NEWTOWN, Pa. - Helius Medical Technologies, Inc. (NASDAQ:HSDT), a neurotech company, has recently completed discussions with the U.S. Food and Drug Administration (FDA) to refine its development plan for a stroke treatment program. This program is focused on assessing cranial-nerve non-invasive neuromodulation (CN-NINM) delivered by PoNS Therapy® for improving gait and dynamic balance in chronic stroke survivors.
The company’s registrational program includes two controlled studies, leveraging an investigator-initiated trial (IIT) at the Medical University of South Carolina (MUSC) and a company-sponsored study. The IIT, which began enrolling participants in September 2023, is a randomized, controlled, double-blinded trial led by Dr. Steven Kautz with Brooks Rehabilitation as a second site.
Dr. Antonella Favit-Van Pelt, Helius’ Chief Medical Officer, highlighted the importance of aligning the clinical study designs with FDA expectations to efficiently advance PoNS Therapy towards potential authorization under its breakthrough designation for stroke.
In Canada, PoNS Therapy has shown significant improvements in gait for stroke patients, evidenced by a 6.74-point increase in the functional gait assessment (FGA) score over 14 weeks. Prior to treatment, over 93% of these patients were considered at risk of falling. Post-treatment, 28% were no longer categorized as such, a notable achievement compared to the minimal impact of standard physical therapy alone.
Dane Andreeff, President and CEO of Helius, expressed the company's commitment to making PoNS Therapy accessible to North American stroke patients who suffer from gait and balance deficits. The therapy's development could potentially save millions in healthcare costs and expedite U.S. authorization, with a regulatory submission planned for early 2025 and marketing authorization anticipated later that year.
If authorized for stroke treatment in the U.S., PoNS could benefit from the Transitional Coverage of Emerging Technologies (TCET) pathway, facilitating Medicare coverage for breakthrough devices. PoNS has received breakthrough designations for multiple sclerosis and stroke, with around 90% of stroke patients covered by Medicare.
This article is based on a press release statement from Helius Medical Technologies, Inc.
InvestingPro Insights
As Helius Medical Technologies, Inc. (NASDAQ:HSDT) works toward FDA authorization for its PoNS Therapy® for stroke treatment, it's important for investors to have a clear picture of the company's financial health and market performance. According to real-time data from InvestingPro, Helius Medical Technologies holds a market capitalization of $4.99 million and a price/book ratio as of Q3 2023 of 1.65, reflecting the company's asset valuation in the market. Despite a modest revenue growth of 3.8% in the last twelve months as of Q3 2023, the company has experienced a significant operating income margin of -1602.53% during the same period, indicating substantial operational costs relative to revenue.
InvestingPro Tips reveal a nuanced financial situation: Helius Medical Technologies has more cash than debt, providing some financial stability, and its liquid assets exceed short-term obligations, suggesting the company can cover its short-term liabilities. However, the company is quickly burning through cash and has not been profitable over the last twelve months. Analysts also do not anticipate the company will be profitable this year, which is a critical consideration for potential investors. Additionally, with no dividend payments to shareholders and a historical price performance that has seen significant declines over the last five years, investors should be aware of the risks associated with this stock.
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