Urodynamix Commences Enrollment In Third IAP Clinical Trial

Main Category: Clinical Trials / Drug Trials
Also Included In: Medical Devices;  GastroIntestinal / Gastroenterology
Article Date: 16 Sep 2007 - 13:00 PDT

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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 Drägerwerk 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.

http://www.urodynamix.com