近日，创新医疗器械公司 Xeltis 宣布完成 5500万美元融资（约合人民币3.9亿） ，用于加速其核心产品 aXess™ 可再生血管通路系统 的临床与商业化进程。 此次资金将支持Xeltis在欧洲和美国的关键注册研究、生产线扩建及早期市场推广，标志着再生型血管植入技术正式迈入规模化应用阶段。 # 血管 通路的" 再生"革 命 在慢性肾病与透析治疗领域，建立长期、稳定的血管通路始终是临床难题。 传统方法主要依赖 动静脉瘘（AVF） 或 人造血管移植（AVG） 。前者成熟慢、失功率高；后者易感染、易堵塞，且患者往往需要多次手术更换。 全球约有5000万名终末期肾病患者，每年新增透析导管手术超过300万例，医疗负担巨大。 在此背景下，兼具快速可用性与长期通畅性的"再生型血管通路"被视为下一代突破方向。 这也是Xeltis所专注的核心赛道——通过引导患者自身组织在体内"再生"出新的血管，实现从人工材料向活体组织的根本转变。 # 源自 欧洲的" 组织再生工程" 与传统人造血管（ePTFE等材料）相比，aXess™ 同时具备以下优势： Xeltis成立于2006年，总部位于瑞士苏黎世，是全球领先的 内源性组织再生（E ...

为助推技术创新，帮助创新企业和产品获得影响力，自2023年起，思宇MedTech连续评选 全球医疗科技榜单和奖项系列（Global MedTech Awards）。2023 年、2024年、2025年上半年，我们已经发布了若干奖项。现于2025年底前补录一批2025年创新企业和产品。 如果企业希望参与，请按照本通知填报，评选结果会以文章的形式发布，并在2026年7月的全球医疗科技大会上补充颁奖。 一、本次补录的奖项名称和评选规则 全球医疗科技产业贡献奖 Global MedTech Industry Contribution Award 评选对象：龙头医疗科技企业 参评标准：已有获批上市的产品，并在医院广泛应用，具有较高的行业影响力，推动了行业发展，且在临床应用、产品创新、经济效益和社会效益方面具有显 著贡献。 全球医疗技术创新奖 Global Medical Technology Innovation Award 评选对象：在医疗技术创新方面有突出表现的企业 参评标准：创新的产品或解决方案，引领细分行业科技发展趋势，能够提高医疗效率、改善诊疗效果、优化患者体验，并为医学学术做出贡献，具备市场潜力 和社会价值 ...

Core Viewpoint - Johnson & Johnson MedTech is transitioning its global business operations from a regional model to a business unit (BU) led structure starting January 1, 2026, to enhance competitiveness and value creation for customers and patients [1][4][10] Group 1: Reasons for Restructuring - The global medical device industry is undergoing significant changes, with advancements in precision medicine, minimally invasive surgery, digital health, robotics, and interventional devices, necessitating faster response times and localized compliance [3] - The traditional regional operational model of large medical device companies is seen as cumbersome and slow, hindering rapid innovation and global promotion [3] Group 2: Strategic Significance of the Restructuring - The divestiture of the orthopedic business DePuy Synthes, which previously accounted for nearly 30% of global MedTech revenue, allows the company to focus on high-growth areas such as cardiovascular, surgical, vision care, and interventional devices [4][10] - The new BU-led structure will enable faster resource allocation, enhance specialized operational capabilities, and improve product commercialization efficiency [4][9] Group 3: New Structural Arrangements - Each business unit will be responsible for its global business performance, managing everything from strategic planning to commercial execution [8] - Supply chain management will be centralized to improve global procurement and distribution efficiency [8] - Functional support departments will be restructured to align with the new BU-led operational model [8] Group 4: Expected Outcomes - The BU-led model will enhance operational efficiency and responsiveness, granting higher autonomy and decision-making flexibility to business units [9] - Resource allocation will become more concentrated and specialized, focusing on high-growth sectors [9] - Accelerated product innovation and global commercialization will be facilitated through closed-loop management from product design to global market launch [9] Group 5: Industry and Market Implications - This restructuring may serve as a trendsetter for other established medical device companies to adapt their structures in response to rapid technological and market changes [11] - The BU-led approach could shorten new product launch cycles, improving the accessibility of innovative devices and treatment solutions for hospitals and patients [11] - Increased competition dynamics may emerge in high-end interventional, digital health, and surgical device sectors, posing challenges for smaller innovative companies and new entrants [11]

