via NEWMEDIAWIRE -- Neovasc, Inc. ("Neovasc" or the
"Company") (NASDAQ, TSX: NVCN), today announced that the
Neovasc Reducer™ (“Reducer”) and Tiara™ (“Tiara”) program were
recently featured at two industry conferences.
The Tiara Mitral Valve Replacement program was
featured at both the PCR e-Course and the TVT Connect
conference.
During the courses, Lenard Conradi M.D.,
University Heart Center Hamburg, Germany, and Gorav Ailawadi, M.D.,
M.B.A., University of Virginia, provided updates on the clinical
performance of the Tiara TA transapical and Tiara TF transfemoral
programs.
The presentations of the Tiara TA system
revealed:
- Excellent procedural safety: 0% procedural
mortality
- High rate of procedural success: 92.4%
- Resolution of MR (None/Trace/Mild)
o 97.3% at 30 Day
o 100% at 1 Year
- Symptom improvement in majority of patients
- Longest follow-up: > 6 years
The Reducer was highlighted during the PCR
e-Course in a Hotline and Innovation session. Stefan Verheye, M.D.,
Ph.D., ZNA Middelheim, Antwerp, Belgium, presented the results of
the REDUCER-I study. REDUCER-I is a multi-center, international,
three-arm prospective and retrospective observational study
enrolling up to 400 patients suffering from refractory angina.
Highlights of the study included:
- 70% of patients with the most severe symptoms saw
improvement in their symptoms following Reducer treatment and the
result was sustained up to 3 years
- Less than 1% of patients experienced a device or
procedure related major adverse event
- Patients experienced a 91% decrease in emergency
department visits from the 12 months prior to baseline compared to
12 months after treatment with Reducer
“We are pleased to see the continued success with
our innovative technologies, Reducer and Tiara,” said Fred Colen,
President and Chief Executive Officer of Neovasc. “It’s gratifying
to see several of the most respected cardiology leaders discussing
our technologies in such prominent programs. We look forward to
expanding our global regulatory approvals so that we can bring
these technologies to more patients around the world.”
About ReducerThe 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 Tiara Tiara is a
self-expanding mitral bioprosthesis specifically designed to treat
mitral valve regurgitation ("MR") by replacing the diseased valve.
Conventional surgical treatments are only appropriate for about
half of MR patients, who number an estimated four million in the
U.S. with a similar number of patients affected
throughout Europe. Tiara is implanted in the heart using a
minimally invasive, transcatheter approach without the need for
open-heart surgery or use of a cardiac bypass machine.
The Tiara valve is not commercially available and
is currently being evaluated in two ongoing clinical trials:
TIARA-I – an early feasibility trial in the United
States, Canada, and Belgium; and TIARA-II – a European
Conformité Européenne Mark trial in
Germany, Italy, Spain, and the United Kingdom. In
addition, patients have also been treated under compassionate
programs in Canada, Italy, Germany, Israel, and
Switzerland.
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.
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
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, the potential expansion of the
patient pool eligible for treatment with Tiara TF as a result of
lower profile valve design, coupled with the innovative delivery
system, expectations regarding the initiation of a clinical
feasibility study in late 2020, expectations as to the
growing cardiovascular marketplace, the safety and efficacy of the
Reducer therapy and the Tiara valve and our ability to expand our
global regulatory approvals. 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.
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