Conceptus Commences STOP Pivotal Study.

Health/Medical Writers

SAN CARLOS, Calif.--(BW HealthWire)--May 30, 2000

Conceptus, Inc. (NASDAQ NM: CPTS), developer of the STOP(TM) non-surgical permanent contraception device for women, today announced the commencement of the Company's pivotal clinical study of the STOP device.

Thomas Price, M.D. successfully placed the STOP device in the first three women enrolled into the trial in his Greenville, South Carolina office. The procedure times ranged from 3 to 15 minutes.

According to Dr. Price, "The STOP device has the potential to revolutionize female sterilization. I expect that STOP will make this procedure easier, quicker, less costly and more comfortable for patients."

Dr. Jay Cooper, Principal Investigator of STOP in the United States further commented, "The excitement expressed by our patients for this procedure has been overwhelming. The STOP procedure has the clear potential, as demonstrated in these cases, to give women a choice for sterilization that does not require general anesthesia, an abdominal incision or a several day recovery period. It has long been a medical and scientific goal to offer patients and physicians this type of contraceptive option, and successful completion of the clinical trial will be a major step towards fulfillment of that goal."

"The commencement of the pivotal study is a major milestone," commented Cindy Domecus, Senior Vice President of Clinical Research and Regulatory Affairs for Conceptus. "I am encouraged by the significant results seen in our Phase II study, which allows us to quantify our level of confidence in moving forward with the pivotal trial. Additionally, several of our clinical sites have already accumulated a significant backlog of candidates for the trial and we are working with all of our physician investigators to quickly complete enrollment." In the pivotal trial, Conceptus will place devices in 400 women at an estimated 10-20 investigational sites. 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.

"As we complete our enrollment objectives," noted Steve Bacich, President and Chief Executive Officer, "we will be moving aggressively to introduce STOP outside the United States by the end of the year."

About STOP

Surgical tubal ligation has become the most common form of contraception worldwide, despite the fact that it is invasive and costly. About 93% of the 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 is performed with local sedation, thus enabling the procedure to be performed in a less costly office setting with reduced reliance on back-up emergency facilities and personnel. 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.

The STOP device is a unique and proprietary micro-coil that is deployed permanently into each fallopian tube using the Company's minimally invasive transcervical tubal access catheter system. Once in place, clinical studies have shown that the STOP device induces an occlusive tissue response. Phase II interim results with STOP include 136 women with proven fertility. There has been a low rate of adverse events, and in excess of 99% of patients rated their tolerance to wearing the STOP device as "good to excellent" at each follow-up visit conducted to date.

About Conceptus

Conceptus, Inc. is developing STOP, an innovative medical device and procedure designed to provide a non-surgical alternative to 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. Additionally, a survey performed by the Centers for Disease Control and Prevention indicates that surgical tubal ligation continues to be the most prevalent form of contraception in the U.S., and that 35% of women age 35-44 have had a surgical tubal sterilization. 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. Additional information about the Company and the STOP device is available at www.conceptus.com.

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, 1999 and other filings with the Securities and Exchange Commission.