Neovasc Announces Publication of Peer-Reviewed Article in EuroIntervention
December 17 2020 - 7:00AM
via NewMediaWire -- Neovasc Inc. (“Neovasc” or the “Company”)
(Nasdaq, TSX: NVCN) announced today
that EuroIntervention, the official journal of EuroPCR and the
European Association of Percutaneous Coronary Interventions
(EAPCI), has published online a peer-reviewed study announcing the
outcomes of patients undergoing Neovasc Reducer™ (“Reducer”)
implantation in the Company’s REDUCER-I trial. The article,
entitled “Coronary Sinus Narrowing for the Treatment of Refractory
Angina A Multi-center Prospective Open-label Clinical Study (The
REDUCER-I Study)”, is the latest of numerous publications
supporting the safety and effectiveness of the Reducer. The trial
examined the safety and efficacy of the coronary sinus (CS) Reducer
in improving angina severity and quality of life in patients
suffering from angina pectoris, refractory to medical and
interventional therapies.
The ongoing REDUCER-I trial is the largest-to-date cohort of
patients undergoing Reducer implantation for the treatment of
refractory angina. Presented in the peer-reviewed article are the
outcomes of the first 228 patients enrolled to this observational
study with up to 2-year follow up. The study reported procedural
success of 99%. Canadian Cardiovascular Society (CCS) Angina Class,
a measure of chest pain severity, improved following the procedure,
together with other measured parameters of functional class and
quality of life.
Prof. Maayan Konigstein, MD, Department of Cardiology, Tel-Aviv
Medical Center, said, “Millions of people around the world suffer
from the debilitating condition of refractory angina. The evidence
from the REDUCER-I Study further supports the European Society of
Cardiology Guidelines that state Reducer may be a safe and
effective treatment option for patients suffering from refractory
angina. These interim analyses provide further evidence supporting
Reducer therapy for patients that are suffering and have no other
treatment options.”
Patients included in the trial were experiencing chest pain, or
angina, despite taking medications or having invasive procedures to
treat their symptoms. Over half of the population had previously
experienced a heart attack, 78% had previously undergone coronary
artery bypass graft surgical procedures, and 70% had coronary
stenting procedures in the past. Despite all of the previous
efforts to control their symptoms, the patients still experienced
chest pain.
Following implantation of the Reducer device, the mean CCS class
improved from 2.8±0.6 to 1.8±0.7 at two years follow-up. 82% of
patients experienced improvement of at least 1 CCS class, and 31%
achieved at least a 2 CCS class improvement, representing a
substantial reduction in symptoms. At baseline, 70% of patients had
CCS class III or IV angina (representing severe disability with
anginal chest pain at rest or at minimal effort). At 6-months,
1-year and two-year follow-up, only 15% of patients remained at
Class III or IV.
Prof. Stefan Verheye, MD, PhD, Antwerp Cardiovascular
Center Middelheim, Antwerp, Belgium, added, “It’s gratifying to see
the interim results of the REDUCER-I Study reinforce the
outstanding results from the COSIRA randomized sham-controlled
trial previously published in The New England Journal of
Medicine. I want to thank the patients and the investigators for
their participation in the trial, and I look forward to completing
the enrollment in this important real-world study.”
The Reducer device is CE marked and commercially available in
Europe.
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.
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 safety and
effectiveness of the Reducer 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.
Citation. Verheye S, Agostoni P, Giannini F,
Hill J, Jensen C, Lindsay S, Stella P, Redwood S, Banai S,
Konigstein M. Coronary Sinus Narrowing for the Treatment of
Refractory Angina A Multi-Center Prospective Open-Label Clinical
Study (The REDUCER-I Study). EuroIntervention 2020; Jaa-872 2020,
doi: 10.4244/EIJ-D-20-00873
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
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