First HIFU patient treated at Allied Urological Services in New York City with the Ablatherm® Robotic HIFU device

Procedures Performed by Dr. Altan Ilkay

Vaulx-en-Velin, FRANCE

LYON, France, June 14, 2016 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced the first prostate ablation treatment performed at a site managed by Allied Urological Services (“Allied”), an affiliate of Austin, Texas based HealthTronics, Inc. in New York, NY, using the Company’s FDA-cleared Ablatherm Robotic HIFU.  Dr. Altan Ilkay, a leading urologist at Allied with significant experience in minimally invasive prostate treatments, performed the procedure.

Dr. Ilkay commented: “The contemporary patient is often not satisfied with the polar choices of active surveillance (do nothing) and radical treatment with surgery or radiation. HIFU is appropriate and attractive for many of the men I see in my clinical practice. It is a versatile technology that allows for tailoring of the procedure to fit the individual patient. The Ablatherm device is a uniquely robotic device that allows for the safe ablation of tissue.”  He added: “The Ablatherm Robotic HIFU provides a very user-friendly interface that allows the physician to focus on the critical, clinical treatment of the patient.”

The Ablatherm Robotic HIFU device used for this procedure is owned by HealthTronics, Inc., a leading provider of mobile medical technologies which is providing access to EDAP’s industry-leading HIFU technology to select urologists [throughout the United States].

Russell Newman, President of HealthTronics, said, “We are excited to add EDAP’s Ablatherm HIFU to our best-in-class portfolio of mobilized medical technologies and to work with our partners at Allied as the first users of the device. Ablatherm and HIFU are an important addition to our suite of technology offerings as they help us meet our commitment of providing physicians with the most innovative tools available for the treatment of their patients.”

Marc Oczachowski, EDAP TMS Chief Executive Officer, added: “We are very pleased that Allied, one of the country’s largest networks of urologists, has established a HIFU program incorporating the EDAP Ablatherm Robotic HIFU device.  In addition, this also extends our relationship with Allied, which has been a longtime user of EDAP’s unique and exclusive Lithotripsy technology, the Sonolith i-move.”

EDAP TMS SA markets today Ablatherm® Robotic HIFU device 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, and

About Allied
Allied was formed in 1998 and is the management company for a urology group that has nine AAAHC-accredited office based surgical sites located throughout the New York metropolitan area that service 280 affiliated urologists. For more information, please visit

About HealthTronics
HealthTronics, Inc., established in 1989 and headquartered in Austin, Texas, provides integrated, mobilized medical technologies and services, as well as physician partnership opportunities. The company brings its advanced technology and support systems to health care providers throughout the United States.  For more information visit

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.


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