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

AIX-EN-PROVENCE, FRANCE--(Marketwired - Apr 28, 2015) - SuperSonic Imagine (EURONEXT PARIS: SSI) (Euronext: SSI, FR0010526814) whose ShearWave Elastography™ (SWE™) and Ultrafast™ Doppler technologies have revolutionized the ultrasound imaging industry, today announced results from a large retrospective multicenter trial¹ of patients with chronic liver disease. These results were formally presented at the 50^th Annual Meeting of the European Association for the Study of the Liver (EASL) by Professor Eva Herrmann of University Hospital Frankfurt Germany, statistician expert of the trial.

To date, over 40 peer-reviewed publications based on single center investigator-initiated trials have demonstrated the reliability and effectiveness of SWE™ in staging patients with chronic liver disease. This presentation at EASL showed for the first time results on a much larger scale (1340 patients) from a global multicenter retrospective meta-analysis. It confirmed the accuracy of SWE™ as a non-invasive alternative to biopsy for staging liver fibrosis/chronic liver disease.

Clinical data from 1340 patients with SWE™ measurements and liver biopsy were collected from 13 sites and retrospectively analyzed as a part of this analysis. This patient population was comprised of chronic hepatitis C (HCV, n=470), chronic hepatitis B (HBV, n=420), non-alcoholic fatty liver disease (NAFLD, n=172) or other liver diseases (n=278). 40.8% of the patients were found to have minimal or no 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 with the fibrosis grade. SWE™ demonstrated robust sensitivity and specificity across all forms of liver disease. The primary endpoint of this trial was the overall performance of SWE™ measured as the area-under-the-receiver-operating-characteristic (ROC) curves (AUROC), using liver biopsy as the reference. AUROC is an indicator of the diagnostic performance of a clinical test to differentiate between patients with and without a disease: the test becomes closer to perfection as the score approaches 100%. Table 1 summarizes this performance: