EDAP TMS SA is presently accelerating adoption of HIFU (High-Intensity Focused Ultrasound 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, and has received 510(k) clearance by the U.S. FDA. Ablatherm Fusion, a complementary option is also FDA cleared. In addition, the Company markets an innovative robot-assisted HIFU device, the Focal One®, dedicated to focal therapy of prostate cancer. Focal One® is CE marked and FDA approved. The Company also develops its HIFU technology for the potential treatment of certain other types of tumors. EDAP TMS produces and distributes other medical equipment such as the Sonolith® lithotripters' range and lasers for the treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL) in most countries including Canada and the U.S.
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