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Received CE mark for innovative robotic HIFU device Focal One ®
Eliminated all outstanding long-term debt and strengthened financial profile
Publication of long-term study reporting 10 year cancer-specific survival and metastatic-free survival rates for prostate cancer patients treated with Ablatherm-HIFU
LYON, France, Aug. 28, 2013 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced today financial results for the second quarter and six months ended June 30, 2013, and provided an update on recent strategic developments.
Marc Oczachowski, EDAP's Chief Executive Officer, stated, "During the quarter, we continued to make strides in our business plan as we strengthened our balance sheet and reached a significant milestone with our innovative technology. In particular, we repaid the full $8 million of our outstanding long-term debt. We also received CE mark in June for Focal One®, our additional and complementary robotic HIFU device, and we have subsequently commenced our commercialization efforts in Europe. In addition, device sales are progressing well as we reach the end of August, with several pending lithotripsy projects that we anticipated closing during the second quarter confirmed in early July due to customer related factors. We continue to strengthen our sales backlog and are working toward closing these in the coming weeks."
In June 2013, EDAP received CE mark (European regulatory approval) for Focal One
®, its new and innovative robotic HIFU device fully dedicated to focal therapy of prostate cancer. The CE mark positions Focal One for commercialization in Europe and in many other countries.
In June 2013, EDAP completed the full redemption of its $8.0 million outstanding long-term debt by using a portion of the net proceeds from the $12.0 million private placement executed in May 2013.
In June 2013, the 100-day meeting with the FDA provided a discussion forum regarding the PMA application for EDAP's Ablatherm-HIFU device for the treatment of localized prostate cancer and confirmed that our submission process is ongoing.