SeaStar Medical Activates 15th Site for its Adult Acute Kidney Injury Pivotal Trial
SeaStar Medical (Nasdaq: ICU) has activated its 15th site, Mayo Clinic, for the NEUTRALIZE-AKI pivotal trial, which is evaluating the safety and efficacy of its Selective Cytopheretic Device (SCD) in treating acute kidney injury (AKI). The trial has currently enrolled 76 subjects, with 6 new enrollments since the start of 2024.
The study aims to evaluate 200 adults with AKI in ICU receiving continuous renal replacement therapy (CRRT). The primary endpoint focuses on 90-day mortality or dialysis dependency compared to standard CRRT care. The company expects a Data Safety Monitoring Board recommendation on interim results by mid-2025 after analyzing the first 100 subjects.
The SCD, which has FDA Breakthrough Device Designation for adults with AKI, targets proinflammatory neutrophils and monocytes during CRRT to reduce hyperinflammation. SeaStar Medical estimates the annual U.S. market opportunity for SCD in adult AKI at $4.7-6.3 billion.
SeaStar Medical (Nasdaq: ICU) ha attivato il suo 15° sito, il Mayo Clinic, per il trial pivotale NEUTRALIZE-AKI, che valuta la sicurezza e l'efficacia del suo Dispositivo Citoferetico Selettivo (SCD) nel trattamento dell'insufficienza renale acuta (AKI). Attualmente, lo studio ha arruolato 76 soggetti, con 6 nuove iscrizioni dall'inizio del 2024.
Lo studio mira a valutare 200 adulti con AKI in terapia intensiva che ricevono terapia sostitutiva renale continua (CRRT). L'obiettivo primario si concentra sulla mortalità a 90 giorni o sulla dipendenza da dialisi rispetto alla cura standard CRRT. L'azienda prevede una raccomandazione del Data Safety Monitoring Board sui risultati intermedi entro metà del 2025, dopo aver analizzato i primi 100 soggetti.
Il SCD, che ha ricevuto la Designazione di Dispositivo Innovativo da parte della FDA per adulti con AKI, mira a colpire i neutrofili e i monociti proinfiammatori durante la CRRT per ridurre l'iperinfiammazione. SeaStar Medical stima che l'opportunità di mercato annuale negli Stati Uniti per il SCD nell'AKI negli adulti sia compresa tra 4,7 e 6,3 miliardi di dollari.
SeaStar Medical (Nasdaq: ICU) ha activado su 15° sitio, la Clínica Mayo, para el ensayo pivotal NEUTRALIZE-AKI, que evalúa la seguridad y eficacia de su Dispositivo Citoferético Selectivo (SCD) en el tratamiento de la lesión renal aguda (AKI). Actualmente, el ensayo ha inscrito 76 sujetos, con 6 nuevas inscripciones desde el inicio de 2024.
El estudio tiene como objetivo evaluar a 200 adultos con AKI en la UCI que reciben terapia de reemplazo renal continuo (CRRT). El objetivo primario se centra en la mortalidad a 90 días o dependencia de diálisis en comparación con la atención estándar de CRRT. La empresa espera una recomendación del Comité de Monitoreo de Seguridad de Datos sobre los resultados interinos para mediados de 2025, tras analizar los primeros 100 sujetos.
El SCD, que tiene la Designación de Dispositivo Innovador de la FDA para adultos con AKI, se dirige a los neutrófilos y monocitos proinflamatorios durante la CRRT para reducir la hiperinflamación. SeaStar Medical estima que la oportunidad de mercado anual en EE. UU. para el SCD en AKI en adultos es de entre 4,7 y 6,3 mil millones de dólares.
SeaStar Medical (Nasdaq: ICU)는 NEUTRALIZE-AKI 주요 임상 시험을 위해 15번째 사이트인 메이요 클리닉을 활성화했습니다. 이 시험은 급성 신손상(AKI) 치료를 위한 선택적 사이토페레틱 장치(SCD)의 안전성과 효능을 평가하고 있습니다. 현재까지 76명의 피험자가 등록되었으며, 2024년 시작 이후 6명의 신규 등록이 이루어졌습니다.
이번 연구는 CRRT(지속적 신장 대체 요법)를 받는 AKI 환자 200명을 평가하는 것을 목표로 하고 있습니다. 주요 목표는 표준 CRRT 치료와 비교하여 90일 사망률 또는 투석 의존성을 중심으로 하고 있습니다. 회사는 첫 100명의 피험자를 분석한 후 2025년 중반에 중간 결과에 대한 데이터 안전 모니터링 위원회의 권고를 예상하고 있습니다.
SCD는 AKI 성인에 대해 FDA 혁신 장치 지정을 받았으며, CRRT 중에 친염증성 중성구 및 단핵구를 타겟으로 하여 과염증을 줄이는 데 초점을 맞추고 있습니다. SeaStar Medical은 성인 AKI를 위한 SCD의 연간 시장 기회를 미국에서 47억에서 63억 달러로 추정하고 있습니다.
SeaStar Medical (Nasdaq: ICU) a activé son 15e site, la Mayo Clinic, pour l'
L'étude vise à évaluer 200 adultes souffrant d'AKI en soins intensifs recevant une thérapie de remplacement rénal continue (CRRT). L'objectif principal se concentre sur la mortalité à 90 jours ou la dépendance à la dialyse par rapport aux soins standard de CRRT. La société s'attend à une recommandation du Comité de Surveillance de la Sécurité des Données concernant les résultats intermédiaires d'ici mi-2025, après analyse des 100 premiers sujets.
