Mr. Philippe Deschamps reports

HELIUS MEDICAL TECHNOLOGIES ANNOUNCES POSITIVE CLINICAL TRIAL RESULTS FROM ITS MULTIPLE SCLEROSIS PILOT STUDY

The multiple sclerosis (MS) pilot study evaluating Helius Medical Technologies Inc.'s investigational portable neuromodulation stimulator (PoNS) device has met all of its study objectives. A total of 14 subjects (seven active and seven sham control) received treatment with the non-invasive brain stimulation technology and concomitant physiotherapy. The independent trial took place at the Montreal Neurological Institute and Hospital and Concordia University's PERFORM Centre. The study objectives were to explore the potential beneficial effects of PoNS stimulation, as previously reported, and to provide data to be used for the design of future studies to support requests for marketing authorization. The study included the first use of functional MRI (fMRI) to measure the effect of PoNS while performing tasks with, and without, stimulation.

Study result highlights:

• fMRI measured the effect of PoNS neurostimulation while performing working memory and mental imagery tasks. Results suggest that the PoNS device may be facilitating neural plasticity.
• fMRI results were significantly different between the active group (who manifested brain function comparable to healthy subjects following treatment) and the control group. (p less than 0.02).
• The PoNS stimulation group showed a statistically significant improvement (p greater than 0.05).
• There was a good safety profile for the PoNS device reported in the study.

Factors to improve recruitment, screening, randomization and execution were identified and will be considered in the design of future MS studies. The results included a power analysis suggesting a sample size of 128 subjects (64 active, 64 sham) would be suitable for a definitive MS study.

"We are delighted with the findings that are consistent with prior studies. The fMRI data show that the PoNS may be changing the way the brain functions," said Helius's chief medical officer, Dr. Jonathan Sackier. "Measuring brain activity and the changes taking place through fMRI is designed to determine in an objective way if, in fact, there are indications of neuroplastic change in the brain."

"This is an exciting and promising development for our company, patients and the health care community. Addressing symptoms caused by MS has been a challenge for the medical community, and we are excited to pursue PoNS as a potential therapeutic tool," said Helius's chief executive officer, Philippe Deschamps. "We reached all the objectives of this study and are optimistic as we continue to advance the PoNS device through clinical trials."

"The researchers from the Montreal Neurological Institute and Hospital are pleased with the execution of this study and are excited by the results as they point to a new frontier in research in brain injury rehabilitation. We are happy to be on the forefront of research that may bring this technology to patients in need," said Dr. Gabriel Leonard, principal investigator for the study. Dr. Yves Lapierre and Dr. Alain Ptito from the Montreal Neurological Institute and Hospital joined Dr. Leonard as investigators in the study.

Helius would like to thank the study investigators Dr. Leonard, Dr. Ptito and Dr. Lapierre, as well as study staff, subjects, and founding scientists. The investigators and sponsor intend to submit study results for publication.

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