Biosense Webster, Inc.

来源：药渡 撰文：五月     编辑：维他命 9月全球药企裁员情况仍然严峻，生物医药寒冬仍在继续。据不完全统计，9月Inventprise、Bluebird bio、百时美施贵宝、Athira Pharma、AGC Biologics及Biosense Webster等十几家公司发布了裁员公告，如表1所示。 表1. 9月药企裁员名单 9月30日 据Fierce Biotech报道，在更新业务战略后，疫苗制造商Inventprise本月早些时候解雇了约7%的员工，大约有14个职位。该公司尚未就裁员发布正式公告。 总部位于华盛顿州的Inventprise在该州拥有三个生产制造地点：两个在雷德蒙德，一个在伍丁维尔。Fierce没有指出裁员将影响哪些地点。 Inventprise最近的新闻稿可以追溯到1月，当时该公司宣布已完成25价肺炎球菌结合疫苗（IVT PCV-25）的II期剂量范围研究的疫苗接种。 9月25日 Bluebird bio于9月24日宣布，为了将现金运营费用减少20%进行企业重组，该公司将裁员约25%。根据9月13日提交给美国证券交易委员会的文件，截至6月30日，这家总部位于马萨诸塞州萨默维尔的生物技术公司拥有375名全职员工，其中包括221名研发人员。 据2024年第二季度财报显示，尽管开创了针对多种疾病的基因疗法，但Bluebird难以让足够多的患者接受治疗。 在9月24日的公告中bluebird指出，作为其重组的一部分，它将进一步加强对镰状细胞病治疗Lyfgenia、脑肾上腺脑白质营养不良基因治疗Skysona和β-地中海贫血治疗Zynteglo的商业开发。Bluebird表示，年初至今，已有41名患者开始了该产品组合的治疗。 9月24日 根据《工人调整和再培训通知法案》的通知，百时美施贵宝在新泽西州劳伦斯维尔的最新裁员使今年和2025年该处被裁员的员工总数达到1,134人。最近的裁员涉及79名员工，他们将在12月12日至明年5月30日期间离开公司。 BMS向Fierce Pharma证实，解雇是其先前宣布的裁员的一部分。4月，BMS的2024年第一季度收益报告显示，它将实施一项“战略生产力计划”，到2025年节省约15亿美元的成本。该计划包括到2024年底裁减约2,200个工作岗位。根据BMS的说法，它将利用节省下来的资金来资助创新，专注于具有最高潜在投资回报的研发项目，并着眼于长期增长。 9月24日 Athira Pharma宣布，作为成本控制措施的一部分，该公司将裁员约70%。根据美国证券交易委员会的一份文件显示，这家总部位于华盛顿州博塞尔的临床阶段生物制药公司预计裁员约49个职位，将在12月31日之前基本完成。被解雇的人包括两名最高管理层，他们的解雇将于10月1日生效。 该公告是在Athira分享其研究性注射fosgonimeton在II/III期LIFT-AD试验中未能显著提高轻度至中度阿尔茨海默病患者的认知或功能后不久发布的。 Athira在9月17日的公告中指出了裁员，该公司表示，它将专注于推进ATH-1105的临床开发，其作为神经退行性疾病的潜在治疗方法，包括肌萎缩侧索硬化症（ALS）。 9月19日 根据《工人调整和再培训通知法案》的通知，总部位于西雅图的合同开发和制造组织 AGC Biologics将于11月22日裁员95名员工，其中科罗拉多州博尔德市85名，华盛顿州博塞尔市10名。该公司没有就裁员或其背后的原因发布正式公告。 AGC为基于蛋白质的生物制剂以及细胞和基因疗法提供药物开发和生产服务。根据其官网，该公司在全球拥有2,500多名员工。 9月16日 根据9月12日提交给美国证券交易委员会的文件，为了减少运营费用，同时考虑为其未来的“战略替代方案”，Oncternal Therapeutics将裁员约10名员工，约占其员工总数的37%。与此次裁员相关的是，Salim Yazji将于10月1日卸任首席医疗官一职。该公司预计将在第三季度基本完成裁员。 同样在9月12日，Oncternal宣布将停止两种药物的临床试验，停止所有产品开发活动，并探索可能包括资产出售以及合并、反向并购的选择。 9月13日 根据工人调整和再培训通知法案的通知，Biosense Webster——现在是Johnson & Johnson MedTech的一部分，将在加利福尼亚州裁员13名员工，自11月21日起生效。根据通知，虽然该公司位于尔湾，但受影响的员工在洛斯加图斯。 9月9日，强生宣布其医疗技术业务，包括Biosense，现在将更名为强生医疗科技。Biosense专门从事心律失常治疗。 9月11日 近日，一位发言人通过电子邮件向BioSpace证实，为生物制药公司提供产品和服务的Charles River Laboratories将裁员3%。这家总部位于马萨诸塞州的公司没有回答有关总共有多少员工被解雇、哪些地点受到影响或裁员生效日期的问题。 然而，根据美国证券交易委员会的一份文件显示，截至2023年12月30日，该公司拥有约21,800名员工，因此裁员可能会影响约650人。根据8月2日的《工人调整和再培训通知法案》通知，马里兰州弗雷德里克的13名工人将于9月30日被解雇。 9月10日 据Endpoints News 9月6日报道，初创公司生物技术公司Vesigen Therapeutics正在裁员。Vesigen首席执行官Paulash Mohsen向该出版物证实了裁员，但没有透露这家马萨诸塞州剑桥市公司有多少员工将受到影响。然而，他确实表示，该组织正在“评估战略选择”。 Vesigen正在努力开发一种用于基因编辑、RNA和蛋白质疗法的新型非病毒递送技术。在5月的一份公告中，该公司指出，它有新数据支持其ARRDC1介导的微泡技术的潜力，该技术可以在功能上将各种有效载荷（包括基因组编辑器）递送到广泛的疾病相关细胞和组织。 9月6日 Connect Biopharma是一家总部位于圣地亚哥的临床阶段生物制药公司，该公司于9月5日宣布已裁员约15%的中国员工，并将进一步裁员。大约15%的裁员发生在12个月的时间里，并于6月30日完成。预计到今年年底，中国分部将有更多裁员。 Connect在公告中表示，裁员是向以美国为中心的公司过渡的一部分。该公司还指出，它已将其主要候选产品rademikibart的制造工艺转移到一家总部位于美国的合同制造商，这将使其能够在2024年和2025年剩余时间内显著降低制造费用。 根据公告，今年早些时候，Connect收到了FDA关于rademikibart治疗哮喘和特应性皮炎的潜在III期注册计划的好评。该公司指出，它正在考虑是否将rademikibart推进到III期计划，或者为其探索其他无需额外融资即可完成的发展机会。 9月6日 根据8月28日的《工人调整和再培训通知法案》通知，BioMarin将于11月1日在加利福尼亚州裁员147名员工。根据美国证券交易委员会的一份文件显示，这些员工可能是此前宣布的全球裁员约225名员工的一部分，该公司预计此次裁员将在今年年底前基本完成。根据该文件，这大约225名员工于8月28日收到了通知。 BioMarin还在5月份在全球裁员了约170名员工。在过去的一个月里，该公司一直在进行其他关键改变。8月下旬，BioMarin宣布了高管重组。9月4日，BioMarin透露，它正在将公司重组为三个关键部门：骨骼疾病、酶疗法和Roctavian。 9月6日 就在8月8日向美国证券交易委员会提交的文件指出经常性亏损、负经营现金流和对额外资本的需求后几周，处于临床阶段的生物制药公司IN8bio于9月4日宣布正在裁员近一半的员工。这将作为保留其现金资源计划的一部分，其中还包括管道优先排序。 根据9月4日提交给美国证券交易委员会的文件，IN8bio将从9月4日起将其纽约市和阿拉巴马州伯明翰工厂的全职员工从37人减少到19人。此外，执行管理团队和董事会同意削减11%的现金薪酬，自9月1日起生效。 9月6日 据MedTech Dive报道，专门从事结构性心脏病的医疗器械公司Edwards Lifesciences将裁员3%的全球员工（约540名员工），以重新调整资源和研发能力。