---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-093161"
form_type: "8-K"
ticker: "HSDT"
cik: "0001610853"
company_name: "Solana Co"
filed_at: "2025-09-25T23:59:59+00:00"
generated_at: "2026-05-17T05:40:19.906251+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Helius files FDA 510(k) for PoNS stroke label expansion; CEO/CFO get $1.5M bonuses that offset severance

## Summary
- FDA 510(k) filed for PoNS stroke label expansion under Breakthrough Device Designation.
- Primary FGA endpoint met: mean improvement >5 points, p<0.05; control <4 points, below MDC.
- CEO Andreeff gets $890k cash bonus; CFO Mathiesen gets $610k; both offset severance, change-in-control claims.
- Bonuses settle any change-in-control claims from September 18, 2025 offerings.
- Data from 159 chronic stroke patients across 10 sites; safety confirmed with no SAEs.

## SEC filing metadata
- accession: 0001104659-25-093161
- form_type: 8-K
- ticker: HSDT
- cik: 0001610853
- company_name: Solana Co
- filed_at: 2025-09-25T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 5.02, 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1610853/000110465925093161/0001104659-25-093161-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1610853/000110465925093161/hsdt-20250924x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-093161
- JSON: https://secwatch.observer/filing/0001104659-25-093161.json
- Plain text: https://secwatch.observer/filing/0001104659-25-093161.txt

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