SeaStar Medical Holding Corp Dossier
Qualitative Analysis
Business overview
SeaStar Medical Holding Corporation (Nasdaq: ICU) is a commercial-stage medical technology company focused on developing and commercializing extracorporeal therapies that target and redirect hyperactivated immune cells. The company's proprietary Selective Cytopheretic Device (SCD) technology is designed to address destructive hyperinflammation, which can lead to organ failure and death in critically ill patients. SeaStar Medical operates through a single reportable Device Segment. Its first commercial product, QUELIMMUNE (SCD-PED), is FDA-approved under a Humanitarian Device Exemption (HDE) for pediatric patients weighing 10 kg or more with acute kidney injury (AKI) due to sepsis or septic conditions requiring continuous renal replacement therapy (CRRT).
Research as of 20 Jun 2026
Strategic Initiatives
Growth programs, investments, and their expected impact
Expanding the commercial footprint of the FDA-approved QUELIMMUNE therapy for ultra-rare pediatric acute kidney injury (AKI) due to sepsis. The initiative focuses on onboarding new top-ranked children's hospitals and driving repeat orders.
Expected impact: Aims to double the customer base by adding 15 new medical centers and achieve approximately $2.0 million in net product revenue for the full year 2026.
Advancing the clinical development of the Selective Cytopheretic Device (SCD) therapy for adult patients with AKI in the ICU receiving continuous renal replacement therapy (CRRT).
Expected impact: Positions the company to submit a modular PMA to the FDA, unlocking the adult AKI market which is approximately 50 times larger than the pediatric market.
Evaluating the broader applicability of the SCD therapy in patients with acute congestive heart failure (CHF) with cardiorenal syndrome (CRS) awaiting left ventricular assist device (LVAD) implantation.
Expected impact: Leverages the FDA's Breakthrough Device Designation to establish rapid pathways to commercialization in a high-severity indication with no current effective treatments.
Mergers, Acquisitions & Partnerships
Recent deals and strategic collaborations
Strategic Partnerships
Enables the evaluation of the Selective Cytopheretic Device (SCD) therapy to reduce hyperinflammation in combat soldiers suffering from severe burns, inhalation injuries, and infections.
Terms: Generated approximately $105 thousand in research-related product sales for SeaStar Medical during the fourth quarter of 2025.