Healthcare Industry News: mitral valve
News Release - May 8, 2014
Neovasc Hires Industry Veteran Vicki Bebeau as Vice President, Clinical AffairsBebeau Brings Her Extensive Experience in Managing Cardiac Device Clinical Programs to the Tiara™ and Neovasc Reducer™ New Product Programs
New Clinical Initiatives for Tiara and the Neovasc Reducer Targeted for 2014 and 2015
VANCOUVER , May 8, 2014 (Healthcare Sales & Marketing Network) - Neovasc Inc. (NVC.V) (the 'Company' or 'Neovasc') today announced that Vicki Bebeau has joined the company in the role of Vice President, Clinical Affairs, a newly-created position. Ms. Bebeau brings Neovasc more than 18 years of experience in clinical trial planning and management at industry leaders St. Jude Medical, Boston Scientific and Medtronic.
"With the ongoing successes of our Tiara™ mitral valve and Neovasc Reducer™ programs, Neovasc is preparing to undertake clinical trial initiatives for both products," noted Alexei Marko , CEO of Neovasc. "We plan to initiate multinational feasibility studies for Tiara in late 2014, and we are targeting a 2015 start for the Reducer clinical program needed for an IDE approval in the United States ."
Mr. Marko added, "These high potential programs are central to our success and we are delighted to have recruited Vicki Bebeau , a highly experienced industry veteran, as our head of Clinical Affairs. Ms. Bebeau has held clinical positions of increasing responsibility at medical device industry leaders St. Jude Medical, Boston Scientific and Medtronic, where she successfully directed multinational clinical studies in Canada , the United States , and Europe ."
Neovasc is preparing to begin formal clinical feasibility studies for its Tiara device for the transcatheter treatment of mitral valve disease later this year. In addition, building on positive results recently reported from the Reducer COSIRA trial, Neovasc has initiated design of a US-IDE study to support an application for FDA approval of the Reducer. The study is expected to begin next year.
"Neovasc has earned a strong reputation in the industry for their development of novel cardiovascular devices addressing major unmet medical needs, and I look forward to playing a key role in advancing the clinical programs that are central to the clinical and commercial success of the Tiara and Reducer new product programs," commented Ms. Bebeau.
Neovasc intends to continue the expansion of its clinical team and related operations to support the Tiara and Reducer product programs.
About Neovasc Inc.
Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace. Its products include the Tiara™ technology in development for the transcatheter treatment of mitral valve disease, the Neovasc Reducer™ for the treatment of refractory angina and a line of advanced biological tissue products that are used as key components in third-party medical products including 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," "forecasts", "targets", 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, including the forecasted start date for the formal clinical feasibility studies of the Tiara and the targeted FDA approval application for the Reducer, 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 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.
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