---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-080908"
form_type: "8-K"
ticker: "CTSO"
cik: "0001175151"
company_name: "Cytosorbents Corp"
filed_at: "2025-08-20T23:59:59+00:00"
generated_at: "2026-05-17T11:05:22.003399+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# FDA upholds DrugSorb-ATR De Novo denial but offers path forward

## Summary
- FDA appeal decision found no safety issues with DrugSorb-ATR but upheld the prior De Novo denial.
- FDA proposed a potential path to market authorization; Company discussing details with the Agency.
- Another appeal avenue with CDRH Director is available within 30 days; Company evaluating.
- CEO states resolution of majority of outstanding issues; device remains an FDA Breakthrough Device.

## SEC filing metadata
- accession: 0001104659-25-080908
- form_type: 8-K
- ticker: CTSO
- cik: 0001175151
- company_name: Cytosorbents Corp
- filed_at: 2025-08-20T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1175151/000110465925080908/0001104659-25-080908-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1175151/000110465925080908/tm2523975d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-080908
- JSON: https://secwatch.observer/filing/0001104659-25-080908.json
- Plain text: https://secwatch.observer/filing/0001104659-25-080908.txt

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