This is an European, prospective, interventional, multicenter clinical investigation that will take place in 2 French sites. 114 adults patients will be included. The study objective is to develop a new method for measuring liver stiffness using FibroScan.

开始日期2024-10-15

申办/合作机构

Echosens SA

NCT05651724 / RecruitingN/A

Global Research Initiative for Patients Screening on MASH - Implementation of an International Transmural Patient Care Pathway

GRIPonMASH will assist (primary) health care providers clinicians to implement the latest patient care pathway, as described by the European Association for the Study of the Liver (EASL), to identify patients at risk of severe metabolic dysfunction-associated steatotic liver disease (MASLD) and to raise awareness. The primary objective is to implement a transmural patient care pathway, in order to identify patients with MASLD and its progressive form metabolic dysfunction-associated steatohepatitis (MASH) in primary care centres and clinics in 10 European countries.

开始日期2023-06-30

申办/合作机构

Institute of Cardiometabolisme Nutrition

[+16]

NCT05567328 / RecruitingN/A

Validation of the New Vibration-guided FibroScan Examination

This is an European, prospective, interventional, multicenter clinical investigation that will take place in 2 French sites. 100 adults patients will be included. The study objective is to compare the applicability between the Research FibroScan and the reference FibroScan examination performed on the liver.

开始日期2022-10-26

申办/合作机构

Echosens SA

100 项与 Echosens SA 相关的临床结果

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0 项与 Echosens SA 相关的专利（医药）

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项与 Echosens SA 相关的文献（医药）

2016-11-01·Journal of computational and theoretical nanoscience

Metal-Oxide-Semiconductor Field-Effect Transistor Resonant Detection on Terahertz Radiation in Optical Exciting Regime

作者: He, Jin ; Zhu, Jingxuan ; Chan, Mansun ; Wang, Wengping ; He, Xiaomeng ; Wu, Wen ; Song, Lei ; He, Ping ; Zhao, Wei

MOSFET resonant detection on terahertz radiation under the optical exciting mode is studied in this paper.The fundamental harmonic resonance frequency of plasma waves in MOSMOSFETs is investigated anal. by the proposed model which covers both the subthreshold region and the strong inversion region.A new simulation method based on the numerical tool established by us before has been used in this work by coupling the crucial optical excitation term.The correctness of the proposed model has been verified by the results of simulation, and extensive characteristics of resonant detection under the optical exciting mode have been predicted by simulation and anal. in detail.

2016-08-01·Journal of computational and theoretical nanoscience

A Physics Based Analytic Model for Gate All Around MOSFETs with SiO₂-Core Si-Shell Architecture

作者: Wang, Wengping ; Chan, Mansun ; He, Jin ; Wu, Wen ; Song, Lei ; Zhang, Xiangyu ; Zhao, Wei ; He, Ping

A physics based analytic model for intrinsic long-channel gate all around (GAA) MOSFETs with SiO₂-core Si-Shell structure is presented in this paper.The analytic channel potential solution of the Poisson's equation in a cylindrical coordinate system with the SiO₂ core Si shell structure is first derived under the gradual channel approximationAnd then, the drain-current equation based on the drift-diffusion mechanism is obtained from Pao-Sah's dual integral, which is expressed as a function of intermediate variable.The model is continuous both from sub-threshold to strong inversion region and from the linear to the saturation region.The model has been extensively verified by 3D numerical simulations with a wide range of geometrical parameters.

2016-05-01·Journal of computational and theoretical nanoscience

Improved Effective Field Decomposition (EFD)-Based Capacitance Model with 3-D Terminal and Terminal Fringe Components

作者: He, Jin ; Wang, Wengping ; Wu, Wen ; He, Ping ; Song, Lei ; Zhang, Aixi ; Zhao, Wei

In this brief, a parasitic capacitance model for a finite single three-dimensional (3-D) wire above an infinite plate is developed based on elec. field decomposition (EFD).The capacitance components at wire ends, i.e., the 3-D terminal and terminal fringe capacitance, are considered by the 3-D elec. field anal.Verified by extensive COMSOL simulations, the model can accurately predict parasitic capacitance for a wide range of 3-D BEOL wire dimensions.

