VANCOUVER, July 16, 2018 /PRNewswire/ - 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.
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SOURCE Neovasc Inc.