NASDAQ, TSX: NVCN
VANCOUVER, Dec. 11, 2018 /PRNewswire/ - 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 Journal of the American College of Cardiology
("JACC") published new, peer reviewed Reducer data describing the
long-term clinical and anatomical follow-up of patients with severe
angina pectoris treated with the Neovasc Reducer™ (the "Reducer")
12 years ago. The publication is entitled: "First-in-Human
Use of Coronary Sinus Reducer in Patients With Refractory
Angina."
"This new data demonstrates the ultimate success of the Reducer
for the treatment of refractory angina, with proof of sustained
efficacy and complete safety for these patients 12 years after
implantation," commented Fred Colen,
Neovasc's President and Chief Executive Officer. "This data
demonstrates the long-term integrity, patency, and sustained
efficacy of the Reducer. As such, it will play an important
role in our effort to generate greater awareness for the Reducer as
we look to become the standard-of-care for patients suffering from
angina pectoris refractory to medical and interventional therapies
in Europe."
The publication is based on a prospective, non-randomized,
single-arm anatomic and clinical evaluation of patients who
underwent Reducer implantation at a single medical center as part
of the first-in-human clinical study1. Seven patients described in
the article were electively implanted with the Reducer in 2005. All
had chronic refractory angina and evidence of reversible myocardial
ischemia. At 12 years, all seven patients reported sustained
improvement of angina class compared with baseline status. The
primary outcome at 12 years was confirmation of the position,
integrity, and patency of the Reducers by computed tomography
angiography (CTA). CTA results were analyzed by the medical center
and an independent core laboratory.
The authors show that all 7 Reducers were patent 12 years
following implantation, with no signs of strut fractures,
dislocation, thrombosis, or migration, and with sustained
improvement in angina class at 6 months and 3 years, also
maintained at 12-year follow-up. They conclude that in patients
with chronic refractory angina, treatment with the Reducer presents
a reasonable, safe, and durable option for symptomatic relief and
improved quality of life.
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 U.S. Food and Drug
Administration (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.2
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 performance of and
commercial strategy for the Reducer, the growing incidence of
refractory angina and the rapidly growing cardiovascular
marketplace. Words and phrases such as "continue", "growing" 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 September 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
|
Banai S, Ben Muvhar
S, Parikh KH, et al. Coronary Sinus reducer stent for the treatment
of chronic refractory angina pectoris. A prospective,
open-label, multicenter, safety feasibility first-in-man study.
Journal of American College of Cardiology 2007;49:1783–9
|
2
|
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.