LYON, France, April 10, 2014 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced its participation at the European Association of Urology (EAU) 2014 Annual Congress that will be held in Stockholm on April 11-15, 2014. EDAP's HIFU and lithotripsy device portfolio will be featured in multiple poster sessions.
John Rewcastle, Ph.D., Medical Director of EDAP TMS, commented, "The EAU is one of the leading global events in the field of urology. Clinical data that will be presented provides further recognition and validation of HIFU for the treatment of prostate cancer. Noteworthy is the interest generated among leading clinicians for our Focal One® device. The presentations to be made on Focal One showcase important milestones in the progression of this device that received the CE mark in June of last year."
The scientific program will include seven poster abstracts pertaining to clinical research by clinicians and scientists utilizing Ablatherm HIFU and Focal One. EDAP's devices will be highlighted in three continuing education courses pertaining to prostate imaging, focal treatment of prostate cancer and an update on stone disease. The Company will host live demonstrations at its booth of both the Focal One and the Sonolith i-move devices. A meeting of the @-Registry users will be held to provide data and publication updates. The @-Registry is an approved global registry of HIFU data from patients with HIFU. This meeting will include discussions by significant luminaries within the European urology community who are also experienced practitioners of Ablatherm-HIFU.
Marc Oczachowski, EDAP's Chief Executive Officer, said, "We are proud that posters highlighting our Ablatherm-HIFU and Focal One devices have been accepted for presentation at the upcoming EAU Annual Congress. This is clear academic recognition of HIFU as a valuable technology for treating prostate cancer and reflects positively on the high level of research supporting Ablatherm-HIFU. This is a key differentiator for EDAP, and reinforces our established leadership in HIFU for the treatment of prostate cancer both from a technological and a clinical standpoint."
About EDAP TMS SA
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 February 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 statements00 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.