SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company, announced today the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) has approved a reduction in the mandatory enrollment size of the SAVE Surveillance Registry from the originally-required 300 patients to only 50 patients.

海星医疗控股公司（纳斯达克股票代码：ICU），一家处于商业化阶段的医疗保健公司，今天宣布美国食品药品监督管理局 (FDA) 生物制品评估与研究中心 (CBER) 批准将 SAVE 监测注册登记的强制性入组人数从原先要求的 300 名患者减少至仅 50 名患者。

This new 50-patient registry size will satisfy the post-approval surveillance requirement by the FDA as outlined in the original Humanitarian Device Exemption (HDE) approval and indicates that FDA believes that continued device safety can be successfully shown with fewer patients than originally required..

这个新的50名患者登记规模将满足FDA在原人道主义器械豁免（HDE）批准中规定的上市后监测要求，表明FDA认为继续证明器械安全性可以通过比最初要求更少的患者成功实现。

The SAVE Surveillance Registry is a Post-Approval Study (PAS) that is designed to confirm the safety of the QUELIMMUNE therapy, which was approved in 2024 as a treatment for children with acute kidney injury (AKI) and sepsis or a septic condition. To date, data from 32 pediatric patients have been entered into the SAVE Surveillance Registry..

SAVE监测注册中心是一项批准后研究（PAS），旨在确认QUELIMMUNE疗法的安全性，该疗法于2024年被批准用于治疗患有急性肾损伤（AKI）和脓毒症或脓毒病状况的儿童。迄今为止，已有32名儿科患者的数据录入到SAVE监测注册中心。

“We are grateful for this decision by the FDA and believe, once the registry is complete, it will enable us to expand the potential organ-sparing and life-saving benefits of our QUELIMMUNE therapy to more pediatric patients with AKI,” stated Eric Schlorff, CEO of SeaStar Medical. “These kids typically have about a 50% survival rate and our data from the first 21 patients in the SAVE Surveillance Registry showed zero device-related adverse events and a clear improvement to 70% survival at 90 days.

“我们对FDA的这一决定表示感激，并相信一旦登记完成，它将使我们能够将QUELIMMUNE疗法潜在的器官保护和挽救生命的好处扩展到更多患有AKI的儿科患者，”SeaStar Medical首席执行官Eric Schlorff表示。“这些患儿通常的生存率约为50%，而我们在SAVE监测登记中的前21名患者的数据表明，没有任何与设备相关的不良事件，并且90天内存活率明显提高至70%。”

This decision is a win-win for patients, their families, health care providers, and the overall health care system. We thank the FDA for their rapid evaluation of the required enrollment size of the mandatory surveillance requirements for the registry.”.

这一决定对患者、他们的家人、医疗保健提供者以及整个医疗保健系统来说是双赢的。我们感谢 FDA 迅速评估了注册登记所需的强制性监测要求的入组规模。

Preliminary results from the SAVE Surveillance Registry were recently presented at the 5th International Symposium on Acute Kidney Injury in Children. The SAVE Surveillance Registry presentation highlighted the role of QUELIMMUNE (Selective Cytopheretic Device for Pediatrics, or SCD-PED) therapy in the treatment of critically ill pediatric patients with life-threatening Acute Kidney Injury (AKI) and sepsis requiring Renal Replacement Therapy (RRT).

SAVE监测注册中心的初步结果最近在第五届国际儿童急性肾损伤研讨会上公布。SAVE监测注册中心的报告强调了QUELIMMUNE（选择性细胞保护装置，儿科用，或SCD-PED）疗法在治疗危重的患有致命性急性肾损伤（AKI）和需要肾脏替代治疗（RRT）的败血症患儿中的作用。

Data from the first 21 pediatric patients with AKI and sepsis requiring RRT showed zero device-related adverse events or infections and no reports of immunosuppressive effects by the device. In addition, outcomes analyses show a 76% survival rate at Day 28 and Day 60, and a 71% survival rate at Day 90.

最初21名患有AKI和脓毒症需要RRT的儿科患者数据显示，设备相关不良事件或感染为零，且无设备导致免疫抑制效果的报告。此外，结果分析显示第28天和第60天的生存率为76%，第90天的生存率为71%。

These new data are on track to validate a 50% reduction in loss of life compared to historical data, as reported in Kidney Medicine..

