Medical Ventures Corp.

Medical Ventures Corp.

July 17, 2007 09:00 ET

Medical Ventures Completes Minimum Enrolment For GAAME Clinical Trial

FDA approves reduced patient sample size

RICHMOND, BRITISH COLUMBIA--(Marketwire - July 17, 2007) - MEDICAL VENTURES CORP. (TSX VENTURE:MEV) announces the U.S. Food & Drug Administration has agreed to accept patient data from the GAAME clinical trial for the Metricath Gemini based on a revised statistical analysis plan that reduces the study's minimum sample population to 107.

The company has already met the revised minimum of 107 enrolled patients (reduced from an initially projected 160), and expects to submit a pre-market approval (PMA) application to the FDA for coronary use of its Metricath Gemini® catheter in Q4 2007.

The smaller sample size is adequate to have a greater than 80% chance of detecting adverse events that occur 1.5% of the time or more. Medical Ventures had initially targeted a 1% detection rate, but reviewed the underlying statistical plan to address concerns about slow patient enrolment stemming from a stringent trial protocol that excluded many patients from study. The FDA determined that a 1.5% detection rate was adequate to supply the needed data in support of the PMA application, thus reducing the number of patients required for the trial.

"We are very happy about the FDA's decision to reduce the GAAME study's required enrolment," said Paul Geyer, Medical Ventures' president and CEO. "We expect this will allow for more timely completion to the trial. We are looking forward to completing this process so that we can bring the Metricath Gemini to the U.S. market. We have been seeing an increased number of positive responses from physicians evaluating our Metricath Libra® system, and we expect the Gemini will be a valuable addition to the product line for doctors treating heart and vascular disease."

While enrollment has already exceeded the 107 patient minimum, Medical Ventures will continue the enrolment phase for an additional few months in order to allow for data which may be lost due to patient follow-up or other causes. Meanwhile, the company has initiated the required process to collect and finalize the trial data, including 30-day follow-up and data analysis, in order to support the PMA submission expected in Q4 2007.

GAAME trial

The GAAME trial (for Gemini Angioplasty and Arterial Measurement Evaluation) is a prospective, non-randomized, multi-centre study reporting the device's safety and effectiveness for pre-dilatation of a lesion or post-dilatation of a stent when used in coronary arteries. The GAAME trial's primary objectives are: 1) freedom from major adverse coronary events at 30 days, and 2) device success as determined by residual diameter stenosis.

Metricath Gemini®

The Metricath Gemini dual-balloon catheter uniquely allows doctors to measure and treat diseased vessels with a single catheter. The device is part of Medical Ventures' patented Metricath® System, which consists of a small electronic console unit and disposable, balloon-tipped catheters. The system allows doctors to measure the internal diameter and area of blood vessels and stents (expandable mesh tubes inserted into narrowed arteries to improve and maintain proper blood flow). These measurements help physicians to select appropriate stents for implantation and to ensure stents are optimally expanded within arteries. The Gemini's high-pressure angioplasty balloon can be used to enlarge vessels or under-deployed stents by expanding 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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