LYON, France, July 7, 2015 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced the adoption of its Focal One system under a pay-per-procedure sale contract by two major University hospitals in Switzerland: the Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne and Geneva University Hospital (GUH).
Pr. Christophe Iselin, Head of the Urology Department at GUH and former President of the Swiss Urology Society, commented: "We have already completed the first successful treatments at Geneva University Hospital using the Focal One HIFU device. Our clinical team is enthusiastic about the opportunity that focal therapy presents, and eager to adopt such an innovative solution for selected prostate cancer patients. Focal One offers an ideal combination of state-of-the-art IRM and real-time ultrasound imaging capabilities, together with targeted HIFU technology capable of highly precise ablation of cancerous prostatic tissue."
Pr. Patrice Jichlinski, Head of the Urology Department at CHUV, added: "We are pleased to announce the signature of a joint Agreement between GUH and CHUV for the shared use of this Focal One HIFU device by our institutions."
Pierre Reboul, EDAP's Business Unit Director, stated: "The addition of these two Swiss University clinical institutions to our growing Focal One installed base is another clear indication of the increasing interest in the focal approach to managing prostate cancer in Europe. Our pay-per-treatment model is well suited to facilitate access to our HIFU technology in Europe, and we intend to continue promoting our HIFU technology as the optimal choice to address the growing demand for targeted therapy in the treatment of prostate cancer."
About EDAP TMS SA
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.