Neovasc Announces Submission of COSIRA-II Protocol Supplement to FDA
August 17 2021 - 9:05AM
via NewMediaWire -- Neovasc Inc. (“Neovasc” or the
“Company”) (Nasdaq, TSX: NVCN) announced today that it has
filed a supplement to the COSIRA-II Investigational Device
Exemption (IDE) Study with the U.S. Food and Drug Administration
(FDA). Following multiple productive discussions with FDA
over the past several months, the protocol for the previously
approved COSIRA-II study has been supplemented in consideration of
additional experience and key questions arising from the October
2020 Circulatory Systems Devices Panel Meeting regarding the
Neovasc Reducer™ (“Reducer”).
COSIRA-II is a randomized, sham-controlled trial
investigating the safety and effectiveness of the Reducer for
patients suffering from refractory angina. The proposed primary
endpoint of the trial is change in exercise tolerance testing time
via a modified Bruce protocol between baseline and 6-month
follow-up. The study is planned to enroll approximately 380
patients at up to 50 sites primarily in the United States. The
trial will include patients with Canadian Cardiovascular Society
(CCS) Class III-IV refractory angina on maximally tolerated medical
therapy without further options for revascularization via coronary
intervention or bypass grafting. The principal investigators of the
trial are Gregg Stone, M.D., Mt. Sinai Health System, New York, NY
and Tim Henry, M.D., Christ Hospital, Cincinnati, OH.
According to literature, COSIRA-II will be the
largest sham-controlled device trial in the history of coronary
artery disease studies.(1) “Submission of the IDE Supplement is an
important step as we work towards commencing the trial this year.
Our intention is to run a definitive trial that will provide the
clinical evidence to answer the outstanding questions from the
FDA,” commented Lisa Becker, Vice President of Regulatory Affairs,
Global Angina Therapies, at Neovasc. “The input from the COSIRA-II
Executive Steering Committee as well as the discussions with FDA
have been instrumental in our efforts to initiate and advance this
trial.”
About Reducer
The Reducer is CE-marked in the European Union and
Under Investigation in the United States 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 that is similar to implanting a coronary stent
and can be completed in approximately 20
minutes.
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.
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. The Company is a leader in the
development of minimally invasive transcatheter mitral valve
replacement technologies, and minimally invasive devices for the
treatment of refractory angina. Its products include the Neovasc
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 Tiara™, for the
transcatheter treatment of mitral valve disease, which is currently
under clinical investigation in the United States, Canada, Israel,
and Europe. For more information, visit: www.neovasc.com.
Forward-Looking Statement Disclaimer
Certain 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 may involve, but are not limited to, the planned details
of the COSIRA-II study and the expected timing thereof, the
Company’s intention to run a definitive trial that will provide
clinical evidence to answer the outstanding questions from the FDA
and the growing cardiovascular marketplace. 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 doubt about the Company's ability to continue as a
going concern; risks related to the recent 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 (the "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, 2020
but not at December 31, 2019 and 2018; risks relating to the Common
Share price being volatile; risks relating to the possibility that
the 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 significant indebtedness, and its effect on the
Company's financial condition; 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; 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 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; 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 Information Form and in
the Management's Discussion and Analysis for the three and six
months ended June 30, 2021 (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)Lauder et al, European Heart Journal (2020) 41,
2556–2569
Investors
Mike Cavanaugh
Westwicke/ICR
Phone: +1.646.877.9641
Mike.Cavanaugh@westwicke.com
Media
Sean Leous
Westwicke/ICR
Phone: +1.646.866.4012
Sean.Leous@westwicke.com
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