Helius Medical Technologies, Inc.
TSX : HSM
OTCQB : HSDT

Helius Medical Technologies, Inc.

September 06, 2016 12:00 ET

Helius Medical Technologies Announces Publication of Positive Results of Russian Pediatric Cerebral Palsy Pilot Study

Researchers Concluded Facilitation of Physiotherapy With the Investigational PoNS™ Device has an Ability to Improve Motor Control in Pediatric Patients With Cerebral Palsy

Results Accepted for Publication and Scheduled for Presentation

NEWTOWN, PENNSYLVANIA--(Marketwired - Sept. 6, 2016) - Helius Medical Technologies, Inc. (TSX:HSM)(OTCQB:HSDT) ("Helius" or the "Company") announces that results from a pilot study, investigating the benefits of PoNS™ technology with physiotherapy in treating symptoms of pediatric Cerebral Palsy (CP), have been accepted for publication in the Russian "Journal of Restorative Medicine and Rehabilitation" (http://www.vvmr.ru/). Results of the study will be presented in an oral session at the International Conference for Innovation in Angio-Neurology held in Moscow on September 23-24, 2016 (http://www.altaastra.com/2016/07/angioneurology), a gathering of more than 500 neurologists, neurosurgeons, trauma doctors and other healthcare practitioners. The PoNS™ is an investigational device that is currently in clinical development in the United States and has not been cleared for commercial distribution.

This 65-subject (45-active, 20 control) study included children (ages 3-13) with Gross Motor Function Classification Scores (GMFCS) ranging from II-IV*. All subjects received 10-days of standard physiotherapy and movement control therapy with the active group receiving 20-25 minutes of concomitant electro-lingual neurostimulation with PoNS™. Primary outcomes were scored by Ashworth Scale (spasticity), Berg Scale (Balance) and GMFCS. Secondary measures included preferred walking speed, step length, lower extremity strength and quality of life measures. Statistically significant differences in spasticity (p< 0.005) and lower limb gross motor function (p<0.00001) were reported in favor of the active group. Positive changes in quality of life, cognitive function, and social status were also observed. The researchers concluded facilitation of physiotherapy with the PoNS™ device can improve motor control in patients with CP.

The study was conducted at the St. Petersburg City Hospital #40 (http://www.gb40.ru/en/index.html) and was sponsored by Altair LLC, Helius' distribution partner in the region (see Helius' press release November 2014).

"We are delighted that independent research continues to support a growing belief in the potential benefits of PoNS™ therapy for an expanding spectrum of disease states," said Jonathan Sackier, Chief Medical Officer, Helius Medical Technologies. "Through our international partnerships and academic relationships, we continue to encourage diligently executed, well designed scientific studies in support of a fundamental understanding of how PoNS™ therapy can benefit treatment of symptoms related to neurologic disease or trauma. We are focusing on neurological diseases that are in need of therapeutic options and are encouraged by the growing clinical data to support the safety and effectiveness of the PoNS™ technology."

*GMFCS: The Gross motor function classification system categorizes children with cerebral palsy into five levels based on their physical abilities. Children in level I can perform most functions however speed, balance and coordination are limited. Levels increase reflecting more severe disability, with children at the highest level, level V, having limited ability to control head and torso position and requiring wheelchair transport.

About PoNS™ Therapy

The PoNS™ device is an investigational non-invasive method to deliver neurostimulation through the tongue. PoNS™ Therapy combines the use of the device with physiotherapy and is currently being evaluated in a pivotal, multicenter, clinical trial for the treatment of balance disorder in subjects with mild to moderate Traumatic Brain Injury (TBI). The PoNS ™ Therapy is also being evaluated in the treatment of symptoms related to other neurologic diseases including Multiple Sclerosis and Cerebral Palsy.

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.

Cautionary Disclaimer Statement:

Certain statements in this news release 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 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 approvals, business initiatives and objectives and use of proceeds from financings or other business initiatives.

Forward-looking statements are often identified by terms such as "will", "may", "should", "anticipate", "expects" 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 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 the short form prospectus filed in connection with the Offering, its Annual Report on Form 10-K filed 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 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.

Contact Information

  • HELIUS CONTACTS:
    Corporate Contact:
    Brian Bapty
    604-652-3950

    Media Contact:
    Becky Kern
    914-772-2310
    media@heliusmedical.com