Helius Medical to Start Registrational Trial

According to officials with Newtown, Pa.-based Helius Medical Technologies Inc., the company recently met with the U.S. Food and Drug Administration as part of the agency’s pre-submission process regarding Helius’s protocol for a double-blind, randomized, sham-controlled study of the safety and effectiveness of the company’s Portable Neuromodulation Stimulator 4.0 device for cranial nerve noninvasive neuromodulation training in subjects with a chronic balance deficit due to mild-to-moderate traumatic brain injury (TBI).

During the meeting, the FDA provided Helius with “valuable feedback” on its TBI study protocol, and informed Helius that it can proceed with the study, officials said. The agency also determined the study to be a non-significant risk device study.

The Portable Neuromodulation Stimulator (PoNS) device is an investigational medical device being studied for the treatment of neurological symptoms caused by disease or trauma as part of a physical therapy program. The PoNS is currently being studied in the United States for the treatment of balance disorder for subjects with mild to moderate traumatic brain injury, and in Canada for the treatment of gait and balance disorder for subjects with multiple sclerosis.

According to the company, the PoNS device is believed to be the first 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 brain stem by two major cranial nerves.

The multi-site TBI study will take place at Oregon Health and Science University Center for Regenerative Medicine (Portland, Ore.), Orlando Regional Medical Center (Orlando, Fla.), and the Montreal Neurofeedback Center (Montreal, Canada).

The primary endpoint of the trial is improvement in chronic balance deficit analyzed by the sensory organization test at five weeks. Recruitment for the study is set to begin in a few weeks.

Helius Medical Technologies is focused non-invasive neurological technologies that amplify the brain’s ability to heal itself. The company intends to file for FDA clearance for the PoNS device.