Report of Foreign Issuer (6-k)
17 July 2018 - 8:05PM
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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July
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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 July 16, 2018 - Nasdaq Schedules Hearing to Consider Neovasc's Appeal of Delisting Determination
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DOCUMENT 1
Nasdaq Schedules Hearing to Consider Neovasc's
Appeal of Delisting Determination
VANCOUVER, July 16, 2018 /CNW/ - Neovasc Inc.
("Neovasc" or the "Company") (NASDAQ, TSX: NVCN), a leader in the development of minimally invasive transcatheter
mitral valve replacement technologies, today announced that The Nasdaq Stock Market LLC ("Nasdaq") has scheduled an oral
hearing for August 30, 2018, at which the Nasdaq Hearings Panel (the "Panel") will consider Neovasc's appeal of the Nasdaq
Listing Qualifications Staff (the "Staff") decision to delist the Neovasc's securities from the Nasdaq Capital Market
for non-compliance with the US$1.00 minimum bid price requirement. The delisting action referenced in the Staff's determination
letter, dated July 6, 2018, has been stayed pending a final decision by the Panel. See the news release issued by the Company on
July 9, 2018 for further information.
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 Neovasc Reducer™ (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 Company's strategy and expectations regarding the process and results of the hearing seeking an additional extension
of time to regain compliance with Nasdaq's minimum bid price requirement, the Company's ability to remain listed on the Nasdaq
Capital Market and the growth of the cardiovascular marketplace. Words and phrases such as "believes", "can",
"scheduled" 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 TSX, 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 March 31, 2018 (copies of which may be obtained at www.sedar.com or www.sec.gov). In particular, the Company
notes that shareholder approval of the reverse stock split does not necessarily guarantee that the Panel will grant it an extension
to regain compliance with the US$1.00 minimum bid price requirement or that, if granted, such extension will be for the additional
180-days requested by the Company. In the event the Panel refuses to grant such extension, the Company's common shares may be delisted
from the Nasdaq Capital Market. In addition to the specified criteria for continued listing, Nasdaq also has broad discretionary
public interest authority that it can exercise to apply additional or more stringent criteria for the continued listing of the
Company's common shares, or suspend or delist securities even if the securities meet all enumerated criteria for continued listing
on the Nasdaq Capital Market. The Nasdaq could use this discretionary authority at any time to delist the Company's common shares.
There can be no assurance that Nasdaq will not exercise such discretionary authority. In addition, even if the Company is granted
an extension by the Panel, there is no assurance that the Company will be able to regain compliance with the minimum bid price
requirement prior to the expiry of any extension, or if it does, that the Company will be able to maintain such compliance as a
result of the risks and uncertainties described above. 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/nasdaq-schedules-hearing-to-consider-neovascs-appeal-of-delisting-determination-300681594.html
SOURCE Neovasc Inc.
View original content: http://www.newswire.ca/en/releases/archive/July2018/16/c7744.html
%CIK: 0001399708
For further information:
CONTACT 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 16:30e 16-JUL-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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July 16, 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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