DePuy Spine, Inc.

System Will Utilize the SIGMA™ HP Partial Knee Implant, Which Demonstrated Improved 12-Year Survivorship Compared to Class PALM BEACH GARDENS, Fla., June 7, 2024 /PRNewswire/ -- Today, Johnson & Johnson MedTech* announced that DePuy Synthes, The Orthopaedics Company of Johnson & Johnson**, has received 510(k) FDA clearance for the clinical application of the VELYS™ Robotic-Assisted Solution in Unicompartmental Knee Arthroplasty (UKA). The expanded indication builds upon the VELYS Robotic-Assisted Solution platform used in Total Knee Arthroplasty (TKA), which has been cleared for use in 20 markets and utilized in over 55,000 procedures1, equipping surgeons with the information needed to help preserve the soft tissue envelope, predict joint stability and work toward returning knee function2. The UKA application is designed for both medial and lateral procedures and will enable surgeons to guide precise implant placement without a CT scan3-4. It is compatible with the SIGMA™ HP Unicondylar Knee System with the new reusable INTUITION™ INSTRUMENTS. The SIGMA™ HP Implant demonstrates improved 12-year survivorship compared to class5 as shown in a national joint registry. "We are committed to continually improving and expanding the capabilities and user experience of our VELYS™ Enabling Technology portfolio," said Aldo Denti, Company Group Chairman, DePuy Synthes. "We are excited to add a robotic-assisted offering with our clinically proven implant for UKA which we believe will address some of the key unmet needs in the partial knee replacement segment, including accuracy and simplicity, that other systems on the market do not fully address. Data and analytics will continue to serve as the backbone of our platform, which reveals real-time, actionable insights for surgeons to empower patient-specific operative decisions with the goal to improve outcomes and deliver personalization at scale." Unicompartmental knee arthroplasty, otherwise known as partial knee replacement, offers potential for bone preservation6 and shortened recovery periods. UKA utilization offers clinical benefits and greater economic efficiency for patients, providers and payors compared to TKA7-8. Despite the benefits, UKA is underutilized due to complexities that include smaller incisions and lack of visibility. Robotics has the opportunity to overcome many of the challenges surgeons face in manual partial knee replacement when they are designed to provide intra-operative insights, more accurate implant alignment and positioning, and more reproducible and consistent outcomes. "Challenges associated with partial knee replacement include lack of access and visibility, which can lead to a longer learning curve and variability in outcomes. Achieving precise alignment and optimal implant placement is paramount for long-term success, and the ability to do so in a reproducible manner continues to be an unmet need in the UKA space9-10," said Dr. John Redmond, orthopedic surgeon performing both knee and hip procedures in Jacksonville, FL.† "The VELYS™ Robotic-Assisted Solution for Unicompartmental Knee Arthroplasty will enable a more personalized procedure that helps drive reproducible outcomes, while insights delivered from its planning and balancing tools will enable better precision and accuracy11. I am excited to see it utilized for UKA procedures and particularly in the ambulatory surgery center setting where its smaller footprint and image-free technology will enable greater operational efficiency." Key features of the VELYS™ Robotic-Assisted Solution for UKA include: The single PROADJUST™ PLANNING SCREEN enables personalized planning to help ensure precise implant placement, alignment, and balance relative to soft tissue. An ACCUBALANCE™ GRAPH for personalized balancing throughout the full range of motion. Compatibility with the SIGMA™ HP Unicondylar Knee System that has been demonstrated to improve 12-year survivorship compared with its class. Complete UKA workflow with UKA-specific functionality. The system will be featured at the Annual Meeting of the American Association of Hip and Knee Surgeons in November. Details on commercial availability will be forthcoming. About Johnson & Johnson MedTech 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 . About DePuy Synthes DePuy Synthes, The Orthopaedics Company of Johnson & Johnson, provides one of the most comprehensive orthopaedics portfolios in the world that helps heal and restore movement for the millions of patients we serve. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, extremities, craniomaxillofacial, spinal surgery and sports medicine, in addition to the VELYS™ Digital Surgery portfolio, are designed to advance patient care while delivering clinical and economic value to healthcare systems worldwide. Building on our proud product innovation and legacy of industry firsts, we are reimagining the orthopaedic landscape with new advancements in medical technologies and digital surgery across the entire continuum of care to Keep People Moving today and tomorrow. For more information, visit . 