项与 Echosens SA 相关的新闻（医药）

2024-11-04

·PRNewswire

Echosens Launches its Liver Health Management (LHM) Platform Globally, Streamlining Liver Care

The cloud-based platform enhances FibroScan® capabilities, providing advanced tools for data-driven liver disease management PARIS, Nov. 4, 2024 /PRNewswire/ -- Liver disease affects an estimated 1.5 billion people worldwide, with many cases going undiagnosed until it's too late. As liver conditions like metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH) become more common, the need for early detection and proactive management has never been more urgent. To address this global health crisis, Echosens has launched its Liver Health Management (LHM) platform—a cloud-based solution designed to streamline liver disease care for healthcare providers in diverse clinical environments. The LHM platform integrates seamlessly with Echosens' FibroScan® technology, offering automated result transfers, biological marker-enhanced exams, and interpretation tools that support more informed, data-driven decision-making. "The LHM platform is designed to meet the growing needs of healthcare providers who are seeing an increase in patients with liver disease," said Dominique Legros, Group CEO of Echosens. "By connecting FibroScan® with the LHM platform, providers can access real-time insights and deliver more precise, data-driven care. The platform unlocks next-level liver disease management, enhancing efficiency and empowering clinicians to streamline workflows, improve patient outcomes, and stay ahead of the rising demand for liver care." Key features of the LHM platform, including worklist synchronization between FibroScan® devices and the platform, remote results interpretation, and secure data storage, allow providers to easily integrate liver care into their clinical workflows. This ensures efficient management of patient data while delivering comprehensive liver assessments. "The LHM platform is transforming our ability to monitor and manage liver disease," said gastroenterologist, Dr. Angelo Paredes. "With automated FibroScan® result transfers and intuitive interpretation tools, we can quickly identify at-risk patients and make informed decisions, allowing us to deliver timely recommendations and interventions to improve patient outcomes." Liver disease often progresses silently, with symptoms appearing only in advanced stages. With one in four people affected by MASLD and many undiagnosed, the LHM platform provides a critical solution by making liver screening routine, accessible, and actionable. "With the increasing prevalence of MASLD and MASH, the LHM platform provides essential support for clinicians seeking to catch the disease early, while it's still reversible," added Legros. "Our goal is to empower clinicians to intervene sooner, giving patients the best chance to improve their liver health, especially as more targeted treatments become available, such as Rezdiffra™, launched by Madrigal Pharmaceuticals earlier this year." For more information or to integrate the LHM platform into your practice, visit . About Echosens A pioneer in liver health, Echosens revolutionized liver diagnostics with FibroScan®, a non-invasive solution for comprehensive liver assessment. Validated by over 4,200 peer-reviewed publications and featured in 180+ international guidelines, FibroScan® is available in more than 127 countries, enabling millions of liver examinations worldwide. . Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

