PRINCETON, N.J., June 04, 2024 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announces the recent data presentation entitled “Early CABG with Intraoperative Haemoadsorption in Patients on Ticagrelor: The Safe and Timely Antithrombotic Removal (STAR) Registry,” at the international EuroPCR 2024 conference in Paris, France - the world-leading course in interventional cardiovascular medicine with over 12,000 attendees - where it was also selected as a top 5 finalist in the best scientific abstract competition..

新泽西州普林斯顿，2024年6月4日（环球通讯社）——细胞吸附剂公司（NASDAQ:CTSO）是重症监护病房和心脏手术中使用血液净化通过其专有聚合物吸附技术治疗危及生命的疾病的领导者，在法国巴黎举行的国际EuroPCR 2024会议上宣布了最近的数据介绍，题为“替卡格雷患者术中血液吸附的早期CABG：安全及时的抗血栓清除（STAR）登记处”，这是世界领先的介入性心血管医学课程，有12000多名参与者，它也被选为最佳科学摘要竞赛的前5名入围者。。

Professor Robert F. Storey, Academic Director and Honorary Consultant Interventional Cardiologist, Cardiology and Cardiothoracic Surgery Directorate, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK and Co-Principal Investigator of the international STAR Registry, presented real-world outcomes on 102 patients on ticagrelor (Brilinta®/Brilique®, AstraZeneca) who underwent non-deferrable coronary artery bypass graft (CABG) surgery with intraoperative CytoSorb® blood purification before completing the recommended 3-day drug washout period, across 23 European heart centers in Germany, U.K., Austria, Sweden, and Belgium..

英国谢菲尔德谢菲尔德教学医院NHS基金会信托基金会心脏病学和心胸外科董事会学术主任兼名誉顾问介入心脏病专家、国际STAR登记处联合首席研究员罗伯特·斯托里教授介绍了在德国、英国、奥地利、瑞典和比利时的23个欧洲心脏中心对102名替卡格雷（Brilinta®/Brilique®，AstraZeneca）患者的真实结果，这些患者在完成推荐的3天药物清除期之前接受了术中CytoSorb®血液净化的不可延迟冠状动脉旁路移植术（CABG）手术。。

In these 102 patients, the mean time from the last dose of ticagrelor was 22.8 hours. The mean age was 63.8 years, approximately 80% were male, and 43% had diabetes

在这102名患者中，从最后一剂替卡格雷开始的平均时间为22.8小时。平均年龄为63.8岁，约80%为男性，43%患有糖尿病

There were no device-related adverse events reported by investigators using intraoperative CytoSorb during CABG surgery

研究人员在CABG手术期间使用术中CytoSorb没有报告与设备相关的不良事件

Overall, severe bleeding according to the Universal Definition of Perioperative Bleeding criteria (UDPB ≥ 3) occurred in 9.8% of patients

总体而言，根据围手术期出血标准的通用定义（UDPB≥3），9.8%的患者发生严重出血

In a subgroup analysis, the study population was divided into 2 groups. Group 1 comprised patients operated <24 hours from last ticagrelor dose (n=61, mean time 12.6 ± 6.5 hours) and Group 2 comprised patients operated more than 24 but less than 72 hours from last dose (n=41, mean time 37.2 ± 10.1 hours).

在亚组分析中，研究人群分为两组。第1组包括从最后一次替格瑞洛剂量开始少于24小时的患者（n=61，平均时间12.6±6.5小时），第2组包括从最后一次剂量开始超过24小时但不到72小时的患者（n=41，平均时间37.2±10.1小时）。

Demographics were similar between the two groups, however, Group 1 patients had significantly higher perioperative risk compared with Group 2 patients based upon the more frequent need for more hazardous emergency surgery (66.1% vs. 12.2%, p<0.001) and the higher baseline predicted surgical risk according to the standardized EuroScore II score (4.2 vs.

两组的人口统计学特征相似，然而，第1组患者的围手术期风险显着高于第2组患者，因为更频繁地需要更危险的急诊手术（66.1%比12.2%，p＜0.001），并且根据标准化的EuroScore II评分（4.2比12.2%，p＜0.001），基线预测的手术风险更高。

1.7, p=0.006). Expectedly, higher risk patients in Group 1 had a higher rate of severe bleeding compared with Group 2 patients (14.8% vs. 2.4%).

