【Helius 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

Partner News

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

“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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