NASDAQ, TSX: NVCN
VANCOUVER, Nov. 6, 2017 /PRNewswire/ - Neovasc Inc.
("Neovasc" or the "Company") (NASDAQ, TSX: NVCN)
announced that it has received approval of the U.S. Food and Drug
Administration ("FDA") to initiate the COSIRA-II IDE pivotal
clinical trial. The trial's purpose will be to demonstrate
the safety and effectiveness of the Company's novel Reducer system
for treatment of patients with refractory angina. Once completed,
the trial data is intended to support an application to the FDA for
approval to begin marketing Reducer in the United States.
Refractory angina is a common and disabling clinical condition,
and a major public health problem, which affects patients' quality
of life, and has a significant impact upon health care
resources.
"Since its commercial launch in Europe two years ago, Reducer has consistently
provided relief of severe symptoms in patients suffering from
refractory angina, resulting in significant improvements in their
quality of life," commented Neovasc CEO, Alexei Marko. "We are eager to replicate our
European clinical and commercial success in the United States, by introducing this
important new therapy for patients who have no other option for
managing their chronic, severe chest pain."
COSIRA-II will be a 380 patient, multicenter, randomized (1:1
ratio), double blinded, sham-controlled clinical trial with up to
35 investigational centers across North America. The
COSIRA-II trial design is very similar to the COSIRA study, a 104
patient study previously conducted in Europe and Canada. The positive results
of that study were published in the New England Journal of
Medicine, February 2015.
Neovasc is currently evaluating start up timelines and funding
options for the COSIRA-II trial.
About the Neovasc 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 can provide 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 Neovasc Reducer™, for the treatment of refractory
angina which is not currently available in the United States and has been available in
Europe since 2015 and the Tiara™,
for the transcatheter treatment of mitral valve disease, which is
currently under investigation in the
United States, Canada and
Europe. The Company also sells a
line of advanced biological tissue products that are used as key
components in third-party medical products including transcatheter
heart valves. 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 regarding the initiation and
timeline of the COSIRA-II clinical trial to demonstrate the safety
and effectiveness of the Reducer system, the size of the trial and
the results of the data from such trial. Words and phrases such as
"intended", 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, risks relating to the Company's litigation with
CardiAQ, including the Company's ability to successfully appeal the
validity of the awards as well as the ruling on inventorship, which
create material uncertainty and which cast substantial doubt on the
Company's ability to continue as a going concern; the substantial
doubt about the Company's ability to continue as a going concern;
risks relating to the Company's need for significant additional
future capital and the Company's ability to raise additional
funding; risks relating to claims by third parties alleging
infringement of their intellectual property rights; 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
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 the Company's 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 the Company's 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 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;
the Company's dependence upon key personnel to achieve the
Company's 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;
the Company's ability to successfully identify and complete
corporate transactions on favorable terms or achieve anticipated
synergies relating to any acquisitions or alliances; 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; 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 the
influence of significant shareholders of the Company over the
Company's business operations and share price. 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 Company's Management's Discussion and
Analysis of Financial Condition and Results of Operations (copies
of which filings may be obtained at www.sedar.com or www.sec.gov,
each of which are included in the Company's Annual Report on Form
40-F). These factors should be considered carefully, and
readers should not place undue reliance on the Company's
forward-looking statements. The Company has no intention and
undertakes no obligation to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise, except as required by law.
SOURCE Neovasc Inc.