SeaStar Medical Holding (ICU) FY Conference Summary Company Overview - **Company Name**: SeaStar Medical Holding - **Ticker Symbol**: ICU (NASDAQ) - **Focus**: Development of QUELIMMUNE Selective Cytopheretic Device for immune-related renal injuries, particularly in critically ill patients facing organ failure [1][2] Core Points and Arguments - **Technology and Approval**: QUELIMMUNE is FDA approved for treating acute kidney injury with sepsis in children under a humanitarian device exemption in 2024 [2][3] - **Market Potential**: - Pediatric AKI market is valued at approximately $100 million with around 4,000 patients in the U.S. - Adult AKI market is significantly larger, with over 200,000 patients annually, representing a market potential of around $4.5 billion [5][18] - **Clinical Studies**: - Pivotal study (NEUTRALIZE-AKI) is currently 60% enrolled, targeting multiple adult indications under breakthrough device designation [4][3] - Clinical data shows a 77% survival rate in pediatric patients treated with QUELIMMUNE, with no patients requiring dialysis after 60 days [12][11] - **Mechanism of Action**: The device targets activated neutrophils and monocytes to quell hyperinflammation without immunosuppression, effectively reducing cytokine storms [8][9][10] Pipeline and Future Indications - **Current Pipeline**: Focus on both pediatric and adult indications, including end-stage renal disease, chronic dialysis, and cardiorenal conditions [4][3] - **Future Studies**: A pivotal randomized controlled study is ongoing for adults, with a primary endpoint of all-cause mortality and dialysis dependency [19][22] Economic Impact and Health Economics - **Cost Savings**: The use of QUELIMMUNE in pediatric patients resulted in a median hospital stay reduction of about 3 days, leading to cost savings for hospitals [16] - **Reimbursement**: The trial has CMS reimbursement, indicating support for the economic viability of the treatment [20] Strategic Focus - **Target Hospitals**: Strategy to focus on the top 50 children's hospitals in the U.S., where 50% of acute kidney injury patients are treated [14] - **Sales and Distribution**: Control over sales and distribution to enhance customer experience and reduce costs [16] Financial Overview - **Market Capitalization**: As of August 12, the stock price was $0.73 with approximately 28 million shares outstanding [23] - **Recent Capital Raise**: Raised around $8.6 million in July 2025 to support ongoing initiatives [24] Conclusion - **Investment Opportunity**: SeaStar Medical presents a best-in-class technology with significant market potential in both pediatric and adult AKI, backed by promising clinical results and a clear strategic focus on commercialization and expansion [25]