content: <HTML><HEAD>
  <TITLE>Prepared by R.R. Donnelley Financial -- Form 8-K</TITLE>
  </HEAD>
    <BODY BGCOLOR="WHITE">
   <HR SIZE="4" NOSHADE COLOR="#000000" ALIGN="left"><DIV><FONT SIZE="1">&nbsp;</FONT></DIV> <DIV ALIGN="center"><FONT FACE="Times New Roman" SIZE="5"><B>SECURITIES AND EXCHANGE COMMISSION </B></FONT></DIV>
  <DIV ALIGN="center"><FONT FACE="Times New Roman" SIZE="2"><B>WASHINGTON, D.C. 20549 </B></FONT></DIV> <DIV><FONT SIZE="2">&nbsp;</FONT></DIV> <HR NOSHADE WIDTH="21%" COLOR="#000000"><DIV><FONT SIZE="1">&nbsp;</FONT></DIV> <DIV ALIGN="center"><FONT
  FACE="Times New Roman" SIZE="5"><B>FORM 8-K </B></FONT></DIV> <DIV><FONT SIZE="1">&nbsp;</FONT></DIV> <DIV ALIGN="center"><FONT FACE="Times New Roman" SIZE="2"><B>CURRENT REPORT </B></FONT></DIV> <DIV ALIGN="center"><FONT FACE="Times New Roman"
  SIZE="2"><B>PURSUANT TO SECTION 13 OR 15(D) OF THE </B></FONT></DIV> <DIV ALIGN="center"><FONT FACE="Times New Roman" SIZE="2"><B>SECURITIES EXCHANGE ACT OF 1934 </B></FONT></DIV> <DIV><FONT SIZE="1">&nbsp;</FONT></DIV> <DIV ALIGN="center"><FONT
  FACE="Times New Roman" SIZE="2"><B>Date of Report (Date of earliest event reported): April 22, 2002 </B></FONT></DIV> <DIV><FONT SIZE="2">&nbsp;</FONT></DIV> <HR NOSHADE WIDTH="21%" COLOR="#000000"><DIV><FONT SIZE="1">&nbsp;</FONT></DIV> <DIV
  ALIGN="center"><FONT FACE="Times New Roman" SIZE="5"><B>CONCEPTUS, INC. </B></FONT></DIV> <DIV ALIGN="center"><FONT FACE="Times New Roman" SIZE="1"><B>(Exact name of registrant as specified in charter) </B></FONT></DIV> <DIV><FONT
  SIZE="1">&nbsp;</FONT></DIV> <DIV ALIGN="center">
  <TABLE CELLSPACING="0" CELLPADDING="0" WIDTH="100%" BORDER="0">
  
  <TR>
  <TD VALIGN="top" ALIGN="center" WIDTH="31%"> <DIV ALIGN="center"><FONT FACE="Times New Roman" SIZE="2"><B>Delaware</B></FONT></DIV> </TD>
  <TD VALIGN="bottom" WIDTH="3%"><FONT FACE="Times New Roman" SIZE="1">&nbsp;</FONT></TD>
  <TD VALIGN="top" ALIGN="center" WIDTH="31%"> <DIV ALIGN="center"><FONT FACE="Times New Roman" SIZE="2"><B>000-27596</B></FONT></DIV> </TD>
  <TD VALIGN="bottom" WIDTH="3%"><FONT FACE="Times New Roman" SIZE="1">&nbsp;</FONT></TD>
  <TD VALIGN="top" ALIGN="center" WIDTH="31%"> <DIV ALIGN="center"><FONT FACE="Times New Roman" SIZE="2"><B>97-3170244</B></FONT></DIV> </TD> </TR>
  <TR>
  <TD VALIGN="top" ALIGN="center" WIDTH="33%"> <DIV ALIGN="center"><FONT FACE="Times New Roman" SIZE="1"><B>(State or other jurisdiction of</B></FONT></DIV> <DIV ALIGN="center"><FONT FACE="Times New Roman" SIZE="1"><B>incorporation or
