---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-062097"
form_type: "8-K"
ticker: "CTSO"
cik: "0001175151"
company_name: "Cytosorbents Corp"
filed_at: "2025-06-24T23:59:59+00:00"
generated_at: "2026-05-18T21:57:30.279875+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# CytoSorbents appeals FDA denial of DrugSorb-ATR De Novo request; decision expected ~60 days

## Summary
- Appeal filed June 18, 2025 under 21 CFR 10.75; FDA denial letter dated April 25, 2025.
- DrugSorb-ATR designed to reduce bleeding risk in CABG patients on Brilinta; had Breakthrough Device Designation.
- Supervisory review includes formal hearing with CDRH senior management; final decision typical within 60 days.
- Health Canada review remains ongoing; company expects a regulatory decision in 2025.

## SEC filing metadata
- accession: 0001104659-25-062097
- form_type: 8-K
- ticker: CTSO
- cik: 0001175151
- company_name: Cytosorbents Corp
- filed_at: 2025-06-24T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1175151/000110465925062097/0001104659-25-062097-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1175151/000110465925062097/tm2518791d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-062097
- JSON: https://secwatch.observer/filing/0001104659-25-062097.json
- Plain text: https://secwatch.observer/filing/0001104659-25-062097.txt

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