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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October
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2018
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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 October 16, 2018 - Neovasc Announces Publication of a Peer-Reviewed Article on Tiara™ Cases in Circulation: Cardiovascular Interventions
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DOCUMENT 1
Neovasc Announces Publication of a Peer-Reviewed
Article on Tiara™ Cases in Circulation: Cardiovascular Interventions
NASDAQ, TSX: NVCN
Accompanying editorial
comment also published by the journal
VANCOUVER, Oct. 16, 2018 /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 an original article was published in
Circulation: Cardiovascular Interventions
titled 'Transcatheter
Mitral Valve Replacement in Patients With Previous Aortic Valve Replacement', which reports for the first time ever the experience
of transcatheter mitral valve replacement ("TMVR") using Neovasc's Tiara™ ("Tiara") valve in patients
with previous aortic valve replacement. The Tiara is a self-expanding mitral bioprosthesis for transcatheter implantation in patients
with Mitral Regurgitation ("MR"), one of the most prevalent valvular heart diseases in western countries. Tiara
is not currently approved for commercial sale in any geographies.
The article describes the periprocedural and
short-term outcomes of patients with severe MR and previous surgical aortic valve prosthesis replacement treated with the Tiara.
The article describes procedural success rate of 100% with no death, myocardial infarction, stroke, major bleeding, or access site
complications at 30 days. In addition, MR was eliminated in patients immediately after implantation. The authors of the article
conclude that, "transapical mitral valve replacement with the Tiara valve in high-risk patients with severe MR and aortic
valve prostheses is technically feasible and can be performed safely." The article is currently available for download at
the American Heart Association Journals website, https://www.ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.118.006412
The editorial comment titled 'Taking Transcatheter
Mitral Valve Replacement to the Next Level' written by Mayra Guerrero and Charanjit Rihal concludes that: "The investigators,
are taking the field of TMVR to the next level where both prosthetic aortic valves and transcatheter mitral prosthesis coexist,
and should be congratulated for their contribution." The article is currently available for download at the American Heart
Association Journals website, https://www.ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.118.007369.
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 is currently being evaluated
in 2 ongoing investigational 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 Neovasc Reducer ™ ("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 growth of the cardiovascular marketplace. Words and phrases such as "continue", "strategy", "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 the warrants (the "Warrants") and senior secured convertible notes (the "Notes") issued pursuant
to the November 2017 underwritten public offering and concurrent private placement (together, the "2017 Financings"),
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 Warrants and Notes issued pursuant to the 2017 Financings, 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 exercise of Warrants or conversion of Notes issued pursuant to the
2017 Financings, 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; risks relating to the Company's ability to successfully
enter into fundamental transactions as defined in the Series C warrants 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 Management's Discussion and Analysis for the quarter ended June 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-announces-publication-of-a-peer-reviewed-article-on-tiara-cases-in-circulation-cardiovascular-interventions-300731607.html
SOURCE Neovasc Inc.
View original content: http://www.newswire.ca/en/releases/archive/October2018/16/c3043.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 07:30e 16-OCT-18
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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October 16, 2018
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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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