EDAP Reports Publication Highlighting Ablatherm's Safety and Efficacy in Prostate Cancer
EDAP Reports Publication Highlighting Ablatherm's Safety and Efficacy in Prostate Cancer
LYON, France, June 10, 2008 (PRIME NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced today that the British Journal of Urology (May 2008) published a systemic and comprehensive literature review of the outcomes of high intensity focused ultrasound (HIFU) as a treatment for prostate cancer. The purpose of this review, which was conducted by The French Association of Urology, was to define the patients for which HIFU should be offered.
A total of 37 published medical journal articles were selected for review, along with several abstracts recently presented at major medical conferences. The review concluded that in the short term, negative biopsy rates are high and PSA levels are substantially decreased and that medium term results with the Ablatherm device seem promising. Additionally, the procedure is well tolerated with a low rate of complications that compares favorably with other treatment options such as radical prostatectomy or radiotherapy. Based on these findings, the French Association of Urology defined HIFU to be indicated for patients aged 70 years or older with clinical stage T1-T2 prostate cancer, PSA of less than 15 and a Gleason score less than 7. This represents a substantial proportion of patients in a PSA screened population.
"HIFU is a recognized therapy for the treatment of prostate cancer following the recommended and official inclusion criteria approved by the French Association of Urologists. The Ablatherm® provides a positive and adapted therapeutic solution to both patients and urologists in the management of localized prostate cancer," stated Dr. Xavier Rebillard, Clinique Beausoleil, Montpellier, France.
Marc Oczachowski, EDAP's Chief Executive Officer, said, "This publication is a clear milestone for Ablatherm® Robotic HIFU. We are proud and excited by the fact that a scientific independent society such as the French Association of Urology acknowledges HIFU as a standard of care for selected primary care patients with localized prostate cancer. We are delighted by this review, which recognizes our long term data in using HIFU for prostate cancer and also confirms both the efficacy and safety of Ablatherm-HIFU."
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 multicenter U.S. Phase II/III clinical trial under an Investigational Device Exemption granted by the FDA. EDAP TMS SA is a leader in HIFU with 20 years of experience and over 16,000 treatments performed. The Company also is developing this technology for the potential treatment of certain other types of tumors. The Company 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 or http://www.urotoday.com.
CONTACT: EDAP TMS SA Investor Relations / Legal Affairs Blandine Confort +33 4 72 15 31 72 bconfort@edap-tms.com The Ruth Group Investors: R.J. Pellegrino 646-536-7009 rpellegrino@theruthgroup.com