Non-invasive Bladder Testing - Laborie Medical Technologies Receives FDA 510(k) Clearance For Tetra(tm) Bladder Monitor System

Main Category: Urology / Nephrology
Also Included In: Prostate / Prostate Cancer;  Medical Devices;  Regulatory Affairs / Drug Approvals
Article Date: 11 Mar 2008 - 3:00 PDT

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Urodynamix Technologies Ltd. (TSX-V:URO) 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(tm) Bladder Monitor System for non-invasive bladder testing.

Tetra(tm) 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(tm) 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.

Urodynamix Technologies Ltd.