Seastar Medical Holding Stock Earnings Reports

SeaStar Medical reported strong commercial and clinical momentum in Q1 2026. QUELIMMUNE net revenue was $495k, up ~69% year-over-year, driven by seven new pediatric hospital customers (17 total) and rising repeat orders; the company expects roughly $2.0M in QUELIMMUNE net revenue for 2026. Clinical progress: the SAVE Registry completed enrollment at 50 pediatric patients (28-day safety analysis underway and planned submission to FDA), and the NEUTRALIZE-AKI pivotal adult trial has enrolled 198 of 339 planned patients with management targeting enrollment completion around year-end 2026 and potential topline results mid-2027. Regulatory strategy includes pursuing a modular PMA and leveraging Breakthrough Device designation to accelerate adult approval pathways. Financials: gross margin remained above 90%; operating expenses were flat at ~$4.1M for the quarter; Q1 net loss was ~$3.5M ($0.90/share) and cash was $9.3M as of March 31, 2026. Management expects modest R&D expense increases (about 5% per quarter) to support trial enrollment while keeping G&A stable. Key near-term investor catalysts: completion of NEUTRALIZE-AKI enrollment, SAVE Registry 28-day safety submission and potential transition to a voluntary post-market study, ongoing FDA engagement on modular PMA/rapid pathways, and continued pediatric commercial adoption/ordering dynamics.