  organization)</B></FONT></DIV> </TD>
  <TD VALIGN="bottom" WIDTH="3%"><FONT FACE="Times New Roman" SIZE="1">&nbsp;</FONT></TD>
  <TD VALIGN="top" ALIGN="center" WIDTH="33%"> <DIV ALIGN="center"><FONT FACE="Times New Roman" SIZE="1"><B>(Commission file number)</B></FONT></DIV> </TD>
  <TD VALIGN="bottom" WIDTH="3%"><FONT FACE="Times New Roman" SIZE="1">&nbsp;</FONT></TD>
  <TD VALIGN="top" ALIGN="center" WIDTH="33%"> <DIV ALIGN="center"><FONT FACE="Times New Roman" SIZE="1"><B>(I.R.S. employer</B></FONT></DIV> <DIV ALIGN="center"><FONT FACE="Times New Roman" SIZE="1"><B>identification&nbsp;no.)</B></FONT></DIV> </TD>
  </TR>
   </TABLE> </DIV> <DIV><FONT SIZE="1">&nbsp;</FONT></DIV> <DIV ALIGN="center"><FONT FACE="Times New Roman" SIZE="2"><B>1021 Howard Avenue </B></FONT></DIV> <DIV ALIGN="center"><FONT FACE="Times New Roman"
  SIZE="2"><B>San Carlos, CA 94070 </B></FONT></DIV> <DIV ALIGN="center"><FONT FACE="Times New Roman" SIZE="1"><B>(Address of principal executive offices) (Zip code) </B></FONT></DIV> <DIV><FONT SIZE="1">&nbsp;</FONT></DIV> <DIV ALIGN="center"><FONT
  FACE="Times New Roman" SIZE="2">Registrant&#146;s telephone number, including area code:&nbsp;&nbsp;<B>(650) 802-7240</B> </FONT></DIV> <DIV><FONT SIZE="2">&nbsp;</FONT></DIV> <HR NOSHADE WIDTH="21%" COLOR="#000000"><DIV><FONT
  SIZE="1">&nbsp;</FONT></DIV> <HR SIZE="4" NOSHADE COLOR="#000000" ALIGN="left">
  
  <p Style='page-break-before:always'>
  <HR  SIZE="3" COLOR="#CCEEFF" WIDTH="100%" ALIGN="CENTER">
   <DIV><FONT SIZE="1">&nbsp;</FONT></DIV> <DIV><FONT FACE="Times New Roman" SIZE="2"><B>ITEM 5.&nbsp;&nbsp;&nbsp;&nbsp;OTHER EVENTS. </B></FONT></DIV> <DIV><FONT SIZE="1">&nbsp;</FONT></DIV> <DIV
  STYLE="text-indent:27px"><FONT FACE="Times New Roman" SIZE="2">On April 22, 2002, Conceptus, Inc. issued a press release announcing it has completed filing of a Pre-Market Approval (PMA) application with the U.S. FDA for
  <I>Essure</I><I></I></FONT><FONT FACE="Times New Roman" SIZE="1"><SUP>&#153;</SUP></FONT><FONT FACE="Times New Roman" SIZE="2" COLOR="#000000"><SUP></SUP>. Text of the press release follows: </FONT></DIV> <DIV><FONT SIZE="1">&nbsp;</FONT></DIV> <DIV
  STYLE="text-indent:27px"><FONT FACE="Times New Roman" SIZE="2"><B>San Carlos, CA, April 22, 2002</B><B></B>&#151;Conceptus, Inc. (NASDAQ NM: CPTS) announced today that it has completed filing of a Pre-Market Approval (PMA) application with the U.S.
