Regulatory Disclaimer

The Portable Neuromodulation Stimulator (PoNS^®) is an authorized medical device in the US. The PoNS device is indicated for use as a short-term treatment of gait deficit due to mild to moderate symptoms from multiple sclerosis (MS) and is to be used as an adjunct to a supervised therapeutic exercise program in patients aged 22 and older by prescription only.

PoNS™ is authorized for sale in Canada for three indications: (i) for use as a short-term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used in conjunction with physical therapy; and (ii) for use as a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and is to be used in conjunction with physical therapy; and (iii) for use as a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from stroke, to be used in conjunction with physical therapy.

PoNS^® is authorized in Australia (AUS TGA) as a non-implantable neurostimulator intended for short-term use by healthcare professionals as an adjunct to a therapeutic exercise program to improve balance and gait. It is not yet commercially available.