EDAP Receives the Prestigious Prix Galien for its Focal One® HIFU device

EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced the award of the prestigious 2016 Prix Galien, in the Medical Device category, for its Focal One HIFU device dedicated to the treatment of localized prostate cancer. The Prix Galien honors major innovative therapies or drugs introduced to the public market and promotes significant advances in healthcare research.

"It is a great honor to receive the prestigious Prix Galien," commented Marc Oczachowsky, EDAP TMS Chief Executive Officer. "This award recognizes the therapeutic excellence of our Focal One HIFU system as an innovative device in the treatment of localized prostate cancer. It also rewards the outstanding work achieved by our dedicated teams and partners in developing and bringing to market this minimally invasive therapy preserving prostate cancer patients’ quality of life. We are very proud to be part of the highly selective group of companies awarded with the prestigious Prix Galien."

The jury reviewed 120 candidates and selected nominees among six categories. Awards were announced during the prestigious Galien gala dinner which took place on December 7, 2016 at the Pavillon d’Armenonville in Paris, France.

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.

About Prix Galien

The Prix Galien was created in France in 1970 by a pharmacist named Roland Mehl. Its aim was to promote significant advances in pharmaceutical research. Until the creation of the Prix Galien, this field of research had remained largely unrecognized. A prominent jury was brought together, including clinicians, toxicologists, pharmacologists and pharmacists. Each year, the award has been an opportunity to give credit to the most important drugs introduced into the public market as well as to the achievements of the best research team in the pharmaceutical field. Since its creation, the Galien award has grown into a major event. It is seen as an influential event by all those interested in pharmaceutical research, including public authorities, scientists, pharmaceutical companies and medical press groups. For this reason, it is also considered as the industry’s equivalent of the Nobel prize and the highest accolade for pharmaceutical research and development. For more information on Prix Galien, please visit http://www.prixgalien.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:
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EDAP TMS SA	
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