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EDAP Reports Fourth Quarter 2012 And Full Year Results

Highlights  

  • Record fourth quarter 2012 revenue of EUR 9.5 million (USD 12.3 million), up 25.3% year-over-year
  • Record full year revenue of EUR 26.1 million (USD 33.6 million), up 16.9% year-over-year
  • Record lithotripsy sales in 2012
  • PMA for Ablatherm®-HIFU for treatment of low risk, localized prostate cancer accepted by the FDA for filing on March 26, 2013

LYON, France, April 2, 2013 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced today financial results for the fourth quarter and year ended December 31, 2012, and provided an update on recent strategic developments.

Marc Oczachowski, EDAP's Chief Executive Officer, stated, "We are very pleased with our record revenues in the fourth quarter, and for the full year 2012. Our sales growth can be attributed to the robust sales of our innovative Sonolith lithotripters around the globe. Customers continue to respond to our innovative products and improving offerings. We continue to aggressively pursue market penetration, and strengthen our sales operations across key markets, including Europe, Asia, and the U.S." 

Mr. Oczachowski continued, "Our PMA application for Ablatherm-HIFU is steadily moving forward through the U.S. FDA review process. Last week we received notification that our PMA had been accepted for Filing Review, less than two months after we submitted the complete application to the FDA.  With this significant milestone completed, we have now entered the substantive review phase, and we are looking forward to a continuing dialog with the agency as the review process advances."

Recent Developments

In March 2013, the U.S. Food and Drug Administration (FDA) provided a positive Filing Review Notification for the EDAP's Pre-Market Approval (PMA) application for its Ablatherm Integrated Imaging HIFU (High Intensity Focused Ultrasound) device for treatment of low risk, localized prostate cancer. The PMA was received by the FDA on February 5, 2013, and was given a filing date of February 28, 2013. The PMA submission included data from the Company's ENLIGHT study, a multi-center U.S. Phase II/III clinical trial that completed the two year follow-up needed to evaluate its primary endpoint in August 2012, as well as data from the Company's extensive worldwide database of treatment information and follow-up data from patients who have undergone HIFU therapy for prostate cancer.

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