Report of Foreign Issuer (6-k)
02 February 2018 - 12:16AM
Edgar (US Regulatory)
SECURITIES AND EXCHANGE COMMISSION
Washington, 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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February
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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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1
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News
Release dated February 1, 2018 - Neovasc Announces Receipt of German NUB Status 1 Designation for Neovasc Reducer™ Procedure for Treatment
of Refractory Angina
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Document 1
Neovasc Announces Receipt of German NUB Status 1 Designation
for Neovasc Reducer™ Procedure for Treatment of Refractory Angina
Participating Hospitals in Germany Now
Eligible to Negotiate Reimbursement for Reducer Procedure
NASDAQ, TSX: NVCN
VANCOUVER, Feb. 1, 2018 /CNW/ - Neovasc, Inc. ("Neovasc"
or the "Company") (NASDAQ, TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve technologies,
today announced that the "Institut für das Entgeltsystem im Krankenhaus" ("InEk"), the German Institute
for the Hospital Remuneration System, has awarded its Neovasc Reducer™ ("Reducer"), a CE-Marked medical device
for the treatment of refractory angina, NUB status 1 designation for 2018.
InEK, is responsible for prioritizing new therapies in Germany
through the NUB process. Yesterday, InEK upgraded the status of the Neovasc Reducer from status 4 to status 1 - the highest priority
designation available.
A NUB decision is valid for one year and can be renewed annually.
The NUB process opens the path for negotiations between hospitals and health insurances on the reimbursement of new medical treatments
in the German system. Based on the new NUB status 1 for the Neovasc Reducer, 107 German hospitals can now negotiate reimbursement
coverage for the Neovasc Reducer therapy under the German health insurance system.
Fred Colen, CEO of Neovasc commented "This significant
upgrade to the highest level in the German NUB status is an exciting development for the Reducer therapy in Europe. For many
patients Angina remains a significant issue and many of them have limited treatment options today. This positive NUB development
will allow additional patients suffering from refractory angina to be treated with the Reducer in Germany."
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.
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 available in
the United States and has been available in Europe since 2015, and the Tiara™ ("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 possible future renewals of NUB decisions, the treatment of additional patients suffering
from refractory angina in Germany with the Reducer, and the growing incidence of refractory angina. Words and phrases such
as "will", "can be" and "growing", 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 Company's need for significant additional future capital and the Company's ability to raise additional funding; risks relating
to the warrants and notes, offered pursuant to the November 2017 public offering of units and private placement of senior secured
convertible notes and warrants (the "Financings"), resulting in significant dilution to the Company's shareholders; 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 it being more expensive for the Company to raise
capital in the future and dilution to investors; risks relating to the Company's Common Share price being volatile; risks relating
to the sale of a significant number of Common Shares; risks relating to the restrictions on the Company entering into certain transactions;
risks relating to the exercise of Warrants or conversion of Notes offered pursuant to the Financings, which may encourage short
sales by third parties; risks relating to claims by third parties alleging infringement of their intellectual property rights;
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 competition in the medical device industry, including the risk that one or more 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 the Company's 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 the Company's 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 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 the Company's 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; the Company's ability to successfully identify and complete corporate transactions on favorable terms
or achieve anticipated synergies relating to any acquisitions or alliances; 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; risks relating
to conflicts of interests among the Company's officers and directors as a result of their involvement with other issuers; and risks
relating to the influence of significant shareholders of the Company over the Company's business operations and share price. These
risk factors and others relating to the Company are discussed in greater detail in the "Risk Factors" sections of the
Company's Annual Information Form and Management's Discussion and Analysis of Financial Condition and Results of Operations, each
of which is included in its Annual Report on Form 40-F, and the Company's Management Discussion and Analysis for the third quarter
of 2017 (copies of which filings may be obtained at
www.sedar.com
or
www.sec.gov
). These factors should be
considered carefully, and readers should not place undue reliance on the Company's forward-looking statements. The Company
has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information,
future events or otherwise, except as required by law.
SOURCE Neovasc Inc.
View original content: http://www.newswire.ca/en/releases/archive/February2018/01/c1064.html
%CIK: 0001399708
For further information:
Investor Relations: Neovasc Inc.,
Chris Clark, 604 248-4138, cclark@neovasc.com
CO: Neovasc Inc.
CNW 07:00e 01-FEB-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:
February 1, 2018
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By:
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/s/
Chris Clark
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Name:
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Chris Clark
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Title:
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Chief Financial Officer
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