Medical Ventures Corp.

Medical Ventures Corp.

October 23, 2006 14:36 ET

Medical Ventures Reports GAAME Clinical Trial Update

All U.S. research sites actively screening patients; renowned cardiologists leading study

RICHMOND, BRITISH COLUMBIA--(CCNMatthews - Oct. 23, 2006) - MEDICAL VENTURES CORP. (TSX VENTURE:MEV), a medical devices company specializing in products for the cardiovascular and surgical markets, announces recent developments in the human clinical trial for its Metricath Gemini® dual-balloon angioplasty device.

Data from the Gemini Angioplasty and Arterial Measurement Evaluation (GAAME) trial will support the company's application to the U.S. Food & Drug Administration to use the product to treat coronary arteries in patients in the United States. The device was approved in Europe for use in coronary and peripheral (non-coronary) vessels in Q3 of this year, while the FDA cleared the Gemini for peripheral use in Q3 2005.

- All nine U.S.-based clinical sites are actively screening GAAME study patients. This brings the total number of active sites to 11, up from five at the end of Q2 2006. Target enrollment to complete the trial is 160 patients. The trial's active centres are:

- Baptist Hospital of Miami (Miami, FL)

- New York-Presbyterian Hospital / Columbia University Medical Center (New York, NY)

- Duke University Medical Center (Durham, NC)

- Florida Cardiovascular Institute (Tampa, FL)

- Leiden University Medical Center (Leiden, The Netherlands)

- Mercy Heart Institute (Sacramento, CA)

- University of Oklahoma Health Sciences Center (Oklahoma City, OK)

- Pasco Cardiology Center (Hudson, FL)

- Sinai Center for Thrombosis Research (Baltimore, MD)

- Thoraxcenter, Erasmus University Medical Center (Rotterdam, The Netherlands)

- Tyler Cardiovascular Clinic (Tyler, TX)

- Two remaining sites, both based in The Netherlands, are completing internal regulatory and contract requirements for final approval to begin enrolling patients. Successful initiation will expand the study's original scope to include 13 trial sites.

- MEV received approval from the U.S. FDA in Q2 2006 to amend the study's protocol to facilitate enrolment at some trial sites. The revision has now been reviewed and accepted by the sites' internal review boards.

- Medical Ventures' clinical team conducted visits with each Dutch site at the end of September. The company continues to do ongoing site visits in the U.S. to monitor the trial's progress and offer assistance.

Medical Ventures counts three renowned interventional cardiologists as the GAAME trial's principal investigators:

- Prof. Willem J. van der Giessen and Dr. Evelyn Regar, of the Thoraxcenter Erasmus UMC in Rotterdam, spearhead the study as GAAME's chief principal investigators. Drs. van der Giessen and Regar are prolific authors in the field of experimental cardiology, while the Thoraxcenter is among the world's best-known cardiology research institutions.

- David E. Kandzari, MD, serves as the trial's lead U.S. investigator, from the Duke UMC site. Dr. Kandzari was recently appointed chief medical officer at Cordis, the cardiology unit of industry giant Johnson & Johnson, and the maker of the Cypher drug-eluting stent. While at Duke, Dr. Kandzari has designed and led numerous clinical trials evaluating novel device technologies and pharmacotherapies in the treatment of coronary and peripheral arterial disease.

Of the GAAME trial's progress, Dr. Kandzari said:

"We've recently refined the trial enrolment criteria so that all sites can enrol patients in a setting that's consistent with routine clinical practice. Amendments to the study design, in addition to the achievement that the majority of our centers are now up and running, has led to a boost in trial enrolment. We anticipate enthusiastic enrolment from the sites and a successful completion to the trial."

Once the trial is complete, Medical Ventures will file a U.S. FDA application to commercialize the Metricath Gemini for coronary artery use in the U.S.

Medical Ventures is exhibiting its Metricath® catheter technology at this week's Transcatheter Cardiovascular Therapeutics (TCT) symposium in Washington, D.C. TCT is the world's largest educational conference related to interventional vascular medicine, attracting over 10,000 physicians annually.

About Metricath Gemini

The Metricath Gemini dual-balloon catheter is part of Medical Ventures' patented Metricath System, consisting 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 help restore blood flow. The Gemini's high-pressure angioplasty balloon can then be used to enlarge vessels or under-deployed stents by expanding the balloon within the artery. The Gemini uniquely allows doctors to measure and treat diseased vessels with a single catheter.

About Medical Ventures Corp.

Medical Ventures Corp. is a medical device company dedicated to developing products that address clinical needs in the quickly growing cardiovascular and surgical marketplace. MEV products help doctors treat a wide range of health concerns, including cardiovascular disease, hernias and obesity. The company develops and manufactures the patented Metricath System catheter technology and PeriPatch™, a range of surgical tissue products. Medical Ventures is also a contract medical device manufacturer. For more information, please visit

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