via NewMediaWire -- Neovasc Inc. (“Neovasc” or the “Company”)
(NASDAQ, TSX: NVCN) today announced that the Neovasc Reducer™
(“Reducer”) is featured in an article published in the latest issue
of the Polish Heart Journal. Entitled “Efficacy of Coronary
Sinus Reducer Implantation in Patients with Chronic Total Occlusion
of the Right Coronary Artery,” the article’s first author is Miha
Mrak, M.D., University Medical Centre Ljubljana, Ljubljana,
Slovenia.
The publication provides new information relating to the use of
the Reducer for the treatment of refractory angina in patients with
chronic total occlusions (CTO) of the right coronary artery (RCA).
Historically, the Reducer has been studied in patients with
ischemia, or lack of adequate oxygenated blood flow, primarily on
the left side of the heart. In this novel study, the authors
compared patients with left-sided ischemia to patients with
right-sided ischemia.
The study evaluated twenty-two consecutive patients with CTO RCA
from 2 centers that were prospectively included and compared to a
historical control group of patients with left-sided ischemia. All
patients underwent evaluation of angina severity and quality of
life at baseline and after 12 months.
The results demonstrated a statistically significant improvement
in the Canadian Cardiovascular Society (CCS) angina score (a
measure of chest pain severity). The mean improvement in the CTO
RCA group from 2.73 (0.46) to 1.82 (0.73) (P <0.001), and in the
left-sided group from 2.67 (0.57) to 1.92 (0.72) (P <0.001),
demonstrated that there was no intergroup difference (P = 0.350).
Significant improvement in all Seattle Angina Questionnaire domains
was also observed. The results suggest that the improvement seen in
patients with right-sided ischemia was similar to the improvement
observed in patients with left-sided ischemia.
“We are pleased to see the recent publication from Dr. Mrak and
his colleagues,” stated Fred Colen, President & Chief
Executive Officer of Neovasc. “The early trials evaluating the
Reducer system were conducted in patients with primarily left-sided
ischemia. Our real-world experience suggests that patients with
right-sided ischemia may also benefit from the Reducer. Research
such as the work done by Dr. Mrak is encouraging and may help
expand the potential pool of treatable patients in the future.”
About Reducer
The Reducer is CE-marked in the European Union and Under
Investigation in the United States 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 can be 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.
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. 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 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
ICR Westwicke
Phone: +1.646.877.9641
Mike.Cavanaugh@westwicke.com
Media
Sean Leous
ICR Westwicke
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 implications of
the results of the publication, the potential of patients with
right-sided ischemia benefiting from the Reducer, the potential
expansion of the pool of treatable patients in the future, the
growing incidence of refractory angina 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 and six months ended June 30, 2021 (copies
of which may be obtained at 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. 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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