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 NASDAQ
in full National Association of Securities Dealers Automated Quotations
U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : GYNE) today announced the beginning of U.S. clinical trials of its Uterine Balloon Therapy(TM) system used to treat excessive menstrual bleeding (menorrhagia menorrhagia /men·or·rha·gia/ (men?ah-ra´jah) hypermenorrhea.
See hypermenorrhea. ) 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 St. Luke's-Roosevelt Hospital Center is a 1,076-bed, full-service community and tertiary care hospital serving New York City’s Midtown West, Upper West Side and parts of Harlem. affiliated with Columbia University Medical School in New York New York, state, United States
New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of , will participate in the randomized ran·dom·ize
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment. 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 Anesthesia, Local Definition
Local or regional anesthesia involves the injection or application of an anesthetic drug to a specific area of the body, as opposed to the entire body and brain as occurs during general 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 hysterectomy (hĭstərĕk`təmē), surgical removal of the uterus. A hysterectomy may involve removal of the uterus only or additional removal of the cervix (base of the uterus), fallopian tubes (salpingectomy), and ovaries Taps Vast Market
Based on a study by the World Health Organization and other research, it is estimated that approximately 18 million menstruating men·stru·ate
intr.v. men·stru·at·ed, men·stru·at·ing, men·stru·ates
To undergo menstruation.
[Late Latin m 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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 obstetrics and gynecology
Medical and surgical specialty concerned with the management of pregnancy and childbirth and with the health of the female reproductive system. at the Johns Hopkins University School of Medicine The Johns Hopkins University School of Medicine, located in Baltimore, Maryland, USA, is a highly regarded medical school and biomedical research institute in the United States. . 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 de·bil·i·tat·ing
Causing a loss of strength or energy.
Weakening, or reducing the strength of.
Mentioned in: Stress Reduction 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 endometrial /en·do·me·tri·al/ (en?do-me´tre-il) pertaining to the endometrium.
n relating to the end-ometrium or cavity of the uterus. 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 de·flate
v. de·flat·ed, de·flat·ing, de·flates
a. To release contained air or gas from.
b. To collapse by releasing contained air or gas.
2. 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 The Columbia University College of Physicians and Surgeons, abbreviated P&S, is a graduate school of Columbia University located on the health sciences campus in the Washington Heights neighborhood of Manhattan. , 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.
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 styl·ize
tr.v. styl·ized, styl·iz·ing, styl·iz·es
1. To restrict or make conform to a particular style.
2. To represent conventionally; conventionalize. 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
Lloyd Benson (SCI (Scalable Coherent Interface) An IEEE standard for a high-speed bus that uses wire or fiber-optic cable. It can transfer data up to 1GBytes/sec.
(hardware) SCI - 1. Scalable Coherent Interface.
2. UART. at Gynecare)