other_material
confidence high
sentiment positive
materiality 0.75
Helius Medical reports positive PoNS Stroke Registrational Program results; FDA submission planned
Solana Co
- Double-blind RCT met primary endpoint: statistically significant improvements in gait/balance with active PoNS therapy (with/without open-label data).
- 159 patients enrolled across three studies; 130 completed 12-week treatment and follow-up at 10 US/Canada sites.
- Minimal adverse events and good tolerability confirmed; key secondary endpoints on fall risk and durability met.
- Company plans FDA submission for gait/balance deficit indication in chronic stroke under Breakthrough Device Designation.
item 8.01