SeaStar Medical (NasdaqCM:ICU) 2026 Conference Summary Company Overview - **Company Name**: SeaStar Medical Holding Corporation - **Ticker Symbol**: ICU - **Industry**: Biotech/Medical Devices - **Mission**: To stop organ failure and save lives through innovative therapies targeting hyperinflammation and acute kidney injury [2][3] Core Points and Arguments Product and Market Potential - **Product**: Quellimune, a selective cytophoretic device (SCD) for treating acute kidney injury (AKI) in pediatric patients [7][10] - **Market Size**: - Pediatric AKI market in the U.S. is approximately $100 million, with about 4,000 children affected annually [3] - Adult AKI market is significantly larger, estimated to be 50 times the pediatric market [3] - **Revenue Potential**: Expected annual revenue of $4-$5 million post-FDA approval for adult indications [3] Clinical Efficacy - **Survival Rates**: Clinical studies show a survival rate increase of 50%-77% for children with AKI treated with Quellimune [10] - **Long-term Outcomes**: Zero patients required long-term dialysis post-treatment, indicating effective kidney recovery [10][11] - **Safety Profile**: No serious adverse events or infections reported, highlighting a clean safety profile [12] Regulatory and Development Strategy - **FDA Designations**: Six breakthrough device designations received, facilitating expedited discussions with the FDA [2][9] - **Current Studies**: - Pivotal study for adult AKI (339 patients) underway, focusing on all-cause mortality and dialysis dependency as endpoints [16][27] - Additional studies for cardiorenal syndrome and bridging to left ventricular assist devices (LVAD) planned [20][21] Commercial Strategy - **Target Hospitals**: Focus on the top 50 children's hospitals in the U.S., aiming to capture 50% of the pediatric AKI market [12][13] - **Customer Growth**: Targeting 20-25 active customers by the end of 2026, up from 10 at the end of 2025 [13][25] - **Cost Savings for Hospitals**: Treatment costs for AKI patients are around $400,000; Quellimune can reduce ICU time and save hospitals between $39,000 and $46,000 per patient [15][28] Financial Health - **Cash Position**: Increased from $47,000 in 2022 to over $13 million as of September 30, 2025 [24] - **Market Capitalization**: Approximately $9 million, trading at or below cash value [25] - **Sales Projections**: Anticipated sales of $1 million for Quellimune by the end of 2025 [25] Additional Insights - **Organ Agnostic Approach**: The therapy targets neutrophils and monocytes, which function across various organs, indicating potential for broader applications beyond AKI [22] - **Educational Efforts**: Significant investment in medical affairs and education to promote understanding and adoption of the therapy [23] - **Reimbursement Strategy**: No reimbursement code required for pediatric use; reimbursement for adult patients is anticipated through CMS [29] This summary encapsulates the key points from the SeaStar Medical conference, highlighting the company's innovative approach to treating acute kidney injury and its strategic plans for growth and market penetration.