in instalments of
25
% per year, the first tranche of
25
% vesting on the first anniversary date of the date of grant and the following tranches vesting on a quarterly basis. The warrants
granted under the June 21, 2019 Stock Option Plan, the May 27, 2021 Stock Option Plan and under the May 25, 2022 Stock Option Plan to
specific beneficiaries (Directors and Management Team) may adopt a manual vesting procedure under certain conditions or a particular
vesting period over 3 years.
The table below presents the outstanding warrants
and their exercise price at the end of each accounting year covered by the financial statements:
Warrants
Weighted
average
exercise
price (€)
Potential
shares
from
exercise of
warrants
Weighted
average
exercise
price per
potential
share (€)
Granted in 2021
3,456,500
1.37
3,456,500
1.37
Outstanding 31 December 2021
8,917,625
1.53
8,917,625
1.53
Granted in 2022
3,930,500
0.68
3,930,500
0.68
Outstanding 31 December 2022
12,257,780
1.23
12,257,780
1.23
Exercisable at 31 December 2022
5,220,520
1.63
5,220,520
1.63
The following table provides an overview of the outstanding potential
shares from warrants per personnel category at December 31, 2022 and 2021:
Category
2022
2021
Executive Director
3,950,000
2,950,000
Non-Executive Directors
248,000
272,000
Management team (excluding the Executive Director)
4,083,000
2,938,000
Other employees, consultants, and former service providers
3,976,780
2,757,625
Total outstanding at December 31
12,257,780
8,917,625
The share-based compensation expense recognized
in the statement of comprehensive income is given below as is the cumulated amount per the consolidated statement of financial position:
Thousands
of $
Years ended December 31
2022
2021
2020
Share-based compensation
867
1,222
1,295
Cumulated Share-based compensation
11,474
10,607
9,385
The Cumulated Share-based compensation amount
is part of the Total Shareholders' Equity on the Consolidated statement of financial position. This amount is presented on the
Consolidated statement of financial position for both exercised and non-exercised warrants.
The weighted average exercise price of all outstanding
warrants (vested and non-vested warrants; assuming 1 warrant = 1 share) is €
1.23
or $
1.32
at December 31, 2022 (€
1.53
or $
1.73
at December 31, 2021; €
1.74
or $
2.14
at December 31, 2020). The weighted average remaining contractual life of all outstanding warrants
at the end of 2022 is
7.31
years (2021:
7.18
years; 2020:
6.70
years).
F-
39
The fair value of each warrant is estimated on
the date of grant using the Black-Scholes methodology with the following assumptions:
Number of warrants granted
Expected
Expected
Risk-free
Expected duration (months)
Dates
to Belgian benef.
to other benef.
Exercise price (€)
dividend Yield
stock price volatility
interest rate
to Belgian benef.
to other benef.
23-Jun-14
12,000
12,000
€
4.13
-
48.12
%
1.78
%
75.32
63.29
9-Feb-15
60,000
95,000
€
4.49
-
46.75
%
0.62
%
79.73
61.71
29-May-15
20,000
30,000
€
4.91
-
46.52
%
0.81
%
64.14
52.11
1-Oct-15
-
83,000
€
4.20
-
48.99
%
0.90
%
72.03
54.02
1-Dec-15
-
18,000
€
3.89
-
51.18
%
0.85
%
70.03
52.01
1-Feb-16
