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Neovasc Inc. (NVC) Announces Publication of Positive Tiara™ Preclinical Data in the Journal JACC: Cardiovascular Interventions


10/29/2013 11:42:02 AM

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--Preclinical Studies Show Innovative Transcatheter Product to Treat Mitral Regurgitation is Safe, Technically Feasible and Results in a Well-Functioning Mitral Bioprosthesis-

--Sets Stage for First-in-Human Implantations Targeted for Early 2014--

TSX Venture Exchange: NVC

VANCOUVER, Oct. 29, 2013 /PRNewswire/ - Neovasc Inc. (TSXV: NVC) today announced that a review of results from preclinical studies of its Tiaravalve for the transcatheter treatment of mitral regurgitation has been published in JACC: Cardiovascular Interventions. The review concludes that implantation of the Tiara valve is technically feasible, safe and results in a stable and well-functioning mitral bioprosthesis.

Tiara is a self-expanding mitral bioprosthesis specifically designed to treat mitral valve regurgitation (MR), a serious and poorly served condition that requires development of highly specialized devices to address the complex mitral anatomy. Mitral regurgitation is often severe and can lead to heart failure and death. Conventional surgical treatments are only appropriate for a small percentage of the estimated four million patients in the US alone.

"This publication reports on a series of successful Tiara implantations that position us to proceed to the first-in-human Tiara studies we are targeting for early 2014," noted Alexei Marko, CEO of Neovasc. "Publication of these results in a prestigious journal highlights the potential value of Tiara for the growing number of MR patients who cannot be treated surgically. We believe the unique Tiara design may provide important advantages, and we look forward to proceeding to studies in humans next year."

The preclinical studies included both acute and chronic animal models, as well as human cadavers. Researchers used trans-apical mitral implantation (TAMI), an approach that accesses the mitral valve through the tip (apex) of the left ventricle. Use of TAMI allows the interventional cardiologist easier access to the mitral valve and also avoids potential risks associated with the longer femoral access route.

The study results demonstrate that implantation of the Tiara valve in healthy swine and sheep is feasible and safe. The researchers developed a rapid and straightforward implantation procedure resulting in a stable and well-aligned functional bioprosthesis for up to 150 days of follow-up. All of the animals receiving the Tiara device exhibited normal clinical status and behavior without any signs of heart failure. There was no significant mitral regurgitation observed, and left ventricular function was normal in all subjects. The chronic animal experiments confirmed the durability and functionality of the Tiara device in ongoing use, including continuing leaflet pliability, lack of leaflet calcification and good tissue coverage of the device's metal frame.

Neovasc researchers presented data from these preclinical Tiara studies yesterday at the 25th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium being held October 27- November 1, 2013, in San Francisco, California.

The article, Banai S, Verheye S, Cheung A, Schwartz M, Marko A, Lane R, Jolicoeur EM, Garceau P, Biner S, Tanguay J-F, Edelman ER, White CJ, Trans Apical Mitral Implantation (TAMI) of the Tiara TM Bio-prosthesis: Pre-Clinical Results, JACC: Cardiovascular Interventions (2013), doi: 10.1016/,is currently available online at http://jaccinter.cardiosource.com/JCIN2013_Banai.pdf. It will also be published in an upcoming edition of JACC: Cardiovascular Interventions.

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: 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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