根据9月3日的《工人调整和再培训通知法案》通知，Edwards将在加州裁员193名员工，自11月8日起生效。加州的裁员可能是整体裁员的一部分。 此次裁员是在Edwards以42亿美元的价格将其重症监护产品组出售给BD（Becton，Dickinson and Company）之后进行的。根据9月3日的公告，该公司将使用净收益为战略计划提供资金，包括先前宣布的收购和股票回购。 MedTech Dive在其文章中指出，Edwards在今年上半年的经导管主动脉瓣置换业务经历了“增长缓慢”。 9月5日 根据8月30日的《工人调整和再培训通知法案》通知，在SEC文件报告公司财务挑战后不久，ImmunityBio将在加利福尼亚州裁员16名员工（卡尔弗城5人，埃尔塞贡多11人）。ImmunityBio的裁员将于10月29日生效。 文件显示，ImmunityBio正面临赤字和现金流挑战。截至6月30日，该公司的累计赤字为32亿美元。在截至6月30日的六个月内，该公司的现金流为2.073亿美元。 9月4日 根据《工人调整和再培训通知法案》的通知，在申请自愿第11章保护*后不到三个月，DermTech将在圣地亚哥裁员51名员工。裁员将于9月6日生效。 根据6月份提交给美国证券交易委员会的文件，专门从事无创皮肤基因组学技术的 DermTech在第二季度裁员15名员工（占其员工人数的20%）。该文件指出，未来可能会发生更多的裁员。 *自愿破产申请的第11章（Chapter 11 Bankruptcy）是一种美国联邦破产法下的法律程序，允许企业或个人在面临财务困境时，通过重组其债务来继续运营，而不是立即清算或停止运营。 9月4日 安斯泰来制药公司旗下的安斯泰来基因疗法公司（Astellas Gene Therapies）正在关闭其位于旧金山的生物制造工厂，并裁员至少17名员工。根据8月27日的《工人调整和再培训通知法案》通知，自10月21日起，将有7人被解雇。根据早些时候的WARN通知，10人于6月19日被解雇。 安斯泰来的一位发言人通过电子邮件告诉BioSpace，此次关闭将影响大约100名员工，但不会确认有多少人被解雇。据发言人称，关闭预计将于2025年3月完成。通过电子邮件发送给BioSpace的一份公司声明称，该设施的计划和项目正在搬迁至北卡罗来纳州桑福德的位置。 参考文献： https://www.biospace.com/biospace-layoff-tracker 专栏作者 五月 药物化学硕博，国外博士后，现从事药物研发工作，热爱医药行业，愿与各位同行互相学习、进步，共同见证创新药的发展。 *声明：本文仅是介绍医药疾病领域研究进展或简述研究概况或分享医药相关讯息，并非也不会进行治疗或诊断方案推荐，也不对相关投资构成任何建议。内容如有疏漏，欢迎沟通指出！ 35年来首款！FDA批准BMS新型精神分裂症药物，5款新药紧随其后…… 重磅！这5款mRNA疫苗"即将问世"，谁将率先撞线? 礼来能否反超诺和诺德？后来者将居上乎？

New CARTO™ 3 System Version 8 software introduces machine learning capabilitiesIncreases efficiency, reproducibility, and accuracyi in the electro-anatomical maps electrophysiologists use in catheter ablation procedures IRVINE, Calif., May 8, 2024 /PRNewswire/ -- Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech, announces the launch of CARTO™ 3 System Version 8, the latest version of the company's leading three-dimension (3D) heart mapping system used in cardiac ablation procedures. The software features new modules including the CARTO ELEVATE™ Module and CARTOSOUND™ FAM Module, designed for efficiency, reproducibility, and accuracy for electrophysiologists performing catheter ablation procedures to treat patients with atrial fibrillation (AFib) and other arrhythmias. Continue Reading CARTO™ 3 System Version 8 features new modules including the CARTO ELEVATE™ Module and CARTOSOUND™ FAM Module, designed for efficiency, reproducibility, and accuracy for electrophysiologists performing catheter ablation procedures. "We are pleased to announce this new version of our CARTO™ 3 System, which reflects our continued focus on harnessing the latest science and technology to advance tools for electrophysiologists to treat cardiac arrhythmias," said Jasmina Brooks, President, Biosense Webster, Inc. "The CARTO™ 3 System has been the cornerstone of catheter ablation procedures for more than a decade, helping electrophysiologists make treatment decisions. This new version advances the CARTO™ 3 mapping and ablation experience through enhanced signal analysis, improved substrate characterization, and utilization of ultrasound technology." New optional CARTO™ 3 System Version 8 modules include: CARTOSOUND™ FAM: the first use of an artificial intelligence algorithm, cleared by the FDA in intracardiac ultrasound for Biosense Webster. The algorithm enables automatic generation of the left atrial anatomy before inserting the catheter to the left atrium, saving time while also providing a highly accurate map. CARTO ELEVATE™: incorporates several new features designed to meet electrophysiologists' needs: Multipolar with