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Economic Analysis Supporting Significant Hospitalization Cost Reduction with SeaStar Medical’s QUELIMMUNE Pediatric Therapeutic Device Presented at ASN Kidney Week 2024 - Update

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SeaStar Medical presented new economic data for its QUELIMMUNE device at ASN Kidney Week 2024, demonstrating significant cost-saving potential in treating pediatric acute kidney injury (AKI). Analysis shows hospitalization costs of $461,736 for pediatric AKI patients requiring CRRT, with QUELIMMUNE projected to save approximately $30,000 per hospitalization. The device achieves cost neutrality after 6 days of therapy and shows a 77% survival rate in children ≥10 kg and ≤22 years, compared to 50% standard care survival rate. The company presented four posters at the conference, including studies on the ongoing NEUTRALIZE-AKI pivotal trial and upcoming NEUTRALIZE-CRS trial.

SeaStar Medical ha presentato nuovi dati economici per il suo dispositivo QUELIMMUNE durante la ASN Kidney Week 2024, dimostrando un significativo potenziale di risparmio nei costi per il trattamento dell'insufficienza renale acuta pediatrica (AKI). L'analisi mostra costi di ospedalizzazione pari a 461.736 $ per i pazienti pediatrici con AKI che richiedono CRRT, con QUELIMMUNE che si prevede possa far risparmiare circa 30.000 $ per ospedalizzazione. Il dispositivo raggiunge la neutralità dei costi dopo 6 giorni di terapia e mostra un tasso di sopravvivenza del 77% nei bambini ≥10 kg e ≤22 anni, rispetto al tasso di sopravvivenza del 50% della cura standard. L'azienda ha presentato quattro poster alla conferenza, inclusi studi sul trial pivotale NEUTRALIZE-AKI in corso e sul prossimo trial NEUTRALIZE-CRS.

SeaStar Medical presentó nuevos datos económicos para su dispositivo QUELIMMUNE en la ASN Kidney Week 2024, demostrando un potencial significativo de ahorro en el tratamiento de la lesión renal aguda pediátrica (AKI). El análisis muestra costos de hospitalización de 461.736 $ para pacientes pediátricos con AKI que requieren CRRT, con QUELIMMUNE proyectado para ahorrar aproximadamente 30.000 $ por hospitalización. El dispositivo alcanza la neutralidad de costos después de 6 días de terapia y muestra una tasa de supervivencia del 77% en niños ≥10 kg y ≤22 años, en comparación con una tasa de supervivencia del 50% en cuidados estándar. La empresa presentó cuatro carteles en la conferencia, incluidos estudios sobre el ensayo pivotal NEUTRALIZE-AKI en curso y el próximo ensayo NEUTRALIZE-CRS.

SeaStar Medical은 ASN Kidney Week 2024에서 소아 급성 신손상(AKI) 치료 시 상당한 비용 절감 잠재력을 보여주는 QUELIMMUNE 장치에 대한 새로운 경제 데이터를 발표했습니다. 분석에 따르면, CRRT가 필요한 소아 AKI 환자의 입원 비용은 461,736달러로, QUELIMMUNE은 입원당 약 30,000달러를 절감할 것으로 예상됩니다. 이 장치는 치료 후 6일 만에 비용 중립성을 달성하며, 10kg 이상 및 22세 이하의 어린이에서 77%의 생존율을 보여줍니다. 이는 표준 치료의 생존율인 50%와 비교됩니다. 회사는 이번 학회에서 진행 중인 NEUTRALIZE-AKI 주요 시험 및 다가오는 NEUTRALIZE-CRS 시험에 대한 연구를 포함해 네 개의 포스터를 발표했습니다.

