Helius Medical announces preliminary results of the PoNSTEP study

Helius Medical Technologies announced preliminary results from its Therapeutic Experience Program open-label observational study which evaluates the impact of subjects’ adherence to the Portable Neuromodulation Stimulator Therapy program that treat gait deficit due to multiple sclerosis. The study treatment phase is complete, and the ongoing post-treatment follow-up phase will be completed by the end of the year, with full results expected to be released in early 2025. The primary endpoint of the study is aimed at demonstrating improvement in DGI from end of the 2-week supervised in-clinic treatment phase to end of the 12-week at-home, unsupervised treatment phase, relative to subjects’ adherence to PoNS device utilization in their weekly PoNS therapy program. Forty-three subjects with gait deficit due to symptoms from multiple sclerosis were enrolled with 41 participants starting the study treatment and 38 participants completing the 14-week study treatment period who are currently undergoing post treatment follow-up. PoNSTEP met the primary endpoint, showing statistically significant mean improvement in DGI during Phase 2 and a linear relationship between PoNS Therapy adherence and improvement in DGI scores from end of Phase 1 to end of treatment at week 14: In Phase 1, the average therapy adherence was almost 90% with a mean improvement of 2.5 points in DGI scores from baseline to the end of week 2 without, however, a clear correlation between adherence and DGI improvement. In Phase 2, the average therapy adherence was 67% with a mean incremental improvement, at week 14, of an additional 2.8 points in DGI scores from the improvement achieved at the end of Phase 1. In contrast to Phase 1, improvement in Phase 2 DGI was significantly moderated by PoNS adherence. Over the course of the 14-week treatment, the average therapy adherence met or exceeded 70% of the recommended, on label, PoNS Therapy utilization and led to a mean improvement of 5.0 points in DGI from baseline to the end of the 14-week treatment period moderated by adherence. Among 23 participants who met or exceeded 70% therapy adherence, more than 65% experienced a cumulative mean DGI improvement of at least 5 points and approximately 74% gained at least 4-point improvement from baseline to end of treatment. The preliminary descriptive analysis of the active treatment data from Phase 1 and Phase 2 demonstrates that, overall, 66% of participants gained a clinically meaningful improvement of at least 4 points in the DGI assessment over the course of the therapy. In addition, 71% of participants gained at least a 2-point improvement in DGI in the first 2 weeks of in-clinic treatment and 68 % had an incremental DGI improvement of at least 2 points over the course of the remaining 12 weeks of at-home therapy. In line with the clinical evidence from PoNS clinical studies and real-world utilization data, 50% of participants who used PoNS Therapy for the recommended 100-120 min/day, equivalent to 85% and 100% therapy adherence respectively, achieved over a 6-point improvement in DGI from baseline over 14 weeks of treatment.