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 VELYS™ Robotic-Assisted Solution. The reader is cautioned not to rely on these forward-looking statements. 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 DePuy Synthes, Inc., Medical Device Business Services, Inc., and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; 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 health care products and services; and trends toward health care 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 , or on request from Johnson & Johnson. None of DePuy Synthes, Inc., Medical Device Business Services, Inc., nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. * Comprising the surgery, orthopaedics, vision, and interventional solutions businesses within Johnson & Johnson's MedTech segment. ** DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates. †John Redmond, MD, is a paid consultant for DePuy Synthes. Important Information: Prior to use, refer to the instructions for use supplied with the device(s) for indications, contraindications, side effects, warnings and precautions. 1 DePuy Synthes. VELYS RAS TKA System Software Approved Country List. Downloaded 5/30/2024. Windchill 201249029 2 Hunter M., et al., Influence of Soft Tissue Releases on 2 Year Outcomes in Total Knee Arthroplasty and Rate of Soft Tissue Releases in Robotic-Assisted Surgery. Current Concepts in Joint Replacement, Dec 2022. Poster No P-124. 3 DePuy Synthes VELYS Robotic-Assisted Solution for Unicompartmental Knee Rev C Surgical Technique Guide. 4 DePuy Synthes VELYS™ Robotic-Assisted Solution for Unicompartmental Knee Summative Evaluation Report. December 2023. Windchill #103414383. 5 National Joint Registry for England, Wales, Northern Ireland and the Isle of Man. Implant Summary Report for DePuy Sigma HP (Uni) Unicondylar. NJR Database extracted 31 Oct 2023, pages 4 - 6 Licensed for use until 6 Nov 2024. 6 "Unicompartmental knee arthroplasty, an enigma, and the 10 enigmas of medical UKA." Journal of Orthopaedics and Traumatology. Sept. 2, 2020. 7 Hauer G, Sadoghi P, Bernhardt GA, et al. Greater activity, better range of motion and higher quality of life following unicompartmental knee arthroplasty: a comparative case-control study. Arch Orthop Trauma Surg. 2020;140(2):231-237. doi:10.1007/s00402-019-03296-3 8 Jansen K, Beckert M, Deckard ER, Ziemba-Davis M, Meneghini RM. Satisfaction and Functional Outcomes in Unicompartmental Compared with Total Knee Arthroplasty: Radiographically Matched Cohort Analysis. JB JS Open Access. 2020;5(3):e20.00051. Published 2020 Sep 28. doi:10.2106/JBJS.OA.20.00051 9 Begum FA, Kayani B, Morgan SDJ, Ahmed SS, Singh S, Haddad FS. Robotic technology: current concepts, operative techniques and emerging uses in unicompartmental knee arthroplasty. EFORT Open Rev. 2020;5(5):312-318. Published 2020 May 5. doi:10.1302/2058-5241.5.190089 10 Mittal, A., Meshram, P., Kim, W. H., & Kim, T. K. (2020). Unicompartmental knee arthroplasty, an enigma, and the ten enigmas of medial UKA. Journal of orthopaedics and traumatology : official journal of the Italian Society of Orthopaedics and Traumatology, 21(1), 15. . 11 Doan G, Courtis P, Hoeffel D. Assessment of Accuracy of a Novel Image Free Robotic-Assisted System for Unicondylar Knee Arthroplasty, Poster 282. Presented at 4H World Arthroplasty Congress. Madrid, Spain. April, 2024. © DePuy Synthes. 2024. All rights reserved. US_DPS_DGSR_350282 Media contact: Ryan Carbain [email protected] SOURCE DePuy Synthes

Johnson & Johnson (J&J) subsidiary DePuy Spine, part of DePuy Synthes, recently announced that it will be laying off 67 employees from its facility in Monument, CO, according to an Oct. 30 WARN Act filing . The cuts come as J&J continues its two-year orthopedic business restructuring in a bid to improve its profitability. DePuy Spine began migrating its supply from its Colorado facility to its Mooresville, IN, distribution center in 2020, after supply chain operation evaluations. This round of layoffs marks the company’s third since July, totaling 92 eliminated positions, and stopping manufacturing at the Colorado site. The 67 employees effected by the layoff will be officially let go between Dec. 29, 2023, and Jan. 11, 2024. J&J explained its plans to exit “less profitable” markets and product lines across its orthopedics business by the end of 2025 during the company’s Q323 earning call . As part of the exit, Joe Work, CFO of J&J, said there would be a short-term revenue disruption in orthopedics of around $250 million over the next two years. However, he also noted that he expected the exit would improve J&J’s ability to meet demand, resulting in accelerated growth and enhanced profitability. Total costs associated with the restructuring program, MD+DI previously reported , are estimated to be between $700 million and $800 million. "We are on a journey of improvement in orthopedics," said Joaquin Duato, J&J CEO, according to a SeekingAlpha transcript of the earnings call. "We want to be number one and number two in every segment we compete. And that is a place where we are not there yet, but we are very confident that we are going to continue to make improvements by investing and by growing in the highest growth segments."

