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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April
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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
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Document 1
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News Release dated April 17, 2019 - Neovasc Announces Peer Reviewed Publication in the International Journal of Cardiology Demonstrating that the Neovasc Reducer™
Improves Diastolic Function in patients suffering from severe angina
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DOCUMENT 1
Neovasc Announces Peer Reviewed Publication
in the International Journal of Cardiology Demonstrating that the Neovasc Reducer™ Improves Diastolic Function in patients
suffering from severe angina
NASDAQ, TSX: NVCN
VANCOUVER, April 17, 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 International Journal of Cardiology (the "IJC") has published a peer reviewed article
demonstrating that coronary sinus ("CS") narrowing through the use of the Neovasc Reducer™ (the "Reducer")
improves diastolic function and relaxation of the heart. The article title is: "The impact of coronary sinus narrowing on
diastolic function in patients with refractory angina."
"We are pleased to report evidence that
CS narrowing may also improve diastolic function in patients with chronic refractory angina and proven myocardial ischemia. We
believe this study has the potential to further encourage cardiologists to treat refractory angina patients with coronary sinus
narrowing without the concern of adverse effects on the relaxation properties of the heart," commented Dr. Shmuel Banai, Medical
Director of Neovasc.
The purpose of the study was to evaluate the
impact of CS narrowing on stiffness and relaxation abilities of the left ventricle (diastolic function) in patients with myocardial
ischemia and severe refractory angina treated with the Reducer. The study demonstrated that treatment with the Reducer may lead
to improvement in diastolic function and echocardiographic parameters of left ventricular relaxation. The results of this trial
may preclude the speculation that coronary sinus narrowing might adversely affect relaxation of the heart muscle. The study
clearly indicates the opposite, and demonstrates that the Reducer not only improved angina status and quality of life of these
patients, but also resulted in a significant improvement in mean diastolic function. The observed improvement in the relaxation
properties of the heart are most probably secondary to the improvement in blood perfusion to ischemic territories of the heart
muscle which is known to be the effect of the Reducer.
About Reducer
The Reducer is CE-marked in the European Union for the treatment of refractory angina, a painful and debilitating condition that
occurs when the coronary arteries deliver an inadequate supply of blood to the heart muscle, despite treatment with standard revascularization
or medical therapy. It affects millions of patients worldwide, who typically lead severely restricted lives as a result of their
disabling symptoms, and its incidence is growing. The Reducer provides relief of angina symptoms by improving blood to ischemic
areas of the heart muscle. Placement of the Reducer is performed using a minimally invasive transvenous procedure that is similar
to implanting a coronary stent and is completed in approximately 20 minutes.
While the Reducer is widely used in Europe,
it is not yet approved for commercial use in the United States. The U.S. Food and Drug Administration ("FDA") granted
Breakthrough Device designation to the Neovasc Reducer in October 2018. This designation is granted by the FDA in order to expedite
the development and review of a device that demonstrates compelling potential to provide a more effective treatment or diagnosis
for life-threatening or irreversibly debilitating diseases. In addition, there must be no FDA approved treatments presently
available, or the technology must offer significant advantages over existing approved alternatives for the FDA to grant Breakthrough
Device designation.
Refractory angina, resulting in continued symptoms
despite maximal medical therapy and without revascularization options, is estimated to affect 600,000 to 1.8 million Americans,
with 50,000 to 100,000 new cases per year.
1
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.
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 or expectations
as to the IJC article having the potential to further encourage cardiologists to treat refractory angina patients with coronary
sinus narrowing without the concern of adverse effects on the relaxation properties of the heart, coronary sinus narrowing not
adversely affecting relaxation of the heart muscle, the likelihood that the observed improvement in the relaxation properties of
the heart are most probably secondary to the improvement in blood perfusion to ischemic territories of the heart muscle, the growing
incidence of refractory angina 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, 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 Notes issued pursuant to the 2017 Financing, which
may encourage short sales by third parties; risks relating to the possibility that the common shares of the Company 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 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 year ended December
31, 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.
1
T. J. Povsic, S. Broderick, K.
J. Anstrom et al., "Predictors of long
-
term clinical endpoints in patients
with refractory angina," Journal of the American Heart Association, vol. 4, no. 2, article e001287, 2015.
View original content:http://www.prnewswire.com/news-releases/neovasc-announces-peer-reviewed-publication-in-the-international-journal-of-cardiology-demonstrating-that-the-neovasc-reducer-improves-diastolic-function-in-patients-suffering-from-severe-angina-300833470.html
SOURCE Neovasc Inc.
View original content: http://www.newswire.ca/en/releases/archive/April2019/17/c1659.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 17-APR-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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April 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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