1.7，p=0.006）。预计，与第2组患者相比，第1组高危患者的严重出血率更高（14.8%比2.4%）。

To provide historical context to these results, Professor Storey presented published results from the European Multicenter Registry on Coronary Artery Bypass Grafting (E-CABG) reporting postoperative UDPB ≥ 3 bleeding rates in patients on ticagrelor undergoing CABG surgery (without CytoSorb) within 24 hours from the last dose of 26.6% and in patients operated between 24 and 72 hours from last dose of 14.8%, both higher than what was observed in the STAR Registry when intraoperative CytoSorb was used in similar patients.

为了为这些结果提供历史背景，Storey教授介绍了欧洲冠状动脉旁路移植术多中心登记处（E-CABG）公布的结果，报告了替卡格雷接受CABG手术（无CytoSorb）的患者术后UDPB≥3出血率从最后一剂26.6%开始24小时内，以及从最后一剂14.8%开始24至72小时内手术的患者，均高于STAR登记处在类似患者中使用术中CytoSorb时观察到的出血率。

“Waiting to undergo CABG surgery for 72 hours after ticagrelor dosing can expose patients to the risk of high platelet reactivity and recurrent ischemic events as the effects of ticagrelor wear off, in addition to causing logistic challenges for hospitals,” stated Professor Storey. 'The STAR registry data show promising potential of intraoperative haemoadsorption in reducing the length of time that ticagrelor needs to be stopped before CABG surgery to prevent troublesome bleeding after surgery.

“替卡格雷给药后等待72小时进行CABG手术，除了给医院带来后勤挑战外，随着替卡格雷的作用减弱，患者还可能面临高血小板反应性和复发性缺血事件的风险，”Storey教授说STAR登记数据显示，术中血液吸附在减少CABG手术前替卡格雷需要停止的时间长度方面具有很大的潜力，以防止手术后出现麻烦的出血。

Overall, this collective experience of hospitals using intraoperative haemoadsorption routinely for ticagrelor removal is very encouraging and supports further study of this approach. Finally, we are very grateful that the importance of the potentially practice-changing data we presented was recognized by the scientific program committee with the selection as a top 5 finalist for the best scientific abstract award among the hundreds of original presentations at this year’s EuroPCR conference.”.

总体而言，医院常规使用术中血液吸附去除替卡格雷的集体经验非常令人鼓舞，并支持对这种方法的进一步研究。最后，我们非常感谢我们提出的潜在实践改变数据的重要性得到了科学计划委员会的认可，并被选为今年EuroPCR会议上数百篇原创演讲中最佳科学摘要奖的前5名入围者。”。

Efthymios Deliargyris, MD, Chief Medical Officer of CytoSorbents stated, “The STAR Registry data continue to provide real-world evidence that intraoperative use of CytoSorb in patients undergoing CABG surgery on ticagrelor is associated with lower rates of serious perioperative bleeding than observed historically when CytoSorb was not used.

CytoSorbents首席医疗官Efthymios Deliargyris医学博士表示，“STAR登记数据继续提供现实世界的证据，表明替卡格雷CABG手术患者术中使用CytoSorb与严重围手术期出血发生率低于历史上未使用CytoSorb时观察到的情况。

The goal of presenting these data at EuroPCR 2024, which was extremely well-attended by the full ecosystem of clinicians involved in the care of acute coronary syndrome patients including cardiologists, interventional cardiologists, and cardiothoracic surgeons, was to increase awareness through the entire chain of clinical care that CytoSorb is the only approved intervention that can expedite care for patients on ticagrelor needing surgical revascularization in the European Union.

在EuroPCR 2024上展示这些数据的目的是通过整个临床护理链提高人们的认识，即CytoSorb是唯一经批准的干预措施，可以加快对欧盟需要手术血运重建的替卡格雷患者的护理。

Since the other two mainstream anti-platelet agents, clopidogrel (Plavix®, BMS, Sanofi-Aventis) and prasugrel (Effient®, Eli Lilly, Daiichi Sankyo), have irreversible effects on platelets, we believe CytoSorb makes ticagrelor a better antiplatelet option for acute coronary syndrome patients since about 5-10% of them will eventually require definitive CABG surgery.

