LYON, France, April 24, 2014 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced that HIFU for the primary treatment and salvage therapy of localized prostate cancer are recommended by the European Urology Association in its 2014 Guidelines released in April at the EAU's Annual Congress held in Stockholm.
In the EAU Guidelines 2014 edition, HIFU is recommended for the primary treatment of localized prostate cancer and received a "C" recommendation grade. HIFU was not previously recommended nor graded by the EAU. HIFU as a salvage therapy following failed radiation therapy was recommended in the 2014 edition with a "B" recommendation grade. In the 2013 edition, HIFU as salvage therapy was recommended as an experimental treatment option without a grade.
The EAU Guidelines aim to help improve clinical practice and are based on a formal review of all of the evidence obtained from peer reviewed publications. Based on the EAU's methodology, each treatment is assigned a recommendation grade, which is not a scale but rather reflects the types of studies used to evaluate the treatment and make the recommendation.
John Rewcastle, Ph.D., EDAP's Medical Director, commented, "The EAU Guidelines on Prostate Cancer are the primary reference for urologists in Europe and many other countries and the primary resource used to establish standards of care for the treatment of prostate cancer. Inclusion in the treatment guidelines as a recommended therapeutic option, which is based on clinical evidence, further validates HIFU technology and the procedure as an accepted clinical practice among health authorities and urologists."
Marc Oczachowski, EDAP's Chief Executive Officer, stated, "The EAU's recommendation for HIFU both as a primary treatment and salvage therapy clearly establishes HIFU as a standard of care for prostate cancer. This is another substantial positive recognition following the recently received reimbursement in France."
Mr. Oczachowski concluded, "EDAP garnered strong visibility at this year's EAU Annual Congress. Focal therapy was a significant topic at the meeting having been featured prominently in both the scientific sessions and the continuing education courses. Our Focal One device is the key facilitator of this targeted treatment approach. The live demonstrations of the Focal One and Sonolith i-move devices in our booth yielded record attendance."
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.