SeaStar Medical(US:ICU)2025-05-14 21:32Financial Data and Key Metrics Changes - The company reported a fourfold increase in net revenue for the first quarter of 2025, achieving $293,000 compared to approximately $68,000 in the fourth quarter of 2024 and $0 in the first quarter of the previous year [31][34] - The net loss for the first quarter of 2025 declined to $3,700,000 compared to a loss of $12,700,000 in the first quarter of 2024 [34] Business Line Data and Key Metrics Changes - The Quellimmune therapy saw increased adoption, driving revenue growth, with all existing customers purchasing the therapy during the quarter [31][32] - The company anticipates a total annual U.S. market opportunity of approximately $100,000,000 based on a pediatric AKI population of about 4,000 patients [14] Market Data and Key Metrics Changes - The adult AKI market represents a significant opportunity with over 200,000 adults affected, translating to a total annual market opportunity of about $4,500,000,000 in the U.S. [9][18] - The company is focusing on the top 50 pediatric sites in the U.S. for Quellimmune therapy adoption, with a strong interest from these institutions [15][16] Company Strategy and Development Direction - The primary goal for 2025 is to grow the customer base for Quellimmune therapy and complete the neutralized AKI pivotal trial [5][11] - The company aims to file a PMA for the adult AKI indication in 2026, contingent on positive trial results [27][37] - The strategic goal includes expanding the addressable market to target other critical unmet medical needs for treating destructive hyperinflammation [28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future opportunities for SeaStar Medical, highlighting the potential to capture a significant portion of the adult AKI market [37] - The company is focused on maintaining careful attention to spending while pushing forward with its commercial launch and clinical trials [30][34] Other Important Information - The neutralized AKI trial has reached the 50% enrollment milestone, triggering an interim analysis by the independent Data Safety Monitoring Board [10][21] - The company has received breakthrough device designations for five other indications, indicating a robust pipeline for future growth [28] Q&A Session Summary Question: How many sites are currently activated for the adult clinical trial? - The company currently has 15 activated sites and plans to activate another five over the next three months [39] Question: What's the total number of pediatric hospitals that you have as customers currently? - The company has six commercially active sites and multiple others moving through the IRB process [41] Question: What sort of pipeline growth have you seen in the first quarter compared to the fourth quarter? - The growth is attributed to the experience of existing sites and word-of-mouth, with hospitals actively engaging in adopting Quellimmune therapy [42][44] Question: How important are the two additional breakthrough designations? - The company views cardiac surgery as a significant opportunity and plans to pursue additional clinical trials funded by grants and investigator-initiated studies [48][51]