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Nov 6, 2014
EDAP Receives FDA Guidance on PMA for Ablatherm-HIFU

EDAP-TMS
EDAP Receives FDA Guidance on PMA for Ablatherm-HIFU

Guidance Provides Specific Recommendations for Amendments to Make PMA Approvable

EDAP TMS SA, today received a letter from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) on its current PMA application for Ablatherm Integrated Imaging Device. The FDA letter stated that while EDAP's Ablatherm-HIFU PMA is not approvable in its current form, it provides specific guidance and recommendations as to a path forward. This guidance was provided in accordance with the requirements of 21 CFR 814.44(f), which states that the FDA, where practical, must identify measures necessary to make the PMA approvable.

Consistent with feedback received during the Gastroenterology and Urology Devices Panel meeting, the FDA has recommended considering a modified indication for use in a population of localized prostate cancer patients that have greater risk of morbidity and/or mortality from their disease. The FDA made further recommendations regarding the potential use of the company's European registry, along with the already existing safety data from the previous U.S. IDE, to support approval for the modified indication. Although additional data and analyses will be necessary to address FDA's requests, the letter did not require a new U.S. IDE study.

In order to continue the process, the Company must submit a major amendment, to include the additional information requested by the FDA, by April 29, 2015. This major amendment, which will have the same PMA number as the Company's initial filing, may extend the FDA review period up to 180 days after submission.

Marc Oczachowski, EDAP's Chief Executive Officer, commented, "This response from the FDA reflects the extensive and ongoing discussions between our team and agency staff since the Advisory Panel meeting in July. We appreciate the FDA providing us with constructive and comprehensive recommendations, and believe this may be a potential opportunity to advance through the approval path for our PMA."