Seastar Medical Holding Stock Earnings Reports

SeaStar Medical reported strong early 2026 commercial momentum for QUELIMMUNE with first-quarter net revenue of $495k, up ~69% year-over-year, driven by 7 new pediatric hospital customers (17 total). Management reiterated a 2026 revenue target of approximately $2.0M and continued emphasis on education/implementation efforts to drive adoption in pediatric AKI. Clinically, the company is progressing the NEUTRALIZE-AKI pivotal trial for adults with 198 of 339 patients enrolled and targets enrollment completion around year-end 2026, positioning for potential topline results in mid-2027. SeaStar is engaging the FDA on a modular PMA strategy and potential rapid review pathways (breakthrough device) to accelerate adult SCD approval. The SAVE Registry reached 50 pediatric patients; top-line 28-day safety data will be submitted to the FDA with a request to convert the mandatory registry to a voluntary post‑marketing study if agreed, which could reduce hospital administrative burden and speed pediatric adoption. Financially, SeaStar reported gross margins >90%, operating expenses ~$4.1M (flat YoY), a Q1 net loss of ~$3.5M ($0.90/share), and cash of $9.3M as of March 31, 2026. R&D spend is expected to increase modestly (~5% each quarter) to support enrollment, while G&A should remain stable.