Neovasc Reducer™ for Treatment of Refractory Angina Featured in Multiple Presentations in Germany
January 22 2020 - 9:00AM
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 that the Neovasc Reducer™
(“Reducer”) was featured in three presentations across Germany this
month.
The presentations included:
- At the 20th Cardiology Symposium, held January 11, 2020 in
Berlin, Prof. Tommaso Gori, Uniklinik Mainz, gave a presentation
during the session “Follow up and Ausblick”, titled, “When there is
no option to treat angina pectoris anymore: The
Reducer”
- At the 20th Cardiology Symposium - Cardiac Surgery Update held
January 17, 2020 in Dortmund, Dr. Joachim Weber-Albers,
St.-Johannes-Hospital Dortmund, presented and moderated a “live in
the box case” during the Coronary Artery Disease session.
- At a workshop held January 22, 2020 in Landshut by the
Krankenhaus Achdorf, in cooperation with Berlin-Chemie and Neovasc,
Dr. Stylianos Pyxaras presented the Reducer as a new treatment
option for chronic angina.
“We are encouraged by the growing use and satisfaction of
physicians with the outcomes of the Reducer Therapy for their
patients,” said Fred Colen, President and Chief Executive Officer
of Neovasc. “Patients with refractory angina continue to suffer
from chest pain despite medical therapy. We are proud to offer a
proven and safe solution that can improve so many lives.”
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 the coronary
arteries deliver an inadequate supply of blood to the heart muscle,
despite treatment with standard revascularization or cardiac 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 within the myocardium of
the heart and 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, 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 of 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. 1
1T. J. Povsic, S. Broderick, K. J. Anstrom et al.,
"Predictors of long‐term clinical endpoints in patients with
refractory angina," Journal of the American Heart Association, vol.
4, no. 2, article e001287, 2015.
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 bringing the Reducer to the U.S. market, the
growing incidence of refractory angina 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
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