---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-215608"
form_type: "8-K"
ticker: "ICU"
cik: "0001831868"
company_name: "SeaStar Medical Holding Corp"
filed_at: "2025-09-24T23:59:59+00:00"
generated_at: "2026-05-17T05:48:30.501281+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# SeaStar Medical DSMB recommends continue NEUTRALIZE-AKI trial; enrollment target raised to 339

## Summary
- DSMB reports zero device-related safety issues in first 100 patients; recommends continuation of pivotal AKI trial.
- Enrollment target increased from 200 to 339 patients to meet statistical power; 137 patients enrolled to date.
- Estimated enrollment completion near end of 2026 based on current rate and new site additions.
- QUELIMMUNE pediatric registry shows 75% 28-day survival and no device-related safety events in first 20 patients.
- Company highlights potential clinical benefit signal; plans to manage capital to support milestones.

## SEC filing metadata
- accession: 0001193125-25-215608
- form_type: 8-K
- ticker: ICU
- cik: 0001831868
- company_name: SeaStar Medical Holding Corp
- filed_at: 2025-09-24T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1831868/000119312525215608/0001193125-25-215608-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1831868/000119312525215608/icu-20250924.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-215608
- JSON: https://secwatch.observer/filing/0001193125-25-215608.json
- Plain text: https://secwatch.observer/filing/0001193125-25-215608.txt

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