EDAP Announces Sylvester Comprehensive Cancer Center in Miami as First Certified U.S. Ablatherm® Robotic HIFU Site

LYON, France, March 10, 2016 -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced that Sylvester Comprehensive Cancer Center at the University of Miami is the first site in the U.S. to be fully certified in the use of Ablatherm Robotic HIFU.

Dipen J. Parekh, M.D., robotic surgeon and urologic oncologist at Sylvester Comprehensive Cancer Center, and Professor and Chairman of the department of Urology at the University of Miami Miller School of Medicine, commented: “We are proud to be the first fully trained and certified Ablatherm Robotic HIFU site in the U.S. In the first several weeks since initiating HIFU treatments, we have successfully performed multiple procedures using Ablatherm, with excellent results. We look forward to using our expertise in offering this non-invasive, targeted procedure to more Sylvester prostate patients in the future.”

Full certification in the use of Ablatherm is awarded after successfully completing the three phases of EDAP’s comprehensive training program. Ablatherm delivers high-intensity focused ultrasound that ablates targeted tumor tissue in the prostate while avoiding healthy tissue, minimizing common side effects such as urinary incontinence and sexual dysfunction. Sylvester was only the second facility in the nation to begin using Ablatherm Robotic HIFU following FDA approval late 2015.

Marc Oczachowski, EDAP TMS Chief Executive Officer, added: “An effective physician training program is key to the continued success of our U.S. rollout of Ablatherm HIFU.  Having launched Ablatherm HIFU in over 50 countries, we have optimized our training process and helped numerous facilities throughout the world initiate patient treatments.  We are pleased that the Sylvester Comprehensive Cancer Center at the University of Miami has become the first fully trained and certified Ablatherm HIFU site in the United States.”

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.

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]