  Food and Drug Administration (FDA) to market Essure</FONT><FONT FACE="Times New Roman" SIZE="1"><SUP>&#153;</SUP></FONT><FONT FACE="Times New Roman" SIZE="2" COLOR="#000000"><SUP></SUP>, the Company&#146;s non-incisional permanent birth control
  procedure. </FONT></DIV> <DIV><FONT SIZE="1">&nbsp;</FONT></DIV> <DIV STYLE="text-indent:27px"><FONT FACE="Times New Roman" SIZE="2">Currently, women in the U.S. who choose permanent birth control must undergo incisional tubal ligation, which
  requires cutting into the abdominal cavity, and typically is done under general anesthesia with a four to six day recovery period. <I>Essure</I> requires no incisions, and can be performed without general anesthesia. Interim data from the Pivotal
  Trial show that women who underwent the <I>Essure </I>procedure typically returned to their normal activities within 1-2 days, and working women typically returned to work in one day or less. </FONT></DIV> <DIV><FONT SIZE="1">&nbsp;</FONT></DIV>
  <DIV STYLE="text-indent:27px"><FONT FACE="Times New Roman" SIZE="2">According to the Centers for Disease Control and Prevention, surgical tubal ligation is the most common method of contraception in the United States. To date, more than 10 million
  women in the U.S., and more than 100 million women worldwide have undergone the procedure. If the FDA approves the <I>Essure</I> PMA, permanent birth control could be revolutionized before the end of the decade. </FONT></DIV> <DIV><FONT
  SIZE="1">&nbsp;</FONT></DIV> <DIV STYLE="text-indent:27px"><FONT FACE="Times New Roman" SIZE="2">&#147;We believe <I>Essure</I> could represent the beginning of a new standard of care, which would ultimately make the choice of permanent birth
  control an easier one for women,&#148; said Steve Bacich, President and CEO of Conceptus. &#147;We are very pleased that we have completed one of the company&#146;s most significant milestones with the submission of this PMA application.
  Importantly, we are one step closer to bringing this option to women in the U.S.&#148; <I></I> </FONT></DIV> <DIV><FONT SIZE="1">&nbsp;</FONT></DIV> <DIV STYLE="text-indent:27px"><FONT FACE="Times New Roman" SIZE="2">If approved by the FDA,
  <I>Essure</I> would be the first device available to offer women an alternative to surgical tubal ligation that doesn&#146;t require an incision and can be done routinely without general anesthesia. To date, in more than 900 woman-years of
  effectiveness testing in the clinical trial, there has not been a pregnancy with <I>Essure</I>. Interim data from the Pivotal Trial also show that 99 percent of women who have relied on the <I>Essure</I> micro-insert for birth control rated their
  long-term comfort as &#145;good&#146; to &#145;excellent&#146;, and 95 percent of patients would recommend the procedure to a friend. Additionally, 92 percent of women who were employed returned to work in one day or less following the day of the
  procedure. </FONT></DIV> <DIV><FONT SIZE="1">&nbsp;</FONT></DIV> <DIV STYLE="text-indent:27px"><FONT FACE="Times New Roman" SIZE="2">Professor Rafael Valle, MD, Northwestern University Medical School, will be presenting the clinical data from the
  <I>Essure</I> Pivotal Trial recently submitted in the PMA at the American College of Obstetrics and Gynecology meeting at the Los Angeles Convention Center on May 7, 2002. </FONT></DIV> <P></P>
   <DIV ALIGN="center"><FONT FACE="Times New Roman" SIZE="2">1 </FONT></DIV>
  
  
  <p Style='page-break-before:always'>
