---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-104669"
form_type: "8-K"
ticker: "CTSO"
cik: "0001175151"
company_name: "Cytosorbents Corp"
filed_at: "2024-10-01T23:59:59+00:00"
generated_at: "2026-05-30T23:03:12.959169+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# CytoSorbents submits DrugSorb-ATR FDA De Novo for CABG bleeding; Q3 sales $8.3-8.5M

## Summary
- DrugSorb-ATR De Novo application submitted to FDA on Sept 27, 2024 for reducing perioperative bleeding in CABG patients on ticagrelor.
- FDA Breakthrough Device Designation, eligible for priority review; decision expected in 2025.
- Health Canada MDL application complete, pending MDSAP certification for submission; decision also expected 2025.
- Q3 2024 product sales estimated $8.3M-$8.5M, up 7-10% YoY from $7.8M.
- Q3 product gross margin estimated 50-60% vs 71% due to production slowdown; issue resolved, normalized margins expected Q4.

## SEC filing metadata
- accession: 0001104659-24-104669
- form_type: 8-K
- ticker: CTSO
- cik: 0001175151
- company_name: Cytosorbents Corp
- filed_at: 2024-10-01T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 2.02, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1175151/000110465924104669/0001104659-24-104669-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1175151/000110465924104669/tm2425307d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-104669
- JSON: https://secwatch.observer/filing/0001104659-24-104669.json
- Plain text: https://secwatch.observer/filing/0001104659-24-104669.txt

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