Medical Ventures Corp.

Medical Ventures Corp.

August 27, 2007 09:00 ET

Medical Ventures Begins FDA Submission Process For Metricath Gemini

First of three PMA application modules submitted

RICHMOND, BRITISH COLUMBIA--(Marketwire - Aug. 27, 2007) - MEDICAL VENTURES CORP. (TSX VENTURE:MEV) has submitted to the U.S. Food and Drug Administration the first of three modules of a pre-market approval (PMA) application for coronary use of the Metricath Gemini® catheter. Submitting the PMA application module initiates the process to obtain FDA approval for the medical device.

The FDA recently granted Medical Ventures the right to submit a modular PMA application rather than a traditional application. A modular application permits the company to submit manufacturing, testing and clinical information as each becomes available rather than in one distinct application package.

"Applying for FDA approval with a modular PMA allows for a more streamlined submission and review process," said Paul Geyer, Medical Ventures' president and CEO. "We see this as a positive first step towards securing FDA approval for coronary use of the Gemini, where it can help doctors optimally size and also treat diseased vessels. Having met our enrolment target for the GAAME trial, we are pleased to initiate this application process."

The first module, containing manufacturing information, was submitted on August 24, 2007. The second module, which contains laboratory and animal testing information, is expected to be submitted in October 2007. The final module, containing results from the GAAME clinical trial and related supporting information, is expected to be submitted by year end. Contents of the first two modules are based on existing data that previously yielded regulatory approvals for the Gemini device in Europe and Canada. Medical Ventures is currently working to collect and analyze data from its GAAME clinical trial, which will form the majority of the final module.

"Doctors increasingly are recognizing the benefits of confirming vessel size and stent expansion in clinical practice," Mr. Geyer said. "We have started to see interest in our Metricath Libra® catheter, which is a 'measurement-only' catheter without the added benefit of a treatment balloon. We believe the Metricath system will continue to gain traction in the marketplace, and approval for use of the Gemini in coronary arteries will significantly expand the market for this device."

About Metricath Gemini®

The Metricath Gemini is a dual-balloon catheter used during angioplasty procedures to treat heart and vascular disease. The catheter features both a low-pressure balloon to measure within arteries and stents, and a high-pressure balloon that can be used to expand vessels or under-deployed stents by inflating the balloon within the artery.

About Medical Ventures Corp.

Medical Ventures Corp. develops, manufactures and commercializes medical devices for the quickly growing vascular and surgical marketplace. MEV products help doctors treat a wide range of health concerns, including vascular disease and obesity. MEV products include the Metricath® vascular measurement system and PeriPatch™, a line of surgical tissue products. Medical Ventures is also a contract medical devices manufacturer. For more information, please visit:

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