Helius Medical Technologies, Inc. Presents Poster at the 2022 Consortium of Multiple Sclerosis Centers (“CMSC”) Annual Meeting

Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that a poster detailing the benefits of the Company’s Portable Neuromodulation Stimulator (“PoNS”) Therapy combined with a therapeutic exercise program was presented at the 2022 Consortium of Multiple Sclerosis Centers (“CMSC”) Annual Meeting held June 1-4, 2022, in National Harbor, Maryland.

“The CMSC Annual Meeting is a wonderful opportunity to engage with thought leaders and researchers in the MS space. We are delighted to share the benefits of our innovative PoNS device and to be part of the community that is working to bring cutting edge interventions to improve gait deficits in patients with MS. It is especially gratifying that our poster was selected out of 150 to receive a prestigious award nomination,” stated Antonella Favit-VanPelt, MD, PhD, Chief Medical Officer of Helius.

“Importantly, this latest dataset provides key real-world evidence of our therapy’s clinical benefits, which can be seen at two weeks from beginning rehabilitation treatment with PoNS. We look forward to continuing to gather real-world evidence through our Therapeutic Experience Program (“TEP”), a multi-center, company-sponsored, open label observational interventional trial to evaluate the impact of subjects’ adherence to PoNS therapy for gait improvement in MS, as well as through patients’ voluntary participation to our upcoming registry program as part of the recently announced Patient Therapy Access Program,” concluded Dr. Favit-VanPelt.

Study Conclusions

• In this analysis of a real-world dataset of patients with MS with generally long duration of disease, translingual neurostimulation (PoNS Therapy) combined with a therapeutic exercise program significantly improved gait deficit at Week 2, the earliest evaluated time point, and at every subsequent time point.
• Gait deficit was assessed by the Functional Gait Assessment (“FGA”) scale. Mean improvements in FGA total scores based on observed data were highly statistically significant at all follow-up time points (paired t-test P
• Analysis of real-world data pooled with the two randomized clinical trials (“RCTs”) demonstrated, consistent with the RCT data, that PoNS Therapy is safe and effective in improving gait deficit in individuals with mild and moderate symptoms from MS. Mean improvement in the Dynamic Gait Index (DGI) assessment from baseline to Week 14 was 4.58 (95% CI: 3.62 to 5.54) for the pooled RWE and RCT analysis including all possible data at all weeks. Over 55% of patients treated with active PoNS therapy experienced ≥4 point-improvement from baseline in the DGI score.