Helius Medical Technologies Announces Pilot Study for PoNS™

NEWTOWN, Pa. & VANCOUVER, British Columbia--(BUSINESS WIRE)--

Helius Medical Technologies, Inc. HSM (“HMT”, or the “Company”) announced today that its flagship PoNS™ technology would be tested in a double-blind, randomized, sham-controlled pilot efficacy study in volunteer human subjects with a chronic balance deficit due to mild-to-moderate traumatic brain injury (TBI). The PoNS™, an investigational medical device that induces neuromodulation by stimulating the cranial nerves found in the tongue, is being studied for the treatment of balance disorder symptoms caused by Traumatic Brain Injury (TBI). The study is being conducted at the Tactile Communication and Neurorehabilitation Laboratory (TCNL) at the University of Wisconsin-Madison. HMT is developing a commercial version of the prototype PoNS™ device used in the trial.

“There has been little advancement over the years for the treatment of symptoms caused by TBI and we are excited to help patients who have tried many different therapies and have limited treatment options,” said Phillipe Deschamps, Chief Executive Officer, Helius Medical Technologies. “This pilot trial will guide next steps in the development of the PoNS™.”

“Our past research has shown the brain improves its ability to heal itself through neuroplasticity. Whether the brain is injured through neurodegenerative disease or the result of a traumatic injury, we are finding this approach is at the heart of successful neurorehabilitation,” said Yuri Danilov, Director of HMT, Director of Neuroscience at TCNL and co-inventor of the PoNS™ device. “We envision a future with a faster and more complete rehabilitation from sensory and motor disorders.”

About the Trial

The 26-week pilot study is expected to include 44 subjects with a chronic balance deficit due to mild-to-moderate TBI. As part of the study, subjects will undergo periodic testing, in-lab exercise training with the PoNS™ for two weeks, and then will continue with PoNS™ use and exercise at home for 12 weeks. The last phase of the study is a 12-week withdrawal period.

This study is presently recruiting subjects. For more information about the PoNS™ pilot trial please contact the TCNL at jruhland@wisc.edu, or see http://go.wisc.edu/i24mx8. This clinicaltrials.gov identifier is NCT02158494.

About CN-NINM and PoNS™

Early clinical research shows that electrical stimulation of the tongue stimulates two major cranial nerves, the trigeminal and the facial. This stimulation is translated into neural impulses, delivered directly into the brain stem and dispersed throughout the brain. This stimulation of the brain stem and other brain structures seems to affect the capacity, organization, and function of these structures. This is known as cranial nerve noninvasive neuromodulation (CN-NINM) and is delivered by the Portable Neuromodulation Stimulator (PoNS™). When combining this neurostimulation with a specific set of physical, cognitive, and/or mental exercises, preliminary results have shown an increase in effectiveness in recovery and relief of targeted neurological symptoms.

About TCNL

Founded in 1992, the Tactile Communication & Neurorehabilitation Laboratory (TCNL), located at the University of Wisconsin-Madison, is a research center that uses the experience of many different areas of science to study the theory and application of applied neuroplasticity, the brain's ability to reorganize in response to new information, needs, and pathways. Their research is aimed at developing solutions for sensory and motor disorder rehabilitation. For more information, please visit, http://tcnl.bme.wisc.edu/.

About Helius Medical Technologies (HMT)

Helius Medical Technologies is a medical technology holding company focused on neurological wellness. HMT seeks to use unique and non-invasive platform technologies that create portals to the brain to amplify its 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.

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