the OPTRELL™ Mapping Catheter for localized unipolar signals to significantly reduce far field potentials and provide a more accurate activation map;ii Complex signals identification for efficient and reproducible identification of critical areas of interest when diagnosing the arrhythmia;i Pattern acquisition to automatically track arrhythmia burden pre- and post-ablation, enabling a more informed decision of the relevant premature activation map; and Enhanced CONFIDENSE™ Module to create optimized maps with higher overall Smart Index scores, ensuring maps are continuously improved.iii "CARTO™ 3 System Version 8 incorporates a novel component, the CARTOSOUND™ FAM Module, which, for the first time, utilizes artificial intelligence to reconstruct the left atrial anatomy, streamlining the process for electrophysiologists,"1,2,iv said Luigi Di Biase, M.D.v, PhD, FACC, FHRS, FESC, System Director Electrophysiology at Montefiore-Einstein Health System and Professor of Medicine (Cardiology), Albert Einstein College of Medicine. "By eliminating the need for manual contouring, the new system represents a new approach to anatomy creation, improving the efficiency of the procedure workflow." "Accuracy and precision in mapping the heart when treating cardiac arrhythmias are critical for electrophysiologists, and therefore, our patients," continued Dr. Di Biase. "The CARTO ELEVATE™ Module raises the bar for electro-anatomical mapping systems used in catheter ablation procedures. Capabilities such as Multipolar mapping make a difference for electrophysiologists in the electrophysiology lab, facilitating a reduction in far-field signal and increased focus on the electrical signals in the patient's heart that contribute to arrhythmias."vi AFib is the most common type of cardiac arrhythmia and affects more than 8 million people in the United States and nearly 50 million people worldwide.vii Catheter ablation is a safe and effective procedure when drugs don't work to help restore the heart's incorrect electrical signals, which cause an abnormal heart rhythm.viii About CARTO™ 3 System Version 8 The CARTO™ 3 System is a three-dimensional mapping system that uses electromagnetic technology to generate real-time maps of a patient's cardiac structures. First launched in 2009, the system is designed to help electrophysiologists navigate the heart by generating 3D maps and pinpoint the exact location and orientation of catheters in the heart during diagnosis and therapeutic procedures for patients with cardiac arrhythmias. CARTO™ 3 System Version 8 includes the CARTO ELEVATE™ Module which features OPTRELL™ Mapping Catheter with MULTIPOLAR to improve signal quality and localized annotation, independent of the catheter orientation. The system also includes the CARTOSOUND™ FAM module to deliver automated 3D shell creation using deep-learning technology. About Biosense Webster Biosense Webster, part of Johnson & Johnson MedTech, leads in cardiac arrhythmia diagnosis and treatment worldwide. We are dedicated to advancing electrophysiology and interventional cardiology tools and solutions for improved patient care. Learn more at biosensewebster.com and connect on LinkedIn and X, formerly Twitter. About Johnson & Johnson MedTechix At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized. For more information, visit thenext.jnjmedtech.com. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the CARTO™ 3 System Version 8 Platform. