Conceptus Announces Commencement of Permanent Contraception Study.

SAN CARLOS, Calif.--(BW HealthWire)--Oct. 17, 1997--Conceptus, Inc. (Nasdaq:CPTS) announced today that it has commenced a phase II study of its S/TOP Permanent Contraception system in Australia.

The S/TOP system is designed to be a non-surgical alternative to surgical tubal ligation, the most commonly used method of contraception worldwide. The S/TOP system is comprised of a unique micro-coil which is designed to be permanently implanted into each fallopian tube using components of Conceptus's platform Transcervical Tubal Access Catheter (T-TAC) technology, in an office setting without the need for general anesthesia.

The phase II study involves device system placement in fertile women who are desirous of permanent contraception (sterilization). Both acute and long-term outcomes will be assessed. Prior to the commencement of the phase II study, Conceptus has been conducting a human study in the U.S. to assess the technical feasibility of transcervical placement of the S/TOP micro-coil device system in women just prior to a scheduled hysterectomy.

Over thirty patients have been enrolled to date in this study. Another U.S. human study which commenced early this year is ongoing to evaluate the ability to place the S/TOP device system in an awake, conscious sedated woman and to evaluate the system's mechanism of action. The patients in this study are scheduled for a hysterectomy within six to twelve weeks after S/TOP device placement, which will facilitate evaluation of tubal occlusion.

"This is a very important milestone for Conceptus," stated Kathryn Tunstall, President and Chief Executive Officer. "The S/Top Permanent Contraceptive device system is the highest-value clinical application of components of our unique Transcervical Tubal Access Catheter (T-Tac) technology platform and, at an estimated $1-3 billion in size, may well be the largest medical device market of all," she added.

Conceptus also announced that it had conducted a market launch of its ERA(TM) resectoscope sheath at the Annual Meeting of the American Association of Gynecological Laparascopy (AAGL) in Seattle, Washington.

The AAGL membership includes high patient-volume interventional gynecologists who are the primary customers for all of Conceptus's planned products. The ERA sheath was highlighted in several scientific presentations by physicians on the subject of operative hysteroscopy, which is a growing non-incisional alternative to hysterectomy for treating dysfunctional uterine bleeding, fibroids and other benign uterine pathology.

Cleared for marketing by the United States Food and Drug Administration (FDA) on September 15, 1997, the ERA sheath eliminates one of the most common and potentially catastrophic complications of operative hysteroscopy, dilutional hyponatremia, a complication which can lead to cardiac arrhythmia, coma and even death.

"The ERA sheath is a very exciting advance in operative hysteroscopy, and may well be the impetus for accelerated growth of these minimally invasive procedures," stated Keith Isaacson, M.D., one of the inventors of the sheath technology. "The sheath provides an enhanced `margin of safety' for the patient, allowing the physician to complete the resection of uterine tissue, without the fear of the significant complications associated with dilutional hyponatremia," he added.

The Company had previously announced a marketing and distribution agreement with Imagyn Medical Technologies (Nasdaq:IMTI), formerly UroHealth, Inc.

The agreement grants to Imagyn an exclusive, worldwide license to the urological applications of the resectoscope sheath, including its use in trans-urethral resection of the prostate (TURP), the standard of care for treating benign prostatic hyperplasia (BPH). Conceptus retained all rights to the gynecological applications of the resectoscope sheath technology.

Conceptus also announced that late in the third-quarter, a manufacturing scale-up issue constrained planned third-quarter shipments of the resectoscope sheath to support initial marketing launch, but that it expects adequate inventory to be available beginning in late October to support both Imagyn Medical Technology's planned market launch (November) and demand for the product from Conceptus's interventional gynecology customers.

Revenues which are expected to be about $300,000 will be below analyst' projections. The earnings-per-share results are expected to be equal to or better than analysts' projections.

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, 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 Feb. 1, 1996, under the heading "Risk Factors" and the Company's other filings with the Securities and Exchange Commission, including the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 1997.

CONTACT: Conceptus, Inc.

Kathryn Tunstall/Sanford Fitch, 650/802-7240