Neovasc Responds to FDA Not-Approvable Letter Regarding Neovasc Reducer™
January 15 2021 - 4:58PM
via NewMediaWire -- Neovasc Inc. (“Neovasc” or the “Company”)
(Nasdaq, TSX: NVCN) announced today that it has received a
“not-approvable” letter from U.S. Food & Drug Administration
(FDA) regarding its PMA submission for the Neovasc Reducer™
(Reducer).
Fred Colen, Neovasc CEO, said, “While we are disappointed in
FDA’s decision, the letter was not unexpected, given the outcome of
the Panel meeting.” He continued, “Millions of patients suffer from
refractory angina, and for many, the Reducer offers hope for
symptom relief. We will continue to evaluate our strategic options
for bringing the Reducer to patients around the world.”
The FDA reviewed Reducer 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. The Reducer is CE-marked in the European Union for
the treatment of refractory angina.
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 Reducer, for the
treatment of refractory angina, which is not currently commercially
available in the United States 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.
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 safety and
effectiveness of the Reducer and 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, market and other conditions 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 nine months ended
September 30, 2020 (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.
Investors
Mike CavanaughWestwicke/ICRPhone:
+1.646.877.9641Mike.Cavanaugh@westwicke.com
MediaSean LeousWestwicke/ICRPhone:
+1.646.866.4012Sean.Leous@westwicke.com
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