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, PA – September 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.
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Brian Bapty, 604-652-3950
Becky Kern, 914-772-2310