via NewMediaWire -- Neovasc Inc. (“Neovasc” or the
“Company”) (NASDAQ, TSX: NVCN) today announced that the
Neovasc Reducer™ (“Reducer”) system has been
granted Prise en Charge Transitoire (“PECT”)
reimbursement in France by the national health
authority, Haute Autorité de Santé (“HAS”). The
decision will be officialized upon
publication in the French Journal
Officiel.
The Reducer is the first therapy to be approved
under the newly established PECT process. It is designed to allow
patients with significant illnesses and no other therapeutic
options to benefit from novel therapies for select indications. The
national approval is for a period of one year, and it can be
renewed.
Prof. Martine Gilard, past President of the French
Society of Cardiology and Director of Interventional
Cardiology, Brest University Hospital, France,
commented, “This is positive news for patients suffering from
refractory angina in France. The clinical data on Reducer therapy
continue to demonstrate efficacy and an excellent safety profile.
It is a strong message from HAS that the very first therapy
approved under the innovative PECT process is the Reducer. This
authorization is a major step for Reducer therapy and will help new
centers in France to begin utilizing the device.”
“One pillar of Neovasc’s value creation strategy
is to expand reimbursement for Reducer to enable broader market
access. The HAS decision builds upon the recent reimbursement
expansion in the United Kingdom, as well as the positive American
Medical Association decision to establish a new Category III CPT
code for coronary sinus reduction procedures in the United States,”
stated Fred Colen, President and Chief Executive Officer of
Neovasc. “We look forward to expanding our presence in France to
support the new reimbursement decision.”
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.
Contacts
ICR Westwicke
Investors:
Mike Cavanaugh
Westwicke/ICR
Phone: +1.617.877.9641
Email: Mike.Cavanaugh@westwicke.com
Media:
Sean Leous
Westwicke/ICR
Phone: +1.646.677.1839 +1.646.866.4012
Email: 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, potential benefits
of the Reducer, the future renewal of the Reducer reimbursement in
France on an annual basis, the potential utilization of the Reducer
by new centres in France, the Company’s expansion in France, 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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