SeaStar Medical Announces Newly Published QUELIMMUNE Health Economic Study Projecting Significantly Reduced Health Care Costs in the Treatment of Pediatric AKI due to Estimated Shorter Hospital Stays and Increased Survival
SeaStar Medical (NASDAQ: ICU) has published a health economic analysis demonstrating significant cost savings with their QUELIMMUNE therapy for pediatric Acute Kidney Injury (AKI) patients. The study, published in the Journal of Medical Economics, projects $69,146 savings per hospitalization compared to standard continuous renal replacement therapy (CRRT).
The analysis reveals that QUELIMMUNE therapy could potentially offset its own costs during the median 6-day treatment period. Key findings show a 77% survival rate with QUELIMMUNE versus standard care, representing a ~50% reduction in mortality. The therapy demonstrates a 98% probability of higher survival odds with a predicted risk difference of 22.4%. The cost reduction is attributed to a 3-day shorter hospital stay and improved survival rates.
QUELIMMUNE received FDA approval in 2024 under a Humanitarian Device Exemption for pediatric AKI patients due to sepsis requiring Renal Replacement Therapy. The company is currently conducting the NEUTRALIZE-AKI pivotal trial in 200 patients.
SeaStar Medical (NASDAQ: ICU) ha pubblicato un'analisi economica sanitaria che mostra risparmi significativi con la sua terapia QUELIMMUNE nei pazienti pediatrici con insufficienza renale acuta (AKI). Lo studio, pubblicato sul Journal of Medical Economics, stima risparmi di $69.146 per ricovero rispetto alla terapia standard di sostituzione renale continua (CRRT).
L'analisi evidenzia che la terapia QUELIMMUNE potrebbe coprire i propri costi nel corso del periodo di trattamento mediano di 6 giorni. I risultati chiave mostrano un tasso di sopravvivenza del 77% con QUELIMMUNE rispetto alle cure standard, corrispondente a una riduzione della mortalità di circa il 50%. La terapia presenta una probabilità del 98% di maggiori probabilità di sopravvivenza con una differenza di rischio prevista del 22,4%. La riduzione dei costi è attribuita a un ricovero più breve di 3 giorni e a tassi di sopravvivenza migliori.
QUELIMMUNE ha ricevuto l'approvazione FDA nel 2024 con una Humanitarian Device Exemption per pazienti pediatrici con AKI dovuta a sepsi che richiedono terapia di sostituzione renale. L'azienda sta attualmente conducendo lo studio pilota NEUTRALIZE-AKI su 200 pazienti.
SeaStar Medical (NASDAQ: ICU) ha publicado un análisis económico sanitario que demuestra ahorros significativos con su terapia QUELIMMUNE en pacientes pediátricos con lesión renal aguda (AKI). El estudio, publicado en el Journal of Medical Economics, proyecta $69,146 de ahorro por hospitalización en comparación con la terapia de reemplazo renal continua estándar (CRRT).
El análisis revela que la terapia QUELIMMUNE podría compensar sus propios costes durante el periodo de tratamiento mediano de 6 días. Los hallazgos clave muestran una tasa de supervivencia del 77% con QUELIMMUNE frente a la atención estándar, lo que representa una reducción de la mortalidad de aproximadamente el 50%. La terapia demuestra una probabilidad del 98% de mayores probabilidades de supervivencia con una diferencia de riesgo prevista del 22,4%. La reducción de costes se atribuye a una estancia hospitalaria 3 días más corta y a mejores tasas de supervivencia.
QUELIMMUNE obtuvo la aprobación de la FDA en 2024 bajo una Humanitarian Device Exemption para pacientes pediátricos con AKI por sepsis que requieren terapia de reemplazo renal. La compañía está llevando a cabo el ensayo pivotal NEUTRALIZE-AKI en 200 pacientes.
SeaStar Medical (NASDAQ: ICU)는 소아 급성 신손상(AKI) 환자에 대한 QUELIMMUNE 치료로 상당한 비용 절감을 보여주는 보건 경제 분석을 발표했습니다. Journal of Medical Economics에 게재된 이 연구는 표준 지속적 신대체요법(CRRT)과 비교해 입원당 $69,146 절감을 예상합니다.
