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Marc Oczachowski, EDAP's Chief Executive Officer, said, "This is a very positive initial step in our Sonolith I-Sys commercialization success in the United States. Just a few weeks after the FDA clearance, we have secured interest from a major U.S. lithotripsy player, HealthTronics, Inc. With its large partnerships network, HealthTronics is the largest lithotripsy user in the U.S. with one of the biggest lithotripters installed base. It was a major goal for us to secure the first machine placement as a reference unit in one of the largest lithotripsy markets in the world."
Marc Oczachowski, continued, "We are actively pursuing our efforts and discussions to build the most suitable and effective network to successfully address the U.S. lithotripsy market. To achieve this goal we are carefully evaluating the marketing options in order to make the optimum decision to exploit our opportunities in the U.S. market. In the meantime, as this initial sale highlights, we will continue to directly offer our high range, fully robotized lithotripter the Sonolith I-Sys to major groups and partnerships in the U.S. Finally, we are extremely pleased to see as a confirmation that our last generation of high range integrated lithotripter was successfully designed to match with the needs and expectations of the American market."
The Sonolith I-Sys received CE mark approval in July 2007, was launched in the E.U. in late 2007 and received U.S. FDA clearance in August 2009. The integrated lithotripter utilizes EDAP's unique and patented electroconductive technology, an advanced shockwave approach differentiated by its superior ability to successfully disintegrate urinary stones in association with combined x-ray or ultrasound systems. The device's superior dual imaging systems and user friendly features have contributed to its impressive adoption, positive treatment outcomes and high standards that benefit both patients and hospitals.
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 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 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.
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: EDAP TMS SA
CONTACT: EDAP TMS SA Blandine Confort Investor Relations / Legal Affairs +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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