Helius Medical Technologies, Inc. Submits Response to U.S. FDA in Pursuit of De Novo Classification and Clearance of the PoNS...
January 11 2021 - 07:05AM
Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius”
or the “Company”), a neurotech company focused on neurological
wellness, today announced that it has submitted its formal response
to the U.S. Food and Drug Administration’s (the “FDA” or “Agency”)
request for additional information.
The FDA’s request for additional information was related to the
Company’s request for de novo classification and clearance of the
Portable Neuromodulation Stimulator (PoNS™) device as a potential
treatment for gait deficit due to symptoms of Multiple Sclerosis
(“MS”), to be used as an adjunct to a supervised therapeutic
exercise program in patients over 18 years of age.
“The Helius team is very excited to announce the timely
submission of our response to the FDA’s request for additional
information,” said Dane Andreeff, Interim President and Chief
Executive Officer of Helius. “The achievement of this important
milestone was made possible by the diligent efforts of our
regulatory and clinical affairs team, and I would like to thank
them for their hard work and dedication in recent months.”
Mr. Andreeff continued: “Looking ahead, we expect that the FDA’s
receipt of our response will enable the FDA to resume its review of
our request for de novo classification and clearance. We remain
committed to our goal of bringing our PoNS technology to the aid of
U.S. patients suffering with gait deficit due to MS-related
symptoms as expeditiously as possible, and hope to receive the
FDA’s decision on our request for de novo classification and
clearance during the first half of this year.”
Additional Background Information:
Helius submitted its request for de novo classification and
clearance of the PoNS device for the treatment of gait deficit due
to symptoms from MS on August 4, 2020, following the receipt of
Breakthrough Designation by FDA in early May. On October 19, 2020,
the Company announced the receipt of the FDA’s request for
additional information, which was received approximately 75 days
following the submission date and placed the FDA’s review on hold
until receipt by the FDA of the requested information.
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 future
growth and operational progress, clinical and 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 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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