Core Insights - The article emphasizes the importance of innovation in the medical technology sector, particularly in China, and aims to connect clinical practices, capital, channels, and regulations to drive high-quality development in the industry [1]. Event Overview - The event is designed for future leaders in healthcare, focusing on "thought zeroing" and "ecological linking" to foster collaboration and innovation in the medical field [3]. - The event will feature a series of workshops and discussions aimed at addressing key challenges in the medical technology industry, including the transition from laboratory to production and the identification of valuable enterprises by capital [12][13]. Workshop Highlights - Workshop 1 will focus on overcoming the "valley of death" in transitioning from laboratory innovations to production lines, featuring experts from various medical and investment backgrounds [12]. - Workshop 2 will address how innovative technologies can effectively solve clinical pain points and deliver value, with insights from medical professionals and investment experts [12]. - Workshop 3 will explore how capital can identify and support genuinely valuable companies in the new economic cycle, featuring discussions led by experienced investors and industry leaders [12]. Keynote Sessions - The keynote session will include discussions on the restructuring of medical interests and the thought processes necessary for medical enterprises to thrive in a changing landscape, led by prominent figures in the healthcare and finance sectors [13]. - Another session will provide an analysis of the macroeconomic and financial landscape in China, offering insights into how these factors impact the medical technology industry [13].

Core Viewpoint - Kestra Medical Technologies has successfully completed a significant common stock offering of approximately $138 million, which will be utilized for ongoing investment and commercialization in the wearable defibrillator (WCD) technology sector [2][13]. Industry Background - Serious cardiac events such as arrhythmias and ventricular fibrillation are major causes of sudden cardiac arrest and sudden cardiac death. For high-risk patients, a wearable cardioverter defibrillator (WCD) is considered an important transitional protective measure [3]. - The traditional WCD market has been dominated by a few products, but increasing demands for device portability, comfort, false alarm rates, and remote monitoring capabilities have created opportunities for technological innovation and commercialization of next-generation WCDs [3]. Company and Positioning - Founded in 2014, Kestra Medical Technologies focuses on wearable medical devices and digital health solutions, aiming to provide protection and care support for high-risk cardiac patients through intuitive, smart, and connected monitoring and treatment technologies [4]. - The core product line includes the ASSURE Cardiac Recovery System, along with a digital platform and patient application, positioning the company as a comprehensive service provider for long-term cardiac management and follow-up [4]. Core Product — ASSURE WCD - The ASSURE WCD is designed for patients at high risk of arrhythmias who are not suitable for immediate ICD implantation [5]. - The system emphasizes comfort, wearability, real-time monitoring, and automatic intervention, allowing patients to receive heart rhythm protection during normal daily activities [9]. Latest Clinical Data - In November 2025, Kestra presented results from the ACE-PAS study at the American Heart Association Scientific Sessions, which included 21,612 patients, making it the largest real-world clinical practice study of WCDs to date. The data confirmed the ASSURE system's safety, effectiveness, and wearability [12]. Use of Funds from Recent Financing - The recent $138 million common stock issuance will provide Kestra with sufficient funds to support further clinical research, scale production, enhance remote monitoring capabilities, and expand market coverage [13][14]. Conclusion - Kestra Medical Technologies is advancing the development of wearable heart rhythm protection devices through the ASSURE WCD and its digital health ecosystem. The data from large-scale real-world studies enhances trust in the device among clinicians and patients, supporting its broader application in arrhythmia protection, monitoring, and remote management [14].

Core Viewpoint - The article emphasizes the necessity for a unified language in the medical technology field, particularly regarding the terminology used for blood pump bearing technologies, to ensure ethical communication and patient safety [2][3]. Group 1: Importance of Terminology - Accurate terminology in medical devices is crucial as it directly impacts clinical decisions and patient safety [2]. - The inconsistency in terminology, particularly regarding "fully magnetically levitated" blood pumps, can lead to misunderstandings among manufacturers, clinicians, and regulators [3][4]. - The call for a standardized language is essential as more Chinese medical devices enter international markets, facing diverse regulatory and cultural challenges [3][4]. Group 2: Case Study of Blood Pump Technologies - The article discusses a specific case involving the CorHeart 6 blood pump, which was described differently by industry representatives and independent experts, highlighting the need for open scientific discussions to resolve such discrepancies [3][4]. - The classification of blood pump bearings is critical, with three fundamental types identified: contact-type plain bearings, hydrodynamic bearings, and magnetic bearings [6][22]. - The differences between magnetic and hydrodynamic bearings are significant, particularly regarding their impact on hemocompatibility and blood damage characteristics [10][27]. Group 3: Recommendations for Manufacturers - Manufacturers are urged to ensure that their descriptions align with international consensus and that the terminology used in marketing and technical documents is clear and consistent [4][5]. - It is recommended that manufacturers disclose the rotor suspension methods of their products, including any combination of magnetic and hydrodynamic support, to promote transparency [5][18]. - The article advocates for the establishment of an independent working group to standardize definitions and classifications of blood pump technologies to enhance scientific clarity and patient safety [12][32].

