SeaStar Medical(US:ICU) Newsfilterยท2025-03-27 20:05Core Insights - SeaStar Medical Holding Corporation reported significant progress in 2024, including the approval and commercial launch of QUELIMMUNE therapy, and the expansion of clinical trials for its Selective Cytopheretic Device (SCD) therapy [2][3] Financial Performance - Net revenue for the year ended December 31, 2024, was $0.1 million, a notable increase from no revenue in 2023, attributed to the launch of QUELIMMUNE therapy [3][4] - The net loss for the year ended December 31, 2024, was $24.8 million, an improvement from a net loss of $26.2 million in 2023, with net loss per share decreasing from $30.26 to $6.63 [8][21] - Cash, cash equivalents, and short-term investments at December 31, 2024, were $1.8 million, excluding proceeds from a $6 million financing completed in February 2025 [8][22] Business Developments - The company received its first product approval for QUELIMMUNE therapy, specifically for pediatric patients with acute kidney injury (AKI) due to sepsis, impacting approximately 4,000 children annually [3][15] - SeaStar Medical added 14 new clinical sites for the NEUTRALIZE AKI pivotal trial, with 94 out of the anticipated 200 patients enrolled [2][3] - The company was awarded its fourth Breakthrough Device Designation for SCD therapy, which is expected to expedite the review and approval processes [2][3] Research and Development - Research and development expenses increased to approximately $9.1 million in 2024 from $6.0 million in 2023, driven by clinical trial expenses and increased personnel costs [5][6] - The National Institutes of Health awarded a $3.6 million grant for a clinical trial evaluating SCD therapy as a bridging strategy for patients with chronic heart failure [3][5] Awards and Recognition - SeaStar Medical received the 2025 Corporate Innovator Award from the National Kidney Foundation for its contributions to improving the lives of pediatric patients with AKI [3][9]