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标题: 超音速想象宣布临床资料，回顾性的多中心试验评估ShearWave [打印本页]

作者: StephenW 时间: 2015-4-29 15:15 标题: 超音速想象宣布临床资料，回顾性的多中心试验评估ShearWave

本帖最后由 StephenW 于 2015-4-29 15:22 编辑

      Press Release                   SuperSonic Imagine Announces Clinical Data From Its Retrospective Multicenter Trial Evaluating ShearWave(TM) Elastography for the Non-Invasive Staging of Patients With Chronic Liver Disease

Published: Apr 28, 2015 1:37 p.m. ET

                                                                        AIX-EN-PROVENCE, FRANCE, Apr 28, 2015 (Marketwired via COMTEX) --SuperSonic Imagine (euronext paris:SSI) (SSI) whose ShearWave Elastography(TM) (SWE(TM)) andUltrafast(TM) Doppler technologies have revolutionized the ultrasoundimaging industry, today announced results from a large retrospectivemulticenter trial(1) of patients with chronic liver disease. Theseresults were formally presented at the 50th Annual Meeting of theEuropean Association for the Study of the Liver (EASL) by ProfessorEva Herrmann of University Hospital Frankfurt Germany, statisticianexpert of the trial.
               To date, over 40 peer-reviewed publications based on single centerinvestigator-initiated trials have demonstrated the reliability andeffectiveness of SWE(TM) in staging patients with chronic liverdisease. This presentation at EASL showed for the first time resultson a much larger scale (1340 patients) from a global multicenterretrospective meta-analysis. It confirmed the accuracy of SWE(TM) asa non-invasive alternative to biopsy for staging liverfibrosis/chronic liver disease.
               Clinical data from 1340 patients with SWE(TM) measurements and liverbiopsy were collected from 13 sites and retrospectively analyzed as apart of this analysis. This patient population was comprised ofchronic hepatitis C (HCV, n=470), chronic hepatitis B (HBV, n=420),non-alcoholic fatty liver disease (NAFLD, n=172) or other liverdiseases (n=278). 40.8% of the patients were found to have minimal orno fibrosis (≤F1), 19.3% had significant fibrosis (≥ F2),14.0% had severe fibrosis (≥F3) and 26.0% had cirrhosis (F4).
               Liver elasticity measurements were found to be well correlated withthe fibrosis grade. SWE(TM) demonstrated robust sensitivity andspecificity across all forms of liver disease. The primary endpointof this trial was the overall performance of SWE(TM) measured as thearea-under-the-receiver-operating-characteristic (ROC) curves(AUROC), using liver biopsy as the reference. AUROC is an indicatorof the diagnostic performance of a clinical test to differentiatebetween patients with and without a disease: the test becomes closerto perfection as the score approaches 100%. Table 1 summarizes thisperformance:
   ----------------------------------------------------------------------------Fibrosis Stage          All patients HCV       HBV       NAFLD----------------------------------------------------------------------------less than or equal to1 vs. greater than orequal to 2             86%       86%       92%       86%----------------------------------------------------------------------------less than or equal to2 vs. greater than orequal to 3             91%       93%       94%       92%----------------------------------------------------------------------------less than or equal to3 vs. 4                95%       96%       97%       96%----------------------------------------------------------------------------                This analysis demonstrated the remarkable ability of SWE(TM) todetermine liver disease severity in a broad range of patients.Specifically, the results revealed the ability to accurately evaluateliver disease caused by hepatitis C, hepatitis B and non-alcoholicfatty liver disease including NASH (non-alcoholic steatohepatitis).
               SWE(TM) is an easy-to-use, non-invasive exam that provides real time,color coded maps with quantitative measurements of liver stiffnessthat help assess chronic liver disease. As a general rule, liverstiffness increases with the severity of liver fibrosis, making it animportant parameter to help physicians determine disease stage. Liverbiopsy has traditionally been considered the gold standard forstaging liver fibrosis but this invasive method has major drawbacks,including significant incidence of morbidity, procedure andhospitalization costs, and clinical shortcomings as fibrosis isunderestimated in 10-30% of cases(2-3).
               The accuracy of SWE(TM) combined with its procedural convenience hasthe potential to significantly reduce the number of liver biopsiesused for the staging of fibrosis and assessment of cirrhosis. Such aparadigm shift will not only save time and hospital costs but alsoreduce morbidity and improve patients' quality of life. Thistechnique may also play a significant role in monitoring antiviraltherapies used to address health concerns such as hepatitis C.
               Jacques Souquet, Ph.D., SuperSonic Imagine's Founder, Executive VicePresident and Chief Strategic and Innovation Officer commented "thismeta-analysis is a seminal body of work for the company because itcorroborates with all previous single center trials to reconfirm theexcellent diagnostic performance of SuperSonic Imagine's ShearWaveElastography (SWE(TM)) for the non-invasive staging of liverdisease".
               (1) Department of Medicine, Goethe University Frankfurt, Frankfurt,Germany (2) Department of Hepato-Gastroenterology,  (3) Departmentof Diagnostic and Interventional Imaging, Centre HospitalierUniversitaire du Haut-Leveque, Bordeaux, France
               SuperSonic Imagine
               Founded in 2005 and based in Aix-en-Provence (France), SuperSonicImagine is a company specializing in medical imaging. The companydesigns, develops and markets a revolutionary ultrasound system,Aixplorer(R), with an UltraFast(TM) platform that can acquire images200 times faster than conventional ultrasound systems. Aixplorer isthe only system that can image two types of waves: ultrasound wavesensure excellent image quality and shear waves, which allowphysicians to visualize and analyze the stiffness of tissue in areal-time, reliable, reproducible and non-invasive manner. Thisinnovation, ShearWave(TM)Elastography, significantly improves thedetection and characterization of numerous pathologies in severalapplications including breast, thyroid, liver and prostate.SuperSonic Imagine has been granted regulatory clearances for thecommercialization of Aixplorer in the main global markets. Over thepast years, SuperSonic Imagine enjoyed the backing of severalprestigious investors, among which Auriga Partners, Edmond deRothschild Investment Partners, Bpifrance, Omnes Capital and NBGI.
               For more information about SuperSonic Imagine, please go towww.supersonicimagine.com.
   Contact information:SuperSonic ImagineMarketing & CommunicationEmmanuelle [email protected] 86 79 03 27NewCapInvestor Relations - EUPierre Laurent / Florent [email protected]+33 1 44 71 98 55Blueprint Life Science GroupInvestor Relations - USCandice [email protected] 375 3340 Ext. 105ComCorpMedia RelationsFlorence [email protected]+33 1 58 18 32 58 - +33 6 88 84 81 74Adelaide [email protected]+33 1 58 18 32 58 - +33 6 70 45 74 37                SOURCE: SuperSonic Imagine
                     (C) 2015  Marketwire L.P.  All rights reserved.

