First Patients Treated With EDAP’s Ablatherm® Robotic HIFU in New York

LYON, France, March 07, 2016 -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced the first prostate ablation treatments performed at Gramercy Surgery Center in New York, NY, using the Company’s FDA-cleared Ablatherm Robotic HIFU. Dr. Ivan Grunberger, Chief of Urology at New York Methodist Hospital and Professor of Clinical Urology at Weill Cornell Medical College, performed the procedures. He was assisted by Dr. Judd Boczko, an Assistant Clinical Professor of Urology at New York Medical College who practices with Westmed Medical Group.

The Ablatherm Robotic HIFU used is owned by American HIFU, LLC, who have mobilized it to provide HIFU access to select urologists and clinics throughout much of the United States.

Dr. Ivan Grunbeger commented: “We are thrilled to begin treating patients with Ablatherm HIFU. Having researched HIFU for more than 20 years and served as an investigator for EDAP’s FDA trial, I am familiar with the device and have a comprehensive understanding of the benefits of HIFU for prostate tissue ablation. This innovative, noninvasive technique has the potential to greatly improve the quality of life of certain prostate cancer patients, and we look forward to using the technology for the benefit of numerous men in the New York area.”

Dr. Judd Boczko added, “It was a privilege to assist in these first prostate ablation cases in New York. Ablatherm HIFU fits with the needs of many of my patients who desire definitive treatment, but were not satisfied with the options available prior to HIFU’s FDA clearance.”

Dan Conley, Chief Executive Officer of American HIFU, LLC, stated, “We are excited to be the first mobile provider of Ablatherm Robotic HIFU in the United States. This device fits our business model exceptionally well and we are seeing great interest. Many of the physicians we already work with have been frustrated until now with the lack of attractive options for the modern prostate patient. HIFU fills a void and we anticipate significant utilization.”

Marc Oczachowski, EDAP TMS Chief Executive Officer, added: “We are very pleased with the adoption that we are experiencing for Ablatherm Robotic HIFU since receiving FDA clearance last quarter. This placement in the New York area is significant in that it provides a large population of both physicians and patients with access to Ablatherm HIFU. We are proud to start implementing Ablatherm HIFU cases in major metropolitan areas with leading surgeons who are recognized for their innovative treatment approaches, such as Dr. Grunberger and Dr Boczko.”

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]