First Pediatric Patient Treated in a Commercial Setting with SeaStar Medical’s FDA-Approved QUELIMMUNE Therapeutic Device
SeaStar Medical Holding (Nasdaq: ICU) has announced the first commercial treatment of a pediatric patient with its FDA-approved QUELIMMUNE™ therapeutic device. This milestone meets the FDA's August 20, 2024 deadline for initiating patient treatments. QUELIMMUNE is designed to treat acute kidney injury (AKI) in pediatric patients weighing 10 kg or more with sepsis or septic conditions requiring kidney replacement therapy (KRT).
Clinical trials have shown promising results, with a 77% survival rate and no dialysis dependency at 60 days for treated children. This is significant given that approximately 4,000 children with AKI require continuous KRT annually in the U.S., with a mortality rate of about 50%. The company aims to improve outcomes and reduce long-term complications for these severely ill children.
SeaStar Medical Holding (Nasdaq: ICU) ha annunciato il primo trattamento commerciale di un paziente pediatrico con il suo dispositivo terapeutico QUELIMMUNE™ approvato dalla FDA. Questo traguardo soddisfa la scadenza del 20 agosto 2024 fissata dalla FDA per l'inizio dei trattamenti sui pazienti. QUELIMMUNE è progettato per trattare lesioni renali acute (AKI) nei pazienti pediatrici che pesano 10 kg o più e presentano sepsi o condizioni settiche che richiedono terapia sostitutiva renale (KRT).
Le sperimentazioni cliniche hanno mostrato risultati promettenti, con un tasso di sopravvivenza del 77% e nessuna dipendenza dalla dialisi a 60 giorni per i bambini trattati. Questo è significativo considerando che circa 4.000 bambini con AKI necessitano di KRT continua annualmente negli Stati Uniti, con un tasso di mortalità di circa il 50%. L'azienda mira a migliorare i risultati e ridurre le complicazioni a lungo termine per questi bambini gravemente malati.
SeaStar Medical Holding (Nasdaq: ICU) ha anunciado el primer tratamiento comercial de un paciente pediátrico con su dispositivo terapéutico QUELIMMUNE™ aprobado por la FDA. Este logro cumple con la fecha límite del 20 de agosto de 2024 establecida por la FDA para iniciar tratamientos en pacientes. QUELIMMUNE está diseñado para tratar lesiones renales agudas (AKI) en pacientes pediátricos que pesen 10 kg o más y presenten sepsis o condiciones sépticas que requieren terapia de reemplazo renal (KRT).
Los ensayos clínicos han mostrado resultados prometedores, con un tasa de supervivencia del 77% y sin dependencia de diálisis a 60 días para los niños tratados. Esto es significativo dado que aproximadamente 4.000 niños con AKI requieren KRT continua anualmente en EE. UU., con una tasa de mortalidad de alrededor del 50%. La empresa busca mejorar los resultados y reducir las complicaciones a largo plazo para estos niños gravemente enfermos.
SeaStar Medical Holding (Nasdaq: ICU)는 FDA 승인된 QUELIMMUNE™ 치료 장치로 소아 환자에 대한 첫 상업적 치료를 발표했습니다. 이 이정표는 환자 치료 시작에 대한 FDA의 2024년 8월 20일 기한을 충족합니다. QUELIMMUNE은 세균성 패혈증이 있거나 신장 대체 요법(KRT)이 필요한 10kg 이상 소아 환자의 급성 신장 손상(AKI)을 치료하기 위해 설계되었습니다.
임상 시험에서는 치료받은 어린이들에게 77%의 생존율과 60일 후 투석 의존 없음을 보여주는 고무적인 결과를 보여줍니다. 미국에서 매년 약 4,000명의 AKI 어린이가 지속적인 KRT가 필요하며 사망률은 약 50%에 이릅니다. 회사는 이러한 중증 어린이들의 치료 결과를 개선하고 장기 합병증을 줄이는 것을 목표로 하고 있습니다.
SeaStar Medical Holding (Nasdaq: ICU) a annoncé le premier traitement commercial d'un patient pédiatrique avec son dispositif thérapeutique QUELIMMUNE™ approuvé par la FDA. Cette étape répond à la date limite du 20 août 2024 fixée par la FDA pour le démarrage des traitements des patients. QUELIMMUNE est conçu pour traiter les lésions rénales aiguës (AKI) chez les patients pédiatriques pesant 10 kg ou plus et présentant une septicémie ou des conditions septiques nécessitant une thérapie de remplacement rénal (KRT).
Les essais cliniques ont montré des résultats prometteurs, avec un taux de survie de 77% et aucune dépendance à la dialyse après 60 jours pour les enfants traités. Cela est significatif étant donné qu'environ 4.000 enfants avec AKI nécessitent une KRT continue chaque année aux États-Unis, avec un taux de mortalité d'environ 50%. L'entreprise vise à améliorer les résultats et à réduire les complications à long terme pour ces enfants gravement malades.
SeaStar Medical Holding (Nasdaq: ICU) hat die erste kommerzielle Behandlung eines pädiatrischen Patienten mit seinem von der FDA genehmigten therapeutischen Gerät QUELIMMUNE™ angekündigt. Dieser Meilenstein erfüllt die Frist der FDA vom 20. August 2024 für den Start der Patientenbehandlungen. QUELIMMUNE ist darauf ausgelegt, akute Nierenschäden (AKI) bei pädiatrischen Patienten mit einem Gewicht von 10 kg oder mehr zu behandeln, die an Sepsis oder septischen Erkrankungen leiden, die eine Nierenersatztherapie (KRT) erfordern.
