via NewMediaWire -- Neovasc, Inc. ("Neovasc" or the "Company")
(NASDAQ, TSX: NVCN) today announced that the journal
EuroIntervention has published an article entitled, “Coronary Sinus
Reducer Implantation Results in Improved Oxygen Kinetics at
Cardiopulmonary Exercise Test in Patients with Refractory
Angina.”
The article, authored by Carlo Zivelonghi, M.D., Antwerp
Cardiovascular Center, Antwerp, Belgium, describes objective
improvements in effort tolerance and oxygen kinetics as assessed by
cardiopulmonary exercise testing (CPET) in patients suffering from
refractory angina treated with Neovasc Reducer™ (“Reducer”)
implantation.
In this multicenter prospective study, 37 patients with chronic
refractory angina undergoing Reducer implantation were evaluated
with CPET at baseline (before treatment) and at six-month follow-up
after implantation of the device. The main endpoints of the
analysis were improvements in VO2 max and in VO2 at anaerobic
threshold (AT), measures which reflect cardiorespiratory
fitness and endurance capacity in exercise
performance.
The results showed that Reducer treatment significantly improved
cardiopulmonary parameters, reflected by improvement in VO2 max
(+0.97 ml/kg/min [+11.3%], 12.2±3.6 ml/kg/min vs 13.2±3.7,
p=0.026), and workload (+12.9 [+34%]; 68±28 W vs 81±49W, p=0.05).
Angina severity reflected by the Canadian Cardiovascular Society
(CCS) grading improved from a mean of 3.2±0.5 to 1.6±0.8,
(p<0.01). Improvements in all Seattle Angina Questionnaire
variables were also shown.
“For the first time, we were able to demonstrate objective
improvement in exercise capacity and oxygen kinetics during
exercise,” said Dr. Maayan Konigstein, M.D., Tel Aviv Medical
Center and Sackler School of Medicine, Tel Aviv
University, Israel. “VO2 max is an indicator of
cardiorespiratory fitness, and the improved cardiopulmonary
exercise capacity following treatment with Reducer is suggestive of
improvement in myocardial ischemia and in exercise tolerance in
these patients.”
Fred Colen, President & Chief Executive Officer of Neovasc,
added, “We congratulate the authors for their innovative work. We
believe demonstrating objective evidence of improvement in
oxygenated blood flow to the heart muscle and related objective
outcomes, such as exercise ability and associated improved key
cardiopulmonary parameters, provides further support for the
improvement in overall clinical outcomes, as already indicated for
patients receiving the Reducer. It is remarkable to see
statistically significant improvements in these important
cardiopulmonary parameters in such a small patient population.”
Improvement in angina symptoms was observed in 32 patients
(86.5%), with a mean improvement in CCS grade at follow up of
1.6±0.8. Only very limited differences in anti-anginal medications
were recorded, with a mean of 1.9±1.1 drugs per patient at baseline
vs 1.8±1.1 at follow-up (p=0.77). Prof. Stefan Verheye, M.D., PhD,
Antwerp Cardiovascular Center Middelheim, Antwerp, Belgium, said,
“It is reassuring to see the consistent improvements in chest pain
in patients treated with the Reducer. The outcomes reported in this
study build upon the literature supporting Reducer as an attractive
option for patients suffering from refractory angina that are not
candidates for traditional revascularization procedures.”
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.
InvestorsMike CavanaughWestwicke/ICRPhone:
+1.646.877.9641Mike.Cavanaugh@westwicke.com
MediaSean LeousWestwicke/ICRPhone:
+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 40-F and in
the Management’s Discussion and Analysis for the year ended
December 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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