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Neovasc Inc. (TSXV: NVC), a developer of novel technologies used to treat vascular disease, has presented results from the follow-up phase of the initial clinical trial of its Neovasc Reducer(TM) product at the American College of Cardiology 2010 annual meeting. The Neovasc Reducer is a novel implantable product designed to treat heart disease patients who suffer from refractory angina. The new data shows that three years after implantation of the Reducer, the majority of patients continued to show measurable improvement in angina symptoms. These three-year results build on the positive six-month data previously reported in the Journal of the American College of Cardiology.

Refractory angina is a painful and debilitating condition that occurs when the coronary arteries deliver an inadequate supply of blood to the heart muscle. It currently affects over two million patients worldwide, who typically lead severely restricted lives, and its incidence is growing. Current treatment options are limited.

The Neovasc Reducer is a unique device that is implanted in the coronary sinus vein. The Reducer is intended to provide relief of refractory angina symptoms by modulating blood flow in the coronary sinus and thereby increasing perfusion of oxygenated blood to areas of the heart muscle were it is most needed. Implantation of the Reducer is performed using a minimally invasive percutaneous procedure that is similar to implanting a coronary stent and takes approximately 20 minutes.

"The results from the Reducer three-year follow-up study confirm the positive data seen in the initial trial and are very promising," said Dr. Shmuel Banai, principal investigator of the study and medical director of Neovasc, who presented the data at the ACC meeting. "We are encouraged by the continuing excellent safety profile of the Reducer and its apparent ability to maintain improvement in angina symptoms over time. This data suggests that the Reducer may offer a viable long-term treatment option for patients with refractory angina who lack other alternatives for relieving their symptoms and improving their quality of life."

The results presented show that implantation of the Neovasc Reducer in the hearts of refractory angina patients is feasible and safe, and that the objective and subjective improvements in angina scores and in ischemia parameters that were seen six months after implantation were maintained for the entire three-year follow-up period. Imaging studies revealed that the Reducer devices were in good functioning condition and were still located at the original site of deployment. There were no reported deaths, heart attacks (myocardial infarctions), strokes or other adverse events attributed to the Reducer.

Based on these positive long-term results, Neovasc is preparing to initiate the COSIRA clinical trial. COSIRA (Coronary Sinus Reduction for Treatment of Refractory Angina) is a randomized, controlled, multi-center trial of the Reducer in patients with refractory angina. It is designed to build on the successful results of the initial Reducer trial and advance the product through the regulatory review process.

"The positive data presented at the ACC meeting support our expectations that the Reducer has the potential to greatly benefit patients suffering from refractory angina, allowing them to resume a more active lifestyle," said Neovasc CEO Alexei Marko. "We look forward to commencing our Reducer COSIRA trial shortly."

* Banai S, Ben Muvhar S, Parikh KH, et. al. Coronary Sinus Reducer Stent for the Treatment of Chronic Refractory Angina Pectoris. J Am Coll Cardiol 2007;49: 1783-9

About Neovasc Inc.

Neovasc Inc. is a specialty vascular device company that develops, manufactures and markets medical devices for the rapidly growing vascular marketplace. The company's current products include the Neovasc Reducer(TM), a novel product in development to treat refractory angina, as well as a line of advanced biological tissue technologies that are used to enhance surgical outcomes and as key components in a variety of third party medical products such as percutaneous heart valves.

For more information, visit or call 604/248-4138.
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Publication:Biotech Equipment Update
Article Type:Financial report
Date:Mar 30, 2010

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