Record Monthly Enrollment Achieved in SeaStar Medical’s Pivotal Adult AKI Trial
SeaStar Medical (Nasdaq: ICU) reports record monthly enrollment of 10 patients in its NEUTRALIZE-AKI pivotal trial, bringing total enrollment to 56. The trial evaluates the company's Selective Cytopheretic Device (SCD) in adults with acute kidney injury receiving continuous renal replacement therapy. With 12 clinical sites now activated, including new teaching hospitals and military facilities, enrollment is expected to accelerate. The trial aims to enroll up to 200 adults, with an interim analysis planned at 100 subjects. The SCD has FDA Breakthrough Device Designation, and the trial received Category B coverage from Medicare & Medicaid for certain expenses.
SeaStar Medical (Nasdaq: ICU) riporta un record di arruolamenti mensili con 10 pazienti nel suo trial fondamentale NEUTRALIZE-AKI, portando il totale degli arruolamenti a 56. Lo studio valuta il Selective Cytopheretic Device (SCD) della società in adulti con insufficienza renale acuta sottoposti a terapia renale sostitutiva continua. Con 12 siti clinici ora attivati, inclusi nuovi ospedali educativi e strutture militari, si prevede un'accelerazione degli arruolamenti. L'obiettivo dello studio è arruolare fino a 200 adulti, con un'analisi intermedia pianificata su 100 soggetti. Lo SCD ha ricevuto la Designazione di Dispositivo Innovativo dalla FDA e lo studio ha ottenuto la copertura di Categoria B da Medicare e Medicaid per alcune spese.
SeaStar Medical (Nasdaq: ICU) informa sobre un récord de inscripciones mensual de 10 pacientes en su ensayo pivotal NEUTRALIZE-AKI, llevando el total de inscripciones a 56. El ensayo evalúa el Selective Cytopheretic Device (SCD) de la compañía en adultos con lesión renal aguda que reciben terapia de reemplazo renal continuo. Con 12 sitios clínicos ahora activados, incluidos nuevos hospitales docentes y instalaciones militares, se espera que las inscripciones se aceleren. El ensayo tiene como objetivo inscribir hasta 200 adultos, con un análisis intermedio planificado para 100 sujetos. El SCD tiene la designación de Dispositivo Innovador por parte de la FDA, y el ensayo recibió cobertura de Categoría B de Medicare y Medicaid para ciertos gastos.
SeaStar Medical (Nasdaq: ICU)는 NEUTRALIZE-AKI의 중요한 시험에서 10명의 환자를 기록적으로 등록했다고 보고하며, 총 등록 환자는 56명에 이릅니다. 이 시험은 만성 신장 대체 치료를 받고 있는 급성 신장 손상 성인에서 회사의 Selective Cytopheretic Device (SCD)를 평가합니다. 현재 12개의 임상 사이트가 활성화되어 있으며, 새로운 교육 병원 및 군 시설이 포함되어 있어 등록이 가속화될 것으로 예상됩니다. 시험의 목표는 최대 200명의 성인을 등록하는 것이며, 100명의 피험자를 대상으로 한 중간 분석이 계획되어 있습니다. SCD는 FDA의 혁신적인 기기 지정을 받았으며, 이 시험은 일부 비용에 대해 Medicare 및 Medicaid로부터 카테고리 B 보장을 받았습니다.
SeaStar Medical (Nasdaq: ICU) annonce un nombre record d'inscriptions mensuelles avec 10 patients dans son essai pivot NEUTRALIZE-AKI, portant le total des inscriptions à 56. L'essai évalue le Selective Cytopheretic Device (SCD) de la société chez des adultes souffrant d'insuffisance rénale aiguë recevant une thérapie de remplacement rénal continue. Avec 12 sites cliniques désormais activés, y compris de nouveaux hôpitaux universitaires et installations militaires, on s'attend à une accélération des inscriptions. L'essai vise à recruter jusqu'à 200 adultes, avec une analyse intermédiaire prévue pour 100 sujets. Le SCD a reçu la désignation de Dispositif Innovant de la FDA, et l'essai a obtenu une couverture de Catégorie B de Medicare et Medicaid pour certaines dépenses.
SeaStar Medical (Nasdaq: ICU) berichtet von einer rekordverdächtigen monatlichen Einschreibung von 10 Patienten in seiner entscheidenden Studie NEUTRALIZE-AKI, sodass die Gesamteinschreibung auf 56 steigt. Die Studie bewertet das Selective Cytopheretic Device (SCD) des Unternehmens bei Erwachsenen mit akuter Niereninsuffizienz, die kontinuierliche Nierenersatztherapie erhalten. Mit nun 12 aktivierten klinischen Standorten, einschließlich neuer Lehrkrankenhäuser und militärischer Einrichtungen, wird eine Beschleunigung der Einschreibungen erwartet. Ziel der Studie ist es, bis zu 200 Erwachsene einzuschreiben, wobei eine Zwischenanalyse bei 100 Teilnehmern geplant ist. Das SCD hat die Breakthrough Device Designation der FDA und die Studie erhielt eine Kategorie-B-Abdeckung von Medicare und Medicaid für bestimmte Kosten.
