Largest Real-World Registry Supporting Neovasc Reducer™ Safety and Efficacy Outcomes Published in International Journal of ...
June 18 2021 - 9:05AM
via NewMediaWire -- Neovasc Inc. (“Neovasc” or the “Company”)
(NASDAQ, TSX: NVCN) today announced the publication of an
article entitled, “Safety and Efficacy of Coronary Sinus Narrowing
in Chronic Refractory Angina: Insights from the RESOURCE Study” in
the International Journal of Cardiology.
The article, authored by Francesco Ponticelli, M.D., Maria
Cecilia Hospital, Cotignola, Italy, describes long-term outcomes of
patients suffering from refractory angina treated with the Neovasc
Reducer™ (“Reducer”) system. The RESOURCE study is an
observational, retrospective registry that includes 658 patients
with refractory angina from 20 centers in Europe, the United
Kingdom and Israel. The prespecified endpoints of the trial were
the amelioration of anginal symptoms evaluated with the Canadian
Cardiovascular Society (CCS) score (a measure of chest pain
severity) and the rates of procedural success and
complications.
At a median follow-up of 502 days after Reducer implantation,
39.7% of patients improved by ≥2 CCS classes (primary endpoint),
and 76% by ≥1 class. The procedure was safe and procedural success
was achieved in 96.7% of attempts. No cases of intra- or
periprocedural-death, myocardial infarction or cardiac tamponade
were observed in the study population. No patient required bailout
conversion to open surgery. The authors described the study as the
largest international real-world registry of patients with
refractory angina who were treated with the coronary sinus
Reducer.
“The data presented in the RESOURCE study confirm the excellent
safety profile of the Reducer device and support good clinical
efficacy,” said Dr. Ponticelli. “It’s encouraging to
see the results in this real-world registry are consistent with the
randomized data on the Reducer. We can now more confidently tell
our patients suffering from refractory angina that there is a safe
therapy that may be able to help them feel better.”
“We are grateful to the patients and the authors of the RESOURCE
study,” stated Fred Colen, President & Chief
Executive Officer of Neovasc. “The participants in the study
represent the types of patients that cardiologists around the world
have been struggling to treat. Patients that have tried medicines,
by-pass surgery and stents still frequently suffer from
debilitating chest pain and have frequently been told there is
nothing else for them to try. We are delighted by the real-world
evidence that supports our unique and innovative Reducer therapy as
a safe and effective option that can now provide relief and an
improved quality of life for many of these patients that previously
had no further 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,
Reducer’s safety and ability to help patients suffering from
refractory angina feel better and the growing cardiovascular
marketplace. Many factors and assumptions could cause the Company's
actual results, performance or achievements to differ materially
from those expressed or implied by the forward-looking statements,
including, without limitation, the doubt about the Company’s
ability to continue as a going concern; risks related to the recent
COVID-19 coronavirus outbreak or other health epidemics, which
could significantly impact the Company’s operations, sales or
ability to raise capital or enroll patients in clinical trials and
complete certain Tiara development milestones on the Company’s
expected schedule; risks relating to the Company’s need for
significant additional future capital and the Company’s ability to
raise additional funding; risks relating to the sale of a
significant number of Common Shares; risks relating to the
possibility that the Company’s common shares (the “Common Shares”)
may be delisted from the Nasdaq or the TSX, which could affect
their market price and liquidity; risks relating to the Company’s
conclusion that it did have effective internal control over
financial reporting as of December 31, 2020 but not at December 31,
2019 and 2018; risks relating to the Common Share price being
volatile; risks relating to the possibility that the Common Shares
may be delisted from the Nasdaq or the TSX, which could affect
their market price and liquidity; risks relating to the Company’s
significant indebtedness, and its effect on the Company’s financial
condition; risks relating to lawsuits that the Company is subject
to, which could divert the Company’s resources and result in the
payment of significant damages and other remedies; risks relating
to claims by third-parties alleging infringement of their
intellectual property rights; risks relating to the Company’s
ability to establish, maintain and defend intellectual property
rights in the Company’s products; risks relating to results from
clinical trials of the Company’s products, which may be unfavorable
or perceived as unfavorable; the Company’s history of losses and
significant accumulated deficit; risks associated with product
liability claims, insurance and recalls; risks relating to use of
the Company’s products in unapproved circumstances, which could
expose the Company to liabilities; risks relating to competition in
the medical device industry, including the risk that one or more
competitors may develop more effective or more affordable products;
risks relating to the Company’s ability to achieve or maintain
expected levels of market acceptance for the Company’s products, as
well as the Company’s ability to successfully build its in-house
sales capabilities or secure third-party marketing or distribution
partners; risks relating to the Company’s ability to convince
public payors and hospitals to include the Company’s products on
their approved products lists; risks relating to new legislation,
new regulatory requirements and the efforts of governmental and
third-party payors to contain or reduce the costs of healthcare;
risks relating to increased regulation, enforcement and inspections
of participants in the medical device industry, including frequent
government investigations into marketing and other business
practices; risks relating to the extensive regulation of the
Company’s products and trials by governmental authorities, as well
as the cost and time delays associated therewith; risks relating to
post-market regulation of the Company’s products; risks relating to
health and safety concerns associated with the Company’s products
and industry; risks relating to the Company’s manufacturing
operations, including the regulation of the Company’s manufacturing
processes by governmental authorities and the availability of two
critical components of the Reducer; risks relating to the
possibility of animal disease associated with the use of the
Company’s products; risks relating to the manufacturing capacity of
third-party manufacturers for the Company’s products, including
risks of supply interruptions impacting the Company's ability to
manufacture its own products; risks relating to the Company’s
dependence on limited products for substantially all of the
Company’s current revenues; risks relating to the Company’s
exposure to adverse movements in foreign currency exchange rates;
risks relating to the possibility that the Company could lose its
foreign private issuer status under U.S. federal securities laws;
risks relating to the possibility that the Company could be treated
as a "passive foreign investment company"; risks relating to
breaches of anti-bribery laws by the Company’s employees or agents;
risks relating to future changes in financial accounting standards
and new accounting pronouncements; risks relating to the Company’s
dependence upon key personnel to achieve its business objectives;
risks relating to the Company’s ability to maintain strong
relationships with physicians; risks relating to the sufficiency of
the Company’s management systems and resources in periods of
significant growth; risks relating to consolidation in the health
care industry, including the downward pressure on product pricing
and the growing need to be selected by larger customers in order to
make sales to their members or participants; risks relating to the
Company’s ability to successfully identify and complete corporate
transactions on favorable terms or achieve anticipated synergies
relating to any acquisitions or alliances; risks relating to
conflicts of interests among the Company's officers and directors
as a result of their involvement with other issuers; and risks
relating to anti-takeover provisions in the Company’s constating
documents which could discourage a third-party from making a
takeover bid beneficial to the Company’s shareholders. These risk
factors and others relating to the Company are discussed in greater
detail in the "Risk Factors" section of the Company's Annual
Information Form and in the Management's Discussion and Analysis
for the three months ended March 31, 2021 (copies of which may be
obtained at www.sedar.com or www.sec.gov). The
Company has no intention and undertakes no obligation to update or
revise any forward-looking statements beyond required periodic
filings with securities regulators, whether as a result of new
information, future events or otherwise, except as required by
law.
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