EDAP Reports Sale of Ablatherm Robotic HIFU to Sylvester Comprehensive Cancer Center

LYON, France, Dec. 21, 2015 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced the sale of an Ablatherm Robotic HIFU device to Sylvester Comprehensive Cancer Center, part of UHealth – the University of Miami Health System.

Dipen J. Parekh, M.D., a robotic surgeon and urologic oncologist at Sylvester, commented: “We are pleased to add Ablatherm Robotic HIFU to our range of prostate ablation tools, as it complements our existing strength in robotic surgery.” Parekh, who is also professor and chair of the Department of Urology and director of Robotic Surgery at the University of Miami Miller School of Medicine adds, “With the recent FDA clearance of HIFU for prostate tissue ablation, this is an exciting time for the urology community and an opportunity to make a meaningful difference in the lives of prostate cancer patients. This is a truly non-invasive technique with the potential of significantly reduced side effects related to surgery and radiation. We look forward to working with EDAP to bring the system online and initiating patient treatments.”

Marc Oczachowski, EDAP TMS Chief Executive Officer, added: “We are excited to have Sylvester and the University of Miami’s Department of Urology among the first academic users of Ablatherm Robotic HIFU in the U.S. This sale is extremely important in our U.S. expansion strategy, which is focused on collaborating with leading academic and scientific centers to further establish the technology and accelerate its clinical recognition. We are honored to be working with such a respected robotic surgeon, urologist and Gold Cystoscope winner as Dr. Dipen Parekh and are looking forward to supporting him and his team.”

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