분석에 따르면 QUELIMMUNE 치료는 중앙값 6일의 치료 기간 동안 자체 비용을 상쇄할 수 있습니다. 주요 결과는 QUELIMMUNE의 생존률 77%로 표준 치료 대비 사망률이 약 50% 감소함을 나타냅니다. 이 치료는 생존 가능성이 더 높을 확률 98%을 보이며 예측된 위험 차이는 22.4%입니다. 비용 절감은 병원 치료 기간이 3일 단축되고 생존률이 개선된 데 기인합니다.
QUELIMMUNE은 2024년 패혈증으로 인해 신대체요법이 필요한 소아 AKI 환자를 대상으로 한 Humanitarian Device Exemption으로 FDA 승인을 받았습니다. 회사는 현재 200명 대상의 NEUTRALIZE-AKI 중추 임상시험을 진행 중입니다.
SeaStar Medical (NASDAQ: ICU) a publié une analyse médico-économique montrant des économies substantielles avec leur thérapie QUELIMMUNE pour les enfants atteints d'insuffisance rénale aiguë (AKI). L'étude, publiée dans le Journal of Medical Economics, projette 69 146 $ d'économies par hospitalisation par rapport à la thérapie de remplacement rénal continue standard (CRRT).
L'analyse révèle que la thérapie QUELIMMUNE pourrait potentiellement compenser ses propres coûts pendant la période de traitement médiane de 6 jours. Les conclusions clés montrent un taux de survie de 77% avec QUELIMMUNE contre les soins standard, soit une réduction de la mortalité d'environ 50%. La thérapie présente une probabilité de 98% d'augmenter les chances de survie avec une différence de risque prédite de 22,4%. La réduction des coûts est attribuée à un séjour hospitalier raccourci de 3 jours et à de meilleurs taux de survie.
QUELIMMUNE a reçu l'approbation de la FDA en 2024 dans le cadre d'une Humanitarian Device Exemption pour les enfants atteints d'AKI due à une septicémie nécessitant une thérapie de remplacement rénal. La société mène actuellement l'essai pivot NEUTRALIZE-AKI chez 200 patients.
SeaStar Medical (NASDAQ: ICU) hat eine gesundheitsökonomische Analyse veröffentlicht, die erhebliche Kosteneinsparungen durch ihre QUELIMMUNE-Therapie bei pädiatrischen Patienten mit akutem Nierenversagen (AKI) zeigt. Die im Journal of Medical Economics veröffentlichte Studie prognostiziert Ersparnisse von $69.146 pro Krankenhausaufenthalt im Vergleich zur standardmäßigen kontinuierlichen Nierenersatztherapie (CRRT).
Die Analyse zeigt, dass die QUELIMMUNE-Therapie ihre eigenen Kosten während der medianen Behandlungsdauer von 6 Tagen ausgleichen könnte. Wichtige Ergebnisse sind eine Überlebensrate von 77% mit QUELIMMUNE gegenüber der Standardversorgung, was einer etwa 50%igen Reduktion der Sterblichkeit entspricht. Die Therapie weist eine 98%ige Wahrscheinlichkeit für höhere Überlebenschancen auf, mit einer prognostizierten Risiko-Differenz von 22,4%. Die Kostenreduktion wird auf einen um 3 Tage kürzeren Krankenhausaufenthalt und verbesserte Überlebensraten zurückgeführt.
QUELIMMUNE erhielt 2024 die FDA-Zulassung im Rahmen einer Humanitarian Device Exemption für pädiatrische AKI-Patienten bei Sepsis, die eine Nierenersatztherapie benötigen. Das Unternehmen führt derzeit die NEUTRALIZE-AKI-Studie mit 200 Patienten durch.
- Significant cost savings of $69,146 per hospitalization with QUELIMMUNE therapy
- 77% survival rate, representing ~50% reduction in mortality compared to standard care
- Therapy potentially offsets its own costs during 6-day treatment period
- Reduced hospital length of stay by approximately 3 days
- FDA approval already secured for pediatric AKI patients
- Major children's medical centers already adopting the therapy
- FDA Breakthrough Device Designation received for six indications
- Limited study size with only 22 patients in QUELIMMUNE cohort
- Currently approved only under Humanitarian Device Exemption, indicating limited market size
- Pivotal trial still ongoing, suggesting full approval not yet achieved
Insights
QUELIMMUNE's economic study shows 18% hospitalization cost savings and improved survival for pediatric AKI patients, potentially accelerating market adoption.
