SeaStar Medical (NasdaqCM:ICU) 2026 Conference Transcript

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.