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Noridian Medicare Now Covers Renessa(R) Treatment for Incontinence in Women
Date:2/24/2009

NEWARK, Calif., Feb. 24 /PRNewswire/ -- Novasys Medical, Inc., a developer of innovative therapies in women's health, announced today that Noridian Administrative Services, LLC, a regional Medicare carrier administering benefits in nine states, is now covering the non-surgical Renessa treatment for women with stress urinary incontinence (SUI). Noridian currently administers benefits for approximately 4 million Medicare beneficiaries in Alaska, Arizona, Montana, North and South Dakota, Oregon, Utah, Washington and Wyoming.

According to Noridian's website, the insurer "will now cover CPT 0193T, transurethral, radiofrequency micro-remodeling of the female bladder neck and proximal urethra for stress urinary incontinence. This includes the Renessa transurethral collagen radiofrequency denaturation procedure." The website goes on to state that "coverage will be allowed when the procedure is performed consistent with FDA labeling and in accordance with the indications supported by peer-reviewed literature." The policy specifies that coverage only applies to cases of moderate to severe female SUI.

"We are very pleased with Noridian's decision," said Debra Reisenthel, Novasys Medical President and Chief Executive Officer. "Noridian is the first regional Medicare carrier to offer coverage for the Renessa procedure, and joins other private insurers, including Aetna US Healthcare, in providing coverage for this safe and effective non-surgical treatment for women who suffer from the debilitating effects of SUI," she continued.

Female Stress Urinary Incontinence

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 a significant number of women. With currently available surgical and non-surgical SUI therapies, many patients and physicians have concerns about safety, recovery, compliance, and/or effectiveness.

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 the patient's own collagen in the tissue, 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 and comfortable, with minimal post-procedure limitations. The Renessa treatment offers an option for women who have tried conservative therapies such as Kegel exercises or biofeedback without success, but who cannot have or do not desire an invasive surgical procedure. To date, over 300 urologists, urogynecologists and gynecologists in 40 states have been trained and have performed the Renessa procedure in over 2500 patients.

About Novasys Medical

Novasys Medical, Inc. is a privately held, venture-backed company which develops innovative therapies in women's health. The company's initial focus is the development and commercialization of the Renessa System, a proprietary, non-surgical approach to the treatment of female stress urinary incontinence (SUI).

For more information, please visit http://www.novasysmedical.com or call (510) 226-4060.


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SOURCE Novasys Medical, Inc.
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