SeaStar Medical Adds Fifth Hospital Customer for QUELIMMUNE
SeaStar Medical (Nasdaq: ICU) has expanded its customer base by shipping QUELIMMUNE™ to a fifth hospital, a California medical center known for pediatric research. QUELIMMUNE, their Selective Cytopheretic Device (SCD), treats critically ill children in ICU with acute kidney injury (AKI) and sepsis.
The company is actively pursuing additional hospital clearances through institutional review board (IRB) approvals, with more than a dozen new medical centers in discussion and seven advancing in the IRB process. Several existing customers have already placed reorders in 2025.
QUELIMMUNE operates under FDA approval through a Humanitarian Device Exemption for children weighing 10kg or more requiring renal replacement therapy. The device uniquely targets proinflammatory neutrophils and monocytes during continuous renal replacement therapy, potentially promoting long-term organ recovery and eliminating future dialysis needs. The SCD has received FDA Breakthrough Device Designation in four indications.
SeaStar Medical (Nasdaq: ICU) ha ampliato la sua clientela inviando QUELIMMUNE™ a un quinto ospedale, un centro medico della California noto per la ricerca pediatrica. QUELIMMUNE, il loro Dispositivo Citoferetico Selettivo (SCD), tratta bambini gravemente malati in terapia intensiva con insufficienza renale acuta (AKI) e sepsi.
La compagnia sta attivamente perseguendo ulteriori autorizzazioni ospedaliere tramite approvazioni del comitato di revisione istituzionale (IRB), con più di una dozzina di nuovi centri medici in discussione e sette in fase avanzata nel processo IRB. Diversi clienti esistenti hanno già effettuato riordini nel 2025.
QUELIMMUNE opera sotto l'approvazione della FDA tramite un'esenzione per Dispositivi Umanitari per bambini che pesano 10 kg o più e richiedono terapia di sostituzione renale. Il dispositivo si concentra in modo unico sui neutrofili e monociti pro-infiammatori durante la terapia di sostituzione renale continua, promuovendo potenzialmente il recupero a lungo termine degli organi ed eliminando la necessità di dialisi futura. L'SCD ha ricevuto la designazione di Dispositivo Innovativo dalla FDA per quattro indicazioni.
SeaStar Medical (Nasdaq: ICU) ha ampliado su base de clientes enviando QUELIMMUNE™ a un quinto hospital, un centro médico en California conocido por la investigación pediátrica. QUELIMMUNE, su Dispositivo Citoféretico Selectivo (SCD), trata a niños críticos en UCI con lesión renal aguda (AKI) y sepsis.
La empresa está buscando activamente obtener más autorizaciones hospitalarias a través de aprobaciones de comités de revisión institucional (IRB), con más de una docena de nuevos centros médicos en discusión y siete avanzando en el proceso de IRB. Varios clientes existentes ya han realizado recompras en 2025.
QUELIMMUNE opera bajo la aprobación de la FDA a través de una Exención de Dispositivo Humanitario para niños que pesan 10 kg o más y necesitan terapia de reemplazo renal. El dispositivo se dirige de manera única a neutrófilos y monocitos proinflamatorios durante la terapia continua de reemplazo renal, promoviendo potencialmente la recuperación a largo plazo de los órganos y eliminando las futuras necesidades de diálisis. El SCD ha recibido la designación de Dispositivo Innovador de la FDA en cuatro indicaciones.
SeaStar Medical (Nasdaq: ICU)는 QUELIMMUNE™를 오랜 연구로 알려진 캘리포니아의 다섯 번째 병원으로 배송하여 고객 기반을 확장했습니다. QUELIMMUNE은 그들의 선택적 세포치료장치(SCD)로, 중환자실에서 급성 신장 손상(AKI) 및 패혈증이 있는 심각한 아동을 치료합니다.
회사는 기관 윤리 위원회(IRB)의 승인을 통해 추가 병원 승인을 적극적으로 추진하고 있으며, 1다스 이상의 새로운 의료 센터와 논의 중이며, 7개 센터는 IRB 프로세스에서 진행 중입니다. 이미 몇몇 기존 고객이 2025년에 재주문을 해왔습니다.
