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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November
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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 November 20, 2018 - JACC: Cardiovascular Interventions Publishes Peer Reviewed Article on Neovasc Reducer™ Patient Case
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DOCUMENT 1
JACC: Cardiovascular Interventions Publishes
Peer Reviewed Article on Neovasc Reducer™ Patient Case
NASDAQ, TSX: NVCN
VANCOUVER, Nov. 20, 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 the Journal of the American College of Cardiology: Cardiovascular Interventions published a peer reviewed
article on the clinical response of a patient that received the Neovasc Reducer™ (the "Reducer"), a medical device
for the treatment of refractory angina, titled,
"Coronary Sinus Reducer Implantation to Reduce the Ischemic Burden in Refractory
Angina."
"Receiving such positive news on the outcome
for this patient after the Reducer treatment, while still at an angina class III level despite optimal anginal drug treatments
before the Reducer treatment, is a testament to the opportunity for our Reducer," commented Fred Colen, Neovasc's President
and Chief Executive Officer. "With this patient presenting as asymptomatic for angina at his 12-week follow up visit, this
is yet another case where the Reducer has provided us with positive feedback from the cardiovascular community in a peer-reviewed
setting. Our goal is to continue generating more data and greater awareness for the Reducer as we look to develop it as the
standard-of-care for Angina in Europe."
The article is based on a 66-year-old man with
a history of hypertension, dyslipidemia, multiple myocardial infarctions, and coronary artery bypass graft surgery that was presented
to the treating physicians with Canadian Cardiovascular Society class III angina persisting despite optimal anti-ischemic therapy
(metoprolol 50 mg twice daily, amlodipine besylate 10 mg, nitrate patch 10 mg/24 h, ranolazine 500 mg twice daily). After being
implanted with the Reducer, at the fourth month outpatient visit the patient was asymptomatic for angina and reported improved
quality of life based on a Seattle Angina Questionnaire mean domain score improvement from 45 to 73 points. A four-month dipyridamole
stress perfusion CMRI showed improved perfusion parameters: ischemic burden 13.3%, down from 22.9% and global myocardial perfusion
reserve index 1.61, up from 1.25 and unchanged scar burden (late gadolinium enhancement 18%).
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 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 Company's plans and expectations concerning the performance of and commercial strategy for the Reducer, the growing
incidence of refractory angina and the rapidly growing cardiovascular marketplace. Words and phrases such as "continue",
"strategy", "would", "may", "could", "should", "expect", "growing"
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 September 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.
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T. J. Povsic, S. Broderick, K. J. Anstrom et al., "Predictors of long
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term clinical endpoints in patients with refractory angina," Journal of the American Heart Association, vol. 4, no. 2, article e001287, 2015.
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View original content:http://www.prnewswire.com/news-releases/jacc-cardiovascular-interventions-publishes-peer-reviewed-article-on-neovasc-reducer-patient-case-300753525.html
SOURCE Neovasc Inc.
View original content: http://www.newswire.ca/en/releases/archive/November2018/20/c6158.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 20-NOV-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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November 20, 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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