EDAP Reports Installation of Ablatherm Robotic HIFU at University of Southern California

LYON, France, Dec. 9, 2015 (GLOBE NEWSWIRE) — EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced the first installation of Ablatherm Robotic HIFU at University of Southern California, Keck Medicine of USC, which will become the first reference and training center for Ablatherm Robotic HIFU in the U.S.

Dr. Inderbir Gill, M.D., Professor & Chairman, USC Institute of Urology at Keck Medicine of the University of Southern California (USC) in Los Angeles, commented:  ”FDA clearance of HIFU is a tremendous milestone for the urology community. We are delighted to be the first in the U.S. to treat patients on a routine basis with the Ablatherm Robotic HIFU, on December 10 and 11, 2015. We look forward to helping appropriate patients using this groundbreaking technology, thus opening new options and horizons for prostate ablation procedures.”  

Marc Oczachowski, EDAP TMS Chief Executive Officer, added: ‘We are thrilled to have the first installation of Ablatherm Robotic HIFU following FDA clearance at such a prestigious university hospital as USC Keck Medical Center, which was one of the first facilities to purchase the device in the U.S. It is an honor to be working with the world class urology team led by Dr. Inderbir Gill, one of the top urologists in the world, and to collaborate with them on the establishment of a state-of-the-art training and reference center for Ablatherm Robotic HIFU in the U.S.”

About EDAP TMS SA

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.

Forward-Looking Statements

In addition to historical information, this press release may contain forward-looking statements. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties, including matters not yet known to us or not currently considered material by us, and there can be no assurance that anticipated events will occur or that the objectives set out will actually be achieved. Important factors that could cause actual results to differ materially from the results anticipated in the forward-looking statements include, among others, the clinical status and market acceptance of our HIFU devices and the continued market potential for our lithotripsy device. Factors that may cause such a difference also may include, but are not limited to, those described in the Company’s filings with the Securities and Exchange Commission and in particular, in the sections “Cautionary Statement on Forward-Looking Information” and “Risk Factors” in the Company’s Annual Report on Form 20-F.

CONTACT: Blandine Confort
         Investor Relations / Legal Affairs
         EDAP TMS SA
         +33 4 72 15 31 72
         bconfort@edap-tms.com
         
         Investors:
         Lee Roth
         The Ruth Group
         646-536-7012
         lroth@theruthgroup.com

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