-Bebeau 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-
TSX Venture Exchange: NVC
VANCOUVER, May 8, 2014 /CNW/ - Neovasc Inc. (TSXV: NVC) (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.
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.
SOURCE: Neovasc Inc.
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