Core Viewpoint - The appointment of Erik Todd as CEO of Swan EndoSurgical marks a significant transition from technology incubation to commercialization for the company, which is focused on developing endoscopic surgical robots for gastrointestinal diseases [2][7]. Industry Background: The Rise of Endoscopic Surgical Robots - Gastrointestinal diseases have a high global incidence, with increasing cases of digestive tumors, early cancers, and complex polyps highlighting the limitations of traditional endoscopic techniques [3]. - The introduction of robotic technology is seen as a natural solution to overcome the bottlenecks of traditional methods, which rely heavily on physician experience and have limited precision [3]. - Major medical device companies are increasingly investing in surgical robotics, with a notable gap in the market for gastrointestinal endoscopic surgeries, which presents a high technical barrier [3]. - Olympus, a leader in endoscopy, is leveraging Swan EndoSurgical to transition from traditional imaging systems to a "robotics + AI + minimally invasive treatment" model [3]. Leadership Transition: From Stryker to Swan - Erik Todd brings over 25 years of experience in medical devices and surgical robotics, recognized as a leader in bringing products to market [4]. - During his tenure at Stryker, he led the development and commercialization of several robotic platforms, including the widely used Mako system [6]. - Todd's expertise in integrating technology innovation with commercial execution is expected to help Swan establish a systematic product development framework and accelerate the transition from concept validation to clinical and market stages [6][7]. Product Direction: Endoscopic Robotic System - Swan is developing a flexible endoscopic robotic system aimed at minimally invasive treatment of complex gastrointestinal conditions, addressing the limitations of traditional endoscopy [10]. - The product roadmap includes five stages, integrating Olympus's high-resolution imaging with Swan's robotic control arms and flexible navigation systems to achieve a closed-loop function of diagnosis, navigation, and treatment [10][14]. - The system aims to perform high-precision operations within natural orifices without surgical incisions, enabling procedures such as tumor resection, suturing, hemostasis, and reconstruction [10][15]. Strategic Significance - Olympus has focused on its medical technology business, with medical segment revenue exceeding 86% after divesting from camera and industrial inspection businesses [16]. - Relying solely on traditional endoscopic device sales is insufficient for long-term growth; through Swan, Olympus aims to achieve a threefold transformation [16]. - The global sales network covering over 4,700 gastrointestinal clinical institutions positions Swan's products for rapid global deployment once approved [16]. Conclusion: Leadership Transition at a Strategic Turning Point - Erik Todd's appointment symbolizes Swan EndoSurgical's shift from technology validation to systematic implementation [17]. - For Olympus, this marks a critical point in executing its "endoscopy + robotics" strategy, indicating a proactive embrace of the second growth curve in surgical intelligence [17]. - The endoscopic robotic sector is still in its early stages but holds significant potential, with Swan's commercialization efforts likely to influence the future landscape of minimally invasive treatments [17][18].

