Helius Medical Technologies, Inc. Announces Publication of Peer-Reviewed Study: Translingual Neural Stimulation with the Port...
September 08 2020 - 7:05AM
Helius Medical Technologies, Inc. (NASDAQ:HSDT) (TSX:HSM) (“Helius”
or the “Company”), a neurotech company focused on neurological
wellness, today announced the publication of an important,
peer-reviewed study titled Translingual Neural Stimulation with the
Portable Neuromodulation Stimulator (PoNS™) Induces Structural
Changes Leading to Functional Recovery in Patients with
Mild-to-Moderate Traumatic Brain Injury. The study was published in
the peer reviewed journal EMJ Radiology. 2020;1[1]:64-71.
Traumatic brain injury (“TBI”) of varying severity can result in
balance and movement disorders, for which the benefits of treatment
with physical therapy has limits. In this study, a 9 patient subset
of the original 43 patients published in “Translingual
Neurostimulation for the Treatment of Chronic Symptoms Due to
Mild-to-Moderate Traumatic Brain Injury” with balance issues
received translingual neural stimulation (“TLNS”) with the PoNS
device, in concert with physical therapy, and the effects on grey
matter volume (“GMV”) in the brain were evaluated. TBI-related
balance and movement impairments were also assessed with the
Sensory Organization Test (“SOT”) and Dynamic Gait Index (“DGI”),
which are validated and objective means of scoring such
deficits.
When comparing pre- and post-intervention
results, the most prominent GMV changes were increases within the
cerebellum and temporal regions, which are involved in automatic
processing of gait, balance, motor control and visual-motion
relationships. Decreases of GMV in the frontal and occipital lobes
(which are involved in conscious/effortful processing of gait,
balance, motor control, and vision) positively correlated to
increases in SOT/DGI scores. These results suggest that TLNS
with the PoNS device could induce brain plasticity changes leading
to positive changes in functional assessments. Overall, these data
indicate that TLNS delivered in conjunction with physical therapy
may offer an integrative way to treat balance disorders after a
mild-to-moderate TBI.
“The University of Wisconsin, Madison, participated in a
multicenter clinical trial of the PoNS to address balance issues
after traumatic brain injury and saw the regimen improve subjects’
outcomes,” said study investigator Dr. Vivek Prabhakaran. “The data
published in this article shows that commensurate with clinical
improvement experienced by these subjects after the PoNS regime,
there were changes in the brain documented with MRI. This suggests
that the PoNS regime induces brain plasticity changes,
which may be relevant for clinical recovery. We
should continue to document these changes in future studies
and are keen to see this treatment deployed to help a massive unmet
clinical need.”
“I am thrilled that the body of scientific
evidence showing the potential beneficial effects of our PoNS
technology continues to grow,” added Dane Andreeff, Interim Chief
Executive Officer of Helius. “It is particularly exciting when we
can observe, as in this work, the brain changing positively
following PoNS Treatment.”
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 (PoNS™). 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 for use in gait deficits in
MS. 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.Mike Piccinino,
CFA443-213-0500investorrelations@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” and similar expressions. Such forward-looking
statements include, among others, statements regarding the
Company’s future clinical and regulatory development plans for the
PoNS device and the potential regulatory clearance of the PoNS
device, the success of the Company’s PoNS device in treating
balance disorders, the success of the Company’s future trials, its
business and commercialization initiatives and objectives, and the
potential receipt of regulatory clearance of the PoNS device in the
United States, the European Union and Australia.
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
impact of the COVID-19 pandemic, uncertainties associated with
clinical trial enrollments and the results of clinical trials,
uncertainties associated with the clinical development process and
regulatory submission and approval process, uncertainties
associated with 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,
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, Quarterly
Report on Form 10-Q for the quarter ended June 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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