SeaStar Medical CEO Honored for Innovating SCD Therapy

DENVER, Sept. 24, 2026 /CourierPR/ -- SeaStar Medical, a commercial-stage healthcare company focused on transformative treatments for critically ill patients, celebrated a significant milestone with the announcement that H. David Humes, M.D., has been awarded the University of Michigan’s 2026 Distinguished University Innovator of the Year for his pioneering work on the Selective Cytopheretic Device (SCD) therapy. The award, presented during the annual Celebrate Invention event on September 24, 2026, in Ann Arbor, Michigan, recognizes Humes’ groundbreaking contributions to the medical community.

Humes’ innovative SCD therapy, commercialized by SeaStar Medical as QUELIMMUNE®, has shown remarkable results in treating critically ill pediatric patients with acute kidney injury (AKI). The therapy, approved in February 2024 under a Humanitarian Device Exemption, has demonstrated a 50% reduction in patient mortality at 60 days, compared to the standard of care. Data from two clinical trials published in *Kidney Medicine* highlighted a 77% survival rate in patients treated with QUELIMMUNE, representing a significant improvement over historical data.

QUELIMMUNE is specifically designed for children with AKI and sepsis or a septic condition weighing 10 kilograms or more who are on antibiotics and being treated in the ICU with renal replacement therapy (RRT). The therapy has shown promising outcomes, with no dialysis required for survivors, and 87.5% of survivors having normal kidney function at Day 60 after ICU discharge. Additional data from the QUELIMMUNE SAVE Registry, published in *Pediatric Nephrology*, further validated these findings, showing a 76% survival rate at Day 28 and Day 60, and a 71% survival rate at Day 90.

The SCD therapy, at the heart of QUELIMMUNE, is a disease-modifying device that neutralizes over-active immune cells and stops the cytokine storm that leads to destructive hyperinflammation. This unique approach aims to promote long-term organ recovery and prevent the need for future continuous RRT, including dialysis. The therapy has broad applications for treating acute and chronic kidney and cardiovascular diseases, where patients currently have no FDA-approved options.

SeaStar Medical is currently conducting the pivotal NEUTRALIZE-AKI clinical trial, evaluating the safety and efficacy of the SCD therapy in 339 adults with AKI in the ICU receiving continuous RRT. The primary endpoint of the trial is a composite of 90-day mortality or dialysis dependency. Secondary endpoints include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at Day 90, and dialysis dependency at one year. The study will also explore the effectiveness of the SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome.

Dr. Humes’ visionary science has transformed the medical community’s understanding of immune system dysregulation in critical illness. By targeting activated white blood cells to stop the hyperinflammatory cascade, his life's work has paved the way for the commercialization of QUELIMMUNE, providing clinicians with a valuable tool to save the lives of critically ill children. Eric Schlorff, Chief Executive Officer of SeaStar Medical, expressed pride in the legacy Humes has built and the potential for the SCD therapy to advance beyond the pediatric indication.

The NEUTRALIZE-AKI trial is expected to provide critical insights into the broader applicability of the SCD therapy, potentially opening new avenues for treating a wide range of acute kidney injuries in adults. SeaStar Medical remains committed to advancing the SCD therapy and exploring its potential in multiple therapeutic indications, with the ultimate goal of improving patient outcomes and reducing the burden of organ failure.