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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
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