SeaStar Medical Announces that Stanford Medicine is Cleared to Actively Enroll Subjects in the Adult Acute Kidney Injury Pivotal Trial
SeaStar Medical announces Stanford Medicine's clearance to enroll subjects in the NEUTRALIZE-AKI pivotal trial for their Selective Cytopheretic Device (SCD). The trial now has 12 active sites with 52 enrolled subjects, including two recently added Department of Defense medical centers. The study will evaluate SCD's safety and efficacy in adults with acute kidney injury (AKI) in ICU receiving continuous kidney replacement therapy (CKRT), aiming to enroll up to 200 adults. The primary endpoint focuses on 90-day mortality or dialysis dependency. The SCD previously received FDA Breakthrough Device Designation, and in July 2024, CMS granted Category B coverage for certain expenses in the trial.
SeaStar Medical annuncia l'autorizzazione da parte di Stanford Medicine per arruolare soggetti nel trial pivotale NEUTRALIZE-AKI per il loro Dispositivo Citoferetico Selettivo (SCD). Il trial ha ora 12 siti attivi con 52 soggetti arruolati, inclusi due centri medici recentemente aggiunti del Dipartimento della Difesa. Lo studio valuterà la sicurezza e l'efficacia dello SCD negli adulti con lesioni renali acute (AKI) in terapia intensiva che ricevono terapia sostitutiva continua del rene (CKRT), puntando ad arruolare fino a 200 adulti. L'obiettivo primario si concentra sulla mortalità a 90 giorni o sulla dipendenza dalla dialisi. Lo SCD ha precedentemente ricevuto la Designazione di Dispositivo Innovativo dalla FDA e a luglio 2024, CMS ha concesso la copertura di Categoria B per alcune spese nel trial.
SeaStar Medical anuncia la autorización de Stanford Medicine para inscribir sujetos en el ensayo pivotal NEUTRALIZE-AKI para su Dispositivo Citoferético Selectivo (SCD). El ensayo ahora cuenta con 12 sitios activos y 52 sujetos inscritos, incluyendo dos centros médicos del Departamento de Defensa recientemente añadidos. El estudio evaluará la seguridad y eficacia del SCD en adultos con lesión renal aguda (AKI) en la UCI que reciben terapia de reemplazo renal continuo (CKRT), con el objetivo de inscribir hasta 200 adultos. El punto final primario se enfoca en la mortalidad a 90 días o dependencia de diálisis. El SCD recibió previamente la Designación de Dispositivo Innovador de la FDA, y en julio de 2024, CMS otorgó la cobertura de Categoría B para ciertos gastos en el ensayo.
SeaStar Medical는 스탠포드 의학에서 선택적 사이토퍼레틱 장치(SCD)를 위한 NEUTRALIZE-AKI 주요 시험에 피험자를 등록할 수 있도록 허가받았다고 발표했습니다. 현재 이 시험은 12개의 활성 사이트와 52명의 등록된 피험자를 보유하고 있으며, 최근에 추가된 두 개의 국방부 의료 센터도 포함됩니다. 이 연구는 지속적 신장 대체 요법(CKRT)을 받는 중환자실의 급성 신손상(AKI) 환자에서 SCD의 안전성과 효능을 평가할 예정이며, 최대 200명의 성인을 등록하는 것을 목표로 합니다. 주요 목표는 90일 사망률 또는 투석 의존도에 중점을 둡니다. SCD는 이전에 FDA의 혁신 기기 지정을 받았으며, 2024년 7월에는 CMS에서 시험의 일부 비용에 대해 B등급 보상을 승인하였습니다.
SeaStar Medical annonce l'autorisation par Stanford Medicine d'inscrire des sujets dans l'essai pivot NEUTRALIZE-AKI pour leur Dispositif Cytophérétiques Sélectif (SCD). L'essai compte désormais 12 sites actifs avec 52 sujets inscrits, y compris deux centres médicaux du département de la Défense récemment ajoutés. L'étude évaluera la sécurité et l'efficacité du SCD chez les adultes souffrant d'insuffisance rénale aiguë (AKI) en soins intensifs recevant une thérapie de remplacement rénal continu (CKRT), visant à inscrire jusqu'à 200 adultes. L'objectif principal se concentre sur la mortalité à 90 jours ou la dépendance à la dialyse. Le SCD a précédemment reçu la désignation de Dispositif Innovant par la FDA, et en juillet 2024, le CMS a accordé une couverture de Catégorie B pour certaines dépenses lors de l'essai.
