Report of Foreign Issuer (6-k)
21 September 2018 - 4:13AM
Edgar (US Regulatory)
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 20, 2018 - Neovasc's Tiara and Reducer to be Featured at TCT 2018 Conference
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DOCUMENT 1
Neovasc's Tiara and Reducer to be Featured
at TCT 2018 Conference
NASDAQ, TSX: NVCN
VANCOUVER, Sept. 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, announced today that its Tiara™ ("Tiara"), a transcatheter treatment of mitral valve disease, and the Neovasc
Reducer™ ("Reducer"), a CE-Marked medical device used for the treatment of refractory angina, will both be featured
in several presentations at the Transcatheter Cardiovascular Therapeutics (TCT) 2018 scientific symposium to take place September
21-25, 2018 in San Diego, California.
"We are pleased to announce that the Neovasc
team will be engaged in many scientific discussions with top Cardiologists from around the world to discuss and advance our
two key product platforms, the Tiara and the Reducer, at the 2018 TCT conference, which is the largest interventional cardiology
conference in the world. There will also be two presentations, specifically regarding our products. This is the most
important educational meeting specializing in interventional cardiovascular medicine every year," stated Fred Colen,
President and Chief Executive Officer of Neovasc.
Select Presentations:
Tiara
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In Session II 'Early TMVR Feasibility and Pivotal Trials'
Dr. Shmuel Banai will offer his presentation entitled, 'Tiara: Device Attributes, Implant Procedure, and Clinical Results' to the
panel on Monday, September 24, 2018 at 9:17 am PT.
Reducer:
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In a Moderated Poster Session: "Selected Early Innovative
Techniques" on Sunday, September 23, 2018, at 10:06 am PT, Dr Yishay Szekely will be presenting on Diastolic Function in Patients
Undergoing Coronary Sinus Reducer Implantation – A Single Center Experience
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 growth of the cardiovascular marketplace. Words and phrases such as 'potential', "believes," "may",
"not yet" 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; risks relating to conflicts of interests among
the Company's officers and directors as a result of their involvement with other issuers; and other factors referenced in the Company's
filings with Canadian and U.S. securities regulators. 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/neovascs-tiara-and-reducer-to-be-featured-at-tct-2018-conference-300715729.html
SOURCE Neovasc Inc.
View original content: http://www.newswire.ca/en/releases/archive/September2018/20/c2479.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-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 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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