SeaStar Medical Grows Customer Base and Expands QUELIMMUNE Surveillance Registry
SeaStar Medical (Nasdaq: ICU) announced the addition of a major Texas-based children's hospital to its QUELIMMUNE therapy customer base. QUELIMMUNE, FDA-approved in 2024 under Humanitarian Device Exemption, treats pediatric patients with ultra-rare Acute Kidney Injury due to sepsis requiring Renal Replacement Therapy.
The company's SAVE Surveillance Registry is collecting safety and organ-related outcomes data comparing QUELIMMUNE to standard care. Additionally, the NEUTRALIZE-AKI pivotal trial has enrolled 119 of 200 planned adult subjects, with interim analysis results expected in Q3. The company holds FDA Breakthrough Device Designation for six indications, including various inflammatory and renal conditions.
SeaStar Medical (Nasdaq: ICU) ha annunciato l'inserimento di un importante ospedale pediatrico del Texas nella sua base clienti per la terapia QUELIMMUNE. QUELIMMUNE, approvata dalla FDA nel 2024 con Humanitarian Device Exemption, 猫 destinata al trattamento di pazienti pediatrici affetti da lesione renale acuta ultra-rara causata da sepsi e che necessitano di terapia sostitutiva renale.
Il Registro di Sorveglianza SAVE dell'azienda raccoglie dati sulla sicurezza e sugli esiti legati agli organi, confrontando QUELIMMUNE con la terapia standard. Inoltre, lo studio chiave NEUTRALIZE-AKI ha arruolato 119 dei 200 soggetti adulti previsti, con risultati dell'analisi intermedia attesi per il terzo trimestre. L'azienda detiene la Designazione di Dispositivo Innovativo della FDA per sei indicazioni, tra cui diverse condizioni infiammatorie e renali.
SeaStar Medical (Nasdaq: ICU) anunci贸 la incorporaci贸n de un importante hospital pedi谩trico de Texas a su base de clientes de la terapia QUELIMMUNE. QUELIMMUNE, aprobada por la FDA en 2024 bajo la Exenci贸n para Dispositivos Humanitarios, trata a pacientes pedi谩tricos con lesi贸n renal aguda ultra-rara causada por sepsis que requieren terapia de reemplazo renal.
El Registro de Vigilancia SAVE de la compa帽铆a est谩 recopilando datos de seguridad y resultados relacionados con 贸rganos comparando QUELIMMUNE con el cuidado est谩ndar. Adem谩s, el ensayo pivotal NEUTRALIZE-AKI ha inscrito a 119 de los 200 sujetos adultos planeados, con resultados del an谩lisis intermedio esperados en el tercer trimestre. La empresa posee la Designaci贸n de Dispositivo Innovador de la FDA para seis indicaciones, incluyendo diversas condiciones inflamatorias y renales.
SeaStar Medical (雮橃姢雼�: ICU)電� 韰嶌偓鞀れ棎 鞙勳箻頃� 欤检殧 鞎勲彊 氤戩洂鞚� QUELIMMUNE 旃橂氩� 瓿犼皾甑办棎 於旉皜頄堧嫟瓿� 氚滍憸頄堨姷雼堧嫟. QUELIMMUNE鞚� 2024雲勳棎 FDA鞚� 鞚鸽弰欤检潣鞝� 鞚橂旮瓣赴 氅挫牅搿� 鞀轨澑霅橃棃鞙茧┌, 韺槇歃濎溂搿� 鞚疙暅 攴鬼潿攴� 旮夓劚 鞁犾啇靸� 頇橃瀽 欷� 鞁犽寑觳挫殧氩曥澊 頃勳殧頃� 靻岇晞 頇橃瀽毳� 旃橂頃╇媹雼�.
须岇偓鞚� SAVE 臧愳嫓 霌彪攵�電� QUELIMMUNE瓿� 響滌 旃橂毳� 牍勱祼頃橂姅 鞎堨爠靹标臣 鞛リ赴 甏�霠� 瓴瓣臣 雿办澊韯半ゼ 靾橃頃橁碃 鞛堨姷雼堧嫟. 霕愴暅, NEUTRALIZE-AKI 欷戩稊 鞛勳儊鞁滍棙鞚� 瓿勴殟霅� 200氇呾潣 靹膘澑 雽�靸侅瀽 欷� 119氇呾潉 霌彪頄堨溂氅�, 欷戧皠 攵勳劃 瓴瓣臣電� 3攵勱赴鞐� 氚滍憸霅� 鞓堨爼鞛呺媹雼�. 須岇偓電� 雼れ枒頃� 鞐检靹� 氚� 鞁犾灔 歆堩櫂鞚� 韽暔頃� 6臧� 鞝侅潙歃濎棎 雽�頃� FDA 順侅嫚 鞚橂旮瓣赴 歆�鞝�(Breakthrough Device Designation)鞚� 氤挫湢頃橁碃 鞛堨姷雼堧嫟.
SeaStar Medical (Nasdaq : ICU) a annonc茅 l'ajout d'un grand h么pital p茅diatrique du Texas 脿 sa client猫le pour la th茅rapie QUELIMMUNE. QUELIMMUNE, approuv茅e par la FDA en 2024 sous exemption pour dispositif humanitaire, traite les patients p茅diatriques atteints d'une insuffisance r茅nale aigu毛 ultra-rare due 脿 une septic茅mie n茅cessitant une th茅rapie de remplacement r茅nal.
