EDAP Announces Opening of two New Ablatherm-HIFU Excellence Urology Centers in the U.S.

Planet edap Inc.
Sep 19,2017

EDAP Announces Opening of two New Ablatherm-HIFU Excellence Urology Centers in the U.S.

University of Chicago Medicine - Dr. A. Shalhav, Chair of Urology Surgery and Director of Robotic Surgery Vituro Health LLC - Dr. S. Scionti, Medical Director and Director of The Scionti Prostate Center in Sarasota, FL

LYON, France, September 19, 2017 -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced successful treatments performed by two excellence and referenced Prostate U.S. centers, using Ablatherm Robotic HIFU.

Dr. Arieh Shalhav, Chair of Urology Surgery and Director of Robotic Surgery at University of Chicago Medicine, commented: "As surgeons, we strive to find effective treatment options that are less disruptive to the human body and life, and set the stage for better, and gentler ways of curing disease. Focal HIFU fills a significant void between active surveillance - a watch and wait approach , which can be stressful - and radical treatments like whole gland removal, radiation or ablation.  HIFU bridges this gap and allows patients to maintain their quality of life."

Dr. Stephen Scionti, the most experienced HIFU urologist in the U.S. and Medical Director of Vituro Health added: "I am captivated by Ablatherm-HIFU; the device is very user friendly and its automatic robotized approach makes it very safe and easy to learn and use. The friendliness of the software and the high quality of the 7.5MHz ultrasound image facilitates treatment in a fast, smooth and accurate manner."

Marc Oczachowski, Chief Executive Officer of EDAP TMS, concluded: "We are honored to have such prominent excellence centers as the University of Chicago Medicine and The Scionti Prostate Center in Florida adopting our Ablatherm Robotic HIFU device. As we are actively opening new HIFU sites in the U.S., it is very rewarding to receive immediate high satisfaction and positive feedback from such key opinion leaders in Urology upon performing their first Ablatherm-HIFU treatments. Such positive live appreciation from physicians confirms Ablatherm-HIFU technical superiority and validates our educational strategy with the close assistance of an experienced KOL proctor."


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.

Investor Contact

Rich Cockrell

Company Contact
Blandine Confort
Investor Relations / Legal Affairs EDAP TMS SA
+33 4 72 15 31 50

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