Helius Medical Technologies Submits FDA 510(k) for PoNS Device Label Expansion in Stroke Treatment

Helius Medical Technologies Submits FDA 510(k) for PoNS Device Label Expansion

Helius Medical Technologies, Inc. (NASDAQ: HSDT) announced the submission of its U.S. Food and Drug Administration (FDA) 510(k) application for the PoNS device, seeking label expansion for gait and balance deficits in patients with chronic stroke symptoms. This regulatory milestone was met with significant market volatility, as HSDT shares experienced a notable decline following the announcement, despite the submission being made under the existing FDA Breakthrough Device Designation.

The Event in Detail: PoNS Device Targets Chronic Stroke Patients

The submission, filed on September 25, 2025, aims to broaden the indication for the Portable Neuromodulation Stimulator (PoNS) device, which is currently approved in the U.S. for gait deficit in patients with mild-to-moderate multiple sclerosis symptoms. The application is supported by robust data from Helius's Stroke Registrational Program (SRP), which involved three clinical trials across 10 sites with 159 chronic stroke survivors. These trials demonstrated statistically significant improvements in gait deficit, with treatment using active PoNS plus physical therapy leading to an adjusted mean change of 5.37 points in the Functional Gait Assessment (FGA) at Week 12, compared to 3.31 points in the control group. This surpassed the 4.2-point threshold considered clinically meaningful, and the therapeutic effect was maintained for at least 12 weeks post-treatment.

Analysis of Market Reaction: Navigating Regulatory Optimism and Investor Caution

Despite the positive clinical data underpinning the FDA submission, Helius Medical Technologies' stock experienced considerable downward pressure. Shares of HSDT saw a decline of 23.24%, reaching an intraday low of $8.65 before recovering to approximately $10. This volatility reflects investor caution regarding the regulatory approval process and broader market uncertainties, even as the Breakthrough Device Designation suggests a potentially expedited review pathway due to unmet medical need. Earlier in June 2025, the stock had already plunged 20.00% intraday, marking a 54.14% cumulative decline over two days, despite presenting positive results from its PoNSTEP study for multiple sclerosis.

Broader Context & Implications: Market Opportunity Amidst Financial Headwinds

The potential label expansion for the PoNS device targets a significant market of over 7 million stroke patients in the U.S., with approximately 80% experiencing gait and balance deficits. This represents a substantial addressable market for Helius Medical Technologies. However, the company faces financial challenges, as indicated by an InvestingPro gross profit margin of -89.15% and declining revenues. This financial backdrop, coupled with the inherent uncertainties of regulatory approval, likely contributed to the cautious investor reaction. The PoNS device's current authorization in Canada for stroke patients, traumatic brain injury, and multiple sclerosis may offer a precedent for its potential U.S. label expansion.

Expert Commentary on the Regulatory Milestone

Dane Andreeff, CEO of Helius, emphasized the significance of the submission:

"Submitting our 510(k) application to the FDA brings the benefits on gait from PoNS Therapy one step closer to stroke patients."

Similarly, Antonella Favit-Van Pelt, Chief Medical Officer at Helius, noted the clinical efficacy:

"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."

Looking Ahead: Regulatory Decisions and Financial Performance in Focus

The market will closely monitor the FDA's review process for the PoNS device's label expansion. A successful approval would significantly expand Helius's market reach and could lead to a positive revaluation of the company's prospects. Conversely, any delays or denial could exacerbate current investor skepticism. The company's upcoming earnings report, scheduled for November 14, 2025, will also provide further insights into its financial health and strategic direction, particularly concerning its ability to navigate financial challenges while pursuing significant market opportunities in neurorehabilitation.

source:

[1] Helius Announces FDA 510(k) Submission for PoNS® Device Label Expansion in Stroke (https://finance.yahoo.com/news/helius-announc ...)[2] Solana Company Stock Plunges 40% After SOL Price Drop Hits Treasury Value - Stocktwits (https://vertexaisearch.cloud.google.com/groun ...)[3] ATAI Life Sciences' BPL-003 Receives FDA Breakthrough Designation - TipRanks.com (https://vertexaisearch.cloud.google.com/groun ...)

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