这些新数据有望验证与历史数据相比，生命损失减少了50%，正如《肾脏医学》所报道的那样。

“The SAVE Surveillance Registry has provided valuable clinical outcomes data on both the safety and efficacy of our QUELIMMUNE therapy, but it has also slowed the adoption process and potential to treat these pediatric patients due to the complexities of setting up and running a patient registry at these medical institutions,” stated Tim Varacek, Senior Vice President, Commercial and Business Operations.

“SAVE 监管登记处为我们的QUELIMMUNE 疗法的安全性和有效性提供了宝贵的临床结果数据，但由于在这些医疗机构建立和运行患者登记处的复杂性，这也减缓了采用过程和治疗这些儿科患者的潜力，”商业和业务运营高级副总裁Tim Varacek表示。

“There has been very strong interest in QUELIMMUNE adoption and we are pleased that we can satisfy FDA’s registry requirements with far fewer patients than expected, enabling a smoother adoption process and potentially expanding the revenue opportunity to capture a larger portion of the total pediatric AKI market which we estimate to be about $100 million in the U.S.

“市场对QUELIMMUNE的采用表现出非常强烈的兴趣，我们很高兴能够以比预期少得多的患者数量满足FDA的注册要求，从而使采用过程更加顺利，并有可能扩大收入机会，以占据更大的小儿AKI市场份额。我们估计美国的这一市场总值约为1亿美元。”

alone.”.

独自一人。”

The QUELIMMUNE therapy has been adopted by some of the highest rated children’s medical centers in the United States. The patented technology behind QUELIMMUNE is known as the Selective Cytopheretic Device (SCD) therapy and has broad applications for treating the destructive hyperinflammation that shuts down organ function and causes loss of life..

QUELIMMUNE 疗法已被美国一些评价最高的儿童医疗中心采用。QUELIMMUNE 背后的专利技术被称为选择性细胞捕获装置（SCD）疗法，具有广泛的应用，可以治疗导致器官功能衰竭和生命丧失的破坏性过度炎症。

About Acute Kidney Injury (AKI) and Hyperinflammation

关于急性肾损伤（AKI）和过度炎症

AKI is characterized by a sudden and temporary loss of kidney function and can be caused by a variety of conditions such as sepsis, severe trauma, surgery, and COVID-19. AKI can cause destructive hyperinflammation, which is the overproduction or overactivity of inflammatory effector cells and other molecules that can be toxic.

急性肾损伤的特点是肾功能突然且暂时性的丧失，可能由多种情况引起，如脓毒症、严重创伤、手术和新冠肺炎。急性肾损伤可导致破坏性的过度炎症，即炎症效应细胞和其他分子的过度产生或过度活跃可能产生毒性。

Damage resulting from this destructive 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 complications including chronic kidney disease or end-stage renal disease (ESRD) requiring dialysis.

急性肾损伤（AKI）中由这种破坏性过度炎症引发的损害可能扩展至其他器官，如心脏或肝脏，并可能导致多器官功能障碍甚至衰竭，从而带来更严重的后果，包括死亡风险的增加。即使在病情缓解后，这些患者仍可能面临并发症，包括慢性肾病或需要透析的终末期肾病（ESRD）。

Extreme hyperinflammation may also contribute to added healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation..

极端的过度炎症也可能导致医疗成本的增加，例如重症监护室（ICU）住院时间延长、对透析和机械通气的依赖增加。

About QUELIMMUNE

关于QUELIMMUNE

The QUELIMMUNE™ therapy is being commercialized for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are on antibiotics and being treated in the ICU with Renal Replacement Therapy (RRT). It was approved in February 2024 under a HDE application that requires medical institutions to also participate in the SAVE Surveillance Registry and complete Institutional Review Board approvals prior to adoption and use of the QUELIMMUNE therapy.

