Conceptus receives U.S. FDA clearance to market minimally invasive urology surgical technology.

SAN CARLOS, Calif.--(BW HealthWire)--Feb. 12, 1997--Conceptus Inc. (NASDAQ:CPTS) announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its Microgyn resectoscope safety sheath and accessories for minimally invasive urologic surgery.

These applications include transurethral resection and ablation (non-incisional removal of tissue) within the urethra, prostate and bladder. One of these procedures, transurethral resection of the prostate (TURP), is used to treat symptomatic, enlarged prostates, a condition known as benign prostatic hyperplasia (BPH), which affects up to 80 percent of men over the age of 50. There are approximately 130,000 TURP procedures performed in the United States annually.

"This FDA clearance is another significant milestone for Conceptus and the first FDA marketing clearance for the technology developed by Microgyn Inc., acquired by Conceptus in 1996," stated Kathryn Tunstall, president and CEO of Conceptus. "While Conceptus remains focused on meeting the clinical needs of the interventional gynecologist, we believe the Microgyn technology holds tremendous utility for the urology community."

Conceptus plans to file a separate 510(k) submission for gynecologic applications of the technology next month. The gynecologic applications of this technology for which Conceptus will seek FDA marketing clearance involve therapeutic hysteroscopy, a less invasive alternative to many of the over 600,000 hysterectomies performed each year in the United States.

The Microgyn resectoscope safety sheath and accessories are designed to enable surgeons to use isotonic (physiologic) irrigating solutions during the performance of electrosurgical urologic procedures to remove abnormal tissue. Currently, electrosurgical procedures can only be performed with hypotonic (low salt) irrigating solutions.

However, there are complications associated with the absorption of large amounts of hypotonic solutions including serious heart, lung, and brain disorders, sometimes leading to coma and death. The use of isotonic solutions should eliminate the incidence of these potentially catastrophic complications.

Conceptus is currently in discussions with potential distribution partners with a strong franchise in urology to market the product line for the urologic applications. For gynecologic applications, the company plans to expand its direct sales force in the United States and utilize specialty distributors in markets outside the United States.

The company is in the process of gearing up for production of the resectoscope safety sheath and accessories and anticipates launching the product in the second quarter of this year.

Conceptus Inc. designs, develops and markets innovative medical devices for the reproductive system. The company's initial focus is on the development of systems to improve the diagnosis and treatment of fallopian tube diseases and disorders, a primary cause of infertility.

In November 1996, Conceptus acquired Microgyn Inc., a company which had developed a novel technology designed to improve the safety and ease-of-use of therapeutic hysteroscopy. Therapeutic hysteroscopy is a growing, less-invasive alternative to hysterectomy. The company is also developing a non-surgical approach to fallopian tube sterilization, the most commonly performed contraceptive procedure worldwide.

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' control, such as strategic planning decisions by management and re-allocation of internal resources, or on factors outside of Conceptus' 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 prospectus dated Feb. 1, 1996, under the heading "Risk Factors."

CONTACT: Conceptus Inc., San Carlos

Kathryn Tunstall or Sanford Fitch, 415/802-7240