NEWTOWN, Pa.--(BUSINESS WIRE)--Helius Medical Technologies, Inc. (CSE:HSM) (OTCQB:HSDT) (“Helius”) is pleased to announce that it recently met with the US Food and Drug Administration (“FDA” or the “Agency”) as part of the Agency’s pre-submission (pre-sub) process regarding Helius’s protocol for its double-blind, randomized, sham-controlled study of the safety and effectiveness of the Portable Neuromodulation Stimulator (PoNS™) 4.0 device for cranial nerve noninvasive neuromodulation (CN-NINM) training in subjects with a chronic balance deficit due to mild-to-moderate traumatic brain injury (TBI).
During the pre-sub meeting, FDA provided Helius with valuable feedback on its TBI study protocol, and thereafter informed Helius that it can proceed with the study. Additionally, the Agency determined the PoNS™ TBI study to be a nonsignificant risk device study.
The multi-site TBI study will take place at Oregon Health and Science University Center for Regenerative Medicine (Portland, OR), Orlando Regional Medical Center (Orlando, FL), and The Montreal Neurofeedback Center (Montreal, QC). The primary endpoint of the trial is improvement in chronic balance deficit analyzed by the sensory organization test (SOT) at 5-weeks. Recruitment for the study is set to begin in a few weeks. In the coming weeks, individuals interested in the recruitment process should visit http://heliusmedical.com/our-research/clinical-trials to learn more.
About Helius Medical Technologies (HMT)
Helius Medical Technologies is a medical technology company focused on neurological wellness. HMT seeks to use unique and non-invasive platform technologies that amplify the brain’s 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.
About the PoNS™
The Portable Neuromodulation Stimulator (PoNS) device is an investigational medical device being studied for the treatment of neurological symptoms caused by disease or trauma as part of a physical therapy program. The PoNS is currently being studied in the United States for the treatment of balance disorder for subjects with mild to moderate Traumatic Brain Injury (mTBI), and in Canada for the treatment of gait and balance disorder for subjects with Multiple Sclerosis (MS).
The PoNS device is believed to be the first non-invasive means for delivering neurostimulation through the tongue. Researchers believe that use of the tongue as a gateway to the brain may be one of the most natural, non-invasive and direct ways to stimulate the brain. The tongue is anatomically unique, being richly inervated by thousands of nerve fibers and interconnected to the brainstem by two major cranial nerves.
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