Company plans to hold a business update conference call in April

该公司计划在4月份举行一次业务更新电话会议

DENVER, March 12, 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, provides updates on the acute kidney injury (AKI) programs it is developing with its patented, first-to-market, cell-directed Selective Cytopheretic Device (SCD) extracorporeal therapy in critically ill patients with AKI..

丹佛，2024年3月12日（环球通讯社）--SeaStar Medical Holding Corporation（Nasdaq:ICU）是一家商业阶段的医疗器械公司，开发专有解决方案以减少重要器官过度炎症的后果，它提供了关于急性肾损伤（AKI）计划的最新信息，该计划是由其专利的，首次上市的细胞定向选择性细胞凝集装置（SCD）开发的AKI危重患者的体外治疗。。

“We now have 21 subjects enrolled across five clinical sites in our NEUTRALIZE-AKI pivotal clinical trial, which is intended to evaluate the safety and efficacy of our SCD in adult AKI patients. Additional sites are progressing through the site activation and contract completion process,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical.

SeaStar Medical首席医疗官凯文·钟（KevinChung）医学博士说：“在我们的NEUTRATE-AKI关键临床试验中，我们现在有21名受试者在五个临床地点登记，该试验旨在评估SCD在成人AKI患者中的安全性和有效性。其他地点正在通过网站激活和合同完成过程取得进展。”。

“We expect the pace of enrollment will accelerate as more medical centers come onboard. We anticipate conducting an interim analysis once we have reached our 90-day primary endpoint in 100 enrolled subjects, which we expect to reach in the second half of 2024.”.

“我们预计，随着更多医疗中心的加入，入学速度将加快。我们预计，一旦我们在100名注册科目中达到90天的主要终点，我们将进行中期分析，预计将在2024年下半年达到。”。

The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomiZEd clinical trial in Acute Kidney Injury) pivotal 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 continuous kidney replacement therapy (CKRT) as the standard of care, compared with the control group receiving only CKRT standard of care.

NEUTRATE-AKI（通过选择性细胞相干装置使中性粒细胞和单核细胞失活-急性肾损伤的随机临床试验）关键试验预计将招募多达200名成年人。该试验的主要终点是除连续肾脏替代疗法（CKRT）作为护理标准外，接受SCD治疗的患者的90天死亡率或透析依赖性的综合，而对照组仅接受CKRT标准护理。

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.

次要终点包括28天的死亡率，前28天的无ICU天数，第90天的主要不良肾脏事件和一年的透析依赖性。该研究还将包括亚组分析，以探讨SCD治疗对脓毒症和急性呼吸窘迫综合征AKI患者的有效性。

More information on the trial is available here..

有关该试验的更多信息，请参见此处。。

In February 2024 the U.S. Food and Drug Administration (FDA) granted a Humanitarian Device Exemption (HDE) Approval Order to the Quelimmune™ pediatric device for use in children weighing 10 kilograms or more with AKI due to sepsis or a septic condition requiring kidney replacement therapy (KRT).

2024年2月，美国食品和药物管理局（FDA）授予Quelimmune™儿科设备人道主义设备豁免（HDE）批准令，用于因败血症或需要肾脏替代疗法（KRT）的败血症而患有AKI的体重10公斤或以上的儿童。

“Interactions with several key target hospitals are underway with plans to expand the commercial rollout with Nuwellis, Inc. during the second quarter,” said Eric Schlorff, CEO of SeaStar Medical. “As our therapeutic device is approved under an HDE, each hospital is required to secure institutional review board approval prior to purchasing the device for use in patients.

SeaStar Medical首席执行官埃里克·施洛夫（EricSchlorff）表示：“正在与几家重点目标医院进行互动，计划在第二季度扩大与Nuwellis，Inc.的商业推广。”。“由于我们的治疗设备是根据HDE批准的，每家医院在购买设备用于患者之前都需要获得机构审查委员会的批准。

We view Quelimmune as a tremendous win for children with AKI requiring CKRT given clinical results from our AKI pediatric trials that showed a 77% survival rate and no dialysis dependency at 60 days in those subjects, as well as for the healthcare system given the average cost of dialysis for a single patient with AKI who develops chronic kidney disease is about $100,000 annually.”.

鉴于我们的AKI儿科试验的临床结果显示，在这些受试者中，存活率为77%，60天时无透析依赖性，对于需要CKRT的AKI儿童来说，我们认为奎利木穆是一个巨大的胜利，对于医疗保健系统来说，单例患有慢性肾病的AKI患者的平均透析费用每年约为10万美元。”。

SeaStar Medical estimates the eligible population for its Quelimmune pediatric device to be approximately 4,000 children annually with AKI. About 20% of the top 50 children’s hospitals already have direct experience with the SCD. Pediatric patients undergoing treatment with the SCD are expected to require, on average, seven SCD units, with the disposable device being changed once every 24 hours.

SeaStar Medical估计其Quelimmune儿科设备的合格人群每年约有4000名患有AKI的儿童。前50家儿童医院中约有20%已经有SCD的直接经验。接受SCD治疗的儿科患者平均需要7个SCD单元，一次性设备每24小时更换一次。

With the Approval Order, SeaStar Medical can build Quelimmune Clinical Kits into inventory in parallel to the hospital approvals process..

根据批准令，SeaStar Medical可以在医院批准流程的同时将Quelimmune临床试剂盒建立在库存中。。

The FDA’s HDE Approval Order was based on a pooled analysis from two non-controlled studies, SCD-PED-01 (funded by the FDA Office of Orphan Products Development) and SCD-PED-02. These studies showed that pediatric patients weighing ≥10kg with AKI requiring CKRT treated with the Quelimmune pediatric device had no device-related serious adverse events or device-related infections, a 77% survival rate, and no dialysis dependency at Day 60.

