ICU · SeaStar Medical Holding Corporation

SeaStar Medical's first quarter 2026 results reflect strong commercial momentum for its QUELIMMUNE therapy in pediatric acute kidney injury (AKI). Net revenue of $0.5 million increased 69% year-over-year, driven by the addition of seven top-rated children's hospitals, bringing the total customer base to 17. The company anticipates approximately $2 million in net product revenue for full year 2026, implying continued acceleration. Research and development expenses decreased slightly to $2.3 million from $2.4 million, primarily due to lower clinical trial costs for the NEUTRALIZE-AKI pivotal trial, partially offset by higher personnel and external service costs. General and administrative expenses remained flat at $1.7 million. Net loss narrowed to $3.5 million ($0.90 per share) from $3.8 million ($4.38 per share) in the prior year period, reflecting revenue growth and stable operating expenses. Cash and cash equivalents stood at $9.3 million as of March 31, 2026, down from $12.0 million at December 31, 2025, reflecting ongoing investment in commercialization and clinical development. Management highlighted progress in the NEUTRALIZE-AKI pivotal trial, which has enrolled 198 of 339 patients, with completion expected around year-end 2026. The company has initiated efforts for a modular PMA submission for the adult AKI indication, targeting FDA filing in 2027. CEO Eric Schlorff noted the adult AKI market is approximately 50 times larger than the pediatric market, underscoring the strategic importance of the trial. Additionally, the company completed enrollment in the SAVE Registry and published real-world data in Pediatric Nephrology, supporting the therapy's safety and efficacy. Overall, the quarter demonstrates successful execution in building the QUELIMMUNE franchise while advancing the pipeline toward a potentially transformative adult indication.