-
10,000
€
4.13
-
51.18
%
0.85
%
67.99
49.97
4-Feb-16
50,000
134,000
€
3.78
-
52.49
%
0.72
%
67.89
49.87
2-Apr-16
-
52,000
€
3.62
-
53.40
%
0.58
%
65.33
53.33
29-May-16
30,000
40,000
€
4.13
-
51.85
%
0.54
%
64.11
52.11
22-Jan-16
-
20,000
€
3.83
-
52.81
%
0.86
%
68.32
56.32
1-Dec-16
-
22,000
€
4.65
-
54.16
%
0.75
%
57.99
39.98
1-Jan-17
-
19,000
€
4.56
-
53.84
%
0.73
%
56.98
50.96
1-Apr-17
-
18,000
€
5.41
-
51.80
%
0.81
%
54.02
48.00
11-Apr-17
20,000
200,000
€
5.35
-
51.83
%
0.72
%
65.68
47.67
29-Jul-17
-
10,000
€
4.72
-
50.95
%
0.87
%
50.10
44.05
1-Sep-17
-
34,000
€
4.92
-
48.08
%
0.71
%
60.99
42.97
2-Nov-17
-
99,000
€
4.61
-
45.23
%
0.66
%
52.93
40.90
20-Jun-17
30,000
30,000
€
4.97
-
51,57
%
0.59
%
81.40
63.39
01-Apr-18
-
42,000
€
3,77
-
46.08
%
0.76
%
54.02
42.02
01-Jun-18
50,000
30,000
€
4,97
-
46.15
%
0.77
%
52.01
40.01
05-Dec-18
-
20,000
€
1,73
-
57.56
%
0.79
%
45.86
33.86
24-Jan-19
-
191,000
€
1,64
-
67.56
%
0.77
%
62.24
50.20
16-May-19
-
1,508,000
€
1,49
-
75.78
%
0.38
%
58.55
46.52
01-Nov-19
-
8,000
€
1,01
-
82.15
%
0.00
%
64.99
46.98
01-Dec-19
-
12,000
€
1,02
-
81.95
%
0.00
%
64.01
45.99
01-Feb-20
-
2,000
€
0,98
-
80.26
%
0.00
%
61.97
49.67
01-Jun-20
-
6,000
€
0,85
-
86.64
%
0.00
%
57.99
45.99
01-Oct-20
-
2,000
€
0,80
-
85.20
%
0.00
%
53.95
35.97
15-Jul-20
-
225,000
€
0,80
-
85.89
%
0.00
%
56.51
38.53
01-Jul-19
60,000
20,000
€
1,28
-
78.70
%
0.07
%
69.01
51.02
24-Jul-19
-
980,000
€
1,24
-
78.64
%
0.00
%
68.25
50.27
15-Jul-20
-
1,598,000
€
0,80
-
85.89
%
0.00
%
56.52
38.53
30-Jul-20
20,000
-
€
1,28
-
87.02
%
0.00
%
56.02
38.04
01-Oct-20
-
10,000
€
1,28
-
85.20
%
0.00
%
53.95
35.97
01-Mar-21
-
2,000
€
1.08
-
65.06
%
0.00
%
48.99
31.00
03-May-21
-
8,000
€
1.16
-
64.59
%
0.01
%
46.92
28.93
01-Jun-21
-
4,000
€
1.18
-
65.82
%
0.01
%
45.96
27.98
27-Jul-21
-
30,000
€
1.36
-
63.36
%
0.00
%
44.12
26.14
27-Jul-21
-
202,500
€
1.36
-
63.36
%
0.00
%
44.12
26.14
24-Nov-21
-
40,000
€
1.05
-
60.78
%
0.14
%
49.25
37.25
03-Jul-21
-
2,570,000
€
1.38
-
63.10
%
0.04
%
44.91
26.93
07-Jul-21
-
600,000
€
1.39
-
63.11
%
0.00
%
44.78
26.79
06-May-22
-
5,000
€
0.75
-
53.16
%
1.64
%
58.85
52.87
04-Aug-22
-
38,000
€
0.80
-
55.63
%
1.41
%
55.89
49.91
03-Aug-22
-
425,000
€
0.68
-
57.05
%
1.50
%
67.96
55.92
03-Aug-22
-
3,125,000
€
0.68
-
57.05
%
1.50
%
73.97
61.94
04-Aug-22
-
10,000
€
0.80
-
55.63
%
1.41
%
73.94
61.91
01-Oct-22
-
312,500
€
0.74
-
57.26
%
2.77
%
72.03
60.00
12-Dec-22
-
15,000
€
0.74
-
58.30
%
2.40
%
69.67
63.65
F-
40
The above inputs for the Black-Scholes model have been determined
based on the following:
●
The
dividend return is estimated by reference to the historical dividend payment of the Company. Currently, this is estimated to be zero
as no dividends have been paid since inception.
●
The
expected volatility was determined using the average volatility of the stock over the last
two years
at the date of grant.
●
Risk-free
interest rate is based on the interest rate applicable for the 10Y Belgian government bond at the grant date
NOTE 25: Related parties
Transactions between the Company and its employees,
consultants or Directors are described below. There were no other related party transactions.
