Helius Medical Technologies, Inc. Initiates Open-Label Study for Registrational Program in Stroke
March 12, 2024 at 08:59 am EDT
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Helius Medical Technologies, Inc. announced the initiation of an open-label study for its registrational program in stroke. The program was established based on encouraging early trial results as well as real-world evidence from Canada, where PoNS is already authorized for treatment of stroke, and aims to establish the effects of cranial-nerve non-invasive neuromodulation (?CN-NINM?), delivered using PoNS Therapy®, on gait and dynamic balance in chronic stroke survivors.
Under the direction of Mark Bowden, PT, PhD, Brooks Rehabilitation (?Brooks Rehabilitation?) will be the first site to enroll patients. Brooks Rehabilitation is already a participant site to the Company?s ongoing investigator-initiated, placebo-controlled study in stroke, led by Dr. Steven Kautz at the Medical University of South Carolina.
Helius Medical Technologies, Inc. is a neurotech company in the medical device field. It is focused on neurologic deficits using orally applied technology platform that amplifies the brainâs ability to engage physiologic compensatory mechanisms enhancing the lives of people dealing with neurologic diseases. It develops, licenses, or acquires non-implantable technologies targeted at reducing symptoms of neurological disease or trauma. Its product Portable Neuromodulation Stimulator (PoNS) is a non-implantable medical device, inclusive of a controller and mouthpiece, which delivers mild electrical stimulation to the surface of the tongue to provide treatment of gait deficit and chronic balance deficit. PoNS Therapy is integral to the overall PoNS solution and is the physical therapy applied by patients during use of the PoNS neuromodulation stimulator. PoNS is used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only.