SeaStar Medical a présenté de nouvelles données économiques pour son dispositif QUELIMMUNE lors de l'ASN Kidney Week 2024, démontrant un potentiel d'économie de coûts significatif dans le traitement des lésions rénales aiguës pédiatriques (AKI). L'analyse révèle des coûts d'hospitalisation de 461.736 $ pour les patients pédiatriques atteints d'AKI nécessitant une CRRT, avec QUELIMMUNE qui devrait permettre d'économiser environ 30.000 $ par hospitalisation. Le dispositif atteint la neutralité des coûts après 6 jours de thérapie et affiche un taux de survie de 77 % chez les enfants de ≥10 kg et ≤22 ans, contre un taux de survie de 50 % pour les soins standard. L'entreprise a présenté quatre affiches lors de la conférence, y compris des études sur l'essai pivot NEUTRALIZE-AKI en cours et l'essai à venir NEUTRALIZE-CRS.

SeaStar Medical hat auf der ASN Kidney Week 2024 neue wirtschaftliche Daten zu seinem Gerät QUELIMMUNE vorgestellt, die ein erhebliches Kostensparpotenzial bei der Behandlung von akuten Nierenverletzungen bei Kindern (AKI) demonstrieren. Die Analyse zeigt Krankenhauskosten von 461.736 $ für pädiatrische AKI-Patienten, die CRRT benötigen, wobei erwartet wird, dass QUELIMMUNE pro Krankenhausaufenthalt etwa 30.000 $ einsparen kann. Das Gerät erreicht nach 6 Tagen Therapie Kosteneutralität und zeigt eine Überlebensrate von 77 % bei Kindern zwischen 10 kg und 22 Jahren, im Vergleich zur Überlebensrate der Standardbehandlung von 50 %. Das Unternehmen präsentierte vier Poster auf der Konferenz, darunter Studien über die laufende NEUTRALIZE-AKI-Studie und die bevorstehende NEUTRALIZE-CRS-Studie.

Positive
  • Projected cost savings of $30,000 per hospitalization with QUELIMMUNE
  • 77% survival rate vs 50% standard care survival rate
  • 0% dialysis dependence at day 60 in clinical studies
  • Cost neutrality achieved after 6 days of therapy
  • FDA Breakthrough Therapy Designation in three indications
Negative
  • Current hospitalization costs of $461,736 per case indicate high treatment burden

Insights

The economic analysis of QUELIMMUNE presents compelling cost implications for healthcare institutions. The $461,736 per hospitalization baseline cost for pediatric AKI patients requiring CRRT represents a significant financial burden. The projected $30,000 cost savings per hospitalization with QUELIMMUNE, driven by improved survival rates (77% vs 50%) and shorter hospital stays, demonstrates strong economic value. Cost neutrality achievement at 6 days of therapy, coupled with 0% dialysis dependence at day 60, suggests favorable long-term economic benefits.

The device's integration with existing CRRT circuits minimizes additional operational costs, while addressing CMS SEP-1 protocol requirements enhances its institutional adoption potential. The combination of cost efficiency and improved clinical outcomes positions QUELIMMUNE as an economically viable solution for pediatric AKI treatment.

The clinical significance of QUELIMMUNE extends beyond cost benefits. The device's selective targeting of proinflammatory neutrophils and monocytes during CRRT represents an innovative approach to managing hyperinflammation in AKI. The 77% survival rate in children ≥10 kg with AKI requiring CRRT is particularly noteworthy, especially given the complex nature of sepsis-related complications.

The FDA's Breakthrough Therapy Designation in three distinct indications (CRS-LVAD, Adult AKI and HRS) underscores the broader therapeutic potential. The 0% dialysis dependence at day 60 from both PED-01 and PED-02 studies suggests sustained therapeutic efficacy, potentially reducing long-term healthcare burden and improving patient outcomes.

Data illustrate the potential of QUELIMMUNE™️ with cost neutrality starting at 6 days of therapy and a significant reduction in total hospitalization costs in children with acute kidney injury

SeaStar Medical’s SCD was featured in four Company presentations
at the premier nephrology conference

CORRECTION: “Importantly, our findings underscore the opportunity for widespread adoption by hospitals to generate cost savings, while also saving lives”

DENVER, Oct. 25, 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 for the first time new data highlighting the cost savings of its first-in-class, cell-directed Selective Cytopheretic Device (SCD) Pediatric therapeutic device, QUELIMMUNE, were presented yesterday at the American Society of Nephrology’s (ASN) Kidney Week 2024, underway in San Diego.

