EDAP Provides Formal Response to FDA Addressing All Concerns Raised in July 2015 Ablatherm HIFU Letter

EDAP TMS SA EDAP, the global leader in therapeutic ultrasound, today announced that on Friday August 21, 2015, it submitted a complete, formal response to the U.S. Food and Drug Administration ("FDA") "Deficiency List" (as such communications about a regulatory filing are officially termed). The FDA review of EDAP's Direct De Novo 510(k) petition had been on hold pending submission of the response. It will allow FDA to resume review. Marc Oczachowski, Chief Executive Officer of EDAP TMS SA, commented: "As anticipated, we were able to provide a complete formal response to the FDA's requests in an expeditious manner, which has enabled them to resume active review of our Direct De Novo petition. A major component of the response was completion of the reprocessing validation tests, which have all passed. We look forward to the ongoing review of our submission, and plan to continue working closely with FDA to move the process forward."