  <HR  SIZE="3" COLOR="#CCEEFF" WIDTH="100%" ALIGN="CENTER">
   <DIV><FONT SIZE="1">&nbsp;</FONT></DIV> <DIV STYLE="text-indent:27px"><FONT FACE="Times New Roman" SIZE="2">There have been no known pregnancies in the clinical trials or in the commercial setting with
  women relying on <I>Essure</I>. However like all birth control methods, pregnancies in the Pivotal Trial are expected with the use of <I>Essure</I>. Adverse events initially preventing reliance on <I>Essure</I> were less than 4 percent and were
  primarily associated with improper device placement. However, some of these women had a second <I>Essure</I> procedure, and were able to rely on the device for contraception. This reduced the adverse events ultimately preventing reliance to 2.5
  percent. Because there are no abdominal incisions and general anesthesia is not required, the risk profile for the <I>Essure</I> procedure, as is typical of hysteroscopic procedures, is expected to be lower, and of a different severity, than that of
  abdominal incisional procedures. This is typified by the minor nature of most of the adverse events. </FONT></DIV> <DIV><FONT SIZE="1">&nbsp;</FONT></DIV> <DIV STYLE="text-indent:27px"><FONT FACE="Times New Roman" SIZE="2">&#147;If approved by the
  FDA, a key factor in the commercial success of <I>Essure</I> would be patient satisfaction,&#148; said Cindy Domecus, Senior Vice President of Clinical Research and Regulatory Affairs at Conceptus. &#147;We&#146;ve had an overwhelming response to
  <I>Essure</I> from women in the clinical trials who have been very satisfied with their quick recovery time and their decision to choose <I>Essure</I>. Conceptus chose to develop a non-incisional form of permanent of birth control because of the
  documented need for contraceptive alternatives, the significant risk associated with unintended pregnancies and abortions, and the infrequent but significant risks of invasive sterilization methods.&#148; </FONT></DIV> <DIV><FONT
  SIZE="1">&nbsp;</FONT></DIV> <DIV STYLE="text-indent:27px"><FONT FACE="Times New Roman" SIZE="2">If approved by the FDA, Conceptus anticipates making <I>Essure</I> available to U.S. women in 2003. The device is currently marketed in Australia,
  Europe, Singapore and Canada. </FONT></DIV> <DIV><FONT SIZE="1">&nbsp;</FONT></DIV> <DIV><FONT FACE="Times New Roman" SIZE="2"><B>About </B><B><I>Essure </I></B><I></I><B><I></I></B><B> </B></FONT></DIV> <DIV><FONT SIZE="1">&nbsp;</FONT></DIV> <DIV
  STYLE="text-indent:27px"><FONT FACE="Times New Roman" SIZE="2"><I>Essure</I> deploys a soft micro-insert into the fallopian tube through the cervix using a minimally invasive transcervical tubal access catheter. Once in place, the device is designed
  to elicit tissue growth in and around the micro-insert to form an occlusion or blockage in the fallopian tube. </FONT></DIV> <DIV><FONT SIZE="1">&nbsp;</FONT></DIV> <DIV><FONT FACE="Times New Roman" SIZE="2"><B>Permanent Birth Control
  </B></FONT></DIV> <DIV><FONT SIZE="1">&nbsp;</FONT></DIV> <DIV STYLE="text-indent:27px"><FONT FACE="Times New Roman" SIZE="2">Surgical tubal ligation has become the most common form of birth control worldwide, despite the fact that it is invasive
  and costly. About 93 percent of the procedures in the U.S. are performed in a hospital or surgi-center under general anesthesia, requiring between four and five hours of hospital recovery time and four to six days before returning to regular
