CytoSorbents更新了 DrugSorb-ATR在美国 FDA的监管状态-动脉网

CytoSorbents Updates U.S. FDA Regulatory Status of DrugSorb-ATR

CISION 等信源发布 2025-08-20 19:00

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FDA appeal decision found no issues with DrugSorb-ATR device safety but upheld the De Novo denial, and proposes a potential path forward for market authorization

FDA上诉决定未发现DrugSorb-ATR设备安全性存在问题，但维持了De Novo拒绝，并提出了获得市场授权的潜在路径。

PRINCETON, N.J.

普林斯顿，新泽西州

，

Aug. 20, 2025

2025年8月20日

/PRNewswire/ --

CytoSorbents Corporation

CytoSorbents公司

(NASDAQ:

（纳斯达克：

CTSO

), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, updates the regulatory status of its appeal with the U.S. Food and Drug Administration (FDA) for De Novo market authorization of DrugSorb™-ATR.

），一家在重症监护室和心脏手术中使用血液净化治疗危及生命状况的领导者，更新了其就DrugSorb™-ATR向美国食品药品监督管理局（FDA）申请De Novo市场授权的监管状态。

在

August 14, 2025

2025年8月14日

, the Company received an FDA appeal decision following its

，公司收到了FDA的上诉决定，随后

July 2025

2025年7月

in-person supervisory administrative review (appeal) meeting with FDA under 21 CFR 10.75. The appeal was in response to an

与FDA根据21 CFR 10.75进行的面对面监督行政审查（上诉）会议。该上诉是对某个问题的回应。

April 25, 2025

2025年4月25日

FDA denial letter of the Company's De Novo application for DrugSorb-ATR. In the appeal decision, the FDA found no issues with device safety but upheld its prior De Novo denial decision citing the need for additional information to support the Company's desired label indication for this FDA Breakthrough Device.

FDA拒绝了公司关于DrugSorb-ATR的De Novo申请。在上诉决定中，FDA认为设备安全性没有问题，但维持了此前拒绝De Novo申请的决定，理由是需要更多资料来支持公司对该FDA突破性设备所期望的标签适应症。

The FDA proactively proposed a potential path forward for market authorization of DrugSorb-ATR and the Company continues interactive discussions with the Agency to seek further clarity on this proposal. The FDA also noted another avenue for appeal to a higher level within the FDA, specifically with the Director of the FDA's Center for Devices and Radiologic Health (CDRH), that must be filed within 30 days of the appeal decision, which the Company is currently evaluating. .

美国食品药品监督管理局（FDA）主动提出了DrugSorb-ATR市场授权的潜在路径，公司继续与该机构进行互动讨论，以寻求对该提案的进一步澄清。FDA还指出另一条上诉途径，即向FDA更高层提出申诉，特别是向FDA设备和放射健康中心（CDRH）主任提出，必须在上诉决定后的30天内提交，公司目前正在评估这一选项。

'The path to FDA approval frequently involves sequential, collaborative discussions with the Agency to address issues that arise during the review process,' stated Dr.

“获得FDA批准的路径通常涉及与该机构进行顺序的、合作性的讨论，以解决审查过程中出现的问题，”博士说道。

Phillip Chan

菲利普·陈

, Chief Executive Officer of CytoSorbents. 'Although we are disappointed that the denial decision was upheld, we believe significant progress has been made with the resolution of the majority of outstanding issues previously raised by the FDA. Importantly, we have affirmed no issues of device safety on which the De Novo standard of a favorable benefit-to-risk profile is established. We appreciate the Agency's offer to find a path forward to market authorization that we plan to discuss with them further. We remain committed to continuing our collaborative interaction with the FDA to bring DrugSorb-ATR, an FDA Breakthrough Device, to the tens of thousands of heart attack patients in the U.S.

CytoSorbents首席执行官表示：“尽管我们对否决决定得以维持感到失望，但我们认为在解决FDA先前提出的大部分未决问题方面已取得重大进展。重要的是，我们确认在设备安全性方面没有任何问题，这是建立有利的收益风险比的De Novo标准的基础。我们感谢该机构提出寻找通往市场授权的路径，我们计划与他们进一步讨论。我们仍然致力于继续与FDA保持合作互动，以将FDA突破性设备DrugSorb-ATR带给美国数万名心脏病发作患者。”

each year who require urgent coronary artery bypass graft (CABG) surgery on ticagrelor. Today, these patients in the U.S. are either forced to delay their needed CABG surgery by many days while still having a heart attack, or face severe and potentially life-threatening perioperative bleeding. Given the millions of people around the world on blood thinners, perioperative bleeding represents an increasingly common and vexing problem for surgeons and their patients, each with a growing compendium of disaster stories.

