Helius Medical Completes Enrollment in Multiple Sclerosis Feasibility Study

Helius Medical Technologies has enrolled the first three subjects in a Multiple Sclerosis (“MS”) feasibility study in Canada.

The trial, taking place at the Montreal Neurological Institute and Hospital and Concordia’s Perform Center in Montreal, Canada, is a double-blind, sham-controlled study of the safety and efficacy of Helius’ Portable Neuromodulation Stimulator (PoNS) device, an investigational medical product designed to induce neuromodulation 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 endpoint, at 14-weeks, is improvement in gait as quantified by the Dynamic Gait Index, Sensory Organization Test and Functional Magnetic Resonance imaging (fMRI).

Achieving full enrollment of this study within our forecasted timeline is a significant milestone for Helius and our research into multiple sclerosis,” said Helius CEO Philippe Deschamps. “This pilot protocol is primarily designed to be an external validation of a previously published, internally managed study of similar design. In addition, the results of this study will help inform the design of a larger, efficacy focused, registrational MS protocol anticipated to begin by the end of the year.”

“We are proud of the progress that has been made in the clinical development and validation of this protocol. We are pleased with the smooth execution of the trial and we are looking forward to the data analyses, which we hope will reflect the hard work of both the clinical team and the subjects,” said Gabriel Leonard, Ph.D., principal investigator of the study. Yves Lapierre, M.D., and Alain Ptito, Ph.D., from the Montreal Neurological Institute and Hospital also are investigators in the study.

The PoNS device is an investigational product being studied for the treatment of neurological symptoms caused by disease or trauma. The PoNS currently is 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 MS.

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 inervated by thousands of nerve fibers and interconnected to the brainstem by two major cranial nerves.