Urodynamix Technologies Ltd.
TSX VENTURE : URO

Urodynamix Technologies Ltd.

December 17, 2007 12:21 ET

Urodynamix Technologies Ltd.: Laborie Medical Technologies Submits 510(k) Application to FDA for Tetra ™ Bladder Monitor System

Non-Invasive Diagnostic Urological Product Features Urodynamix's NIRS Technology

VANCOUVER, BRITISH COLUMBIA--(Marketwire - Dec. 17, 2007) - Urodynamix Technologies Ltd. (TSX VENTURE:URO) today announced that its worldwide distribution partner, Laborie Medical Technologies Inc. (Laborie), filed a 510(k) submission to the U.S. Food and Drug Administration (FDA) seeking clearance to market the Tetra™ Bladder Monitor System, a new device for non-invasive testing and evaluation of bladder activity, in the U.S.

Tetra™ is a non-invasive diagnostic urological product based on Urodynamix's near infrared spectroscopy (NIRS) technology that provides urologists with clinically relevant information about the health and function of the bladder. As an accessory to Laborie's premium urodynamics equipment, Tetra™ allows non-invasive evaluation and assists in the diagnosis of patients with urinary incontinence (UI) and lower urinary tract symptoms (LUTS).

"We are pleased that Laborie has filed an FDA application for Tetra™, the first of several non-invasive diagnostic urological products Urodynamix is developing," said Barry Allen, President and CEO of Urodynamix. "We look forward to FDA's review and the opportunity to provide our partners and physicians with an important new approach to the diagnosis of widespread, chronic conditions such as UI and LUTS."

The typical review period for a 510(k) submission is approximately 90 days, and Urodynamix expects the first commercial orders of Tetra™ to ship in the first quarter of 2008 upon regulatory clearance with full product launch planned for the 2008 American Urological Association (AUA) Annual Meeting in the second quarter of 2008.

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 breakthrough 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.

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