Conceptus Announces S/TOP IDE Approval.

SAN CARLOS, Calif.--(BW HealthWire)--Aug. 21, 1998--Conceptus, Inc., (NASDAQ:CPTS), a leading company in the emerging women's health market, announced today that it has received permission from the US Food and Drug Administration (FDA) to begin limited US Phase II clinical trials of its S/TOP (Selective Tubal Occlusion Procedure) device for permanent contraception.

The initial study, involving fifteen patients, will be conducted at a single site, with investigator Dr. Jay Cooper, clinical professor at the University of Arizona School of Medicine. Dr. Cooper has been the principal investigator for Conceptus's peri-hysterectomy and pre-hysterectomy clinical trials of the S/TOP device and has been a primary clinical advisor to the company for this program.

Dr. Cooper has also been a significant contributor to patient enrollment in trials of previously studied hysteroscopic sterilization devices. A world renowned hysteroscopist, Dr. Cooper serves on the board of the American Association of Gynecological Laparoscopy.

"We are eager to begin Phase II clinical trials in the U.S., especially with such an experienced and well regarded investigator as Dr. Cooper, who is already experienced in placement of the S/TOP device due to his participation in the Phase I clinical studies of the device", stated Kathryn Tunstall, president and CEO of Conceptus.

"The commencement of clinical effectiveness trials of the S/TOP device in the US is a major clinical and regulatory milestone for Conceptus", she added. Conceptus began its first Phase II clinical trial at a single site in Australia last year.

Conceptus, Inc. designs and develops innovative interventional medical devices for use in reproductive medicine. The company has developed the STARRT(TM) Falloposcopy and T-TAC(TM) catheter systems to improve the diagnosis and treatment of fallopian tube diseases and disorders, a primary cause of infertility.

The company has also developed the ERA(TM) Resectoscope Sleeve, incorporating novel technology designed to improve the safety and ease-of-use of therapeutic hysteroscopy, a growing, less-invasive alternative to hysterectomy.

Except for the historical information contained herein, the matters discussed in this press 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, 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 Conceptus's control, such as strategic planning decisions by management and re-allocation of internal resources, or on factors outside of Conceptus's control, such as delays by regulatory authorities, scientific advances by Conceptus or 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, 1997, the Company's prospectus dated February 1, 1996, under the heading "Risk Factors" and the Company's other filings with the Securities and Exchange Commission.

    CONTACT: Conceptus, Inc.
              Kathryn Tunstall, 415/802-7240