Urodynamix Technologies
Ltd. (TSX-V:URO) announced that enrollment has commenced in a new
clinical study evaluating the safety and efficacy of its NIRS IAP Monitor
investigational device. The Company's NIRS patient monitoring technology
is less invasive than conventional intra-abdominal pressure ("IAP")
measurement procedures, and additionally offers a continuous measure of
tissue perfusion without the risk of catheter-induced infection or trauma.
The new study will evaluate Urodynamix's NIRS IAP Monitor as a continuous
and non-invasive method for monitoring abdominal perfusion parameters in
laparoscopic surgery patients at Foothills Medical Centre in Calgary,
Alberta. Laparoscopic surgery, also referred to as minimally invasive or
keyhole surgery, is a modern surgical technique in which operations are
performed through small abdominal incisions while the abdomen is inflated
to elevate the abdominal wall above the internal organs. During
laparoscopy, a gas insufflator is used to increase and measure IAP
directly, providing an ideal situation to compare NIRS measurements with
intraoperative IAP as measured using the insufflator.
Urodynamix believes that its NIRS technology may be used to continually
and non-invasively monitor IAP and abdominal tissue ischemia in a variety
of ICU patient populations. Preliminary data from 10 patients at Foothills
Medical Centre confirmed that NIRS measurements of the abdominal wall
correlated with IAP in the patients studied (see news release dated
January 17, 2007 for details). Data obtained from the new intraoperative
study is expected to confirm the accuracy of the device for ICU monitoring
applications, however intraoperative patient monitoring is not currently
an intended use of the device.
The Company also continues to enroll patients in the expanded NIRS IAP
Study of ICU patients at Foothills Medical Centre. Data from these
clinical trials will be used to validate the use of NIRS for IAP
monitoring in patients at risk of developing abdominal compartment
syndrome, or ACS - a devastating condition that develops with an acute and
rapid elevation in IAP. Untreated ACS is fatal, and recent studies have
confirmed the importance of early intervention and treatment in these
patients.
Urodynamix is actively pursuing strategic relationships with world-class
medical device companies that specialize in patient monitoring solutions.
This market is currently dominated by companies such as GE Healthcare,
Philips Medical Systems, Spacelabs Healthcare, Nellcor-Tyco, Masimo
Corporation and Dr?¤gerwerk AK.
About IAP and ACS
Abdominal compartment syndrome (ACS) is multiple organ dysfunction caused
by elevated pressure in the abdomen. It is estimated that up to 50% of ICU
patients develop pathological increases in IAP, and that one in eleven may
develop ACS, which is fatal if untreated. Despite improved treatment
options, the overall mortality rate of ACS remains over 50%.
Continuous IAP monitoring may allow clinicians to detect the onset of ACS
earlier and intervene before clinical signs develop, resulting in
significant cost savings and improved patient outcomes. According to the
American Hospital Association, approximately 60,000 adult ICU beds in the
United States equate to nearly 5 million adult ICU patients per year in
North America alone. This represents a significant initial market
opportunity for the Company's NIRS IAP Monitor and recurring consumables
revenue for 24/7 monitoring of critical care patients. There is also a
significant unmet need for continuous IAP monitoring in cardiac, GI and
orthopaedic surgical recovery units and emergency departments.
About Urodynamix Technologies Ltd.
Urodynamix is developing a portfolio of non-invasive diagnostic products
for large and growing global healthcare markets. The Company is currently
developing medical devices that use near-infrared spectroscopy (NIRS) to
aid in the diagnosis and treatment of urological conditions,
intra-abdominal hypertension and compartment syndrome, erectile
dysfunction and vascular diseases. Urodynamix's disruptive technology has
the potential to beneficially affect more than 200 million people
worldwide.
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