Helius Medical Technologies, Inc. (NASDAQ:HSDT) (TSX:HSM) (“Helius”
or the “Company”), a neurotech company focused on neurological
wellness, today announced that its registrational clinical trial,
TBI-001, was published on April 29, 2020 in Neuromodulation:
Technology at the Neural Interface. The TBI-001 trial found that
PoNS Treatment™ provided significant improvement in balance in
patients with a chronic balance deficit following a
mild-to-moderate traumatic brain injury (“mmTBI”).
This newly-published, 122 subject, multicenter, double-blind
randomized clinical trial, found that the PoNS Treatment, which
pairs translingual neurostimulation using the Portable
Neuromodulation Stimulator (PoNS™) device with therapeutic
activities, significantly improves balance and gait. Conducted by
researchers at 7 clinical sites across the US and Canada, this
trial, which was completed in 2017, is the second double-blind,
randomized clinical trial to demonstrate the level of balance
improvement PoNS Treatment provides to patients suffering
from chronic balance deficit as a result of a mild-to-moderate
traumatic brain injury. For more information on the TBI-001 trial
and its results, see the published journal article.
“Whether traumatic brain injuries are mild, moderate or severe,
the devastating effects can last a lifetime,” said Philippe
Deschamps, Chief Executive Officer of Helius Medical Technologies.
“We are excited to announce the publication of this 122 subject,
multicenter, double-blind, randomized, clinical trial in a
peer-reviewed journal and believe that it provides important
clinical support for the PoNS Treatment as new, novel, valuable
treatment option for patients suffering from the effects of
mmTBI.”
The PoNS Treatment involves the use of the PoNS device in
conjunction with therapeutic activities. The PoNS device sits on
the surface of a patient’s tongue and delivers mild, gentle
electrical impulses to the surface of the tongue. These impulses
excite the neural network flowing to the brain. This neural
activity, combined with therapeutic activities, is believed to
enable “neuroplasticity” which may restore lost function.
The TBI-001 trial evaluated subjects who had experienced a
mild-to-moderate traumatic brain injury at least one year prior to
receiving the PoNS Treatment and had reached a plateau in recovery
(according to their healthcare providers) with physical therapy
alone. Subjects used the PoNS device for 5 weeks in conjunction
with therapeutic activities. At the end of the 5-week treatment
program, patients demonstrated improved balance and gait.
Researchers found that 67.2 percent of the pooled patient
population who completed 5 weeks of PoNS Treatment experienced a
clinically and statistically significant improvement in balance, as
indicated in their mean SOT (Sensory Organizational Test) scores at
2 weeks and 5 weeks compared to baseline. Mean DGI (Dynamic Gait
Index) scores were significantly increased from baseline at weeks 2
and 5.
Exploratory endpoints, such as the headache disability index,
sleep quality index and quality of life measure index were also
observed as part of the trial. While further analysis and research
is needed, there was an indication of improvements in these
exploratory endpoints. Demonstrated improvements in balance and
gait, coupled with potential improvements in the exploratory
endpoints, may allow treated individuals to experience improved
quality of life.
Mr. Deschamps continued: “We are very encouraged by the results
of the clinical trial. As a result of their improvements in balance
and gait, many of our patients reported being able to perform
independent self-care tasks, like dressing and showering, that were
once beyond their reach prior to receiving PoNS Treatment.”
Katherine Webb, a patient enrolled in the study described her
experience during the study. “It had been 4 and a half years since
my injury when I first started the study. For those 4 and a half
years, I had not been able to put one foot in tandem in front of
the other and walk with my feet in a row without tipping or falling
over due to loss of balance. It was early February of 2017, and
with the device in my mouth, I walked the line. The Physiotherapist
FaceTimed my husband and daughter who were flooded with tears as
they watched. As a result of my improved balance throughout the
study I experienced many more firsts since my TBI, like washing my
hair without having to balance against the shower walls for
stability,” said Katherine Webb.
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
Treatment
The Portable Neuromodulation Stimulator (PoNS)
is a 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. Investor Relations
Contact:
Westwicke Partners on behalf of Helius Medical Technologies,
Inc.Mike Piccinino,
CFA443-213-0500investorrelations@heliusmedical.com
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