Neovasc Announces Circulatory System Devices Panel Meeting Date for Neovasc Reducer™ Device
July 09 2020 - 7:30AM
via NEWMEDIAWIRE -- Neovasc, Inc. ("Neovasc" or the "Company")
(NASDAQ, TSX: NVCN), announced today that it has been informed
by the U.S. Food and Drug Administration (FDA) that
the Circulatory System Devices Panel of the Medical Devices
Advisory Committee will review the premarket approval application
(PMA) for the Neovasc Reducer™ device (“Reducer”) at its October
27, 2020 meeting. Neovasc is seeking approval for Reducer in the
U.S. for the treatment of patients suffering from refractory angina
pectoris despite guideline directed medical therapy, who are
unsuitable for revascularization by coronary artery bypass grafting
(CABG) or by percutaneous coronary intervention (PCI).
“Today’s announcement marks a significant milestone for Neovasc,
as we continue to work closely with the FDA towards approval of the
Reducer in the United States,” said Fred Colen, President and Chief
Executive Officer of Neovasc. “We look forward to discussing the
role that Reducer can play in alleviating the suffering that
refractory angina patients endure.”
The FDA granted Breakthrough Device designation to the Reducer
for the treatment of refractory angina in October 2018.
Neovasc submitted a PMA for the Reducer device in December
2019.
About Reducer The Reducer is CE-marked in the
European Union for the treatment of refractory angina, a painful
and debilitating condition that occurs when there
is inadequate supply of blood to parts of the heart muscle,
despite current treatment therapies, including any form of standard
revascularization and drug therapies. It affects millions
of patients worldwide, who typically lead severely restricted lives
as a result of their disabling symptoms, and its incidence is
growing. The Reducer provides relief of angina symptoms by altering
blood flow in the heart’s circulatory system, thereby increasing
the perfusion of oxygenated blood to ischemic areas of the heart
muscle. Placement of the Reducer is performed using a minimally
invasive transvenous procedure that is similar to implanting a
coronary stent and is completed in approximately 20 minutes.
While the Reducer is not approved for commercial use in the
United States, it is currently under PMA review. The FDA granted
Breakthrough Device designation to the Reducer in October
2018. This designation is granted by the FDA in order to expedite
the development and review of a device that demonstrates compelling
potential to provide a more effective treatment or diagnosis for
life-threatening or irreversibly debilitating diseases. In
addition, there must be no FDA approved treatments presently
available, or the technology must offer significant advantages over
existing approved alternatives.
Refractory angina, resulting in continued symptoms despite
maximal medical therapy and without revascularization options, is
estimated to affect 600,000 to 1.8 million Americans, with 50,000
to 100,000 new cases per year.
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.
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
incidence of refractory angina, potential FDA approval of the
Reducer in the United States 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, 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 months ended
March 31, 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 Cavanaugh
Westwicke/ICR
Phone: +1.646.877.9641
Mike.Cavanaugh@westwicke.com
Media
Sean Leous
Westwicke/ICR
Phone: +1.646.677.1839
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