NEWTOWN, PA — Helius Medical Technologies, Inc. (NASDAQ: HSDT) announced encouraging results from its PoNSTEP study, presented at the 2025 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting. The findings highlight the long-term benefits of PoNS Therapy for people with multiple sclerosis (MS), especially in improving gait deficits.
The study demonstrated that adherence to PoNS Therapy is crucial for achieving and sustaining clinically meaningful improvements in gait disability. Over 14 weeks of therapy and into a six-month follow-up period, patients adhered to a structured regimen combining the Portable Neuromodulation Stimulator (PoNS) device with physical therapy. The data also aligns with prior findings indicating PoNS Therapy’s effectiveness in treating balance deficits associated with traumatic brain injury (TBI).
“The results from this study were received with great interest as they provide the first clinical trial evidence of the long-term therapeutic benefits of PoNS Therapy for functional rehabilitation in the MS population,” said Dr. Antonella Favit-Van Pelt, Chief Medical Officer at Helius. “We are encouraged by the growing recognition of the importance of PoNS’ direct effect on the central nervous system and its targeted mechanism of action.”
During the CMSC meeting, Helius also emphasized its recent reimbursement milestones. The company’s efforts with federal and private payers are designed to increase access to PoNS Therapy for MS patients across the U.S. “We are excited by the positive conversations had at CMSC regarding both the therapeutic impact of the data presented and the recent announcement of reimbursement,” said Dane Andreeff, Helius’ President and CEO. “We anticipate that increased coverage will lower barriers to prescription and expand access to this critical therapy.”
The PoNSTEP study, an open-label multi-center trial, followed 43 MS patients with gait deficits across six U.S. Centers of Excellence. Participants underwent PoNS Therapy in two phases, beginning with supervised sessions and transitioning to home-based therapy. Data showed steady improvements measured by the Dynamic Gait Index (DGI), along with sustained effects well after treatment concluded.
PoNS Therapy, delivered via a non-invasive, tongue-stimulating mouthpiece, was approved in the U.S. for short-term use in MS patients 22 and older. Already available in Canada and Australia for MS and other conditions such as stroke and TBI, the therapy has proven effective in improving gait and balance performance.
By providing clinical evidence and securing payer support, Helius aims to drive accessibility to PoNS Therapy, helping MS patients achieve better mobility and quality of life. These advancements reaffirm the company’s commitment to innovation in neuromodulation and rehabilitation.
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