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Dr. Scionti, Medical Director of Vituro Health and most experienced HIFU urologist in the U.S. to start treating with Ablatherm in September

September 5, 2017

LYON, France, August 31, 2017 — EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced that the Company signed a partnership agreement with Vituro Health LLC, an Alabama-based organization providing HIFU therapy nationwide to patients with prostate cancer. Vituro Health has been offering HIFU Sonablate technology to its patients for years and has decided to add Ablatherm-HIFU to its portfolio to enlarge its offering. Ablatherm will be made available to Vituro Health physicians in their training facility in Sarasota, Florida or on a mobile basis, hence offering the opportunity to access Ablatherm-HIFU technology on demand.

Dr. Stephen Scionti, Medical Director at Vituro Health and Founder and Director of The Scionti Prostate Center in Sarasota, FL, commented: “I am excited to partner with EDAP and expand our offering using their technology.  EDAP’s technology has been the most widely used in the world and we will now have all FDA approved HIFU technologies available to treat our patients”.

Clete Walker, Chief Executive Officer of Vituro Health, added: “Expanding our offering to include EDAP’s technology allows us to offer our partners more value and enhances our precision prostate program.  Additionally, adding EDAP to our industry leading training program allows us to ensure physicians are properly trained before they perform cases on qualified patients.”

Marc Oczachowski, Chief Executive Officer of EDAP TMS, commented: “We are extremely proud to partner with Vituro Health, and bring our Ablatherm-HIFU Robotic technology into their center of excellence site in Sarasota Florida, The Scionti Prostate Center. This is going to be a great National and International reference center for EDAP’s unique and superior HIFU technology.”

Oczachowski added: “EDAP is honored by Dr. Stephen Scionti’s choice to incorporate our Ablatherm HIFU device in his practice. Dr. Scionti is by far the most experienced HIFU urologist in the US and has performed more than a thousand treatments over more than a decade. We are looking forward to assisting his training program and first cases in September under the proctorship of the most experienced HIFU user in the world, Prof Stefan Thueroff from Munich, Germany”.

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. Ablatherm Fusion is not FDA cleared yet. 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 cleared. 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-prostate.com.

About Vituro Health

Vituro Health empowers men with comprehensive prostate care during all stages of their lives. We arm partner physicians with HIFU (high intensity focused ultrasound) technology and other patient-centric, concierge services to elevate the standard of care and patient experiences. Vituro Health serves patients nationwide and is headquartered in Birmingham, Ala., with partnering physicians in Birmingham, Sarasota, Fla., Jacksonville, Fla., Atlanta, Philadelphia, Pa. the Washington metropolitan area, Dallas, Tex., Las Vegas, Nev., and Phoenix, Ariz., who are carefully selected based on their depth of experience, expertise and dedication to achieving the highest levels of patient outcomes. For more information and to learn about our physicians, visit www.viturohealth.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.


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