作者: StephenW 时间: 2015-4-29 15:23

新闻稿
超音速想象宣布临床资料，回顾性的多中心试验评估ShearWave（TM）弹性成像的患者的无创分期慢性肝病

发布时间：2015年4月28日下午1时37分ET

普罗旺斯地区艾克斯，法国，2015年4月28日（通过COMTEX Marketwired） - 超音速想象（巴黎证交所：SSI）（SSI），其ShearWave弹性成像（TM）（SWE（TM））和超快（TM）技术，多普勒有革命性的超声成像行业，今天宣布从慢性肝病一个大型回顾性的多中心试验（1）的结果。这些结果正式提出了在欧洲协会的第50届年会的肝脏（EASL）由大学医院德国法兰克福，试验统计学家专家伊娃·赫尔曼教授的研究。

迄今为止，基于单中心研究者发起的试验超过40同行评审出版物已经论证SWE（TM）的可靠性和有效性分期慢性肝病。此报告在EASL显示为来自全球多中心的回顾性荟萃分析规模更大的第一次结果（1340例）。它证实SWE（TM）的准确性作为一种非侵入性的替代活检分期肝纤维化/慢性肝病。

从1340例患者的临床资料SWE（TM）的测量和肝活检是从13个地点收集并追溯这一分析的一部分进行分析。这种患者群是由慢性丙型肝炎（HCV中，n = 470），慢性乙型肝炎病毒（HBV，N = 420），非酒精性脂肪肝病（NAFLD中，n = 172）或其它肝脏疾病（N = 278）。的患者的40.8％被发现具有最小或无纤维化（≤F1），19.3％有显著纤维化（≥F2），14.0％有重度纤维化（≥F3）和26.0％患有肝硬化（F4）。

被发现肝脏弹性测量得到很好的相关性与纤维化等级。 SWE（TM）证明强大的敏感性和特异性在所有形式的肝脏疾病。该试验的主要终点是瑞典（TM）的测量为面积下的接收器，操作特征（ROC）曲线（AUROC）的整体性能，使用肝活检作为参考。 AUROC是临床试验的诊断性能的一个指标具有和不具有疾病的患者之间进行区分：在测试变得更接近完美为得分接近100％。表1总结了这样的表现：

