SeaStar Medical Adds Second Hospital Customer for QUELIMMUNE

Core Insights - SeaStar Medical has successfully shipped its Selective Cytopheretic Device (SCD), QUELIMMUNE, to a second hospital, marking a significant step in its direct sales model [1][2] - The company aims to have QUELIMMUNE available in four to five leading pediatric hospitals by the end of 2024, highlighting its growth strategy and market penetration efforts [2] Product Overview - QUELIMMUNE is designed for critically ill children with acute kidney injury (AKI) and sepsis, and it has received FDA approval under a Humanitarian Device Exemption (HDE) [1][3] - The device is expected to reduce hospitalization costs by approximately $30,000 per patient, primarily due to lower death rates and shorter hospital stays compared to standard care [3] Economic Impact - The cost of treating pediatric patients with AKI on continuous renal replacement therapy (CRRT) exceeds $460,000 per hospitalization, indicating a substantial market opportunity for QUELIMMUNE [3] - The device's implementation could lead to significant healthcare savings while providing critical care to very sick children [2][3] Regulatory and Operational Aspects - QUELIMMUNE requires Institutional Review Board (IRB) approval from each hospital before commercial sales can occur, which includes training for critical care teams [5] - The company is actively working to secure additional IRB clearances and expand its customer base under HUD requirements [2][5] Clinical Development - SeaStar Medical is conducting the NEUTRALIZE-AKI pivotal trial to evaluate the SCD's safety and effectiveness in adults with AKI, with the adult version of the device receiving FDA Breakthrough Device Designation [8] - The SCD technology aims to modulate the immune response in patients, potentially improving long-term organ recovery and reducing the need for future renal replacement therapy [7][8] Company Background - SeaStar Medical is focused on developing innovative medical technologies that address excessive inflammation in critically ill patients, with a commitment to improving patient outcomes through its proprietary therapies [9]