EDAP Announces Focal One(R) HIFU Installation at Germany's Martini-Klinik

LYON, France, June 9, 2015 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced the installation of a Focal One system under a Revenue-per-procedure ("RPP") contract with the Martini-Klinik at the University Hospital Hamburg-Eppendorf (UKE) in Germany.

The Martini-Klinik is the world's largest prostate cancer center by treatment volume, conducing approximately 2,200 prostate cancer procedures per year.

Dr. Georg Salomon, MD, PhD, Senior Physician at the Martini-Klinik and Associate Professor of Urology at the University of Hamburg commented: "Like all other cancers, there is no single, universal solution to treat prostate cancer and with that in mind, the Martini-Klinik has added Focal One HIFU to its therapeutic portfolio. Focal therapy is a promising, minimally invasive treatment option for select patients. We are proud to offer this innovative treatment to our patients and will be assessing the long term outcomes of this emerging therapeutic approach. The addition of Focal One reinforces the Martini-Klinik's position at the forefront of urologic care where the most experienced physicians utilize cutting edge technology to provide unrivalled, individualized care to the contemporary prostate cancer patient."

Judith Johannsen, EDAP GmbH's General Manager for Germany, added: "A facility as prominent as Martini-Klinik using Focal One represents an important validation of our technology, and we are confident that our device will become an invaluable asset for the center. Dr. Salomon is a renowned member of the urological community and we look forward to working with him to bring HIFU treatment to a growing number of patients in need."

Marc Oczachowski, EDAP's Chief Executive Officer, concluded: "We are extremely pleased that Martini-Klinik has chosen to adopt Focal One through this RPP agreement, which we expect will support the continued growth of our procedure-driven revenue. This is another clear indication of the growing appreciation for focal therapy among thought leaders in urology. Moreover, it supports our belief that Focal One has the potential to become a must-have therapeutic technology in today's prostate cancer treatment paradigm."


EDAP TMS SA markets today Ablatherm® for high-intensity focused ultrasound (HIFU) treatment of localized prostate cancer outside the U.S. HIFU treatment is shown to be a minimally invasive and effective treatment option 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. EDAP TMS is currently pursuing a Direct De Novo petition in parallel of a PMA for Ablatherm 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 uncertainties of the U.S. FDA clearance process, 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. Ablatherm-HIFU treatment is in clinical trials, but not FDA-cleared or marketed in the United States.

CONTACT: Blandine Confort Investor Relations / Legal Affairs EDAP TMS SA +33 4 72 15 31 72 bconfort@edap-tms.com Investors: Lee Roth The Ruth Group 646-536-7012 lroth@theruthgroup.com