2024-11-01

·动脉网

十亿级器械大单品，借力新药研发再度翻红

2024年，一款医疗器械大单品被代谢相关脂肪性肝炎（MAFLD/MASH）药物研发带火。在MASH药物临床试验中离不开一种技术：瞬时弹性成像技术（TE）。肝脏瞬时弹性成像仪可以无创定量诊断肝纤维化和脂肪肝，在药物临床试验中筛选患者，对患者进行科学和精确的分级，并评估MASH药物的临床效果。 2024年，MASH领域取得了重大进展，全球首个针对MASH的创新药物Rezdiffra获批上市，并在其说明书中推荐使用肝脏瞬时弹性成像仪进行检测。此外，全球还有多个MASH药物重要管线在研，未来10-15年将有10余种NASH药物获批。今年，MASH领域发生了超过20亿美元的交易。GLP-1和小型核酸药物在MASH治疗领域的应用也引起了广泛关注。 MASH药物的研发和临床应用将大大提升肝脏瞬时弹性成像仪的市场需求，这一医疗器械大单品市场将进一步扩容。肝脏瞬时弹性成像仪由Echosens、海斯凯尔两家企业主导。Echosens母公司福瑞股份公布的财报数据显示：2024年上半年肝纤维化诊断仪器销售额达到4.2亿元。海斯凯尔则完成了多轮亿元级融资，全球装机量已超过3000台。肝脏瞬时弹性成像仪已问世超过二十年，如何成长为医疗器械中的超级大单品？MASH药物的火热又将如何影响这一产品市场规模？ 01 肝纤维化诊断是肝病逆转、阻断肝癌最重要的环节 TE是用于诊断肝纤维化和脂肪肝的产品。肝纤维化是各种慢性肝脏损害所导致的肝脏纤维结缔组织过度沉积，也是发展为肝硬化的共同途径。而肝纤维化的早期阶段具有可逆性，若能早期识别并及时治疗干预，能够较好地延缓肝病的进展、改善预后。最新研究表明，脂肪肝也有可能跳跃式发展。多项研究证实了这一可能性，一项回顾性数据分析显示，16%的肝癌是由单纯性非酒精性脂肪肝转变而来。随着肝纤维化程度的加深，肝脏的硬度会逐渐增加。健康的肝脏触摸是柔软的，而发生纤维化的肝脏，触感如同我们的鼻头，产生肝硬化的肝脏触感就如同我们的额头。瞬时弹性成像的基本原理就是剪切波在固体中传播，硬度越高，传播速度越快。以此来诊断肝纤维化的阶段。但早期肝纤维化病变很难得到无创精准诊断。多数慢性肝病所致肝纤维化乃至早期肝硬化无特异性症状、体征及常规血液生物化学指标异常，如果不进行肝脏组织病理学检查则不易被及时发现。而TE技术的突破性在于为肝纤维化诊断提供了精准无创的诊断方式，减少了医院进行有创的活检。瞬时弹性成像技术（TE）是一种无创定量检查方法，其通过专用探头通过机械振动产生固定频率剪切波，同时发出高频超声信号追踪剪切波在肝脏内的传播速度，结合肝脏组织学模型给出定量的肝组织弹性值（LSM）,以评估纤维化程度。超声在人体中的传播由于吸收、散射、反射等原因会发生衰减，脂肪肝肝细胞内富集脂肪微滴，对超声散射效果明显，脂肪肝程度越重，超声散射越严重，声衰减越大。 TE同时追踪超声信号在肝脏组织传播过程中的能量衰减，给出脂肪肝的定量检测结果脂肪衰减参数(UAP)，以评估肝脂肪变程度。简单来说，TE设备同时测定肝组织弹性值（LSM）和受控衰减参数（CAP），分别反映肝纤维化和肝脂肪变程度。 02 专利是TE市场最强护城河 TE产品在市场推广时，最常被问到的问题是TE和超声的差异。业内人士表示：“超声是一种无创定性检查方法，而TE是无创定量检测方法。超声通过超声探头发送高频声波并接收反射回来的信号，生成人体内部结构的图像。在肝纤维化的诊断中，根据肝脏大小、边缘钝度、肝实质的粗糙程度、表面结节、肝动脉周围淋巴结大小、门静脉血流速度、脾脏大小等评估肝纤维化的程度。在脂肪肝的诊断中，超声波在遇到不同密度的组织时，声波的反射和折射会发生变化，从而判断是否存在脂肪肝，对脂肪肝患者而言，由于脂肪的堆积，声波反射会变强，从而形成明亮的影像。超声诊断的特异度和敏感度差异较大，更容易受到仪器设备、解剖部位及操作者的技术和经验等因素的影响。相对于超声技术检查，瞬时弹性成像技术提供的检查结果更为客观且定量。瞬时弹性成像可以理解为难度更高的一种超声技术。主要技术壁垒体现在数据的量化。需要诱发安全稳定的剪切波和准确计算出剪切波的传导速度。人体组织接受外力的承受范围是有限的，在安全允许范围内的剪切波幅度很小，速度慢且广，衰减也很快。正是因为如上人体内剪切波的这些特点，检测剪切波的平台就要求有尽可能优的剪切波源、尽可能快的检测速率、尽可能宽的检测视野和尽量集中的检测能量。对于振动控制、超声换能器、剪切波传播速度测量提出较高要求。业内人士表示：“实现精准准确的检测涉及诸多技术。其中海量原始数据的累积与算法分析能力是产品检测准确性和精度的保障。” 而随着参与者增多，专利是重要的护城河。专利护城河可以有效保护企业的核心技术，限制竞争对手的进入。这使得企业能够在瞬时弹性成像市场中保持独特的竞争优势，确保市场份额和盈利能力。例如，海斯凯尔通过其核心专利技术，成功打破了国外技术的垄断，迅速占领了市场份额。 03 两家企业主导市场根据YH Research的数据，2023年全球弹性成像市场的收入已经达到了23.9亿美元，预计在未来几年将以5.9%的复合年增长率（CAGR）持续增长，预计到2030年市场规模将突破35.79亿美元。在市场格局方面，福瑞股份的子公司Echosens所推出的FibroScan在海外市场上占据主导地位。而在中国市场，海斯凯尔的产品装机量领先，市场份额较大。 