NKF Honors SeaStar Medical, with 2025 Corporate Innovator Award

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SeaStar Medical (Nasdaq: ICU) has been awarded the 2025 Corporate Innovator Award from the National Kidney Foundation for their groundbreaking QUELIMMUNE Selective Cytopheretic Device. The device received FDA approval in February 2024 as the first therapeutic solution for treating pediatric Acute Kidney Injury (AKI) due to sepsis.

Each year, approximately 4,000 children with AKI in the U.S. require continuous kidney replacement therapy, facing a 50% mortality rate. Of those who survive, 10-25% experience long-term complications including chronic kidney disease and lifetime dialysis dependency.

The award will be presented during the NKF Spring Clinical Meetings in Boston from April 9-13, 2025. This recognition places SeaStar Medical among notable past recipients including Keryx Biopharmaceuticals, Janssen Pharmaceuticals, Merck, Otsuka Pharmaceuticals, Relypsa, and UnitedHealth Group.

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Company recognized for treatment recently approved in the U.S. for pediatric acute kidney injury (AKI) due to sepsis.

NEW YORK, March 18, 2025 /PRNewswire/ -- SeaStar Medical (Nasdaq: ICU) has been selected to receive the 2025 Corporate Innovator Award from the National Kidney Foundation (NKF) at the 2025 Spring Clinical Meetings in Boston.

In February 2024, SeaStar Medical's QUELIMMUNE Selective Cytopheretic Device for Pediatrics (SCD-PED) received FDA approval as the first and only therapeutic device for the treatment of pediatric Acute Kidney Injury (AKI) due to sepsis.

"AKI has devastatingly highly rates of morbidity and mortality, especially in children" said Kevin Longino, CEO, National Kidney Foundation and a kidney transplant recipient. "This 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." 

Each year in the U.S., approximately 4,000 children with AKI, the majority of whom are septic, require continuous kidney replacement therapy (KRT), with a mortality rate of approximately 50%. Many of those who survive experience long-term complications that can include chronic kidney disease and a lifetime of dialysis (approximately 10 to 25% of patients that survive). The standard of care, kidney replacement therapy, has remained unchanged for decades and patient outcomes have not improved.

"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." 

The Corporate Innovator Award was established to recognize industry leaders that 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, Jannsen Pharmaceuticals, part of J&J, Merck, Otsuka Pharmaceuticals Company, Relypsa, Inc., and UnitedHealth Group. The 2025 award will be presented to SeaStar Medical during the NKF Spring Clinical Meetings in Boston, which will be held from April 9 - 13.

NKF Spring Clinical Meetings
For more than 30 years, nephrology healthcare professionals from across the country have come to the NKF Spring Clinical Meetings to learn about the newest developments related to all aspects of nephrology practice; network with colleagues; and present their research findings. The NKF Spring Clinical Meetings are designed for meaningful change in the multidisciplinary and interprofessional healthcare teams' skills, performance, and patient health outcomes. It is the only conference of its kind that focuses on translating science into practice for the entire healthcare team. This year's Spring Clinical Meetings will be held April 9 - 13 in Boston. 

Acute Kidney Injury
AKI is characterized by a sudden and temporary loss of kidney function and can be caused by a variety of conditions such as COVID-19, sepsis, severe trauma and surgery. AKI can cause hyperinflammation, which is the overproduction or overactivity of inflammatory effector cells and other molecules that can be toxic. Damage resulting from this extreme hyperinflammation in AKI can progress to other organs, such as the heart or liver, and potentially to multi-organ dysfunction or even failure that could result in worse outcomes, including increased risk of death. Even after resolution, these patients may face complications including chronic kidney disease or end-stage renal disease requiring dialysis. Extreme hyperinflammation may also contribute to added healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation.

Kidney Disease
In the United States, more than 35 million adults are estimated to have kidney disease, also known as chronic kidney disease (CKD)—and approximately 90 percent don't know they have it. About 1 in 3 adults in the U.S. are at risk for kidney disease. Risk factors for kidney disease include: diabetes, high blood pressure, heart disease, obesity, and family history. People of Black or African American, Hispanic or Latino, American Indian or Alaska Native, Asian American, or Native Hawaiian or Other Pacific Islander descent are at increased risk for developing the disease. Black or African American people are about four times as likely as White people to have kidney failure. Hispanics experience kidney failure at about double the rate of White people. 

About SeaStar Medical

SeaStar Medical is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life. SeaStar's first commercial product, QUELIMMUNE (SCD-PED), was approved in 2024 by the U.S. Food and Drug Administration (FDA). It is the only FDA approved product for the ultra-rare condition of life-threatening acute kidney injury (AKI) due to sepsis or a septic condition in critically ill pediatric patients. SeaStar's Selective Cytopheretic Device (SCD) therapy has been awarded Breakthrough Device Designation for four therapeutic indications by the FDA, enabling the potential for a speedier pathway to approval and preferable reimbursement dynamics at commercial launch. The company is currently conducting a pivotal trial of its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy, a life-threatening condition with no effective treatment options that impacts over 200,000 adults in the U.S. annually.

For more information visit www.seastarmedical.com or visit us on LinkedIn or X.

About the National Kidney Foundation
The National Kidney Foundation is revolutionizing 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. For more information about kidney disease, please visit www.kidney.org/.

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SOURCE National Kidney Foundation

FAQ

What is the significance of SeaStar Medical's (ICU) QUELIMMUNE device FDA approval?

QUELIMMUNE is the first and only FDA-approved therapeutic device for treating pediatric Acute Kidney Injury due to sepsis, marking a breakthrough in an area where treatment options haven't changed for decades.

How many children could benefit from SeaStar Medical's (ICU) QUELIMMUNE treatment annually?

Approximately 4,000 children with AKI in the U.S. require continuous kidney replacement therapy annually, with most cases being sepsis-related.

What is the current mortality rate for pediatric AKI patients that SeaStar Medical (ICU) aims to address?

The current mortality rate is approximately 50%, with 10-25% of survivors experiencing long-term complications including chronic kidney disease and lifetime dialysis dependency.

When will SeaStar Medical (ICU) receive the 2025 Corporate Innovator Award?

SeaStar Medical will receive the award during the NKF Spring Clinical Meetings in Boston, scheduled for April 9-13, 2025.

What sets SeaStar Medical's (ICU) QUELIMMUNE apart from existing treatments?

QUELIMMUNE is the first therapeutic innovation in decades for pediatric AKI treatment, offering an alternative to standard kidney replacement therapy which has shown no improvement in patient outcomes.