QUELIMMUNE은 10kg 이상의 체중이 있는 아동에게 신장 대체 요법이 필요한 경우, 인도적 기기 면제(Humanitarian Device Exemption)를 통해 FDA의 승인을 받았습니다. 이 장치는 지속적인 신장 대체 요법 중에 염증을 유발하는 호중구와 단핵구를 유니크하게 표적화하여 장기 회복을 장기적으로 촉진하고 향후 투석 필요성을 제거할 가능성이 있습니다. SCD는 4개의 적응증에 대해 FDA 혁신 기기 지정을 받았습니다.
SeaStar Medical (Nasdaq: ICU) a élargi sa clientèle en expédiant QUELIMMUNE™ à un cinquième hôpital, un centre médical californien connu pour sa recherche pédiatrique. QUELIMMUNE, leur Dispositif Cytophorétique Sélectif (SCD), traite des enfants gravement malades en réanimation souffrant d'insuffisance rénale aiguë (AKI) et de sepsis.
L'entreprise recherche activement d'autres autorisations hospitalières par le biais d'approbations de comités d'examen institutionnels (IRB), avec plus d'une douzaine de nouveaux centres médicaux en discussion et sept en avance dans le processus IRB. Plusieurs clients existants ont déjà passé des commandes de réapprovisionnement en 2025.
QUELIMMUNE fonctionne sous l'approbation de la FDA grâce à une Exemption de Dispositif Humanitaire pour les enfants pesant 10 kg ou plus nécessitant une thérapie de remplacement rénal. Le dispositif cible de manière unique les neutrophiles et monocytes pro-inflammatoires lors de la thérapie continue de remplacement rénal, promouvant potentiellement la récupération à long terme des organes et éliminant les besoins futurs de dialyse. Le SCD a reçu la désignation de Dispositif Innovant de la FDA pour quatre indications.
SeaStar Medical (Nasdaq: ICU) hat seine Kundenbasis erweitert, indem es QUELIMMUNE™ an ein fünftes Krankenhaus, ein medizinisches Zentrum in Kalifornien, das für die pädiatrische Forschung bekannt ist, geliefert hat. QUELIMMUNE, ihr selektives zytophoretisches Gerät (SCD), behandelt schwer kranke Kinder auf der Intensivstation mit akuter Nierenverletzung (AKI) und Sepsis.
Das Unternehmen verfolgt aktiv weitere Krankenhausgenehmigungen durch institutionelle Überprüfungsboard (IRB) Genehmigungen, mit mehr als einem Dutzend neuer medizinischer Zentren in Diskussion und sieben im IRB-Prozess. Mehrere bestehende Kunden haben bereits Nachbestellungen für 2025 aufgegeben.
QUELIMMUNE arbeitet unter der FDA-Zulassung durch eine humanitäre Geräteeinzahlung für Kinder mit einem Gewicht von 10 kg oder mehr, die eine Nierenersatztherapie benötigen. Das Gerät zielt einzigartig auf proinflammatorische Neutrophile und Monozyten während der kontinuierlichen Nierenersatztherapie ab und fördert potenziell die langfristige Organregenerierung und beseitigt zukünftige Dialysebedürfnisse. Das SCD hat für vier Indikationen die FDA-Durchbruch-Gerätebezeichnung erhalten.
- Expanded customer base to 5 hospitals with new California medical center addition
- Multiple existing customers have placed reorders in 2025
- Pipeline of 12+ potential new medical centers with 7 in IRB approval process
- FDA Breakthrough Device Designation in 4 different indications
- market approval under Humanitarian Device Exemption restricts widespread adoption
- Product currently to patients weighing 10kg or more
Insights
The addition of a fifth hospital customer for QUELIMMUNE marks a significant milestone in SeaStar Medical's commercialization strategy. This expansion to a renowned California pediatric center not only validates the technology but also provides strategic positioning in a major healthcare market. The reorder activity from existing customers is particularly noteworthy, as it demonstrates both clinical utility and operational integration success.
