SeaStar Medical Expands QUELIMMUNE Adoption for Critically Ill Pediatric Patients with Acute Kidney Injury (AKI)
SeaStar Medical (NASDAQ: ICU) announced that Texas Children's Hospital has adopted its QUELIMMUNE therapy for treating pediatric patients with Acute Kidney Injury (AKI). The therapy, FDA-approved in 2024 under a Humanitarian Device Exemption, has shown remarkable results with a 77% survival rate compared to standard care, representing a 50% reduction in mortality.
The Selective Cytopheretic Device (SCD) therapy works by neutralizing over-active immune cells and stopping cytokine storms in critically ill patients. Clinical data showed no dialysis requirement for survivors at Day 60 post-ICU discharge. The company is currently conducting the NEUTRALIZE-AKI pivotal trial in 200 adults and has received FDA Breakthrough Device Designation for six different indications.
SeaStar Medical (NASDAQ: ICU) ha annunciato che il Texas Children's Hospital ha adottato la sua terapia QUELIMMUNE per il trattamento dei pazienti pediatrici con Lesione Renale Acuta (AKI). La terapia, approvata dalla FDA nel 2024 con un'esenzione per dispositivi umanitari, ha mostrato risultati straordinari con un tasso di sopravvivenza del 77% rispetto alle cure standard, rappresentando una riduzione del 50% della mortalit脿.
La terapia con il Dispositivo Citoforetico Selettivo (SCD) agisce neutralizzando le cellule immunitarie iperattive e bloccando le tempeste di citochine nei pazienti in condizioni critiche. I dati clinici hanno evidenziato l'assenza di necessit脿 di dialisi per i sopravvissuti al Giorno 60 dopo la dimissione dalla terapia intensiva. Attualmente, l'azienda sta conducendo lo studio cardine NEUTRALIZE-AKI su 200 adulti e ha ricevuto dalla FDA la Designazione di Dispositivo Innovativo per sei diverse indicazioni.
SeaStar Medical (NASDAQ: ICU) anunci贸 que el Texas Children's Hospital ha adoptado su terapia QUELIMMUNE para tratar a pacientes pedi谩tricos con Lesi贸n Renal Aguda (AKI). La terapia, aprobada por la FDA en 2024 bajo una Exenci贸n de Dispositivo Humanitario, ha mostrado resultados notables con una tasa de supervivencia del 77% en comparaci贸n con el cuidado est谩ndar, representando una reducci贸n del 50% en la mortalidad.
La terapia con el Dispositivo Citofor茅tico Selectivo (SCD) funciona neutralizando las c茅lulas inmunitarias hiperactivas y deteniendo las tormentas de citoquinas en pacientes cr铆ticamente enfermos. Los datos cl铆nicos mostraron que los sobrevivientes no requirieron di谩lisis al d铆a 60 despu茅s del alta de la UCI. Actualmente, la compa帽铆a est谩 llevando a cabo el ensayo pivotal NEUTRALIZE-AKI en 200 adultos y ha recibido la Designaci贸n de Dispositivo Innovador de la FDA para seis indicaciones diferentes.
SeaStar Medical (NASDAQ: ICU)電� 韰嶌偓鞀� 鞏措Π鞚� 氤戩洂鞚� 旮夓劚 鞁犾啇靸�(AKI) 靻岇晞 頇橃瀽 旃橂毳� 鞙勴暣 鞛愳偓鞚� QUELIMMUNE 旃橂氩�鞚� 霃勳瀰頄堧嫟瓿� 氚滍憸頄堨姷雼堧嫟. 鞚� 旃橂氩曥潃 2024雲� FDA鞚� 鞚鸽弰鞝� 旮瓣赴 氅挫牅(Humanitarian Device Exemption) 鞀轨澑鞚� 氚涭晿鞙茧┌, 響滌 旃橂 雽�牍� 77% 靸濎〈鞙�鞚� 氤挫棳 靷毳犾潉 50% 臧愳唽鞁滌及鞀惦媹雼�.
