8th November,
2021 – Helius Medical Technologies issued a press
release, which is summarized as follows:
Multi-center, company-sponsored, open label observational
interventional trial to evaluate impact of subjects’ adherence to PoNS therapy
for gait improvement in Multiple Sclerosis
Program to include 10-12 U.S. Centers of Excellence;
enrollment to commence in Q4 2021
Helius Medical
Technologies, Inc. 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?”
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