Newtown, PA– December 2, 2016 – Helius Medical Technologies, Inc. (TSX: HSM, HSM.S, OTCQB: HSDT) (“Helius”) and HealthTech Connex Inc, (HTC) are pleased to announce, based on favorable preliminary results, the expansion of a comprehensive study to further characterize physiological changes in improved cognitive function resulting from investigational PoNS™ Therapy in healthy subjects.
Characterizing the brain’s healing response to neurological trauma or disease is a key research goal for Helius and HTC. This shared focus resulted in HTC partnering as a clinical site for Helius’ registrational study in balance disorder resulting from Traumatic Brain Injury (TBI) (see press release August 31, 2016).
In addition to the registrational study, Helius and HTC have been performing a comprehensive study in healthy adults to measure the benefit of investigational PoNS™ Therapy on physiological improvements associated with cognition. The study uses HTC’s expertise in measuring and quantifying physiological changes in brain function.
“Based on favorable preliminary results, we have expanded the protocol to both confirm and further characterize the changes we are observing,” says Helius CEO, Philippe Deschamps.
The current study builds from earlier functional brain imaging results from Helius’ pilot Multiple Sclerosis study which showed increased cognitive activity in individuals receiving investigational PoNS™ Therapy. Functional brain imaging provides a vital means of objectively measuring improvements in brain physiology associated with neuroplasticity, which may not be detected by routine clinical testing, such as neuropsychological assessments.
Work pioneered by Dr. Ryan D’Arcy with his team at HTC (Ghosh Hajra et al. 2016), has led to the development of a novel approach to extract novel brain vital signs from brainwaves recorded from electroencephalography (EEG). The team isolated well-established brainwave markers for auditory sensation, basic attention, and cognitive processing. In this current study, researchers focused specifically on the cognitive marker, a response known as the N400, to measure PoNS™ specific improvements in speech processing and semantic comprehension.
Under a Health Canada and IRB approved protocol, HTC and Helius researchers have completed examination of 24 healthy volunteers, half of whom were given investigational PoNS™ Therapy concurrent with an existing cognitive enhancement protocol and the other half whom had only the cognitive enhancement protocol. Participants were assessed for a host of baseline measures, followed by five days of therapy and a post-evaluation period. Brain vital sign data was monitored throughout all three phases. Initial results demonstrated a consistent acceleration of learning effects in the PoNS ™ Therapy group. Based on the promising results, along with full appreciation of the potential significance of this breakthrough, Helius and HTC have expanded the study to a larger sample of healthy individuals to confirm and further explore the potential benefits of PoNS ™ Therapy on cognitive function.
About PoNS™ Therapy
The Portable Neuromodulation Stimulator (PoNS™) is an investigational non-invasive device designed to deliver neurostimulation through the tongue. PoNS™ Therapy combines the use of the device with physical therapy and is currently being evaluated in a multicenter clinical trial for the treatment of balance disorder for subjects with mild to moderate Traumatic Brain Injury.
About Helius Medical Technologies, Inc.
Helius Medical Technologies is a medical technology company focused on neurological wellness. Helius seeks to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. Helius intends to file for FDA clearance for the PoNS™ device. For more information, please visit www.heliusmedical.com.
The Toronto Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.
About HealthTech Connex Inc.
HealthTech Connex, Inc. is a health technology company working to revolutionize the practice of clinical neuroscience through advanced technologies based on the highest quality science and innovation. Located in Surrey, British Columbia, Canada, it is one of the first companies to emerge from the city’s Innovation Boulevard, an agile partnership of health, business, higher education and government creating new health technologies to improve peoples’ lives. www.HTCBrainVitalSigns.com
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Helius Medical Technologies
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