Helius Medical Technologies(US:HSDT) Globenewswire·2025-07-21 11:00Core Viewpoint - Helius Medical Technologies, Inc. announced positive outcomes from the PoNS Stroke Registrational Program, supporting a planned FDA submission for treating gait and balance deficits in chronic stroke patients under the Breakthrough Device Designation [1][2]. Group 1: Clinical Trials and Results - The PoNS Stroke Registrational Program included two pivotal clinical studies: a double-blind, randomized controlled trial and a single-arm trial, initiated in April 2024, following positive FDA interaction [2][3]. - A total of 159 patients were enrolled across the three studies, with 130 completing both the treatment and follow-up phases, conducted at 10 clinical sites in the US and Canada [3]. - The primary endpoints focused on improving gait and balance deficits after 12 weeks, with secondary endpoints assessing fall risk and durability of effect, showing statistically significant improvements with active PoNS therapy [4][7]. Group 2: Market Potential and Future Plans - Over 7 million stroke patients experience symptoms, with approximately 80% suffering from balance and gait deficits, indicating a substantial market opportunity [5]. - Helius plans to submit an application to the FDA for stroke indication during Q3 2025, aiming to provide an impactful treatment for stroke survivors [5][10]. Group 3: Product Overview - The Portable Neuromodulation Stimulator (PoNS) is a non-implantable device that delivers neurostimulation through a mouthpiece, used in conjunction with physical rehabilitation to improve balance and gait [6][10]. - PoNS has received authorization in Canada for treating gait deficits due to stroke and is also approved in Australia for similar uses [9].