Remuneration
of key management personnel
During the year ended December 31, 2022, the executive management
team included four members:
1. Chief Executive Officer, Mr. Michael McGarrity
2. Executive Vice President of Corporate Development & General
Counsel, Mr. Joseph Sollee
3. Chief Financial Officer, Mr. Ron Kalfus
4. Chief Commercial Officer, Mr. John Bellano
Their combined remuneration package, including employer taxes, amounted
to the following:
Thousands of $
except per personnel, warrants & share amounts
For
The Years ended December 31
2022
2021
2020
Number of management members and Executive Directors
4
4
4
Short-term employee benefits
1,550
1,545
1,535
Post-employment benefits
54
52
23
Other employment costs
219
207
174
Total benefits
1,822
1,804
1,732
IFRS share-based compensation expense
863
982
596
Number of warrants offered
2,200,000
2,200,000
1,183,000
Cumulative outstanding warrants
8,088,000
5,888,000
3,688,000
Exercisable warrants
3,618,642
1,282,238
1,036,250
The following table sets forth the number of warrants that were exercised,
granted and accepted in aggregate by the four members of the executive management team:
2022
2021
2020
Number of warrants exercised
0
0
0
Number of new warrants granted and accepted
2,200,000
2,200,000
1,183,000
Annualized IFRS cost for existing warrants
$
863,000
$
982,000
$
596,000
No loans, quasi-loans or other guarantees are
outstanding with members of the executive management team.
F-
41
Remuneration
of the Board
The total remuneration of the Board of Directors
(including the Executive Director) in 2022, 2021, and 2020 was $
876,000
, $
863,000
, and $
775,000
, respectively (excluding VAT, stock-based
compensation and reimbursement of expenses). No advances or credits have been granted to any member of the Board of Directors. None of
the members of the Board of Directors have received any non-monetary remuneration other than warrants as disclosed above.
Transactions with Non-Executive
Directors
Since 2012, the Non-Independent Directors do
not receive a fee payment for attending and preparing for Board meetings or for assisting the Company with Board matters. They receive
reimbursement for expenses directly related to the Board meetings, totaling less than $
23,000
in 2022.
The Independent Directors receive a fee for attending
and preparing meetings of the Board of Directors and for assisting the Company with Board matters, and they receive reimbursement for
expenses directly related to the Board meetings. In 2022, 2021, and 2020, fees and expense reimbursement in the amount of $
314,000
, $
302,000
,
and $
231,000
, respectively, were paid to independent members of the Board of Directors.
No warrants were granted to Non-Executive Directors in 2022 and no
warrants were exercised in 2022.
NOTE 26: Significant agreements, commitments
and contingencies
Fair
value of Other financial liabilities
On September 18, 2015, MDxHealth acquired MDxHealth
BV (former NovioGendix), a Dutch molecular diagnostic research and service company with expertise in the urological oncology. The terms
of the acquisition consisted of initial consideration paid in
1,086,956
shares of MDxHealth common stock, issued at €
4.14
representing
the average closing price of the Company's shares on Euronext Brussels during a period of 30 days ending on September 17, 2015.
In addition to this equity, additional cash consideration of €
250,000
was paid. On top of the acquisition price, MDxHealth is committed
to pay future milestone fees. The Company paid €
1.0
million, being $
1
million regarding these milestone fees in 2017. The Company
is contractually required to pay at maturity to the holder of the obligation the amount of maximum $
2.2
million. Based on its judgement
and estimates, the management believes future milestones will be paid in 2023 and 2024. The fair value of this contingent consideration
as of December 31, 2022 is estimated at $
1.2
million over the period 2022-2023 (2021: $
1.6
million) and was accounted for as other financial
liabilities (current and non-current) as detailed in Note 16.
As part of the acquisition of the GPS business
from Exact Sciences in August 2022, an aggregate earn-out amount of up to $
70
million is to be paid by MDxHealth to Exact Sciences upon
achievement of certain revenue milestones related to fiscal years 2023 through 2025, with the maximum earn-out payable in relation to
2023 and 2024 not to exceed $
30
million and $
40
million, respectively. The contingent consideration has been assessed at $
50.5
million
which has been accounted for under other non-current liabilities as further detailed in Note 3. The liability recognized reflects a probability-weighted
estimate at the current net present value which is expected to become payable. Future fair value adjustments to this contingent consideration
will be recognized in the statement of profit or loss. The value of the contingent liability for GPS is $
52.9
million as of December 31,
2022, and was accounted for as other non-current financial liabilities as detailed in Note 16.
F-
42
Collaborative
research agreements and clinical research agreements
The Company has entered into numerous agreements
with universities, medical centers and external researchers for research and development work and for the validation of the Company's
technology and products. These agreements typically have durations of
one
to
three
years
. The Company must pay fixed fees to the collaborators
and in exchange typically receives access and rights to the results of the work.
MDxHealth collaborates on research and clinical
development with many of the world's leading academic and government cancer research institutes. These important relationships
provide the Company with additional resources and expertise for clinical marker validation as well as access to patient samples for testing.
