FDA Advisory Panel Recommends Conditional Premarket Approval of Gynecare's ThermaChoice Uterine Balloon Therapy System.

MENLO PARK, Calif.--(BW Healthwire)--Oct. 7, 1997--

ThermaChoice Is an Investigational Therapy in the

United States

Gynecare(TM), Inc. (NASDAQ:GYNE), today announced that the Obstetrics and Gynecology Devices Panel of the U.S. Food and Drug Administration's (FDA) Medical Devices Advisory Committee has recommended to the FDA that it approve Gynecare's application for premarket approval (PMA) of its ThermaChoice(TM) Uterine Balloon Therapy(TM) system pending certain conditions. ThermaChoice is designed as a minimally invasive, eight-minute, outpatient treatment for excessive menstrual bleeding (menorrhagia), a debilitating condition that affects 19 percent of all menstruating women.

The Advisory Panel recommended the approval of ThermaChoice pending certain conditions including: completion of one-year follow-up data on all patients treated in the U.S. clinical trial; revision of professional and patient labeling; resolution of certain software and minor engineering issues; monitoring of patients treated with ThermaChoice after premarket approval for two years; and collaboration with the FDA to resolve certain physician training issues. The FDA will consider the Advisory Panel's recommendation in its final review of Gynecare's premarket approval application.

In response to the Advisory Panel's recommendation, Roseanne Hirsch, Gynecare's president and CEO said, "This is exciting and positive news for both Gynecare and the many American women for whom ThermaChoice could offer relief. We intend to work expeditiously to supply the requested information and to provide any additional assistance to the FDA in support of our PMA application."

About ThermaChoice and the U.S. Clinical Trial

ThermaChoice is an investigational therapy in the United States. It is intended to be a one-time, eight-minute treatment performed under local anesthesia in an outpatient setting for excessive menstrual bleeding. During the ThermaChoice procedure, a balloon catheter is inserted vaginally into the uterus and inflated with sterile solution, which is then heated to 87 degrees Celsius for eight minutes. The balloon is then deflated and the catheter is withdrawn and discarded. The intended thermal ablation of the uterine lining results from the contact of the endometrium with the heated ThermaChoice balloon. ThermaChoice, which is currently marketed internationally, has been used to treat approximately 3,000 women worldwide.

Gynecare's U.S. clinical trial was intended to assess the safety and efficacy of ThermaChoice as a treatment for excessive menstrual bleeding, or menorrhagia, a condition that affects 19 percent of menstruating women worldwide. During the clinical trial, ThermaChoice was compared under numerous criteria to electrosurgical ablation using a rollerball. Electrosurgical ablation has been shown to be an effective alternative to hysterectomy for the treatment of menorrhagia (New England Journal of Medicine, July 1996). The six-month follow-up data from the ThermaChoice trial indicate results similar to those obtained with electrosurgical ablation using a rollerball to reduce excessive bleeding to normal levels or less.

The six-month results from Gynecare's clinical trial are based on follow-up data on the randomized treatment of 255 women who recorded blood flows of more than 80cc each month. In all, 131 patients were treated with ThermaChoice and 124 patients underwent electrosurgical ablation using a rollerball at 12 medical centers across the United States and two in Canada.

About Gynecare

Gynecare, Inc., headquartered in Menlo Park, Calif., designs, develops and markets innovative, minimally invasive and cost-effective medical devices for the treatment of uterine disorders. In August 1997, Gynecare and Johnson & Johnson (NYSE:JNJ) executed a definitive agreement to merge Gynecare with the Ethicon, Inc. division of Johnson & Johnson. The stock-for-stock merger is subject to the approval of Gynecare, Inc., shareholders and other customary conditions and has not been completed. Gynecare's initial product, the ThermaChoice Uterine Balloon Therapy system, is currently undergoing clinical evaluation in the United States as a treatment for excessive menstrual bleeding. The ThermaChoice system is approved for marketing in Canada and 12 other countries. Gynecare has received 510(k) clearance from the U.S. Food and Drug Administration to market its VersaPoint(TM) system, a treatment for uterine fibroids.

This press release contains language that may constitute forward-looking statements for purposes of the Securities Act of 1933 and the Securities Exchange Act of 1934. These forward-looking statements reflect certain of the company's current beliefs and expectations with respect to FDA approval of the ThermaChoice Uterine Balloon Therapy system and are subject to a number of risks that may cause actual events and results to differ materially from the forward-looking statements. These risks include: 1) the risk that the company's PMA application will not be approved by the FDA; 2) the risk that any FDA approval of the PMA application will be for a more limited indication than requested by the company; 3) the risk that further clinical trials of the ThermaChoice product could be required by the FDA and that such clinical trials could identify significant technical or other obstacles that would have to be overcome prior to FDA approval of the PMA application; and 4) the risk of changes in existing regulations or adoption of new government regulations or policies which could prevent or delay regulatory approval of the company's products. Failure to obtain approval of the PMA application, or to obtain such approval on a timely basis, would have a material adverse effect on the company's business, financial conditions and results of operations. Investors are encouraged to review the company's annual and quarterly reports on Form 10K and Form 10Q for a fuller discussion of the risks and uncertainties regarding the company's business and products. -0-

Note to Editors: Gynecare, ThermaChoice, Uterine Balloon Therapy and VersaPoint are trademarks of Gynecare, Inc.

CONTACT: Gynecare, Inc.

Malcolm M. Farnsworth Jr., 650/614-2530

or

Schwartz Communications, Inc.

Hallie Loring or Hope Freundlich, 415/512-0770

hloring or [e-mail]