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Biosense Webster, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of regulatory approvals; uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of healthcare products and services; and trends toward healthcare cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at sec.gov, jnj.com or on request from Johnson & Johnson. Neither of Biosense Webster, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. © Johnson & Johnson Biosense Webster, Inc. 2024. All rights reserved. US_BWI_NAVI_362505.1 SOURCE Biosense Webster

Findings from the admIRE study – freedom from atrial arrhythmia recurrence at 12 months – support the submission of the VARIPULSE™ Platform among U.S. patients IRVINE, Calif., March 25, 2024 /PRNewswire/ -- Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTechi, announced the submission of the VARIPULSE™ Platform for Premarket Approval Application (PMA) to the U.S. Food & Drug Administration (FDA). The submission was supported by results from the admIRE study, a prospective, multi-center, non-randomized trial. The VARIPULSE™ Platform is comprised of the VARIPULSE™ Catheter, a fully integrated variable-loop multielectrode catheter; the TRUPULSE™ Generator, a pulsed field ablation (PFA) generator; and the CARTO™ 3 System VARIPULSE™ Software, which provides full integration with the world's leading 3D cardiac mapping system. The VARIPULSE™ Platform is designed to enable pulmonary vein isolation with the versatility of a catheter loop, a simple generator user interface, and a mapping system that provides an intuitive, reproducible workflow with real-time visualization, contact indicator, and PF tagging mechanisms. "The VARIPULSE™ Platform, differentiated by its CARTO™ 3 System integration and mapping capabilities, is part of a versatile portfolio of PFA tools that Biosense Webster is developing to meet the varied needs of electrophysiologists and their patients," said Jasmina Brooks, President, Biosense Webster, Inc. "Based on the results from the admIRE clinical trial, we are confident that this innovation has the promise to deliver significant value and differentiated capabilities, and become an important tool for the treatment of AFib." Twelve-month outcomes data from the pilot phase of the admIRE study, which assessed the safety and efficacy of the VARIPULSE™ Platform among U.S. patients, were presented as a late-breaker at the 2024 AF Symposium.1 Among 20 patients who completed the 12-month follow-up visit, 100% achieved acute success from ablation procedures and 80% remained free from atrial arrhythmia recurrence at one year.1 No procedure or device-related primary adverse events were reported in the pilot phase of the study.1,ii For patients who had received ablation, median procedure and fluoroscopy times were 90.0 and 3.5 minutes, respectively, likely attributable to integration with the CARTO™ 3 System.1 Full admIRE study results will be presented later this year. AFib is the most common type of cardiac arrhythmia and affects more than 6 million people in the United States and nearly 38 million people worldwide.2,3 Approximately 1 in 4 adults over the age of 40 are at risk for developing AFib.4 Despite these projections, many people are unfamiliar with AFib symptoms, available treatment options, and the importance of early treatment to avoid disease progression.5 