EDAP Successfully Expands HIFU Business and Approval in New Territories
EDAP Successfully Expands HIFU Business and Approval in New Territories
LYON, France, Sep 10, 2009 (GlobeNewswire via COMTEX News Network) -- EDAP TMS S.A. (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced today the expansion of Ablatherm-HIFU into new territories as part of the Company's global growth strategy:
* The Taiwan Department of Health (TDOH) officially approved the Ablatherm-HIFU device as a minimally invasive treatment for patients with prostate cancer. * The first Ablatherm-HIFU device was sold in South America (Bolivia), opening the continent to Ablatherm-HIFU technology.
Dr. Rene Heredia, Head of Urology Dept at Centro de Urologia Avanzada de la Clinica Incor Santa Cruz de la Sierra, commented, "Ablatherm-HIFU now offers an important treatment option in Bolivia for patients with localized prostate cancer. The device has demonstrated clear benefits and successful treatment outcomes, while its minimally invasive, robotic aspect preserves patients' quality of life. We are extremely pleased to be able to offer this state-of-the-art treatment option to our patients."
Marc Oczachowski, Chief Executive Officer of EDAP TMS, stated, "I am excited about EDAP's progress in expanding our global HIFU business. The recent approval of Ablatherm-HIFU by the Taiwanese Department of Health confirms our ability to successfully achieve regulatory approval and bring new devices to market. I am also very pleased with our first Ablatherm-HIFU sale in South America, reflecting the full commitment of our dedicated sales force and distribution partners in further penetrating new markets."
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. 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 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, http://www.hifu-planet.com and http://www.pcaresearch.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. 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 FDA-approved or marketed in the United States.
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SOURCE: EDAP TMS SA
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 Nick Laudico 646-536-7030 nlaudico@theruthgroup.com
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