The PoNS device is used to treat dynamic gait and balance deficits caused due to symptoms from stroke. Credit: Colin Behrens / Pixabay.

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.