---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-26-034531"
form_type: "8-K"
ticker: "ICU"
cik: "0001831868"
company_name: "SeaStar Medical Holding Corp"
filed_at: "2026-11-03T13:30:35+00:00"
generated_at: "2026-11-03T13:35:23.352164+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.72
calibrated_materiality_score: 0.72
confidence: "high"
source: SEC EDGAR
---

# FDA Confirms SeaStar Medical's QUELIMMUNE SAVE Registry Fulfilled Post-Approval Requirements

## Summary
- FDA's CBER determined the QUELIMMUNE Pediatric SAVE Surveillance Registry met post-approval study requirements under the original Humanitarian Device Exemption.
- SAVE Registry data showed 90-day survival of 65.1% for QUELIMMUNE patients (N=43) versus 47.5% for KID cohorts (N=196), P=0.043.
- Registry patients showed no device-related adverse events; results were presented as a late-breaker at ASN Kidney Week 2026.
- FDA's decision lets hospitals use QUELIMMUNE without SAVE Registry research infrastructure, expanding access at centers that previously could not participate.
- CEO Eric Schlorff noted these children typically have about a 50% survival rate with traditional supportive care alone.

## SEC filing metadata
- accession: 0001437749-26-034531
- form_type: 8-K
- ticker: ICU
- cik: 0001831868
- company_name: SeaStar Medical Holding Corp
- filed_at: 2026-11-03T13:30:35+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.72
- calibrated_materiality_score: 0.72
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1831868/000143774926034531/0001437749-26-034531-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1831868/000143774926034531/icu20261102_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-26-034531
- JSON: https://secwatch.observer/filing/0001437749-26-034531.json
- Plain text: https://secwatch.observer/filing/0001437749-26-034531.txt

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