SeaStar Medical Announces 2026 Milestones

Core Insights - SeaStar Medical is focused on expanding the adoption of its QUELIMMUNE therapy for ultra-rare pediatric acute kidney injury (AKI) and advancing its Selective Cytopheretic Device (SCD) therapy for adult AKI, targeting a potential market of $4.5 billion [1][2] Group 1: QUELIMMUNE Therapy - The QUELIMMUNE therapy is designed for children with AKI and sepsis, approved under a Humanitarian Device Exemption, requiring participation in the SAVE Surveillance Registry [3] - Clinical studies show a 77% survival rate for patients treated with QUELIMMUNE, indicating a 50% reduction in loss of life compared to historical data [4] - The customer base for QUELIMMUNE has expanded to 10 top-rated children's hospitals, with expectations of achieving approximately $2 million in net product revenue in 2026 [8] Group 2: SCD Therapy Development - The SCD therapy is being advanced for adult AKI through the NEUTRALIZE-AKI pivotal trial, with enrollment completion expected by the end of 2026 [2][6] - The FDA has granted Breakthrough Device Designation for the SCD therapy in both adult AKI and acute chronic heart failure (CHF) with cardiorenal syndrome, facilitating a faster approval process [2][10] - The company is exploring broader applications of the SCD therapy, including its use in patients with CHF awaiting left ventricular assist device (LVAD) implantation [2][10] Group 3: Market Opportunities - The potential market for the SCD therapy in adult patients with AKI and CHF is described as a multi-billion-dollar opportunity in the U.S. alone [2] - The company aims to leverage rapid regulatory pathways to commercialize the SCD therapy across various hyperinflammatory conditions [2][10] - The successful outcome of the NEUTRALIZE-AKI trial could lead to a Premarket Approval application in 2027, with expectations for rapid approval and early adoption [2]