NASDAQ, TSX: NVCN
VANCOUVER, June 16, 2017 /CNW/ - Neovasc Inc.
("Neovasc" or the "Company") (NASDAQ, TSX: NVCN)
reported today that the District Court in Munich, Germany has partially found in favour
of Edwards Lifesciences Corporation (formerly CardiAQ Valve
Technologies Inc.) ("CardiAQ"), in its case against Neovasc.
In this case, CardiAQ had claimed ownership rights to one of
Neovasc's European patent applications for its Tiara™ mitral valve
replacement technology. The German court found CardiAQ had
contributed in part to the invention of the Tiara™ and awarded to
CardiAQ co-entitlement rights to the disputed Tiara™ European
patent application. There are no monetary awards associated
with this matter. Neovasc intends to appeal this
decision.
In a related matter, Neovasc is currently appealing the 2016
decision from the U.S District Court for the District of
Massachusetts which among other
things granted co-inventorship rights to CardiAQ on one of
Neovasc's granted U.S. patent applications. This appeal is
now before the United States Court
of Appeals for the Federal Circuit in Washington D.C. An
expedited appeal schedule has been set with all the briefings from
both parties now submitted. The Company expects oral argument on
its appeal in August 2017 and a
ruling is expected to follow, prior to the end of 2017.
Pending the outcome of the U.S. Court of Appeals, Neovasc, in
consultation with its European and North American legal advisors,
will vigorously defend its position that the case in Germany is without merit and will explore all
options regarding the appellate process.
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, including the Company's intention to appeal the German
court decision to higher German courts, the timing of the oral
hearing at the United States Court
of Appeals and the timing of a decision from the United States Court of Appeals. Words and
phrases such as "intends", "expects", 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.