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Neovasc Inc. (NVC) Completes Enrollment in COSIRA Trial Assessing Efficacy of Reducer™ Product for Treatment of Refractory Angina


5/13/2013 9:58:29 AM

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-Full Data from COSIRA Trial Expected Around Year's End-
-Initial Data from Reducer Patient Registries To Be Presented at EuroPCR 2013-

TSX Venture Exchange: NVC

VANCOUVER, May 13, 2013 /CNW/ - Neovasc Inc. (TSXV: NVC), today announced the completion of patient enrollment in its COSIRA trial designed to further assess the efficacy and safety of the Neovasc Reducer, a novel percutaneous device for the treatment of refractory angina. The COSIRA (Coronary Sinus Reducer for Treatment of Refractory Angina) trial is a double-blinded, randomized, sham-controlled multicenter trial intended to demonstrate the efficacy of the Reducer in a controlled population of refractory angina patients. It was conducted in the UK, Europe and Canada.

"COSIRA was designed as a rigorous study to provide definitive evidence of the efficacy of the Reducer in improving the quality of life of patients with refractory angina, and we look forward to sharing six-month follow-up data from the trial in a peer-reviewed forum around year's end," said Shmuel Banai, MD, Chief Medical Officer of Neovasc. "In addition, we are seeing encouraging initial patient data from our Reducer Registries, which we look forward to reporting at EuroPCR next week."

Results of a published, prospective three-year pilot clinical study have demonstrated that the Reducer is safe and effective in providing relief of angina symptoms in refractory angina patients. The Reducer has received a CE mark designation in Europe for the treatment of refractory angina.

Neovasc CEO Alexei Marko noted, "Patient outcome data from our Reducer pilot studies and the Registry patients enrolled to date have been very promising. If the COSIRA results are consistent with past data, we can move forward with commercialization plans for this novel product that has the potential to help alleviate painful and debilitating symptoms in millions of angina patients who currently lack effective treatment options."

The Neovasc Reducer is a percutaneous device designed to treat the millions of patients worldwide who suffer from refractory angina, which occurs when there is an inadequate supply of blood to the heart muscle. Refractory angina currently affects an estimated one million patients in Europe, who often lead severely restricted lives. The incidence of refractory angina is growing, yet treatment options are limited.

About Neovasc Inc.
Neovasc Inc. is a specialty medical device company that develops, manufactures and markets products for the rapidly growing global cardiovascular marketplace. Its products include the Neovasc Reducer for the treatment of refractory angina and the Tiara transcatheter mitral valve replacement device in development for the treatment of mitral regurgitation. In addition, Neovasc's advanced biological tissue products are widely used as key components in a variety of third-party medical products, such as transcatheter heart valves. For more information, visit: www.neovasc.com.

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; history of losses and lack of and uncertainty of revenues, ability to obtain required financing, receipt of regulatory approval of product candidates, ability to properly integrate newly acquired businesses, 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. Although the Company believes that expectations conveyed by the forward-looking statements are reasonable based on the information available to it on the date such statements were made, no assurances can be given as to the future results, approvals or achievements. 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 except as otherwise required by applicable law.

SOURCE Neovasc Inc.



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