Helius Medical Technologies Achieves Full Enrollment in Canadian MS Feasibility Study

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NEWTOWN, Pa.--Helius Medical Technologies (“Helius”, “HMT”, or the “Company”) announced that it has achieved full enrollment for its Multiple Sclerosis pilot clinical trial at the Montreal Neurological Institute. The trial, “Examining the efficacy of non-invasive neuromodulation in reducing symptoms of Multiple Sclerosis, launched in February 2015, is a 14-subject, blinded feasibility study investigating Helius’ Portable Neuromodulation Stimulator (PoNS™) and physiotherapy protocol on the rehabilitation of balance and gait symptoms in subjects with Multiple Sclerosis.

“Non-invasive neuromodulation to improve gait in chronic multiple sclerosis: a randomized double blind controlled pilot trial”

Subjects enrolled in the study receive treatment with the PoNS 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 DGI (Dynamic Gait Index) and improvement in balance as measured by the Sensory Organization Test (SOT). The study, including data analysis, is expected to conclude in Q4 2015.

“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 significant 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,” added Dr. Gabriel Leonard, Principal Investigator of the study.

* “Non-invasive neuromodulation to improve gait in chronic multiple sclerosis: a randomized double blind controlled pilot trial”: Journal of NeuroEngineering and Rehabilitation 2014, 11:79

About the PoNS

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 (mTBI), and in Canada for the treatment of gait and balance disorder for subjects with Multiple Sclerosis (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 innervated by thousands of nerve fibers and interconnected to the brainstem by two major cranial nerves.

About Helius Medical Technologies (HMT)

Helius Medical Technologies is a medical technology company focused on neurological wellness. HMT seeks to use unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. HMT intends to file for U.S. Food and Drug Administration clearance for the PoNS™ device. For more information, please visit www.heliusmedical.com.

About the Montreal Neurological Institute

The Montreal Neurological Institute and Hospital – (“The Neuro”) is a world-leading destination for brain research and advanced patient care. Since its founding in 1934 by renowned neurosurgeon Dr. Wilder Penfield, The Neuro has grown to be the largest specialized neuroscience research and clinical center in Canada, and one of the largest in the world. The seamless integration of research, patient care, and training of the world’s top minds make The Neuro uniquely positioned to have a significant impact on the understanding and treatment of nervous system disorders. The Montreal Neurological Institute is a McGill University research and teaching institute. The Montreal Neurological Hospital is part of the Neuroscience Mission of the McGill University Health Centre.

Cautionary Disclaimer Statement:

The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

This news release contains forward-looking statements relating to the completion of the listing of the Company’s shares on the Canadian Securities Exchange and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the Canadian Securities Exchange and other risks detailed from time to time in the filings made by the Company with securities regulations.

The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.

 

Contacts

Helius Medical Technologies
Investor Relations:
778-588-7144
info@heliusmedical.com
or
Corporate Contact:
Phil Deschamps, 614-596-2597
pdeschamps@heliusmedical.com
or
Media Contact:
Becky Kern, 914-772-2310
media@heliusmedical.com

DISCLOSURE: The views and opinions expressed in this article are those of the authors, and do not represent the views of equities.com. Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions. To read our full disclosure, please go to: http://www.equities.com/disclaimer

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