SeaStar Medical Reports Positive Results for QUELIMMUNE Therapy in Pediatric Acute Kidney Injury (AKI) from the First 20 SAVE Surveillance Registry Patients
SeaStar Medical (Nasdaq: ICU) has reported positive preliminary results from its SAVE Surveillance Registry for the QUELIMMUNE therapy in treating pediatric patients with acute kidney injury (AKI) and sepsis. The data from the first 20 pediatric patients showed 75% survival rate through 28 days, potentially exceeding a 50% reduction in mortality compared to historical data.
The therapy demonstrated no device-related safety events and was particularly effective in critically ill patients who received it as a last resort. The company plans to collect AG真人官方-World Evidence (RWE) for up to 300 patients, including 90-day survival and dialysis dependency data. The QUELIMMUNE therapy, based on Selective Cytopheretic Device (SCD) technology, has been implemented at leading U.S. children's medical centers and has received FDA Breakthrough Device Designation for six different applications.
SeaStar Medical (Nasdaq: ICU) ha riportato risultati preliminari positivi dal suo registro di sorveglianza SAVE per la terapia QUELIMMUNE nel trattamento di pazienti pediatrici con insufficienza renale acuta (AKI) e sepsi. I dati dei primi 20 pazienti pediatrici hanno mostrato un tasso di sopravvivenza del 75% a 28 giorni, potenzialmente con una riduzione della mortalit脿 superiore al 50% rispetto ai dati storici.
La terapia non ha evidenziato eventi avversi correlati al dispositivo ed 猫 stata particolarmente efficace nei pazienti critici trattati come ultima risorsa. L'azienda prevede di raccogliere Evidenze dal Mondo AG真人官方e (RWE) fino a 300 pazienti, includendo dati sulla sopravvivenza a 90 giorni e sulla dipendenza dalla dialisi. La terapia QUELIMMUNE, basata sulla tecnologia Selective Cytopheretic Device (SCD), 猫 stata adottata nei principali centri pediatrici statunitensi e ha ottenuto la designazione FDA Breakthrough Device per sei diverse indicazioni.
SeaStar Medical (Nasdaq: ICU) ha informado resultados preliminares positivos de su registro de vigilancia SAVE para la terapia QUELIMMUNE en el tratamiento de pacientes pedi谩tricos con lesi贸n renal aguda (AKI) y sepsis. Los datos de los primeros 20 pacientes pedi谩tricos mostraron una tasa de supervivencia del 75% a 28 d铆as, potencialmente superando una reducci贸n del 50% en la mortalidad en comparaci贸n con datos hist贸ricos.
La terapia no present贸 eventos de seguridad relacionados con el dispositivo y fue especialmente eficaz en pacientes cr铆ticamente enfermos que la recibieron como 煤ltimo recurso. La compa帽铆a planea recopilar Evidencia del Mundo AG真人官方 (RWE) para hasta 300 pacientes, incluyendo datos de supervivencia a 90 d铆as y dependencia de di谩lisis. La terapia QUELIMMUNE, basada en la tecnolog铆a Selective Cytopheretic Device (SCD), se ha implementado en los principales centros m茅dicos pedi谩tricos de EE.UU. y ha recibido la designaci贸n FDA Breakthrough Device para seis aplicaciones diferentes.
SeaStar Medical (雮橃姢雼�: ICU)電� 旮夓劚 鞁犾啇靸�(AKI) 氚� 韺槇歃濎潉 鞎撽碃 鞛堧姅 靻岇晞 頇橃瀽 旃橂毳� 鞙勴暅 QUELIMMUNE 旃橂氩�鞐� 雽�頃� SAVE 臧愳嫓 霌彪攵�鞚� 旮嶌爼鞝侅澑 鞓堧箘 瓴瓣臣毳� 氤搓碃頄堨姷雼堧嫟. 觳橃潓 20氇呾潣 靻岇晞 頇橃瀽 雿办澊韯办棎靹� 28鞚� 靸濎〈鞙澊 75%搿� 雮橅儉雮�, 瓿缄卑 雿办澊韯办棎 牍勴暣 靷毳犾澊 50% 鞚挫儊 臧愳唽頃� 臧�電レ劚鞚� 氤挫榾鞀惦媹雼�.
