Healthcare Industry News: Ablatherm
News Release - December 13, 2007
EDAP Announces First Published Long-Term Study of HIFU for Localized Prostate CancerLYON, France, Dec. 13, 2007 (Healthcare Sales & Marketing Network) -- EDAP TMS S.A. (NasdaqGM:EDAP ) the global leader in High Intensity Focused Ultrasound treatment of prostate cancer announces the release of the first multi-center long-term study of HIFU uses for the treatment of localized prostate cancer. The study's lead author, Dr. Andreas Blana, concludes that Ablatherm-HIFU efficacy is competitive to currently accepted nonsurgical standards of care, such as radiotherapy, but offers patients milder side effects.
Dr. Blana stated, ``This study is the first of its kind in examining the long-term results of HIFU treatment. This innovative and revolutionary treatment clearly has the capacity to help men with prostate cancer. Indeed, I would say it is an excellent treatment option for men with localized prostate cancer, and it should be part of a doctor's armory when treating the disease.''
The study tracks 140 patients treated at multiple sites in Europe between 1997 and 2001. The study notes that nearly 9 of 10 participants (86%) achieved negative biopsies following Ablatherm treatment, and PSA after 5 years was low or stable in nearly 8 of 10 participants (77%). Follow-up ranged up to 9 years with a mean of 6.4 years and all patients tracked at least 5 years. Median nadir PSA achieved was 0.16 ng/ml with a number of patients achieving 0.0 ng/ml, and 68.4% of patients achieved nadir PSA of below 0.5 ng/ml. The study concludes Ablatherm-HIFU is effective in treating organ confined prostate cancer and is a valid alternative to current treatments such as radiotherapy.
In an editorial accompanying the published article, Dr. Vincenzo Ficarra from the University of Padua, Italy said, ``These data confirm the efficacy of HIFU in patients with localized prostate cancer also at long-term follow-up. These oncologic results can be considered competitive with those reported after radical prostatectomy or external-beam radiation therapy.''
Dr. Ficarra continued, ``Beyond the oncologic outcomes, the article by Blana et al confirmed the very promising functional data of HIFU treatments in terms of urinary continence and recovery of erectile function.''
Dr. John Rewcastle, Medical Director of EDAP, said, ``This is a very significant publication. Not only is it yet another positive report of the efficacy and mild morbidity profile of HIFU, it demonstrates the durability of the procedure in terms of cancer control over a period of many years. This further solidifies the role of HIFU as a primary prostate cancer therapy in countries where it is already approved for routine clinical use. In the United States, HIFU is an investigational device and is being studied under an FDA approved IDE investigation. The data from this study is relevant to the U.S. study as it demonstrated that short-term results are indicative of longer term cancer control.''
A summary of the study can be obtained online at European Urology at: http://www.europeanurology.com/article/PIIS0302283807013814/abstract
EDAP TMS S.A. develops and markets Ablatherm, the most advanced and clinically proven choice for High Intensity Focused Ultrasound (HIFU) treatment of localized prostate cancer. The company is currently in U.S. FDA Phase II/III Clinical Trials at major U.S. centers including Duke University, Vanderbilt University, Florida Foundation of Healthcare, and others. Participating sites can be viewed online at http://www.clinicaltrials.gov by searching for ``Ablatherm.''
Ablatherm-HIFU is fully approved in the EU and other countries worldwide. More than 14,500 treatments have been completed at more than 165 centers globally. Clinical documentation compiled over more than 10 years provides peer reviewed data attesting to efficacy, safety and repeatability of the treatment outcomes among centers.
Ablatherm-HIFU is a treatment for patients with newly diagnosed localized prostate cancer or who have failed radiotherapy treatment. The company is also developing this technology for the potential treatment of certain other types of tumors. EDAP TMS S.A. also produces and commercializes medical equipment for treatment of urinary tract stones using Extra-corporeal Shockwave Lithotripsy (ESWL).
EDAP TMS S.A. also produces and commercializes medical equipment for treatment of urinary tract stones using Extra-corporeal Shockwave Lithotripsy (ESWL).
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. Such statements are based on management's current expectations and are subject to a number of uncertainties 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. Ablatherm-HIFU treatment is in clinical trials but not yet FDA approved or marketed in the United States.
Source: EDAP TMS
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