靹犿儩鞝� 靹疙彫旃橂旮瓣赴(SCD) 旃橂氩曥潃 瓿柬櫆靹� 氅挫棴 靹疙彫毳� 欷戫檾鞁滍偆瓿� 欷戩 頇橃瀽鞚� 靷澊韱犾勾鞚� 韽拲鞚� 彀嫧頃橂姅 氚╈嫕鞙茧 鞛戩毄頃╇媹雼�. 鞛勳儊 雿办澊韯办棎 霐半ゴ氅� 欷戫櫂鞛愳嫟 韲挫洂 60鞚� 頉� 靸濎〈鞛愳棎瓴� 韴劃鞚� 頃勳殧頃橃 鞎婌晿鞀惦媹雼�. 須岇偓電� 順勳灛 200氇呾潣 靹膘澑鞚� 雽�靸侅溂搿� 頃橂姅 NEUTRALIZE-AKI 欷戩稊 鞛勳儊鞁滍棙鞚� 歆勴枆 欷戩澊氅�, FDA搿滊秬韯� 6臧�歆� 鞝侅潙歃濎棎 雽�頃� 順侅嫚 鞚橂旮瓣赴 歆�鞝�(Breakthrough Device Designation)鞚� 氚涭晿鞀惦媹雼�.
SeaStar Medical (NASDAQ : ICU) a annonc茅 que le Texas Children's Hospital a adopt茅 sa th茅rapie QUELIMMUNE pour traiter les patients p茅diatriques atteints d'insuffisance r茅nale aigu毛 (IRA). Cette th茅rapie, approuv茅e par la FDA en 2024 dans le cadre d'une exemption pour dispositif humanitaire, a montr茅 des r茅sultats remarquables avec un taux de survie de 77% compar茅 aux soins standards, repr茅sentant une r茅duction de 50% de la mortalit茅.
La th茅rapie par le dispositif cytophor茅tique s茅lectif (SCD) agit en neutralisant les cellules immunitaires hyperactives et en arr锚tant les temp锚tes de cytokines chez les patients en 茅tat critique. Les donn茅es cliniques ont montr茅 qu'aucun des survivants n'a eu besoin de dialyse 60 jours apr猫s la sortie de l'unit茅 de soins intensifs. L'entreprise m猫ne actuellement l'essai pivot NEUTRALIZE-AKI sur 200 adultes et a re莽u la d茅signation de dispositif r茅volutionnaire de la FDA pour six indications diff茅rentes.
SeaStar Medical (NASDAQ: ICU) gab bekannt, dass das Texas Children's Hospital seine QUELIMMUNE-Therapie zur Behandlung p盲diatrischer Patienten mit akutem Nierenversagen (AKI) 眉bernommen hat. Die Therapie, die 2024 von der FDA im Rahmen einer Humanitarian Device Exemption zugelassen wurde, zeigte bemerkenswerte Ergebnisse mit einer 脺berlebensrate von 77% im Vergleich zur Standardbehandlung, was eine Reduktion der Sterblichkeit um 50% bedeutet.
Die Therapie mit dem Selective Cytopheretic Device (SCD) wirkt, indem sie 眉beraktive Immunzellen neutralisiert und Zytokinst眉rme bei kritisch kranken Patienten stoppt. Klinische Daten zeigten, dass 脺berlebende 60 Tage nach der Entlassung aus der Intensivstation keine Dialyse ben枚tigten. Das Unternehmen f眉hrt derzeit die 狈贰鲍罢搁础尝滨窜贰-础碍滨-厂肠丑濒眉蝉蝉别濒蝉迟耻诲颈别 mit 200 Erwachsenen durch und hat von der FDA f眉r sechs verschiedene Indikationen die Breakthrough Device Designation erhalten.
- Clinical data shows 77% survival rate with QUELIMMUNE versus standard care
- No dialysis required for survivors at Day 60 after ICU discharge
- FDA Breakthrough Device Designation received for six different indications
- Successful adoption by nationally recognized Texas Children's Hospital
- Limited to Humanitarian Device Exemption application, indicating ultra-rare cases
- Adult pivotal trial still ongoing, suggesting limited current market reach
Insights
Texas Children's Hospital adoption of QUELIMMUNE therapy represents significant commercial validation for SeaStar's life-saving pediatric AKI treatment.
The adoption of QUELIMMUNE by Texas Children's Hospital marks a crucial commercial milestone for SeaStar Medical's innovative therapy. This nationally recognized institution's decision validates the therapy's clinical value proposition in a particularly vulnerable patient population - pediatric patients with acute kidney injury (AKI) due to sepsis requiring renal replacement therapy.