The commercial momentum is building with 7 hospitals in active IRB approval process out of 12+ engaged centers, suggesting a well-defined growth trajectory toward their 20-hospital target for 2025. The HDE approval pathway, while limiting the addressable market, provides a strategic entry point in a high-unmet-need population where traditional treatment options are
QUELIMMUNE's unique mechanism of action in modulating the inflammatory response, rather than just removing pathogens, positions it distinctively in the market. The technology's integration with existing CRRT systems reduces implementation barriers, while its potential to eliminate future dialysis needs presents a compelling value proposition for healthcare systems.
The broader potential is underscored by four FDA Breakthrough Device Designations in additional indications, including adult AKI and chronic dialysis. This pipeline diversity could significantly expand the addressable market beyond the current pediatric focus, though careful monitoring of clinical development and regulatory pathways will be important for investors.
DENVER, Jan. 27, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage therapeutic medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, has shipped QUELIMMUNE™ to a California medical center recognized as a world leader in pediatric research and treatments, increasing commercial customers to five. QUELIMMUNE is the company’s Selective Cytopheretic Device (SCD) for treating critically ill children in the intensive care unit (ICU) with acute kidney injury (AKI) and sepsis.
“We are delighted that QUELIMMUNE is now available to treat severely ill children at yet another prominent academic medical center,” said Tim Varacek, SeaStar Medical Senior Vice President, Commercial & Business Operations. “We are actively working to secure additional hospital clearances by gaining institutional review board (IRB) approvals for using QUELIMMUNE within their facilities. Currently, we are engaged with more than a dozen new medical centers, with seven of these hospitals advancing into the IRB approval process. Additionally, I’m pleased to report that several of our current customers have reordered QUELIMMUNE for their institutions since the beginning of this year.”
“We know of no other commercially available therapy that can modify the inflammatory process once it’s triggered to help repair the damage caused by an overactive immune system. It’s gratifying to expand access to our potentially lifesaving therapy to more pediatric patients as we make headway in our goal of having more than 20 hospitals utilizing QUELIMMUNE this year,” said Eric Schlorff, SeaStar Medical CEO.
QUELIMMUNE is being commercialized following U.S. Food and Drug Administration (FDA) approval for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are being treated in the ICU with renal replacement therapy (RRT). QUELIMMUNE was approved under a Humanitarian Device Exemption (HDE) application, having met the applicable criteria with clinical results showing safety and probable clinical benefit in a limited population of critically ill children with AKI who have few treatment options.
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 COVID-19, sepsis, severe trauma and surgery. AKI can cause hyperinflammation, which is the overproduction or overactivity of inflammatory effector cells and other molecules that can be toxic. Damage resulting from 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 requiring dialysis. Hyperinflammation may also contribute to added healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation.
Selective Cytopheretic Device
The Selective Cytopheretic Device (SCD) is a patented cell-directed extracorporeal device that employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during continuous renal replacement therapy (CRRT) and reduces the hyperinflammatory milieu including the cytokine storm. Unlike pathogen removal and other blood-purification tools, the SCD is integrated with CRRT hemofiltration systems 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 and eliminate the need for future renal replacement therapy (RRT), including dialysis.
The SCD has been awarded FDA Breakthrough Device Designation in four indications:
- Cardiorenal Syndrome with Left Ventricular Assist Device
- Adult Acute Kidney Injury
- Hepatorenal Syndrome
- Chronic Dialysis
About SeaStar Medical
SeaStar Medical is a commercial-stage therapeutic medical technology company that is redefining how extracorporeal therapies may reduce the consequences of excessive inflammation on vital organs. SeaStar Medical’s novel technologies rely on science and innovation to provide life-saving solutions to critically ill patients. The Company is developing and commercializing cell-directed extracorporeal therapies that target the effector cells that drive systemic inflammation, causing direct tissue damage and secreting a range of pro-inflammatory cytokines that initiate and propagate imbalanced immune responses. 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 1995. These forward-looking statements include, without limitation, the ability of the SCD to treat patients with AKI and other diseases; our ability to secure additional hospital clearances to use the SCD; our ability to expand the number of hospitals using QUELIMMUNE; and anticipated cost savings for patients, healthcare providers, and the healthcare system more generally from the adoption of the SCD. 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 access funding under existing agreements; (vi) the risk that third-parties 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 does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.
Contact:
Alliance Advisors IR
Jody Cain
(310) 691-7100
Jcain@allianceadvisors.com
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FAQ
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