SeaStar Medical Projects Multibillion-Dollar Market Potential for its Selective Cytopheretic Device in Initial Target Indications

Core Insights - SeaStar Medical Holding Corporation estimates a U.S. total addressable market for its Selective Cytopheretic Device (SCD) in five clinical indications to be between $25 billion and $33 billion, pending FDA approvals [1][2]. Market Overview - The estimated annual U.S. patient populations and total addressable markets for the five clinical indications are as follows: - Adult Acute Kidney Injury (AKI): 210,000 patients, market size of $4,700 million to $6,300 million, clinical trial costs of $154 million [2] - Cardiorenal Syndrome without LVAD: 580,000 patients, market size of $13,100 million to $17,400 million, clinical trial costs of $5 million [2] - Adult Acute Respiratory Distress Syndrome (ARDS): 200,000 patients, market size of $4,500 million to $6,000 million, clinical trial costs of $10 million [2] - Adult Hepatorenal Syndrome: 50,000 patients, market size of $1,100 million to $1,500 million, clinical trial costs of $4 million [2] - Cardiorenal Syndrome with LVAD: 60,000 patients, market size of $1,400 million to $1,800 million, clinical trial costs of $4 million [2] Regulatory Milestones - The SCD has received FDA Breakthrough Device Designation for three indications: adult AKI, hepatorenal syndrome, and cardiorenal syndrome with LVAD, which facilitates faster development and priority review by the FDA [2][6]. - The company has achieved a significant regulatory milestone by securing approval for the SCD-Pediatric, branded as QUELIMMUNE, for treating critically ill children with AKI and sepsis [2][7]. Clinical Trials - The NEUTRALIZE-AKI pivotal trial aims to enroll up to 200 adults, with 69 subjects already enrolled. The primary endpoint is a composite of 90-day mortality or dialysis dependency [8]. - Secondary endpoints include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at Day 90, and dialysis dependency at one year [8]. Company Overview - SeaStar Medical is a commercial-stage medical technology company focused on developing cell-directed extracorporeal therapies to mitigate excessive inflammation in critically ill patients [9].