Neovasc Announces FDA Advisory Panel Result on Neovasc Reducer™ Medical Device for the Treatment of Refractory Angina
October 28 2020 - 7:00AM
via NewMediaWire -- Neovasc Inc. ("Neovasc" or the "Company")
(NASDAQ, TSX: NVCN) today announced that the United
States Food and Drug Administration’s (FDA’s) Circulatory
System Devices Advisory Panel voted 14 to 4 “in favor” that the
Neovasc Reducer™ is safe when used as intended, and voted 1 to 17
"against" on the issue of a reasonable assurance of effectiveness.
The third vote was 13 to 3 "against” (2 abstained) on whether the
relative benefits outweighed the relative risks.
“We would like to thank the FDA, the panel and members of the
public that offered their insights during yesterday’s Circulatory
System Devices Advisory Panel meeting,” said Fred Colen, President
and Chief Executive Officer of Neovasc. “Clearly, we are
disappointed with the meeting’s outcome, and we will provide
further updates in the coming weeks.”
The Reducer is currently under review by the
agency for treatment of patients with refractory angina pectoris
despite guideline directed medical therapy, who are unsuitable for
revascularization by coronary artery bypass grafting or by
percutaneous coronary intervention.
About Neovasc Inc.
Neovasc is a specialty medical device company that develops,
manufactures and markets products for the rapidly growing
cardiovascular marketplace. The Company is a leader in the
development of minimally invasive transcatheter mitral valve
replacement technologies, and minimally invasive devices for the
treatment of refractory angina. Its products include the Neovasc
Reducer™, for the treatment of refractory angina, which is not
currently commercially available in the United States (2 U.S.
patients have been treated under Compassionate Use) and has been
commercially available in Europe since 2015, and Tiara™, for the
transcatheter treatment of mitral valve disease, which is currently
under clinical investigation in the United States, Canada, Israel
and Europe. For more information,
visit: www.neovasc.com. Click here for a link to the
most recent corporate update.
Investors
Mike Cavanaugh
Westwicke/ICR
Phone: +1.646.877.9641
Mike.Cavanaugh@westwicke.com
Media
Sean Leous
Westwicke/ICR
Phone: +1.646.866.4012
Sean.Leous@westwicke.com
Forward-Looking Statement Disclaimer
Certain statements in this news release contain
forward-looking statements within the meaning of the U.S. Private
Securities Litigation Reform Act of 1995 and applicable Canadian
securities laws that may not be based on historical fact.
When used herein, the words "expect", "anticipate", "estimate",
"may", "will", "should", "intend," "believe", and similar
expressions, are intended to identify forward-looking
statements. Forward-looking statements may involve, but are
not limited to the growing cardiovascular marketplace.
Forward-looking statements are based on estimates and assumptions
made by the Company in light of its experience and its perception
of historical trends, current conditions and expected future
developments, as well as other factors that the Company believes
are appropriate in the circumstances. Many factors could
cause the Company's actual results, performance or achievements to
differ materially from those expressed or implied by the
forward-looking statements, including those described in the "Risk
Factors" section of the Company's Annual Report on Form 20-F and in
the Management's Discussion and Analysis for the three and six
months ended June 30, 2019 (copies of which may be obtained
at www.sedar.com or www.sec.gov). These
factors should be considered carefully, and readers should not
place undue reliance on the Company's forward-looking statements.
The Company has no intention and undertakes no obligation to update
or revise any forward-looking statements, whether as a result of
new information, future events or otherwise.
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