via NewMediaWire – Neovasc, Inc. ("Neovasc" or the "Company")
(NASDAQ, TSX: NVCN) today announced the United States Food and Drug
Administration (“FDA”) has approved a protocol supplement to the
COSIRA-II Investigational Device Exemption (“IDE”) Trial. The
approval expands the number of patients eligible for treatment in
the trial and adds two previously planned imaging sub-studies
designed to provide insights into the safety and mechanism of
action of the Neovasc Reducer™ (“Reducer”). The timing of the
approval is ahead of the Company’s internal target and will allow
for additional patients to be treated.
The newly approved supplement adds a single, non-randomized arm
to the existing protocol that allows enrollment of patients who are
believed to benefit from Reducer implantation to reduce their
angina symptoms, but who do not otherwise qualify for the
randomized arm. These patients are well defined within the protocol
and include patients with non-obstructive coronary artery disease
who were previously ineligible for treatment. In addition, the
expansion allows patients with predominantly right-sided ischemia,
and those unable to perform a treadmill test due to amputation, to
be included. All patients in the newly approved arm will receive a
Reducer device per protocol. The two imaging sub-studies, utilizing
Computed Tomography (CT) and Positron Emission Tomography (PET),
aim to provide further support for the Reducer’s safety profile and
mechanism of action.
There are over two million angiograms performed per year in the
United States, most of which are performed on patients with angina.
Nearly 40% of patients receiving angiograms do not have obstructive
coronary artery disease. While approximately 35% of patients with
obstructive coronary disease are women, the percentage of patients
with non-obstructive disease that are women approaches 55%.1 The
newly added arm in the COSIRA-II study provides an opportunity to
study the Reducer in the non-obstructive population.
“Today’s news is a big win for patients suffering from
refractory angina,” National Co-principal Investigator Tim Henry,
M.D., Christ Hospital, Cincinnati, commented. “I’m pleased that
these specific patients previously ineligible for the Trial will
now be able to be treated with the Reducer. The PET and CT
sub-studies will give us important insights into the mechanism of
action and safety of the Reducer, and the addition of patients with
non-obstructive coronary disease will enable us to treat a much
broader patient population.”
COSIRA-II is a randomized, double-blind, placebo-controlled
trial investigating the safety and effectiveness of the Reducer for
patients suffering from refractory angina. The primary endpoint of
the trial is change in exercise tolerance testing time via a
modified Bruce protocol between baseline and six-month follow-up.
The study is planned to randomize 380 patients at up to 50 sites in
the United States and Canada and the primary study analysis will
still be performed on the randomized population. The newly added
arm allows for up to 270 additional patients. There is no change to
the sample size in the original randomized arm and Neovasc still
expects to complete enrollment on schedule by the end of 2023.
“FDA approval of this IDE Supplement is another important
milestone for Neovasc and for patients suffering from angina,”
commented Lisa Becker, Neovasc Vice President of Regulatory
Affairs. “We are particularly encouraged to investigate the Reducer
in a population that disproportionately affects women. We
appreciate the collaboration and rigor of FDA in the advancement of
this important addition to the COSIRA-II trial.”
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. Reducer is
investigational in the United States in the COSIRA-II clinical
trial. Refractory angina, resulting in continued symptoms despite
maximal medical therapy and without revascularization options,
affects millions of patients worldwide, who typically lead severely
restricted lives because of their disabling symptoms. The Reducer
is designed to alter blood flow within the myocardium of the heart
and increase the perfusion of oxygenated blood to ischemic areas of
the heart muscle, which may provide relief of angina symptoms.
About Neovasc Inc.
Neovasc is a specialty medical device company that develops and
markets products for the rapidly growing cardiovascular
marketplace. Its products include 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.
1 Patel et al, N Engl J Med 2010; 362:886-895
InvestorsMike CavanaughICR WestwickePhone:
+1.646.877.9641Mike.Cavanaugh@westwicke.com
MediaSean LeousICR WestwickePhone:
+1.646.866.4012Sean.Leous@westwicke.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 aim of the
COSIRA-II sub-studies to provide further support for the Reducer’s
safety profile and mechanism of action, the opportunity the
COSIRA-II sub-studies provide to study the Reducer in women with
non-obstructive disease, the anticipated procedures and timelines
of the COSIRA-II study and the growing cardiovascular marketplace.
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,
risks around the Company's ability to continue as a going concern;
risks around the Company's history of losses and significant
accumulated deficit; risks related to the 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 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, 2021 and 2020 but not
at December 31, 2019; risks relating to the Common Share price
being volatile; risks relating to the Company's significant
indebtedness, and its effect on the Company's financial condition;
risks relating to the influence of significant shareholders of the
Company over our business operations and share price; 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; 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; risks relating
to future issuances of equity securities by the Company, or sales
of common shares or conversions of convertible notes, and exercise
of warrants, options and restricted stock units by our existing
security holders, causing the price of the Company's securities to
fall; 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 Report on Form 20-F for the year ended
December 31, 2021 and the Company’s Management Discussion and
Analysis for the three months ended March 31, 2022 (a copy of which
may be obtained at 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 (copies of which may be obtained at www.sedar.com or
www.sec.gov), whether because of new information, future events or
otherwise, except as required by law.
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