Dr. Kevin Chung, Chief Medical Officer at SeaStar Medical Holding Corporation, and Dr. Stuart L. Goldstein from Cincinnati Children’s Hospital Medical Center, recently discussed the promising results of QUELIMMUNE, a medical device developed to treat pediatric patients with acute kidney injury (AKI) due to sepsis or septic conditions. The device, which received FDA approval under a Humanitarian Device Exemption in February 2024, targets the cytokine storm associated with severe AKI, offering hope where previous treatments have fallen short.
Pediatric AKI, a sudden episode of kidney failure, poses a significant risk to children, with a mortality rate of 50% among the approximately 4,000 cases reported annually in the U.S. QUELIMMUNE’s ability to halve this mortality rate to 25% represents a groundbreaking advancement in pediatric care. Moreover, the device has shown rapid improvements in patient conditions within 24 to 48 hours, a result that surprised even the researchers involved in the trials.
The implications of QUELIMMUNE’s success extend beyond pediatric AKI. SeaStar Medical is currently exploring its application in treating adult AKI, with ongoing trials aiming to enroll 200 patients. The device’s organ- and disease-agnostic nature, coupled with its six Breakthrough Device Designations from the FDA, suggests potential for treating a wide range of conditions where the innate immune system is disturbed. This development marks a significant step forward in medical science, offering new hope for patients with life-threatening conditions.
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