SeaStar Medical to Showcase New Mechanistic Data Highlighting the Immunomodulatory Effect of the Selective Cytopheretic Device in Acute Kidney Injury at ASN Kidney Week
SeaStar Medical Holding (Nasdaq: ICU) announces the presentation of new analyses of clinical data supporting the immunomodulating effect of the Selective Cytopheretic Device (SCD) at the American Society of Nephrology (ASN) 2024 Kidney Week. The data shows how the SCD significantly lowered biomarkers related to inflammation in critically ill patients with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT).
A poster presentation will highlight how SCD treatment significantly reduced the Neutrophil: Lymphocyte Ratio (NLR), a powerful biomarker linked to poor outcomes across various diseases. This provides further mechanistic clinical evidence of leukocyte immunomodulation in hyperinflammatory conditions such as AKI and sepsis.
The Company's pediatric SCD, QUELIMMUNE™, was approved by the FDA as a Humanitarian Use Device in February 2024. SeaStar Medical continues to enroll patients in its adult NEUTRALIZE-AKI pivotal trial and advance other indications like cardiorenal syndrome.
SeaStar Medical Holding (Nasdaq: ICU) annuncia la presentazione di nuove analisi dei dati clinici che supportano l'effetto immunomodulante del Dispositivo Citoforetico Selettivo (SCD) durante la Kidney Week 2024 della American Society of Nephrology (ASN). I dati mostrano come il SCD abbia significativamente ridotto i biomarcatori legati all'infiammazione nei pazienti critici con lesioni renali acute (AKI) che necessitano di terapia sostitutiva continua del rene (CKRT).
Una presentazione poster sottolineerà come il trattamento SCD abbia ridotto significativamente il rapporto Neutrofili:Linfociti (NLR), un potente biomarcatore collegato a scarsi esiti in varie patologie. Questo fornisce ulteriori evidenze meccanicistiche cliniche dell'immunomodulazione dei leucociti in condizioni iperinfiammatorie come AKI e sepsi.
Il SCD pediatrico dell'azienda, QUELIMMUNE™, è stato approvato dalla FDA come Dispositivo di Uso Umanitario nel febbraio 2024. SeaStar Medical continua a arruolare pazienti nel suo studio pivotale NEUTRALIZE-AKI per adulti e a sviluppare altre indicazioni come la sindrome cardiorenale.
SeaStar Medical Holding (Nasdaq: ICU) anuncia la presentación de nuevos análisis de datos clínicos que apoyan el efecto inmunomodulador del Dispositivo Citoforetico Selectivo (SCD) en la Kidney Week 2024 de la American Society of Nephrology (ASN). Los datos muestran cómo el SCD redujo significativamente los biomarcadores relacionados con la inflamación en pacientes críticamente enfermos con lesión renal aguda (AKI) que requieren terapia de reemplazo renal continua (CKRT).
Una presentación de póster destacará cómo el tratamiento SCD redujo significativamente la Relación Neutrófilo:Linfocito (NLR), un potente biomarcador vinculado a malos resultados en diversas enfermedades. Esto proporciona más evidencia clínica mecanicista de la inmunomodulación de leucocitos en condiciones hiperinflamatorias como AKI y sepsis.
El SCD pediátrico de la compañía, QUELIMMUNE™, fue aprobado por la FDA como Dispositivo de Uso Humanitario en febrero de 2024. SeaStar Medical continúa inscribiendo pacientes en su ensayo pivotal NEUTRALIZE-AKI para adultos y avanzando en otras indicaciones como el síndrome cardiorrenal.
SeaStar Medical Holding (Nasdaq: ICU)는 2024년 미국 신장학회(ASN) Kidney Week에서 선택적 사이토퍼레틱 장치(SCD)의 면역 조절 효과를 뒷받침하는 새로운 임상 데이터 분석을 발표한다고 발표했습니다. 데이터는 SCD가 지속적인 신장 대체 요법(CKRT)을 필요로 하는 급성 신장 손상(AKI)의 중환자에서 염증 관련 바이오마커를 크게 낮춘 방법을 보여줍니다.
포스터 발표에서는 SCD 치료가 다양한 질환에서 나쁜 결과와 관련된 강력한 바이오마커인 호중구: 림프구 비율(NLR)을 어떻게 상당히 감소시켰는지를 강조할 것입니다. 이는 AKI 및 패혈증과 같은 과도한 염증 상태에서 백혈구 면역 조절에 대한 추가적인 기전적 임상 증거를 제공합니다.
회사의 소아 SCD인 QUELIMMUNE™은 2024년 2월 FDA로부터 인도적 사용 장치로 승인받았습니다. SeaStar Medical은 성인 NEUTRALIZE-AKI 중심 시험에 환자를 계속 모집하고 심장 신장 증후군과 같은 다른 적응증을 발전시키고 있습니다.
SeaStar Medical Holding (Nasdaq: ICU) annonce la présentation de nouvelles analyses de données cliniques soutenant l'effet immunomodulateur du Dispositif Cytophorétique Sélectif (SCD) lors de la Kidney Week 2024 de l'American Society of Nephrology (ASN). Les données montrent comment le SCD a considérablement réduit les biomarqueurs liés à l'inflammation chez des patients gravement malades souffrant d'insuffisance rénale aiguë (AKI) nécessitant une thérapie de remplacement rénal continue (CKRT).
Une présentation par affiche mettra en évidence comment le traitement SCD a considérablement réduit le Rapport Neutrophiles:Lymphocytes (NLR), un puissant biomarqueur lié à de mauvais résultats dans diverses maladies. Cela fournit des preuves cliniques supplémentaires de la modulation immunitaire des leucocytes dans des conditions hyperinflammatoires telles que l'AKI et la septicémie.
