via NewMediaWire -- Neovasc Inc. (“Neovasc” or the “Company”)
(NASDAQ, TSX: NVCN) today announced that the Centers for
Medicare and Medicaid Services (“CMS”) has assigned the Neovasc
Reducer™ (“Reducer”) implant procedure a new outpatient
reimbursement code payment status indicator, enabling U.S.
hospitals to be reimbursed for the device and implant procedure.
Effective January 1, 2023, the implantation of the
Reducer in an outpatient setting is assigned to Healthcare Common
Procedure Coding System (“HCPCS”) code 0645T and payable under the
Ambulatory Payment Classifications (“APC”) Code 5194, Level 4
Endovascular Repair. APCs are the U.S. government’s method of
paying for outpatient services for the Medicare and Medicaid
programs. The new classification enables the device and procedure
to be reimbursed in the current COSIRA-II clinical trial single arm
registry and upon potential commercial approval in the United
States. The randomized arm of the COSIRA-II clinical trial
previously received reimbursement approval in the United States
under a dedicated HCPCS code (C9783).
“Today’s news is another important step in
securing coding, coverage, and payment for the Reducer in the
United States. We now have adequate reimbursement for the Reducer,
in the CMS population, for both inpatient and outpatient
procedures, both during the COSIRA-II Clinical Trial, and upon
potential commercialization in the United States,” stated Neovasc
President and Chief Executive Officer Fred Colen. “Our
reimbursement journey has been remarkably successful around the
world. We are beginning to see broader adoption in markets where we
have successfully obtained reimbursement and look forward
to continued rapid growth and commercial expansion.”
Neovasc began a comprehensive reimbursement
program in 2019 to establish all the necessary components for
diagnosis and treatment of refractory angina in the United States.
The Company has worked tirelessly with its physician advisors,
consultants, CMS, the American Medical Association, and multiple
cardiology societies to secure all the necessary approvals and
codes for the diagnosis of refractory angina and the implantation
of the Reducer in both inpatient and outpatient settings.
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.
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, and it is being studied
in the COSIRA-II Clinical Trial. Breakthrough 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 under clinical
investigation in the United States and has been commercially
available in Europe since 2015, and Tiara™, a product under
clinical investigation for the transcatheter treatment of mitral
valve disease. The company remains committed to the ongoing
follow-up of patients in Tiara clinical trials and has paused all
other Tiara activities. For more information
visit: www.neovasc.com.
InvestorsMike CavanaughICR WestwickePhone:
+1.646.877.9641Mike.Cavanaugh@westwicke.com
MediaSean LeousICR WestwickePhone:
+1.646.866.4012 Sean.Leous@westwicke.com
Forward-Looking Statement DisclaimerCertain
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 contained in the news
release may involve, but are not limited to, statements regarding
the aims and objectives of the Reducer study, the nature and
implications of the results of the Reducer study, the potential
commercialization of the Reducer in the United States, the broader
adoption of reimbursements, the growing incidence of refractory
angina, the growth of the cardiovascular marketplace, the Company’s
beliefs with respect to the best use of its cash and workforce
resources, the Company assessment of the potential size of the
ANOCA market and the early timing of treatment when compared
to the current target market, the Company’s plans to continue work
on its mitral and tricuspid valve intellectual property portfolio
and commitment to Tiara patient surveillance and clinical trial
follow-up and the growing cardiovascular marketplace.
Forward-looking statements are based on estimates and assumptions
made by the Company in light of its experience and its perception
of historical trends, current conditions and expected future
developments, as well as other factors that the Company believes
are appropriate in the circumstances. 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, risks around the Company's ability to continue as a
going concern; risks around the Company's history of losses and
significant accumulated deficit; risks related to the 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 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, 2021 and 2020
but not at December 31, 2019; risks relating to the Common Share
price being volatile; risks relating to the Company's significant
indebtedness, and its effect on the Company's financial condition;
risks relating to the influence of significant shareholders of the
Company over our business operations and share price; 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; 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; risks relating
to future issuances of equity securities by the Company, or sales
of common shares or conversions of convertible notes, and exercise
of warrants, options and restricted stock units by our existing
security holders, causing the price of the Company's securities to
fall; 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 Report on Form 20-F for the year ended
December 31, 2021 and the Company's Management Discussion and
Analysis for the three and six months ended June 30, 2022 (a copy
of which may be obtained at 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 (copies of which may be obtained
at www.sedar.com or www.sec.gov), whether because of
new information, future events or otherwise, except as required by
law.
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