Urodynamix Technologies Ltd.
TSX VENTURE : URO

Urodynamix Technologies Ltd.

March 10, 2008 09:00 ET

Urodynamix Technologies Ltd.: Laborie Medical Technologies Receives FDA 510(k) Clearance for Tetra™ Bladder Monitor System

FDA Approval Paves the Way for Commercial Launch of Urodynamix's NIRS Technology

VANCOUVER, BRITISH COLUMBIA--(Marketwire - March 10, 2008) - Urodynamix Technologies Ltd. (TSX VENTURE:URO) today announced that its worldwide distribution partner, Laborie Medical Technologies Inc. (Laborie) has obtained 510(k) clearance from the U.S. Food and Drug Administration to market their urodynamic equipment with the Tetra™ Bladder Monitor System for non-invasive bladder testing.

Tetra™ is a non-invasive diagnostic medical device based on Urodynamix's near infrared spectroscopy (NIRS) technology. As an accessory to Laborie's premium urodynamics systems, Tetra™ uses NIRS for non-invasive testing of bladder activity to aid in the diagnosis of patients with lower urinary tract symptoms (LUTS).

"Receiving FDA clearance for the Tetra™ Bladder Monitor System is a significant milestone for Urodynamix," commented Barry Allen, President and CEO of Urodynamix. "This initial regulatory approval was received ahead of schedule due to the prompt review by the FDA and thorough work of Regulatory and R&D departments at both Urodynamix and Laborie."

In 2007, Urodynamix entered into a worldwide licensing agreement with Laborie to distribute NIRS technology in acute care settings (see news release dated May 17, 2007 for details). Upon successful completion of manufacturing qualification, Urodynamix expects to commence commercial shipments of Tetra™ in March as previously targeted.

Laborie's initial launch of Tetra™ in the United States is scheduled to begin in the second quarter of 2008, with important marketing activities planned at the 2008 American Urological Association (AUA) Annual Meeting in Orlando, Florida from May 17-22, 2008.

Laborie intends to seek Health Canada licensing and CE Mark approval for the Tetra™ Bladder Monitor System in April and expects to begin Tetra™ marketing activities in Canada and Europe during the second quarter of 2008.

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.

On behalf of the Board,

Barry Allen, President & CEO

Urodynamix Technologies Ltd.

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.

Contact Information