SuperSonic Imagine to Showcase Its Non-Invasive, 60-Second Liver Assessment Exam as an Alternative to Biopsy

Regulatory News:

SuperSonic Imagine (Paris:SSI) (Euronext: SSI, FR0010526814), the highly innovative ultrasound company, announced today that the clinical benefits of its ShearWave^TM Elastography (SWE^TM) technology for non-invasive assessment of patients with chronic liver disease will be presented while attending the Liver Meeting^® 2015. The meeting is taking place November 13th – 17th in San Francisco, CA.

To date, over 60 liver disease-focused publications have demonstrated the reliability and effectiveness of SWE to assess the severity of liver fibrosis in several different clinical situations. In April 2015, results of a large scale (1340 patients) global multicenter retrospective study were presented at the EASL (European Association for the Study of the Liver) annual meeting and confirmed the accuracy of SWE as a non-invasive alternative to biopsy for staging liver fibrosis. Several etiologies of chronic liver diseases were evaluated including chronic hepatitis C, chronic hepatitis B, nonalcoholic fatty liver disease (NAFLD) and others.

SWE is a 60-second non-invasive exam that provides a quantitative color-coded map to visualize and analyze tissue stiffness during an examination. Liver stiffness increases with the severity of liver fibrosis, making it an important parameter to help physicians determine the level of advancement of fibrosis.

Liver biopsy has traditionally been considered the standard for assessing liver fibrosis severity but this invasive method has major drawbacks, including significant incidence of morbidity, procedure and hospitalization costs, and clinical shortcomings as fibrosis is underestimated in 10-30% of the cases^(1-2). In addition, because of its invasive nature, biopsy is not ideal for repeated follow-up exams.

The accuracy of SWE combined with its procedural convenience has the potential to significantly reduce the number of liver biopsies. With the advancement of recent anti-viral therapies, the majority of hepatitis C patients can be cured of the virus. These patients often require both an initial assessment and follow-up evaluation. Having the option to utilize a non-invasive solution such as SuperSonic Imagine’s image-guided assessment technology can be beneficial for physicians, patients and hospitals.

"Supersonic Imagine is committed to bringing innovative solutions to physicians to help in the evaluation and treatment of patients with chronic liver disease. This is the ideal meeting to demonstrate our real time ShearWave Elastography technology to hepatologists from around the globe. Our image-guided non-invasive technology is an accurate, easy-to-use and pain-free alternative to traditional diagnostic options such as liver biopsies. We are looking forward to presenting more information regarding our suite of technologies to improve care for patients with chronic liver diseases,” commented Tom Egelund, Chief Executive Officer of SuperSonic Imagine.

The Company will be exhibiting at booth #529 throughout the meeting. Posters of clinical studies from the USA and Europe relating to SuperSonic Imagine’s ShearWave Elastography technology will also be presented.

The Liver Meeting^® is a registered trademark of the American Association for the Study of Liver Diseases.

1. Sampling error and intraobserver variation in liver biopsy in patients with chronic HCV infection. Regev A, Berho M, Jeffers LJ, Milikowski C, Molina EG, Pyrsopoulos NT, Feng ZZ, Reddy KR, Schiff ER. Am J Gastroenterol. 2002 Oct;97(10):2614-8. Sources of variability in histological scoring of chronic viral hepatitis. Rousselet MC, Michalak S, Dupré F, Croué
2. A, Bedossa P, Saint-André JP, Calès P; Hepatitis Network 49. Hepatology. 2005 Feb;41(2):257-64.

SuperSonic Imagine

Founded in 2005 and based in Aix-en-Provence (France), SuperSonic Imagine is a company specializing in medical imaging. The company designs, develops and markets a revolutionary ultrasound system, Aixplorer®, with an UltraFast™ platform that can acquire images 200 times faster than conventional ultrasound systems. Aixplorer is the only system that can image two types of waves: ultrasound waves ensure excellent image quality and shear waves, which allow physicians to visualize and analyze the stiffness of tissue in a real-time, reliable, reproducible and non-invasive manner. This innovation, ShearWave™ Elastography, significantly improves the detection and characterization of numerous pathologies in several applications including breast, thyroid, liver and prostate. SuperSonic Imagine has been granted regulatory clearances for the commercialization of Aixplorer in the main global markets. Over the past years, SuperSonic Imagine enjoyed the backing of several prestigious investors, among which Auriga Partners, Edmond de Rothschild Investment Partners, Bpifrance, Omnes Capital and NBGI.

For more information about SuperSonic Imagine, please go to www.supersonicimagine.com.

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