via NewMediaWire -- Neovasc Inc. (“Neovasc” or the “Company”)
(NASDAQ, TSX: NVCN) today announced
the publication of a case series in the
journal Cardiovascular Revascularization Medicine describing
successful uses of the Neovasc Reducer™ (“Reducer”) under a
compassionate use protocol in the United States. The patients
were treated under the care of Ryan Gindi, M.D., and the procedures
were performed by Gerald Koenig, M.D., Ph.D, both from the Division
of Cardiology, Henry Ford Hospital, Detroit. Following the
commencement of the COSIRA-II Trial in the United States,
qualifying patients are now eligible to be treated in a clinical
trial for the device.
“We are pleased to publish the one-year outcomes of the first
two patients treated with the Reducer device in the United States,”
stated Dr. Gindi. “As a clinical cardiologist in a large
metropolitan practice, I am confronted with the challenges of
treating patients with refractory angina every day. It’s gratifying
to see the positive impact the Reducer device has had on our
patients.”
The first patient treated with the Reducer is a 59-year-old male
with diabetes suffering from severe coronary artery disease and
debilitating refractory angina. The patient had a history of
multiple stenting procedures, radiation therapy to treat blocked
stents, and extensive medications to treat his chest pain. Despite
all efforts to alleviate his anginal symptoms, he lived a
significantly restricted lifestyle because of his chest pain. After
implantation of the Reducer device, the patient became largely
asymptomatic and did not require any further interventional
therapy. He described walking several miles around Washington, D.C.
without angina.
The second patient is another 59-year-old male with an extensive
history of coronary artery disease who previously suffered multiple
heart attacks, underwent coronary artery bypass surgery and had
multiple stenting procedures to control his symptoms. Despite all
efforts and extensive medications, he remained severely restricted
by his angina, and was subsequently treated with the Reducer
device. A year following the procedure, he described being able to
ride a bicycle 35 miles on hilly terrain without angina.
“It’s encouraging to see such positive results on the first two
patients treated with the Reducer in the United States," said Dr.
Koenig. “I have seen first-hand the positive impact that it
can have on patients, and we are excited to participate in the
COSIRA-II clinical trial at Henry Ford Hospital.”
COSIRA-II is a clinical trial designed to evaluate the
safety and effectiveness of the Reducer in treating patients
suffering from refractory angina. The randomized, double blinded,
placebo-controlled trial will enroll approximately 380 patients in
the United States and Canada at as many as 50 investigational
sites. The primary endpoint of the trial is the change in exercise
tolerance testing time measured at six months via a treadmill
test.
“Now that the COSIRA-II clinical study is underway, we have the
opportunity to bring the Reducer therapy to patients suffering from
refractory angina in the United States,” commented Fred Colen,
Chief Executive Officer at Neovasc. “It is rewarding to see such
positive results on the early US patients treated under
compassionate use.”
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. 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.
While the Reducer is not approved for commercial use in the
United States, the FDA has granted Breakthrough Device designation
to the Reducer. This designation is granted by the FDA to
prioritize review of subsequent regulatory submissions for a device
that demonstrates compelling potential to provide a more effective
treatment of a life-threatening or irreversibly debilitating
disease, represents breakthrough technology for which no approved
alternatives exist or offers significant advantages over existing
alternatives, and the availability of which is in the best interest
of patients.
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. 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.
Contacts
Investors:
Mike Cavanaugh
ICR Westwicke
Phone: +1.617.877.9641
Email: Mike.Cavanaugh@westwicke.com
Media:
Sean Leous
ICR Westwicke
Phone: +1.646.866.4012
Email: Sean.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, potential benefits
of the Reducer, details of the COSIRA-II trails, the opportunity to
bring the Reducer therapy to patients suffering from refractory
angina in the United States, the growing incidence of refractory
angina 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 nine months ended September 30, 2021 (copies of
which may be obtained at 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. 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.
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