Urodynamix Technologies Ltd. Receives FDA 510(k) Clearance For UroNIRS 2000 Bladder Monitor System
Vancouver, BC - Urodynamix Technologies Ltd. recently announced that it has obtained 510(k) clearance from the U.S. Food and Drug Administration to market the UroNIRS 2000 Bladder Monitor System - a second generation non-invasive medical device that uses near infrared spectroscopy (NIRS) to aid in the diagnosis of lower urinary tract symptoms (LUTS) in a 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 expand distribution of its UroNIRS products into urology office markets targeting the 20 million men in the U.S. with symptoms of benign prostatic hyperplasia (BPH) many of whom require diagnosis prior to effective treatment.
"We are pleased to achieve another major milestone in the execution of our business strategy. The Company has orders in hand and will begin shipments of the uroNIRS 2000 in the first quarter of 2009. This new 510(k), received in 94 days, is another example of continued excellence in execution of our product development strategy. The uroNIRS 2000 is a key part of our expansion from the acute care market into the larger office based urology market. This device will be more accessible, user friendly and cost effective than our previous version and will allow expansion into the larger urologists office market where our non-invasive fast diagnostic procedure will have the most value," said Barry Allen, President and CEO of Urodynamix. "In addition to our existing relationships with MMS and Laborie, we will expand our distribution in the short term to include broader office based distribution channels."
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 2000 device has an 86% success rate for accurately identifying obstructed male patients, most of whom are good surgical candidates.
The Company has applied for and expects to receive CE mark for European approval of the device in the first quarter of 2009, for European launch in the second quarter.
Urodynamix entered into worldwide licensing agreements with Medical Measurement Systems (MMS) and Laborie Medical Technologies in 2008 to distribute uroNIRS 2000 technology in office urology markets (see news release dated October 21, 2008 for details). Urodynamix expects to commence commercial shipments of uroNIRS 2000 immediately.
SOURCE: Urodynamix Technologies Ltd.