Report of Foreign Issuer (6-k)
June 16 2017 - 11:24AM
Edgar (US Regulatory)
SECURITIES AND EXCHANGE COMMISSION
Washington, 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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June
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2017
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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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1
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News
Release dated June 16, 2017 - Neovasc Announces German Court Ruling
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Document 1
Neovasc Announces German Court Ruling
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.
View original content: http://www.newswire.ca/en/releases/archive/June2017/16/c5768.html
%CIK: 0001399708
For further information:
Investor Relations: Neovasc Inc.,
Chris Clark, 604 248-4138, cclark@neovasc.com
CO: Neovasc Inc.
CNW 10:44e 16-JUN-17
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:
June 16, 2017
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By:
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/s/
Chris Clark
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Name:
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Chris Clark
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Title:
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Chief Financial Officer
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