由于其他两种主流抗血小板药物氯吡格雷（Plavix®，BMS，Sanofi-Aventis）和普拉格雷（Effient®，Eli Lilly，Daiichi Sankyo）对血小板具有不可逆转的作用，我们认为CytoSorb使替卡格雷成为急性冠状动脉综合征患者更好的抗血小板选择，因为其中约5-10%最终需要进行明确的CABG手术。

This differentiating feature of ticagrelor, together with its upcoming loss of patent exclusivity and the availability of generic formulations, will likely further expand the market opportunity for CytoSorb.”.

替卡格雷的这一与众不同的特征，加上其即将失去专利排他性和仿制药的可用性，可能会进一步扩大CytoSorb的市场机会。”。

CytoSorb® is approved in the European Union for the removal of cytokines, bilirubin, and myoglobin. CytoSorb is also E.U. approved for the removal of the antithrombotic drugs, ticagrelor and rivaroxaban, during cardiothoracic surgery. CytoSorb® is not yet approved or cleared in the United States or Canada for any indication..

CytoSorb®在欧盟被批准用于去除细胞因子、胆红素和肌红蛋白。CytoSorb也被欧盟批准用于在心胸外科手术中去除抗血栓药物替卡格雷和利伐沙班。CytoSorb®尚未在美国或加拿大获得任何适应症的批准或批准。。

About CytoSorbents Corporation (NASDAQ: CTSO)

关于CytoSorbents Corporation（纳斯达克：CTSO）

CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses that can lead to massive inflammation, organ failure and patient death.

CytoSorbents Corporation是重症监护病房和心脏外科通过血液净化治疗危及生命的疾病的领导者。其主导产品CytoSorb®已获得欧盟批准，并在全球75个国家销售。它是一种体外细胞因子吸附器，可减少常见危重疾病中的“细胞因子风暴”或“细胞因子释放综合征”，从而导致大量炎症，器官衰竭和患者死亡。

In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove antithrombotic drugs and inflammatory mediators that can lead to postoperative complications, including severe bleeding and multiple organ failure.

在这些疾病中，死亡风险可能极高，有效的治疗方法很少（如果有的话）。CytoSorb也用于心胸外科手术期间和之后，以去除可能导致术后并发症的抗血栓药物和炎症介质，包括严重出血和多器官衰竭。

As of March 31, 2024, more than 237,000 CytoSorb devices have been used cumulatively. 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 ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures.

截至2024年3月31日，累计使用了237000多个CytoSorb设备。CytoSorb最初是在欧盟CE标志下推出的第一种细胞因子吸附器。在肝病和创伤等临床情况下，胆红素和肌红蛋白的去除以及心胸外科手术中替格瑞洛和利伐沙班的去除分别获得了额外的CE标记扩展。

CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. It has neither been cleared nor approved in the U.S. for the indication to treat patients with COVID-19 Infection. The FDA EUA will be effective until the declaration, that circumstances exist justifying the authorization of the emergency use of the CytoSorb device during the COVID-19 pandemic, is terminated under section 564(B)(2) of the Act, or the EUA is revoked under section 564(g) of the Act..

CytoSorb还在美国获得FDA紧急使用授权，用于即将发生或确诊呼吸衰竭的成人重症新型冠状病毒肺炎患者。它在美国既没有被批准也没有被批准用于治疗新型冠状病毒感染患者的适应症。FDA EUA将一直有效，直到根据该法案第564（B）（2）节终止声明，即存在证明在新型冠状病毒肺炎大流行期间紧急使用CytoSorb设备的情况，或者根据该法案第564（g）节撤销EUA。。

The DrugSorb™-ATR antithrombotic removal system, an Investigational Device based on the same polymer technology as CytoSorb, has received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures.

