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Investing.com -- Helius Medical (TASE:BLWV) Technologies Inc (NASDAQ:HSDT) stock surged 60% after the neurotech company announced positive outcomes from its PoNS Stroke Registrational Program, supporting a planned FDA submission for treating gait and balance deficits in chronic stroke patients.
The company reported that its double-blind randomized clinical trial met its primary endpoint, demonstrating statistically significant improvements in gait and/or balance deficit in stroke patients using the Portable Neuromodulation Stimulator (PoNS) therapy. The studies also confirmed minimal adverse events and good treatment tolerability.
Helius initiated the registrational program in March 2024 following positive interactions with the FDA regarding study design and endpoints. The program included two pivotal sponsor-initiated clinical studies and was supported by a pilot investigator-initiated trial. A total of 159 patients were enrolled across three studies at 10 clinical sites in the US and Canada, with 130 completing the full 24-week protocol.
"More than 7 million patients suffer from the symptoms of stroke and about 80% of them have balance and gait deficit, resulting in a large addressable market with a high risk of falling," said Dane Andreeff, Helius’ CEO.
The PoNS device currently has FDA Breakthrough Device Designation for stroke rehabilitation but remains investigational for this specific use in the United States. Helius plans to file its FDA submission for the stroke indication during the third quarter of 2025.
The company’s Chief Medical Officer, Antonella Favit-Van Pelt, indicated that detailed study results will be released this quarter.
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