Catheter ablation is a safe and effective procedure when drugs don't work to help restore the heart's incorrect electrical signals, which cause an abnormal heart rhythm.6 Learn more about Biosense Webster's PFA research and clinical evidence here. About admIRE The admIRE study (Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the Biosense Webster IRE Ablation System) (NCT05293639) is a prospective, multi-center, single-arm study to demonstrate the safety and long-term effectiveness of the VARIPULSE™ Platform when used for isolation of pulmonary veins in treatment of patients in the United States with symptomatic drug refractory paroxysmal AFib. Pulmonary vein isolation (PVI) was achieved using the VARIPULSE™ Platform. The study consisted of a pilot phase, which assessed initial device safety and effectiveness, and a pivotal phase, which assessed these against pre-specified performance goals. The primary safety endpoint was incidence of early onset (within seven days) primary adverse events; atrio-esophageal fistula (within 90 days); cardiac tamponade or perforation (within 30 days); and PV stenosis (within 12 months). Acute procedure success (defined as confirmed entrance block at the end of procedure) and freedom from documented atrial arrhythmia recurrence at 12 months were also assessed. About the VARIPULSE™ Platform The VARIPULSE™ Platform is Biosense Webster's Irreversible Electroporation ablation system. The fully integrated platform includes the VARIPULSE™ Catheter, TRUPULSE™ Generator, and CARTO™ 3 Mapping System VARIPULSE™ Service Pack Software. In January 2024, Biosense Webster announced that the VARIPULSE™ Platform received its first regulatory approval from the Japan Ministry of Health, Labour and Welfare for the treatment of symptomatic drug refractory recurrent paroxysmal AFib using PFA. In the U.S., the VARIPULSE™ Catheter and TRUPULSE™ Generator are currently investigational and are not approved by FDA. In Europe, the TRUPULSE™ generator received CE mark in late 2023 and the VARIPULSE™ Catheter received CE mark in February 2024. About Biosense Webster Biosense Webster, Inc. is the global market leader in the science and technology behind the diagnosis and treatment of cardiac arrhythmias. Part of Johnson & Johnson MedTech, the specialized medical-technology company is headquartered in Irvine, California, and works across the world to advance the tools and solutions that help electrophysiologists identify, treat, and deliver care. Learn more at biosensewebster.com and connect on LinkedIn and X, formerly Twitter. About Johnson & Johnson MedTechi At Johnson & Johnson MedTech,i we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the VARIPULSE™ Platform clinical trials. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Biosense Webster, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of regulatory approvals; uncertainty of commercial success; challenges to patents; competition, including technological advances, new products, and patents attained by competitors; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of healthcare products and services; and trends toward healthcare cost containment. A further list and descriptions of these risks, uncertainties, and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at sec.gov, jnj.com or on request from Johnson & Johnson. Neither of Biosense Webster, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.