QUELIMMUNE™ 疗法正在商业化，用于体重在10公斤或以上的患有急性肾损伤（AKI）和脓毒症或脓毒性状况的儿童，这些患者正在使用抗生素并在重症监护室（ICU）接受肾脏替代治疗（RRT）。该疗法于2024年2月通过人道主义设备豁免（HDE）申请获批，要求医疗机构在采用和使用QUELIMMUNE™ 疗法之前，还需参与SAVE监测登记系统并完成机构审查委员会的批准。

This prolongs the adoption timeline by medical institutions, but provides important data on the use of QUELIMMUNE in the “real-world” setting..

这延长了医疗机构的采用时间线，但提供了在“真实世界”环境中使用 QUELIMMUNE 的重要数据。

Data from two clinical studies of the QUELIMMUNE therapy, published in Kidney Medicine, showed a 77% survival rate in patient treated with QUELIMMUNE versus standard of care, representing an approximate 50% reduction in loss of life compared to historical data in this patient population. No dialysis was required for survivors and 87.5% of survivors had normal kidney function at Day 60 after ICU discharge.

发表在《肾脏医学》上的两项关于QUELIMMUNE疗法的临床研究数据显示，接受QUELIMMUNE治疗的患者生存率为77%，而标准治疗的生存率较低，与该患者群体的历史数据相比，生命损失减少了约50%。幸存者无需进行透析，87.5%的幸存者在重症监护室出院后第60天肾功能正常。

Recent data presented from the first 21 patients in the SAVE Surveillance Registry mirror the clinical trial results..

SAVE 监测注册中心前 21 名患者的数据与临床试验结果相似。

In January 2025, SeaStar Medical was awarded the 2025 Corporate Innovator Award by the National Kidney Foundation for its significant contribution to improving the lives of pediatric patients with AKI based on the approval and introduction of the QUELIMMUNE therapy.

2025年1月，SeaStar Medical因在基于QUELIMMUNE疗法的批准与推广方面为改善急性肾损伤（AKI）儿科患者生活做出重要贡献，被国家肾脏基金会授予2025年度企业创新奖。

About the NEUTRALIZE-AKI Pivotal Trial

关于NEUTRALIZE-AKI关键试验

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 the SCD therapy in 200 adults with AKI in the ICU receiving CRRT. The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with the SCD therapy in addition to CRRT as the standard of care, compared with the control group receiving only CRRT standard of care.

NEUTRALIZE-AKI（通过选择性细胞吸附装置实现中性粒细胞和单核细胞失活——急性肾损伤中的随机临床试验）关键试验正在评估SCD疗法在ICU接受连续性肾脏替代治疗（CRRT）的200名急性肾损伤（AKI）成人患者中的安全性和有效性。该试验的主要终点是，与仅接受CRRT标准治疗的对照组相比，接受SCD疗法联合CRRT标准治疗的患者在90天死亡率或透析依赖性上的复合指标。

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 the SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome. .

次要终点包括 28 天的死亡率、前 28 天内无 ICU 的天数、第 90 天的主要肾脏不良事件以及一年时的透析依赖性。该研究还将包括亚组分析，以探索 SCD 治疗在脓毒症和急性呼吸窘迫综合征的 AKI 患者中的有效性。

About the SeaStar Medical Selective Cytopheretic Device Therapy

关于SeaStar Medical选择性细胞治疗装置疗法

The Selective Cytopheretic Device (SCD) therapy is designed as a disease-modifying device that neutralizes over-active immune cells and stops the cytokine storm that yields destructive hyperinflammation and creates a cascade of events that wreak havoc in the patient’s body. The SCD therapy has broad applications in multiple acute and chronic kidney and cardiovascular diseases, representing patients who today have no FDA-approved options for treating their disease.

选择性细胞治疗装置（SCD）被设计为一种疾病修饰装置，能够中和过度活跃的免疫细胞，阻止导致破坏性过度炎症的细胞因子风暴，并防止一系列对患者身体造成严重损害的连锁反应。SCD疗法在多种急性和慢性肾病及心血管疾病中具有广泛的应用，代表了目前尚无FDA批准治疗方案的患者群体。

Unlike pathogen removal and other blood-purification tools, the SCD therapy is integrated with an existing CRRT hemofiltration system 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, eliminate the need for future RRT, including dialysis, and prevent loss of life..

