---
schema_version: "secwatch.filing_event.v1"
accession: "0000929638-25-003494"
form_type: "8-K"
ticker: "CTSO"
cik: "0001175151"
company_name: "Cytosorbents Corp"
filed_at: "2025-09-16T23:59:59+00:00"
generated_at: "2026-05-17T06:26:49.639953+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# CytoSorbents to file new DrugSorb-ATR De Novo application after FDA appeal upholds denial but offers expedited path

## Summary
- FDA appeal upheld prior De Novo denial for DrugSorb-ATR, citing need for additional label-indication data; no safety issues found.
- Company will file new De Novo application with new real-world data; expects expedited review under Breakthrough Device designation.
- Pre-submission meeting request to FDA next month; formal meeting anticipated in Q4 2025; standard decision expected mid-2026.
- Withdrew Health Canada Request for Reconsideration; will submit new application after FDA clarity.
- Management focuses on core business growth, cost control, and near breakeven by end of 2025.

## SEC filing metadata
- accession: 0000929638-25-003494
- form_type: 8-K
- ticker: CTSO
- cik: 0001175151
- company_name: Cytosorbents Corp
- filed_at: 2025-09-16T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1175151/000092963825003494/0000929638-25-003494-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1175151/000092963825003494/a8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000929638-25-003494
- JSON: https://secwatch.observer/filing/0000929638-25-003494.json
- Plain text: https://secwatch.observer/filing/0000929638-25-003494.txt

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