via NEWMEDIAWIRE -- Neovasc Inc. ("Neovasc" or the "Company")
(NASDAQ, TSX: NVCN), today announced positive interim results
of the REDUCER-I study during the PCR E-Course. Stefan Verheye, MD,
PhD, ZNA Middelheim, Antwerp, Belgium presented the results of the
trial during the Hotline and Innovation Session.
REDUCER-I is a multi-center, international, three-arm
prospective and retrospective observational study enrolling up to
400 patients suffering from refractory angina. The patients
included in the study have exhausted other treatment options
including drug-therapy and represent a difficult-to-treat
population. Today’s presentation provided data from 241 patients
enrolled in the study, with up to three years follow-up, making it
the largest and longest duration Neovasc ReducerTM data set
presented to date. The primary efficacy endpoint of the study is
improvement in chest pain, or angina, as measured by the Canadian
Cardiovascular Society (“CCS”) grading system.
Highlights of the study included:
· 70% of
patients saw improvement in their symptoms by at least 1 CCS Class
that was maintained through 3 years.
·
34% of patients saw improvement in their symptoms by at least 2 CCS
Classes that was maintained through 3 years.
·
Prior to treatment, ~70% of patients were CCS Class 3-4, the most
severe classes of symptoms.
·
After treatment with Reducer through 2-year follow-up, ~16% of
patients were CCS Class 3-4.
·
Patients experienced a 91% decrease in emergency department visits
from the 12 months prior to baseline compared to 12 months after
treatment with Reducer.
·
Less than 1% of patients experienced a device or procedure related
major adverse event.
“We believe the results from the REDUCER-I study
demonstrate that for patients suffering from the debilitating
effects of refractory angina, Reducer therapy is safe and offers a
sustained improvement in symptoms,” said Dr. Verheye. “Today’s
findings reinforce the results of the COSIRA
study published in the New England Journal of
Medicine and align with the current European Society of
Cardiology Guidelines for the treatment of chronic
coronary syndromes."
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.
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. The 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. 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 “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, the growing cardiovascular
marketplace and the safety and efficacy of the Reducer therapy.
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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