QUELIMMUNE Registry Data Show 65% Day-90 Survival in Pediatric Sepsis-AKI
ICU sits 56% above its 52-week low of $2.07.
Summary
SeaStar's post-approval SAVE registry data, presented as a late-breaker at ASN Kidney Week 2026, show 65.1% Day 90 survival for QUELIMMUNE-treated pediatric sepsis-AKI patients versus 47.4% in a matched historical KID cohort (P=0.043, odds ratio 2.07). Survival to hospital discharge was also significantly higher (P=0.04), and no device-related adverse events occurred. The mortality models pointed to a 34%-40% reduction in hazard of death, though the frequentist models missed statistical significance and the landmark Day 90 sensitivity analysis came in at P=0.074. This is the strongest real-world evidence yet for the company's only approved product, and it lands after the October 7 Breakthrough Device Designation for the SCD in a second indication. The commercial read-through matters most: SeaStar reported just $0.6M in Q2 revenue and disclosed going-concern doubt with $7.0M of cash, so adoption data like this is the main lever for the pediatric launch. Final results are expected in a peer-reviewed manuscript.
At the time of this announcement, ICU was trading at $3.22 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $14.2M. The 52-week trading range was $2.07 to $6.48. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: GlobeNewswire.