---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-043534"
form_type: "8-K"
ticker: "CTSO"
cik: "0001175151"
company_name: "Cytosorbents Corp"
filed_at: "2025-05-01T23:59:59+00:00"
generated_at: "2026-05-22T23:46:49.757545+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.78
calibrated_materiality_score: 0.78
confidence: "high"
source: SEC EDGAR
---

# CytoSorbents receives FDA denial for DrugSorb-ATR De Novo; plans appeal if unresolved

## Summary
- FDA issued denial letter on April 25, 2025 for DrugSorb-ATR De Novo Request, citing remaining deficiencies.
- DrugSorb-ATR is a Breakthrough Device to reduce bleeding in CABG surgery patients on Brilinta.
- CytoSorbents has met with FDA and will continue discussions; formal appeal due within 60 days if unresolved.
- CEO expects final regulatory decision still in 2025 despite the denial.
- No therapies currently approved in U.S. for this indication; tens of thousands of patients at risk annually.

## SEC filing metadata
- accession: 0001104659-25-043534
- form_type: 8-K
- ticker: CTSO
- cik: 0001175151
- company_name: Cytosorbents Corp
- filed_at: 2025-05-01T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.78
- calibrated_materiality_score: 0.78
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1175151/000110465925043534/0001104659-25-043534-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1175151/000110465925043534/tm2511160d2_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-043534
- JSON: https://secwatch.observer/filing/0001104659-25-043534.json
- Plain text: https://secwatch.observer/filing/0001104659-25-043534.txt

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