Echosens由法国人Laurent Sandrin博士在2001年与其他合伙人共同创立。该公司曾获得凯辉资本和奥博资本的投资。2016年，福瑞股份以2000万欧元的价格收购了Echosens，使其成为全资子公司。 FibroScan的核心竞争力在于其在全球100多个国家和地区的广泛应用，并且被世界卫生组织（WHO）、欧洲肝病学会（EASL）、亚太肝病研究学会（APASL）、美国肝病研究学会（AASLD）等多家权威机构纳入肝病检测指南或作为官方推荐的肝脏弹性检测设备。在中国，海斯凯尔成立于2010年，基于清华大学实验室的技术，推出了瞬时弹性成像产品FibroTouch，全球装机量已超过3000台。与此同时，海斯凯尔获得了美国FDA、欧盟CE、日本PMDA、澳大利亚TGA、韩国KFDA、俄罗斯RZN等海外市场认证，产品已销往全球60多个国家或地区。随着瞬时弹性成像（TE）市场的关注度不断提升，迈瑞医疗、乐普医疗和意领医疗等多家新进入者也加入了竞争。迈瑞医疗利用其在超声领域的技术积累，推出了自己的瞬时弹性成像系统Hepatus系列，该产品已在国内外和北美市场上市。初创公司意领科技推出了首创的掌上无线肝弹仪，这款产品以其便携小巧的特点区别于市场上的推车型瞬时弹性成像设备。在TE市场中，核心竞争力主要体现在以下几个方面：首先，医生会关注设备是否与肝穿刺具有一致性，以及是否进行了与肝穿刺对比的试验。其次，产品的临床专家认可度也是一个重要指标，即产品是否得到了临床专家的广泛认可。这些指标通常受到产品细节差异的影响，如频率和算法的不同。国内市场主要TE产品 04 未来增长看点随着MASH药物的上市，瞬时弹性成像（TE）市场有望迎来进一步的扩张。未来TE市场的增长将由三大关键因素驱动：第一大增长因素是MASH药物的获批，这将推动TE检测需求的提升。MASH的致病机理复杂，缺乏有效的评估手段，且美国FDA对临床终点的要求较高。此外，药物机制可能过于间接，单一药物疗效不佳，且副作用发生率高。长期以来，MASH缺乏明确的治疗手段。 2024年，这一领域终于取得了突破。Madrigal Pharmaceuticals研发的Rezdiffra于3月14日获得美国FDA的批准上市，成为40年来首款获此批准的MASH药物。根据Madrigal Pharmaceuticals 2024年第二季度的财报，Rezdiffra上市后第一个季度的销售额达到了1460万美元，超出了预期。同时，还有十余款MASH新药接近上市。 TE设备在MASH药物的应用中扮演着重要角色，它可以用于早期筛选出MASH患者，并基于TE的定量特性评估MASH药物的疗效。鉴于中国糖尿病合并脂肪肝和肥胖合并脂肪肝的患者数量庞大，MASH药物研究的增多和获批将显著提升TE诊断的需求。面对MASH药物带来的新机遇，全球的主要参与者都在积极准备。福瑞股份与多家国际大型药企达成合作，FibroScan在MASH药物研发中用于患者的入组初筛和临床疗效评估，推动FibroScan成为全球MAFLD/MASH诊断领域的黄金标准。据专家透露，海斯凯尔已研发出能够对代谢功能障碍相关脂肪性肝炎（MASH）进行量化检测的设备，多家医院参与了此功能的验证，有望成为最早的对于MASH进行直接量化检测的设备。第二大市场增长驱动因素是脂肪肝患者群体的增长。目前，TE技术主要应用于肝病科和感染科，随着MASH药物的开发，内分泌科也将开始使用TE技术。过去，TE技术主要面向病毒性肝炎导致的肝纤维化患者群体。随着国家消除肝炎行动的推进、疫苗的普及和母婴阻断措施的实施，病毒性肝炎的新发患者数量正在逐渐减少，导致TE的存量市场也在逐渐缩减。然而，脂肪肝的市场正在逐渐扩大。单纯性脂肪肝可以经过四步转化：发展为脂肪性肝炎（MASH）、肝纤维化、肝硬化，最终可能导致肝癌。但是最新研究表明，脂肪肝也有可能跳跃式发展。多项研究证实了这一可能性，一项回顾性数据分析显示，16%的肝癌是由单纯性非酒精性脂肪肝转变而来。随着肥胖和2型糖尿病（T2DM）的流行，全球非酒精性脂肪性肝病的患病率和发病率不断上升，尤其是在中国情况更为严重。根据中国肝硬化临床诊治共识意见中的数据，尽管中国MAFLD患者人数尚缺乏准确数据，但预计中国MAFLD患者人数将从2016年约2.44亿上升至2030年约3.15亿，其中新发MAFLD相关失代偿期肝硬化患者人数约75万。作为传统的肝病大国，中国面临的形势不容乐观。第三大市场增长驱动力是体检市场的需求增长。在体检市场中，国家规定公民入学、就业不得要求进行乙肝检测。体检中心可以通过TE设备更早地帮助客户发现肝纤维化和脂肪肝疾病。 TE技术自问世以来已有二十年，随着MASH药物的获批，它再次焕发生机，诊疗需求有望提升，打开全新的增量市场。TE这一十亿级单品有望实现跨越式增长。 *参考文献：【共识】瞬时弹性成像技术诊断肝纤维化专家共识（2018年更新版）——中国肝脏病杂志【共识】肝纤维化诊断及治疗共识（2019年）好多人都有的脂肪肝会变成肝癌？是真的！——浙大二院 *封面图片来源：pexels 如果您认同文章中的观点、信息，或想进一步讨论，请与我们联系；也可加入动脉网行业社群，结交更多志同道合的好友。近期推荐声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。动脉网，未来医疗服务平台

