Helius Medical Technologies, Inc. Announces FDA Has Granted the PoNS Device Breakthrough Device Designation for the Treatment...
12 May 2020 - 9:05PM
Helius Medical Technologies, Inc. (NASDAQ:HSDT) (TSX:HSM) (“Helius”
or the “Company”), a neurotech company focused on neurological
wellness, today announced that it has received Breakthrough
Designation for its 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.
“We are extremely pleased to receive this designation for our
PoNS device,” said Philippe Deschamps, the Company’s CEO. “We look
forward to working with FDA to process our application, with the
ultimate goal of bringing our innovative technology to the aid of
patients suffering with gait deficit due to MS-related symptoms, by
providing them with a non-drug, non-implantable treatment that has
the potential to significantly improve their ability to walk.”
The Breakthrough Devices Program is a voluntary program for
certain medical devices and device-led combination
products that provide for more effective treatment or
diagnosis of life-threatening or irreversibly debilitating diseases
or conditions.
The goal of the Breakthrough Devices Program is to provide
patients and health care providers with timely access to these
medical devices by speeding up their development, assessment, and
review, while preserving the statutory standards for premarket
approval, 510(k) clearance, and De Novo marketing authorization,
consistent with FDA’s mission to protect and promote public
health.
The Breakthrough Devices Program replaces the Expedited Access
Pathway and Priority Review for medical devices. The FDA considers
devices granted designation under the Expedited Access Pathway to
be part of the Breakthrough Devices Program.
The Breakthrough Devices Program offers manufacturers an
opportunity to interact with the FDA's experts through several
different program options to efficiently address topics as they
arise during the premarket review phase, which can help
manufacturers receive feedback from the FDA and identify areas of
agreement in a timely way. Manufacturers can also expect
prioritized review of their submission.
It is important to note that Breakthrough Device Designation
does not change the requirements for approval of an application for
a marketing authorization under section 510(k) of the Food, Drug,
and Cosmetic Act.
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 (PoNS™). For more information, visit
www.heliusmedical.com.
About the PoNS Device and PoNS
Treatment
The 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 gait deficit due to mild and moderate
symptoms from MS and is to be used in conjunction with physical
therapy and indicated as a short term treatment (14 weeks) chronic
balance deficit due to mild-to-moderate traumatic brain injury 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 Form 10-Q for the quarter ended March 31, 2020 filed
on May 11, 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.
Investor Relations Contact:Westwicke Partners
on behalf of Helius Medical Technologies, Inc.Mike Piccinino,
CFA443-213-0500investorrelations@heliusmedical.com
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