Helius Medical Technologies, Inc. Launches Therapeutic Experience Program; NYU Langone Health Is Initial Clinical Trial Site
November 08 2021 - 6:05AM
Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the
“Company”), a neurotech company focused on neurological wellness,
today announced the launch of its Therapeutic Experience Program
(“TEP”) with NYU Langone Health as its first Center of Excellence.
The TEP study is designed to assess adherence to Portable
Neuromodulation Stimulator (PoNS) therapy in patients with multiple
sclerosis (“MS”).
“We are excited to partner with one of the
nation’s premier academic medical centers on this important program
aiming to provide US clinicians with the opportunity to evaluate
PoNS therapy for MS patients with gait deficit in a real-world
environment,” said Antonella Favit-Van Pelt, M.D., Ph.D., Helius'
Chief Medical Officer. “Through NYU Langone Health and future
Centers of Excellence, the TEP study will enable key opinion
leaders in the management of MS to build their knowledge of PoNS
therapy and advise the broader medical community.”
“For people with mild to moderate symptoms of
MS, gait deficit can greatly affect function, independence, and
quality of life,” said Leigh E. Charvet, PhD, NYU Langone Health.
“So far, non-pharmacological interventions have had limitations,
but Helius' clinical evidence has shown that PoNS can be an
effective therapeutic option for our patients. We’re thrilled to
move forward and participate in the program as, for clinicians, the
TEP study will answer a crucial scientific question: what impact
does patient’s adherence to PoNS therapy regimen have on a
meaningful therapeutic outcome?”
About the Therapeutic Experience
Program
The Therapeutic Experience Program (“TEP”) is a
Helius-sponsored, open label observational, interventional
multi-center outcome research trial designed to assess adherence to
on-label PoNS therapy for improvement in gait deficits for patients
with multiple sclerosis (“MS”) in a real-world clinical setting.
The study will rate subjects’ adherence to PoNS therapy, which
combines the PoNS device with physical therapy, to better
understand the relationship between adherence to the treatment
regimen and therapeutic functional outcome. The primary endpoint of
the study is maintenance of gait improvement from the end of
supervised therapy (Phase 1) to the end of unsupervised therapy
(Phase 2) in relation to the subject’s adherence to PoNS therapy.
The secondary endpoint is improvement of gait and balance deficit
over time and clinical global impression of change.
The study will be conducted at ten to twelve
Centers of Excellence across the United States, with an estimated
four PoNS devices per site. Enrollment is expected to begin late in
the fourth quarter of 2021 and continue through mid-2022. A total
of fifty to sixty patients with MS are expected to take part in the
program.
About Helius Medical Technologies,
Inc.
Helius Medical Technologies is a leading
neurotech company in the medical device field focused on neurologic
deficits using non-implantable platform technologies that amplify
the brain’s ability to compensate and promotes neuroplasticity,
aiming to improve the lives of people dealing with neurologic
diseases. 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
Therapy
The Portable Neuromodulation Stimulator (PoNS)
is an innovative non-surgical device, inclusive of a controller and
mouthpiece, which delivers electrical stimulation to the surface of
the tongue to provide treatment of gait deficit. The PoNS device 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. It is authorized for sale in Canada for two
indications: (i) PoNS is authorized for use as a short term
treatment (14 weeks) of chronic balance deficit due to
mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used
in conjunction with physical therapy; and (ii) PoNS is authorized
for use 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.
About NYU Langone Health
NYU Langone Health is a world-class,
patient-centered, integrated academic medical center, known for its
excellence in clinical care, research, and education. It comprises
more than 200 locations throughout the New York area, including six
inpatient locations, a children’s hospital, three emergency rooms
and a level 1 trauma center. Also part of NYU Langone Health is the
Laura and Isaac Perlmutter Cancer Center, a National Cancer
Institute designated comprehensive cancer center, and NYU Grossman
School of Medicine, which since 1841 has trained thousands of
physicians and scientists who have helped to shape the course of
medical history. For more information, visit
www.nyulangone.org.
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,” “expect,”
“continue,” “will,” “goal,” “aim” and similar expressions. Such
forward-looking statements include, among others, statements
regarding expected enrollment, patient participation and other
details of the TEP study and the ability of key opinion leaders in
the management of MS to build their knowledge of PoNS® therapy and
advise the broader medical community.
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, secure state distribution licenses, build a
commercial team and build relationships with Key Opinion Leaders,
neurology experts and neurorehabilitation centers, market awareness
of the PoNS device, future clinical trials and the clinical
development process, manufacturing and supply chain risks, the
product development process and FDA regulatory submission review
and approval process, other development activities, ongoing
government regulation, and other risks detailed from time to time
in the “Risk Factors” section of the Company’s Annual Report on
Form 10-K for the year ended December 31, 2020, its Quarterly
Report on Form 10-Q for the quarter ended June 30, 2021 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.
Investor Relations Contact
Lisa M. Wilson, In-Site Communications, Inc.T:
212-452-2793E: lwilson@insitecony.com
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