secwatch.observer — SEC 8-K summary
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Issuer:     SeaStar Medical Holding Corp (ICU)
CIK:        0001831868
Form:       8-K
Filed at:   2023-11-22T23:59:59+00:00
Accession:  0000950170-23-065623
Event type: earnings
Sentiment:  neutral
Materiality: 0.60
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

SeaStar Medical Q3 net loss $7.4M; FDA Approvable Letter for pediatric AKI device received
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- Net loss $7.4M ($0.37/share) vs $1.9M ($0.26/share) YoY; no revenue as pre-commercial stage.
- Cash $73,000 at Sep 30, raised $3.5M convertible notes in Aug-Sep 2023.
- Received FDA Approvable Letter for SCD-PED; formal approval expected Dec 2023-Jan 2024.
- Breakthrough Device Designation granted for cardiorenal and hepatorenal syndromes in Sep-Oct 2023.
- NEUTRALIZE-AKI adult trial enrolled 7 patients; target 200 at up to 30 U.S. sites.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1831868/000095017023065623/0000950170-23-065623-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1831868/000095017023065623/icu-20231121.htm
  HTML page:      https://secwatch.observer/filing/0000950170-23-065623

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer