Mr. Philippe Deschamps reports

HELIUS MEDICAL TECHNOLOGIS ANNOUNCES FIRST THREE SUBJECTS ENROLLED IN CANADIAN MULTIPLE SCLEROSIS FEASIBILITY STUDY

Helius Medical Technologies Inc. has enrolled the first three subjects in the multiple sclerosis feasibility study at the Montreal Neurological Institute and Hospital, and Concordia's Perform Center. The trial "Examining the efficacy of Non-invasive Neuromodulation in reducing symptoms of Multiple Sclerosis," is a double-blind, sham-controlled study of the safety and efficacy of Helius's portable neuro-modulation stimulator (PoNS) device, an investigational medical device that is designed to induce neuro-modulation by stimulating the cranial nerves found in the tongue. A total of 14 subjects will receive treatment with the non-invasive brain stimulation device and concomitant physiotherapy designed to improve both balance and gait. The primary end point, at 14 weeks, is improvement in gait as quantified by the dynamic gait index, sensory organization test and functional magnetic resonance imaging. The study is expected to conclude this summer.

"We are very pleased to begin this trial, as the design is the basis of the registrational multiple sclerosis study scheduled to initiate later in the year," said Helius's chief executive officer, Philippe Deschamps.

"The Montreal Neurological Institute and Hospital is excited to be leading the effort in this research. We are proud to be at the forefront of testing new technologies for the treatment of neurological symptoms," said Dr. Gabriel Leonard, principal investigator for the study. Dr. Yves Lapierre and Dr. Alain Ptito from the Montreal Neurological Institute and Hospital join Dr. Leonard as investigators in the study.

About the PoNS

The 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 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.

The PoNS device is believed to be the first non-invasive means for delivering neuro-stimulation 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 fibres and interconnected to the brain stem by two major cranial nerves.

Study participation

To learn more about this trial or recruitment opportunities, please contact Marcel Mazaltarim at 1-866-331-3431.

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