Orchestra BioMed Holdings (NasdaqGM:OBIO) Update / Briefing November 12, 2025 08:00 AM ET Speaker2Greetings. Welcome to Orchestra BioMed's third quarter 2025 corporate update call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to Kel ...

财报发布信息 - 公司计划于11月18日美股市场开盘前发布2026财年第二季度财报 [1] - 上一季度每股收益为1.26美元，超出市场一致预期2.44% [1] - 在过去四个季度中，公司每股收益均超出市场预期，平均超出幅度为2.20% [1] 第二季度业绩预期 - 第二季度营收市场一致预期为88.6亿美元，暗示同比增长5.4% [2] - 第二季度每股收益市场一致预期为1.31美元，暗示同比增长4% [2] - 每股收益预期在过去60天内保持不变 [2] 心血管业务板块表现 - 心血管业务部门预计将保持强劲势头，营收预计同比增长8.4% [3][5] - 心脏消融解决方案增长加速，得益于PulseSelect和Affera Sphere-9脉冲场消融系统的强劲市场接受度 [3] - 在结构性心脏领域，Evolut FX+ TAVR设备预计在包括日本在内的多个地区持续获得市场份额 [4] - 公司可能受益于竞争对手退出市场，从而获得更多国际收入份额 [4] - 高端心脏节律管理产品（包括AURORA EV-ICD、Micra无导线起搏器）的持续强劲采用预计利好季度表现 [4] 神经科学业务板块表现 - 神经科学业务部门营收预计同比增长1.5% [8] - 颅骨与脊柱技术业务预计实现强劲销售，由AiBLE脊柱技术生态系统的持续采用驱动 [6] - 核心脊柱和神经外科业务预计对整体业绩做出有利贡献 [6] - 神经调控业务表现可能受到疼痛刺激和美国Inceptiv闭环脊髓刺激器强劲增长的支撑 [7] - 用于帕金森病患者的BrainSense自适应脑深部电刺激技术的持续采用预计利好脑调控销售 [7] - 公司于9月获得Altaviva设备（一种微创植入式胫神经调控疗法）的FDA批准 [7] - 专科治疗业务在第一季度受到中国招标定价和Neurovascular的Pipeline Vantage召回影响，但第二季度情况可能已改善 [8] 医学外科业务板块表现 - 医学外科业务部门营收预计同比增长5.4% [11] - 第二季度可能看到对LigaSure血管密封技术的强劲需求，推动先进能源产品线的份额增长 [10] - 业绩预计得到ProGrip自固定聚酯网片、电外科和食管业务的增长支撑，与上一季度类似 [10] - 公司AI驱动的Touch Surgery生态系统不断扩大的覆盖范围可能对其整体收入产生积极影响 [10] 糖尿病业务板块表现 - 糖尿病业务部门营收预计同比增长9.2% [9][14] - 业务势头强劲，得益于MiniMed 780G自动胰岛素输送系统和Simplera Sync连续血糖监测传感器在国际市场的优势 [12] - Guardian 4 CGM传感器和延长输注组可能持续看到强劲采用 [12] - 公司在季度内达成关键FDA里程碑：SmartGuard算法被批准作为互操作自动血糖控制器，可与雅培的Instinct传感器集成；MiniMed 780G获准用于需要胰岛素的2型成人糖尿病患者 [13] - 公司可能推进将糖尿病业务分拆为独立上市公司（名为MiniMed）的计划 [14] 其他医疗股表现 - Veeva Systems第三季度每股收益预计同比增长11.43%，过去四个季度平均盈利超出预期9.71% [16][17] - Alpha Cognition Inc 2025年预计盈利增长率为27.7%，高于行业13%的增长水平，过去四个季度平均盈利超出预期21.74% [17][18] - Ascendis Pharma第三季度每股亏损预计同比改善78.3%，过去四个季度平均盈利超出预期11.15% [19]