FDA的HDE批准令基于两项非对照研究的汇总分析，即SCD-PED-01（由FDA孤儿产品开发办公室资助）和SCD-PED-02。这些研究表明，体重≥10kg且需要使用Quelimmune儿科设备进行CKRT治疗的AKI患儿在第60天没有与设备相关的严重不良事件或设备相关的感染，存活率为77%，并且没有透析依赖性。

The SCD-PED-01 (weight range ≥15 kg) and SCD-PED-02 (weight range ≥10 kg) studies demonstrated 75% and 83% survival rates, respectively..

SCD-PED-01（体重范围≥15 kg）和SCD-PED-02（体重范围≥10 kg）研究分别显示存活率分别为75%和83%。。

SeaStar Medical also announces that its executive management team plans to hold a business update conference call in April to discuss progress with its AKI programs and opportunities in other indications, and to answer questions. Details regarding this call will be made available in the coming weeks..

SeaStar Medical还宣布，其执行管理团队计划于4月举行一次业务更新电话会议，讨论AKI计划的进展和其他适应症的机会，并回答问题。有关此电话的详细信息将在未来几周内提供。。

About Hyperinflammation

关于过度炎症

Hyperinflammation is the overproduction or overactivity of inflammatory cells that can lead to damage of vital organs. It occurs when the body overproduces inflammatory effector cells and other molecules that can be toxic, damaging to vital organs and result in multi-organ failure and even death. This is known as the cytokine storm..

过度炎症是炎症细胞的过度产生或过度活跃，可导致重要器官受损。当身体过度产生炎症效应细胞和其他可能有毒的分子，损害重要器官并导致多器官衰竭甚至死亡时，就会发生这种情况。这被称为细胞因子风暴。。

About The Selective Cytopheretic Device

关于选择性细胞相干器件

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 that causes inflammation, organ failure and possible death in critically ill patients.

选择性细胞粘附装置（SCD）是一种获得专利的细胞定向体外装置，它采用免疫调节技术在CKRT期间选择性靶向促炎性中性粒细胞和单核细胞，并减少高炎症环境，包括导致炎症，器官衰竭和危重病患者可能死亡的细胞因子风暴。

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. The SCD selectively targets the most highly activated proinflammatory neutrophils and monocytes.

与病原体去除和其他血液净化工具不同，SCD与CKRT血液滤过系统整合，以选择性靶向促炎单核细胞并将其转变为修复状态，并促进活化的中性粒细胞减少炎症。SCD选择性靶向活化程度最高的促炎性中性粒细胞和单核细胞。

These cells are then returned back into the body through the blood, and the body is signaled to lower its inflammatory environment and focus on repair. This unique immunomodulation approach may promote long-term organ recovery and eliminate the need for future KRT, including dialysis. Quelimmune is the official brand name for the Selective Cytopheretic Device in pediatrics that has received FDA HDE Approval based on safety and probable efficacy. .

然后，这些细胞通过血液返回体内，并向身体发出信号，以降低其炎症环境并专注于修复。这种独特的免疫调节方法可能会促进长期器官恢复，并消除对未来KRT（包括透析）的需求。Quelimmune是儿科选择性细胞凝集装置的官方品牌，该装置已获得FDA HDE基于安全性和可能有效性的批准。。

About SeaStar Medical

关于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.

SeaStar Medical是一家商业化的医疗技术公司，正在重新定义体外治疗如何减少过度炎症对重要器官的影响。SeaStar Medical的新技术依靠科学和创新为危重病人提供挽救生命的解决方案。

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..

该公司正在开发和商业化细胞导向的体外疗法，其靶向驱动全身炎症的效应细胞，引起直接组织损伤并分泌一系列促炎细胞因子，从而引发和传播不平衡的免疫反应。有关更多信息，请访问www.seastarmedical.com或访问我们的LinkedIn或X。。

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, the SCD’s ability to treat hyperinflammation and the expected results of clinical trials and studies.

本新闻稿包含1955年《私人证券诉讼改革法案》中“安全港”条款含义内的某些前瞻性声明。这些前瞻性陈述包括但不限于SCD治疗过度炎症的能力以及临床试验和研究的预期结果。

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”，“项目”，“期望”，“预期”，“估计”，“打算”，“战略”，“未来”，“机会”，“计划”，“可能”，“应该”，“将”，“将”，“将是”，“将继续”，“将可能产生”等词语以及类似的表达旨在识别此类前瞻性陈述。前瞻性陈述是基于当前预期和假设的关于未来事件的预测、预测和其他陈述，因此会受到可能导致实际结果与预期结果产生重大差异的重大风险和不确定性的影响。

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 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.

这些因素大多不在SeaStar Medical的控制范围内，很难预测。可能导致实际未来事件与预期结果产生重大差异的因素包括但不限于：（i）SeaStar Medical可能无法获得其SCD候选产品的监管批准的风险；（ii）SeaStar Medical可能无法筹集足够资金来资助其运营（包括临床试验）的风险；（iii）SeaStar Medical及其当前和未来合作者无法成功开发和商业化其产品或服务，或在开发和商业化过程中出现重大延误的风险，包括未能获得相关联邦和州监管机构对其产品的批准，（iv）SeaStar Medical可能永远无法实现或维持盈利能力的风险；（v） SeaStar Medical的风险。

Contact:

联系人：

LHA Investor Relations

LHA投资者关系

Jody Cain

乔迪·凯恩

(310) 691-7100

(310) 691-7100

Jcain@lhai.com

Jcain@lhai.com

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