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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May
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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 May 6, 2019 - Neovasc Announces Treatment of 1,000th Refractory Angina Patient with Neovasc Reducer™
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DOCUMENT 1
Neovasc Announces Treatment of 1,000th
Refractory Angina Patient with Neovasc Reducer™
NASDAQ, TSX: NVCN
VANCOUVER, May 6, 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,
announced today that 1,000 patients diagnosed with refractory angina have been treated with the Neovasc Reducer™ ("Reducer").
These patients have been treated in Europe, the Middle East, Canada, and the United States (the two patients treated in the U.S.
were treated under compassionate use). Three patients were treated simultaneously by Dr. Francesco Giannini and Prof. Antonio
Colombo at the Maria Cecilia Hospital in Cotignola, Italy, Prof. Marco Valgimigli at the Inselspital Universitätsspital Bern,
Switzerland and Prof. Javier Escaned at the Hospital Clinico San Carlos in Madrid, Spain.
"Regular bouts of angina can significantly
impact a patient's quality of life. This is especially true when these people suffer from refractory angina, which is angina that
persists despite optimal drug therapy and revascularization. For many of these patients, angina changes their life unexpectedly
and the prospect of living with this pain for the rest of their lives is difficult to bear," says Prof. Banai, Director Division
of Cardiology at the Tel Aviv Medical Center and Medical Director for Neovasc.
"We are pleased to have treated the 1,000th
patient to receive the Reducer therapy at the Inselspital Universitätsspital Bern". The procedure was performed by Prof.
Marco Valgimigli and is expected to offer symptomatic relief from invalidating angina after coronary artery bypass surgery 19 years
ago and multiple percutaneous coronary interventions afterwards.
The Reducer therapy now totals medical evidence
spanning 1,000 patients and 14 years of follow up. This substantial evidence demonstrates that the Reducer alleviates refractory
angina symptoms in about 80% of the treated patients. The procedure lasts about 20 minutes and has been shown to be very safe and
straightforward.
"It is important to note that the clinical
results obtained in a randomized trial have been replicated in 'real life' hospital settings across several countries," stated
Dr. Giannini. "The fact that the Reducer therapy is effective and safe is very important for refractory angina patients, as
this chronic condition significantly impairs their quality of life and they have very limited treatment options."
"I have been following the development
of the Reducer therapy for many years. I am pleased to see how its clinical data has continued to build. With the 1,000
th
patient treated milestone, I believe it is time we encourage our colleagues and societies to inform their refractory angina patients
that there may be a treatment option available to them today," says Prof. Colombo.
"There is great interest in the cardiology
community for the Reducer device. Published data from real-world experience, which has now reach 1000 patients, supports the very
solid evidence obtained in the randomized, sham-controlled COSIRA trial on the value of coronary sinus reduction in patients with
refractory angina. this is particularly important for this group of patients with limited options", stated Prof. Escaned.
"We are pleased to reach this milestone
and view the increasing use of the Reducer to treat refractory angina patients around the world as a testament to the positive
impact the device has had on patients compared to other treatment options. This momentum is mostly attributable to the commercialization
strategy that we have implemented for the Reducer in Europe, which has generated growing interest among leading cardiologists,"
stated Fred Colen, CEO of Neovasc.
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. The Reducer is not commercially available in the United States, the FDA however granted the Reducer
the Breakthrough Device Designation in October of last year. Refractory Angina 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.
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
regarding the growing interest for the Reducer among leading cardiologists, the growing incidence of refractory angina and the
rapidly 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.
View
original content:http://www.prnewswire.com/news-releases/neovasc-announces-treatment-of-1-000th-refractory-angina-patient-with-neovasc-reducer-300844227.html
SOURCE Neovasc Inc.
View original content: http://www.newswire.ca/en/releases/archive/May2019/06/c4729.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 06-MAY-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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May 6, 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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