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Gynecare begins U.S. clinical trials of non-surgical alternative to hysterectomy; New outpatient therapy for excessive menstrual bleeding has been 95% successful in international trials.

MENLO PARK, Calif.--(BUSINESS WIRE)--Jan. 23, 1996--Gynecare(TM), Inc. (NASDAQ: GYNE) today announced the beginning of U.S. clinical trials of its Uterine Balloon Therapy(TM) system used to treat excessive menstrual bleeding (menorrhagia) in women.

Physicians at 13 prestigious academic and medical centers in the U.S., including Boston's Brigham & Women's Hospital and St. Luke's-Roosevelt Hospital Center affiliated with Columbia University Medical School in New York, will participate in the randomized trials, which will consist of 250 patients between the ages of 30 and 50. The Uterine Balloon Therapy system is designed as a non-surgical alternative to the 120,000 to 180,000 hysterectomies performed annually in the U.S. to treat excessive menstrual bleeding.

Gynecare's Uterine Balloon Therapy system is designed as a one-time, eight-minute procedure that can usually be performed under local anesthesia in an outpatient setting. The Uterine Balloon Therapy system is designed to reduce or eliminate excessive menstrual flow, a condition which affects approximately 19% of women worldwide. As of December 1995, results from international clinical trials, which involved 300 patients, show that the Uterine Balloon Therapy system is 95% successful in treating menorrhagia among the 75 patients with at least six months of follow-up. Physicians define success in treating menorrhagia as a reduction to normal menstrual bleeding levels or less.

New Alternative to Hysterectomy Taps Vast Market

Based on a study by the World Health Organization and other research, it is estimated that approximately 18 million menstruating women aged 30 to 50 who live in the U.S., Europe, Canada and Japan perceive their menstrual bleeding to be excessive. Ultimately, treatment for excessive menstrual bleeding accounts for between 20% and 30% of the 600,000 hysterectomies performed annually in the United States. It is estimated that there are more than 1.5 million hysterectomies performed each year, worldwide.

"Gynecare is committed to improving the quality of women's healthcare," said Bill Hunter, president and CEO of Gynecare. "We believe that the Uterine Balloon Therapy system has the potential to improve the quality of women's lives, without the usual risks of major, invasive surgery."

Non-Surgical Approach Would Significantly Lower Healthcare Costs

Unlike hysterectomy, which is performed under general anesthesia and requires a hospital stay and extended recovery period, Gynecare's Uterine Balloon Therapy system offers the potential of combining both medical and cost benefits resulting from a one-time, non-surgical solution to excessive menstrual bleeding.

The Uterine Balloon Therapy system may significantly reduce overall health costs according to Robert London, M.D., assistant professor of Obstetrics and Gynecology at the Johns Hopkins University School of Medicine. Dr. London is also Regional Manager of Women's Health Care and Special Programs at the Mid-Atlantic Permanente Medical Group, a division of Kaiser Permanente, and a member of Gynecare's Medical Advisory Board. "By avoiding hysterectomy, a major surgical procedure, we eliminate its associated pre-operative, surgical and post-operative costs. I expect that the Uterine Balloon Therapy system will enhance the quality of our patients' lives, and will also result in savings between $7,000 and $10,000 for each procedure that is performed as an alternative to a hysterectomy."

According to hospital discharge data and company estimates, the annual cost of hysterectomies performed in the United States for treatment of excessive menstrual bleeding is estimated to be between $750 million and $1.8 billion. The cost of a hysterectomy typically ranges from $5,000 to $12,000. The cost for the Uterine Balloon Therapy procedure is expected to be $2,000 to $3,000.

How Gynecare's Uterine Balloon Therapy System Works

"Gynecare's Uterine Balloon Therapy system may help change how doctors and patients think about treating the debilitating condition of excessive menstrual bleeding," said Brian Walsh, M.D., chief of the division of surgical gynecology at Brigham & Women's Hospital in Boston. "I believe the Uterine Balloon Therapy system may become the therapy of choice in treating menorrhagia, a neglected disease which affects millions of women."

Gynecare's Uterine Balloon Therapy system, designed as a one-time treatment, enables the removal of the endometrial lining of the uterus, the primary source of menstrual bleeding, through a patented method called thermal ablation. A balloon catheter is inserted vaginally, through the cervix and into the uterus, and is inflated with a small amount of sterile fluid to conform to the shape of the uterus. A heating element inside the balloon then raises the temperature to approximately 87 degrees Celsius, which is maintained for eight minutes. Finally, the balloon is deflated and the balloon catheter is removed and discarded.

"I set out to design a simple, safe solution to the problem of excessive menstrual bleeding, for both doctors and their patients," said Robert Neuwirth, M.D., Babcock Professor in the department of Obstetrics and Gynecology, Columbia University College of Physicians and Surgeons, director emeritus at St. Luke's-Roosevelt Hospital Center, and inventor of the thermal ablation procedure. "The Uterine Balloon Therapy system is a new therapy which allows women who suffer from menorrhagia to lead a normal life. Our international clinical investigators have reported that this device, which uses thermal ablation to remove the endometrial lining, has a 95% success rate. I'm excited that the U.S. trials are beginning and hope to continue to prove the effectiveness of the procedure." Dr. Neuwirth is a member of Gynecare's Medical Advisory Board.

Women who are interested in learning more about the clinical trials of the Gynecare Uterine Balloon Therapy system may obtain further information by calling 1-800/455-5117.

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Note to producers and editors: for television, B-roll is available with Gynecare Uterine Balloon Therapy system patients, animation of the technology and close-ups of the device. For print media, color graphics are included in a press kit.

Gynecare, Inc. (NASDAQ:GYNE), headquartered in Menlo Park, Calif., completed its initial public offering in November 1995. Gynecare designs, develops and markets innovative and cost-effective medical devices for the treatment of uterine disorders. The Company's initial product, the Uterine Balloon Therapy system, is used to treat women who experience heavy menstrual bleeding, and is currently being marketed in 24 countries worldwide.

Gynecare, Uterine Balloon Therapy, the eight-minute non-surgical solution, and the stylized Gynecare logo are trademarks of Gynecare, Inc.

CONTACT: For investor inquiries: For media inquiries:

Gynecare, Inc. Schwartz Communications, Inc.

Mac Farnsworth Hallie Loring or

Chief Financial Officer Deirdre O'Connell

(415) 614-2530 (617) 431-0770

or

Lloyd Benson (SCI at Gynecare)

(415) 614-2500

or

Shirley Macbeth

(415) 912-2825
COPYRIGHT 1996 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1996, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Date:Jan 23, 1996
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