The clinical data supporting QUELIMMUNE is compelling - demonstrating a
SeaStar's Selective Cytopheretic Device works through an elegant immunomodulatory mechanism, neutralizing hyperactive immune cells to interrupt the cytokine storm that drives hyperinflammation and subsequent organ damage. This approach represents a paradigm shift from conventional renal replacement therapies that focus solely on filtration rather than addressing the underlying inflammatory pathology.
The FDA's multiple Breakthrough Device Designations across six indications signals the therapy's potential versatility beyond the current approved use. The ongoing NEUTRALIZE-AKI pivotal trial in adults could substantially expand the addressable market if successful. Each new indication represents a potential new revenue stream, with the current pediatric approval establishing clinical credibility while generating initial commercial traction.
Nationally Recognized Texas Children鈥檚 Hospital Adds First-In-Class Therapy as a Potential Life-Saving Treatment in Ultra-Rare Cases of Pediatric AKI
DENVER, July 08, 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 has been adopted for use by the nationally recognized Texas Children鈥檚 Hospital. The QUELIMMUNE therapy was approved by the U.S. Food and Drug Administration (FDA) in 2024 under a Humanitarian Device Exemption application 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 and subsequently published in showed a
鈥淲e are thrilled that Texas Children鈥檚 Hospital has begun adopting QUELIMMUNE as another potential means to save lives and help young patients avoid life-long dialysis,鈥� stated Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. 鈥淪ince QUELIMMUNE鈥檚 FDA approval, we have maintained a post-marketing registry, which has provided encouraging reports from multiple children鈥檚 hospitals, highlighting organ-sparing and life-saving outcomes for pediatric patients who previously had little hope of survival.鈥�
SeaStar Medical introduced its Selective Cytopheretic Device (SCD) therapy under the brand name QUELIMMUNE to the pediatric market in mid-2024 based on the serious unmet need for organ-sparing and life-saving therapies in this patient population. The SCD therapy is designed to be broadly applicable 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鈥檚 body.
SeaStar Medical is currently conducting the NEUTRALIZE-AKI pivotal trial that is evaluating the safety and efficacy of the SCD therapy in 200 adults 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听
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鈩� 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. Data from two clinical studies of the QUELIMMUNE therapy, published in , 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 NEUTRALIZE-AKI Pivotal Trial听
The (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device 鈥� 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鈥檚 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.听
About the SeaStar Medical Selective Cytopheretic Device听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鈥檚 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 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 RRT, including dialysis, and prevent loss of life.听听
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鈥檚 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鈥檚 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, a life-threatening condition with no effective treatment options that impacts over 200,000 adults in the U.S. annually.
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Forward-Looking Statements听
This press release contains certain forward-looking statements within the meaning of the 鈥渟afe harbor鈥� provisions of the Private Securities Litigation Reform Act of 1955. These forward-looking statements include, without limitation, SeaStar Medical鈥檚 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 鈥渂elieve,鈥� 鈥減roject,鈥� 鈥渆xpect,鈥� 鈥渁nticipate,鈥� 鈥渆stimate,鈥� 鈥渋ntend,鈥� 鈥渟trategy,鈥� 鈥渇uture,鈥� 鈥渙pportunity,鈥� 鈥減lan,鈥� 鈥渕ay,鈥� 鈥渟hould,鈥� 鈥渨ill,鈥� 鈥渨ould,鈥� 鈥渨ill be,鈥� 鈥渨ill continue,鈥� 鈥渨ill likely result,鈥� 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鈥檚 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鈥檚 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鈥檚 Annual Report on Form 10-K, including those under the 鈥淩isk Factors鈥� section therein and in SeaStar Medical鈥檚 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.听
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FAQ
What is the survival rate for pediatric patients treated with SeaStar Medical's (ICU) QUELIMMUNE therapy?
What conditions has SeaStar Medical's (ICU) QUELIMMUNE therapy received FDA Breakthrough Device Designation for?
When did SeaStar Medical (ICU) receive FDA approval for QUELIMMUNE therapy?
How does SeaStar Medical's (ICU) QUELIMMUNE therapy work?
What is the current status of SeaStar Medical's (ICU) adult clinical trials?
