¡¾Helius Medical Technologies-Product PoNS¡¿Helius Medical Technologies, Inc. Announces FDA Breakthrough Device Designation for the Treatment of Dynamic Gait and Balance Deficits Following a Stroke
2021-08-17 19:51

17th August, 2021 - Helius Medical Technologies issued a press release, which is summarized as follows: 

Helius Medical Technologies, Inc. today announced that it has received Breakthrough Designation from the U.S. Food and Drug Administration (¡°FDA¡±) for its PoNS™ device with the proposed indication for use as a temporary treatment of dynamic gait and balance deficits due to symptoms from stroke, to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over.

¡°We are very pleased to announce the receipt of Breakthrough Designation for our PoNS device to treat stroke-induced gait and balance deficits,¡± said Helius CEO, Dane Andreeff. ¡°Strokes are a large and growing cause of long-term disability in the United States. An estimated 7 million Americans are living with stroke-related complications, and more than 80% of stroke survivors are estimated to develop gait impairment.¡±

Mr. Andreeff continued: ¡°Obtaining Breakthrough Designation represents an important milestone in our path to providing this underserved patient population with a non-drug, non-implantable treatment option that has the potential to significantly improve their gait and balance, their ability to walk and perform daily tasks. We look forward to building on this achievement by utilizing the Breakthrough Devices Program to facilitate our pursuit of U.S. regulatory clearance for treatment of stroke-induced symptoms in close collaboration with the FDA.¡±

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