Die klinischen Studien haben vielversprechende Ergebnisse gezeigt, mit einer Überlebensrate von 77% und ohne Dialyseabhängigkeit nach 60 Tagen bei behandelten Kindern. Dies ist bedeutsam, da in den USA jährlich etwa 4.000 Kinder mit AKI eine kontinuierliche KRT benötigen, mit einer Sterblichkeitsrate von etwa 50%. Das Unternehmen hat sich zum Ziel gesetzt, die Ergebnisse zu verbessern und langfristige Komplikationen für diese schwer kranken Kinder zu reduzieren.
- FDA approval of QUELIMMUNE for pediatric AKI treatment
- First commercial treatment successfully administered
- Met FDA deadline for initiating patient treatments
- Clinical trials showed 77% survival rate with no dialysis dependency at 60 days
- No device-related serious adverse events or infections reported in trials
- None.
SeaStar Medical’s QUELIMMUNE represents a significant advancement in the treatment of acute kidney injury (AKI) for pediatric patients with sepsis. The FDA approval and subsequent use in a commercial setting validate the device's clinical effectiveness, particularly given the high mortality rate of 50% among children with AKI requiring continuous kidney replacement therapy (KRT). From a medical research perspective, the pooled analysis showing a 77% survival rate with no dialysis dependency at 60 days is highly promising. This suggests QUELIMMUNE could drastically improve outcomes for these patients, offering a potentially life-saving therapy where options are currently limited.
The initiation of treatment using SeaStar Medical's QUELIMMUNE in a commercial setting is a major milestone for the company. This FDA-approved device addresses a critical need, evidenced by the annual incidence of 4,000 pediatric AKI cases requiring continuous KRT in the U.S. alone. The positive clinical data and the absence of device-related serious adverse events position QUELIMMUNE favorably in the market. For investors, this translates to a strengthening of SeaStar Medical's market position and potential revenue growth. Given the urgency and severity of AKI in pediatric patients, widespread adoption of QUELIMMUNE could drive significant financial gains for the company.
SeaStar Medical’s ability to meet the FDA's treatment deadline is a clear demonstration of its operational efficiency and regulatory compliance. The QUELIMMUNE device fills a critical gap in the pediatric AKI treatment landscape, where current interventions are often limited and result in high mortality and morbidity rates. The 77% survival rate from clinical trials suggests a competitive edge in the market. For stakeholders, this milestone not only enhances the company's credibility but also potentially expands its market share within the therapeutic device industry. This approval could pave the way for similar regulatory achievements and product deployments in the future.
DENVER, July 23, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical) reports treatment of the first patient in a commercial setting with QUELIMMUNE™, its U.S. Food and Drug Administration (FDA)-approved, patented cell-directed extracorporeal therapy to treat acute kidney injury (AKI) in pediatric patients weighing 10 kilograms or greater with sepsis or a septic condition requiring kidney replacement therapy (KRT). With this development, the Company has now met the August 20, 2024 FDA deadline to begin patient treatments, which is designated in the FDA’s approval of QUELIMMUNE.
“This commercial milestone is highly gratifying to the SeaStar Medical team that has worked so hard to make QUELIMMUNE available to patients in need. Results from completed clinical trials show the potential of QUELIMMUNE to save the lives and decrease dialysis dependency of these severely ill children with AKI, and we are dedicated to ensuring widespread access to our therapeutic device,” said Eric Schlorff, CEO of SeaStar Medical. “We have now met the FDA’s requirement for a timely first treatment.”
Each year in the U.S., approximately 4,000 children with AKI require continuous KRT, with a mortality rate of approximately
About Acute Kidney Disease (AKI)
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. In critically ill patients with AKI, a dysregulated immune response can lead to hyperinflammation, which may contribute to significant morbidity, including prolonged ICU stays, increased reliance on dialysis and mechanical ventilation, and higher hospital costs. Damage resulting from this dysregulated response in AKI can progress to other organs, such as the heart or liver. Multi-organ dysfunction or even failure can lead to 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.
About QUELIMMUNE
QUELIMMUNE is SeaStar Medical’s first Selective Cytopheretic Device (SCD) to receive FDA approval. This therapeutic device selectively targets the most highly activated proinflammatory neutrophils and monocytes and restores them to a reparative state. QUELIMMUNE consists of a SCD pediatric (SCD-PED) cartridge and blood tubing set that are connected in-line to an existing hemodialysis delivery system’s extracorporeal continuous KRT circuit in a process that takes about 15 minutes. The Company expects that, on average, a full course of treatment for children with AKI will require three to seven days of treatment, with the disposable SCD-PED cartridge being replaced every 24 hours.
SeaStar Medical is actively enrolling patients in the adult NEUTRALIZE-AKI pivotal clinical trial. The adult AKI population is 50 times larger than the pediatric population, which the Company believes represents a multibillion-dollar market opportunity. The SCD is a platform technology with potential in multiple disease conditions affected by hyperinflammation.
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, SeaStar Medical’s expectations with respect to the amount and timing of future QUELIMMUNE commercial sales; commercial acceptance of QUELIMMUNE; 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 “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 do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.
Investor Contact:
LHA Investor Relations
Jody Cain
(310) 691-7100
Jcain@lhai.com
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