NEWTOWN, PA — Helius Medical Technologies, Inc., a prominent player in the healthcare technology sector, has announced a significant stride towards revolutionizing stroke therapy. The company has concluded negotiations with the U.S. Food and Drug Administration (FDA) to optimize the development plan for its innovative stroke program.
The program focuses on evaluating the effects of cranial-nerve non-invasive neuromodulation (CN-NINM) using PoNS Therapy® on gait and dynamic balance in chronic stroke survivors. The approach includes two controlled studies that will enroll around 100 subjects, marking a significant step forward in stroke therapy research.
The clinical program will also feature a randomized, controlled, double-blinded investigator-initiated trial (IIT) led by Dr. Steven Kautz from the Medical University of South Carolina. This trial, which began enrolling 60 participants in September 2023, is being conducted in collaboration with Dr. Mark Bowden at Brooks Rehabilitation.
Dr. Antonella Favit-Van Pelt, Helius’ Chief Medical Officer, highlighted the significance of the FDA’s approval, stating, “Meeting the agency’s expectations provides us with an efficient path to delivering PoNS Therapy to stroke patients.”
The potential of PoNS Therapy was demonstrated in a real-world evidence database analysis of Canadian stroke patients. It revealed a significant and clinically meaningful improvement in gait, with over a quarter of patients no longer at risk of falling after a 14-week treatment regimen.
Helius’ CEO, Dane Andreeff, emphasized the company’s commitment to enhancing access to PoNS Therapy for stroke patients in North America. He stated, “Our development approach aims to not only save millions in healthcare costs but also expedite authorization in the U.S., where an estimated 80% of the seven million stroke patients experience impaired walking.”
The proposed Transitional Coverage of Emerging Technologies (TCET) pathway could expedite Medicare coverage of certain breakthrough devices, including PoNS Therapy. If authorized to treat stroke in the U.S., PoNS would have temporary coverage within six months after FDA market authorization.
The move by Helius Medical Technologies is a promising development for stroke patients and the healthcare industry. With the potential to significantly improve gait and balance in stroke survivors, PoNS Therapy could redefine the future of stroke rehabilitation.
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