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| |  Reliance Urinary Control Insert Receives FDA Approval NEEDHAM, Mass., Aug. 21, 1996 -- UroMed Corporation (Nasdaq: URMD) today received Food and Drug Administration (FDA) approval to market the Reliance(R) Urinary Control Insert in the United States. The Reliance Urinary Control Insert is a unique new treatment for urinary incontinence offering an alternative to adult diapers. A first of its kind product, Reliance is a small, self-administered, discreet, single-use device designed to immediately prevent urine leakage caused by female stress urinary incontinence (loss of bladder control). This approval notification is recognition of four years of extensive clinical research and comes after an expedited Pre-Market Approval (PMA) review conducted in just under a year as well as a unanimous panel recommendation on July 25, 1996. According to a national health and nutrition survey, an overwhelming 33 percent of Americans experience some type of urinary incontinence. Stress urinary incontinence is the involuntary loss of urine during coughing, sneezing, laughing, exercise, or any other physical activity that increases abdominal pressure. Contrary to popular belief, incontinence is common among women of all ages. A study published in Contemporary Urology estimates that 50 percent to 75 percent of women in chronic care facilities have urinary incontinence. The study also indicates that a startling 20 percent of women 40 to 60 years of age reportedly suffer from stress urinary incontinence, the most common type of incontinence in women. Research indicates that reduced quality-of-life is a serious issue for women suffering from incontinence. Most women do not discuss their condition with anyone, including their doctor. Surveys indicate that, on average, women wait three years before discussing incontinence with their physicians. Their reluctance is primarily related to embarrassment in discussing this condition with anyone. Once they do discuss this, many women find treatments unfortunately are limited, costly and often unsuccessful or inadequate. Currently, it is estimated that the cost of these unsatisfactory treatments is $16 billion annually in the United States. "Urinary incontinence has serious economic, social and psychological effects including discomfort, embarrassment, loss of dignity and low self- esteem. These effects cause difficulties in the workplace, at social activities and during exercise; in short, every aspect of a sufferer's life is compromised," said John Simon, chairman and chief executive officer of UroMed. "Reliance is designed to offer the millions of women who suffer from stress urinary incontinence, a non-surgical, reliable alternative to adult diapers and pads providing a combination of both physical and psychological benefits." Product Specifications The Reliance Urinary Control Insert has a unique design that allows freedom and reliability similar to that provided by a tampon. Measuring one-fifth the size of a tampon, the small, self-administered, discreet, single-use device is a breakthrough in the prevention of urine leakage. Reliance is easily placed into the urinary channel with the help of an applicator. A gentle push on the applicator fills the insert with air so that it acts as a barrier and prevents urine leakage. When a woman wishes to urinate, she pulls a string, the balloon deflates and the insert is removed. Clinical Results According to extensive clinical trial results presented to the FDA, Reliance effectively controlled urine loss in 95 percent of patients studied. Nearly all patients who were followed for a year said they experienced significant quality-of-life improvements and 97 percent of those patients said they would recommend Reliance to another incontinence sufferer. "The high degree of effectiveness achieved by Reliance in controlling urine loss suggests that it is an important new product for many female incontinence sufferers," stated David Staskin, M.D., Director of the Urodynamics and Continence Center at Boston's Beth Israel Hospital and an Assistant Professor of Urology at Harvard Medical School. "Now that it is available, the improvement reported in quality-of-life can be offered to many more women who have had to curtail or eliminate certain activities altogether because of their Bonnie Dellinger, a participant in the Reliance clinical trial comments, "I have been using Reliance for two years now. It's comfortable and it fits my lifestyle and, most importantly, there's no leakage. I was dry from the start. Reliance allowed me to take walks, travel, swim, dance and play with my grandchildren again." "Reliance has changed my life," commented Anna Briones. "At 23 years of age, I had stress incontinence. I became a slave to my bladder. I would leak at the most inappropriate times, when I sneezed, laughed, ran or even picked up groceries. Finally, my quality-of-life has been restored." Reliance will be available in five lengths through prescription only later this year. Women with mild symptoms may use it occasionally while those with moderate to severe symptoms may use Reliance continuously throughout the day. For more information on the Reliance Urinary Control Insert, individuals should consult their healthcare provider or call 1-800-222-4886. UroMed Corporation focuses solely on developing patient-focused products for urological and gynecological disorders. The RelianceUrinary Control Insert is UroMed Corporation's first developed and patented product. John Simon founded the company in October of 1990. Since that time, the company has assembled a management team with strong backgrounds in medical devices, product invention, manufacturing and medical product marketing. The company also has formed prestigious scientific and medical advisory teams to assist in the research and development of its products. NOTE: The Reliance Urinary Control Insert is a registered trademark of UroMed Corporation.
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