每年都有需要在服用替卡格雷期间进行紧急冠状动脉搭桥术（CABG）的患者。如今，这些美国患者要么在心脏病发作时被迫延迟数天接受所需的CABG手术，要么面临严重且可能危及生命的围手术期出血。鉴于全球有数百万人在使用抗凝药物，围手术期出血对外科医生及其患者来说，正成为一个日益普遍且棘手的问题，相关的灾难性案例也越来越多。

All of us unfortunately know a colleague, friend, spouse, parent, or other loved one on a blood thinner who has either faced or may face this risk of catastrophic bleeding. Our technology is being used around the world to address this risk, and our goal is to bring this important therapy to U.S. and Canadian surgeons and patients here at home.' .

不幸的是，我们所有人都认识一位正在使用血液稀释剂的同事、朋友、配偶、父母或其他亲人，他们要么已经面临，要么可能面临大出血的风险。我们的技术正在世界各地被用来应对这一风险，我们的目标是将这一重要的治疗方法带给美国和加拿大的外科医生及患者。

About CytoSorbents Corporation (NASDAQ:

关于CytoSorbents公司（纳斯达克：

CTSO

)

CytoSorbents Corporation

CytoSorbents公司

is a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery through blood purification. CytoSorbents' proprietary blood purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption.

是通过血液净化治疗重症监护病房和心脏手术中危及生命的病症的领导者。CytoSorbents 的专有血液净化技术基于生物相容性、高孔隙率的聚合物微珠，这些微珠可以通过孔隙捕获和表面吸附来主动去除血液和其他体液中的有毒物质。

Cartridges filled with these beads can be used with standard blood pumps already found in hospitals (e.g. dialysis, continuous renal replacement therapy or CRRT, extracorporeal membrane oxygenation or ECMO, and heart-lung machines), where blood is repeatedly recirculated outside the body, through our cartridges where toxic substances are removed, and then back into the body. CytoSorbents' technologies are used in a number of broad applications. Specifically, two important applications are 1) the removal of blood thinners during and after cardiothoracic surgery to reduce the risk of severe bleeding, and 2) the removal of inflammatory agents and toxins in common critical illnesses that can lead to massive inflammation, organ failure, and patient death.

装有这些微珠的滤芯可以与医院现有的标准血液泵（例如透析、连续性肾脏替代治疗或CRRT、体外膜氧合或ECMO以及心肺机）配合使用，通过这些设备将血液反复在体外循环，流经我们的滤芯以去除有毒物质，然后再回到体内。CytoSorbents的技术被应用于许多广泛的领域。具体来说，两个重要的应用是：1）在心胸外科手术期间和术后去除血液稀释剂，以降低严重出血的风险；2）在常见的重症疾病中去除炎症介质和毒素，这些疾病可能导致严重的炎症、器官衰竭甚至患者死亡。

The breadth of these critical illnesses includes, for example, sepsis, burn injury, trauma, lung injury, liver failure, cytokine release syndrome, and pancreatitis, as well as the removal of liver toxins that accumulate in acute liver dysfunction or failure, and the removal of myoglobin in severe rhabdomyolysis that can otherwise lead to renal failure. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments..

这些危重疾病的广度包括，例如，脓毒症、烧伤、创伤、肺损伤、肝衰竭、细胞因子释放综合征和胰腺炎，以及去除在急性肝功能障碍或衰竭中积累的肝毒素，以及在严重横纹肌溶解中去除肌红蛋白，否则可能导致肾衰竭。在这些疾病中，死亡风险可能极高，且有效治疗方法很少（如果有的话）。

CytoSorbents' lead product,

Cytosorbents的主打产品，

CytoSorb

, is approved in the European Union and distributed in over 70 countries worldwide, with nearly 300,000 devices used cumulatively to date. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for .

