other_material
confidence high
sentiment positive
materiality 0.65
SeaStar Medical DSMB recommends continue NEUTRALIZE-AKI trial; enrollment target raised to 339
SeaStar Medical Holding Corp
- 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.
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