Helius Medical touts PoNS TBI-treatment trial data despite primary effectiveness miss

Helius Medical Technologies (TSX:HSM) today released results from a registrational trial of its Portable Neuromodulation Stimulator, used to treat patients with chronic balance deficits due to mild-to-moderate traumatic brain injuries, touting positive effects but a missed primary effectiveness endpoint. The Newtown, Penn.-based company’s PONS system is designed to treat neurological symptoms, caused by trauma or disease, non-invasively through the tongue. “We are excited to be on the forefront of research that may bring this novel and exciting therapy to patients in need. The investigators and research teams from the Montreal Neurofeedback Center, Orlando Regional Medical Center, Oregon Health and Sciences University, Health Tech Connex, Inc., Virginia Commonwealth University, MedStar National Rehabilitation Hospital and University of Wisconsin – Madison are pleased with the execution of this study and look forward to further analysis and publication of the results,” study coordinating principal investigator Dr. Alain Ptito of the McGill University Health Centre said in a prepared statement. The 122-patient double-blind, randomized, sham-controlled trial aimed to explore the safety and effectiveness of the PoNS system for treating chronic balance deficits due to mild or moderate TBIs, and evaluated them over 5 weeks of treatment. Endpoints for effectiveness were assessed with the Sensory Organization Test. The primary endpoint was a responder rate analysis ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Neuromodulation/Neurostimulation Helius Medical Technologies Source Type: news