，在欧盟获得批准，并在全球超过70个国家销售，迄今累计使用近30万台设备。CytoSorb最初在欧盟以CE标志推出，是首个细胞因子吸附器。随后获得了额外的CE标志扩展，分别用于肝病和创伤等临床条件下的胆红素和肌红蛋白去除，以及。

ticagrelor

替格瑞洛

and

和

rivaroxaban

利伐沙班

removal in cardiothoracic surgery procedures. CytoSorb has also received

在心胸外科手术过程中去除。CytoSorb也已经获得

FDA Emergency Use Authorization

FDA紧急使用授权

in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. CytoSorb is not yet approved or cleared in the United States.

在美国，用于治疗即将面临或已确诊呼吸衰竭的成年重症新冠肺炎患者。CytoSorb尚未在美国获得批准或 clearance。

In the U.S. and Canada, CytoSorbents is developing the DrugSorb™-ATR antithrombotic removal system, an investigational device based on an equivalent polymer technology to CytoSorb, to reduce the severity of perioperative bleeding in high-risk surgery due to blood thinning drugs. It has received two .

在美国和加拿大，CytoSorbents 正在开发 DrugSorb™-ATR 抗凝血去除系统，这是一种基于与 CytoSorb 相同聚合物技术的研究性设备，旨在减轻因血液稀释药物引起的高危手术围手术期出血的严重程度。该系统已获得两项批准。

FDA Breakthrough Device Designations

FDA突破性医疗器械认定

: one for the removal of

：一个为了去除

ticagrelor

替格瑞洛

and another for the removal of the

另一个用于移除

direct oral anticoagulants (DOAC) apixaban and rivaroxaban

直接口服抗凝药（DOAC）阿哌沙班和利伐沙班

in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. In September 2024, the Company

在紧急心胸手术过程中的心肺旁路回路。2024年9月，公司

submitted a De Novo Request to the U.S. FDA

向美国FDA提交了De Novo申请

requesting marketing approval to reduce the severity of perioperative bleeding in CABG patients on the antithrombotic drug ticagrelor, which was

请求批准用于减少接受抗血栓药物替卡格雷治疗的CABG患者围手术期出血的严重程度，该药物

accepted for substantive review in October 2024

2024年10月接受实质审查

. On April 25, 2025, the FDA issued a denial letter regarding the Company's De Novo Request for DrugSorb-ATR, identifying remaining deficiencies that must be addressed before the De Novo Request can be granted, and the device can be authorized for commercialization in the U.S. In

2025年4月25日，FDA就公司提交的DrugSorb-ATR的De Novo申请发布了一封拒绝信，指出在De Novo申请获得批准及该设备在美国被授权商业化之前，仍需解决的缺陷问题。

July 2025

2025年7月

, the Company had an in-person administrative appeal meeting with FDA under 21 CFR 10.75. The appeal hearing included FDA senior leadership and review team, Company management, its FDA regulatory counsel, and its external cardiac surgical experts. On

公司根据《美国联邦法规》第21章10.75条与FDA进行了面对面的行政上诉会议。上诉听证会包括FDA高级领导和审查团队、公司管理层、其FDA法规顾问以及外部心脏外科专家。

August 14, 2025

2025年8月14日

, the FDA issued a response to the Company's appeal that found no issues with device safety but upheld its prior De Novo denial decision citing the need for additional information to support the Company's desired label indication for this FDA Breakthrough Device. FDA proactively proposed a potential path forward for market authorization of DrugSorb-ATR and the Company continues interactive discussions with the Agency to seek further clarity on this proposal. The FDA also noted another avenue for appeal to a higher level within the FDA, specifically with the Director of the FDA's Center for Devices and Radiologic Health (CDRH) that must be filed within 30 days of the appeal decision, which the Company is currently evaluating..