DrugSorb™-ATR抗血栓清除系统是一种基于与CytoSorb相同的聚合物技术的研究设备，已获得两项FDA突破性设备指定，一项用于去除替卡格雷，另一项用于去除直接口服抗凝剂（DOAC）阿哌沙班和利伐沙班在紧急心胸手术期间的体外循环回路中。

The Company has completed the FDA-approved, randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 140 patients at approximately 30 centers in U.S. and Canada to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery.

该公司已经完成了美国和加拿大大约30个中心140名患者的FDA批准的随机对照STAR-T（安全及时的抗血栓清除替卡格雷）研究，以评估术中使用DrugSorb ATR是否可以降低接受替卡格雷并接受心胸外科手术的患者围手术期出血风险。

This pivotal study is intended to support U.S. FDA and Health Canada marketing approval for DrugSorb-ATR in this application..

这项关键性研究旨在支持美国FDA和加拿大卫生部在此应用中对DrugSorb ATR的营销批准。。

CytoSorbents’ 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. Its technologies have received non-dilutive grant, contract, and other funding of approximately $50 million from DARPA, the U.S.

细胞吸附剂的纯化技术基于生物相容性高多孔聚合物珠，可以通过孔隙捕获和表面吸附主动去除血液和其他体液中的有毒物质。它的技术已经从美国DARPA获得了约5000万美元的非稀释性拨款、合同和其他资金。

Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S.

卫生与公众服务部（HHS）、国立卫生研究院（NIH）、国家心肺血液研究所（NHLBI）、美国陆军、美国空军、美国特种作战司令部（SOCOM）、空军物资司令部（USAF/AFMC）等。该公司拥有许多上市产品和正在开发的产品，这些产品基于这种独特的血液净化技术，受到许多美国发行的保护。

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. For more information, please visit the Company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and X..

以及国际专利和注册商标，以及多项正在申请的专利申请，包括ECOS-300CY®、CytoSorb XL™、HemoDefense RBC™、HemoDefense BGA™、VetResQ®、K+Control™、DrugSorb™、Contrast Sorb等。有关更多信息，请访问公司网站www.cytosorbents.com和www.cytosorb.com，或在Facebook和X上关注我们。。

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, statements about potential exposures resulting from our cash positions, representations and contentions, 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.

本新闻稿包括前瞻性声明，旨在获得1995年《私人证券诉讼改革法》确立的免责安全港的资格。这些前瞻性陈述包括但不限于关于我们的计划、目标、未来目标和业务前景的陈述，关于我们的现金头寸、陈述和争论产生的潜在风险的陈述，并且不是历史事实，通常通过使用“可能”、“应该”、“可能”、“预期”、“计划”、“预期”、“相信”、“估计”、“预测”、“潜在”、“继续”等术语来识别，尽管一些前瞻性陈述的表达方式不同。

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, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 14, 2024, 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.

您应该知道，本新闻稿中的前瞻性陈述代表了管理层当前的判断和期望，但我们的实际结果、事件和表现可能与前瞻性陈述中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2024年3月14日提交给SEC的10-K表年度报告中讨论的风险，这些风险由10-Q表季度报告中报告的风险更新，以及我们不时向股东发布的新闻稿和其他通信中所述的风险，这些通信试图向利益相关方告知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 statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws..

我们提醒您不要过度依赖任何此类前瞻性声明。我们没有义务公开更新或修改任何前瞻性声明，无论是由于新信息、未来事件或其他原因，联邦证券法要求的除外。。

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U.S. Company Contact:

U、 美国公司联系人：

Kathleen Bloch, CFO

首席财务官Kathleen Bloch

305 College Road East

学院路东305号

Princeton, NJ 08540

新泽西州普林斯顿08540

+1 (732) 398-5429

+1 (732) 398-5429

kbloch@cytosorbents.com

kbloch@cytosorbents.com

Investor Relations Contact:

投资者关系联系人：

Eric Ribner

Eric Ribner

LifeSci Advisors, LLC

LifeSci Advisors有限责任公司

250 W 55th St, #3401

250 W第55街，#3401

New York, NY 10019

纽约州纽约市，邮编：10019

+1 (646) 751-4363

+1 (646) 751-4363

ir@cytosorbents.com

ir@cytosorbents.com