Report of Foreign Issuer (6-k)
June 17 2019 - 11:13AM
Edgar (US Regulatory)
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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June
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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 June 17, 2019 - Tiara™ Featured in Presentation at 11th Annual TVT 2019
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DOCUMENT 1
Tiara™ Featured in Presentation
at 11th Annual TVT 2019
NASDAQ, TSX: NVCN
VANCOUVER, June 17, 2019 /CNW/ - Neovasc Inc.
("Neovasc" or the "Company") (NASDAQ, 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 its Tiara™ ("Tiara") transcatheter mitral valve replacement device was featured in a presentation
at the 11th Annual Transcatheter Valve Therapy Conference ("TVT 2019"). TVT 2019 is part of The Structural Heart Disease
Summit held June 12-15 in Chicago, Illinois.
In a presentation titled "The TIARA Program:
Attributes, Challenges, and Early Clinical Data" Dr. Anson Cheung, Clinical Professor of Surgery and Director of Cardiac Transplant
of British Columbia, and Principal Investigator for the Tiara Early Feasibility Study at St Paul's Hospital, Vancouver Canada,
provided an update on the latest progress on the Tiara, including the challenging anatomical considerations, patient characteristics,
procedural outcomes, and symptom improvement of patients treated with Tiara.
"We are pleased to report yet another
comprehensive clinical update on our Tiara clinical studies to the Medical community, this time in the USA" commented Fred
Colen, Neovasc's President and Chief Executive Officer. "It continues to show solid progress, plus consistent and encouraging
clinical results. The transfemoral trans-septal Tiara system, as showcased at the Paris EuroPCR conference to invited Cardiologists
and Surgeons earned high marks for Neovasc's team after demonstrating complete understanding of the complex issues associated with
this delivery method and the implemented solutions to both the Tiara valve and the delivery system."
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 (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.
Forward-Looking Statement Disclaimer
Certain statements in this news release contain forward-looking statements within the meaning of the U.S. Private Securities
Litigation Reform Act of 1995 and applicable Canadian securities laws that may not be based on historical fact, including without
limitation statements containing the words "believe", "may", "plan", "will", "estimate",
"continue", "anticipate", "intend", "expect" and similar expressions. Forward-looking statements
may involve, but are not limited to, beliefs and expectations relating to the continued progress and clinical results of the Tiara
and the growing cardiovascular marketplace. 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 possibility that the Company's common shares may be delisted from the Nasdaq Capital Market or the Toronto
Stock Exchange, including Nasdaq's discretionary public interest authority to apply more stringent criteria for continued listing
or suspend or delist securities, which could affect their market price and liquidity; the substantial doubt about the Company's
ability to continue as a going concern; risks relating to the 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 the senior
secured convertible Notes issued pursuant to the 2017 Financing, which may encourage short sales by third parties; risks relating
to the Company's conclusion that it did not have effective internal control over financial reporting as at December 31, 2018; 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; risks relating to the Company's ability to successfully
enter into fundamental transactions as defined in the Notes issued pursuant to the 2017 Financings; 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 the Management's Discussion and Analysis for the three months ended
March 31, 2019 (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/tiara-featured-in-presentation-at-11th-annual-tvt-2019-300868036.html
SOURCE Neovasc Inc.
View original content: http://www.newswire.ca/en/releases/archive/June2019/17/c6518.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 08:55e 17-JUN-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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June 17, 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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