EDAP Announces Sale of Focal One(R) HIFU Device to Mannheim University Hospital, Germany

LYON, France, Oct. 7, 2014 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced the first successful treatments performed at Germany's Mannheim University Hospital ("UMM"), using the Company's Focal One® HIFU device.

UMM is home to one of the largest urological Centers in Germany, with more than 4,000 patients treated annually. The Department of Urology at UMM is headed by prominent urologist Pr. M.S. Michel, also Chairman of the Academy of German Urologists. The UMM Urology Department is a large certified prostate cancer center, offering the most advanced innovative imaging and therapeutic technologies to address prostate cancer.

Pr. Michel commented: "HIFU with Focal One, together with its innovative MRI – ultrasound image fusing capabilities, is definitely the most promising therapy for men with early stage prostate cancer; UMM is proud to be one of the early adopters of this revolutionary device, and among the first in the world to offer this therapeutic option to prostate cancer patients."

Marc Oczachowski, EDAP's Chief Executive Officer, added, "We are very pleased to add one of the largest German Prostate Cancer Centers, Mannheim University Hospital, to our growing number of Focal One adopters. This trend confirms the positioning of our Focal One HIFU system as a viable complement to current prostate cancer treatments at leading Institutions."

EDAP TMS recently presented its innovative technologies at the 66th Congress of the German Society of Urology held October 1 – 4, 2014, in Dusseldorf, Germany. The Company's presentation included live Focal One demonstrations, which were well-attended by urologists. Feedback from the demonstrations confirmed significant physician interest in adopting this HIFU tool to address the needs of prostate cancer patients.


EDAP TMS SA markets today Ablatherm® for high-intensity focused ultrasound (HIFU) treatment of localized prostate cancer. 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 and commercialized in Europe as a treatment for prostate cancer and is currently under regulatory review in the U.S. following submission of the Pre-Market Approval Application in February 2013 after the completion of a multi-center U.S. Phase II/III clinical trial under an Investigational Device Exemption (IDE) granted by the FDA. In March 2013, the Company introduced a new innovative 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 commercializes medical equipment (the Sonolith® range) for treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL). 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 approval 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-approved 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 / Sam Martin The Ruth Group 646-536-7012 / 7008 lroth@theruthgroup.com / smartin@theruthgroup.comSource:EDAP TMS SA