Core Insights - Helius Medical Technologies has filed a 510(k) submission with the FDA for the PoNS device to expand its label for treating gait and balance deficits in chronic stroke patients [1][5] - The PoNS device has demonstrated statistically significant improvements in gait deficits compared to control groups in clinical trials [2][4] Company Overview - Helius Medical Technologies focuses on neurologic deficits using an orally applied technology platform that enhances neuroplasticity and compensatory mechanisms in the brain [8] - The company's first commercial product is the Portable Neuromodulation Stimulator (PoNS), which is designed for home use alongside physical rehabilitation [5][8] Clinical Trial Results - The PoNS device showed a mean improvement of 5.37 points in the Functional Gait Assessment (FGA) at Week 12, compared to 3.31 points in the control group, indicating statistical superiority [4] - The treatment was well tolerated, with no serious adverse events related to the PoNS device reported across the trials [4] Regulatory and Market Position - The PoNS device is already authorized for sale in Canada and Australia for various indications related to gait and balance deficits [7] - The FDA submission is seen as a significant step towards increasing patient access to the PoNS therapy for stroke rehabilitation [5]

Core Insights - The PoNS Therapeutic Experience Program (PoNSTEP) study demonstrates long-term benefits of PoNS Therapy for gait deficits in individuals with Multiple Sclerosis (MS) [1][2] - The study results were presented at the 2025 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, highlighting the importance of treatment adherence for achieving clinically meaningful improvements [2][3] Study Details - The PoNSTEP study is an open-label, observational, interventional multi-center research study assessing adherence to PoNS Therapy for gait deficits in MS patients [5] - The study involved 43 MS participants and was conducted at six Centers of Excellence across the United States [5] - The primary endpoint is the maintenance of gait improvement from the end of supervised therapy to the end of unsupervised therapy, with secondary endpoints including maintenance of improvement over six months [5] Treatment and Mechanism - PoNS Therapy combines the Portable Neuromodulation Stimulator (PoNS) device with physical therapy, applied for 100-120 minutes per day [5][7] - The PoNS device delivers mild electrical impulses to the tongue and is indicated for short-term treatment of gait deficits due to mild-to-moderate MS symptoms [7][8] Clinical Impact and Recognition - The study provides the first clinical trial evidence of PoNS Therapy's long-term benefits for functional rehabilitation in the MS population [3] - There is growing recognition of PoNS Therapy's direct effect on the central nervous system and its targeted mechanism of action compared to other interventions [3] Reimbursement and Access - Helius Medical Technologies has successfully obtained initial reimbursement from federal and private payers, which is expected to lower barriers to prescribing PoNS Therapy [4] - The company is actively engaging with health insurance providers to expand access to PoNS Therapy for all individuals with MS [3][4]