NASDAQ, TSX: NVCN
VANCOUVER, Oct. 3, 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 positive 12-week follow-up data from the first U.S.
patient implanted with a Neovasc Reducer™ (the "Reducer"), a
CE-Marked medical device for the treatment of refractory angina.
The Compassionate Use case was conducted in June 2018.
The treating physicians have reported that prior to the
patient's procedure in June, he told his doctors he could walk
about two blocks before experiencing angina, which he rated a 7-8
out of 10 on a pain scale. He also used nitroglycerin two to three
times per week to alleviate symptoms. At an August 12, 2018 follow-up appointment 12 weeks
after the procedure, he reported walking several miles without any
symptoms and taking nitroglycerin one or two times per month. He
said he was rarely experiencing chest discomfort, and any chest
pain was rated at a 3-4 out of 10.
"The positive 12-week follow-up report provided on our first
U.S. patient implanted with a Reducer under compassionate
use is in line with the results from our clinical studies and
the general European experience, as expressed in other medical
publications. We are pleased that this patient was able to
benefit from the Reducer therapy and is able to resume a more
active and more normal life, with much less pain and discomfort,"
commented Fred Colen, Neovasc's President and Chief
Executive Officer.
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 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 growing
incidence of refractory angina and the growth of the cardiovascular
marketplace. Words and phrases such as "continue", "strategy",
"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 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.
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.