NASDAQ, TSX: NVCN
VANCOUVER, Oct. 10, 2018 /CNW/ - Neovasc Inc. ("Neovasc" or
the "Company") (NASDAQ: NVCN) (TSX: NVCN), a leader in the
development of minimally invasive transcatheter mitral valve
replacement technologies and in the development of minimally
invasive devices for the treatment of refractory angina, today
announced that the U.S. Food and Drug Administration (the "FDA")
has granted Breakthrough Device designation to the Neovasc Reducer™
(the "Reducer"), a medical device for the treatment of refractory
angina, which is not currently approved for commercial sale in the
U.S.
The FDA grants Breakthrough Device designation in order to
expedite the development and review of a device that demonstrates
compelling potential to provide a more effective treatment or
diagnosis for life-threatening or irreversibly debilitating
diseases. To qualify as a Breakthrough Device, there must either be
no FDA approved treatments presently available, or the technology
must offer significant advantages over existing approved
alternatives.
"We are pleased that the FDA has approved our request for
Breakthrough Device designation for the Reducer. We will now start
a process of further discussions and filings with the FDA, to
obtain further guidance as to the regulatory pathway for entrance
into the U.S. market. This designation supports our belief that
this technology offers a significant benefit to patients suffering
from refractory angina," commented Fred
Colen, Neovasc's President and Chief Executive Officer. "We
look forward to working closely with FDA through this regulatory
process."
Refractory angina, resulting in continued symptoms despite
maximal available 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.1
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 in the heart's
circulatory system, thereby 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.
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 the 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 the Tiara™, for the transcatheter treatment of mitral valve
disease, which is currently under clinical investigation in
the United States, Canada and Europe. For more information, visit:
www.neovasc.com.
This news release contains forward-looking statements within the
meaning of the U.S. Private Securities Litigation Reform Act of
1995 and applicable Canadian securities laws regarding the
Company's plans and expectations concerning the regulatory pathway
for the Reducer's potential entrance into the U.S. market,
including the process for securing FDA approval of the Reducer, the
growing incidence of refractory angina in the U.S. and individuals
suffering from the condition being identified as patients for the
Reducer, and the rapid growth of the cardiovascular marketplace.
Words and phrases such as "in order to", "potential", "will",
"belief", "look forward", "new" and "growing", and similar words or
expressions, are intended to identify these forward-looking
statements. 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, the substantial doubt about the Company's ability to
continue as a going concern; risks relating to the warrants (the
"Warrants") and senior secured convertible notes (the "Notes")
issued pursuant to the November 2017
underwritten public offering and concurrent private placement
(together, the "2017 Financings"), resulting in significant
dilution to the Company's shareholders; risks relating to the
Company's need for significant additional future capital and the
Company's ability to raise additional funding; risks relating to
cashless exercise and adjustment provisions in the Warrants and
Notes issued pursuant to the 2017 Financings, which could make it
more difficult and expensive for the Company to raise additional
capital in the future and result in further dilution to investors;
risks relating to the sale of a significant number of common shares
of the Company; risks relating to the exercise of Warrants or
conversion of Notes issued pursuant to the 2017 Financings, which
may encourage short sales by third parties; risks relating to the
possibility that the Company's common shares may be delisted from
the Nasdaq Capital Market or the Toronto Stock Exchange, which
could affect their market price and liquidity; risks relating to
the Company's common share price being volatile; risks relating to
the influence of significant shareholders of the Company over the
Company's business operations and share price; risks relating to
the Company's significant indebtedness, and its effect on the
Company's financial condition; risks relating to claims by third
parties alleging infringement of their intellectual property
rights; 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; 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 of
the Company's 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; 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 associated with the extensive
regulation of the Company's products and trials by governmental
authorities, as well as the cost and time delays associated
therewith; risks associated with post-market regulation of the
Company's products; health and safety risks associated with the
Company's products and industry; risks associated with 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; risk 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 breaches of
anti-bribery laws by the Company's employees or agents; risks
associated with 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;
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 associated with 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 the
Company's ability to successfully enter into fundamental
transactions as defined in the Series C warrants issued pursuant to
the 2017 Financings; 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; and
risks relating to conflicts of interests among the Company's
officers and directors as a result of their involvement with other
issuers. 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 and in Management's Discussion
and Analysis for the quarter ended June 30,
2018 (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.
1T. J.
Povsic, S. Broderick, K. J. Anstrom et al., "Predictors of
long‐term clinical endpoints in patients with refractory angina,"
Journal of the American Heart Association, vol. 4, no. 2, article
e001287, 2015.
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SOURCE Neovasc Inc.