，FDA 对公司上诉的回应指出，设备安全性没有问题，但维持了之前的 De Novo 拒绝决定，理由是需要更多资料来支持公司对该 FDA 突破性设备的预期标签适应症。FDA 主动提出了一条潜在的市场授权路径给 DrugSorb-ATR，公司也正与 FDA 保持互动讨论，以进一步明确该提议的具体内容。FDA 还提到了另一条上诉途径，即向 FDA 内更高级别的官员——具体为 FDA 设备和放射健康中心 (CDRH) 主任提出申诉，该申诉必须在上诉决定后的 30 天内提交，公司目前正在评估这一选项。

In November 2024, the Company received its MDSAP

2024年11月，公司收到了其MDSAP

certification and submitted its Medical Device License (MDL) application to Health Canada

认证并提交其医疗器械许可证（MDL）申请至加拿大卫生部

. On June 26, 2025, Health Canada issued a Notice of Refusal of the Company's Medical Device License application, identifying remaining deficiencies that must be addressed before the application may be granted and the device authorized for commercialization. As part of Health Canada's prescribed reconsideration process, and after discussions with Health Canada, the Company has filed a Level 1 'Request for Reconsideration' and with agreement from the Medical Devices Directorate Bureau Director, will pursue the review following the completion of the Company's review with the U.S. FDA. .

2025年6月26日，加拿大卫生部发布了一份拒绝公司医疗器械许可证申请的通知，指出了在申请获得批准及设备获准商业化之前必须解决的剩余缺陷。作为加拿大卫生部规定的复审程序的一部分，并在与加拿大卫生部讨论后，公司已提交了第一级“复审请求”，并在医疗器械局主任的同意下，将在公司完成与美国FDA的审查后继续进行审查。

DrugSorb-ATR is not yet granted or approved in either

DrugSorb-ATR 尚未在任何地方获得授权或许可。

the United States

美国

或

Canada

加拿大

。

The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, ContrastSorb, and others..

公司拥有众多基于这种独特的血液净化技术的已上市产品和在研产品，该技术受到许多已颁发的美国和国际专利以及注册商标的保护，并且还有多项专利申请正在审批中，包括ECOS-300CY®、CytoSorb-XL™、HemoDefend-RBC™、HemoDefend-BGA™、VetResQ®、K+ontrol™、DrugSorb™、ContrastSorb等。

For more information, please visit the Company's website at

如需更多信息，请访问公司网站

https://ir.cytosorbents.com/

or follow us on

或关注我们

Facebook

脸书

and

和

。

Forward-Looking Statements

前瞻性声明

This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, representations and contentions, and the outcome of our regulatory submissions, and are not historical facts and typically are identified by use of terms such as 'may,' 'should,' 'could,' 'expect,' 'plan,' 'anticipate,' 'believe,' 'estimate,' 'predict,' 'potential,' 'continue' and similar words, although some forward-looking statements are expressed differently.

本新闻稿包含符合1995年《私人证券诉讼改革法案》所设立的安全港免责条款的前瞻性陈述。这些前瞻性陈述包括但不限于关于我们计划、目标、业务前景、陈述与主张以及监管提交结果的声明，并非历史事实，通常通过使用诸如“可能”、“应该”、“可能”、“预期”、“计划”、“预见”、“相信”、“估计”、“预测”、“潜在”、“继续”等术语来识别，尽管某些前瞻性陈述表达方式有所不同。

You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, our restructuring of our direct sales team and strategy in Germany, our ability to resolve deficiencies in the FDA appeal decision and to identify a path forward for market authorization, our ability to resolve deficiencies in the Health Canada Notice of Refusal and/or successfully appeal Health Canada's decision, and the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 31, 2025, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business.

您应当知悉，本新闻稿中的前瞻性陈述代表了管理层当前的判断和预期，但我们的实际结果、事件和表现可能与这些前瞻性陈述中所述的内容存在重大差异。可能导致或促成这种差异的因素包括但不限于：我们在德国对直销团队和策略进行的重组、我们解决FDA上诉决定中缺陷并确定市场授权路径的能力、我们解决加拿大卫生部拒绝通知中的缺陷和/或成功上诉加拿大卫生部决定的能力，以及我们在截至2025年3月31日提交给美国证券交易委员会（SEC）的年度报告Form 10-K中讨论的风险，这些风险会在我们后续提交的季度报告Form 10-Q、新闻稿及其他致股东的沟通文件中更新，以试图告知相关方可能影响我们业务的风险和因素。

We caution you not to place undue reliance upon any such forward-looking sta.

我们提醒您不要对任何此类前瞻性陈述给予过度依赖。

U.S. Company Contact:

美国公司联系方式：

Peter J. Mariani

彼得·J·马里亚尼

, Chief Financial Officer

，首席财务官

305 College Road East

东学院路305号

Princeton, NJ

普林斯顿，新泽西州