Neovasc Inc. Provides Update on Tiara™ Transcatheter Mitral Valve and Reducer™ Programs
TSX Venture Exchange: NVC
VANCOUVER, March 4, 2014 /CNW/ - Neovasc Inc. (TSXV: NVC) today provided an update on the company's Tiara™ transcatheter mitral valve and Reducer™ programs and associated presentations at upcoming medical conferences. The company confirmed that the first patient implanted with a Tiara valve on January 30, 2014 continues to recover as expected, demonstrating good mitral valve function with no mitral regurgitation and trivial paravalvular leak. Neovasc also reported that in February, a second patient with severe functional mitral regurgitation was successfully implanted with a Tiara valve. This second implant was completed without procedural difficulties or complications and resulted in the immediate elimination of the mitral regurgitation and no paravalvular leak. The patient is recovering uneventfully. Further details of these first Tiara cases will be presented by members of the implanting medical team at EuroPCR 2014, the annual congress of the European Association of Percutaneous Cardiovascular Interventions, that will be held May 20-23, 2014 in Paris, France.
Neovasc also announced that the results of its COSIRA study have been accepted for presentation as a Featured Clinical Research Presentation at the American College of Cardiology (ACC) 63rd Annual Scientific Session & Expo being held in Washington DC, March 29-31, 2014. The COSIRA study is a multicenter, randomized, sham controlled study conducted to evaluate the safety and effectiveness of Neovasc's Reducer product for the treatment of refractory angina. Principal investigator Dr. Stefan Verheye will be presenting the full results of the trial at a session being held on March 29 at 4:45pm ET, room 206. In November, 2013 Neovasc announced topline data from the COSIRA study indicating that the trial had met its primary efficacy endpoint.
Tiara is a self-expanding mitral bioprosthesis specifically designed to treat mitral valve regurgitation by replacing the diseased valve. Significant mitral regurgitation can lead to heart failure and death. Conventional surgical treatments are only appropriate for about half of mitral regurgitation patients, who number an estimated four million in the US alone. Tiara is implanted in the heart using a minimally-invasive, transcatheter approach and is designed to replace the diseased native mitral valve without the need for open heart surgery or use of a cardiac bypass machine. The clinical procedure to implant a Tiara valve takes about an hour in total and is completed via a catheter inserted into the heart through a small incision between the patient's ribs.
The Reducer product is intended for the treatment of refractory angina, a painful and debilitating condition that occurs when the coronary arteries deliver an inadequate supply of blood to the heart muscle, despite treatment with standard revascularization or cardiac drug therapies. It affects millions of patients worldwide, who typically lead severely restricted lives as a result of their disabling symptoms, and its incidence is growing. The Reducer provides treatment for angina symptoms by altering blood flow in the heart muscle's circulatory system, thereby increasing the perfusion of oxygenated blood to ischemic areas of the heart muscle. Placement of the Reducer is performed using a minimally invasive transvenous procedure that is similar to implanting a coronary stent and takes approximately 20 minutes.
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 value 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: third-party claims regarding our intellectual property, continued success of clinical trials, 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, including in the Company's annual information form. 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.
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