Conceptus Announces Organizational Changes and Successful Phase II Study/planned International Pivotal Trial of Stop Non-surgical Permanent Contraception Device.

Business/Health Editors

SAN CARLOS, Calif.--(BW HealthWire)--Jan. 5, 2000

Conceptus, Inc. (CPTS) announced today several organizational changes. Steven Bacich, a sixteen-year industry veteran and formerly Conceptus's Vice President of Research and Development, was elected President and Chief Executive Officer and a Director, replacing Kathryn A. Tunstall. Ms. Tunstall was elected Chairman of the Board of Directors. Howard Palefsky, formerly Chairman of the Board of Directors, will also remain on the board and has been elected its Vice-Chairman.

"Over the past two years, Steve Bacich has led the effort to develop the STOP(TM) non-surgical permanent contraception device," said Ms. Tunstall. "Steve's exceptional leadership, his technical expertise and in-depth understanding of clinical markets have contributed significantly to the success of the STOP program," she added. Of Kathryn Tunstall, Howard Palefsky said, "For over six years, her vision, energy and persistence have been instrumental in Conceptus's development and in the progress of the STOP program. Her continued guidance as Chairman will be most welcome and appreciated."

Conceptus also announced the resignations of board members Thomas McConnell and Robert Kuhling. "Rob Kuhling and Tom McConnell have served on Conceptus's board since its spin-off from Target Therapeutics, at which time they led our initial private financing. We thank them for their exemplary service to Conceptus," stated Ms. Tunstall. In addition to Mr Palefsky, Ms. Tunstall, and Mr. Bacich, continuing board members include Richard Randall, Florence Comite, M.D., and Sanford Fitch.

Conceptus also announced that based upon the successful interim results of its expanded phase II study of the STOP(TM) non-surgical permanent contraception device, it plans to commence an international pivotal (phase III) study in the first half of 2000, with clinical sites in the U.S., Australia and Europe. Accordingly, in the first quarter, the Company plans to submit an Investigational Device Exemption (IDE) to the US Food and Drug Administration (FDA). Conceptus believes it has sufficient capital resources to complete enrollment of the pivotal trial.

Phase II interim results as of December 31, 1999 include 134 women with proven fertility enrolled in the study. Seventy of these women have completed the three-month period of alternative contraception required by the study protocol and are relying solely on the STOP device for contraception. To date, with these seventy women, Conceptus has accumulated 273 woman-months of effectiveness with no reported pregnancies.

Over the past year, Conceptus evaluated several opportunities as part of its previously announced strategic advisory agreement with CIBC World Markets (November 2, 1998). As a result of the favorable data from its phase II study and plans for a pivotal study however, Conceptus has decided to focus its resources solely on its STOP device, which addresses one of the largest medical device markets.

"The STOP system could have a profound impact on the contraception choices available to women," stated Steve Bacich, President and Chief Executive Officer. "Just ten years ago it seemed revolutionary to think that many open surgical procedures could be performed laparoscopically, through small incisions. However, as the benefits to patients, physicians and payors became evident, laparoscopic abdominal procedures became the standard of care, and laparoscopic tubal sterilization has become the most common method of contraception worldwide. We believe that STOP can further advance the standard of care by eliminating the risks of incisional surgery, including the risks of general anesthesia. In addition, since the STOP procedure does not involve puncturing the abdomen, scarring is eliminated and the time required for patient recovery should be significantly reduced."

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, 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 the Company'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, 1998 and its Quarterly Report on form 10-Q for the quarter ended September 30, 1999 and other filings with the Securities and Exchange Commission.