LYON, France, June 7, 2012 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced that the National Institute for Health and Clinical Excellence (NICE), an independent organization that advises the National Health Service (NHS) of the United Kingdom on treatment and care, recently published guidance regarding focal therapy using High Intensity Focused Ultrasound (HIFU) to treat localized prostate cancer.
In its International Procedure Guidance 424 on focal HIFU, the NICE guidance highlights the "potential for focal HIFU to avoid many of the complications of more radical treatment procedures" for localized prostate cancer in properly selected patients.
Marc Oczachowski, Chief Executive Officer of EDAP TMS, said, "NICE is a highly respected institution, and the positive guidance they issued on the use of focal HIFU is a clear indicator of the growing official recognition of HIFU in treating localized prostate cancer. We are very pleased to see that NICE highlighted the strong ability for focal treatment using HIFU to preserve patient quality of life. This guidance further demonstrates the strong future of the technology in the modern environment of prostate cancer management."
Ablatherm-HIFU data has been presented at the 5th International Symposium on Focal Therapy and Imaging in Prostate and Kidney Cancer, held from June 6 to June 8, 2012 in Durham, North Carolina.
Marc Oczachowski concluded, "Focal HIFU has been a major topic of discussion at the Focal Therapy and Imaging Symposium this week. Dr. E. Baco, from Oslo University Hospital, Norway, presented data regarding successful outcomes as a result of treatment with Ablatherm-HIFU for patients who failed radiotherapy. The study, 'Hemi salvage HIFU in patients with radiorecurrent prostate cancer' demonstrated focal HIFU efficiency with a very good preservation of patient quality of life, and further confirms targeted HIFU as a satisfactory, non-invasive therapeutic approach in the treatment of localized prostate cancer."
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.