Neovasc Reducer System Receives First National Reimbursement in Europe
June 07 2021 - 9:05AM
via NewMediaWire – Neovasc Inc. (“Neovasc” or the “Company”)
(NASDAQ, TSX: NVCN) today announced that the Neovasc Reducer®
(“Reducer”) system has been granted national reimbursement in
England as a result of being included in the High-Cost Tariff
Excluded Devices (HCTED) national catalogue.
The National Health Service England (NHS England) has a
nationwide purchase and supply system for specific categories of
high-cost tariff-excluded medical devices used in specialized
services designed to support the accelerated adoption of effective
new technologies. These are devices NHS England has agreed should
be paid for separately from the national tariff for a medical
procedure. Hospital providers can now order the Reducer and bill
the cost of the device directly to NHS England.
Prof. Jonathan Hill, MD, Consultant Interventional Cardiologist
at Royal Brompton & Harefield NHS Foundation Trust, London,
U.K., commented, “The clinical data on Reducer therapy, much of it
developed in the UK, continues to demonstrate efficacy and
excellent safety. Inclusion in the HCTED catalogue is an important
step for Reducer therapy and will help new centers to begin
utilizing the device. This is good news for the many patients
suffering from refractory angina in the UK.”
“Expanding reimbursement for Reducer to enable broader market
access has been a cornerstone of the value creation strategy at
Neovasc. We are pleased with the NHS decision that follows the
positive American Medical Association decision to establish a new
Category III CPT code to report the transcatheter implantation of a
coronary sinus reduction device,” stated Fred Colen, President and
Chief Executive Officer of Neovasc. “We are honored that the NHS
has assessed the Reducer as an effective new therapy for patients.
The NHS is recognized as a leading authority on health and care
excellence. Their decision will help accelerate the adoption of
Reducer therapy in the UK and will benefit patients.”
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.
InvestorsMike CavanaughWestwicke/ICRPhone:
+1.646.877.9641Mike.Cavanaugh@westwicke.com
MediaSean LeousWestwicke/ICRPhone:
+1.646.866.4012Sean.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
continuation of clinical data on Reducer therapy demonstrating
efficacy and excellent safety, inclusion of the Reducer in the
HCTED catalogue helping new centers to begin utilizing the device,
the NHS decision helping to accelerate the adoption of Reducer
therapy in the UK and benefiting patients 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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