SeaStar’s QUELIMMUNE Breakthrough

In a significant advancement for pediatric care, SeaStar Medical’s QUELIMMUNE therapy has demonstrated promising results in treating acute kidney injury (AKI) caused by sepsis in children. The therapy, officially known as the Selective Cytopheretic Device for Pediatrics (SCD-PED), received FDA approval in February 2024 under a Humanitarian Device Exemption (HDE). (seastarmedical.com)

FDA Approval and Adoption

QUELIMMUNE is the first and only FDA-approved device for treating pediatric AKI due to sepsis or septic conditions. It is intended for children weighing at least 10 kilograms who require renal replacement therapy. The device integrates into existing hemodialysis systems, offering a seamless addition to current treatment protocols. (seastarmedical.com)

Following its approval, QUELIMMUNE has been adopted by several top-rated children’s hospitals across the United States. This adoption underscores the medical community’s confidence in the therapy’s efficacy and safety. (globenewswire.com)

Safeguard patient information with TrueNASs self-healing data technology.

Positive Early Results

Preliminary data from the SAVE Surveillance Registry, which monitors the real-world application of QUELIMMUNE, have been encouraging. In the first 20 pediatric patients treated, there were no device-related safety events, and 75% survived through 28 days. These outcomes suggest a potential 50% reduction in mortality compared to historical data, as reported in Kidney Medicine. (globenewswire.com)

Dr. Kevin Chung, Chief Medical Officer of SeaStar Medical, highlighted the significance of these findings, noting that many patients were critically ill and received QUELIMMUNE as a last resort. The therapy provided these children a fighting chance, leading to survival during the immediate life-threatening period. (globenewswire.com)

Recognition and Future Prospects

In recognition of its innovative approach, SeaStar Medical received the 2025 Corporate Innovator Award from the National Kidney Foundation. This accolade acknowledges the company’s contribution to improving the lives of pediatric patients with AKI. (kidney.org)

Looking ahead, SeaStar Medical plans to expand the SAVE Surveillance Registry to include up to 300 patients. This expansion aims to further validate QUELIMMUNE’s safety and efficacy, potentially leading to broader adoption and informing payer discussions. (globenewswire.com)

The success of QUELIMMUNE represents a beacon of hope for pediatric patients battling AKI due to sepsis. As more data becomes available, the medical community anticipates a transformative impact on treatment protocols, offering improved outcomes for critically ill children.

References

• SeaStar Medical. (2024). QUELimmune – SeaStar Medical. Retrieved from (seastarmedical.com)

• SeaStar Medical. (2025). SeaStar Medical Reports Positive Results for QUELIMMUNE Therapy in Pediatric Acute Kidney Injury (AKI) from the First 20 SAVE Surveillance Registry Patients. Retrieved from (globenewswire.com)

• National Kidney Foundation. (2025). NKF Honors SeaStar Medical, with 2025 Corporate Innovator Award. Retrieved from (kidney.org)

• SeaStar Medical. (2025). SeaStar Medical Reports Positive Early Results for QUELIMMUNE Therapy in Pediatric Acute Kidney Injury (AKI) at the 5th International Symposium on Acute Kidney Injury in Children. Retrieved from (globenewswire.com)

• SeaStar Medical. (2025). SeaStar Medical Grows Customer Base and Expands QUELIMMUNE Surveillance Registry. Retrieved from (globenewswire.com)