与病原体清除和其他血液净化工具不同，SCD 疗法整合到现有的连续性肾脏替代治疗（CRRT）血液过滤系统中，能够选择性地靶向并将促炎性单核细胞转化为修复状态，同时促使活化的中性粒细胞降低炎症性。这种独特的免疫调节方法可能促进器官的长期恢复，消除未来对包括透析在内的肾脏替代治疗（RRT）的需求，并防止生命损失。

About SeaStar Medical

关于SeaStar Medical

SeaStar Medical is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life. SeaStar’s first commercial product, QUELIMMUNE (SCD-PED), was approved in 2024 by the U.S. Food and Drug Administration (FDA). It is the only FDA approved product for the ultra-rare condition of life-threatening acute kidney injury (AKI) due to sepsis or a septic condition in critically ill pediatric patients.

SeaStar Medical是一家处于商业化阶段的医疗保健公司，专注于为面临器官衰竭和生命威胁的重症患者提供变革性治疗。SeaStar的首个商业化产品QUELIMMUNE（SCD-PED）于2024年获得美国食品药品监督管理局（FDA）批准。这是唯一获FDA批准用于治疗因脓毒症或败血状态导致危及生命的急性肾损伤（AKI）的超罕见病症的产品，专门针对重症儿科患者。

SeaStar’s Selective Cytopheretic Device (SCD) therapy has been awarded Breakthrough Device Designation for six therapeutic indications by the FDA, enabling the potential for a speedier pathway to approval and preferable reimbursement dynamics at commercial launch. The company is currently conducting a pivotal trial of its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy (CRRT), a life-threatening condition with no effective treatment options that impacts over 200,000 adults in the U.S.

SeaStar公司的选择性细胞保护装置（SCD）疗法已被FDA授予突破性设备称号，涵盖六种治疗适应症，这使得该疗法在审批过程中可能享有更快的通道，并在商业上市时获得更优的报销机制。该公司目前正在对需要连续肾脏替代治疗（CRRT）的成年急性肾损伤（AKI）患者进行SCD疗法的关键试验，这是一种危及生命的疾病，目前尚无有效治疗方案，仅在美国就影响超过20万名成年人。

annually..

每年。

For more information visit www.seastarmedical.com or visit us on LinkedIn or X.

有关更多信息，请访问 www.seastarmedical.com 或在 LinkedIn 或 X 上访问我们。

Forward-Looking Statements

前瞻性声明

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 anticipated adoption our products; anticipated cost savings for patients, healthcare providers, and the healthcare system more generally from the adoption of the SCD therapy; the total addressable market for pediatric SCD applications; the ability of SeaStar Medical to increase market share and generate sales with respect to the total addressable market for pediatric SCD applications; 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.

本新闻稿包含某些前瞻性陈述，这些陈述符合1955年《私人证券诉讼改革法案》中“安全港”条款的含义。这些前瞻性陈述包括但不限于SeaStar Medical对以下方面的预期：我们产品的预期采用情况；采用SCD疗法为患者、医疗服务提供者以及更广泛的医疗系统带来的预期成本节约；儿科SCD应用的总可寻址市场；SeaStar Medical增加市场份额并在儿科SCD应用的总可寻址市场中产生销售的能力；SCD治疗急性肾损伤（AKI）及其他疾病的能力；预期的监管审批流程和商业化时间表；以及SeaStar Medical满足预期时间表的能力。

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.

诸如“相信”、“预测”、“预期”、“设想”、“估计”、“打算”、“战略”、“未来”、“机会”、“计划”、“可能”、“应该”、“将要”、“将会”、“将继续”、“很可能会导致”等词语旨在识别这些前瞻性陈述。前瞻性陈述是对未来事件的预测、推测和其他基于当前预期和假设的陈述，因此，受重大风险和不确定性的制约，可能导致实际结果与预期结果存在重大差异。

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 candidat.

大多数这些因素都是SeaStar Medical无法控制的，而且难以预测。可能导致实际未来事件与预期结果存在重大差异的因素包括但不限于：(i) SeaStar Medical可能无法获得其SCD产品候选的监管批准的风险。

Contact:

联系人：

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Source: globenewswire.com

来源：globenewswire.com