Helius Medical Technologies Announces Authorization from Health Canada to Market the PoNS™ Device for the Treatment of Gait...
March 24 2020 - 7:05AM
Helius Medical Technologies, Inc. (NASDAQ:HSDT) (TSX:HSM) (“Helius”
or the “Company”), today announced that its Canadian Class II
license amendment application for the treatment of gait deficit in
patients with mild and moderate symptoms from multiple sclerosis
(“MS”) has received marketing authorization from Health Canada.
Helius’ Portable Neuromodulation Stimulator (PoNS™) device is now
authorized to be marketed for the short-term treatment (14 weeks)
of gait deficit due to mild and moderate symptoms from MS and is to
be used in conjunction with physical therapy, in addition to the
short-term treatment (14 weeks) of chronic balance deficit due to
mild-to-moderate traumatic brain injury and is to be used in
conjunction with physical therapy.
“We are very pleased to receive regulatory
clearance to market our PoNS Treatment to the approximately 93,500
patients in Canada who suffer from MS,” said Philippe Deschamps,
Chief Executive Officer of Helius. “Given the chronic and
progressive nature of this potentially debilitating
neurodegenerative disease, we feel that there is a strong clinical
need for novel therapies such as our PoNS Treatment. We are proud
to provide MS patients with a treatment option that has the
potential to improve or restore their gait function, or in other
words their ability to walk."
The PoNS treatment is available through
authorized Treatment Centers throughout Canada. For a list of
the authorized treatment centers in Canada please visit
www.ponstreatment.ca.
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 product in development is the Portable
Neuromodulation Stimulator (PoNSTM). For more information, visit
www.heliusmedical.com. About the PoNS Device and PoNS
TreatmentThe Portable Neuromodulation Stimulator (PoNS) is
an authorized class II, non-implantable medical device authorized
for sale in Canada. PoNS is intended as a short term treatment (14
weeks) of chronic balance deficit due to mild-to-moderate traumatic
brain injury and is to be used in conjunction with physical therapy
and indicated as a short term treatment (14 weeks) of gait deficit
due to mild and moderate symptoms from MS and is to be used in
conjunction with physical therapy. The PoNS is an
investigational medical device in the United States, the European
Union, and Australia, and is currently under review for clearance
by the AUS Therapeutic Goods Administration. PoNS Treatment is
currently not commercially available in the United States, the
European Union or Australia.
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” and similar expressions. Such forward-looking
statements include, among others, statements regarding the
Company’s future clinical and regulatory development plans for the
PoNS, the success of the Company’s planned study, business and
commercialization initiatives and objectives, the potential receipt
of regulatory clearance of the PoNS device in the United States,
the European Union and Australia and the Company’s revenue
guidance.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 the
uncertainties associated with clinical trial enrollments and the
results of clinical trials, uncertainties associated with the
clinical development process and FDA regulatory submission and
approval process, including the Company’s capital requirements to
achieve its business objectives and other risks detailed from time
to time in the filings made by the Company with securities
regulators, and including the risks and uncertainties about the
Company’s business described in the “Risk Factors” sections of the
Company’s Annual Report on Form 10-K for the year ended December
31, 2019, 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.
Contact: Investor Relations Westwicke Partners on behalf of
Helius Medical Technologies, Inc. Mike Piccinino, CFA
investorrelations@heliusmedical.com
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