  activities. Development of a non-incisional method of tubal ligation has been an elusive goal for researchers since the 1970&#146;s. </FONT></DIV> <DIV><FONT SIZE="1">&nbsp;</FONT></DIV> <DIV STYLE="text-indent:27px"><FONT FACE="Times New Roman"
  SIZE="2">An <I>Essure </I>procedure does not require cutting or penetrating the abdomen and can be performed in a less costly procedure setting without general anesthesia. Accordingly, a woman is expected to average 15 minutes of hysteroscopic time
  for the <I>Essure</I> procedure and to return home about 45 minutes after the procedure is completed. During the Pivotal Trial, 92 percent of <I>Essure</I> patients who were employed returned to work in one day or less, excluding the day of the
  procedure. Reliance on <I>Essure</I> does not involve taking drugs or hormones. </FONT></DIV> <DIV><FONT SIZE="1">&nbsp;</FONT></DIV> <DIV><FONT FACE="Times New Roman" SIZE="2"><B>About Conceptus </B></FONT></DIV> <DIV><FONT
  SIZE="1">&nbsp;</FONT></DIV> <P></P>
   <DIV ALIGN="center"><FONT FACE="Times New Roman" SIZE="2">2 </FONT></DIV>
  
  
  <p Style='page-break-before:always'>
  <HR  SIZE="3" COLOR="#CCEEFF" WIDTH="100%" ALIGN="CENTER">
   <DIV STYLE="text-indent:27px"><FONT FACE="Times New Roman" SIZE="2">Conceptus, Inc. is developing <I>Essure</I>, an investigational medical procedure, designed to provide a non-incisional alternative to
  tubal ligation, the leading form of birth control worldwide. <I>Essure</I> is currently an investigational device in the United States, and studies are ongoing to support the product&#146;s safety and effectiveness. </FONT></DIV> <DIV><FONT
  SIZE="1">&nbsp;</FONT></DIV> <DIV STYLE="text-indent:27px"><FONT FACE="Times New Roman" SIZE="2">Data from the United Nations show that worldwide, 33 percent of reproductive couples using birth control rely on surgical tubal ligation. Additionally,
  a survey performed by the United States Centers for Disease Control and Prevention indicates that surgical tubal ligation continues to be the most prevalent form of birth control in the U.S., and that 35 percent of women age 35-44 have had a
  surgical tubal sterilization. An estimated 700,000 surgical tubal ligations are performed each year in the United States. </FONT></DIV> <DIV><FONT SIZE="1">&nbsp;</FONT></DIV> <DIV STYLE="text-indent:27px"><FONT FACE="Times New Roman" SIZE="2">The
  <I>Essure </I>procedure is based on a unique and proprietary catheter delivery system for minimally invasive transcervical tubal access. </FONT></DIV> <DIV><FONT SIZE="1">&nbsp;</FONT></DIV> <DIV STYLE="text-indent:27px"><FONT FACE="Times New Roman"
  SIZE="2"><I>Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements, the accuracy of which is necessarily subject to risks and uncertainties. The receipt of regulatory
  approvals, results of product development programs, and clinical efficacy of and market demand for products, among other matters discussed in this release, may differ significantly from the discussion of such matters in the forward-looking
  statements. Such differences may be based upon factors within the Company&#146;s control, such as strategic planning decisions by management and re-allocation of internal resources, or on factors outside of the Company&#146;s control, such as delays
  by regulatory authorities, scientific advances by third parties and introduction of competitive products, as well as those factors set forth in the Company&#146;s Annual Report on Form 10-K for the year ended December 31, 2001 and other filings with
