---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-065280"
form_type: "8-K"
ticker: "CTSO"
cik: "0001175151"
company_name: "Cytosorbents Corp"
filed_at: "2025-07-02T23:59:59+00:00"
generated_at: "2026-05-18T09:35:03.492487+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# CytoSorbents: FDA appeal hearing set; Health Canada refuses DrugSorb-ATR license

## Summary
- FDA confirmed appeal hearing under 21 CFR 10.75; supervisory review expected to complete by end of August 2025.
- Health Canada issued Notice of Refusal for DrugSorb-ATR Medical Device License, citing non-compliance with regulations.
- Company intends to file Level 1 Request for Reconsideration with Health Canada by July 25, 2025.
- DrugSorb-ATR is an FDA Breakthrough Device to reduce bleeding in CABG surgery patients on Brilinta (ticagrelor).
- CEO states no approved therapies exist in U.S. or Canada; final regulatory decisions expected by end of 2025.

## SEC filing metadata
- accession: 0001104659-25-065280
- form_type: 8-K
- ticker: CTSO
- cik: 0001175151
- company_name: Cytosorbents Corp
- filed_at: 2025-07-02T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1175151/000110465925065280/0001104659-25-065280-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1175151/000110465925065280/tm2519729d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-065280
- JSON: https://secwatch.observer/filing/0001104659-25-065280.json
- Plain text: https://secwatch.observer/filing/0001104659-25-065280.txt

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