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Helius Medical Technologies, Inc. (NASDAQ: HSDT), today announced the filing of its U.S. Food and Drug Administration (FDA) 510(k) submission for the PoNS (Portable Neuromodulation Stimulator) device label expansion seeking an indication for gait and balance deficit in patients with chronic stroke symptoms. The submission was made with data generated in its Stroke Registrational Program (SRP) and was filed under its current FDA Breakthrough Device Designation.
All statistical analyses for the Functional Gait Assessment (FGA) primary endpoint demonstrated PoNS superior effectiveness in improving gait deficit by achieving a clinically meaningful mean improvement of more than 5 points, which was statistically significant across all studies (p<0.05) and was maintained for at least 12 weeks after completion of the therapy. Conversely the control group achieved, across all trials, a mean FGA improvement of less than 4 points, which fell below the 4.2-point Minimal Detectable Change (MDC) that reflects clinical meaningfulness of the therapeutic intervention.
"Substantial evidence across the SRP trials supports the superiority of active PoNS Therapy® as compared to physical therapy alone, when applied in standard clinical settings for stroke rehabilitation," said Antonella Favit-Van Pelt, M.D., Ph.D., Helius' Chief Medical Officer. "The totality of data in stroke survivors with gait deficits confirms the broader evidence of PoNS therapeutic effect in improving walking disability by enhancing and potentiating the benefit of physical therapy. Consistent with the existing body of clinical evidence, PoNS also confirms to be a safe and well tolerated therapy."
PoNS efficacy and safety was clinically established from three clinical trials across 10 sites and 159 enrolled chronic stroke survivors with gait deficit due to stroke. The studies were structured to assess the effectiveness and safety of the PoNS device in conjunction with routine physical rehabilitation therapy over a 12-week treatment period. Participants were also followed for 12 weeks after completion of treatment to assess durability of treatment effect. Primary efficacy endpoints for gait (by FGA) and balance (by the Berg Balance Score), as well as key secondary endpoints including risk of falling (determined by FGA <23) and durability of effect (established at <30% reduction of FGA improvement 12 week after completion of study treatment) were analyzed, across the two pivotal studies, using a propensity score design methodology adjusted for multiplicity control. Study success was achieved by demonstrating superiority, using the Hochberg method, for either primary endpoint, which, then, allowed for analysis of the key secondary endpoints with the same methodology.
Overall, the primary endpoint was met and statistically significant for the FGA primary endpoint. In the primary analysis of the pooled pivotal randomized controlled and single-arm studies, treatment with active PoNS plus physical therapy (PT) led to an adjusted mean change in FGA of 5.37 points (95% CI: 4.23 to 6.52) at Week 12 as compared to a change of 3.31 points (95% CI 1.96 to 4.76) in the control group (sham PoNS plus PT). The treatment group difference by propensity adjustment was 2.06 (95% CI 0.29 to 3.84) with a 2-sided p-value of 0.0233 that met the Hochberg requirement for multiplicity (< 0.025) and, therefore, demonstrated statistical superiority. Durability of active PoNS therapeutic effect achieved at Week 12 was also demonstrated, with a mean percentage reduction in FGA ranging between -4.71% and -4.97% and with 89.7% (95% CI 81.8% to 97.5%) of subjects meeting the durability performance goal. Improvement from baseline to Week 12 was also demonstrated for BBS in the active PoNS group although it did not reach statistically significant between-group separation. Similarly, risk of falling was resolved in 17.4% of subjects in the active PoNS group as compared to 8.9% in the control subjects, albeit not statistically significant. Treatment with PoNS was confirmed to be safe and well-tolerated with no incidence of treatment-related SAEs, across the SRP trials and existing RWE data, and adverse events (ranging between 0.0% and 14.8%) that were unrelated to the PoNS device.
Posted In: HSDT
