Second Quarter 2012 Highlights
- Revenues increased 61% year-over-year to EUR 6.1 million (USD 7.8 million)
- Strong lithotripsy sales with fourteen devices sold globally
- Strengthened third quarter device backlog to sixteen lithotripsy devices at the end of August 2012
- Completed U.S. FDA HIFU trial two year follow-up phase in June 2012
- On track to file PMA submission for Ablatherm-HIFU Phase II/III clinical trial in fourth quarter 2012
- Retained Greenleaf Health as strategic advisor on U.S. FDA submission
LYON, France, Aug. 30, 2012 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced today financial results for the second quarter ended June 30, 2012.
Marc Oczachowski, EDAP's Chief Executive Officer, commented, "Market acceptance of our renewed lithotripsy device platform continues to grow and contributed to our strong second quarter results. Our quarterly revenues rose 61% year-over-year reflecting the sale of fourteen lithotripsy devices. Our strengthened global sales team is continuing to transform sales leads into confirmed purchase orders as our replenished device backlog now stands at sixteen lithotripsy machines."Mr. Oczachowski continued, "The two year anniversary of the last patient treated in the ENLIGHT trial was in June 2012 and the subsequent patient follow-up visits and data collection were completed in the second half of August in line with our IDE approved clinical protocol. The EDAP teams in the U.S. and France are compiling the PMA submission file, inclusive of both clinical and manufacturing data, for a projected filing in the fourth quarter of 2012. Recent Developments In August, EDAP retained Greenleaf Health LLC, a full service regulatory consulting firm, to provide high-level strategic guidance regarding the final stages of its Ablatherm-HIFU (High Intensity Focused Ultrasound) ENLIGHT U.S. Phase II/III clinical trial for the indication of low risk, localized prostate cancer. Greenleaf Health joins the established EDAP team of experts, both internal and external, inclusive of specialized legal, regulatory, and Clinical Research Organization advisors.