Helius Medical Technologies Inc (NASDAQ:HSDT) shares are rising Monday after the company announced a positive outcome from the Portable Neuromodulation Stimulator (PoNS) Stroke Registrational Program.
What Happened: Micro-cap Helius Medical said key primary outcomes indicate its double-blind randomized clinical trial of active PoNS therapy met its primary endpoint, demonstrating statistically significant improvements in gait and/or balance deficit due to stroke. The company noted the study showed good tolerability and minimal adverse event incidents.
Helius plans to submit the results to the FDA under the current breakthrough device designation for an indication in stroke during the third quarter.
“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, CEO of Helius.
“We look forward to a positive outcome of the submission to the FDA and to bringing this impactful treatment to everyone living with the consequences of a stroke.”
Helius had a market cap of just $6.23 million as of Friday's close, with a total float of approximately 699,990 shares. Low-float micro-cap stocks tend to be extremely volatile, which may be driving some of Monday’s volatility.
According to Benzinga Pro, Helius also has very high short interest of 58.96%, which is likely contributing to the surge in shares on Monday.
HSDT Price Action: Helius Medical Technologies shares were up 55.1% at $13.80 at the time of publication Monday, according to Benzinga Pro.
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