  the Securities and Exchange Commission. </I></FONT></DIV> <DIV><FONT SIZE="1">&nbsp;</FONT></DIV> <DIV ALIGN="center"><FONT FACE="Times New Roman" SIZE="2">### </FONT></DIV> <P></P>
   <DIV ALIGN="center"><FONT FACE="Times New Roman" SIZE="2">3 </FONT></DIV>
  
  
  <p Style='page-break-before:always'>
  <HR  SIZE="3" COLOR="#CCEEFF" WIDTH="100%" ALIGN="CENTER">
   <DIV><FONT SIZE="1">&nbsp;</FONT></DIV> <DIV ALIGN="center"><FONT FACE="Times New Roman" SIZE="2"><B>SIGNATURES </B></FONT></DIV> <DIV><FONT SIZE="1">&nbsp;</FONT></DIV> <DIV
  STYLE="text-indent:27px"><FONT FACE="Times New Roman" SIZE="2">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
  </FONT></DIV> <DIV><FONT SIZE="1">&nbsp;</FONT></DIV> <DIV ALIGN="right">
  <TABLE CELLSPACING="0" CELLPADDING="0" WIDTH="40%" BORDER="0">
  
  <TR>
  <TD VALIGN="top" COLSPAN="3" WIDTH="43%"> <DIV STYLE="margin-left:13px; text-indent:-13px"><FONT FACE="Times New Roman" SIZE="2">C<SMALL>ONCEPTUS</SMALL>, I<SMALL>NC</SMALL>.</FONT></DIV> <DIV STYLE="margin-left:13px; text-indent:-13px"><FONT
  FACE="Times New Roman" SIZE="2">(Registrant)</FONT></DIV> </TD> </TR>
  <TR>
  <TD HEIGHT="24"> </TD> </TR>
  <TR>
  <TD VALIGN="top" WIDTH="3%"> <DIV STYLE="margin-left:13px; text-indent:-13px"><FONT FACE="Times New Roman" SIZE="2">By:</FONT></DIV> </TD>
  <TD VALIGN="bottom" WIDTH="3%"><FONT FACE="Times New Roman" SIZE="1">&nbsp;</FONT></TD>
  <TD VALIGN="top" ALIGN="center" WIDTH="43%"> <DIV ALIGN="center"><FONT FACE="Times New Roman" SIZE="2">/s/&nbsp;&nbsp;&nbsp;&nbsp;G<SMALL>LEN</SMALL> K. F<SMALL>URUTA&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</SMALL></FONT></DIV> <HR NOSHADE
  COLOR="#000000" ALIGN="left"></TD> </TR>
  <TR>
  <TD> <FONT SIZE="1">&nbsp;</FONT></TD>
  <TD VALIGN="bottom" WIDTH="3%"><FONT FACE="Times New Roman" SIZE="1">&nbsp;</FONT></TD>
  <TD VALIGN="top" ALIGN="center" WIDTH="43%"> <DIV ALIGN="center"><FONT FACE="Times New Roman" SIZE="1"><B>Glen K. Furuta</B></FONT></DIV> <DIV ALIGN="center"><FONT FACE="Times New Roman" SIZE="1"><B>Vice President, Finance &amp;
  Administration</B></FONT></DIV> <DIV ALIGN="center"><FONT FACE="Times New Roman" SIZE="1"><B>and Chief Financial Officer</B></FONT></DIV> </TD> </TR>
   </TABLE> </DIV> <DIV><FONT SIZE="1">&nbsp;</FONT></DIV> <DIV><FONT SIZE="1">&nbsp;</FONT></DIV> <DIV><FONT SIZE="1">&nbsp;</FONT></DIV> <DIV STYLE="margin-left:13px; text-indent:-13px"><FONT
  FACE="Times New Roman" SIZE="2">Dated:&nbsp;&nbsp;&nbsp;&nbsp;April 23, 2002 </FONT></DIV> <P></P>
   <DIV ALIGN="center"><FONT FACE="Times New Roman" SIZE="2">4 </FONT></DIV>
  
   </BODY></HTML>
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metadata_filer: {"company-data": {"conformed-name": "CONCEPTUS INC", "cik": "0000896778", "assigned-sic": "3841", "irs-number": "973170244", "state-of-incorporation": "DE", "fiscal-year-end": "1231"}, "filing-values": {"form-type": "8-K", "act": "34", "file-number": "000-27596", "film-number": "02619864"}, "business-address": {"street1": "1021 HOWARD AVE", "city": "SAN CARLOS", "state": "CA", "zip": "94070", "phone": "4158027240"}, "mail-address": {"street1": "1021 HOWARD AVENUE", "city": "SAN CARLOS", "state": "CA", "zip": "94070"}}
text: Prepared by R.R. Donnelley Financial -- Form 8-K
  SECURITIES AND EXCHANGE COMMISSION
  WASHINGTON, D.C. 20549
  FORM 8-K
  CURRENT REPORT
  PURSUANT TO SECTION 13 OR 15(D) OF THE
  SECURITIES EXCHANGE ACT OF 1934
  Date of Report (Date of earliest event reported): April 22, 2002
  CONCEPTUS, INC.
