Helius Medical Technologies (CSE: HSM) (OTCQB: HSDT) ("Helius", or the "Company") and the U.S. Army Medical Research and Materiel Command ("USAMRMC") announce the launch of a Phase 3 clinical trial to investigate the safety and effectiveness of the Portable Neuromodulation Stimulator ("PoNS™") 4.0 device, 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 trial is intended to serve as the basis for seeking Canadian and U.S. marketing approvals of the PoNS™. The PoNS™ is an investigational medical device that is designed to induce neuromodulation by stimulating the cranial nerves found in the tongue. The trial, a double-blind, randomized, sham-controlled study of the safety and effectiveness of the PoNS™ device for cranial nerve noninvasive neuromodulation ("CN-NINM") training in subjects with a chronic balance deficit due to mTBI, is a seven-month study being conducted at three sites: the Montreal Neurofeedback Center; the Oregon Health & Science University Center for Regenerative Medicine; and the Orlando Regional Medical Center. A total of 120 subjects will participate in the study. The primary endpoint at five weeks is improvement in chronic balance deficit as analyzed by the Sensory Organization Test ("SOT"). The purpose of this study is to demonstrate that cranial nerve non invasive neuromodulation ("CN-NINM"), which combines the PoNS™ device with a unique physiotherapy regiment, may provide new rehabilitative opportunities for patients suffering from chronic symptoms. "Together with our partners at the USAMRMC, we are very pleased to announce the launch of our pivotal Phase 3 mTBI trial today," said Helius' CEO, Philippe Deschamps. "Traumatic Brain Injury ("TBI") remains a serious public health problem both for the military and civilian populations for which there have been almost no new developments in treatment since the introduction of physical therapy several decades ago. There is also a large population of TBI patients who develop chronic symptoms, for which traditional physical therapy has proven ineffective."