Securities
and Exchange Commission
w
ashington,
D.C. 20549
FORM 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For the month of
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March
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2019
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Commission File Number
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001-36458
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Neovasc
Inc.
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(Translation of registrant’s name into English)
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Suite 5138 - 13562 Maycrest Way
Richmond, British Columbia, Canada, V6V 2J7
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(Address of principal executive offices)
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Indicate by check mark whether the registrant
files or will file annual reports under cover of Form 20-F or Form 40-F:
Indicate by check mark if the registrant is
submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
DOCUMENTS INCLUDED AS PART OF THIS REPORT
Document
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Document 1
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News Release dated March 21, 2019 - Neovasc Wins German Court Appeal; Announces German Court's Decision to Dismiss CardiAQ's Claim to Co-inventorship of a European
Patent for Tiara™
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DOCUMENT 1
Neovasc Wins German Court Appeal; Announces
German Court's Decision to Dismiss CardiAQ's Claim to Co-inventorship of a European Patent for Tiara™
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 Conformite Europeenne 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.
View
original content:http://www.prnewswire.com/news-releases/neovasc-wins-german-court-appeal-announces-german-courts-decision-to-dismiss-cardiaqs-claim-to-co-inventorship-of-a-european-patent-for-tiara-300816340.html
SOURCE Neovasc Inc.
View original content: http://www.newswire.ca/en/releases/archive/March2019/21/c0937.html
%CIK: 0001399708
For further information:
Chris Clark, Chief Financial Officer,
Neovasc Inc., 604 248-4138, cclark@neovasc.com; Jeremy Feffer, LifeSci Advisors, LLC, 212-915-2568, jeremy@lifesciadvisors.com
CO: Neovasc Inc.
CNW 07:50e 21-MAR-19
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly
authorized.
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Neovasc
Inc.
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(Registrant)
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Date:
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March 21, 2019
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By:
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/s/
Chris Clark
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Name: Chris Clark
Title: Chief
Financial Officer
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