Conceptus Announces First U.S. Phase II S/TOP Procedures and FDA Approval to Commence Second U.S. Study Site.

SAN CARLOS, Calif.--(BW HealthWire)--Dec. 14, 1998--Conceptus, Inc., (Nasdaq:CPTS) announced today that it has enrolled its first two U.S. patients in a Phase II study of its S/TOP (Selective Tubal Occlusion Procedure) permanent contraceptive system.

The S/TOP system, which has been in Phase II studies in two investigational sites in Australia prior to the commencement of the U.S. study, is designed to be a non-surgical alternative to surgical tubal ligation, the most commonly used method of contraception worldwide. In the first two U.S. cases, Dr. Jay M. Cooper, clinical professor at the University of Arizona School of Medicine, achieved bi-lateral placement of S/TOP coil devices in less than thirty minutes per case.

"The STOP transcervical sterilization procedure has the potential to offer a viable alternative to traditional laparoscopic sterilization techniques," stated Dr. Cooper, the principal investigator of the S/TOP permanent contraceptive device system. A world renowned hysteroscopist, Dr. Cooper serves on the board of the American Association of Gynecological Laparoscopy and has conducted extensive research in hysteroscopic sterilization techniques.

"For many women, the prospect of a transcervical approach for permanent sterilization seems more natural and less invasive," stated Dr. Cooper. "The STOP procedure is designed to be performed in an office setting in less than fifteen minutes, with minimal anesthetic or analgesia required. Laparoscopic sterilization, on the other hand, generally requires an ambulatory surgical setting, general anesthesia, and an abdominal incision, even if it's a small one," he added.

The S/TOP permanent contraception system is comprised of a unique micro-coil which is intended to be permanently implanted into each fallopian tube using components of Conceptus's platform Transcervical Tubal Access Catheter (T-TAC) technology.

The Phase II study is designed to evaluate the system's contraceptive effectiveness as well as the ability of physicians to place the device in a setting without general anesthesia. None of the forty-five pre-hysterectomy or Phase II clinical cases completed thus far have required the use of general anesthesia.

Conceptus also announced that it has received permission from U.S. Food and Drug Administration (FDA) to expand its Phase II clinical studies of the S/TOP permanent contraceptive system to a second U.S. investigator, Dr. Thomas M. Price, Associate Professor at the University of South Carolina Medical School at Columbia.

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 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 management and re-allocation of internal resourcl as those factors set forth in the Company's Aurities and Exchange Commission.