SeaStar Medical is not a typical “pre-clinical biotech on a slide deck”. The company has already crossed the line into real-world use: QUELIMMUNE (the pediatric implementation of the SCD) is approved by the US Food and Drug Administration via HDE and has been adopted by a growing group of leading US children’s hospitals. Early registry data suggest improved survival and kidney recovery in some of the sickest patients in the ICU, with no device-related safety signals reported so far