The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Helius Medical Technologies’ Portable Neuromodulation Stimulator (PoNS) device.
The designation allows the non-surgical device to be used as a temporary treatment for dynamic gait and balance deficits after a stroke as an adjunct to a therapeutic exercise programme in patients aged 22 years and above.
It delivers electrical stimulation to the tongue surface to provide treatment of gait deficit.
The device is commercially available in Canada for use as a short-term treatment (14 weeks) of gait deficiency due to mild-to-moderate symptoms from traumatic brain injury in conjunction with physical therapy.
In the US, it is authorised and indicated for patients with prescription only.
Helius Medical Technologies CEO Dane Andreeff said: “Strokes are a large and growing cause of long-term disability in the United States. An estimated seven million Americans are living with stroke-related complications, and more than 80% of stroke survivors are estimated to develop gait impairment.
“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 utilising the Breakthrough Devices Program to facilitate our pursuit of US regulatory clearance for treatment of stroke-induced symptoms in close collaboration with the FDA.”
Currently, the device is an investigational medical device in Australia and is under premarket review by the Australia Therapeutic Goods Administration.