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.
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