Significant Revenue Growth
SeaStar Medical reported a fourfold increase in first-quarter revenue compared to the fourth quarter of 2024, driven by the increased adoption of QUELIMMUNE therapy.
FDA Breakthrough Device Designations
The company received two new breakthrough device designations from the FDA for their SCD therapy, expanding their pipeline indications to address hyperinflammation during adult and pediatric cardiac surgery.
NEUTRALIZE-AKI Trial Progress
The NEUTRALIZE-AKI trial for adult patients reached a 50% enrollment milestone, triggering an interim analysis by the Data Safety Monitoring Board.
Pediatric Market Expansion
QUELIMMUNE therapy has been adopted by multiple new nationally recognized children's hospitals, indicating growing market penetration.
Strong Market Potential for Adult AKI
The adult AKI market presents a $4.5 billion annual opportunity, with plans to file a PMA in 2026.