Urodynamix Submits 510(k) Filing To FDA For Second Generation Bladder Monitor

Main Category: Urology / Nephrology
Also Included In: Regulatory Affairs / Drug Approvals;  Infectious Diseases / Bacteria / Viruses
Article Date: 18 Sep 2008 - 7:00 PDT

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Urodynamix Technologies Ltd. (TSX-V:URO) announced that it has submitted a 510(k) filing to the U.S. Food and Drug Administration (FDA) for its second-generation UroNIRS 2000 Bladder Monitor System - a non-invasive medical device that uses near infrared spectroscopy (NIRS) to diagnose lower urinary tract symptoms (LUTS) in the urology office setting.

UroNIRS 2000 is a standalone device that does not require conventional external or peripheral urodynamics equipment for its operation, unlike first generation UroNIRS technology. This will allow Urodynamix to broaden distribution of its UroNIRS products and expand from hospitals and clinics into urology office markets. This office-based device will provide Urodynamix and its current and future distribution partners with greater access to the 20 million men in the U.S. with symptoms of benign prostatic hyperplasia (BPH) who require diagnosis prior to effective treatment.

UroNIRS 2000 is based on a wireless tablet PC with Urodynamix's proprietary sensor configuration and is compact, portable and specifically designed for ease of use in the physician's office setting. The non-invasive procedure is used to confirm the presence of bladder outlet obstruction in men by identifying patients that have healthy bladder function yet suffer from weak urinary stream, hesitancy, urinary retention and related symptoms. UroNIRS 2000 is safer, faster, less expensive and more comfortable than conventional catheter-based diagnostics for the same condition. Clinical studies have shown that the UroNIRS device has an 86% success rate for accurately identifying obstructed male patients, most of whom are good surgical candidates.

Urodynamix will launch this new product with expanded distribution on a worldwide basis and expects to announce these new partnership(s) within 30 days.

"We are very pleased with the performance, quality, and customer-driven features of our UroNIRS system and are excited to be bringing this new technology to market as part of our strategy of developing the hospital market and then expanding into the Urologist office market," said Barry Allen, President and CEO of Urodynamix. "We look forward to FDA's review and the opportunity to provide our partners and physicians with an important new non-invasive approach to managing a widespread, chronic condition such as LUTS."

The typical review period for a 510(k) submission is approximately 90 days, and Urodynamix expects the first commercial orders of UroNIRS to ship in the first quarter of 2009 upon regulatory clearance.

About Urodynamix Technologies Ltd.

Urodynamix Technologies is a Canadian medical device company developing and commercializing non-invasive medical technology based on proprietary applications of near-infrared spectroscopy (NIRS). The Company is currently focused on products that aid in the diagnosis and treatment of urinary incontinence, lower urinary tract symptoms, prostate cancer, benign prostatic hyperplasia, and traumatic increases in intra-abdominal pressure that cause abdominal compartment syndrome. Urodynamix's breakthrough medical technology has the potential to beneficially affect more than 200 million people worldwide.

Certain information contained in this press release may be forward-looking and is subject to unknown risks, which could cause actual results to differ materially from those set forth or implied herein. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, it can give no assurance that such expectations will prove correct. The TSX Venture Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this release.

Urodynamix Technologies Ltd.