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NEWTOWN, Pa. - Helius Medical Technologies, Inc. (NASDAQ:HSDT), a neurotech company with a market capitalization of $3.84 million, announced significant findings from the PoNS Therapeutic Experience Program (PoNSTEP) study, which demonstrated durable long-term effects of the Portable Neuromodulation Stimulator (PoNS) therapy on gait improvement in individuals with Multiple Sclerosis (MS). According to InvestingPro data, while the company maintains strong liquidity with a current ratio of 3.61, it faces challenges with negative gross margins and accelerated cash burn.
The study, involving 43 patients with mild-to-moderate MS gait deficits, revealed a total mean improvement of 5.00 in the Dynamic Gait Index (DGI) at week 14, with statistically significant results (p
The research emphasized the importance of adherence to the therapy regimen. During Phase 2 of the study, average adherence was 71%, and a linear association between adherence levels and gait improvement was observed. Further, participants with adherence levels of 85% or higher showed a mean DGI improvement of 3.7 points, compared to a 2.0-point improvement for those with less adherence.
At a six-month follow-up, only one of the 28 reassessed patients exhibited a 30% or greater decline in DGI, indicating the long-term therapeutic effect of PoNS therapy. The study's results support the efficacy of PoNS therapy in improving gait deficits due to MS and highlight the role of neuroplasticity in maintaining these improvements.
Antonella Favit-Van Pelt, M.D., Ph.D., Chief Medical (TASE:PMCN) Officer of Helius, stated the PoNSTEP study is a key milestone in understanding neuromodulation's role in gait function rehabilitation. Dane Andreeff, President and CEO of Helius, expressed satisfaction with the study's corroboration of PoNS Therapy's effectiveness and emphasized the importance of treatment compliance.
PoNS therapy is currently available in the United States as a treatment for gait deficit due to MS for patients 22 years and older, and in Canada and Australia for additional indications. The study's findings are set to be presented at upcoming scientific conferences, as Helius Medical Technologies continues to explore the potential of PoNS therapy in improving the lives of those with neurological diseases. The market has responded positively to these developments, with the stock showing a significant return of over 21% in the past week and 53% year-to-date. For deeper insights into HSDT's valuation and 15+ additional ProTips, visit InvestingPro, where you'll find comprehensive analysis in the Pro Research Report, part of our coverage of 1,400+ US equities.
This article is based on a press release statement from Helius Medical Technologies.
In other recent news, Helius Medical Technologies has exceeded the initial enrollment target for its stroke registrational program, indicating progress in demonstrating the Portable Neuromodulation Stimulator's (PoNS) effectiveness. Additionally, the company has secured final Medicare payment rates for the PoNS device from the Centers for Medicare and Medicaid Services (CMS), a significant step despite ongoing disputes over the pricing determinations. However, Maxim Group has downgraded Helius due to these reimbursement rate concerns.
In the midst of these developments, preliminary results from Helius's ongoing PoNSTEP study show significant improvement in Dynamic Gait Index scores for multiple sclerosis patients using PoNS Therapy. Furthermore, the company is preparing for FDA submission for stroke authorization, and is exploring the expansion of PoNS therapy for traumatic brain injury patients. Despite facing a revenue decline of 36.62% over the last year, Helius has extended its financial stability into 2025 following a successful public offering. These are the recent developments at Helius Medical Technologies.
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