---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-23-130093"
form_type: "8-K"
ticker: "CTSO"
cik: "0001175151"
company_name: "Cytosorbents Corp"
filed_at: "2023-12-28T23:59:59+00:00"
generated_at: "2026-06-07T06:14:45.935657+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# CytoSorbents STAR-T trial misses primary effectiveness endpoint in overall population; positive trend in CABG subgroup

## Summary
- STAR-T trial did not meet primary composite effectiveness endpoint in overall 140-patient population.
- Safety endpoint met; DSMB found no safety issues with DrugSorb-ATR device.
- In isolated CABG subgroup (over 90% of patients), reduced bleeding complications observed, including serious events.
- Company expects to complete full data analysis in weeks and may submit to FDA/Health Canada.
- Full results to be presented at ACC 2024 in Atlanta next April if accepted.

## SEC filing metadata
- accession: 0001104659-23-130093
- form_type: 8-K
- ticker: CTSO
- cik: 0001175151
- company_name: Cytosorbents Corp
- filed_at: 2023-12-28T23:59:59+00:00
- event_type: other_material
- 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/1175151/000110465923130093/0001104659-23-130093-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1175151/000110465923130093/tm2333824d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-130093
- JSON: https://secwatch.observer/filing/0001104659-23-130093.json
- Plain text: https://secwatch.observer/filing/0001104659-23-130093.txt

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