Le SCD, qui a reçu la désignation de Dispositif Novateur de la FDA pour les adultes atteints d'AKI, cible les neutrophiles et les monocytes pro-inflammatoires pendant la CRRT afin de réduire l'hyperinflammation. SeaStar Medical estime que l'opportunité de marché annuelle pour le SCD dans l'AKI chez les adultes aux États-Unis se situe entre 4,7 et 6,3 milliards de dollars.
SeaStar Medical (Nasdaq: ICU) hat seine 15. Stelle, die Mayo-Klinik, für die NEUTRALIZE-AKI entscheidende Studie aktiviert, die die Sicherheit und Wirksamkeit seines selektiven zytophärenetischen Geräts (SCD) bei der Behandlung von akuter Niereninsuffizienz (AKI) bewertet. Die Studie hat derzeit 76 Probanden eingeschlossen, wobei seit Beginn des Jahres 2024 6 neue Einschreibungen vorgenommen wurden.
Die Studie zielt darauf ab, 200 Erwachsene mit AKI auf der Intensivstation, die eine kontinuierliche Nierenersatztherapie (CRRT) erhalten, zu bewerten. Der primäre Endpunkt konzentriert sich auf die 90-Tage-Sterblichkeit oder Dialyseabhängigkeit im Vergleich zur Standard-CRRT-Behandlung. Das Unternehmen erwartet eine Empfehlung des Data Safety Monitoring Boards zu den Zwischenresultaten bis Mitte 2025, nachdem die ersten 100 Probanden analysiert wurden.
Das SCD, das von der FDA den Status eines bahnbrechenden Geräts für Erwachsene mit AKI erhalten hat, zielt in der CRRT auf proinflammatorische Neutrophile und Monozyten ab, um eine Hyperinflammation zu reduzieren. SeaStar Medical schätzt das jährliche Marktpotential für das SCD bei erwachsenen AKI-Patienten in den USA auf 4,7 bis 6,3 Milliarden Dollar.
- Trial enrollment progressing with 76 subjects and 15 active sites
- FDA Breakthrough Device Designation received for multiple indications
- Large market opportunity of $4.7-6.3 billion annually in U.S. for adult AKI indication
- Interim analysis results not expected until mid-2025
- Still requires 124 more subjects to complete full trial enrollment
Insights
The activation of Mayo Clinic as the 15th trial site for SeaStar Medical's NEUTRALIZE-AKI pivotal study represents notable progress in their clinical development program. The trial has already enrolled 76 patients, with 6 new enrollments since the start of 2025, showing steady recruitment momentum toward the critical 100-patient interim analysis milestone.
In simple terms, SeaStar's SCD technology works like a smart filter that targets and calms down specific inflammatory cells during kidney dialysis, potentially helping patients recover from severe kidney injury without needing long-term dialysis. Think of it as a "reset button" for the immune system's response in critically ill patients.
The market opportunity is substantial, with SeaStar estimating a
The anticipated mid-2025 interim analysis will be a important inflection point for both the company and investors. If positive, these results could accelerate the path to market and validate the technology's potential across multiple indications. The focus on both mortality reduction and healthcare cost savings through prevented complications could make this an attractive option for healthcare systems if approved.
DENVER, Jan. 22, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces that Mayo Clinic is now cleared to enroll subjects in the company’s NEUTRALIZE-AKI pivotal trial, increasing the number of activated sites to 15.
“We are thrilled to activate another large academic center to our study,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “Enrollment in the trial currently stands at 76 with six subjects enrolled since the first of the year. We look forward to our next major milestone of reaching our 100th subject for our interim analysis soon.”
The SCD previously received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for adults with AKI, which is awarded to a therapy to treat a serious or life-threatening condition with preliminary clinical evidence indicating it may demonstrate substantial improvement over available therapies on clinically significant endpoints.
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 SeaStar Medical’s proprietary therapeutic SCD in 200 adults with acute kidney injury (AKI) in the intensive care unit (ICU) receiving continuous renal replacement therapy (CRRT). The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with SCD 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 SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome.
SeaStar Medical plans to conduct an interim analysis at the trial’s 90-day primary endpoint with the first 100 subjects. Given the current pace of enrollment, the company anticipates a Data Safety Monitoring Board (DSMB) recommendation on the interim results by mid-2025.
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 chronic kidney disease or end-stage renal disease requiring dialysis, among other complications. Hyperinflammation may also contribute to added healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation.
According to SeaStar Medical estimates, the annual U.S. total addressable market for the SCD in the adult AKI indication is
Selective Cytopheretic Device
The Selective Cytopheretic Device (SCD) employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during 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 and neutrophils to a reparative state. This unique immunomodulation approach has been shown to promote long-term organ recovery and eliminate the need for future renal replacement therapy (RRT), including dialysis.
In addition to Adult AKI, the SCD has been awarded FDA Breakthrough Device Designation in the following indications:
- Cardiorenal Syndrome with Left Ventricular Assist Device
- Hepatorenal Syndrome
- Chronic Dialysis
About SeaStar Medical
SeaStar Medical is a commercial-stage 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; anticipated patient enrollment and the expansion of the clinical trial sites; the estimated annual sales for the addressable AKI market; the Company’s ability to gain market share in the AKI market; the timing of current and planned future clinical trials; 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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