NASDAQ, TSX: NVCN
VANCOUVER, March 21, 2019 /CNW/ - Neovasc Inc. ("Neovasc" or
the "Company") (NASDAQ: NVCN)(TSX: NVCN), a leader in the
development of minimally invasive transcatheter mitral valve
replacement technologies and in the development of minimally
invasive devices for the treatment of refractory angina, today
announced that the Higher Regional Court in Munich, Germany, on appeal by Neovasc, has
dismissed the case in full, brought by Edwards Lifesciences
CardiAQ LLC ("CardiAQ") against Neovasc in Germany. In this case, CardiAQ had originally
claimed full ownership rights to one of Neovasc's European patent
applications for its Tiara™ ("Tiara"). In June, 2017, the
first-instance court in Munich had
awarded co-ownership rights to CardiAQ. Both parties had appealed
this decision. CardiAQ withdrew its appeal for full ownership
during the course of the appeal. In dismissing the remainder of
CardiAQ's case, the German court now found that CardiAQ had not
contributed to the invention of the Tiara and found Neovasc to be
the rightful inventor and owner of all rights to the disputed Tiara
European patent application.
"We are pleased that after full consideration of the evidence,
the German courts have now recognized that CardiAQ made no
contribution to the invention or development of the Tiara," stated
Fred Colen, CEO of Neovasc. "With
this decision, which we strongly believe would be confirmed, even
if appealed to and accepted as a case by the German Supreme Court,
Neovasc is free to pursue its European patent application and has
the sole right to commercialize the Tiara in Europe and help treat patients suffering from
debilitating mitral valve disease. We will continue to vigorously
defend our intellectual property against any attempts by third
parties to infringe on these rights."
For further details, please see the Material Change Report filed
by the Company on SEDAR and furnished to the SEC on EDGAR under
Form 6-K.
About Tiara
Tiara is a self-expanding mitral
bioprosthesis specifically designed to treat mitral valve
regurgitation (MR) by replacing the diseased valve. Conventional
surgical treatments are only appropriate for about half of MR
patients, who number an estimated four million in the U.S. with a
similar number of patients affected throughout Europe. Tiara is implanted in the heart using
a minimally invasive, transapical transcatheter approach without
the need for open-heart surgery or use of a cardiac bypass
machine.
The Tiara valve is currently being evaluated in 2 ongoing
clinical trials: TIARA-I—an early feasibility trial in the United States, Canada, and Belgium—and TIARA-II—a European
Conformité Européenne Mark Trial in
Germany, Italy, and the United Kingdom. In addition, patients have
also been treated under compassionate programs in Canada, Italy, Germany, Israel, and Switzerland.
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 Reducer, for the treatment of refractory angina, which
is not currently commercially available in the United States and has been commercially
available in Europe since 2015,
and the Tiara, for the transcatheter treatment of mitral valve
disease, which is currently under clinical investigation in
the United States, Canada and Europe. 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 rapidly
growing cardiovascular marketplace. Words and phrases such as
"continue", "strategy", "goal", "would", "may", "could", "should",
"expect" 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, the substantial doubt
about the Company's ability to continue as a going concern; risks
relating to senior secured convertible notes (the "Notes") issued
pursuant to the November 2017 private
placement (the "2017 Financing"), resulting in significant dilution
to the Company's shareholders; risks relating to the Company's need
for significant additional future capital and the Company's ability
to raise additional funding; risks relating to cashless exercise
and adjustment provisions in the Notes issued pursuant to the 2017
Financing, which could make it more difficult and expensive for the
Company to raise additional capital in the future and result in
further dilution to investors; risks relating to the sale of a
significant number of common shares of the Company; risks relating
to the conversion of Notes issued pursuant to the 2017 Financing,
which may encourage short sales by third parties; risks relating to
the possibility that the Company's common shares may be delisted
from the Nasdaq Capital Market or the Toronto Stock Exchange, which
could affect their market price and liquidity; risks relating to
the Company's common share price being volatile; risks relating to
the influence of significant shareholders of the Company over the
Company's business operations and share price; risks relating to
the Company's significant indebtedness, and its effect on the
Company's financial condition; risks relating to claims by third
parties alleging infringement of their intellectual property
rights; risks relating to lawsuits that the Company is subject to,
which could divert the Company's resources and result in the
payment of significant damages and other remedies; 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 use of
the Company's products in unapproved circumstances, which could
expose the Company to liabilities; risks relating to competition in
the medical device industry, including the risk that one or more of
the Company's 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 its 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 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 the Company's dependence on limited
products for substantially all of the Company's current revenues;
risks relating to the Company's exposure to adverse movements in
foreign currency exchange rates; risks relating to the possibility
that the Company could lose its foreign private issuer status under
U.S. federal securities laws; 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; risks relating to the Company's
dependence upon key personnel to achieve its 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; risks relating to 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; and risks relating to conflicts of interests among
the Company's officers and directors as a result of their
involvement with other issuers. These risk factors and others
relating to the Company are discussed in greater detail in the
"Risk Factors" section of the Company's Annual Report on Form 20-F
and in Management's Discussion and Analysis for the quarter ended
September 30, 2018 (copies of which
may be obtained at www.sedar.com or www.sec.gov). The Company has
no intention and undertakes no obligation to update or revise any
forward-looking statements beyond required periodic filings with
securities regulators, whether as a result of new information,
future events or otherwise, except as required by law.
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SOURCE Neovasc Inc.