Helius Medical Technologies has launched the first clinical version of the Portable Neuromodulation Stimulator (PoNS) 4.0 device.
The PoNS 4.0 device is manufactured by Ximedica LLC and will be used in Helius’ registrational clinical trial, to investigate its safety and effectiveness for the treatment of balance disorder caused by traumatic brain injury.
Helius CEO Philippe Deschamps said: "The PoNS 4.0 device represents the combined design and engineering efforts of Helius and our valuable partner, Ximedica.
"Clinical device readiness keeps Helius on track with our published timelines for trial completion and submission to regulatory agencies for marketing approval."
About the PoNS
The Portable Neuromodulation Stimulator (PoNS) device is an investigational medical device being studied for the treatment of neurological symptoms caused by disease or trauma.
The PoNS is currently being studied in the United States and Canada for the treatment of balance disorder for subjects with mild to moderate Traumatic Brain Injury (mTBI), and in Canada for the treatment of gait and balance disorder for subjects with Multiple Sclerosis (MS).
The PoNS device is a non-invasive means for delivering neurostimulation through the tongue. Researchers believe that use of the tongue as a gateway to the brain may be one of the most natural, non-invasive and direct ways to stimulate the brain.
The tongue is anatomically unique, being richly inervated by thousands of nerve fibers and interconnected to the brainstem by two major cranial nerves.