LAKE ZURICH, Ill.--(

伊利诺伊州苏黎世湖--(

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)--Fresenius Kabi, an operating company of Fresenius, specializing in lifesaving medicines and technologies, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Adaptive Nomogram - an alternate algorithm that will be available in the Aurora Xi Plasmapheresis System - designed to optimize plasma collection efficiency..

)--费森尤斯（Fresenius）旗下一家专门从事救生药物和技术的运营公司费森尤斯·卡比（Fresenius Kabi）今天宣布，美国食品和药物管理局（FDA）已批准其自适应列线图510（k）许可证，这是一种可用于极光Xi血浆分离系统的替代算法，旨在优化血浆采集效率。。

The newly cleared Adaptive Nomogram considers each donor’s individual characteristics in calculating the volume of plasma to collect, enabling an average 11.5%

新清除的自适应列线图在计算血浆收集量时考虑了每个供体的个体特征，平均达到11.5%

increase in plasma collection per donation while maintaining safe and effective operation. The Aurora Xi Plasmapheresis System

在保持安全有效运行的同时，增加每次捐赠的血浆采集量。Aurora Xi血浆分离系统

now benefits from enhanced capabilities that allow plasma centers to improve collection efficiency and support a greater supply of plasma-derived therapies.

现在受益于增强的功能，使血浆中心能够提高收集效率并支持更多的血浆衍生疗法。

“This FDA clearance marks a significant step forward for Fresenius Kabi in advancing the efficiency and sustainability of plasma collection,” said Dr. Christian Hauer, President, MedTech at Fresenius Kabi. 'The Adaptive Nomogram represents a breakthrough in donor experience innovation, leveraging donor data to deliver one of the most personalized and optimized plasma collection processes available today.'.

“FDA的批准标志着费森尤斯·卡比在提高血浆采集效率和可持续性方面迈出了重要的一步，”费森尤斯·卡比医学技术总裁克里斯蒂安·豪尔博士说。“自适应列线图代表了捐赠者体验创新的突破，利用捐赠者数据提供当今最个性化和优化的血浆采集过程之一。”。

The 510(k) clearance was supported by a multicenter, prospective randomized controlled clinical trial, conducted to evaluate the Adaptive Nomogram in Aurora Xi Software Version 2.0 as compared to Aurora Xi with the existing Optimized Nomogram. The trial entailed more than 52,400 procedures at three of Takeda’s BioLife Plasma donation centers.

510（k）清除率得到了一项多中心前瞻性随机对照临床试验的支持，该试验旨在评估Aurora Xi软件2.0版中的自适应列线图，与现有优化列线图的Aurora Xi相比。该试验需要在武田的三个生物生命血浆捐赠中心进行52400多次手术。

The primary endpoint - to demonstrate that the overall rate of significant hypotensive adverse events (SHAEs, IQPP DAE Classification 1.2-1.6) in donors using the Aurora Xi Adaptive Nomogram algorithm was less than double the SHAE rate in donors using the Aurora Xi Optimized Nomogram algorithm - was met.

主要终点-证明使用Aurora Xi自适应列线图算法的供体中显着低血压不良事件（SHAE，IQPP DAE分类1.2-1.6）的总体发生率低于使用Aurora Xi优化列线图算法的供体中SHAE发生率的两倍-得到满足。

The trial also demonstrated that the Adaptive Nomogram increased the volume of plasma collected per completed donation by an average of 88.0 mL (11.5%, plasma without anticoagulant) while increasing procedure time an average of 3 minutes 37 seconds (9.7%)..

该试验还表明，自适应列线图使每次完成捐赠的血浆收集量平均增加了88.0 mL（11.5%，血浆无抗凝剂），同时使手术时间平均增加了3分37秒（9.7%）。。

“This new Adaptive Nomogram will help us personalize each plasma donation and improve our efficiency, while our organization continues to safeguard the health of our donors,' said Hema Tallman, Global Head of BioLife Plasma Services at Takeda. 'We were grateful for the opportunity to collaborate with Fresenius Kabi on the clinical trial, and we look forward to being the first company to introduce it in our plasma donation centers in the coming months.'.

武田生物生命血浆服务全球负责人赫玛·塔尔曼（Hema Tallman）说：“这种新的自适应列线图将帮助我们个性化每一次血浆捐赠，提高我们的效率，同时我们的组织将继续保护捐赠者的健康。我们很感谢有机会与费森尤斯·卡比（Fresenius Kabi）合作进行临床试验，我们期待着在未来几个月成为第一家将其引入我们血浆捐赠中心的公司。”。

Plasma-derived therapies are essential for treating a wide range of conditions, including immune deficiencies, bleeding disorders, and neurological diseases. By increasing plasma collection efficiency, Fresenius Kabi reinforces its commitment to improving access to these critical therapies while supporting the global plasma supply chain..

血浆衍生疗法对于治疗多种疾病至关重要，包括免疫缺陷，出血性疾病和神经系统疾病。通过提高血浆采集效率，费森尤斯·卡比（Fresenius Kabi）加强了其在支持全球血浆供应链的同时改善获得这些关键疗法的承诺。。

“The approval of the Adaptive Nomogram testifies to Fresenius Kabi’s dedication to continuous innovation in the field of apheresis,” said Bryan Blickhan, Executive Vice President, MedTech R&D at Fresenius Kabi. “We remain focused on providing state-of-the-art solutions that enable plasma centers to help improve outcomes for both donors and patients.”.