Le SCD pédiatrique de la société, QUELIMMUNE™, a été approuvé par la FDA en tant que Dispositif d'Usage Humanitaire en février 2024. SeaStar Medical continue d'inscrire des patients dans son essai pivot NEUTRALIZE-AKI pour adultes et avance d'autres indications telles que le syndrome cardiorénal.
SeaStar Medical Holding (Nasdaq: ICU) kündigt die Präsentation neuer Analysen klinischer Daten an, die die immunmodulatorische Wirkung des Selektiven Zytophoretischen Geräts (SCD) während der Kidney Week 2024 der American Society of Nephrology (ASN) unterstützen. Die Daten zeigen, wie das SCD Biomarker, die mit Entzündungen bei kritisch kranken Patienten mit akutem Nierenversagen (AKI), die eine kontinuierliche Nierenersatztherapie (CKRT) benötigen, signifikant senken konnte.
Eine Posterpräsentation wird hervorheben, wie die SCD-Behandlung das Neutrophil:Lymphocyte-Verhältnis (NLR) signifikant reduziert hat, einen starken Biomarker, der mit schlechten Ergebnissen bei verschiedenen Krankheiten verbunden ist. Dies liefert weitere mechanistische klinische Beweise für die Immunmodulation von Leukozyten in hyperinflammatorischen Zuständen wie AKI und Sepsis.
Das pädiatrische SCD des Unternehmens, QUELIMMUNE™, wurde im Februar 2024 von der FDA als Humanitarian Use Device genehmigt. SeaStar Medical setzt die Patientenrekrutierung in seiner Erwachsenensstudie NEUTRALIZE-AKI fort und entwickelt weitere Indikationen wie das kardiorenale Syndrom.
- Presentation of new clinical data supporting SCD's immunomodulating effect at ASN 2024 Kidney Week
- SCD treatment significantly reduced NLR, a powerful biomarker linked to poor outcomes
- FDA approval of pediatric SCD (QUELIMMUNE™) as a Humanitarian Use Device in February 2024
- Ongoing enrollment in adult NEUTRALIZE-AKI pivotal trial
- Advancement of other indications like cardiorenal syndrome
- None.
Insights
This presentation of new mechanistic data on the Selective Cytopheretic Device (SCD) at ASN Kidney Week is noteworthy, but not immediately impactful for investors. The data further supports the SCD's ability to reduce inflammation biomarkers in acute kidney injury (AKI) patients, specifically lowering the neutrophil:lymphocyte ratio (NLR). While this adds to the scientific understanding of the device's mechanism, it doesn't represent a significant market catalyst.
The company's recent FDA approval for the pediatric SCD (QUELIMMUNE™) in February 2024 was more impactful. The ongoing enrollment in the adult NEUTRALIZE-AKI pivotal trial is the next major milestone investors should watch. This presentation may help build credibility and interest among nephrologists, potentially aiding future adoption if the adult trial is successful.
For a company with a
DENVER, Oct. 15, 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 the presentation of new analyses of clinical data further supporting the immunomodulating effect of the Selective Cytopheretic Device (SCD) at the American Society of Nephrology (ASN) 2024 Kidney Week to be held October 24-27 in San Diego. Abstracts for the meeting are available here.
“We are excited to showcase these analyses at the world’s premier nephrology meeting that further describe how the SCD significantly lowered biomarkers related to inflammation in this critically ill population of patients with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT),” said Sai Prasad N. Iyer, PhD, SeaStar Medical Senior Vice President of Medical Affairs and Research. “These data further explain mechanistically how the SCD is addressing hyperinflammation and helps restore immune balance in these critically ill patients.”
In a poster presentation, titled Immunomodulatory Effect of Selective Cytopheretic Device (SCD) on Neutrophil: Lymphocyte Ratio (NLR) and Hematologic Parameters from Multiple Acute Kidney Injury (AKI) Trials, the authors explain that NLR is a powerful biomarker with elevated levels linked to poor outcomes across a wide range of diseases. An analysis of multiple AKI clinical studies showed that SCD treatment significantly reduced NLR, providing further mechanistic clinical evidence of leukocyte immunomodulation in hyperinflammatory conditions such as AKI and sepsis with potential applicability to other diseases.
“NLRs are easy to calculate and can be done using a patient’s complete blood count without need for any additional tests,” said Kevin Chung, MD, SeaStar Medical Chief Medical Officer. “This is one of several abstracts featuring the SCD that will be presented at ASN 2024 Kidney Week. We plan to have a significant presence at the meeting.”
The Company’s pediatric SCD was approved by the U.S. Food and Drug Administration (FDA) as a Humanitarian Use Device (HDE) in February of this year, and the Company continues to enroll patients with its adult NEUTRALIZE-AKI pivotal trial, as well as advance other indications like cardiorenal syndrome.
ASN Kidney Week
ASN Kidney Week is the world’s premier nephrology meeting with more than 12,000 kidney professionals from across the globe expected to attend the 2024 event. ASN Kidney Week provides participants exciting and challenging opportunities to exchange knowledge, learn the latest scientific and medical advances, and listen to engaging and provocative discussions with leading experts in the field.
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 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, QUELIMMUNE™, 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 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, 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 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
# # #
FAQ
What is SeaStar Medical presenting at ASN Kidney Week 2024?
How does the SCD (ICU) affect inflammation biomarkers in AKI patients?
When was SeaStar Medical's pediatric SCD approved by the FDA?
What ongoing clinical trials is SeaStar Medical (ICU) conducting for the SCD?
