SeaStar Medical to Distribute QUELIMMUNE Directly to Hospital Customers

Core Insights - SeaStar Medical Holding Corporation has taken full responsibility for the direct sales, marketing, and distribution of its therapeutic device QUELIMMUNE, aimed at treating pediatric acute kidney injury (AKI) due to sepsis or septic-like conditions [1][2] - The company is focused on a successful commercial rollout of QUELIMMUNE, with initial demand exceeding expectations from its first customer, Cincinnati Children's Hospital [2][5] - SeaStar Medical anticipates recognizing 100% of revenue from QUELIMMUNE sales in the U.S., which is projected to be 3x-4x times more revenue per unit compared to previous arrangements [2][5] Company Overview - SeaStar Medical is a commercial-stage medical technology company that develops proprietary solutions to mitigate hyperinflammation's effects on vital organs [6] - The company specializes in cell-directed extracorporeal therapies that target effector cells driving systemic inflammation, which can lead to tissue damage and imbalanced immune responses [6] Product Details - QUELIMMUNE, also known as the Selective Cytopheretic Device (SCD) Pediatric, is designed to reduce hyperinflammation during continuous kidney replacement therapy (CKRT) [4][5] - The device has received FDA approval under a Humanitarian Device Exemption (HDE) for use in critically ill children with AKI, showing a 77% reduction in mortality rate and no dialysis dependency at Day 60 in clinical studies [5][4] - Each year, approximately 4,000 children in the U.S. require CKRT for AKI, with a high associated mortality rate of around 50% [5] Future Outlook - The company is streamlining relationships with pediatric hospitals to facilitate the integration of QUELIMMUNE into existing treatment protocols [2] - SeaStar Medical is exploring new strategic partnerships to accelerate the adoption of QUELIMMUNE technology among critically ill pediatric patients [2]