Helius Medical Technologies, Inc. Regains Compliance with Nasdaq Listing Standards
January 19 2021 - 7:05AM
Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius”
or the “Company”), a neurotech company focused on neurological
wellness, today announced that it received written notice from The
Nasdaq Stock Market LLC that the Company’s minimum bid price
deficiency has been cured, and that the Company is in compliance
with all applicable listing standards. Accordingly, the scheduled
hearing before the Hearings Panel to appeal the previous
determination of non-compliance has been cancelled, and shares of
the Company’s Class A common stock will continue to be listed and
trade on The Nasdaq Capital Market under the ticker “HSDT.”
About Helius Medical Technologies, Inc.
Helius Medical Technologies is a neurotech company focused on
neurological wellness. The Company’s purpose is to develop, license
and acquire unique and non-invasive platform technologies that
amplify the brain’s ability to heal itself. The Company’s first
commercial product is the Portable Neuromodulation Stimulator
(PoNSTM). For more information,
visit www.heliusmedical.com.
About the PoNS™ Device and PoNS Treatment™
The Portable Neuromodulation Stimulator (PoNS™) is authorized
for sale in Canada as a class II, non-implantable, medical device
intended as a short term treatment (14 weeks) of gait deficit due
to mild and moderate symptoms from multiple sclerosis (MS), and
chronic balance deficit due to mild-to-moderate traumatic brain
injury (mmTBI) and is to be used in conjunction with physical
therapy. The PoNS™ is an investigational medical device in the
United States, the European Union (“EU”), and Australia (“AUS”).
The device is currently under review for de novo classification and
clearance by the FDA. It is also under premarket review by the AUS
Therapeutic Goods Administration. PoNS™ is currently not
commercially available in the United States, the European Union or
Australia.
Investor Relations Contact:
Westwicke Partners on behalf of Helius Medical Technologies,
Inc.Jack Powellinvestorrelations@heliusmedical.com
Cautionary Disclaimer Statement:
Certain statements in this news release are not based on
historical facts and constitute forward-looking statements or
forward-looking information within the meaning of the U.S. Private
Securities Litigation Reform Act of 1995 and Canadian securities
laws. All statements other than statements of historical fact
included in this news release are forward-looking statements that
involve risks and uncertainties. Forward-looking statements are
often identified by terms such as “believe,” “continue,” “look
forward,” “will,” “committed to,” “goal,” “expect,” “remain,”
“hope” and similar expressions. Such forward-looking statements
include, among others, statements regarding the Company’s ability
to remain listed on The Nasdaq Capital Market, the Company’s
regulatory development plans for the PoNS device, and potential
regulatory clearance of the PoNS device, including expected timing
for the FDA to resume its review of our request for de novo
classification and clearance and expected timing for receipt of the
FDA’s decision on such request.
These statements involve substantial known and unknown risks and
uncertainties. There can be no assurance that such statements will
prove to be accurate and actual results and future events could
differ materially from those expressed or implied by such
statements. Important factors that could cause actual results to
differ materially from the Company’s expectations include
uncertainties associated with the Company’s ability to meet the
continued listing requirements of The Nasdaq Capital Market,
clinical development process and FDA regulatory submission and
approval process, including that the Company’s request for de novo
classification and clearance may be declined by the FDA, that the
FDA is not required to and may not respond to the Company’s request
in the timeframe indicated by its de novo review goals or in the
time the Company expects, whether the Company’s response will be
satisfactory to the FDA, whether the FDA will require additional
information, whether the Company will be able to provide it in a
timely manner and whether such additional information will be
satisfactory to the FDA, uncertainties regarding the Company’s
capital requirements to achieve its business objectives, the impact
of the COVID-19 pandemic, uncertainties associated with future
clinical trials and other development activities, and other risks
detailed from time to time in the filings made by the Company with
securities regulators, including the risks and uncertainties
described in the “Risk Factors” sections of the Company’s Annual
Report on Form 10-K for the year ended December 31, 2019, Quarterly
Report on Form 10-Q for the quarter ended September 30, 2020 and
its other filings with the United States Securities and Exchange
Commission and the Canadian securities regulators, which can be
obtained from either at www.sec.gov or www.sedar.com.The reader is
cautioned not to place undue reliance on any forward-looking
statement. The forward-looking statements contained in this news
release are made as of the date of this news release and the
Company assumes no obligation to update any forward-looking
statement or to update the reasons why actual results could differ
from such statements except to the extent required by law.
The Toronto Stock Exchange has not reviewed and does not accept
responsibility for the adequacy or accuracy of the content of this
news release.
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