The contract will support Helius’ registrational trial investigating the safety and effectiveness of the Portable Neuromodulation Stimulator (PoNS), a non-invasive brain stimulation device that is being developed for the treatment of balance disorder in patients with mild-to-moderate Traumatic Brain Injury (mTBI).
The PoNS is an investigational medical device that is designed to induce neuromodulation by stimulating the cranial nerves found in the tongue.
NHC and the USAMRMC also have a Collaborative Research and Development Agreement which was modified in January 2015. In the modified agreement, NHC takes over sponsorship of the regulatory pathway, with support from the USAMRMC.
"This important contract represents the dedication and commitment that Helius and the USAMRMC have towards delivering a therapy for traumatic brain injury patients. There is a large unmet need in both the war fighter and civilian population and this is a big step forward," said Helius CEO Phil Deschamps.
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 innervated by thousands of nerve fibers and interconnected to the brainstem by two major cranial nerves.
