First Prostate Ablation Treatments Performed Using EDAP’s FDA Approved Ablatherm® Robotic HIFU at Sylvester Comprehensive Cancer Center, in Miami, Florida

LYON, France, Jan. 25, 2016 -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced the first prostate ablation treatments performed at Sylvester Comprehensive Cancer Center, Miami, using FDA approved Ablatherm Robotic HIFU. Sylvester Center will serve as the Ablatherm HIFU training and proctoring center for the U.S. East Coast and a door opened to the South American Market.

Dipen J. Parekh, M.D., robotic surgeon and urologic oncologist at Sylvester Cancer Center, and Professor and Chairman of department of Urology, commented: “We are extremely delighted at doing the first cases using the revolutionary robotic EDAP HIFU system on men with prostate cancer. All of our patients left the hospital within four hours of their procedure. This is a truly noninvasive technique exploring focal ablation in men with prostate cancer with the potential of significantly reducing treatment related morbidity, especially urinary incontinence and sexual dysfunction. We look forward to benefiting appropriate patients with prostate cancer using this state of the art technology.”

Marc Oczachowski, EDAP TMS Chief Executive Officer, added: “We are very pleased with the first Ablatherm Robotic HIFU treatments recently performed at Sylvester Center following the Ablatherm sale recorded at the end of 2015. We expect Sylvester Center Urology Department, headed by Dr. D.J. Parekh, will become the training and proctoring center for Ablatherm HIFU in the U.S.”

Oczachowski, continued: “With our proven leadership in HIFU for prostate tissue ablation, we are convinced that partnering with luminary academic and reference centers in the U.S. will help establish our superior technology and its clinical recognition. We believe Ablatherm adoption by U.S. urologists will be strengthened and accelerated by the proctoring assistance of Ablatherm key experts in the use of Ablatherm HIFU who are already recognized experts in the field of Prostate Cancer Robotic Surgery. We, at EDAP, are building the future of Ablatherm HIFU in the U.S. with the support of key scientific and clinical leaders. Bringing Ablatherm Robotic HIFU to U.S. patients is our priority.”

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
[email protected]

Investors:
Lee Roth
The Ruth Group
646-536-7012
[email protected]