---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-146082"
form_type: "8-K"
ticker: "ICU"
cik: "0001831868"
company_name: "SeaStar Medical Holding Corp"
filed_at: "2023-05-16T23:59:59+00:00"
generated_at: "2026-06-15T00:02:04.781707+00:00"
event_type: "earnings"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# SeaStar Medical Q1 net loss $5.3M; FDA non-approvable letter for pediatric SCD HDE

## Summary
- Net loss of $5.3M ($0.40/sh) vs $1.0M ($0.14/sh) in Q1 2022; cash $725,000 as of Mar 31, 2023.
- FDA issued non-approvable letter for pediatric AKI HDE; 90-120 day plan to resubmit, targeting late 2023 approval.
- Adult NEUTRALIZE-AKI trial site activated; first patient enrollment expected soon; topline results expected in 2025.
- Closed first $3.3M tranche of $9.8M convertible debt; second tranche $2.2M closed after quarter-end.

## SEC filing metadata
- accession: 0001193125-23-146082
- form_type: 8-K
- ticker: ICU
- cik: 0001831868
- company_name: SeaStar Medical Holding Corp
- filed_at: 2023-05-16T23:59:59+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/1831868/000119312523146082/0001193125-23-146082-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1831868/000119312523146082/d496122d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-146082
- JSON: https://secwatch.observer/filing/0001193125-23-146082.json
- Plain text: https://secwatch.observer/filing/0001193125-23-146082.txt

## Key facts
- Earnings Releases
  SeaStar Medical Holding Corp reported the three months ended March 31, 2023 results: net income $5.3 million, EPS $0.40 per share.
  - Period: the three months ended March 31, 2023
  - Net income: $5.3 million
  - EPS: $0.40 per share
  - Result: reported results
  source text: The net loss for the first quarter of 2023 was $5.3 million, or $0.40 per share, compared with a net loss of $1.0 million, or $0.14 per s
  evidence_url: https://www.sec.gov/Archives/edgar/data/1831868/000119312523146082/0001193125-23-146082-index.htm

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