Healthcare Industry News:  Urgent PC 

Devices Urology Neurology FDA

 News Release - July 5, 2006

Uroplasty, Inc. Announces FDA Clearance for Their Next-Generation Device to Treat Overactive Bladder

MINNEAPOLIS, July 5 (HSMN NewsFeed) -- Uroplasty, Inc. (Amex: UPI ) announced that their next-generation Urgent® PC Neuromodulation System is now available for sale in the United States. The Urgent PC product is a non-surgical nerve stimulation device for the treatment of overactive bladder symptoms. The Company received FDA 510(k) clearance July 3rd to market this new Urgent PC model.

Over 34 million Americans suffer from overactive bladder symptoms of urinary urgency, urinary frequency or urge incontinence. And, for many individuals with overactive bladder symptoms, the treatments they tried or considered are unsatisfactory. Physicians, patients and payers are embracing the office-based therapy provided by the Urgent PC. The minimally invasive therapy is a cost and clinically effective, non-surgical, non-drug alternative treatment for an individual with an overactive bladder.

David Kaysen, President and CEO, is confident the features of the new Urgent PC model will facilitate quick market adoption. "The enhanced user interface and programmed treatment settings of this new model truly deliver both form and function. Our U.S. sales organization is eager to introduce the new device to their customers. With this third regulatory agency approval, we can now sell our next-generation product in all our major markets -- in the U.S., in Europe and in Canada."

Uroplasty, Inc., headquartered in Minnetonka, Minnesota, with wholly-owned subsidiaries in The Netherlands and the United Kingdom, is a medical device company that develops, manufactures and markets innovative, proprietary products for the treatment of voiding dysfunctions, including urinary and fecal incontinence, overactive bladder and vesicoureteral reflux.

The Urgent® PC Neuromodulation System is a proprietary, minimally invasive nerve stimulation device designed for office-based treatment of overactive bladder symptoms of urge incontinence, urinary urgency and urinary frequency. Application of neuromodulation therapy targets specific nerve tissue and disrupts the signals that lead to the symptoms of overactive bladder. Uroplasty sells the Urgent PC system in the United States, in Canada and in countries recognizing the CE mark. Outside the United States, the Urgent PC is also indicated for the treatment of fecal incontinence.

The I-STOP(TM) Mid-Urethral Sling is a biocompatible, tension-free sling used to treat female stress urinary incontinence. The I-STOP sling provides a hammock-like support for the urethra to prevent urine leakage associated with activities such as coughing, laughing, lifting or jumping. Uroplasty sells the I-STOP Sling in the United Kingdom and in the United States.

Macroplastique® Implants, Uroplasty's patented soft tissue bulking agent, is used to treat both female and male urinary incontinence and to treat vesicoureteral reflux in children. When Macroplastique is injected into tissue, it stabilizes and "bulks" the tissue, providing the surrounding muscles with increased capability to control the flow of urine. Additionally, Uroplasty markets soft tissue bulking agents for specific indications such as PTQ(TM) Implants for the treatment of fecal incontinence, VOX® Implants for the treatment of vocal cord rehabilitation and Bioplastique® for augmentation or restoration of soft tissue defects in plastic surgery indications. Uroplasty's bulking products are sold outside the United States.

The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for certain forward-looking statements. This press release contains forward-looking statements, which reflect our views regarding future events and financial performance. These forward-looking statements are subject to certain risks and uncertainties, including those identified below, which could cause actual results to differ materially from historical results or those anticipated. The words "aim," "believe," "expect," "anticipate," "intend," "estimate" and other expressions, which indicate future events and trends, identify forward-looking statements. Actual future results and trends may differ materially from historical results or those anticipated depending upon a variety of factors, including, but not limited to: the effect of government regulation, including when and if we receive approval for marketing products in the United States; the impact of international currency fluctuations on our cash flows and operating results; the impact of technological innovation and competition; acceptance of our products by physicians and patients, our historical reliance on a single product for most of our current sales; our ability to commercialize our recently licensed product lines; our intellectual property and the ability to prevent competitors from infringing our rights; the ability to receive third party reimbursement for our products; the results of clinical trials; our continued losses and the possible need to raise additional capital in the future; our ability to manage our international operations; our ability to hire and retain key technical and sales personnel; our dependence on key suppliers; future changes in applicable accounting rules; and volatility in our stock price.

Source: Uroplasty

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