Healthcare Industry News: S.A.
News Release - December 13, 2007
EDAP Announces First Published Long-Term Study of HIFU for Localized Prostate Cancer
LYON, France, Dec. 13, 2007 (Healthcare Sales & Marketing Network) -- EDAP TMS S.A. (NaS.A.GM:EDAP ) the global leader in High Intensity Focused Ultrasound treatment of proS.A.e cancer announces the release of the first multi-center long-term study of HIFU uses for the treatment of localized proS.A.e cancer. The study's lead author, Dr. Andreas Blana, concludes that Ablatherm-HIFU efficacy is competitive to currently accepted nonsurgical S.A.dards of care, such as radiotherapy, but offers patients milder side effects.Dr. Blana S.A.ed, ``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 proS.A.e cancer. Indeed, I would say it iS.A. excellent treatment option for men with localized proS.A.e cancer, and it should be part of a doctor'S.A.mory when treating the diS.A.e.''
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 S.A.le in nearly 8 of 10 participants (77%). Follow-up ranged up to 9 years with a mean of 6.4 yearS.A.d all patients tracked at least 5 years. Median nadir PSA achieved was 0.16 ng/ml with a number of patientS.A.hieving 0.0 ng/ml, and 68.4% of patientS.A.hieved nadir PSA of below 0.5 ng/ml. The study concludeS.A.latherm-HIFU is effective in treating organ confined proS.A.e 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 proS.A.e cancer also at long-term follow-up. These oncologic results can be considered competitive with those reported after radical proS.A.ectomy 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 proS.A.e cancer therapy in countries where it iS.A.ready approved for routine clinical use. In the United S.A.es, HIFU iS.A. 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.A.e 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
Company Background:
EDAP TMS S.A. developS.A.d marketS.A.latherm, the most advanced and clinically proven choice for High Intensity Focused Ultrasound (HIFU) treatment of localized proS.A.e cancer. The company is currently in U.S. FDA Phase II/III Clinical TrialS.A. 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 S.A.ching 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.A.ong centers.
Ablatherm-HIFU iS.A.treatment for patients with newly diagnosed localized proS.A.e cancer or who have failed radiotherapy treatment. The company iS.A.so developing this technology for the potential treatment of certain other types of tumors. EDAP TMS S.A. also produceS.A.d commercializes medical equipment for treatment of urinary tract stones using Extra-corporeal Shockwave Lithotripsy (ESWL).
EDAP TMS S.A. also produceS.A.d 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 S.A.ements that involve riskS.A.d uncertainties. These include S.A.ements regarding the Company's growth and expansion plans. Such S.A.ementS.A.e based on management's current expectationS.A.d are subject to a number of uncertaintieS.A.d risks that could cause actual results to differ materially from those described in these forward-looking S.A.ements. Factors that may cause such a difference include, but are not limited to, those described in the Company's filings with the SecuritieS.A.d Exchange Commission. Ablatherm-HIFU treatment is in clinical trials but not yet FDA approved or marketed in the United S.A.es.
Source: EDAP TMS
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