via NewMediaWire -- Neovasc Inc. (“Neovasc” or
the “Company”) (NASDAQ, TSX: NVCN) today announced that
the United Kingdom’s Interventional Procedures Programme at the
National Institute for Health and Care Excellence (“NICE”) has
issued guidance supporting the implantation of the Neovasc Reducer™
(“Reducer”) in appropriate patients suffering from refractory
angina, a painful and debilitating condition that causes chest pain
when other treatment options have failed or are not possible.
NICE’s current guideline on stable angina
describes recommendations on managing stable angina that has not
responded to treatment. For these stable angina patients who are
refractory to treatment, NICE has limited its recommendations to
addressing the psychological factors of patients’ pain. Prior to
the new guidance supporting coronary sinus reduction, NICE has not
supported any therapeutic interventions.
NICE’s recommendation is important, as it supports
the very first therapeutic intervention for stable angina patients
who have not responded to treatment.
According to the new guidance document, “Coronary
sinus narrowing device implantation is indicated for people in whom
other treatment options (medical or surgical) have failed or are
not possible (refractory angina). The aim is to reduce symptoms and
to improve quality of life.”
An independent advisory committee is
responsible for making the interventional procedures
recommendations. The committee includes both health professionals
and people familiar with the issues that can affect patients and
caregivers. The coronary sinus narrowing device was recommended
with “Special Arrangements”, which according to NICE, “...is often
made when the procedure is considered to be emerging practice in
the National Health Service.” It places emphasis on the need
for informed consent and suggests that clinicians using these
procedures should collect data and enter them into a national
database. The guidance further recommends that patient selection
should be done by a multidisciplinary team and the procedure should
only be done in centers by interventional cardiologists with
specific training in the technique.
Prof. Jonathan Hill, MD, Consultant Interventional
Cardiologist at Royal Brompton & Harefield NHS Foundation
Trust, London, U.K., commented, “The NICE committee that
evaluated the coronary sinus narrowing device extensively reviewed
the available clinical data regarding the Reducer device. Today’s
guidance document is good news for patients in the United Kingdom
suffering from refractory angina that haven’t had treatment options
supported by NICE guidance.”
“Today’s NICE guidance offers new hope for
patients,” stated Fred Colen, President and Chief Executive Officer
of Neovasc. “Health authorities around the world recognize the
expertise of NICE. We’re gratified that the committee chose to
evaluate the Reducer, and we are pleased with their decision. The
new guidance, coupled with the expanded reimbursement granted by
NICE earlier this year, will help to expand access to the Reducer
therapy for patients that previously had no good 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
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 from the NICE guidance, 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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