NEWTOWN, PA — Helius Medical Technologies, Inc. (Nasdaq: HSDT) announced this week that Health Canada has expanded the indication for PoNS to include use as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from stroke, to be used in conjunction with physical therapy. PoNS is already authorized in Canada for use as a short term treatment of chronic balance deficit due to mild to moderate TBI and gait deficit due to mild and moderate symptoms from MS.
“An estimated 878,000 Canadians are currently living with stroke, with more than 89,000 new strokes occurring each year. Walking impairment is a major source of post-stroke disability and we’re thrilled that patients suffering gait deficit due to stroke can now have access to this important therapy,” said Helius President and Chief Executive Officer Dane Andreeff. “PoNS has been commercially available in Canada since 2019 for MS and TBI, and it’s gratifying to know Health Canada has found that PoNS Therapy can provide significant and clinically meaningful gait improvement also in stroke patients, suggesting that PoNS Therapy provides an effective therapeutic benefit regardless of the underlying condition.”
PoNS Therapy applied in a real-world setting provides a significant and clinically meaningful improvement in gait or balance to patients with MS, TBI, and chronic stroke. “Patients suffering a gait deficit due to mild and moderate stroke symptoms face a clear medical need that is not fully met due to limitations of current treatment methods, including pharmacologic agents and rehabilitation activities alone,” said Dr. Antonella Favit-Van Pelt, Helius’ Chief Medical Officer.
A real-world evidence (RWE) database analysis showed that mild and moderate stroke patients using PoNS Therapy for their gait deficit experienced a significant amelioration of their gait averaging a 6.74-point improvement in the functional gait assessment (FGA) score over a 14-wk treatment period (95% CI: 4.85 to 8.63). Overall, 69.2% of patients experienced at least a 5-point FGA improvement, which is larger than the 4.2-point minimal detectable change usually seen in stroke patients.
“Improvement of gait ability represents an important milestone in the rehabilitation of stroke patients and translates into meaningful therapeutic outcomes, such as decreasing the risk of falling,” said Dr. Favit-Van Pelt.
In the RWE study, before starting PoNS Therapy, the majority of patients were considered at risk of falling (as determined by an FGA<23 score at baseline). Routine rehabilitative physical therapy does not usually provide a meaningful shift in the risk of falling for stroke patients (~1-3%). After treatment with PoNS therapy, 28% of patients were no longer at fall risk at the end of the 14-week treatment period.
In Canada, patients with MS and mild to moderate TBI have experienced the benefit of being treated with PoNS Therapy.
“When we look at PoNS Therapy efficacy data on improving gait or balance deficits in the three indications allowed in Canada,” continued Dr. Favit-Van Pelt, “it appears that PoNS employs a shared mechanism of action that is likely to modulate mechanisms of gait and balance control across these three medical conditions.”
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