NEWTOWN, Pa. - Helius Medical Technologies, Inc. (NASDAQ:HSDT), a neurotech company specializing in neuromodulation therapies, has announced the start of a new open-label study to evaluate its Portable Neuromodulation Stimulator (PoNS) for treating gait and balance deficits in chronic stroke survivors.
The study, part of a program to gain U.S. authorization for PoNS under its breakthrough designation for stroke, is set to begin enrolling patients at Brooks Rehabilitation this month.
Brooks Rehabilitation in Jacksonville, Fla., renowned for its comprehensive physical rehabilitation system, will be the first site to enroll patients in the study. The study is designed to build on promising early trial results and experiences from Canada, where PoNS is already authorized for stroke treatment.
The initiative aims to demonstrate the effects of cranial-nerve non-invasive neuromodulation (CN-NINM), delivered using PoNS Therapy, on improving gait and dynamic balance.
Dr. Antonella Favit-Van Pelt, Helius's Chief Medical Officer, expressed excitement about working with Brooks Rehabilitation and Dr. Mark Bowden, a leading expert in neurorehabilitation. Dr. Bowden, who is also contributing to the international guidelines for stroke rehabilitation, highlighted the potential of PoNS Therapy to significantly benefit over five million stroke patients suffering from walking and balance disabilities.
PoNS Therapy involves a non-implantable device that provides neurostimulation through a mouthpiece connected to a controller. It is currently indicated in the United States as a short-term treatment for gait deficit due to mild-to-moderate multiple sclerosis (MS) symptoms and is used alongside a supervised therapeutic exercise program.
The open-label study is an extension of Helius's ongoing efforts to expand clinical research and bring PoNS Therapy closer to U.S. authorization. The study's results are expected to support the company's regulatory submissions and potential future approvals.
This initiative is part of Helius Medical Technologies' broader commitment to addressing neurological deficits through innovative therapies. The company's approach amplifies the brain's natural mechanisms and promotes neuroplasticity, aiming to improve the lives of those affected by neurological diseases.
The information reported is based on a press release statement from Helius Medical Technologies, Inc.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.