Neovasc Comments on Clinical Cardiology Journal Publication
March 02 2021 - 9:00AM
via NewMediaWire -- Neovasc, Inc. ("Neovasc" or the "Company")
(NASDAQ, TSX: NVCN) today announced that the journal Clinical
Cardiology has published an article entitled, “Long-term outcomes
of patients undergoing coronary sinus reducer implantation - A
multicenter study.”
The article, authored by Maayan Konigstein, M.D., Tel Aviv
Medical Center and Sackler School of Medicine, Tel Aviv University,
Israel describes the long-term outcomes in 99 patients treated with
the Neovasc Reducer™ (“Reducer”) enrolled between September 2010
and October 2017.
The study followed patients for a mean of 3.9 years (min 2.1,
max 8.5). The mean Canadian Cardiovascular Society (CCS) angina
class, a measure of chest pain severity, was 3.1 ± 0.5 at baseline
and it improved to 1.66 ± 0.8 at 1 year (p < .001), and it
remained low through 2-years and at last follow-up (1.72 ± 0.8 and
1.71 ± 0.8, p > 0.5 for both, in comparison to 1 year). At
baseline, 91% of patients reported severe disabling angina (CCS
class 3–4), at 1 year only 17.9% suffered from disabling angina, p
< .001, and this portion remained low over time (19% at last
follow up). There were no procedure-related complications.
“Refractory angina has historically been very difficult to treat
effectively. It’s reassuring to see the long-term sustained safety
and clinical benefits of the Reducer therapy,” said Dr. Konigstein.
“The majority of patients treated with the Reducer experienced
long-term relief of angina as well as improvement in their quality
of life.”
Fred Colen, President & Chief Executive Officer of Neovasc,
stated, “It’s gratifying to see the evidence supporting the Reducer
continue to mount. The safety of the procedure, coupled with the
long-lasting reduction in chest pain offers hope to patients that
otherwise have no treatment options.”
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.
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: +1.646.866.4012
Sean.Leous@westwicke.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 long-term
sustained safety, efficacy and clinical benefits of the Reducer
therapy, the Reducer therapy’s impact on patients’ quality of life
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, market
and other conditions 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, 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.
Neovasc (NASDAQ:NVCN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Neovasc (NASDAQ:NVCN)
Historical Stock Chart
From Sep 2023 to Sep 2024