Marc Oczachowski, EDAP's Chief Executive Officer, commented, "The reception EDAP received at this major medical event confirms our superiority and expertise in developing and offering new innovative medical devices. Our newly introduced range of lithotripters, Sonolith i-move and i-sys, benefited from the highest recognition from urologists as an innovator meeting their patient needs and expectations. We are confident that our unique innovation capability among lithotripsy players will support our continued growth as the market leaders and increase our market share."
"In HIFU, long experienced urologists and opinion leaders clearly addressed the issue of preservation of quality of life for patients with prostate cancer. Existing therapies, requiring total gland removal, result in major side effects, unacceptable to patients. HIFU is today regarded as the potential solution to focally treat the tumor only, while preserving patient's quality of life with an effective control of the disease."
Marc Oczachowski concluded, "We are encouraged by the strong and positive feedback received during this major medical event on our recent investments to consistently introduce new and innovative concepts, products and technologies to the urology community. This conference was very well attended and EDAP was very successful in attracting a significant number of delegates to see and discuss its technologies."
About EDAP TMS SAEDAP TMS SA develops and markets Ablatherm, the most advanced and clinically proven choice 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. Approved in Europe as a treatment for prostate cancer, Ablatherm-HIFU (High Intensity Focused Ultrasound) is currently undergoing evaluation in a multi-center U.S. Phase II/III clinical trial under an Investigational Device Exemption granted by the FDA, the ENLIGHT U.S. clinical study. The Company also is developing this technology for the potential treatment of certain other types of tumors. EDAP TMS SA also produces and commercializes medical equipment 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 contains forward-looking statements that involve risks and uncertainties. These include statements regarding the Company's growth and expansion plans, the conclusiveness of the results of and success of its Ablatherm-HIFU clinical trials and expectations regarding the IDE submission to and approval by the FDA of the Ablatherm-HIFU device. Such statements are based on management's current expectations and are subject to a number of uncertainties, including the uncertainties of the regulatory process, and risks that could cause actual results to differ materially from those described in these forward-looking statements. Factors that may cause such a difference 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 email@example.com Investors: Stephanie Carrington The Ruth Group 646-536-7017 firstname.lastname@example.org
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