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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September
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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 September 19, 2018 - Neovasc Announces 100th Patient to Receive Reducer Therapy in Germany
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DOCUMENT 1
Neovasc Announces 100th Patient to Receive
Reducer Therapy in Germany
NASDAQ, TSX: NVCN
VANCOUVER, Sept. 19, 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, announced today that a Neovasc Reducer™ (the "Reducer") has now been implanted in 100 patients in Germany.
The Reducer is a wire mesh implanted into a vein in the heart which treats patients with refractory angina.
A growing number of patients suffer from significant
angina despite optimal medication and prior revascularisations (via percutaneous coronary intervention or coronary artery bypass
graft), or when revascularization is not feasible or when the risks is too great. Refractory angina can lead to significant disability,
limited quality of life, multiple medications and frequent hospital admissions.
"This important milestone in Germany was
reached earlier than originally anticipated, thanks in large part to the Reducer being awarded NUB-status 1 earlier this year.
With awareness of the Reducer therapy continuing to build among cardiologists, we are well on our way to tripling the number of
implants in Germany for 2018 as compared to last year," stated Fred Colen, President and Chief Executive Officer of Neovasc.
Dr. Steffen Schnupp, Klinikum Coburg, Germany,
commented "We see a growing number of patients presenting with refractory angina, despite optimal medical treatment and revascularization
therapies. The Reducer therapy is a welcome option for these patients in my center."
Dr. Schnupp and his colleague, Dr. Ashraf Salem,
implanted the 100th Reducer in Coburg, Germany. The procedure was uneventful and lasted less than 30 minutes.
"We have treated over 25 patients with
the Reducer and observe a high success rate. Ninety percent of our patients have reported a relief of symptoms and an improved
quality of life," said Dr. Salem.
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 usually 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™ (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 tripling of the number of Reducer implants in Germany for 2018 as compared to last year, the growing incidence of
refactory angina and the rapidly growing cardiovascular marketplace. Words and phrases such as "expected" 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; 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 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 June 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.
View original content:http://www.prnewswire.com/news-releases/neovasc-announces-100th-patient-to-receive-reducer-therapy-in-germany-300715404.html
SOURCE Neovasc Inc.
View original content: http://www.newswire.ca/en/releases/archive/September2018/19/c3866.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 10:20e 19-SEP-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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September 19, 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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