SeaStar Medical Holding Corporation (ICU) showcased new positive real-world data from its QUELIMMUNE SAVE Registry, along with new mechanistic insights into its Selective Cytopheretic Device therapy, at the AKI & CRRT 2026 conference.
The company said the findings reinforce the therapy's role in treating critically ill pediatric patients with life-threatening acute kidney injury (AKI) and sepsis requiring renal replacement therapy.
AKI is a sudden loss of kidney function often triggered by severe infection, trauma or organ failure, and can lead to destructive hyperinflammation and multi-organ dysfunction. Children with septic AKI face historically high mortality rates, making effective treatment options urgently needed.
New data from the QUELIMMUNE SAVE Registry showed no device-related adverse events, no infections and no signs of immunosuppression in the first 21 pediatric patients treated. Preliminary outcomes demonstrated a 76% survival rate at Day 28 and Day 60, and 71% at Day 90- results that are on track to validate an approximate 50% reduction in mortality compared to historical data, consistent with earlier clinical trial findings.
SeaStar Medical also presented investigator-led research showing that the SCD therapy modulates the immune response by shifting pro-inflammatory monocytes toward an anti-inflammatory, reparative phenotype. The company said this unique immunomodulatory mechanism may help counteract the hyperinflammation that drives organ failure in AKI.
In addition to the data presentations, SeaStar Medical hosted an educational symposium featuring leading pediatric nephrology experts and introduced the first Advanced Practice Provider Panel to support broader adoption of QUELIMMUNE, which was approved in 2024 under a Humanitarian Device Exemption.
The company is also advancing its NEUTRALIZE-AKI pivotal trial in adults with AKI requiring continuous renal replacement therapy, a condition with no effective treatment options and affecting more than 200,000 adults annually in the U.S.
ICU has traded between $2.07 and $16.80 over the past year. The stock closed yesterday's trading at $3.62, up 32.12%. During the overnight session the stock fell to $3.60, down 0.55%.
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