EDAP Reports Growing Momentum in Europe for HIFU Treatment of Prostate Cancer

  • Live Focal One HIFU treatment at Robotic Urology Congress, Bilbao, Spain
  • Strong participation in German Urology Society Congress
  • Dedicated Intensive training program being implemented following purchase of Focal One by private group of Hospitals in France

LYON, France, Sept. 24, 2015 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today provided an update on the growing momentum being experienced by HIFU technology in the European market, in particular the rapidly increasing interest in the use of focal therapy in the treatment of prostate cancer.

On September 15-17, 2015, EDAP actively participated in the EAU Robotic Urology Section (ERUS) congress held in Bilbao, Spain, where a remote prostate cancer HIFU treatment using Focal One® was performed live by Dr. Rochat and Dr. Regusci from the Geneva Beaulieu Hospital. The HIFU treatment was shown live to more than 300 robotic surgeons with interactive discussions taking place. The event was well attended by leading urologists with a focus on robotic surgery who are seeking a focal option to complement their surgical offering for prostate cancer.

Additionally, multiple EDAP products, including the Company's Focal One technology, are being showcased at the 67th Congress of the German Society of Urology (DGU) in Hamburg, Germany, taking place September 23- 26, 2015. In addition to exhibits of EDAP's innovative urological technologies, the event will feature live demonstrations of Focal One HIFU, which addresses urologists' increasing demand for a dedicated solution for the focal treatment of prostate cancer.

Finally, with the recent Focal One sale to Medipôle Partenaires, one of the largest private Hospital groups in France, EDAP is clearly expanding its HIFU penetration in the French territory. Medipôle Partenaires will be using the Focal One device on a mobile basis with the equipment being shared between more than ten private urology centers throughout the country. EDAP and Medipôle Partenaires are now conducting a dedicated, intensive training program for the group's urologists. The adoption of HIFU for prostate cancer in France is being supported by the French authorities' decision to reimburse HIFU treatment within the framework of innovative technologies programs ("Forfait Innovation").

Marc Oczachowski, EDAP's Chief Executive Officer, commented: "Today, we see clear evidence of the increasing adoption of HIFU in Europe, with especially strong interest in our Focal One HIFU technology. The rapidly growing demand for focal HIFU technology among robotic prostate cancer surgeons is excellent news for EDAP given our leadership in the space. Moreover, it speaks to the significant unmet need for a non-invasive, focal therapy option to strengthen the modern prostate cancer treatment armamentarium."


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