by Meg Flippin Benzinga
DETROIT, MICHIGAN - July 11, 2025 (NEWMEDIAWIRE) - When it comes to unmet needs in the nephrology space, acute kidney injury remains a significant concern. That’s particularly true regarding pediatric AKI – each year, about 4,000 children with AKI require continuous renal replacement therapy (RRT), with a mortality rate of approximately 51-58%. Many of those who survive experience long-term complications that can include chronic kidney disease and a lifetime of dialysis.
Despite that, not enough has been done to find an effective treatment. So it’s not surprising that SeaStar Medical (NASDAQ: ICU), which has had success with its U.S. FDA-approved medical device QUELIMMUNE, was selected to receive the 2025 Corporate Innovator Award from the National Kidney Foundation (NKF).
Joining Some Heavy Hitters
The Corporate Innovator Award was established to recognize industry leaders who advance the field of nephrology by addressing an unmet medical need or improving upon an existing practice, therapeutic or technology. Past Corporate Innovator Award recipients have included Keryx Biopharmaceuticals Inc., Janssen Pharmaceuticals (part of Johnson & Johnson), Merck & Co. Inc., Otsuka Pharmaceuticals Co. Ltd., Relypsa Inc. and other similarly notable names.
QUELIMMUNE is SeaStar’s humanitarian medical device to treat pediatric patients with AKI due to sepsis or a septic condition. The device is connected in-line to an existing continuous kidney replacement therapy (CKRT) circuit. QUELIMMUNE is designed to target the innate immune response. When patients get very sick, the immune system becomes dysregulated and triggers what’s commonly referred to as the cytokine storm. The QUELIMMUNE device is designed specifically to target the cytokine storm at the source.
Cutting Mortality Rates, Improving Quality Of Life
QUELIMMUNE was granted approval under a Humanitarian Device Exemption (HDE) by the FDA in February 2024, with clinical data establishing safety and probable benefit for this use. A pooled analysis of data published in Kidney Medicine from two studies, SCD-PED-01 (funded by the FDA Office of Orphan Products Development) and SCD-PED-02, showed that pediatric patients treated with the QUELIMMUNE had no device-related serious adverse events or device-related infections, a 77% reduction in mortality rate and no dialysis dependency after 60 days. Published data in the Journal of the American Society of Nephrology (JSAN) show that about 13% have CKD and approximately 2% need long-term dialysis.
“AKI has devastatingly high rates of morbidity and mortality, especially in children,” said Kevin Longino, CEO, National Kidney Foundation and a kidney transplant recipient. “The Corporate Innovator Award recognizes SeaStar Medical’s significant contribution to improving the lives of pediatric patients with AKI and we congratulate them on this achievement.” SeaStar is currently engaged in a trial evaluating the safety and efficacy of QUELIMMUNE to treat adult AKI. As of June 23, 2025, the study has 108 patients enrolled, and the company is shooting for a total of 200.
75 Years Of Impact
Receiving the award from NKF was a big deal for SeaStar, given the work the foundation has done since its inception in 1950. Over the past 75 years, the NKF has helped revolutionize the fight to save lives by eliminating preventable kidney disease, accelerating innovation for the dignity of the patient experience and dismantling structural inequities in kidney care, dialysis and transplantation.
The NKF has successfully advocated for the establishment of the Medicare End-Stage Renal Disease (ESRD) benefit, providing federal coverage for nearly all Americans with kidney failure, launched the Kidney Disease Outcomes Quality Initiative (KDOQI®), which set clinical practice guidelines that have improved patient care and collaborated with the American Society of Nephrology (ASN) to promote equity in kidney care nationwide. The foundation is also responsible for doubling the number of adults with kidney disease who are aware of their condition and doubling the number of individuals at risk or living with chronic kidney disease who receive recommended testing.
In the United States, more than 35 million adults are estimated to have kidney disease and approximately 90% don’t know they have it. About 1 in 3 adults in the U.S. are at risk for kidney disease. SeaStar Medical has received FDA Breakthrough Device Designation for the development of its SCD therapy in patients with End-Stage Renal Disease and hopes to one day help these patients as well.
“SeaStar Medical is honored to be recognized by the National Kidney Foundation as a recipient of the Corporate Innovator Award,” said Eric Schlorff, Chief Executive Officer of SeaStar Medical. “It can only be matched by the exhilaration we experience when we hear from the medical community how QUELIMMUNE has helped save children’s lives and avoided long term dialysis. We are grateful for this award, and also, for the tireless efforts of the National Kidney Foundation to help patients with kidney disease.”
Featured image courtesy of SeaStar Medical.
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