  (Exact name of registrant as specified in charter)
  Delaware
  000-27596
  97-3170244
  (State or other jurisdiction of
  incorporation or
  organization)
  (Commission file number)
  (I.R.S. employer
  identification no.)
  1021 Howard Avenue
  San Carlos, CA 94070
  (Address of principal executive offices) (Zip code)
  Registrant's telephone number, including area code:
  (650) 802-7240
  ITEM 5.    OTHER EVENTS.
  On April 22, 2002, Conceptus, Inc. issued a press release announcing it has completed filing of a Pre-Market Approval (PMA) application with the U.S. FDA for
  Essure
  ™
  . Text of the press release follows:
  San Carlos, CA, April 22, 2002
  —Conceptus, Inc. (NASDAQ NM: CPTS) announced today that it has completed filing of a Pre-Market Approval (PMA) application with the U.S.
  Food and Drug Administration (FDA) to market Essure
  ™
  , the Company's non-incisional permanent birth control
  procedure.
  Currently, women in the U.S. who choose permanent birth control must undergo incisional tubal ligation, which
  requires cutting into the abdominal cavity, and typically is done under general anesthesia with a four to six day recovery period.
  Essure
  requires no incisions, and can be performed without general anesthesia. Interim data from the Pivotal
  Trial show that women who underwent the
  Essure
  procedure typically returned to their normal activities within 1-2 days, and working women typically returned to work in one day or less.
  According to the Centers for Disease Control and Prevention, surgical tubal ligation is the most common method of contraception in the United States. To date, more than 10 million
  women in the U.S., and more than 100 million women worldwide have undergone the procedure. If the FDA approves the
  Essure
  PMA, permanent birth control could be revolutionized before the end of the decade.
  "We believe
  Essure
  could represent the beginning of a new standard of care, which would ultimately make the choice of permanent birth
  control an easier one for women," said Steve Bacich, President and CEO of Conceptus. "We are very pleased that we have completed one of the company's most significant milestones with the submission of this PMA application.
  Importantly, we are one step closer to bringing this option to women in the U.S."
  If approved by the FDA,
  Essure
  would be the first device available to offer women an alternative to surgical tubal ligation that doesn't require an incision and can be done routinely without general anesthesia. To date, in more than 900 woman-years of
  effectiveness testing in the clinical trial, there has not been a pregnancy with
  Essure
  . Interim data from the Pivotal Trial also show that 99 percent of women who have relied on the
  Essure
  micro-insert for birth control rated their
  long-term comfort as 'good' to 'excellent', and 95 percent of patients would recommend the procedure to a friend. Additionally, 92 percent of women who were employed returned to work in one day or less following the day of the
  procedure.
  Professor Rafael Valle, MD, Northwestern University Medical School, will be presenting the clinical data from the
  Essure
  Pivotal Trial recently submitted in the PMA at the American College of Obstetrics and Gynecology meeting at the Los Angeles Convention Center on May 7, 2002.
  1
  There have been no known pregnancies in the clinical trials or in the commercial setting with
  women relying on
  Essure
  . However like all birth control methods, pregnancies in the Pivotal Trial are expected with the use of
  Essure
  . Adverse events initially preventing reliance on
  Essure
  were less than 4 percent and were
  primarily associated with improper device placement. However, some of these women had a second
  Essure
  procedure, and were able to rely on the device for contraception. This reduced the adverse events ultimately preventing reliance to 2.5
  percent. Because there are no abdominal incisions and general anesthesia is not required, the risk profile for the
  Essure
  procedure, as is typical of hysteroscopic procedures, is expected to be lower, and of a different severity, than that of
  abdominal incisional procedures. This is typified by the minor nature of most of the adverse events.
