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NEWTOWN, Pa., Jan. 08, 2018 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (TSX:HSM) (TSX:HSM.WT) (OTCQB:HSDT) (“Helius” or the “Company”), a medical technology company focused on neurological wellness, announced today that researchers have completed a study evaluating the investigational Portable Neuromodulation Stimulator (“PoNS”) on brain activity.

The objective of the study, conducted at HealthTech Connex, Inc. in Surrey, British Columbia, was to: 1) evaluate whether a single, twenty-minute session of two PoNS stimulation waveforms - High Frequency (HF) and Low Frequency (LF) - impacted objective measures of brain activity recorded by high density 64-channel electroencephalography (EEG); and 2) whether there were differences between the two PoNS stimulation waveforms. The study randomized a total of 20 healthy neurologically intact participants into two groups to counterbalance exposure order to each PoNS stimulation waveform.

Brain waves were recorded from each participant for 20 minutes before using the PoNS, 20 minutes while using either the HF or LF PoNS device, and then for 20 minutes without the device in the mouth. After a 1 week period, participants repeated the same procedure, this time stimulating with the alternative PoNS device tested in their initial visit. Each subject’s EEG brain activity was then analyzed using Time/Frequency Power Analysis and a Spatial Microstate Analysis.

Highlights of study results:

  • EEG results confirmed that Translingual Neurostimulation (TLNS), electrical energy delivered through the PoNS device to the tongue, generated statistically significant differences in brain activity.

  • Statistically significant increases in Alpha frequencies of brain waves, which are associated with relaxation and reflection, and Theta frequencies of brain waves, which are associated with idea generation, were observed in the post-stimulation rest period for the HF-first group. The results for the HF-first group suggests an important exposure effect for PoNS stimulation.

  • Statistically significant increases in Alpha changes pre-to-post stimulation, which are associated with relaxation and reflection, were present when data for both HF and LF waveform groups were evaluated in combination.

  • Significant increases in attention-related brain activity were also seen in the HF group. The effects began during PoNS stimulation and continued to increase following stimulation to a level that was significantly greater than baseline.

“We are delighted with these findings as they confirm several important assumptions about our PoNS technology. Most importantly, the EEG data confirm that even a single PoNS stimulation session has an impact on brain activity,” said Helius’ Chief Medical Officer, Dr. Jonathan Sackier. “The results also provide insights on the differences between PoNS waveforms and potential opportunities for research that will continue to drive improved and more effective technology.”

“We have seen very positive results in our participation as a site for the Helius’ Traumatic Brain Injury trial completed in 2017 with PoNS Therapy and this new work reveals some intriguing observations. When both levels of PoNS stimulation are combined, we see a statistically significant increase in brain activity during the post-stimulus period and the HF pulse seems to have a clearly different exposure effect on brain activity. The implications of seeing these effects is very exciting and as a result, we are pushing ahead with further work in this area and look forward to publishing these data,” said Dr. Ryan D’Arcy, President and Chief Scientific Officer at HealthTech Connex.

About PoNS Therapy

The PoNS is an investigational, non-invasive, medical device designed to deliver neurostimulation through the tongue. Clinical research has shown that electrical stimulation of the tongue activates two major cranial nerves – the trigeminal nerve and the facial nerve. Electrical stimulation of these cranial nerves creates a flow of neural impulses that are then delivered directly into the brain stem and cerebellum. PoNS Therapy combines the use of the PoNS device with physical therapy. The company has completed its clinical trials for balance disorder in patients with mild to moderate Traumatic Brian Injury (TBI) and are looking forward to submitting an application for marketing authorization in the US and other jurisdictions for the PoNS device in the first half of 2018. Additional trials in multiple sclerosis, stroke and cerebral palsy have shown promising results and provide support for pursuing additional indications for use. 

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.

About HealthTech Connex.

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 within the Health and Technology District in Surrey, British Columbia, Canada, HealthTech Connex’s premier focus is on developing advanced brain technologies to objectively monitor brain vital signs. HealthTech Connex launched the Centre for Neurology Studies connecting clinicians, scientists and engineers with advanced R&D and innovative clinical neuroscience breakthroughs to deliver the largest possible societal benefits. www.HealthTechConnex.com

Work pioneered by Dr. Ryan D’Arcy and his team (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.

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

Cautionary Disclaimer Statement:

Certain statements in this news release and to be made in this morning’s presentation are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws (“forward-looking statements”).

All statements other than statements of historical fact included in this news release and in this morning’s presentation are forward-looking statements that involve risks and uncertainties. Such forward-looking statements include, among others, statements regarding ongoing or planned clinical research, expected future development timelines, regulatory submissions and approvals or other business initiatives and objectives.

Forward-looking statements are often identified by terms such as “estimate” “intend” and similar expressions.

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 of the Company to achieve its business objectives and other risks detailed from time to time in the filings made by the Company with securities regulators.

The reader is cautioned that assumptions used in the preparation of any forward-looking statements 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 statement. 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 and this morning’s presentation are expressly qualified by this cautionary statement. Risks and uncertainties about the Company’s business are more fully discussed in the Company’s disclosure materials, including its Annual Report on Form 10-K and other filings with the United States Securities and Exchange Commission and the Canadian securities regulators and which can be obtained from either at www.sec.gov or www.sedar.com.

The forward-looking statements contained in this news release and to be made on this morning’s presentation are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law.


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