Conceptus Receives FDA Approval to Commence Pivotal Trial of STOP Device.

Business Editors & Health Writers

SAN CARLOS, Calif.--(BW HealthWire)--March 29, 2000

Enrollment in 400-patient global study to begin in Q2 2000

All clinical sites to utilize the Internet for timely data collection

and auditing

Conceptus, Inc. (NASDAQ NM:CPTS), developer of the STOP(TM) (Selective Tubal Occlusion Procedure) non-surgical permanent contraception device for women, today announced that the Food and Drug Administration (FDA) has granted approval for commencement of the Company's pivotal study of STOP. The Company plans to begin study enrollment in the second quarter of 2000.

In the pivotal trial, Conceptus will place devices in 400 women at an estimated 10-20 investigational sites in the U.S., Europe and Australia. The protocol requires 12 months of follow-up after each patient begins to rely on STOP for contraception, which occurs three months after the STOP placement procedure. Clinical endpoints of the study include pregnancy prevention, and safety and comfort during and after the STOP procedure.

"We worked closely with the FDA in preparation for the IDE filing, providing histological evidence of the mechanism of action of the STOP device and the safety and effectiveness data from our Phase II study. This approval, based upon the strength of our proposal and scientific data gathered to date, represents a significant achievement for the regulatory and scientific team at Conceptus," said Steve Bacich, president and chief executive officer. "In light of the positive Phase II data collected to date, we are enthusiastically proceeding into the pivotal trial," he added.

"We are delighted to reach this important milestone, and look forward to initiating our global pivotal study," said Cindy Domecus, senior vice president of clinical research and regulatory affairs. Ms. Domecus added that all clinical sites will provide study data to a centralized source via the Internet. "This Web-assisted data collection will allow instantaneous access to study progress and more rapid data monitoring. As a result, we hope to reduce the time required to analyze the data and prepare the PMA application," she added.

The Company expects to complete enrollment in the pivotal study by the second quarter of 2001. Although marketing of the STOP device in the U.S. will require successful completion of the pivotal study and FDA approval, Conceptus plans to begin marketing the STOP device in select international markets beginning in 2001. The Company is actively assessing options for global distribution, and expects to obtain a CE mark by calendar year-end.

STOP is a non-surgical permanent contraceptive device designed to be less invasive than the 800,000 U.S. and 16 million worldwide surgical tubal ligation procedures performed annually. Despite the fact that it is invasive and costly, surgical tubal ligation has become the most common form of contraception worldwide. A vast majority of such procedures in the U.S. are performed in a hospital or surgi-center under general anesthesia, requiring 4-5 hours of hospital recovery time and resulting in 3-4 days off work. In contrast, because a STOP procedure does not require cutting or penetrating the abdomen, the procedure can usually be performed in about 20 minutes using local sedation, thus enabling the procedure to be performed in a less costly office setting. Accordingly, a woman is expected to spend about 2-3 hours of her day for a STOP procedure, and have a rapid return to normal activities. STOP also represents a drug-free alternative to long-term use of oral contraceptives or hormonal implants.

The STOP device features a proprietary micro-coil designed to be deployed permanently into each fallopian tube using the Company's minimally invasive transcervical tubal access catheter system. Once in place, clinical data have shown that the STOP device induces an occlusive tissue response in the lumen of the fallopian tube. In the Phase II study of STOP involving 134 women with proven fertility, as of February 29, 2000, more than 500 women-months of effectiveness data have been accumulated with no reported pregnancies, and a low rate of adverse events. Importantly, in excess of 95% of all patients in the study have reported that the comfort of wearing the STOP device is "very good to excellent" at each follow-up point completed thus far after device placement.

About Conceptus

Conceptus, Inc. is developing STOP, an innovative medical device designed to provide a non-surgical alternative to surgical tubal ligation, the leading form of contraception worldwide. Data from the United Nations show that worldwide, 30% of reproductive couples using contraception rely on surgical tubal ligation. A survey performed by the Centers for Disease Control indicates that surgical tubal ligation is the No. 1 form of contraception in the U.S., and that 35% of women age 35-44 have had a tubal ligation. An estimated 800,000 surgical tubal ligations are performed each year in the U.S., of which 93% are performed in a hospital or surgi-center and require general anesthesia.

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 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 other filings with the Securities and Exchange Commission.