01四年来首次季度亏损砍管线、裁员，会影响中国市场吗？新冠的故事已接近落幕。辉瑞三季报显示，该公司自2019年以来首次出现季度亏损。辉瑞三季报发布后的投资者电话会上，大家更关心的是它的减肥药。三季报披露，辉瑞营收132.32亿美元，同比下降42%；净利润由去年同期盈利86.08亿美元，转为亏损23.82亿美元。这样降幅的原因是，在这个季度，新冠疫苗和口服抗病毒药Paxlovid的销售额分别比去年同期下降70%、97%。今年以来，减肥药成为新的热点，礼来和诺和诺德股价均上涨超过40%，辉瑞却跌了40％。在新冠之后找到新的增长点，是辉瑞的当务之急。最新消息显示，辉瑞正在削减5项临床试验项目，包括两个II期项目和三个I期项目。其中，砍掉的II期项目，一个是用于治疗牛皮癣和特应性皮炎的局部PDE4抑制剂(PF-07038124)，另一个用于治疗局灶节段性肾小球硬化。I期项目都集中在癌症领域，两个针对非小细胞肺癌，另一个针对实体瘤。砍管线、停止临床，都是跨国药企用来穿越周期的常见做法——对那些数据不佳的项目及时止损。今年年初公布2022年财报之后，辉瑞就已砍掉了8个项目：其中包括新冠口服抗病毒药Paxlovid的两个适应症，因为3期试验结果不佳。还包括一项中期类风湿关节炎候选项目和三项二期癌症项目。此外，还有一种治疗软骨发育不全的药，在2019年一度成为辉瑞的研发核心，并被欧洲EMA和美国FDA授予孤儿药资格，但辉瑞在后来的收益报告中表示，该药物由于未能通过II期研究而被搁置。出于类似理由，辉瑞当时还停止了四种早期候选药物的研究。此外，药企穿越周期的常见做法还包括裁员。此前，辉瑞宣布了一项多年期、全公司范围的成本调整计划，预计将实现至少35亿美元的节省目标，其中10亿美元将于2023年实现，剩下的将于2024年实现。据美国媒体报道，辉瑞计划于2024年2月在新泽西州格拉德斯通裁员791人，其在科罗拉多州博尔德市的研究机构正在进行裁员，此外，辉瑞还将关闭在北卡罗来纳州的两家工厂。裁员对中国区会有多大影响？不久前有媒体援引辉瑞中国区疑似内部信称，辉瑞新冠疫苗并未在中国商业化，因此新冠相关产品收入暴跌对中国业务影响很小，中国业务较去年实现了两位数的增长，并超额完成了预算，“这表明中国的情况与世界其他地区不同，因此，在中国的成本缩减将是很少的。”两个月前，辉瑞中国区已有一些调整：辉瑞中国区疫苗事业部、医院急症事业部等组织架构调整，辉瑞全球肿瘤学部门重组成为独立业务单元。不过，辉瑞早已预见到今天的市场变化，因此已提前布局新的产品。年初，辉瑞首席执行官Albert Bourla曾表示，预测新冠相关收入将在2023年大幅下降，因此强调研发是推动该公司发展的命脉，将2023年的研发预算提高了8.7%。三季报显示，辉瑞非新冠产品在第三季度的收入同比增长10%。这显示了希望。02砍管线、裁员……多家跨国药企新一轮调整近日，多家跨国药企发布2023Q3财报，同时伴随着多家企业的密集调整。11月1日，葛兰素史克（GSK）发布2023Q3业绩：营收81.47亿英镑（约合99.3亿美元），同比增长16%。这很大程度上得益于其全球首款RSV疫苗，这款疫苗销售总额达到32.2亿英镑。不过，在三季报中，GSK还宣布了三项早期管线削减计划：其中两款抗癌药物，分别是LAG-3靶向抗体和小分子STING激动剂。此外，该公司还放弃了一个同样在一期开发阶段、治疗艰难梭菌感染的重组蛋白疫苗。强生近日公布的财报显示，第三季度销售额增长6.8%，达到 214 亿美元。同时，强生高管在与投资者举行的季度财报电话会议上表示，强生正在重组旗下DePuy Synthes骨科业务。 