SeaStar Medical to Present Early SAVE Registry Data of QUELIMMUNE in Pediatric Acute Kidney Injury at the 5th International Symposium on Acute Kidney Injury in Children
SeaStar Medical (Nasdaq: ICU) announced the upcoming presentation of preliminary results from the SAVE Surveillance Registry at the 5th International Symposium on Acute Kidney Injury in Children. The presentation will focus on QUELIMMUNE therapy for pediatric patients with acute kidney injury (AKI) and sepsis requiring renal replacement therapy.
Two abstracts will be presented on September 27, 2025, covering early post-approval real-world clinical experience and the SAVE Registry study design. The registry aims to collect Real-World Evidence from up to 300 patients, tracking 90-day survival, dialysis dependency, and safety data.
SeaStar Medical (Nasdaq: ICU) ha annunciato l'imminente presentazione dei risultati preliminari del SAVE Surveillance Registry al 5th International Symposium on Acute Kidney Injury in Children. La presentazione si concentrerà sulla terapia QUELIMMUNE per pazienti pediatrici con insufficienza renale acuta (AKI) e sepsi che necessitano di terapia di sostituzione renale.
Due abstract verranno presentati il 27 settembre 2025, riguardanti l'esperienza clinica reale precoce post‑approvazione e il design dello studio del SAVE Registry. Il registro mira a raccogliere evidenze dal mondo reale da fino a 300 pazienti, monitorando sopravvivenza a 90 giorni, dipendenza dalla dialisi e dati di sicurezza.
SeaStar Medical (Nasdaq: ICU) anunció la próxima presentación de los resultados preliminares del Registro de Vigilancia SAVE en el 5º Simposio Internacional sobre Lesión Renal Aguda en Niños. La presentación se centrará en la terapia QUELIMMUNE para pacientes pediátricos con lesión renal aguda (AKI) y sepsis que requieren terapia de reemplazo renal.
Se presentarán dos resúmenes el 27 de septiembre de 2025, cubriendo la experiencia clínica del mundo real poco después de la aprobación y el diseño del estudio del Registro SAVE. El registro tiene como objetivo recoger evidencia del mundo real de hasta 300 pacientes, siguiendo la supervivencia a 90 días, la dependencia de diálisis y datos de seguridad.
SeaStar Medical (나스닥: ICU)은 5번째 국제 소아 급성 신손상 학회에서 SAVE Surveillance Registry의 예비 결과 발표가 있을 예정이라고 발표했습니다. 발표는 QUELIMMUNE 치료를 초점으로, 신부전(AKI) 및 패혈증으로 신대체요법이 필요한 소아 환자에 대한 치료를 다룰 예정입니다.
두 편의 초록이 2025년 9월 27일에 발표되며, 승인 후 초기 실세계 임상 경험과 SAVE Registry 연구 설계에 대해 다룹니다. 레지스트리는 최대 300명의 환자를 대상으로 실세계 증거를 수집하고, 90일 생존율, 투석 의존성, 안전 데이터를 추적하는 것을 목표로 합니다.
SeaStar Medical (Nasdaq: ICU) a annoncé la présentation prochaine des résultats préliminaires du registre SAVE Surveillance Registry lors du 5e Symposium international sur l’insuffisance rénale aiguë chez l’enfant. La présentation portera sur la thérapie QUELIMMUNE pour les patients pédiatriques souffrant d’une insuffisance rénale aiguë (AKI) et d’une sepsis nécessitant une thérapie de remplacement rénal.
Deux résumés seront présentés le 27 septembre 2025, couvrant l’expérience clinique réelle peu après l’approbation et la conception de l’étude du registre SAVE. Le registre vise à collecter des preuves du monde réel auprès de jusqu’à 300 patients, en suivant la survie à 90 jours, la dépendance à la dialyse et les données de sécurité.
SeaStar Medical (Nasdaq: ICU) kündigte die bevorstehende Präsentation der vorläufigen Ergebnisse des SAVE Surveillance Registry auf dem 5. Internationalen Symposium über akutes Nierenversagen bei Kindern an. Die Präsentation wird sich auf die QUELIMMUNE-Therapie für pädiatrische Patienten mit akuter Niereninsuffizienz (AKI) und Sepsis konzentrieren, die eine renale Austauschtherapie benötigen.
Zwei Abstracts werden am 27. September 2025 vorgestellt, die die frühere postgenehmigte Real-World-Erfahrung und das Studiendesign des SAVE Registry abdecken. Das Registry zielt darauf ab, Real-World-Evidence von bis zu 300 Patienten zu sammeln und dabei 90-Tage-Überleben, Dialyseabhängigkeit und Sicherheitsdaten zu verfolgen.
