NOVASYS GETS FDA CLEARANCE FOR THE RENESSA SYSTEM

The FDA has cleared Novasys Medical's Renessa System for the treatment of stress urinary incontinence (SUI) due to hypermobility in women who have failed conservative care and are not candidates for surgical therapy.

Renessa is a non-surgical approach to the treatment of SUI -- the involuntary leakage of urine associated with laughing, coughing, sneezing, sexual and recreational activities. It is able to be performed within 20 minutes in a physician's office or an outpatient center. The Renessa treatment applies controlled heat using a single-use transurethral probe to tissue targets within the lower urinary tract, denaturing collagen at multiple small treatment sites. The treated microscopic sites increase tissue resistance during healing to involuntary leakage at times of increased intra-abdominal pressure, reducing or eliminating SUI episodes. No bandages or dressings are required, and women can safely resume most activities immediately following treatment.

FDA clearance was based on safety and efficacy results associated with a 12 month, multicenter clinical trial involving more than 170 women at 10 sites nationwide. The treatment is targeted at women who fail to respond to conservative care and are not candidates for surgery.