Uroplasty's Macroplastique® for Stress Urinary Incontinence (SUI), Received USFDA Approvable Letter

Filed in archive Diagnostics , Treatment on September 15, 2006

Uroplasty, Inc. (Amex: UPI) has recently received an approvable letter from the USFDA relating to its pre-market approval (PMA) application for Macroplastique® Implants for the treatment of female stress urinary incontinence (SUI).

The most common type of urinary incontinence affecting approximately 13 million Americans (85% of whom are women), stress urinary incontinence (SUI) is described as the sudden, accidental loss of urine during normal, everyday activities such as sneezing, coughing, laughing, straining or lifting items.

The approvable letter was issued following USFDA's completion of the scientific review of the safety and efficacy of Macroplastique®. The USFDA found the PMA approvable subject to Uroplasty's manufacturing facilities, methods and controls being audited and in compliance with applicable Quality System Requirements. Uroplasty's manufacturing facilities in Minneapolis, Minnesota and Eindhoven, The Netherlands, is currently under USFDA audit.

According to David B. Kaysen, Uroplasty's President and CEO:

"Macroplastique is already a market leader and a preferred treatment outside the U.S. for SUI resulting primarily from intrinsic sphincter deficiency. Since its introduction in Europe, over 60,000 people have been treated with Macroplastique and numerous clinical publications reinforce the safety and efficacy of this product.

I am pleased that our development efforts, now supported by the FDA's scientific review of our safety and clinical data, are bringing us within clear sight of PMA approval and the ability to market this product in the United States.

Our direct sales team is excited about adding Macroplastique to our platform of voiding dysfunction products. With this response from the FDA, we will begin preparing for the launch of Macroplastique across the U.S."

Macroplastique®, patented by Uroplasty, is a soft tissue, injectable bulking agent for use in a minimally-invasive, out-patient procedure to treat female SUI which primarily results from intrinsic sphincter deficiency.

A condition in which certain muscles circling the urethra weaken and can no longer properly close to hold urine, intrinsic sphincter deficiency is experienced by 25 % of SUI sufferer.

When Macroplastique® is injected by a physician into the tissues surrounding the urethra; the increased "bulk" allows the urethra to close more effectively and prevents urine from leaking.

Read more details from the press release (a pdf file).