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U.S. ENLIGHT Ablatherm-HIFU clinical trial completed enrollment in June 2010 and entered two year follow-up phase
Lithotripsy division revenues increased 10.2% year-over-year to EUR 16.8 million (USD 22.2 million), fueled by innovative lithotripter product line
Outstanding convertible debt further reduced by USD 6.6 million to USD 10.5 million at 12/31/10, down from USD 17.1 million at 12/31/09
LYON, France, March 29, 2011 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced today financial results for the fourth quarter and full year ended December 31, 2010.
Marc Oczachowski, EDAP's Chief Executive Officer, stated, "During 2010, EDAP achieved a major strategic milestone by completing patient enrollment in its ENLIGHT Ablatherm-HIFU U.S. FDA trial. Preliminary patients' follow-up shows satisfactory outcomes with very low side effects comparable to the European clinical results obtained over the past fifteen years, and facilitating the preservation of patients' quality of life. The final data is yet to be submitted to the U.S. FDA for PMA review.
"Over the past year, the economic environment has impacted our HIFU division as hospitals are delaying some capital equipment expenditures. We remain very encouraged by the growing signals on the prominent role HIFU is expected to play in the therapeutic arsenal against prostate cancer. As exemplified by the significant interest at our booth at the European Association of Urology's Annual Congress held last week in Vienna, we are seeing an increasing interest in Ablatherm-HIFU as we position it as the preferred focal therapy treatment option in line with the prostate cancer treatment paradigm shift. The international urological community and patients are demanding a best-in-class device that combines accurate ablative treatment and quality of life preservation, and this is the optimal positioning of our Ablatherm-HIFU solution.
"We are pleased to see return on our investment over the past few years in our lithotripsy innovation. Our continued growth in lithotripsy revenues is a clear demonstration that this market remains very dynamic and in need of technological innovation. EDAP is the only company in this field to have completely renewed its range of products and, more importantly to have implemented new features, concepts and innovation that specifically address the needs of both patients and urologists. We continue to actively pursue opportunities to take market share across the global lithotripsy market and see significant growth potential as we pursue our regulatory filing strategy in both Japan and the US, the two largest markets worldwide."