NASDAQ, TSX: NVCN
VANCOUVER, Sept. 1, 2017 /CNW/ - 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("Neovasc" or the "Company") (NASDAQ, TSX: NVCN) reported today, in a non-precedential opinion, a panel of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.
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