费森尤斯·卡比（Fresenius Kabi）医学技术研发执行副总裁布莱恩·布利坎（BryanBlickhan）表示：“自适应列线图的批准证明了费森尤斯·卡比（Fresenius Kabi）致力于在单采领域不断创新。我们仍然专注于提供最先进的解决方案，使血浆中心能够帮助改善捐赠者和患者的预后。”。

Key Facts About the Adaptive Nomogram with Aurora Xi

关于Aurora Xi自适应列线图的关键事实

Increased Plasma Yield – Enables the collection of an average of 11.5% more plasma per donation, supporting higher production of plasma derived therapies.

提高血浆产量–使每次捐赠的血浆平均多收集11.5%，从而支持血浆衍生疗法的更高产量。

Maintained Donor Safety – The nomogram adjusts collection parameters based on individual donor characteristics, to provide a safe and comfortable experience.

保持捐赠者的安全性-列线图根据个体捐赠者的特征调整采集参数，以提供安全舒适的体验。

The Adaptive Nomogram will debut in Takeda’s BioLife plasma donation centers in the United States.

自适应列线图将在美国武田生物生命血浆捐赠中心首次亮相。

About The Aurora Xi Plasmapheresis System

关于Aurora Xi血浆置换系统

The Aurora Xi Plasmapheresis System, consisting of the Aurora Xi instrument (hardware and software) and a Plasmacell Xi disposable set, is an automated plasmapheresis system intended for source plasma collection. Whole blood is drawn from the donor and plasma is separated from concentrated cells using a rapidly rotating separator (membrane filter).

Aurora Xi血浆置换系统由Aurora Xi仪器（硬件和软件）和Plasmacell Xi一次性套件组成，是一种用于源血浆采集的自动血浆置换系统。从供体中抽取全血，并使用快速旋转的分离器（膜过滤器）将血浆与浓缩细胞分离。

The plasma is collected in a collection container and residual cellular components are then returned to the donor..

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Source Plasma Collection

源血浆采集

Source plasma collection is a process in which human plasma is obtained directly from donors, typically through a procedure called plasmapheresis. This plasma is crucial for creating plasma-based therapies used to treat immune deficiencies, blood disorders, and other medical conditions.

来源血浆采集是直接从供体获得人血浆的过程，通常通过称为血浆置换术的程序。这种血浆对于创建用于治疗免疫缺陷，血液疾病和其他医疗状况的基于血浆的疗法至关重要。

About Fresenius Kabi

关于费森尤斯·卡比

As a global health care company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of patients with critical and chronic conditions. With more than 43,000 employees and present in more than 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies..

。该公司的产品、技术和服务用于治疗和护理危重和慢性病患者。费森尤斯·卡比（Fresenius Kabi）拥有43000多名员工，分布在100多个国家，其庞大的产品组合专注于提供高质量和救生药物和技术。。

In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status – notably as the only corporation offering both product groups.

在生物制药领域，费森尤斯·卡比为自身免疫性疾病和肿瘤学提供了尖端的生物仿制药。凭借在临床营养领域的领先市场地位，广泛的肠内和肠外产品组合对患者的营养状况产生了明显的影响，尤其是作为唯一一家同时提供这两种产品的公司。

In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is a global leader in supplying blood collection bags and devices, supporting blood banks and health care facilities worldwide. The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care..

在MedTech，该公司提供重要的输液泵、细胞和基因治疗设备、一次性用品等。费森尤斯·卡比（Fresenius Kabi）是全球领先的采血袋和设备供应商，为全球血库和医疗保健设施提供支持。该公司的静脉注射仿制药和输液疗法每年在急诊医学、外科、肿瘤学和重症监护领域帮助挽救数百万人的生命。。

Fresenius Kabi takes a holistic approach to health care and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of almost 450 million patients annually. With Vision 2026, as part of the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of health care..

费森尤斯·卡比（Fresenius Kabi）采用整体的医疗保健方法，独特地结合了经验、专业知识、创新和奉献精神，每年为近4.5亿患者的生活带来改变。凭借2026年愿景，作为#FutureFresenius战略的一部分，该公司正在开发、生产和销售新产品和技术，并渴望扩大其作为全球领先治疗供应商的地位，改善患者护理，为利益相关者创造可持续价值，塑造医疗保健的未来。。

Fresenius Kabi is an operating company of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing health care solutions on a global scale.

费森尤斯·卡比（Fresenius Kabi）是费森尤斯集团（Fresenius Group）的一家运营公司，该集团与赫利奥斯（Helios）和基罗·萨路德（Quirónsalud）一起成立于1912年。作为一个团队，费森尤斯集团的公司致力于在全球范围内提供救生和改变生命的医疗保健解决方案。

For more information, please visit

有关更多信息，请访问

www.fresenius-kabi.com

www.fresenius-kabi.com

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This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing.

本版本包含前瞻性声明，这些声明会受到各种风险和不确定性的影响。由于某些因素，例如业务、经济和竞争条件的变化、监管改革、临床试验结果、汇率波动、诉讼或调查程序的不确定性以及融资的可用性，未来的结果可能与这些前瞻性声明中描述的结果存在重大差异。

Fresenius Kabi does not undertake any responsibility to update the forward-looking statements in this release..

费森尤斯·卡比不承担更新本版本中前瞻性声明的任何责任。。