财报

2024-03-26

·PRNewswire

ECHOSENS APPOINTS DR. VICTOR DE LÉDINGHEN AS CHIEF MEDICAL OFFICER

PARIS, March 26, 2024 /PRNewswire/ -- Echosens announced today the appointment of Victor de Lédinghen, MD PhD, as the company's new Chief Medical Officer. With over two decades of clinical experience, Dr. de Lédinghen brings unparalleled expertise to advance Echosens' mission of revolutionizing liver health diagnostics. Continue Reading Echosens is thrilled to announce Victor de Lédinghen, MD PhD as the new Chief Medical Officer. As one of the earliest adopters of Echosens' FibroScan® technology since 2003, Dr. de Lédinghen has steadfastly advocated for its pivotal role in patient management. His tenure as a Professor of Hepatology at Bordeaux University Hospital, alongside a research stint at Cornell University, underscores his profound impact on the field of hepatology. His dedication to advancing liver health is evident through his impressive contributions, including over 400 articles and 300 national and international congressional communications. His expertise in chronic liver diseases, particularly MASH, has been instrumental in shaping clinical practice worldwide. In addition to his academic accolades, Dr. de Lédinghen has consulted for esteemed pharmaceutical companies such as Gilead, BMS, and Abbvie, among others. His deep-rooted connections within the medical community further Echosens' commitment to championing collaboration and innovation. As Chief Medical Officer, Dr. de Lédinghen will lead Echosens' clinical evidence-generation efforts, represent the company in medical forums, foster physician and pharmaceutical partnerships, and contribute to product development. In conjunction with this appointment, Céline Fournier will continue her work as VP of Medical Affairs at Echosens while reporting to Dr. de Lédinghen. Her dedication and expertise complement Dr. de Lédinghen's vision, ensuring a seamless transition and continued excellence in medical affairs. Reflecting on his new role, Dr. de Lédinghen shared, "I've been using FibroScan in clinical practice for twenty years, and I deeply understand its importance in daily patient management. I'm excited to share my experience to continue to advance the development of FibroScan and its pivotal role in the non-invasive diagnosis and monitoring of chronic liver diseases, in particular MASH. Patients also appreciate FibroScan not only because it's safe, but because they can follow the evolution and progression of their liver disease – becoming actors in their own health. Our mission is to ensure patients around the world can access and benefit from FibroScan." His appointment marks a significant milestone for Echosens, signaling a new era of innovation and collaboration in liver health. For more information on Echosens' liver health solutions, visit echosens.com. About Echosens A pioneer in its field, Echosens, significantly changed the practice of liver assessment with FibroScan®, the non-invasive solution for the comprehensive management of liver health. FibroScan® is recognized worldwide and validated by over 4,200 peer-reviewed publications and 180+ international guidelines. Echosens has made FibroScan® available in over 127 countries, enabling millions of liver examinations worldwide. SOURCE Echosens