earnings
confidence high
sentiment neutral
materiality 0.60
SeaStar Medical Q3 net loss $7.4M; FDA Approvable Letter for pediatric AKI device received
SeaStar Medical Holding Corp
2023-Q3 EPS reported
-$1.02
- 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.