SeaStar Medical (وول ستوك: ICU) أعلن عن العرض القادم للنتائج الأولية من سجل SAVE Surveillance في المؤتمر الدولي الخامس حول الإصابة الكلوية الحادة لدى الأطفال. سيتمحور العرض حول علاج QUELIMMUNE للمرضى الأطفال المصابين بانخفاض وظيفة الكلى الحاد (AKI) وبالإنتان الذي يتطلب علاجاً بديلاً للكلى.
سيتم تقديم ملخصين في 27 سبتمبر 2025، يغطيان الخبرة السريرية الواقعية بعد الحصول على الموافقة وتصميم دراسة سجل SAVE. يهدف السجل إلى جمع أدلة من العالم الحقيقي حتى 300 مريض، مع تتبع البقاء على قيد الحياة لمدة 90 يوماً، والاعتماد على الغسل الكلوي، وبيانات السلامة.
SeaStar Medical (纳斯达克: ICU)宣布将在第5届国际儿童急性肾损伤研讨会上公布SAVE Surveillance Registry的初步结果。此次报告将聚焦QUELIMMUNE治疗，针对需要肾脏替代治疗的急性肾损伤（AKI）并发败血症的儿科患者。
将于2025年9月27日公布两个摘要，涵盖批准后早期真实世界的临床经验以及SAVE Registry的研究设计。该登记旨在从多达300例患者收集真实世界证据，追踪90天存活率、透析依赖性和安全性数据。
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DENVER, Sept. 23, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company, announced today that preliminary results from the SAVE Surveillance Registry will be presented by SeaStar Medical and its research collaborators at the 5th International Symposium on Acute Kidney Injury in Children. The SAVE Registry presentation will highlight the role of QUELIMMUNE (Selective Cytopheretic Device for Pediatrics, or SCD-PED) therapy in the treatment of critically ill pediatric patients with life-threatening Acute Kidney Injury (AKI) and sepsis requiring Renal Replacement Therapy (RRT). Safety data will also be presented.
A second accepted abstract will also be presented and include details of the SAVE Registry study design. It will be presented concurrent with the SAVE Registry data on Saturday, September 27, 2025, 6:20 – 8:00 pm Eastern Time. The presentations are as follows:
- Early Post-Approval Real-World Clinical Experience of the Selective Cytopheretic Device (SCD) in Pediatric Acute Kidney Injury (AKI)
- Study Design of the SAVE Registry: Selective Cytopheretic Device for PediAtrics SurVeillance Registry
The SAVE Surveillance Registry is a Real-World Evidence (RWE) surveillance program that is designed to confirm safety and efficacy of the QUELIMMUNE therapy. Medical institutions employing the QUELIMMUNE therapy will continue to collect RWE for up to the first 300 patients treated with QUELIMMUNE. Specific outcomes data will include 90-day survival and dialysis dependency along with safety data with plans to compare to an existing control group of patients with similar severity of illness. SeaStar Medical believes that initial results from the SAVE Surveillance Registry will support broader adoption of the QUELIMMUNE therapy, inform payer discussions, and complement the company’s ongoing effort to recruit patients into its adult NEUTRALIZE-AKI pivotal trial.
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 QUELIMMUNE
The QUELIMMUNE™ therapy is being commercialized for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are on antibiotics and being treated in the ICU with Renal Replacement Therapy (RRT). It was approved in February 2024 under a Humanitarian Device Exemption application that requires medical institutions to also participate in the SAVE Surveillance Registry and complete Institutional Review Board approvals prior to adoption and use of the QUELIMMUNE therapy. This prolongs the adoption timeline by medical institutions, but provides important data on the use of QUELIMMUNE in the “real-world” setting.
Data from two clinical studies of the QUELIMMUNE therapy, published in Kidney Medicine, showed a
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 the SeaStar Medical Selective Cytopheretic Device Therapy
The Selective Cytopheretic Device (SCD) therapy is designed as a disease-modifying device that neutralizes over-active immune cells and stops the cytokine storm that yields destructive hyperinflammation and creates a cascade of events that wreak havoc in the patient’s body. The SCD therapy has broad applications in multiple acute and chronic kidney and cardiovascular diseases, representing patients who today have no FDA-approved options for treating their disease. Unlike pathogen removal and other blood-purification tools, the SCD therapy is integrated with an existing CRRT hemofiltration system to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. This unique immunomodulation approach may promote long-term organ recovery, eliminate the need for future RRT, including dialysis, and prevent loss of life.
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 six 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 (CRRT), 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.
Contact:
IR@SEASTARMED.COM
FAQ
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