SeaStar Medical’s stock dropped 13.2% after the quarter, driven primarily by cautious commentary on the pace of enrollment in the NEUTRALIZE-AKI pivotal trial and the still small commercial scale of QUELIMMUNE revenue, which constrains near-term growth visibility.

• QUELIMMUNE revenue increased 69% year-over-year to $495,000, supported by the addition of 7 new hospital customers in Q1.
• The company maintains a target of 15 new hospital adoptions for the full year, reflecting modest but steady customer growth.
• Enrollment for the adult AKI pivotal trial stands at 198 of 339 planned patients, with efforts underway to expand clinical sites to complete enrollment by end of 2026.
• Management highlighted ongoing discussions with the FDA on modular PMA submission and potential rapid approval pathways, but no new regulatory milestones were announced this quarter.
• Despite commercial and clinical progress, the relatively early-stage adoption and cautious outlook on trial enrollment tempo likely contributed to investor disappointment.