鞚� 旃橂氩曥潃 旮瓣赴 甏�霠� 鞎堨爠 靷贝鞚� 鞐嗢棃鞙茧┌, 斓滍泟鞚� 靾橂嫧鞙茧 韴棳霅� 欷戩 頇橃瀽鞐愱矊 韸鬼瀳 須臣鞝侅澊鞐堨姷雼堧嫟. 須岇偓電� 斓滊寑 300氇呾潣 頇橃瀽毳� 雽�靸侅溂搿� 鞁れ牅 靹戈硠 歃濌卑(RWE)毳� 靾橃頃� 瓿勴殟鞚措┌, 90鞚� 靸濎〈鞙臣 韴劃 鞚橃〈霃� 雿办澊韯半ゼ 韽暔頃� 鞓堨爼鞛呺媹雼�. Selective Cytopheretic Device(SCD) 旮办垹鞐� 旮半皹頃� QUELIMMUNE 旃橂氩曥潃 氙戈淡 欤检殧 靻岇晞 鞚橂 靹柬劙鞐愳劀 霃勳瀰霅橃棃鞙茧┌, 鞐劘 臧�歆� 雼るジ 鞝侅毄 攵勳暭鞐� 雽�頃� FDA 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 rapport茅 des r茅sultats pr茅liminaires positifs issus de son registre de surveillance SAVE concernant la th茅rapie QUELIMMUNE dans le traitement des patients p茅diatriques atteints d'insuffisance r茅nale aigu毛 (IRA) et de sepsie. Les donn茅es des 20 premiers patients p茅diatriques ont montr茅 un taux de survie de 75 % 脿 28 jours, d茅passant potentiellement une r茅duction de 50 % de la mortalit茅 par rapport aux donn茅es historiques.
La th茅rapie n'a pr茅sent茅 aucun 茅v茅nement ind茅sirable li茅 au dispositif et s'est av茅r茅e particuli猫rement efficace chez les patients en 茅tat critique qui l'ont re莽ue en dernier recours. La soci茅t茅 pr茅voit de collecter des donn茅es en conditions r茅elles (RWE) pour jusqu'脿 300 patients, incluant la survie 脿 90 jours et la d茅pendance 脿 la dialyse. La th茅rapie QUELIMMUNE, bas茅e sur la technologie Selective Cytopheretic Device (SCD), a 茅t茅 mise en 艙uvre dans les principaux centres m茅dicaux p茅diatriques am茅ricains et a obtenu la d茅signation FDA Breakthrough Device pour six applications diff茅rentes.
SeaStar Medical (Nasdaq: ICU) hat positive vorl盲ufige Ergebnisse aus seinem SAVE Surveillance Register f眉r die QUELIMMUNE-Therapie bei der Behandlung p盲diatrischer Patienten mit akutem Nierenversagen (AKI) und Sepsis gemeldet. Die Daten der ersten 20 p盲diatrischen Patienten zeigten eine 脺berlebensrate von 75% nach 28 Tagen, was m枚glicherweise eine Reduktion der Sterblichkeit um mehr als 50% im Vergleich zu historischen Daten bedeutet.
Die Therapie zeigte keine ger盲tebezogenen Sicherheitsvorf盲lle und war besonders wirksam bei kritisch kranken Patienten, die sie als letzte Option erhielten. Das Unternehmen plant, AG真人官方-World-Evidence (RWE) f眉r bis zu 300 Patienten zu sammeln, einschlie脽lich Daten zur 90-Tage-脺berlebensrate und Dialyseabh盲ngigkeit. Die QUELIMMUNE-Therapie, basierend auf der Selective Cytopheretic Device (SCD)-Technologie, wurde in f眉hrenden US-Kinderkliniken eingesetzt und hat f眉r sechs verschiedene Anwendungsgebiete die FDA Breakthrough Device Designation erhalten.