今年3月，由于其骨科业务业绩近年来表现欠佳，强生首次宣布了涉及骨科业务的重组计划，“降本增效”被重点提及。重组过程中将裁员至少1000人，预计将于2025年底完成。近日，强生公司旗下DePuy Spine确认其在美国科罗拉多州的一家工厂裁员67人，这家工厂在过去几个月已裁员20余人。不过，裁员的同时，强生近日宣布将在哥斯达黎加建造一座约20万平方英尺的生产工厂，重点生产骨科和心脏节律解决方案相关产品，面向全球市场供货，预计未来三年内将创造3000个工作岗位。安进公司财报显示，2023年第三季度总营收69.03亿美元，较上年同比增长4%。这主要得益于多种产品的销量增长。其中包括一款前列腺癌药物，是2021年以9 亿美元预付款收购而来。同时，安进公司也宣布决定放弃一款在研药物，这是由于不久前，那款双特异性T细胞吸引剂的Ib期研究结果不佳。赛诺菲三季报显示，营收119.64亿欧元，同比增长3.2%，前三个季度总营收321.51亿欧元，同比增长3.9%。带来赛诺菲业绩增长的一个重要产品是度普利尤单抗（达必妥），前三个季度销售额高达77.25亿欧元，今年第三季度营收28.47亿欧元，同比增长32.8%。而在赛诺菲近日发布2023Q3财报的同时，赛诺菲还宣布将全面更新其战略，其中包括分拆消费者保健业务。几年来，赛诺菲一直在剥离非主营产品，将发展重点放在了高价值的原研药和疫苗。去年，赛诺菲出售了17种药物，还以11亿美元将旗下PD-1药物的全球权益退还给再生元。前年，它还卖掉了16种消费者保健产品，涵盖感冒和流感药物、护肤品和食品补充剂。同时，赛诺菲也在加大创新药研发和收购，今年3月，赛诺菲以近29亿美元收购一家公司，获得其已上市的一款1型糖尿病药物。罗氏诊断公司与辉瑞的情况多少有些相似。随着新冠相关检测业务的大幅缩减，该公司也面临一定压力。截至2023年第三季度，罗氏诊断报告称，其收入按不变汇率计算同比下降了5％，从39亿瑞士法郎下降到33.3亿瑞士法郎。在排除新冠相关产品销售的情况下，基础业务在该季度增长了7％。近日，罗氏诊断首席执行官Matt Sause在三季报发布后的电话会议上表示，将通过近期和未来发布的几款产品，解决新冠大流行后许多实验室面临的人员和工资压力。“提高实验室和工作流程自动化的效率是我们中心实验室业务成功的关键因素。”最近，诺和诺德是多家跨国药企中最大的“赢家”。其财报显示，今年前三季度总营收1663.98亿丹麦克朗（约合241.71亿美元），同比增长29%。其中，糖尿病和肥胖护理业务收入是超级营收主力，达到1538.06亿丹麦克朗（223.42亿美元），同比增长36%。这部分里，今年大热的GLP-1类糖尿病产品收入853.71亿丹麦克朗（124.01亿美元），同比增长45%。随后，诺和诺德将销售额增长预期重新调整为增长32-38%，将营业利润增加预期重新调整为增长40-46%。据2023年第15届中国医药企业家科学家投资家大会上的消息，2022年，全球大型公司研发管线贡献份额下降，小公司（只有一两种药物的公司）贡献在2021年上升后又在2022年再次下降，而中型公司贡献的份额上升，成为管线数量增长的主要驱动因素。行业的增长要靠创新药驱动。无论是大药企还是Biotech，在寒冬下都在调整管线。两年来，全球生物科技进入低潮调整期。收缩、聚焦核心竞争力、寻找下一个增长点，是多家药企现阶段共同的主题。2023年最后两个月，各大药企还将有怎样的举措？END作者 | 长风来源 | 赛柏蓝赛柏蓝药械交流57群扫描下方二维码，进入赛柏蓝药械交流群