SeaStar Medical Holding Corporation announced that the U.S. Food and Drug Administration (FDA) approved the Company's investigational device exemption (IDE) application to conduct a pivotal study evaluating the effectiveness of its Selective Cytopheretic Device (SCD) in reducing hyperinflammation in adults with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT). The Company plans to begin enrollment in this 200-patient randomized, controlled trial in March 2023. The study's primary endpoint is a composite of 90-day mortality and dialysis dependency of patients treated with SCD in addition to CKRT standard of care, compared with the
control group receiving CKRT standard of care. The Company's innovative SCD is a patented cell-directed extracorporeal therapy that selectively targets the most highly activated pro-inflammatory neutrophils and monocytes to stop the cytokine storm that can cause organ failure and death. SCD therapy is currently delivered through continuous CKRT to target and neutralize pro-inflammatory neutrophils and monocytes, allowing the body to return to homeostasis.