NASDAQ, TSX: NVCN
VANCOUVER, Sept. 1, 2017 /PRNewswire/ - Neovasc
Inc. ("Neovasc" or the "Company") (NASDAQ, TSX: NVCN)
reported today, in a non-precedential opinion, a panel of
the United States Court of Appeals
for the Federal Circuit affirmed the judgment of the United States
District Court for the District of Massachusetts in the case of CardiAQ Valve
Tech., Inc. v. Neovasc Inc. The panel also affirmed the
district court's decision not to enjoin Neovasc's Tiara™
program.
In summary, if the judgement is not altered through additional
appellate proceedings, Neovasc must pay the full judgement of
approximately US$112 million, of
which approximately US$70 million is
already held in an escrow account. There are no other
monetary damages arising from this award; and Neovasc remains the
joint inventor of the '964 patent, one of the patents in the Tiara™
patent family, along with two employees of CardiAQ Valve
Technologies, Inc., both parties having freedom to use the patent
without an obligation to pay royalties to the other.
Neovasc is presently considering whether to pursue further
appellate review of the panel's decisions on the other issues
presented by the judgment and will continue to evaluate all other
options.
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 concerning its litigation with
CardiAQ. Words and phrases such as "intends", "expects",
"considering", "continue", 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.