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Dec 11, 2015
EDAP Receives Russian Regulatory Approval for Focal One® HIFU Device

EDAP Receives Russian Regulatory Approval for Focal One® HIFU Device

EDAP TMS SA, the global leader in therapeutic ultrasound, today announced that Russia's Federal Service for Surveillance in Healthcare (Roszdravnadzor) has approved Focal One for sale in Russia. Russia is currently the largest market for EDAP's Ablatherm® robotic HIFU technology.

Marc Oczachowski, EDAP TMS Chief Executive Officer, commented: "This is another important milestone for EDAP and its Focal One technology, and a significant advancement for Russian patients who will now have access to our next-generation focal HIFU treatment for prostate cancer. Focal One will well complement EDAP Robotic HIFU offering in Russia, where we already gather our largest installed base of Ablatherm devices."

Focal One combines the latest imaging modalities with EDAP's proprietary, cutting-edge HIFU technology into one unique device. Focal One combines the latest improvements of MRI in the diagnosis of prostate cancer with precision HIFU and a high performance ultrasound tool to validate treatment efficiency. These characteristics make Focal One the first device to address the need for an optimal focal therapy for prostate cancer while preserving patient quality of life.


EDAP TMS SA markets today Ablatherm® for high-intensity focused ultrasound (HIFU) for prostate tissue ablation in the U.S. and for treatment of localized prostate cancer in the rest of the world. HIFU treatment is shown to be a minimally invasive and effective option for prostatic tissue ablation with a low occurrence of side effects. Ablatherm-HIFU is generally recommended for patients with localized prostate cancer (stages T1-T2) who are not candidates for surgery or who prefer an alternative option, or for patients who failed radiotherapy treatment. Ablatherm-HIFU is approved for commercial distribution in Europe and some other countries including Mexico and Canada, and has received 510(k) clearance by the U.S. FDA. The Company also markets an innovative robot-assisted HIFU device, the Focal One®, dedicated to focal therapy of prostate cancer. Focal One® is CE marked but is not FDA approved. The Company also develops its HIFU technology for the potential treatment of certain other types of tumors. EDAP TMS SA also produces and distributes medical equipment (the Sonolith® lithotripters' range) for the treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL) in most countries including Canada and the U.S. For more information on the Company, please visit http://www.edap-tms.com, and http://www.hifu-planet.com.