Helius Medical, Inc Receives U.S. Marketing Authorization for the PoNS™ Device
March 29 2021 - 5:30AM
Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius”
or the “Company”), a neurotech company focused on neurological
wellness, today announced that its wholly owned subsidiary, Helius
Medical, Inc, has received marketing authorization from the U.S.
Food and Drug Administration (“FDA”) for the Portable
Neuromodulation Stimulator (PoNS™) device.
The PoNS device is indicated for use as a short
term treatment of gait deficit due to mild-to-moderate symptoms
from multiple sclerosis (“MS”) and is to be used as an adjunct to a
supervised therapeutic exercise program in patients 22 years of age
and over by prescription only .
“With the receipt of FDA marketing
authorization, Helius is proud to announce that our PoNS device is
now the first, and only, medical device cleared in the U.S. for
this indication,” said Dane Andreeff, Interim President and Chief
Executive Officer of Helius. “This milestone represents the most
important achievement of our organization since its inception, and
I would like to thank our dedicated employees, our shareholders,
and the people who participated in the research for making it
possible. MS is a chronic, degenerative and often debilitating
disease that is estimated to affect approximately 1 million
patients in the U.S. Many of these patients experience problems
with their gait, or walking, as a result of MS which can severely
restrict their mobility and daily activities. Our aim in obtaining
marketing authorization is to provide MS patients suffering from
gait deficit with a non-drug, non-implantable treatment that has
the potential to significantly improve their ability to walk, and
potentially enhance their safety and quality of life as a
result.”
Mr. Andreeff continued: “For this vastly
underserved population of MS patients with a clear medical need and
few viable treatments, our innovative PoNS device and treatment
represents a new therapeutic option with demonstrated results.
Specifically, its safety and efficacy has been demonstrated in two
clinical studies and a retrospective analysis of real-world data
which were submitted to, and assessed by, the FDA as part of our
request for marketing authorization. The receipt of FDA marketing
authorization represents an important validation of both the
strength and quality of this supporting data, and ultimately the
safety and efficacy of our PoNS device.”
Mr. Andreeff concluded: “Looking ahead, Helius
remains committed to providing our PoNS Treatment to patients as
efficiently and effectively as possible. We are focused on
preparing to commercialize our PoNS Treatment in the U.S., which we
expect to begin in the first quarter of 2022. As part of our
pre-commercial activities, we will continue to work with the
Centers for Medicaid and Medicare with the goal of obtaining
reimbursement coverage under the Medicare Coverage of Innovative
Technology, or MCIT, pathway for FDA cleared and designated
breakthrough devices. Longer-term, we also intend to pursue
additional indications for our PoNS device to expand access to our
platform technology in order to help as many patients as
possible.”
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 an innovative non-surgical medical device, inclusive of a
controller and mouthpiece, which delivers mild electrical
stimulation to the surface of the tongue to provide treatment of
gait deficit and is indicated for use in the United States as a
short term treatment of gait deficit due to mild-to-moderate
symptoms from multiple sclerosis (MS) and is to be used as an
adjunct to a supervised therapeutic exercise program in patients 22
years of age and over by prescription only. The PoNS device 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 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 device is an investigational medical device in the European
Union (“EU”) and Australia (“AUS”). It is currently under premarket
review by the AUS Therapeutic Goods Administration.
Investor Relations Contact:
Westwicke Partners on behalf of Helius Medical
Technologies, Inc.Jack Powell, Vice
Presidentinvestorrelations@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,”
“looking ahead,” “look forward,” “will,” “committed to,” “goal,”
“expect,” “remain,” “aim,” “potential” and similar expressions.
Such forward-looking statements include, among others, statements
regarding the Company’s future growth and operational progress, the
next phase of the Company’s market development activities, clinical
and regulatory development plans for the PoNS device, the ability
of the PoNS device to significantly improve MS patients’ ability to
walk, and as a result may enhance their safety and quality of life,
expected time to commercialization and the Company’s ability to
obtain reimbursement coverage under the MCIT pathway and to secure
marketing authorization for additional indications.
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 capital
requirements to achieve its business objectives, the impact of the
COVID-19 pandemic, the Company’s ability to train physical
therapists in the supervision of the use of the PoNS Treatment, the
Company’s ability to secure contracts with rehabilitation clinics,
the Company’s ability to obtain national Medicare coverage and to
obtain a reimbursement code so that the PoNS device is covered by
Medicare and Medicaid, the Company’s ability to build internal
commercial infrastructure, market awareness of the PoNS device,
future clinical trials, manufacturing and supply chain risks,
potential changes to the MCIT program resulting from the 60-day
deferral of the program implementation, the product development
process and FDA regulatory submission review and approval process,
other development activities and ongoing government regulation, 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, 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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