The newly published health economic analysis of SeaStar Medical's QUELIMMUNE therapy presents compelling data that could significantly accelerate market adoption. The study demonstrates an estimated
What makes this particularly noteworthy is how these cost savings are achieved: through meaningful clinical improvements. The data shows QUELIMMUNE therapy is associated with approximately 3-day shorter hospital stays and—more importantly—significantly better survival odds (adjusted odds ratio of 13.4, p=0.01). The Bayesian analysis indicates a
The study's methodology appears robust, comparing matched patient datasets from two pediatric registries (KID Registry, N=106; ppCRRT Registry, N=210) against QUELIMMUNE-treated patients (N=22). While the sample size is relatively small, which is typical for pediatric rare conditions, the results align with previously published clinical findings showing a
From a market perspective, SeaStar's mention that "many of the most highly regarded children's medical centers have already adopted" the therapy, including a recent adoption by a prominent Philadelphia pediatric hospital, suggests momentum in real-world implementation. This economic data could significantly strengthen the value proposition for additional centers, especially as hospitals face increasing financial pressures while seeking to improve outcomes.
Beyond its current Humanitarian Device Exemption approval for pediatric AKI due to sepsis, SeaStar is pursuing broader applications through their NEUTRALIZE-AKI pivotal trial in adults and has secured FDA Breakthrough Device Designation for six indications—signaling potential for substantial market expansion if successful.
Study shows approximately
DENVER, Sept. 02, 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 the publication of a health economic analysis estimating significant cost savings with the use of the QUELIMMUNE therapy in pediatric patients with Acute Kidney Injury (AKI) in the ICU setting. The analysis, as presented in the Journal of Medical Economics (IJME) estimates a cost savings of
“Data from the QUELIMMUNE clinical studies showed organ sparing and life-saving benefits for critically ill pediatric patients with AKI requiring CRRT,” stated Kevin Chung, MD, Chief Medical Officer of SeaStar Medical and co-author of the publication. “Our analysis shows that the QUELIMMUNE therapy may “pay for itself” with the projected savings.”
Dr. Chung continued, “Many of the most highly regarded children’s medical centers have already adopted the QUELIMMUNE therapy, including, most recently, a prominent pediatric hospital in Philadelphia. We believe that this added economic benefit will support broader adoption of QUELIMMUNE therapy with a clear understanding of its beneficial implications in patient care.”
Highlights from the IJME publication include:
- A historical matched analysis of pediatric patients receiving CRRT without QUELIMMUNE from the Prospective Pediatric CRRT (ppCRRT) Registry found significantly better survival with QUELIMMUNE versus CRRT alone (adjusted odds ratio 13.4; P=0.01). Bayesian analysis indicated a
98% probability of higher survival odds with the QUELIMMUNE therapy, with a predicted risk difference of22.4% . There are no other approved selective therapies in the US for pediatric patients with AKI due to sepsis on CRRT. These data were also previously published in 2024 in Kidney Medicine. - Given the encouraging survival rates among critically ill children treated with the QUELIMMUNE therapy, the objective of the health economic study was to determine its financial impact to a health care system from an inpatient perspective by combining publicly available hospitalization cost data with non-cost clinical metrics derived from prior QUELIMMUNE studies and estimating the effect of the QUELIMMUNE therapy on inpatient hospital costs among a pediatric population receiving CRRT.
- Analysis of matched patient data sets to patients in the QUELIMMUNE studies (N=22) were derived from two pediatric patient registries: the Kid’s Inpatient Database (KID) Registry (N=106) and the ppCRRT Registry (N=210).
- Modeled hospitalization costs from the KID and ppCRRT cohorts were
$457,092 and$389,451 respectively, versus a lower estimated cost of$320,304 for pediatric patients treated with the QUELIMMUNE therapy for a median of 6 days. Compared to the ppCRRT Registry cohort, the QUELIMMUNE therapy yields an estimated savings of$69,146 per hospitalization. The cost reduction is driven by two key metrics: reduced hospital length of stay of approximately 3 days and improved survival.
