Healthcare Industry News: Sonolith
News Release - May 31, 2012
EDAP Aligns Management Team to Maximize Global OpportunitiesCEO Marc Oczachowski Established in U.S.
CFO Eric Soyer Named General Manager, EDAP TMS France
CEO EDAP TMS Japan Jean-Francois Bachelard Named EDAP Asia Operations Supervisor
LYON, France, May 31, 2012 -- (Healthcare Sales & Marketing Network) -- EDAP TMS SA (Nasdaq:EDAP ), the global leader in therapeutic ultrasound, has aligned its management team to focus on the U.S. opportunities for both its Ablatherm(R) High Intensity Focused Ultrasound (HIFU), and its newest extracorporeal shockwave lithotripsy (ESWL) platform, the Sonolith(R) i-move.
"After careful consideration, the Board came to the conclusion that the U.S. market is critically important for EDAP," said Philippe Chauveau, Chairman of the Board of Directors of EDAP TMS. "We see significant growth drivers in the U.S., both in the lithotripsy market and in continuing to drive our Ablatherm-HIFU program toward FDA submission, targeted for fourth quarter 2012. With Marc headquartered in the U.S., we believe that EDAP will be better able to seize these opportunities and increase shareholder value."
Marc Oczachowski said, "There are clear milestones and important challenges for EDAP in the U.S., and it is crucial that we concentrate our efforts on seizing these opportunities. My presence in the U.S. will assure that I am an integral part of the team working to advance our Ablatherm-HIFU submission to the FDA and focusing on accelerating our sales and marketing initiatives to aggressively penetrate the ESWL market."
Mr. Oczachowski continued, "I will be able to focus a great majority of my time and efforts on our U.S. priorities and opportunities, as I know I can count on a very solid and professional team in both Europe and Asia to continue working on our projects and growth initiatives outside of the U.S."
About EDAP TMS SA
EDAP TMS SA develops and markets Ablatherm(R), 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 multi-center U.S. Phase II/III clinical trial under an Investigational Device Exemption (IDE) 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 (the Sonolith(R) range) 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.
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, the conclusiveness of the results of and success of its Ablatherm-HIFU clinical trials and expectations regarding the IDE submission to and approval by the FDA of the Ablatherm-HIFU device. Such statements are based on management's current expectations and are subject to a number of uncertainties, including the uncertainties of the regulatory process, 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 and in particular, in the sections "Cautionary Statement on Forward-Looking Information" and "Risk Factors" in the Company's Annual Report on Form 20-F. Ablatherm-HIFU treatment is in clinical trials, but not FDA-approved or marketed in the United States.
Source: EDAP TMS
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