Houston Methodist Hospital, Houston, TX Acquires and Installs EDAP’s Ablatherm® Robotic HIFU

LYON, France, April 25, 2016 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced the sale and installation of Ablatherm Robotic HIFU at Houston Methodist Hospital, Houston, Texas. The hospital is the first location in Texas to install EDAP’s noninvasive HIFU device for the ablation of prostate tissue.

Dr. Brian J. Miles, M.D., professor of urology at Weill Cornell Medicine and Baylor College of Medicine, commented: "We are delighted to add EDAP Technomed’s High Intensity Focused Ultrasound (HIFU) system to the technology we already use for the treatment of prostate cancer at Houston Methodist. HIFU will allow us to help more men and to refine our treatment options for each patient. This technology will have a strong role in the management of recurrent cancer in men who have failed radiation, but also as a primary therapy in men with newly diagnosed early disease. As we grow with HIFU, I believe it will expand, not only therapeutic options we have to offer, but will also open a new arena of research to define yet unknown curative therapies for prostate cancer."

Dr. David Mobley, M.D., associate professor clinical urology, Weill Cornell Medicine, added: “I have performed many HIFU procedures over the past few years, and for most men this is extremely well-tolerated, with minimal downtime, side effects or complications. My experience has demonstrated a very high rate of cure of prostate cancer by carefully choosing the proper patient for this therapy. Many of my patients are pleased that this therapy is now available in the U.S. and will soon be up and running at Houston Methodist. This is a breakthrough event for men with prostate cancer.”

Marc Oczachowski, EDAP TMS Chief Executive Officer, concluded: “I am very pleased with the purchase and adoption of Ablatherm Robotic HIFU by Methodist Hospital in Houston. The installation of our technologies at a prominent facility such as Houston Methodist is a key milestone and an important step toward making the benefits of Ablatherm available to the greatest possible number of appropriate patients. We are committed to the execution of this strategy, and to maximizing Ablatherm’s footprint nationwide as we bring this novel therapeutic option to physicians as well as patients in need.”

Houston Methodist Hospital is an 828–bed medical facility in Houston, Texas. The hospital is consistently ranked in U.S. News & World Report’s “Best Hospitals” list.

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