SeaStar Medical Holding Corporation (NASDAQ: ICU) presented new clinical data and research on its QUELIMMUNE therapy at the AKI & CRRT 2026 conference. The company showcased expanded real-world data from pediatric patients and investigator-led research on the immunomodulatory effects of its Selective Cytopheretic Device (SCD) therapy.

The SAVE Registry data from 18 months post-approval showed no device-related adverse events in pediatric patients treated with QUELIMMUNE. The registry reported survival rates of 69% at both Day 28 and Day 60, consistent with previous clinical trial results in the same patient population.

Separate in vitro research demonstrated that the SCD therapy modulates monocytes toward an anti-inflammatory, reparative phenotype. The gene expression study provided insights into the mechanism of action of the device in treating hyperinflammatory conditions.

QUELIMMUNE received FDA approval in February 2024 under a Humanitarian Device Exemption for treating critically ill pediatric patients with acute kidney injury and sepsis who weigh 10 kilograms or more and require renal replacement therapy. The therapy is designed for children on antibiotics being treated in intensive care units.

Previous clinical trials published in Kidney Medicine showed a 77% survival rate for patients treated with QUELIMMUNE versus standard care, representing approximately a 50% reduction in mortality compared to historical data. Among survivors, 87.5% had normal kidney function at Day 60 after ICU discharge.

The company is conducting the NEUTRALIZE-AKI pivotal trial evaluating the SCD therapy in 339 adults with acute kidney injury receiving continuous renal replacement therapy. The trial's primary endpoint is a composite of 90-day mortality or dialysis dependency.

SeaStar Medical also hosted an educational symposium featuring pediatric acute kidney injury experts and an Advanced Practice Provider Panel to discuss treatment approaches and expand community adoption of the therapy.