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Helius Medical Technologies, Inc. Launches Therapeutic Experience Program; NYU Langone Health Is Initial Clinical Trial Site
-- Multi-center, company-sponsored, open label observational interventional trial to evaluate impact of subjects’ adherence to PoNS® therapy for gait
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[{"type":"text","content":"-- 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 -- NEWTOWN, Pa., Nov. 08, 2021 (GLOBE NEWSWIRE) -- 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 bet...