Supersonic Imagine Receives Regulatory Approval in Japan for New Advancements on the Aixplorer® Ultrasound System

Regulatory News:

SuperSonic Imagine (Paris:SSI) (Euronext: SSI, FR0010526814), the highly innovative ultrasound company, announced regulatory approval by Japan’s medical device regulatory authority, the Ministry of Health, Labour and Welfare, for the most recent advancements on the Aixplorer ultrasound system. These new innovations will be showcased during the JSUM/AFSUMB congress May 27 – 29 in Kyoto, Japan by SuperSonic Imagine’s distribution partner, Konica Minolta.

Several new ultrasound probes recently received regulatory clearance to be used in a broad range of clinical applications including the evaluation of liver disease, prostate cancer, obstetrics and musculoskeletal assessment. In addition to these new probes, patients will now have access to a new solution for microvascular visualization – Angio PL.U.S. – PLanewave UltraSensitive^TM imaging. Angio PL.U.S. provides a new level of microvascular imaging through significantly improved color sensitivity and spatial resolution while maintaining exceptional 2D imaging. It increases the detail of real-time flow information available during ultrasound diagnostic exams. This information is instrumental in helping the diagnosis of cancerous tissues in areas such as the breast, liver, lymph nodes and thyroid as well as musculoskeletal pathologies such as inflammation in tendons.

Angio PL.U.S. complements two important innovations on the Aixplorer approved last year in Japan - ShearWave^TM Elastography (SWE™) and UltraFast^TM Doppler. Aixplorer is the only ultrasound system available that provides real-time SWE™ to quantify tissue stiffness. Tissue stiffness is used by physicians to help identify potentially malignant or other diseased tissue. SuperSonic Imagine’s Aixplorer also provides UltraFast Doppler that combines Color Flow Imaging and Pulsed Wave Doppler into one simple exam, providing physicians with exam results simultaneously and helping to increase patient throughput.

"We are pleased to have received approval for the latest innovations on Aixplorer, our ultrasound system that has been widely adopted throughout Japan with the help of our partner Konica Minolta,” said Jacques Souquet, SuperSonic Imagine’s Founder and Chief Innovation Officer. "Japan is the third largest ultrasound market in the world, therefore securing approval for these advanced technologies is critical milestone for our continued success.”

Konica Minolta will be exhibiting the latest innovations on the Aixplorer at booth #S-05, during AFSUMB, May 27 – 29 in Kyoto, Japan.

About 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^TM 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^TM 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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