  "If approved by the
  FDA, a key factor in the commercial success of
  Essure
  would be patient satisfaction," said Cindy Domecus, Senior Vice President of Clinical Research and Regulatory Affairs at Conceptus. "We've had an overwhelming response to
  Essure
  from women in the clinical trials who have been very satisfied with their quick recovery time and their decision to choose
  Essure
  . Conceptus chose to develop a non-incisional form of permanent of birth control because of the
  documented need for contraceptive alternatives, the significant risk associated with unintended pregnancies and abortions, and the infrequent but significant risks of invasive sterilization methods."
  If approved by the FDA, Conceptus anticipates making
  Essure
  available to U.S. women in 2003. The device is currently marketed in Australia,
  Europe, Singapore and Canada.
  About
  Essure
  Essure
  deploys a soft micro-insert into the fallopian tube through the cervix using a minimally invasive transcervical tubal access catheter. Once in place, the device is designed
  to elicit tissue growth in and around the micro-insert to form an occlusion or blockage in the fallopian tube.
  Permanent Birth Control
  Surgical tubal ligation has become the most common form of birth control worldwide, despite the fact that it is invasive
  and costly. About 93 percent of the procedures in the U.S. are performed in a hospital or surgi-center under general anesthesia, requiring between four and five hours of hospital recovery time and four to six days before returning to regular
  activities. Development of a non-incisional method of tubal ligation has been an elusive goal for researchers since the 1970's.
  An
  Essure
  procedure does not require cutting or penetrating the abdomen and can be performed in a less costly procedure setting without general anesthesia. Accordingly, a woman is expected to average 15 minutes of hysteroscopic time
  for the
  Essure
  procedure and to return home about 45 minutes after the procedure is completed. During the Pivotal Trial, 92 percent of
  Essure
  patients who were employed returned to work in one day or less, excluding the day of the
  procedure. Reliance on
  Essure
  does not involve taking drugs or hormones.
  About Conceptus
  2
  Conceptus, Inc. is developing
  Essure
  , an investigational medical procedure, designed to provide a non-incisional alternative to
  tubal ligation, the leading form of birth control worldwide.
  Essure
  is currently an investigational device in the United States, and studies are ongoing to support the product's safety and effectiveness.
  Data from the United Nations show that worldwide, 33 percent of reproductive couples using birth control rely on surgical tubal ligation. Additionally,
  a survey performed by the United States Centers for Disease Control and Prevention indicates that surgical tubal ligation continues to be the most prevalent form of birth control in the U.S., and that 35 percent of women age 35-44 have had a
  surgical tubal sterilization. An estimated 700,000 surgical tubal ligations are performed each year in the United States.
  The
  Essure
  procedure is based on a unique and proprietary catheter delivery system for minimally invasive transcervical tubal access.
  Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements, the accuracy of which is necessarily subject to risks and uncertainties. The receipt of regulatory
  approvals, results of product development programs, and clinical efficacy of and market demand for products, among other matters discussed in this release, may differ significantly from the discussion of such matters in the forward-looking
  statements. Such differences may be based upon factors within the Company's control, such as strategic planning decisions by management and re-allocation of internal resources, or on factors outside of the Company's control, such as delays
  by regulatory authorities, scientific advances by third parties and introduction of competitive products, as well as those factors set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2001 and other filings with
  the Securities and Exchange Commission.
  ###
  3
  SIGNATURES
  Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
  C
  ONCEPTUS
  , I
  NC
  .
  (Registrant)
  By:
  /s/    G
  LEN
  K. F
  URUTA
  Glen K. Furuta
  Vice President, Finance &
  Administration
  and Chief Financial Officer
  Dated:    April 23, 2002
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