Dec 14, 2016

EDAP Announces Focal One® HIFU Sale to Foch Hospital, Paris

Growing Adoption of Focal One HIFU in France

LYON, France, Dec. 14, 2016 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced the sale of a Focal One® system to Foch Hospital, Paris, one of the largest private hospitals in the Paris Area.

Pr. Thierry Lebret, Head of Urology and Kidney Transplantation Department at Foch Hospital and recently appointed President of the French Urology Association, commented: "Our team is enthusiastic about the acquisition of Focal One HIFU as it responds to a growing demand for more non-invasive prostate cancer treatments. This innovative system adds to our portfolio of solutions offered to prostate cancer patients. Focal One combines state-of-the-art IRM and real-time ultrasound imaging capabilities with targeted HIFU technology to allow precise ablation of prostatic tissue, with reduced side effects."

Pierre Reboul, EDAP TMS France Business Unit Director, added: "We are very pleased with this Focal One acquisition by the prominent Foch Hospital under the leadership of Pr. Lebret. This investment confirms the growing adoption of HIFU for the management of prostate cancer in France as demonstrated during the recent French Urology Association Congress held in Paris last November. Our HIFU Club, organized during this event, gathered more than 50 French Focal One users who shared their experience and appetite for the technology's capabilities. We look forward to continued expansion of HIFU access to more prestigious centers in France."

Marc Oczachowski, EDAP's Chief Executive Officer, concluded: "Interest in our innovative HIFU technologies is clearly growing as we continue to open and train new state-of-the-art and academic centers in France and internationally. In addition, it supports our belief that Focal One has the potential to become a primary therapeutic option in modern prostate cancer management."


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. 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 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.


Blandine Confort

Investor Relations / Legal Affairs EDAP TMS SA

+33 4 72 15 31 72







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