The company became public in June 2014 and raised money to perform formal registrational clinical trials and other scientific activities to support regulatory clearance in the US, Canada, Europe and Australia. PoNS™ is now authorized and commercially available in Canada for the acute treatment of chronic balance deficit due to mild-to-moderate traumatic brain injury (mmTBI), and is used in conjunction with physical therapy (PT). The device is limited to prescription use. PoNS™ is an investigational device and currently under review for market clearance by an EU Notified Body and by TGA. PoNS™ is not commercially available in the US, EU, or Australia.
Helius continues to pursue beyond-reproach scientific studies to support its technology and looks forward to responsibly driving access to PoNS Treatment™ to help improve the lives of people dealing with symptoms of neurological disease and trauma in the future.