NASDAQ, TSX: NVCN
VANCOUVER, Oct. 9, 2018 /PRNewswire/ - 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 it has received written notification from the Nasdaq
Hearings Panel (the "Panel") notifying the Company that it has
regained compliance with the minimum bid price requirement under
Nasdaq Listing Rule 5550(a)(2) for continued listing on the Nasdaq
Capital Market (the "Nasdaq"), that it is in compliance with all
other applicable continued listing requirements and that the Panel
has determined to continue the listing of the Company's common
shares on the Nasdaq. Accordingly, Neovasc is in compliance with
all applicable Nasdaq listing standards and the Panel considers
this matter closed.
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
continued listing of the Company's common shares on the Nasdaq and
the growth of the cardiovascular marketplace. Words and phrases
such as "continue", "may", "will" 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 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). In particular,
the Company notes in addition to the specified criteria for
continued listing, The Nasdaq Stock Market LLC 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. The Nasdaq Stock Market LLC could
use this discretionary authority at any time to delist the
Company's common shares. There can be no assurance that the Company
will be able to sustain compliance with the Nasdaq listing
standards or that The Nasdaq Stock Market LLC will not exercise
such discretionary authority. 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.