--"Encouraging" Short-Term Data from Innovative Product to Treat Mitral Regurgitation Using Transcatheter Approach--
--Chronic Animal Studies Underway in Preparation for Potential First Human Implantations in 2013--
TSX Venture Exchange: NVC
VANCOUVER, Sept. 18, 2012 /CNW/ - Neovasc Inc. (TSXV: NVC) today announced that acute results from preclinical studies of its TiaraTM valve for the transcatheter treatment of mitral regurgitation were published in the Journal of the American College of Cardiology (JACC). The study reports that the initial experience with the Tiara transcatheter mitral valve was encouraging and that implantation of Tiara valves was feasible, relatively straightforward and resulted in a securely-implanted, well-functioning device that maintained good hemodynamics in the test animals. The study, which will be published in the October 9, 2012 edition of JACC, is currently available on-line.
"We are very pleased with the results of our Tiara implantations in preclinical animal models," noted Alexei Marko, CEO of Neovasc. "Publication of the first results from the acute phase of these studies in a prestigious journal such as JACC highlights the potential value of Tiara for the treatment of patients with mitral regurgitation who cannot be treated surgically. We look forward to sharing long-term Tiara results from studies in chronic animal models at TCT 2012 next month."
In the published study, Tiara valves were implanted successfully in 81% of the test animals, with total procedure times ranging from 17 to 26 minutes. In the successful implantations, angiographic and echo imaging demonstrated excellent function of the Tiara, with no obstruction of the left ventricular outflow tract, no pericardial effusion, no encroachment on the aortic valve, no transvalvular gradients and most importantly, no significant paravalvular leak. All animals remained hemodynamically stable during the implant procedure without the need for rapid pacing.
The report, Tiara: A Novel Catheter-Based Mitral Valve Bioprosthesis: Initial Experiments and Short-Term Pre-Clinical Results, was authored by Shmuel Banai, MD, E. Marc Jolicoeur, MD, Marc Schwartz, RCIS, Patrick Garceau, MD, Simon Biner, MD, Jean-Francois Tanguay, MD, Raymond Cartier, MD, Stefan Verheye, MD, Christopher J. White, MD and Elazer Edelman, MD, PhD. It is being published in the Journal of the American College of Cardiology, Vol. 60, No. 15, 2012, and is currently available on-line at:
About Neovasc Inc.
Neovasc Inc. is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace. Its products include the Neovasc Reducer™ for the treatment of refractory angina, the Tiara™ technology in development for the transcatheter treatment of mitral valve disease and a line of advanced biological tissue products that are used as key components in a variety of third-party medical products, such as vascular surgical patches and 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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