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Renessa

Novasys Medical has developed a non-surgical approach to treat stress urinary incontinence (SUI) due to bladder outlet hypermobility: the Renessa® System. The Renessa treatment uses a small probe which a physician passes through the urethra. The treatment can be performed in the convenience of a physician's office or other outpatient setting. There are no incisions, bandages or dressings required. Recovery is rapid and comfortable, with minimal post-procedure limitations.

The Renessa procedure uses radiofrequency energy (RF) to generate controlled heat at low temperatures in tissue targets within the lower urinary tract. The heat denatures collagen in the tissue at multiple small treatment sites. Upon healing, the treated tissue is firmer, increasing resistance to involuntary leakage at times of heightened intra-abdominal pressure, such as laughing, coughing or during exercise, thereby reducing or eliminating SUI episodes.

RF has been routinely used by physicians in the treatment of numerous conditions for many decades. At higher temperatures than those generated by the Renessa System, RF energy can cut and/or ablate tissue for the treatment of upper airway disorders, cardiac arrhythmias, benign prostate hyperplasia, excessive uterine bleeding (menorrhagia) and other conditions. Low temperature RF is used to treat luminal disorders such as gastroesophageal reflux disease, fecal incontinence, and now, female stress urinary incontinence.

Benefits of the Renessa® treatment include:

•  Non-surgical, in-office procedure
•  Single treatment
•  No incisions, bandages, or dressings
•  Excellent safety profile, well tolerated
•  Can be performed using local anesthesia + oral sedation
•  Rapid recovery with minimal limitations

In a U.S. clinical study, the majority of women who underwent the Renessa treatment experienced a significant improvement in quality of life measures such as reduced daily leak episodes and reduced or eliminated pad use. Key 12 month clinical outcomes in Renessa patients are as follows:

•  76% of patients reported a reduction in incontinence episodes;
•  59% of women reduced their daily episodes by at least half;
•  58% of women eliminated the need for pads;

•  More than a third of the women treated were completely dry.

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