NEWTOWN, PA — Helius Medical Technologies, Inc. (Nasdaq: HSDT) has announced promising results from its PoNS Therapeutic Experience Program (PoNSTEP), demonstrating the effectiveness of its PoNS Therapy in improving gait deficits for people with mild-to-moderate multiple sclerosis (MS). The study highlights long-term therapeutic benefits and a strong connection between treatment adherence and improved outcomes.
The PoNSTEP study involved 43 patients with gait impairments caused by MS who underwent 14 weeks of rehabilitation, combining the Portable Neuromodulation Stimulator (PoNS) device with physical therapy. Results revealed a significant mean improvement of 5.00 points on the Dynamic Gait Index (DGI) at week 14 (p<0.001). Critically, therapy adherence emerged as a key factor in achieving these gains, with higher adherence correlating to deeper improvements during the home-based phase of treatment.
Dr. Antonella Favit-Van Pelt, Helius’ Chief Medical Officer, emphasized the significance of these findings. “The results from this study validate existing evidence of the efficacy of PoNS across clinical data and real-world utilization of the therapy by demonstrating durability of effect as further evidence of its long-term therapeutic benefits,” she stated. “PoNS Therapy’s neuromodulation effect on brain mechanisms of motor control is likely to enhance neuroplasticity and contribute to maintain PoNS therapeutic effect on gait deficit in people with MS.”
The 6-month follow-up phase confirmed the durability of the therapy’s effects, with only one participant showing significant functional decline post-treatment. Furthermore, the study observed only a minimal mean decline in DGI scores of -4.1%, indicating PoNS Therapy’s lasting benefits.
Dane Andreeff, President and CEO of Helius, highlighted the importance of treatment compliance. “We are pleased to report the PoNSTEP study results corroborate the known evidence of PoNS Therapy’s efficacy in improving gait deficit due to MS,” he said. “Like many therapeutics, treatment compliance is key to achieving incremental and lasting therapeutic beneficial effects with PoNS Therapy. This important study provides convincing evidence of the role of neuroplasticity for durable gait function improvement in MS.”
Conducted across six Centers of Excellence in the U.S., the PoNSTEP study is a significant step forward in advancing neuromodulation as a therapy for MS patients. With its innovative PoNS device and increasing clinical evidence, Helius Medical Technologies aims to bring effective gait rehabilitation solutions to patients facing mobility challenges.
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