---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-048520"
form_type: "8-K"
ticker: "CTSO"
cik: "0001175151"
company_name: "Cytosorbents Corp"
filed_at: "2025-05-14T23:59:59+00:00"
generated_at: "2026-05-21T07:58:59.311181+00:00"
event_type: "earnings"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# CytoSorbents Q1 product rev $8.7M (-3%); FDA denies DrugSorb-ATR De Novo

## Summary
- Product revenue $8.7M, flat constant currency vs Q1 2024 $9.0M; gross margin 71% vs 77%.
- Net loss improved to $1.5M ($0.02/shr) from $6.1M; adjusted net loss $3.7M ($0.06/shr).
- FDA denied DrugSorb-ATR De Novo on Apr 25, 2025; company plans formal appeal for 2025 decision.
- Rights offering raised $6.8M net; cash & restricted cash $13.1M at Mar 31 vs $9.8M Dec 31.
- Germany sales disruption offset by E.U. distributor growth; opened Dubai subsidiary.

## SEC filing metadata
- accession: 0001104659-25-048520
- form_type: 8-K
- ticker: CTSO
- cik: 0001175151
- company_name: Cytosorbents Corp
- filed_at: 2025-05-14T23:59:59+00:00
- event_type: earnings
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1175151/000110465925048520/0001104659-25-048520-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1175151/000110465925048520/tm2515144d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-048520
- JSON: https://secwatch.observer/filing/0001104659-25-048520.json
- Plain text: https://secwatch.observer/filing/0001104659-25-048520.txt

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