LYON, France, May 17, 2012 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), a global leader in therapeutic ultrasound, announced today that its Ablatherm® High Intensity Focused Ultrasound (HIFU) will be featured in two presentations supporting the technology's efficacy for the treatment of localized prostate cancer, both as a primary care option and as a salvage treatment. The data, as well as EDAP's extracorporeal shock wave lithotripsy (ESWL) platform, the Sonolith® i-move, will be featured at the American Urological Association (AUA) 2012 Annual Meeting, held May 19-23 in Atlanta, GA.
EDAP is a pioneer of ESWL for the non-invasive treatment of urinary stones. Its eighth-generation Sonolith i-move was cleared by the FDA in August 2011 and has already been installed in three locations in the U.S. It will be available for live demonstration at AUA booth #2837.
Ablatherm-HIFU is approved in Europe and currently investigational in the U.S. as a minimally invasive treatment for localized prostate cancer. It uses ultrasound waves to heat and ablate the targeted tumor tissue, while reducing the risk of collateral tissue and nerve damage, compared to more invasive, traditional therapies. The two-year follow-up phase for a pivotal multicenter U.S. Phase II/III clinical trial (ENLIGHT) is expected to be completed at the end of June 2012 and outcomes data are expected to be submitted to the U.S. FDA in the fourth quarter of 2012.
Scientific Session Highlights:
Date/Time: Sunday, May 20, 10:30 AM
Podium 382: Salvage HIFU after failed external beam radiation: 6 years biochemical survival and morbidity of 982 patients from a multicenter database – Six year oncologic outcomes of High Intensity Focused Ultrasound as salvage treatment of localized prostate cancer recurrence following external beam radiation therapy. Outcomes from 982 patients followed with the @-Registry.Date/Time: Tuesday, May 22, 1:00 PM
Poster 1813: Oncological outcomes of high-intensity focused ultrasound for localized prostate cancer in 1098 consecutive patients –Outcomes of patients treated with High Intensity Focused Ultrasound as a primary care option for localized prostate cancer, and to determine factors influencing the outcomes. Outcomes from 1098 patients.
Additionally, three posters highlighting HIFU will be presented on Saturday, May 19, 2012, at the 27th Annual Meeting of the Engineering and Urology Society, held in conjunction with AUA. Dr. Christian Chaussy of the University Regensburg, Germany and a member of the Company's Scientific Advisory Board, and Dr. Thuroff of Harlaching Hospital, Munich, will present their findings and be available to answer questions.
Poster 21: 15 Years transrectal High Intensity Focused Ultrasound in Localized Prostate Cancer therapy: Impact of neoadjuvant TURP before HIFU on Oncological Efficacy–Analysis of the oncological efficacy of TURP before HIFU as therapy for localized prostate cancer according to PSA Nadir.
Poster 40: 15 Years Transrectal High Intensity Focused Ultrasound in Prostate Cancer Therapy: Development of Side Effects –Analysis of overall side effects of combined TURP and HIFU as therapy for localized prostate cancer, analysis of influence of three therapeutic strategies using HIFU, and evaluation of the relative influence of neoadjuvant TURP on side effects.
Poster 41: Treatment of Locally Advanced Prostate Cancer with Transrectal High Intensity Focused Ultrasound (HIFU) delays Androgen Deprivation Therapy (ADT) – Evaluation of the efficacy of local TURP and HIFU treatment in patients with locally advanced prostate cancer and the necessity of ADT.
About EDAP TMS SA
EDAP 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 (IDE) 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 (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 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.