“We are thrilled to present a high-quality analysis highlighting the significant potential cost-saving benefits of QUELIMMUNE to the healthcare system in treating critically ill children with acute kidney injury (AKI) at this renowned nephrology conference," said Eric Schlorff, CEO of SeaStar Medical. “QUELIMMUNE is another tool in the arsenal for hospitals to defeat pediatric AKI with sepsis. Sepsis is a big challenge, which is why the Centers for Medicare & Medicaid Services (CMS) developed the SEP-1 protocol and quality metric for hospital systems to perform against.

“Importantly, our findings underscore the opportunity for widespread adoption by hospitals to generate significant cost savings while also saving lives,” he added. “Utilization of QUELIMMUNE is also operationally efficient. It fits directly into existing continual renal replacement therapy (CRRT) circuits.”

The poster, titled Cost Impact of An Immunomodulatory Selective Cytopheretic Device in Pediatrics (SCD-PED) in AKI due to Sepsis (AKI-S), presents an analysis of the Kids’ Inpatient Database (KID) revealing that the hospitalization cost of pediatric patients with AKI requiring CRRT, a majority of whom were septic, was $461,736 per hospitalization, highlighting an exceptionally high financial burden on institutions and the healthcare system. Data from KID and SeaStar Medical’s SCD-PED studies indicate that hospitalization costs were significantly lower for critically ill children with AKI on CRRT who were treated with QUELIMMUNE, a majority of whom were septic, compared with historical average hospital costs for children not treated with QUELIMMUNE. Treatment with QUELIMMUNE results in a projected cost savings of approximately $30,000 per hospitalization principally driven by the lower expected death rate and shorter length of stay versus standard of care.

Additional benefits of QUELIMMUNE included a cost-effective solution for institutions starting at 6 days of QUELIMMUNE therapy, which produced cost neutrality for QUELIMMUNE afforded by the high survival rate of 77% in children ≥10 kg and age ≤22 years with AKI requiring CRRT treated with QUELIMMUNE, versus the control survival rate of approximately 50%. Further, the combined observed outcomes of 0% dialysis dependence at day 60 from the SCD PED-01 and SCD-PED-02 studies illustrate the durability of QUELIMMUNE therapy.  

The SeaStar Medical team has a significant presence at Kidney Week 2024, with a total of four posters being presented by the Company. A second poster describes the mechanistic effects of reducing hyperinflammatory markers in patients with AKI. Additional SeaStar Medical posters that highlight the design of the ongoing NEUTRALIZE-AKI pivotal trial and the upcoming NEUTRALIZE-CRS trial are summarized below:  

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 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 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 amount and timing of future QUELIMMUNE commercial sales; the ability of SeaStar Medical to meet the demand for and the revenue recognition on 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:

Alliance Advisors IR
Jody Cain
(310) 691-7100
Jcain@allianceadvisors.com

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FAQ

What are the cost savings of QUELIMMUNE for pediatric AKI treatment?

QUELIMMUNE is projected to save approximately $30,000 per hospitalization compared to standard care, achieving cost neutrality after 6 days of therapy.

What is the survival rate for children treated with QUELIMMUNE (ICU)?

QUELIMMUNE shows a 77% survival rate in children ≥10 kg and ≤22 years with AKI requiring CRRT, compared to approximately 50% survival rate with standard care.

What clinical trials did SeaStar Medical (ICU) present at ASN Kidney Week 2024?

SeaStar Medical presented four posters, including the NEUTRALIZE-AKI pivotal trial and NEUTRALIZE-CRS trial designs, along with economic analysis of QUELIMMUNE.

SeaStar Medical Holding Corporation

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