PRINCETON, N.J., June 13, 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 launch and immediate availability of its PuriFi™ hemoperfusion machine in the E.U., following approval and certification under the E.U. Medical Device Regulation (MDR). The PuriFi peristaltic blood pump features a number of dif ...

PRINCETON, N.J., June 05, 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, announces that it will host its 2024 Virtual Annual Stockholders Meeting tomorrow, June 6, 2024 at 10 AM EDT. CytoSorbents Corporation Virtual Annual Stockholder Meeting When: Thursday, June 6, 2024, at 10:00 ΑΜ EDT Webcast: www.virtualshareholdermeeting.com/CTSO2024 Requirements: As descri ...

PRINCETON, N.J., June 05, 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, announces that it will host its 2024 Virtual Annual Stockholders Meeting tomorrow, June 6, 2024 at 10 AM EDT. CytoSorbents Corporation Virtual Annual Stockholder Meeting When: Thursday, June 6, 2024, at 10:00 ΑΜ EDT Webcast: www.virtualshareholdermeeting.com/CTSO2024 Requirements: As descri ...

财务数据和关键指标变化 - 第一季度产品销售额约为900万美元,较2023年同期的790万美元增加14% [8][14] - 第一季度产品毛利率为76%,较2023年同期的68%增加800个基点,符合公司75%-80%的指引 [8][17][18] 各条业务线数据和关键指标变化 - 公司正在积极推进PuriFi血液灌流泵在国际市场的推出,预计将在本季度内交付并启动销售 [10] - 公司已累计交付237,000台设备,预计今年将达到250,000台 [9] 各个市场数据和关键指标变化 - 欧洲直销和分销国家市场表现良好,帮助推动了第一季度的强劲销售增长 [53][57] - 中欧市场如德国、奥地利、瑞士等已经趋于稳定,公司正在采取措施以推动这些市场的进一步发展 [53][57] 公司战略和发展方向及行业竞争 - 公司正在积极推进DrugSorb-ATR系统在美国FDA和加拿大卫生部的注册申请,预计将于第三季度提交 [35][37][38] - 公司认为DrugSorb-ATR适合走FDA的de novo审批途径,并有望获得优先审评 [35][36] - 公司看好未来市场机遇,包括人口老龄化、抗凝药使用增加、肝病流行等趋势 [39] 管理层对经营环境和未来前景的评论 - 管理层对公司的近期进展和未来发展前景表示乐观,包括销售增长、毛利率提升、PuriFi推出、融资等 [39] - 管理层认为公司有能力通过不断创新和推动血液净化技术的发展来推动行业转型 [39] 问答环节重要的提问和回答 问题1 **Yuan Zhi 提问** 为什么选择走de novo而不是PMA审批途径 [42] **Makis Deliargyris 回答** 主要是基于STAR-T临床试验数据,de novo审批更适合这种低中风险医疗器械 [43][44] 问题2 **Sean Lee 提问** 第一季度强劲的产品销售增长是由什么推动的 [51] **Christian Steiner 回答** 主要来自于欧洲直销市场和分销国家市场的良好表现 [53][57] 问题3 **Tom Kerr 提问** DrugSorb-ATR在美加两个市场的审批时间线是否相关联 [63] **Vincent Capponi 回答** 两个市场的审批是独立的,可能会有不同的时间线 [65][66]

Exhibit 99.1 CytoSorbents Reports First Quarter 2024 Results · Product Sales up a robust 14% over prior year, and a significant 22% sequentially · Enhanced profitability with gross margins that surged an absolute 8% to reach 76%, reflecting stronger operational efficiencies · STAR-T data presented at AATS support a favorable benefit-to-risk profile of DrugSorb-ATR in coronary artery bypass graft (CABG) patients · On track for U.S. Food and Drug Administration (FDA) De Novo and Health Canada submissions for ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-36792 CYTOSORBENTS CORPORATION (Exact name of registrant as specified in its charter) Delaware 98-0373793 (State or other jurisdiction of (I.R.S. Employer ...

PRINCETON, N.J., May 02, 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, today announced that it will host a virtual Key Opinion Leader and Analyst-Investor Day on Monday, May 6, 2024 from 11:30 AM to 1:30 PM ET. To register, click here. The program will cover the significant challenge of severe perioperative blee ...

CytoSorbents Corporation宣布举办STAR-T随机对照试验结果展示 - CytoSorbents Corporation宣布其关键性美国和加拿大Safe and Timely Antithrombotic Removal of Ticagrelor (STAR-T)随机对照试验的最终结果将在美国胸外科协会(AATS)第104届年会上作为晚期临床试验报告展示[1] - STAR-T演示的详细信息包括：104th美国胸外科协会年会，成人心脏科学会议：试验和趋势，标题为一项关键性随机对照试验，检查急需心脏手术患者体内去除Ticagrelor的安全性和有效性[2] - CytoSorbents将在AATS演示后于5月6日举办虚拟KOL和投资者日，由研究的首席调查员对STAR-T关键试验结果进行回顾，并讨论CytoSorb®的实际使用情况，该产品使用与DrugSorb-ATR相同的聚合物技术，已在欧盟获得批准[3]

业绩总结 - CytoSorbents公司2023年第四季度核心CytoSorb销售同比增长10%[24] - CytoSorb 2023年总收入达3630万美元，同比增长5%[39] - 2023年CytoSorb产品销售额为3100万美元，较2022年的2860万美元增加约240万美元，增长9%[41] 新产品和新技术研发 - STAR-T试验被选为美国胸外科协会年会的突破性演示[16] - HemoDefend-BGA项目获得1700万美元的DoD拨款，有望推向市场[30] - ECOS-300CY获得欧盟批准，用于器官移植，有望提高临床结果[31] 市场扩张和并购 - 预计Brilinta市场份额将增长，可能使美国和加拿大的总可寻址市场扩大一倍[22] - CytoSorb在全球范围内销售，覆盖欧盟、东南亚、中东、澳大利亚、新西兰、印度、拉丁美洲等多个国家[80] 未来展望 - 预计在2025年下半年获得FDA和加拿大卫生部的批准后开始商业化[21] - 预计2024年第四季度现金燃烧率将降至每季度约300万美元[83]

STAR-T trial results selected for a Breakout Presentation at the American Association of Thoracic Surgery Annual Meeting in late-April 2024 CytoSorbents intends to submit DrugSorb-ATR for regulatory approval to U.S. Food & Drug Administration (FDA) and Health Canada this year CytoSorb core sales increased approximately 10% year-over-year 2023 Product gross margins increased to 72% Cumulative CytoSorb treatments surpassed 228,000 PRINCETON, N.J., March 14, 2024 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (N ...