Announcement Made at European Society of
Cardiology Congress 2019 in Paris,
France
NASDAQ, TSX: NVCN
VANCOUVER, Sept. 3, 2019 /CNW/ - Neovasc, Inc. ("Neovasc" or
the "Company") (NASDAQ, 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 its
Neovasc Reducer™ (the "Reducer") for the treatment of patients
suffering from refractory angina has been added to the European
Society of Cardiology (ESC) Practice Guidelines. The ESC now
recommends that the Reducer might be considered for the treatment
of patients with angina, refractory to medical and interventional
therapies. The announcement was made at the ESC Congress 2019 in
Paris, France.
ESC Guidelines summarize and evaluate all available scientific
evidence with the aim of assisting physicians in selecting the best
evidence-based therapies and management strategies for an
individual patient with a given condition. This set of
recommendations takes into account the impact on outcomes, as well
as the risk-benefit ratio of a particular diagnosis or therapy, as
reflected in the available scientific data. ESC Guidelines
represent the official position of the European Society of
Cardiology on a given topic and are regularly updated.
"We are honored that our Reducer has been added to the
Guidelines of the ESC, one of the most prestigious and influential
cardiology-related organizations in the world," said Professor
Shmuel Banai, M.D., Medical Director
of Neovasc. "The addition of the Reducer to the ESC Guidelines is a
reflection of the substantial amount of high-quality clinical
evidence published to date in scientific medical literature
supporting the safety and efficacy of the Reducer in treating
refractory angina and improving quality of life for patients.
We are also pleased with the significant place that microvascular
angina is taking in the ESC Guidelines and believe that this is
indicative of the unmet need for patients suffering from angina
without obstructive coronary artery disease."
"We are very excited that, for the first time, the ESC has
expressed its clear support for our therapy, and view this as a
significant milestone for our Reducer program for the treatment of
patients with refractory angina," said Fred
Colen, CEO of Neovasc. "This ESC recommendation is an
important step towards the establishment of the Reducer as a
standard of care for the treatment of patients with refractory
angina. The ESC recommendation represents critical
third-party validation regarding the potential of the Reducer to
safely and effectively treat patients with refractory angina.
We are confident that our Reducer therapy represents one of the
most promising alternatives for patients with refractory
angina."
Importantly, the Reducer was the only non-pharmaceutical
treatment included in the "Major New Recommendations" section of
the 2019 ESC Guidelines. In addition, the Reducer enters the
ESC Guidelines at the highest recommendation class for therapies
addressing refractory angina.
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.
While the Reducer is not approved for commercial use in
the USA, the FDA granted Breakthrough Device designation to
the Neovasc 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 for 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.1
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.
Forward-Looking Statement Disclaimer
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 beliefs as to clinical evidence
supporting the safety and efficacy of the Reducer, the
establishment of the Reducer as a standard of care for the
treatment of refractory angina, the potential pathways and
timelines to accessing the U.S. market with respect to the Reducer,
the growing incidence of refractory angina and the rapidly growing
cardiovascular marketplace. Words and phrases such as "continue",
"strategy", "goal", "would", "may", "could", "should", "expect" and
"will", 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 senior secured convertible notes (the "Notes")
issued pursuant to the November 2017 private placement
(together, the "2017 Financing"), 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 Notes issued pursuant to the 2017
Financing, 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 conversion of Notes issued pursuant to the 2017 Financing,
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 conclusion that it did not have effective internal
control over financial reporting as at December 31, 2018;
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 Notes issued pursuant to the 2017 Financing; 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 three and six
months ended June 30, 2019 (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.
1
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T. 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.