Neovasc Achieves Design Freeze for Transfemoral Trans-septal Tiara™ Mitral Valve System
February 12 2020 - 8:30AM
via NEWMEDIAWIRE -- Neovasc, Inc. ("Neovasc" or the "Company")
(NASDAQ, TSX: NVCN), a leader in the development of minimally
invasive transcatheter mitral valve replacement technologies and in
the development of minimally invasive devices for the treatment of
refractory angina, announced today achievement of design freeze for
its fully retrievable transfemoral trans-septal Tiara™ (“TF/TS
Tiara”) system, including a modified, lower profile valve and a
steerable delivery system.
“This design freeze is a significant milestone for the Company,”
commented Fred Colen, President and Chief Executive Officer at
Neovasc. “We have advanced our program and met our quality system
phase gate review for developing a transformational TF/TS Tiara
system that offers meaningful advantages for physicians and
patients. The trackability, single piece self-anchoring design,
large valve opening area, lower profile valve and full
retrievability until the point of final release combine to make
what we believe to be a best-in-class system.”
About the TF/TS Tiara
System
The TF/TS Tiara System allows for a controlled and predictable
implantation procedure similar to Neovasc’s Tiara transapical
device. Unlike competitive systems in development, the TF/TS
Tiara system features a single piece design that does not require a
two-stage deployment process nor a docking mechanism for valve
securement. The single piece design allows for a simplified
stepwise deployment and maintains a large valve opening, or
effective orifice area, to maximize blood flow through the valve.
The lower profile valve design, coupled with the innovative
delivery system should expand the potential patient pool eligible
for treatment. The Company expects to initiate a clinical
feasibility study in late 2020.
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 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 “plans”, “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,
statements regarding the Company’s belief that the TF/TS Tiara is a
best in class system, expectations as to initiating a clinical
feasibility study in late 2020 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 and nine
months ended September 30, 2019 (copies of which may be obtained
at www.sedar.com or www.sec.gov). In particular, any
pathway to U.S. market approval by the FDA carries considerable
risk, and there can be no assurance that the PMA will be approved
by the FDA in a timely manner or at all, or that the receipt of the
Administrative Acceptance Review Notification by the Company means
that the FDA will agree with the Company's substantive conclusions
set forth in the PSA. In the event that the PMA is approved by the
FDA, there can be no assurance that Neovasc will be successful in
commencing commercialization of Reducer in the United States on a
timely basis or at all, or of the total addressable market size for
Reducer. 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
Sean.Leous@icrinc.com
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