SeaStar Medical shares surge 10.08% premarket after real-world data shows 71% 90-day survival, no adverse events, and FDA cuts registry to 50 patients.

Monday, Feb 9, 2026 8:37 am ET1min read
ICU--
SeaStar Medical surged 10.08% in premarket trading following the publication of favorable real-world data for its QUELIMUNE therapy in Pediatric Nephrology. The study reported a 71% 90-day survival rate in 21 pediatric patients with acute kidney injury and sepsis, with no device-related adverse events. The results aligned with clinical trial outcomes and validated a 50% reduction in mortality compared to historical data. Additionally, the FDA reduced the required enrollment for the SAVE Registry from 300 to 50 patients, signaling regulatory confidence in the therapy’s safety and efficacy. These developments reinforced the therapy’s potential to address an unmet medical need and supported broader adoption, driving optimism among investors.

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