SeaStar Medical's QUELIMMUNE Shows Promise in Treating Pediatric AKI
June 27th, 2025 1:40 PM
By: Newsworthy Staff
SeaStar Medical's QUELIMMUNE device, approved by the FDA, significantly reduces mortality rates in pediatric patients with acute kidney injury (AKI) by targeting the cytokine storm at its source.
Dr. Kevin Chung, Chief Medical Officer at SeaStar Medical Holding Corporation, and Dr. Stuart L. Goldstein from Cincinnati Children's Hospital Medical Center, discussed the impact of QUELIMMUNE, a humanitarian medical device approved by the U.S. FDA for treating pediatric acute kidney injury (AKI) due to sepsis. The device, which targets the cytokine storm responsible for hyperinflammation in AKI, has shown to reduce mortality rates from 50% to 25% in clinical trials.
QUELIMMUNE's approval under a Humanitarian Device Exemption marks a significant advancement in pediatric AKI treatment, offering hope where previous treatments failed, especially in severe cases requiring dialysis. Dr. Goldstein highlighted the device's rapid effectiveness, with patients showing improvement within 24 to 48 hours and many surviving without the need for chronic dialysis, a rare outcome in such cases.
Beyond pediatric AKI, SeaStar Medical is exploring QUELIMMUNE's potential in treating adult AKI and other conditions where the innate immune system is disturbed, supported by six Breakthrough Device Designations from the FDA. This development represents a pivotal step forward in addressing life-threatening conditions with limited treatment options.
Source Statement
This news article relied primarily on a press release disributed by NewMediaWire. You can read the source press release here,
