SeaStar Medical's QUELIMMUNE Earns Corporate Innovator Award

Recognition of QUELIMMUNE in Nephrology

In the large and complex field of nephrology, one of the most pressing issues is acute kidney injury (AKI), with pediatric cases raising particular concern. Approximately 4,000 children facing AKI annually require continuous renal replacement therapy, leading to high mortality rates that can reach as much as 58%. Survivors often face long-term consequences, including chronic kidney disease and a reliance on dialysis.

SeaStar Medical's Notable Accomplishment

SeaStar Medical, known for its innovative U.S. FDA-approved device QUELIMMUNE, has been recognized with the 2025 Corporate Innovator Award from the National Kidney Foundation (NKF). This acknowledgment is a testament to SeaStar's commitment to addressing unmet medical needs in the pediatric nephrology space.

Prior Recipients of the Award

The Corporate Innovator Award honors significant advancements in health, specifically in treating kidney conditions. Previous awardees include major players like Keryx Biopharmaceuticals, Janssen Pharmaceuticals, Merck & Co., and Otsuka Pharmaceuticals, highlighting SeaStar's position among leading innovators.

How QUELIMMUNE Works

QUELIMMUNE is specifically engineered to support pediatric patients suffering from AKI due to sepsis. By connecting to existing continuous kidney replacement therapy circuits, it aims to regulate immune responses effectively. The device targets the innate immune system, particularly during instances of severe illness when a dysregulated immune response results in dangerous cytokine storms.

Clinical Effectiveness and Safety

Recently granted Humanitarian Device Exemption by the FDA in early 2024, QUELIMMUNE has demonstrated clinical efficacy and safety through data pooled from studies conducted with pediatric patients. Findings show that those treated with QUELIMMUNE experienced a remarkable 77% reduction in mortality rates and no serious device-related adverse events within 60 days of treatment.

Long-term Goals and Current Trials

The interest in QUELIMMUNE is evident, as SeaStar Medical actively works on trials to assess its effectiveness in adult patients with AKI. Currently, a trial is ongoing, boasting 108 participants, with a goal of reaching 200. The NIH-funded studies reinforce SeaStar's role in combating the high morbidity and mortality rates associated with AKI, especially in children.

A Legacy of Influence by the National Kidney Foundation

The NKF has a storied history of pushing the boundaries of kidney health awareness and treatment since its formation in 1950. Their efforts have revolutionized the management of kidney disease through advocacy and innovation. With over 35 million adults in the United States estimated to have chronic kidney disease—many unaware of their condition—the foundation's work continues to save lives by providing critical resources and establishing guidelines for patient care.

Future Aspirations

As SeaStar Medical’s CEO Eric Schlorff expressed, being honored with the Corporate Innovator Award reflects not only gratitude for the impact QUELIMMUNE has had on children's lives but also recognizes the ongoing efforts of the NKF to improve kidney health. The company is excited about the potential to significantly impact not just pediatric healthcare but aims to expand their innovations to assist adult patients facing similar challenges in the future.

Frequently Asked Questions

What is QUELIMMUNE?

QUELIMMUNE is a medical device developed by SeaStar Medical to treat pediatric patients with acute kidney injury associated with sepsis.

Who awarded SeaStar Medical with the Corporate Innovator Award?

The National Kidney Foundation awarded SeaStar Medical the 2025 Corporate Innovator Award in recognition of its advancements in nephrology.

What significant results have QUELIMMUNE studies shown?

Studies indicate a 77% reduction in mortality rates and no device-related serious adverse events among pediatric patients treated with QUELIMMUNE.

What are the future plans for QUELIMMUNE?

SeaStar Medical plans to expand its trials to assess QUELIMMUNE's effectiveness in adult patients suffering from acute kidney injury.

How does the National Kidney Foundation support kidney health?

The NKF advocates for improved kidney healthcare standards, promotes awareness of kidney disease, and supports research for innovative treatments.

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