MDxHealth's collaborators include such prestigious institutions as Johns Hopkins University Medical Institutions (US), Duke University
Medical Center (US), Harvard Medical School (US), Cleveland Clinic (US), University of Colorado (US) and University of California at
Los Angeles (US) among others.
Intellectual
property in-licensing agreements
The Company has entered into numerous agreements
with universities and companies for in-licensing intellectual property. These agreements typically require the Company to pay an up-front
fee, annual maintenance fees and/or minimum annual royalty fees, legal fees related to the patents, and certain milestone and royalty
fees if the patents are eventually used in a commercialized product. In addition, the Company must provide the licensor with periodic
reports.
Commercial
and intellectual property sub-licensing agreements
The Company has entered into numerous partnering
and sub-licensing agreements. With regards to the Company's developed tests, the Company has entered into a range of marketing and
sales arrangements with commercial entities. These important relationships provide the Company with additional resources and infrastructure
to expand the geographic reach and awareness of the Company's solutions, primarily in relation to the Confirm mdx and Select mdx
tests. MDxHealth's marketing partners include, Ferrer Internacional (Spain), Teva Pharmaceuticals (Israel), and SouthGenetics (South
and Central America), LifeLabs (Canada) and, in the US, LabCorp, Miraca Life Sciences, Bostwick Laboratories.
In regard to intellectual property that MDxHealth
has developed or improved, MDxHealth has sublicensed certain of its non-core technologies to commercial partners, several of whom have
launched products that generate royalties and other fees. These sublicenses include an exclusive sublicense to Laboratory Corporation
of America (LabCorp) for the MGMT test, which LabCorp began to commercialize in North America in 2008, and an exclusive sublicense to
Vesica Health, Inc. for the Company's patented AssureMDx test for the purpose of bladder cancer detection on a worldwide basis.
F-
43
Litigation
As of the date of this document and as far as
MDxHealth is aware, the Company is not involved in any material legal proceedings.
NOTE 27: Subsequent events
On February 3, 2023, the Company announced the
pricing of a registered public offering of
10,000,000
American Depositary Shares ("ADSs") (each representing
10
ordinary
shares of the Company without nominal value) at a price to the public of $
4.00
per ADS (
equivalent to a price of €0.364 per share,
assuming an exchange rate of €1 = $1.0988 as published by the European Central bank on February 2, 2023 and a 10-for-1 ADS to share
ratio
) for total gross proceeds of $
40.0
million before deducting commissions and estimated offering expenses.
On March 6, 2023, the Company announced that,
in the context of the above-mentioned offering, the underwriters exercised the option to purchase additional ADSs, on the same terms
and conditions as stated above, in the amount of
750,000
ADSs for gross proceeds of $
3.0
million, bringing the aggregate gross proceeds
from this transaction to $
43.0
million.
On April 19, 2023, the Company announced that it has received notice
that its Select mdx for Prostate Cancer test has successfully completed the technical assessment process with the Molecular Diagnostics
Services (MolDX) Program developed by Palmetto GBA. Select mdx will be reimbursed throughout the U.S. for Medicare patients who meet coverage
conditions under the foundational Local Coverage Determination (LCD) for Molecular Biomarkers to Risk-Stratify Patients at Increased Risk
for Prostate Cancer.
NOTE 28: Subsidiaries
The Company has the following two wholly-owned direct subsidiaries:
MDxHealth
    Inc.
Address
15279 Alton Parkway – Suite 100 – Irvine, CA 92618
Incorporation
    Date
April 14, 2003
Number
    of employees
236 at December 31, 2022, 176 at December 31, 2021 and 163 at December 31, 2020.
MDxHealth
B.V.
Address
Transistorweg 5, 6534 AT Nijmegen, The Netherlands
Incorporation
    Date
October 18, 2006
Incorporated
    into MDxHealth on
September 18, 2015
Number
    of employees
12 at December 31, 2022, 11 at December 31, 2021 and 9 at December 31, 2020.
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44
NOTE 29: Principal audit fees and services
During the past fiscal year, in addition to their
usual activity, the statutory auditor performed additional activities on behalf of the Company mainly for the issuance of special reports
related to warrant plans, grant report certification, for participation to the audit committees and for participation to special projects.
The detail is presented in the table below:
For the years ended
in thousands of $
in thousands of €
December 31
2022
2021
2020
2022
2021
2020
Audit fee for statutory and consolidated financials
239
182
85
226
155
75
Other audit fees
191
183
-
180
156
-
Audit related and other services
42
17
10
39
14
8
Total
472
382
95
445
325
83
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