---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-25-009304"
form_type: "8-K"
ticker: "HSDT"
cik: "0001610853"
company_name: "Solana Co"
filed_at: "2025-07-21T23:59:59+00:00"
generated_at: "2026-05-18T05:06:46.808897+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Helius Medical reports positive PoNS Stroke Registrational Program results; FDA submission planned

## Summary
- 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.

## SEC filing metadata
- accession: 0001558370-25-009304
- form_type: 8-K
- ticker: HSDT
- cik: 0001610853
- company_name: Solana Co
- filed_at: 2025-07-21T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1610853/000155837025009304/0001558370-25-009304-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1610853/000155837025009304/hsdt-20250721x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-25-009304
- JSON: https://secwatch.observer/filing/0001558370-25-009304.json
- Plain text: https://secwatch.observer/filing/0001558370-25-009304.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.