NEWTOWN, Pa. - Helius Medical Technologies, Inc. (NASDAQ:HSDT), a neurotech company, has announced preliminary results from a study evaluating its Portable Neuromodulation Stimulator (PoNS®) Therapy for gait deficits in multiple sclerosis (MS) patients. The PoNSTEP study, which is still in progress with full results expected in early 2025, has met its primary endpoint, showing a significant mean improvement in Dynamic Gait Index (DGI) scores, particularly among participants who adhered to the therapy regimen.
The study enrolled 43 subjects, with 38 completing the 14-week treatment period. Initial findings indicate a linear relationship between adherence to the weekly PoNS Therapy and DGI score improvements. In the first phase of the study, while high adherence was noted, no clear correlation between adherence and DGI improvement was observed. However, during the second phase, where participants continued therapy at home, a significant correlation emerged.
The average therapy adherence during the second phase was 67%, with an additional mean improvement of 2.8 points in DGI scores from the end of the first phase. Participants who met or exceeded 70% adherence experienced notable improvements in their gait deficits. Over two-thirds of participants achieved a clinically meaningful improvement in their DGI assessment over the therapy course.
Dr. Salvatore Napoli, Medical Director at Neurology Center of New England, noted the importance of the at-home rehabilitation component of PoNS Therapy in achieving optimal results and the high compliance rates among patients.
The PoNS device is a non-implantable, orally applied therapy that delivers neurostimulation in conjunction with physical rehabilitation exercises. The ongoing study aims to better understand the relationship between therapy adherence and gait deficit improvement in a real-world clinical setting.
Helius Medical Technologies specializes in neurologic deficits using technology that promotes neuroplasticity. The PoNS device is currently indicated for use in the United States for gait deficit due to mild-to-moderate MS symptoms and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only.
The company expects to complete the PoNSTEP study by the end of 2024 and release comprehensive results in early 2025. This announcement is based on a press release statement from Helius Medical Technologies.
In other recent news, Helius Medical Technologies has reported its Q2 2024 financial results, revealing a decrease in total revenue from the previous year, along with an operating loss. Despite this, the company remains hopeful for future revenue growth due to recent developments, such as the strategic expansion of its PoNS therapy accessibility for multiple sclerosis patients. This includes partnerships with federal agencies like Lovell Government Services and the anticipation of Medicare reimbursement.
The company has also extended its financial stability into 2025, thanks to a successful public offering. Furthermore, Helius Medical Technologies is preparing for FDA submission for stroke authorization and is investigating the expansion of PoNS therapy for traumatic brain injury patients.
The company's Q2 revenue was $182,000, a decrease from last year's $256,000, and it reported an operating loss of $3.2 million. However, the company is expecting a significant revenue boost with the expected Medicare reimbursement, effective from October 1, 2024.
These are just some of the recent developments at Helius Medical Technologies, a company that, despite current financial challenges, is laying the groundwork for potential growth in the healthcare market.
InvestingPro Insights
As Helius Medical Technologies (NASDAQ:HSDT) reports promising preliminary results for its PoNS Therapy, it's crucial to consider the company's financial health and market performance. According to InvestingPro data, HSDT's market capitalization stands at a modest $2.41 million, reflecting its status as a small-cap biotech company.
Two relevant InvestingPro Tips highlight the company's current challenges. Firstly, HSDT is "quickly burning through cash," which is not uncommon for biotech firms investing heavily in research and development. Secondly, the stock has "taken a big hit over the last week," with a 1-week price total return of -14.65%.
These insights underscore the volatile nature of biotech investments, especially for companies like Helius that are still in the clinical trial phase. While the PoNSTEP study results are encouraging, investors should be aware that HSDT's revenue for the last twelve months as of Q2 2024 was only $0.59 million, with a significant revenue decline of -29.7% over the same period.
It's worth noting that InvestingPro offers 12 additional tips for HSDT, providing a more comprehensive analysis for those interested in delving deeper into the company's prospects and challenges.
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