- Record monthly enrollment of 10 new patients, reaching 56 total participants
- Expansion to 12 activated clinical sites with more planned by December
- FDA Breakthrough Device Designation status for adult AKI treatment
- Medicare & Medicaid Category B coverage approval for trial expenses
- Recent FDA approval for pediatric device QUELIMMUNE under HDE
- Still requires 144 more patients to reach full trial enrollment target
- Interim analysis requires additional 44 patients before evaluation
Insights
The acceleration in enrollment for the NEUTRALIZE-AKI pivotal trial represents significant progress for SeaStar Medical's adult AKI program. The record monthly enrollment of 10 patients and total enrollment reaching 56 patients demonstrates strong clinical site engagement. The expansion to 12 activated clinical sites, including prestigious teaching hospitals and military facilities, suggests robust infrastructure for trial completion.
The trial's design targeting 200 adults with an interim analysis at 100 subjects is well-structured for evaluating both safety and efficacy. The composite primary endpoint of 90-day mortality or dialysis dependency is clinically meaningful, while secondary endpoints provide comprehensive assessment of patient outcomes. The potential addressable market of 210,000 AKI patients annually in the U.S. represents substantial commercial opportunity if the trial succeeds.
The trial's accelerating enrollment and expanded site network strengthens SeaStar Medical's market position in the AKI space. The FDA Breakthrough Device Designation and CMS Category B coverage are significant advantages, potentially expediting both regulatory approval and market access. The company's strategy of diversifying clinical sites across research institutions, community hospitals and government facilities demonstrates commercial foresight in building broad market penetration channels.
The recent FDA approval of QUELIMMUNE™ for pediatric AKI provides validation of the underlying technology platform and could support future adoption of the adult indication. The multiple breakthrough designations across different indications (CRS-LVAD, AKI, HRS) suggest potential for pipeline expansion and market growth beyond the initial AKI focus.
DENVER, Nov. 01, 2024 (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, reports setting a new monthly enrollment record with 10 critically ill acute kidney injury (AKI) patients added to the NEUTRALIZE-AKI pivotal trial during the past month, bringing total enrollment to 56. This trial is evaluating the safety and efficacy of the Company’s proprietary therapeutic Selective Cytopheretic Device (SCD) in adults with AKI in the intensive care unit (ICU) receiving continuous renal replacement therapy (CRRT).
“The pace of enrollment in our NEUTRALIZE-AKI trial has quickly accelerated, with 14 new subjects enrolled in slightly more than six weeks,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “With three new clinical sites joining our trial in October and more due to be activated by December, we are optimistic that this pace will continue and likely even increase.”
“A total of 12 clinical sites are now activated and we are optimistic about enrollment continuing at a rapid pace,” said Eric Schlorff, SeaStar Medical CEO. “Last month another prestigious teaching hospital and two premier military medical facilities opened for enrollment, which is in keeping with our strategy of clinical site selection. Critically ill patients with AKI are admitted to all types of facilities, whether top research institutions, community hospitals or government facilities. The range of institutions participating in the NEUTRALIZE-AKI trial demonstrates the ease with which our potentially lifesaving SCD can be incorporated into standard hemofiltration equipment, and helps set the stage for future commercialization. Our goal is to maximize access to the approximate 210,000 patients with AKI in the U.S. each year who may benefit from our device, regardless of where they are treated.”
SeaStar Medical’s 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. In July 2024, the Centers for Medicare & Medicaid Services granted Category B coverage for certain expenses incurred by medical centers when treating Medicare or Medicaid patients enrolled in NEUTRALIZE-AKI.
NEUTRALIZE-AKI Pivotal Trial
The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomIZEd clinical trial in Acute Kidney Injury) is expected to enroll up to 200 adults. 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. The Company is targeting enrollment of 100 subjects for performing an interim analysis on the trial’s 90-day primary endpoint. 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.
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.
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 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 RRT, including dialysis.
The SCD has been awarded U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation in three indications:
- Cardiorenal Syndrome – Left Ventricular Assist Device (CRS-LVAD)
- Adult Acute Kidney Injury (AKI)
- Hepatorenal Syndrome (HRS)
QUELIMMUNE™, the SCD-Pediatric device, is being commercialized following FDA approval for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are being treated in the ICU with RRT. QUELIMMUNE was approved in February 2024 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.
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 1955. These forward-looking statements include, without limitation, the ability of SCD to treat patients with AKI and other diseases; anticipated patient enrollment and the expansion of the clinical trial sites; the anticipated Medicare and Medicaid reimbursement by CMS for patients enrolled in clinical trials; the expected regulatory approval process and timeline for commercialization; and the ability of SeaStar Medical to meet the expected timeline. 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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