Core Viewpoint - The article highlights the recent completion of a multi-million yuan Pre-A round financing by Maikesi Medical Technology, aimed at advancing product development and clinical registration in the vascular emergency and life support sector, thereby strengthening its leading position in domestic production [2]. Industry Background - The incidence of critical conditions such as cardiogenic shock and aortic hemorrhage is on the rise, with emergency and circulatory support equipment heavily reliant on imports. The aging population and increasing burden of cardiovascular diseases necessitate effective restoration of circulatory function within the "golden rescue time" [3]. - Internationally, life support equipment represented by VAD and REBOA is gaining attention in critical care and pre-hospital emergency fields. However, existing imported products face issues like high costs and significant risks, making domestic alternatives essential for industry upgrades [3]. Company Introduction - Established in 2023 and headquartered in Shaoxing, Maikesi Medical is one of the few companies in China focusing on the entire chain of "intervention + emergency + service" for life support devices. The core team comprises experts from cardiovascular intervention, mechanical design, and emergency medicine [6]. - Since its inception, the company has aimed to develop a comprehensive technology and service system, focusing on high-risk PCI, cardiogenic shock, trauma, and pre-hospital emergency scenarios, with a product pipeline that combines proprietary intellectual property and mass production capabilities [6]. Product Introduction - Maikesi Medical has developed three core products: 1. **PulseVAD®**: A catheter-based artificial heart system with a diameter of less than 14Fr, reducing vascular damage and limb ischemia risks. It operates in a bionic pulsatile mode, providing effective blood flow support [9]. 2. **Mcsreboa®**: A resuscitative aortic occlusion balloon that integrates ultrasound guidance and automatic inflation technology, enhancing success rates in emergency situations [10]. 3. **Smartpress™**: An intelligent CPR device that ensures stable and precise chest compressions, improving resuscitation quality and neurological recovery rates [11]. - This product combination creates a complete closed-loop from intervention support to emergency resuscitation, addressing critical treatment scenarios [11]. Financing Purpose - The recent financing will focus on: - Advancing clinical registration and certification for core products - Establishing high-standard production lines and quality systems - Strengthening market education and clinical training systems - Promoting collaboration between pre-hospital emergency, intensive care, and intervention centers [12]. - The company plans to complete core product registrations and achieve mass production within two years, while also initiating overseas registration and collaboration processes to build an internationally competitive life support technology platform [12].

2025年12月1日，美国医疗科技公司 Akura Medical （隶属 Shifamed 投资组合公司）宣布完成 5300 万美元（约合人民币 3.75亿 ） C 轮融资 。本轮融资由卡塔尔投 资局（Qatar Investment Authority，QIA）领投，现有投资者继续参投，资金将用于推动公司核心产品 Katana 血栓取栓系统和辅助软件 NavIQ 的临床研究、注册申报 和全球化市场拓展，并计划在卡塔尔建立合资机构以支持国际化布局。 # 血栓治疗：从 抗凝 到机械干预 ，市场需求日益 紧迫 静脉血栓栓塞 (VTE) 包括深静脉血栓 (DVT) 与肺栓塞 (PE)，是全球范围内严重的心血管公共卫生问题。据统计，每年美国约有数十万例 VTE 事件，并导致大量病 死与致残。传统治疗手段主要依赖抗凝或溶栓，但对于急性、大量栓塞或对药物治疗无效的患者来说，疗效有限，且风险不低。 近年来，随着介入方法和导管技术的发展，机械性血栓切除 (thrombectomy) 成为一种重要补充方案。但现有装置常面临导管尺寸大、操作复杂、对栓子形态适应 差、取栓效率不稳定等问题。如何在保证安全性的同时，提高取栓效率、减 ...

Core Viewpoint - The article emphasizes that the surgical procedure is only the beginning of treatment, and the recovery phase is equally crucial for determining the overall effectiveness of the treatment [3][21]. Group 1: Surgical and Recovery Process - Surgical techniques address structural issues, but the patient's return to normal function relies on post-operative tissue regeneration and recovery rhythm [3][4]. - The recovery process is complex due to the dynamic and sensitive healing environment of the nasal cavity and middle ear, which requires balancing multiple goals [4][5]. Group 2: Challenges in Recovery - Key challenges in recovery include maintaining controlled hemostasis, promoting epithelialization, minimizing secondary damage, and adapting to different surgical techniques [5]. - Material science plays a significant role in achieving a controllable way to support the body's natural healing rhythm [5]. Group 3: Importance of Predictability in Materials - The continued use of biodegradable porous materials over the past two decades highlights the importance of predictability, repeatability, and long-term validation in recovery [6][8]. - NasoPore, a biodegradable porous packing material, has been widely adopted due to its ability to provide a controllable and stable solution during recovery [8]. Group 4: Mechanisms of NasoPore - NasoPore features a connected porous structure that balances support and moisture in the healing environment [9]. - It has a controllable fragmentation mechanism that reduces secondary trauma by naturally breaking down without the need for removal [10]. - The material is customizable and can be shaped to fit the surgical cavity, ensuring a controlled local drug delivery system [11][12]. Group 5: Quality of Recovery Experience - The quality of recovery experience is a shared concern for both doctors and patients, requiring guidance and appropriate support during the recovery window [14]. - NasoPore has shown to reduce pain and anxiety, improve comfort, and lower the burden of follow-up care [15][16]. Group 6: Clinical Evidence and Outcomes - Clinical studies indicate that NasoPore significantly reduces bleeding and improves mucosal healing compared to non-absorbable materials [19][20]. - The material's properties contribute to lower rates of adhesion and better overall recovery outcomes, particularly in sensitive patients [20][21].