Cincinnati Children's Hospital highlights QUELIMMUNE therapy's impact on pediatric patients, featuring a father's experience and rapid recovery story.
Quiver AI Summary
SeaStar Medical Holding Corporation announced that Cincinnati Children’s Hospital Medical Center will showcase the QUELIMMUNE therapy in a two-part video series, highlighting its adoption for pediatric patients. The first video features discussions between medical professionals on the therapy's potential to combat destructive hyperinflammation linked to organ failure. The second video shares the inspiring recovery story of a young patient, Kurt, who benefited from the therapy after heart surgery complications. The QUELIMMUNE therapy, approved in 2024 for critically ill children suffering from acute kidney injury (AKI) and sepsis, is recognized for its safety and clinical benefits, with SeaStar Medical beginning its commercial launch in July 2025. The videos are part of a broader effort to illustrate the therapy's impact, especially as SeaStar has received accolades for its contributions to pediatric medicine.
Potential Positives
- SeaStar Medical's QUELIMMUNE therapy features a compelling success story from a pediatric patient at Cincinnati Children's Hospital, highlighting its effectiveness in facilitating rapid recovery.
- The company was awarded the 2025 Corporate Innovator Award by the National Kidney Foundation, underscoring its contributions to improving pediatric care for acute kidney injury (AKI).
- QUELIMMUNE therapy is the only FDA-approved product for treating life-threatening AKI due to sepsis in critically ill pediatric patients, reflecting a significant milestone in medical advancements for this vulnerable population.
- The introduction of QUELIMMUNE therapy comes at a time when there are few treatment options for critically ill children with AKI, addressing a critical unmet need in the healthcare market.
Potential Negatives
- The QUELIMMUNE therapy, while showing promise, is noted to only be available under a Humanitarian Device Exemption, suggesting limitations in broader applicability and potential scrutiny regarding its efficacy.
- The press release does not provide specific data on the long-term effectiveness of QUELIMMUNE therapy, which could raise concerns about its value compared to other treatments.
- The focus on a singular patient success story may lead to perceptions of anecdotal evidence rather than substantive clinical outcomes, which could undermine trust in the therapy's broader effectiveness.
FAQ
What is QUELIMMUNE therapy?
QUELIMMUNE therapy is a treatment for children with acute kidney injury (AKI) and sepsis, designed to reduce hyperinflammation.
When was QUELIMMUNE therapy approved?
QUELIMMUNE therapy was approved in February 2024 under a Humanitarian Device Exemption for critically ill pediatric patients.
What is the focus of the two-part video series?
The video series focuses on the adoption of QUELIMMUNE therapy and a patient's recovery experience at Cincinnati Children's Hospital.
How does QUELIMMUNE therapy impact pediatric patients?
The therapy potentially improves outcomes for critically ill children suffering from AKI by mitigating harmful hyperinflammatory responses.
What recognition has SeaStar Medical received for QUELIMMUNE?
SeaStar Medical was awarded the 2025 Corporate Innovator Award for significant contributions to pediatric AKI treatment advancements.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
Cincinnati Children’s Hospital Medical Center Discusses QUELIMMUNE Therapy Adoption
A Father and Patient Describe Their Real-Life Experience with the QUELIMMUNE Therapy
DENVER, June 24, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life announced today that the QUELIMMUNE therapy will be featured in a two-part video series that will be available on the SeaStar Medical website. The videos describe the adoption and the use of the QUELIMMUNE therapy for pediatric patients at the nationally recognized Cincinnati Children’s Hospital Medical Center and an interview with a father and his son, a pediatric patient in the ICU at Cincinnati Children’s who experienced a rapid recovery to good health following the use of the QUELIMMUNE therapy.
The events will be broadcast and can be viewed as followed:
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QUELIMMUNE Adoption: Stuart Goldstein, MD, FAAP, FNKF, at Cincinnati Children’s and Kevin Chung, MD, MACP, FCCM, Chief Medical Officer of SeaStar Medical, discuss QUELIMMUNE and its potential to reduce the destructive hyperinflammation that shuts down organs and takes lives.
- Available today, June 24, 2025, at 11:00 am Eastern Time on the Investor Relations section of Sea Star Medical’s website on the Events and Presentations page.
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A QUELIMMUNE Patient Journey: Following heart surgery for a congenital condition, Kurt’s recovery was impacted by a hyperinflammatory response by his immune system. Organ failure and respiratory distress set in. QUELIMMUNE therapy was administered, and Kurt and his father tell their story of Kurt’s rapid progress and recovery.
- Available June 26, 2025, at 11:00 am Eastern Time on the Investor Relations section of Sea Star Medical’s website on the Events and Presentations page.
About QUELIMMUNE
The QUELIMMUNE™ therapy is being commercialized for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are being treated in the ICU with Renal Replacement Therapy (RRT). The QUELIMMUNE therapy was approved in February 2024 under a Humanitarian Device Exemption application, having met the applicable criteria with clinical results showing safety and probable clinical benefit in a limited population of critically ill children with AKI who have few treatment options. SeaStar Medical commenced its commercial launch of the QUELIMMUNE therapy in July 2025. In January 2025, SeaStar Medical was awarded the 2025 Corporate Innovator Award by the National Kidney Foundation for its significant contribution to improving the lives of pediatric patients with AKI based on the approval and introduction of the QUELIMMUNE therapy.
About Acute Kidney Injury (AKI) and Hyperinflammation
AKI is characterized by a sudden and temporary loss of kidney function and can be caused by a variety of conditions such as sepsis, severe trauma, surgery and COVID-19. AKI can cause destructive hyperinflammation, which is the overproduction or overactivity of inflammatory effector cells and other molecules that can be toxic. Damage resulting from this destructive 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 (ESRD) requiring dialysis. Extreme hyperinflammation may also contribute to added healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation.
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.
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