- 75% patient survival rate through 28 days, potentially exceeding 50% reduction in mortality
- No device-related safety events reported in preliminary results
- FDA Breakthrough Device Designation received for six different applications
- Adoption by leading U.S. children's medical centers
- Successful treatment of critically ill patients who received therapy as last resort
- Registry data still preliminary with only 20 patients analyzed
- Additional long-term survival and dialysis dependence data still pending
- Full 300-patient AG真人官方-World Evidence collection still ongoing
Insights
SeaStar's QUELIMMUNE therapy shows promising survival rates in pediatric AKI patients, potentially expanding market opportunities and strengthening commercial outlook.
The preliminary results from SeaStar Medical's SAVE Surveillance Registry represent a significant clinical milestone for their QUELIMMUNE therapy. With
What's clinically meaningful here is the absence of device-related safety events coupled with the survival benefit in an extremely vulnerable patient population. The fact that many patients received QUELIMMUNE as a "last resort" suggests the therapy may be effective even in the most challenging cases. This real-world evidence could substantially strengthen QUELIMMUNE's clinical positioning.
The registry's planned expansion to 300 patients will provide robust real-world data on 90-day survival and dialysis dependency outcomes. This approach is strategically sound - generating post-approval evidence to support broader clinical adoption while simultaneously informing payer discussions about reimbursement. The adoption by leading children's medical centers further validates clinical confidence in the technology.
Beyond pediatrics, SeaStar's ongoing NEUTRALIZE-AKI pivotal trial in adults and the multiple FDA Breakthrough Device Designations across various inflammatory conditions highlight the platform potential of their Selective Cytopheretic Device technology. If successful, this could dramatically expand the addressable market beyond the current Humanitarian Device Exemption approval, potentially transforming treatment paradigms for hyperinflammatory conditions affecting vital organs.
DENVER, July 22, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company, announced today positive preliminary results from the which is assessing the use of the in the treatment of critically ill pediatric patients with life-threatening Acute Kidney Injury (AKI) and sepsis requiring Renal Replacement Therapy (RRT). Based on the data collected from the first 20 pediatric patients in the SAVE Surveillance Registry, there were no device related safety events with the QUELIMMUNE therapy and
SeaStar also reported that additional analyses of the preliminary results of the SAVE Surveillance Registry are expected to mirror the clinical data that was submitted to the U.S. Food and Drug Administration (FDA) to support the approval of QUELIMMUNE under a Humanitarian Device Exemption. These data, including additional 60-day and 90-day survival results, as well as dialysis dependence outcomes, will be submitted as an abstract later this summer to a prominent pediatric nephrology conference taking place in the fall.
鈥淲hat is perhaps most remarkable about these data is that many of the patients who were treated with QUELIMMUNE were incredibly sick, with most receiving this therapy as a last resort. It is likely that many of these patients would not have otherwise survived,鈥� stated Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. 鈥淭he fact that they survived the immediate life-threatening period suggests that the QUELIMMUNE therapy gave these kids a fighting chance.鈥�
The SAVE Surveillance Registry is a AG真人官方-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 similar illness severity. 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鈥檚 ongoing effort to recruit patients into its adult NEUTRALIZE-AKI pivotal trial.
The QUELIMMUNE therapy has been adopted by some of the highest rated children鈥檚 medical centers in the United States. The patented technology behind QUELIMMUNE is known as the Selective Cytopheretic Device (SCD) therapy and has broad applications for treating the destructive hyperinflammation that shuts down organ function and causes loss of life. 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聽
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
罢丑别听聽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聽聽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 鈥渞eal-world鈥� setting.
Data from two clinical studies of the QUELIMMUNE therapy, published in聽, 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 NEUTRALIZE-AKI Pivotal Trial聽
罢丑别听聽(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.聽
About the SeaStar Medical Selective Cytopheretic Device聽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 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鈥檚 first commercial product,聽, 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 (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聽聽or visit us on聽听辞谤听.
Forward-Looking Statements聽
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 the anticipated adoption our products; anticipated cost savings for patients, healthcare providers, and the healthcare system more generally from the adoption of the SCD therapy; 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.聽
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FAQ
What are the preliminary results of SeaStar Medical's QUELIMMUNE therapy for pediatric AKI patients?
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