-------------------------------------------------- --------------------------
纤维化期所有患者HCV HBV NAFLD
-------------------------------------------------- --------------------------
小于或等于
1对大于或
等于2 86％86％92％86％
-------------------------------------------------- --------------------------
小于或等于
2与大于或
等于3 91％93％94％92％
-------------------------------------------------- --------------------------
小于或等于
3比4 95％96％97％96％
-------------------------------------------------- --------------------------

这个分析证实了显着的SWE（TM）的能力，以确定在范围广泛的患者肝脏疾病的严重程度。具体而言，结果显示，以准确地评价所引起的丙型肝炎，B型肝炎与非酒精性脂肪肝疾病，包括NASH（非酒精性脂肪性肝炎）肝脏疾病的能力。

SWE（TM）是一种易于使用的，非侵入性的检查，可提供实时，颜色编码与肝脏硬度的定量测量，有助于评估慢性肝病的地图。一般来说，肝纤维化程度肝脏硬度增加，使得它来帮助医生确定病情阶段的一个重要参数。肝活检历来被认为是黄金标准分期肝纤维化，但这种侵入性的方法有重大缺陷，包括发病率，程序和住院费用显著的发病率和临床缺点纤维化被低估的情况下10-30％（2-3 ）。

SWE（商标）结合其程序方便的精度有可能显著减少用于纤维化和肝硬化的评估的分期肝脏活检的数量。这种模式的转变，不仅节省时间和住院费用也降低发病率，提高患者的生活质量。这种技术还可以在监测用于解决健康问题的抗病毒疗法，如丙型肝炎。发挥显著作用

雅克Souquet，博士，超音速想象的创始人，执行副总裁兼首席战略和创新官评论说：“这个荟萃分析是公司工作的开创性的身体，因为它与所有以前的单中心试验证实再次确认了优异的诊断超音速的性能Imagine的ShearWave弹性成像（SWE（商标）），用于肝脏疾病的非侵入性的分段“。

（1）医药，法兰克福大学，法兰克福，德国系（2）肝，消化科，（3）诊断和介入影像，大学中心医院杜浩特，莱韦克塔，法国波尔多系

超音速想象

成立于2005年，总部设在普罗旺斯地区艾克斯（法国），超声波想象是一家专门从事医疗影像。该公司设计，开发和销售革命性的超声系统，Aixplorer（R），具有超快（TM）平台，可以获取图像比传统的超声波系统快200倍。 Aixplorer是唯一的系统，可以像两种波：超声波保证优异的图像质量和横波，其允许医师可视化和分析组织的硬度在一个实时的，可靠的，可再现的和非侵入性的方式。这个创新，ShearWave（商标）弹性成像，显著提高了检测和许多病理特征在若干应用中，包括乳腺癌，甲状腺癌，肝癌和前列腺。超音速试想已获得监管许可的Aixplorer在全球主要市场的商业化。在过去几年中，超音速试想一下，享有众多著名投资者的支持，其中Auriga Partners公司，爱德蒙得洛希尔投资伙伴，Bpifrance，适用的资本和NBGI。

有关超音速更多信息试想一下，请到www.supersonicimagine.com。

联系信息：
超音速想象
营销与传播
艾曼纽城
[email protected]
04 86 79 03 27

NewCap
投资者关系 - 欧盟
皮埃尔·洛朗/弗洛朗阿尔巴
[email protected]
+33 1 44 71 98 55

蓝图生命科学集团
投资者关系 - 美国
康迪斯诺尔
[email protected]
415 375 3340分机。 105

ComCorp
媒体关系
佛罗伦萨Portejoie
[email protected]
+33 1 58 18 32 58 - +33 6 88 84 81 74
阿德莱德Manester
[email protected]
+33 1 58 18 32 58 - +33 6 70 45 74 37

来源：超音速想象

作者: emilykwok335 时间: 2015-4-29 15:39

是類似於firboscan 的檢測技術嗎？

作者: StephenW 时间: 2015-4-29 16:55

回复 emilykwok335 的帖子

是, 都测量刚度(stiffness), firboscan用机械力(mechnical), shearWave用集中的声力(focused acoustic force).

作者: 咬牙硬挺 时间: 2015-4-29 18:09

感谢分享

作者: Grey 时间: 2015-4-29 21:42

我感觉FIBROSCAN不太准，不知道这个准确度是否有提高，哎，但是等普及到中国不知道什么时候，而且那些进了FIBROSCAN的医院肯定不会马上进这个机器的

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