诉讼概述 - 针对Inspire Medical Systems, Inc (NYSE: INSP) 提起的证券集体诉讼已提交 [2] - 该诉讼旨在为在2024年8月6日至2025年8月4日期间因涉嫌证券欺诈而遭受损失的股东挽回损失 [2] 指控内容 - 公司被指控在Inspire V新产品的发布上做出虚假陈述和/或进行隐瞒 [3] - 实际上Inspire V的市场需求疲软 因为供应商拥有大量过剩库存且不愿转向新疗法 [3] - 公司曾向投资者保证已采取所有必要措施以确保成功发布 并称发布进展顺利 但这些陈述与事实不符 [3] - 公司未能完成产品发布所需的基本准备工作 包括未完成对“许多”治疗中心客户的培训和入职 [3] - 公司未能建立基本的IT系统 包括客户审批流程 [3] - 公司未能确保关键的保险公司理赔软件得到妥善更新以促进理赔处理和支付 [3] - 公司未能在产品发布时确保医疗保险报销到位 [3]

Nov 12, 2025 8:45 AM Eastern Standard Time Owlet Partners with Rhapsody to Connect Remote Baby Monitoring Data to EHRs Share Collaboration bridges home and hospital, creating a secure pathway for pediatric insights to be managed and shared. Owlet partners with Rhapsody to securely connect infant vital signs from Owlet's FDA-cleared, prescription pulse oximeter, BabySat®, directly into their existing electronic health record (EHR) workflows. LEHI, Utah--(BUSINESS WIRE)--Owlet, Inc. ("Owlet†or the "Company†...

TORONTO, Nov. 12, 2025 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue, announced today that it has entered into an exclusive distribution and supply agreement for its TULSA-PRO® system with Getz Healthcare, a leading distributor of medical devices, equipment and consumables, in Australia and New Zealand. The ...

Key Takeaways Alcon's Q3 core EPS rose above estimates despite a 2.5% year-over-year decline. ALC's revenues reached $2.59B, up 6.4% year over year but slightly below consensus expectations. New launches like PanOptix Pro and Unity VCS supported ALC's growth across surgical and vision segments. Alcon, Inc. (ALC) delivered third-quarter 2025 core earnings per share (EPS) of 79 cents, down 2.5% from the year-ago quarter’s figure. At the constant exchange rate or CER, the figure decreased 4% year over year. Ho ...

"Placing digital pathology at the center of diagnostic workflows has the potential to transform the way we approach cancer diagnosis and prevention,†said Paul van Diest, Professor, Department of Pathology, University Medical Center Utrecht. "The ability to image and review more specimen types on a single system will help pathologists think beyond traditional boundaries and bring greater accuracy and efficiency to our work.†Nov 12, 2025 8:11 AM Eastern Standard Time Hologic Introduces Digital Pathology Cap ...

Safe harbor Forward-looking statements Third-Quarter 2025 Earnings Presentation November 11, 2025 1 This press release contains, and our officers and representatives may from time to time make, certain "forward-looking statements" within the meaning of the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as "anticipate," "intend," "commitment," "look forward," "maintain," "plan," "goal," "seek," "target," "assume," ...

CARMEL, Ind., Nov. 12, 2025 (GLOBE NEWSWIRE) -- NeurAxis, Inc. (“NeurAxis” or the “Company”) (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies for chronic and debilitating conditions in children and adults, today announced new medical policy coverage for Percutaneous Electrical Nerve Field Stimulation (PENFS), representing approximately 566,000 total covered lives, in Michigan. With this addition, approximately 82% of commercially insured pediatric beneficiaries i ...

Key Takeaways J&J's MedTech unit posted $8.43B in Q3 sales, up 5.6% on an operational basis.Cardiovascular growth from Abiomed and Shockwave drove stronger MedTech results.J&J plans to spin off its Orthopaedics arm to sharpen focus on faster-growing MedTech areas.Johnson & Johnson's (JNJ) medical devices segment, known as MedTech, offers products in the orthopedics, surgery, cardiovascular and vision markets. The MedTech segment accounts for around 36% of J&J’s total revenues.In the third quarter, MedTech s ...