QUELIMMUNE was approved by the US Food and Drug Administration (FDA) in 2024 under a Humanitarian Device Exemption for pediatric patients with AKI due to sepsis or a septic condition on antibiotic therapy and requiring Renal Replacement Therapy (RRT). Clinical data from the FDA application, subsequently published in Kidney Medicine, showed a
SeaStar Medical is currently conducting the NEUTRALIZE-AKI pivotal trial to evaluate the safety and efficacy of the SCD therapy in 200 patients with AKI in the ICU receiving CRRT. It has received FDA Breakthrough Device Designation for this indication and five others, including:
- Systemic inflammatory response in adult cardiac surgery
- Systemic inflammatory response in pediatric cardiac surgery to prevent post-operative adverse complications and outcomes
- Adult cardiorenal syndrome awaiting left ventricular assist device (LVAD) implantation
- End-stage renal disease (ESRD) requiring chronic dialysis
- Adult hepatorenal syndrome (HRS)
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 (SCD-PED) therapy is SeaStar Medical’s first commercial product based on its patented Selective Cytopheretic Device (SCD) technology. The QUELIMMUNE™ therapy is being commercialized for children (age 22 or younger) with AKI and sepsis or a 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 obtain Institutional Review Board approval 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 April 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 NEUTRALIZE-AKI Pivotal Trial
The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomIZEd clinical trial in Acute Kidney Injury) pivotal trial is evaluating the safety and efficacy of the SCD therapy in 200 adults with AKI in the ICU receiving CRRT. The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with the SCD therapy in addition to CRRT as the standard of care, compared with the control group receiving only CRRT standard of care. Secondary endpoints include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at Day 90 and dialysis dependency at one year. The study will also include subgroup analyses to explore the effectiveness of the SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome.
About the SeaStar Medical Selective Cytopheretic Device (SCD) Therapy
The 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 is designed for 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 continuous renal replacement therapy (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 CRRT, 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. The QUELIMMUNE (SCD-PED) therapy is SeaStar Medical’s first commercial product based on its patented Selective Cytopheretic Device (SCD) technology. It was approved in 2024 by the U.S. Food and Drug Administration (FDA). QUELIMMUNE 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 US annually.
For more information visit www.seastarmedical.com or visit us on LinkedIn or X.
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1955. These forward-looking statements include, without limitation, SeaStar Medical’s expectations with respect to anticipated patient enrollment and the expansion of the clinical trial sites; the total addressable market for adult SCD applications; the ability of SeaStar Medical to gain market share and generate sales with respect to the total addressable market for adult SCD applications; the ability of SCD to treat patients with AKI and other diseases; the expected regulatory approval process and timeline for commercialization; and the ability of SeaStar Medical to meet the expected timeline. Words such as “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside SeaStar Medical’s control and are difficult to predict. Factors that may cause actual future events to differ materially from the expected results include, but are not limited to: (i) the risk that SeaStar Medical may not be able to obtain regulatory approval of its SCD product candidates; (ii) the risk that SeaStar Medical may not be able to raise sufficient capital to fund its operations, including current or future clinical trials; (iii) the risk that SeaStar Medical and its current and future collaborators are unable to successfully develop and commercialize its products or services, or experience significant delays in doing so, including failure to achieve approval of its products by applicable federal and state regulators, (iv) the risk that SeaStar Medical may never achieve or sustain profitability; (v) the risk that SeaStar Medical may not be able to secure additional financing on acceptable terms; (vi) the risk that third-party suppliers and manufacturers are not able to fully and timely meet their obligations, (vii) the risk of product liability or regulatory lawsuits or proceedings relating to SeaStar Medical’s products and services, (viii) the risk that SeaStar Medical is unable to secure or protect its intellectual property, and (ix) other risks and uncertainties indicated from time to time in SeaStar Medical’s Annual Report on Form 10-K, including those under the “Risk Factors” section therein and in SeaStar Medical’s other filings with the SEC. The foregoing list of factors is not exhaustive. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and SeaStar Medical assumes no obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.
Contact:
IR@SEASTARMED.COM
FAQ
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