Urodynamix Technologies Ltd. Receives FDA 510(k) Clearance for UroNIRS 2000(TM) Bladder Monitor System
05 Janvier 2009 - 8:00PM
Marketwired Canada
Urodynamix Technologies Ltd. (TSX VENTURE:URO) today announced that it has
obtained 510(k) clearance from the U.S. Food and Drug Administration to market
the UroNIRS 2000(TM) 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(TM) 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(TM) 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(TM) 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(TM) 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(TM) 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(TM) 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(TM) immediately.
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.
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