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 27, 2019 - Neovasc Announces Presentations on Tiara™ for Treatment of Mitral Regurgitation and Reducer™ for
Treatment of Refractory Angina at the CSI Frankfurt 2019 Conference
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DOCUMENT 1
Neovasc Announces Presentations on Tiara™
for Treatment of Mitral Regurgitation and Reducer™ for Treatment of Refractory Angina at the CSI Frankfurt 2019 Conference
NASDAQ, TSX: NVCN
VANCOUVER, June 27, 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 its Tiara™ ("Tiara") transcatheter mitral valve replacement device and its Neovasc Reducer™
("Reducer") device for the treatment of refractory angina were highlighted in presentations at the CSI Frankfurt
2019 conference, being held June 26-29, 2019, at the Congress Center Frankfurt, in Frankfurt, Germany.
Lenard Conradi, M.D., Surgical Director of
Minimally Invasive and Transcatheter Heart Valve Procedures, University Heart Center Hamburg, Department of Cardiovascular Surgery,
provided an overview of the TIARA™ program, including in-depth imaging required for screening patients and clinical evidence
demonstrating the resolution of mitral regurgitation and improvement in NYHA on Wednesday, June 26
th
.
Professor Shmuel Banai, M.D., Neovasc's Medical
Director, presented an overview of the Reducer's performance following more than 1000 devices implanted in Europe on Thursday,
June 27
th
. In the presentation evidence-based data was presented, demonstrating the high efficacy and safety profile
of the Reducer in reducing angina severity, improving quality of life, improving exercise capacity and improving systolic and diastolic
function of the heart.
CSI Frankfurt is the flagship conference on
catheter therapy of congenital, structural and valvar heart interventions. The congress will feature extended Focus Workshops on
a wide range of topics in the field, such as PFO closure, TAVI, ASD closure, mitral interventions, and many more. Further
information can be found here: https://www.csi-congress.org/.
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 two ongoing clinical trials: TIARA-I—an early feasibility trial in the United States, Canada, and Belgium;
and TIARA-II—a European Conformité Européenne Mark Trial in Germany, Italy, Israel,
The Netherlands, Spain, and the United Kingdom. In addition, patients have also been treated under compassionate programs
in Canada, Italy, Germany, Israel, and Switzerland.
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 cardiac drug therapies. 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
altering blood flow in the heart's circulatory system, thereby increasing the perfusion of oxygenated 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 not approved for commercial
use in the USA, 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.
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 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.
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-presentations-on-tiara-for-treatment-of-mitral-regurgitation-and-reducer-for-treatment-of-refractory-angina-at-the-csi-frankfurt-2019-conference-300875385.html
SOURCE Neovasc Inc.
View original content: http://www.newswire.ca/en/releases/archive/June2019/27/c8480.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
CO: Neovasc Inc.
CNW 08:55e 27-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 27, 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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