Helius Medical submits FDA application for stroke treatment device

NEWTOWN, Pa. - Helius Medical Technologies, Inc. (NASDAQ:HSDT), a medical device company with a market capitalization of $592.1 million and experiencing significant stock volatility according to InvestingPro, has submitted a 510(k) application to the U.S. Food and Drug Administration seeking approval for its Portable Neuromodulation Stimulator (PoNS) device to treat gait and balance deficit in patients with chronic stroke symptoms.

The application, filed under the company’s existing FDA Breakthrough Device Designation, is supported by data from its Stroke Registrational Program. According to the company’s press release, clinical trials showed the PoNS device produced a mean improvement of more than 5 points in the Functional Gait Assessment (FGA), exceeding the 4.2-point threshold considered clinically meaningful. This development comes as InvestingPro data shows the company faces challenges with a gross profit margin of -89.15% and declining revenues.

The submission includes data from three clinical trials conducted across 10 sites with 159 enrolled chronic stroke survivors. Participants used the device in conjunction with physical therapy over a 12-week treatment period and were followed for an additional 12 weeks to assess durability of results.

"Treatment with active PoNS plus physical therapy led to an adjusted mean change in FGA of 5.37 points at Week 12 compared to 3.31 points in the control group," said Antonella Favit-Van Pelt, Chief Medical Officer at Helius.

The device delivers mild electrical stimulation to the tongue and is currently approved in the United States for treating gait deficit in patients with mild-to-moderate multiple sclerosis symptoms. In Canada, it has already received authorization for use in stroke patients, as well as for traumatic brain injury and multiple sclerosis.

The company reported no treatment-related serious adverse events during the trials, with adverse events ranging between 0.0% and 14.8% that were unrelated to the PoNS device.

Helius did not provide an expected timeline for FDA review of the application. The company’s next earnings report is scheduled for November 14, 2025, as tracked by InvestingPro, which offers 12 additional exclusive ProTips and comprehensive analysis through its Pro Research Report, helping investors make informed decisions about companies like Helius Medical Technologies.

In other recent news, Helius Medical Technologies, Inc. announced a significant strategic pivot, raising $500 million through a private placement offering to focus on a Solana blockchain treasury. This financing effort, led by Pantera Capital and Summer Capital, aims to transform the company into a Solana-focused treasury entity. The offering includes common stock and pre-funded warrants, with the potential to raise an additional $750 million if all warrants are exercised. Furthermore, Helius Medical has successfully regained compliance with Nasdaq’s equity listing requirements, meeting the minimum stockholders’ equity threshold of $2.5 million. In another development, the company reported positive results from its PoNS Stroke Registrational Program, achieving statistically significant improvements in treating gait and balance deficits in chronic stroke patients. These results support a planned FDA submission for the PoNS therapy. Additionally, the company has seen substantial interest in its private investment in public equity offering, which could ultimately deliver over $1.25 billion in capital. These recent developments reflect Helius Medical’s strategic shift and ongoing efforts to enhance its financial standing and expand its therapeutic offerings.

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