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New Data Presented on the Renessa(R) Treatment for Female Stress Urinary Incontinence
Date:11/9/2007

have been better in a slightly more severely affected population of women. And as has been the case in all four previous studies and in our commercial experience, there have been no serious adverse events reported," he states.

The company previously reported long term clinical outcomes from its U.S. Pivotal Trial which confirmed an improvement in quality of life and a reduction in the frequency and severity of incontinence episodes in the majority of women almost 4 years after treatment.

SUI is the involuntary leakage of urine associated with laughing, coughing, sneezing and recreational activities. The condition is caused by a variety of factors, most commonly childbirth, and often restricts the social, professional, and personal lives of an estimated 15 million women in the U.S. alone. With currently available surgical and non-surgical SUI therapies, many patients and physicians have concerns about safety, recovery, compliance, and/or effectiveness. In fact, it is estimated that approximately 80% of women with SUI do not seek treatment of any kind due to concerns over recovery time, possible complications or lack of confidence in the effectiveness of available options. The Renessa procedure offers women a new non-surgical approach to the effective treatment of SUI.

The FDA-cleared Renessa System includes a small probe which a physician passes through the natural opening of the urethra (transurethral). The probe heats multiple small treatment sites in the submucosa of the bladder neck and upper urethra, denaturing collagen in the tissue. Upon healing, the treated tissue is firmer, resulting in increased resistance to involuntary leakage at times of increased abdominal pressure, such as laughing, coughing or during exercise, thereby reducing or eliminating leaks.

The Renessa treatment can be performed in the convenience of a physician's office using local anesthesia. There are no incisions, bandages or dressings required. Recovery is rapid a
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SOURCE Novasys Medical, Inc.
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