Le registre de surveillance SAVE de la soci茅t茅 collecte des donn茅es sur la s茅curit茅 et les r茅sultats li茅s aux organes, comparant QUELIMMUNE aux soins standards. De plus, l'essai pivot NEUTRALIZE-AKI a recrut茅 119 des 200 sujets adultes pr茅vus, avec des r茅sultats d'analyse interm茅diaire attendus au troisi猫me trimestre. La soci茅t茅 d茅tient la d茅signation de dispositif innovant de la FDA pour six indications, incluant diverses affections inflammatoires et r茅nales.
SeaStar Medical (Nasdaq: ICU) gab die Aufnahme eines gro脽en Kinderkrankenhauses in Texas in seine QUELIMMUNE-Therapie-Kundendatenbank bekannt. QUELIMMUNE, von der FDA im Jahr 2024 unter der Humanitarian Device Exemption zugelassen, behandelt p盲diatrische Patienten mit 盲u脽erst seltenem akutem Nierenversagen infolge von Sepsis, die eine Nierenersatztherapie ben枚tigen.
Das SAVE Surveillance Registry des Unternehmens sammelt Sicherheits- und organbezogene Ergebnisdaten, die QUELIMMUNE mit der Standardbehandlung vergleichen. Zudem wurden im 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 bereits 119 von 200 geplanten erwachsenen Probanden eingeschlossen, wobei Zwischenergebnisse f眉r das dritte Quartal erwartet werden. Das Unternehmen besitzt die FDA Breakthrough Device Designation f眉r sechs Indikationen, darunter verschiedene entz眉ndliche und renale Erkrankungen.
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Insights
SeaStar Medical expands QUELIMMUNE user base and progresses in NEUTRALIZE-AKI trial, with key data expected in Q3 2025.
SeaStar Medical's addition of a nationally-recognized Texas children's hospital to its QUELIMMUNE customer base represents important commercial traction for their FDA-approved therapy for pediatric acute kidney injury (AKI). The QUELIMMUNE therapy received FDA approval in 2024 under a Humanitarian Device Exemption (HDE) for a very specific, ultra-rare condition: pediatric patients with life-threatening AKI due to sepsis while on antibiotic therapy and requiring renal replacement therapy.
The ongoing SAVE Surveillance Registry will provide critical post-approval data to validate the therapy's performance in real-world settings. This registry approach is strategically valuable as it captures safety outcomes and organ-related metrics that can strengthen the clinical evidence supporting QUELIMMUNE's efficacy beyond the initial approval data. The company's announcement that early registry data will be presented at a medical conference later this year could provide validation that influences adoption decisions at other pediatric centers.
Equally significant is the enrollment progress in the NEUTRALIZE-AKI pivotal trial, which has now reached
Highest Rated Children鈥檚 Medical Centers Now Employ QUELIMMUNE for听Ultra-Rare Cases of Pediatric AKI
HDE Surveillance Registry Data Captures Key Metrics for听Future Analysis of QUELIMMUNE Performance
DENVER, July 16, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company announced today that it has added a nationally-recognized, Texas-based children鈥檚 hospital to its growing customer base of QUELIMMUNE therapy users. The was approved by the U.S. Food and Drug Administration in 2024 under a Humanitarian Device Exemption (HDE) to treat pediatric patients with life-threatening, ultra-rare Acute Kidney Injury (AKI) due to sepsis or a septic condition on antibiotic therapy and requiring Renal Replacement Therapy (RRT).
As part of SeaStar Medical鈥檚 QUELIMMUNE approval, these notable medical institutions also committed to participate in the that is recording safety outcomes as well as various other organ-related and life-saving outcomes for pediatric patients treated with QUELIMMUNE versus those on standard of care treatment. Analyses of early data from this Registry are expected to be presented at a medical conference later this year.
鈥淲e are making solid progress with our introduction of QUELIMMUNE to the top children鈥檚 hospitals in the U.S. and are pleased to be gathering significant additional data on its performance through our 鈥� stated Eric Schlorff, CEO of SeaStar Medical. 鈥淎s previously discussed, the underlying treatment mechanism delivered with the use of QUELIMMUNE therapy is the same in the adult AKI trial, NEUTRALIZE-AKI. We are also making good progress on patient enrollment of this trial with 119 of our planned 200 subjects enrolled.鈥�
The NEUTRALIZE-AKI pivotal trial is evaluating the safety and efficacy of the SCD therapy in 200 adults with AKI in the ICU receiving CRRT. An interim analysis is underway with results from this analysis anticipated late in the third quarter. In addition, SeaStar Medical 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 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 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 , 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.
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, , 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 status of SeaStar Medical's (ICU) NEUTRALIZE-AKI trial in 2025?
What is SeaStar Medical's QUELIMMUNE therapy approved for?
How many FDA Breakthrough Device Designations does SeaStar Medical have in 2025?
What data is being collected in SeaStar Medical's SAVE Surveillance Registry?
Which new healthcare facility joined SeaStar Medical's QUELIMMUNE customer base?
