Medical Ventures Corp.

Medical Ventures Corp.

November 07, 2007 08:30 ET

Medical Ventures' Metricath Gemini Influenced Stent Selection, Course of Treatment in GAAME Trial

Physician feedback results indicate clinical utility

RICHMOND, BRITISH COLUMBIA--(Marketwire - Nov. 7, 2007) - MEDICAL VENTURES CORP. (TSX VENTURE:MEV), a medical devices company specializing in products for the vascular and surgical markets, has released physician feedback from its Metricath Gemini® dual-balloon angioplasty device clinical trial.

Physicians participating in the GAAME (Gemini Angioplasty and Arterial Measurement Evaluation) trial responded to a questionnaire administered for each patient as part of the human trial assessing safety and effectiveness of the Metricath Gemini when used in coronary arteries. Physician feedback on using the device in 112 patient cases was collected and analyzed. The 112 patients make up the data population for the company's application to the U.S. Food & Drug Administration for coronary approval of the device.

The results indicate that the Metricath Gemini has clinical utility, as it provided physicians with sizing information that influenced their course of treatment in a significant percentage of the GAAME trial procedures.

Clinical utility highlights

An overview of the physicians' responses shows the following key results:

Metricath Gemini was used to measure reference vessels and to pre-dilate (open up) vessels prior to stent implantation in 68 of 112 total cases (61%). Direct stenting (implantation of the stent without pre-dilating the vessel in advance) was performed in the remaining 44 cases (39%).

- In 56% of pre-dilatation cases (38/68), Metricath measurements influenced the physicians' selection of stent size for implantation.

- In 49% of pre-dilatation cases (33/68), Metricath measurements influenced the target diameter of the treatment area.

- In 30% of all cases (34/112), Metricath measurements influenced the physician's decision whether to post-dilate the stent (Post-dilatation is often required to fully expand an under-expanded or under-sized stent).

- In 41% of direct stenting cases, doctors reported Metricath measurements influenced their decision to post-dilate.

In response to the collected feedback, Medical Ventures' president and chief operating officer, Alexei Marko, said:

"This information shows that the Metricath Gemini's ability to indicate vessel and stent size made a sizeable impact on how doctors in the GAAME trial chose to proceed with treating patients. From this feedback, we can see that doctors used the Metricath's measurements to help guide their decisions on selecting stent size roughly half the time Metricath was used prior to stenting. Further, Metricath readings influenced the doctors' choices to post-dilate stents in about a third of cases. In short, Metricath provided these doctors with valuable information that helped them to choose stent size and to determine whether further dilatation was necessary to achieve full stent expansion."

Mr. Marko continued: "Clinical research has shown repeatedly that fitting stents optimally within arteries is a key factor in patient outcomes, whether the stents used are drug-eluting or bare metal. To be able to help guide stenting techniques to ensure the best treatment scenarios at a minimal cost makes the Metricath a very compelling technology.

"Because the Metricath Gemini offers users a PCI (angioplasty) balloon and the ability to take precise measurements with a single device, measurement can be adopted easily and cost-effectively into any PCI procedure. We are thrilled to see this feedback from the GAAME trial investigators. We anticipate completing the GAAME trial data report and submitting for FDA approval of the Gemini before the end of the year."

Medical Ventures has submitted two of three modules of its pre-market approval (PMA) application to the U.S. FDA. The first two modules, which outlined product manufacturing and laboratory and animal testing information, are under review. This information previously yielded regulatory approvals for the Metricath Gemini in Europe and in Canada. Medical Ventures anticipates submitting the third and final module, based largely on results of the GAAME trial, before the end of 2007.

About Metricath Gemini®

The Metricath Gemini is a dual-balloon catheter system used during angioplasty procedures to treat heart and vascular disease. The catheter features a low-pressure balloon to measure within arteries and stents, helping doctors confirm stent selection and expansion for optimal treatment outcomes. The Metricath Gemini also features a high-pressure angioplasty balloon that can be used to expand vessels or under-expanded stents by inflating the balloon within the artery.

About Medical Ventures Corp.

Medical Ventures Corp. develops, manufactures and markets 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.

Statements contained herein that are not based on historical or current fact, including without limitation statements containing the words "anticipates", "believes", "may", "continues", "estimates", "expects", and "will" and words of similar import, constitute "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, among others, the following: general economic and business conditions, both nationally and in the regions in which the Company operates; technology changes; competition; changes in business strategy or development plans; the ability to attract and retain qualified personnel; existing governmental regulations and changes in, or the failure to comply with, governmental regulations; liability and other claims asserted against the Company; and other factors referenced in the Company's filings with Canadian securities regulators. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. The Company does not assume the obligation to update any forward-looking statements.

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