Initial Clinical Results for New Omnisure™ Sling Released at the AUGS Annual Meeting

RAYNHAM, Mass.-(Business Wire)-September 25, 2009 - Mpathy Medical, a rapidly growing medical device company which has developed and brought to market a range of less invasive surgical solutions used to restore pelvic health to women, released the initial clinical results for its newest product, Omnisure™, a novel full length sling for treatment of female stress urinary incontinence (SUI) at the American Urogynecologic Society’s (AUGS) Annual Meeting.

“Omnisure™ joins Minitape® to complete our sling product line, enabling us to address the full spectrum of SUI patients,” stated Ian Stevens, Chief Executive Officer, Mpathy Medical. “Omnisure™ is a highly effective, less invasive, full length sling constructed with our outstanding Smartmesh® Technology. Minitape® additionally offers intra and post-operative adjustability allowing exceptionally high cure rates among a higher risk patient population.”

The initial clinical results for Omnisure™ were presented by one of the study’s leading investigators, Kathryn Arendt, MD, FACOG of the Center for Women’s Health Care at Evergreen. In this ongoing multi-center series of US-based surgeons, 61 patients with SUI underwent the Omnisure™ procedure. The patients were evaluated at both the time of implant and via a follow-up appointment at 4-6 weeks. The data showed a 92.4% cure rate defined as patients who were reported as “dry” after the procedure. The patient satisfaction rate was 100%. Three minor complications of transient thigh and buttock pain were reported, but later resolved.

Omnisure™ is a novel full length sling which uses the narrowest needle option available allowing an incision-less exit at the skin level. Omnisure’s patented SmartFix™ Technology reduces the amount of mesh in the obturator space resulting in minimal complications. In a published series performed on a high risk patient population of 76 patients, Minitape® demonstrated a 97% cure rate¹ by combining the distinct features of intra and post-operative adjustment, internal fixation anchors, and external stabilization. Both Omnisure™ and Minitape® utilize the superior Smartmesh Technology under the urethra to encourage optimal tissue integration.

“My use of Omnisure™ for the surgical treatment of SUI has resulted in exceptionally high cure rates and patient satisfaction,” stated Kathryn Arendt, MD, FACOG, Center for Women’s Health at Evergreen, Kirkland, WA. “The lightweight mesh and narrow needle allow me to perform the procedure with minimal tissue trauma in the obturator tunnel.”

About Mpathy Medical

Mpathy Medical is a rapidly growing medical device company which has developed and brought to market a range of surgical solutions used to restore pelvic health to women. Mpathy Medical’s core product lines - Restorelle®, Omnisure™, and Minitape® - are used by surgeons specializing in urogynecology, gynecology, and urology to treat female stress urinary incontinence (SUI) and pelvic organ prolapse (POP). Founded in 2003 by a surgeon, Dr. James Browning, Mpathy Medical supplies the only mesh surgical solutions designed specifically for the female anatomy. The mesh - branded Smartmesh® - is a physiologically compatible, ultra lightweight polypropylene mesh which encourages superior collagen growth and works in concert with the patient’s own natural tissue for optimum safety and results. Smartmesh® is the only mesh material designed specifically for the female anatomy and physiology, and uniquely has a near zero erosion rate and low complication profile. The company is headquartered in Glasgow, Scotland with US operations in Raynham, MA and has received 510(k) clearance to market by the FDA in the US and CE marking in the UK for all its medical devices. To learn more about Mpathy Medical, visit www.mpathymedical.com.

¹ Alinsod, R. (2009). Recent advances in tape slings for female urinary stress incontinence. Reviews in Obstetrics & Gynecology. (2)1, 45-50.

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