SeaStar Medical Adds Fifth Hospital Customer for QUELIMMUNE

Core Insights - SeaStar Medical Holding Corporation has successfully shipped its Selective Cytopheretic Device (SCD), QUELIMMUNE, to a leading pediatric medical center in California, increasing its commercial customer base to five [1][2] - The company aims to expand the use of QUELIMMUNE to over 20 hospitals within the year, with ongoing efforts to secure additional hospital clearances and institutional review board (IRB) approvals [2][3] Company Overview - SeaStar Medical is a commercial-stage therapeutic medical device company focused on developing solutions to mitigate hyperinflammation effects on vital organs [1][6] - The company’s QUELIMMUNE device is specifically designed for critically ill children suffering from acute kidney injury (AKI) and sepsis, approved by the FDA under a Humanitarian Device Exemption (HDE) [3][6] Product Details - QUELIMMUNE targets proinflammatory neutrophils and monocytes during continuous renal replacement therapy (CRRT), aiming to reduce hyperinflammation and promote organ recovery [5][6] - The device has received FDA Breakthrough Device Designation for four indications, highlighting its potential in treating severe conditions [6][7] Market Context - Acute Kidney Injury (AKI) can lead to severe complications, including multi-organ dysfunction and increased healthcare costs due to prolonged ICU stays and reliance on dialysis [4] - The innovative approach of QUELIMMUNE may provide a unique solution in a market with limited treatment options for critically ill pediatric patients [3][4]