SeaStar Medical gibt bekannt, dass Stanford Medicine die Genehmigung erteilt hat, Probanden in die entscheidende NEUTRALIZE-AKI-Studie für ihr Selektives Zytopheretisches Gerät (SCD) einzuschreiben. Die Studie hat nun 12 aktive Standorte mit 52 eingeschriebenen Probanden, darunter zwei kürzlich hinzugefügte medizinische Zentren des Verteidigungsministeriums. Die Studie wird die Sicherheit und Wirksamkeit von SCD bei Erwachsenen mit akuter Nierenverletzung (AKI) auf der Intensivstation, die eine kontinuierliche Nierenersatztherapie (CKRT) erhalten, evaluieren, mit dem Ziel, bis zu 200 Erwachsene zu rekrutieren. Der primäre Endpunkt konzentriert sich auf die Sterblichkeit nach 90 Tagen oder Dialyseabhängigkeit. Das SCD erhielt zuvor von der FDA die Anerkennung als Durchbruchgerät, und im Juli 2024 gewährte CMS eine Kategorie-B-Abdeckung für bestimmte Ausgaben in der Studie.
- FDA Breakthrough Device Designation obtained for SCD in adult AKI treatment
- CMS granted Category B coverage for trial expenses
- Expansion to 12 active trial sites, including Stanford Medicine
- 52 subjects already enrolled in the pivotal trial
- None.
Insights
The activation of Stanford Medicine as a trial site for SeaStar Medical's NEUTRALIZE-AKI pivotal trial represents significant progress in evaluating their Selective Cytopheretic Device (SCD). The study has now reached 52 enrollments across 12 activated sites, with important CMS reimbursement support driving site recruitment.
The trial's robust design, targeting up to 200 adults, focuses on critical endpoints including 90-day mortality and dialysis dependency. The SCD's unique immunomodulation approach, already FDA-approved for pediatric use (QUELIMMUNE™), could revolutionize AKI treatment by addressing the root cause of hyperinflammation rather than just managing symptoms.
The recent pediatric FDA approval under HDE and Breakthrough Device Designation for adults demonstrate regulatory confidence in this technology, while CMS coverage significantly de-risks the trial's execution by ensuring financial feasibility for participating centers.
This development strengthens SeaStar Medical's clinical program and market position in several ways. Stanford Medicine's participation adds significant credibility and could accelerate enrollment rates. The CMS reimbursement for trial expenses reduces financial barriers for participating centers and patients, potentially speeding up the path to completion.
The company's dual-market strategy - pursuing both pediatric and adult applications - creates multiple revenue opportunities. With QUELIMMUNE™ already commercialized for pediatric use, positive adult trial results could substantially expand the addressable market. The AKI treatment market represents a significant commercial opportunity, given the high costs associated with current standard care and complications.
DENVER, Oct. 23, 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, announces that Stanford Medicine is cleared to actively enroll subjects in the NEUTRALIZE-AKI pivotal trial. With the recent addition of two Department of Defense medical centers, 12 sites are now activated to enroll subjects in the trial with enrollment at 52.
“It goes without saying that Stanford is an incredibly important site,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “The recent decision by the U.S. Centers for Medicare and Medicaid Services (CMS) to reimburse certain expenses for Medicare patients enrolled in this trial is proving critical in recruiting new medical sites. We are delighted that Stanford will be working with us to help change the standard of care for our most critically ill patients.”
SeaStar Medical’s Selective Cytopheretic Device (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, CMS granted Category B coverage for certain expenses incurred by medical centers treating Medicare or Medicaid patients enrolled in the NEUTRALIZE-AKI pivotal trial.
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 adults with acute kidney injury (AKI) in the intensive care unit (ICU) receiving continuous kidney replacement therapy (CKRT). The trial 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 CKRT as the standard of care, compared with the control group receiving only CKRT 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.
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 SCD is a patented cell-directed extracorporeal device that employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during CKRT and reduces the hyperinflammatory milieu including the cytokine storm. Unlike pathogen removal and other blood-purification tools, the SCD is integrated with CKRT 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 KRT, including dialysis.
The SCD-Pediatric device, brand named QUELIMMUNE™, is being commercialized following earning FDA approval for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are being treated in the ICU with KRT. 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:
LHA Investor Relations
Jody Cain
(310) 691-7100
Jcain@lhai.com
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FAQ
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