FDA wants more from Edap on Ablatherm de novo bid

Edap (NSDQ:EDAP) today said the FDA wants more on its bid for de novo approval of its Ablatherm HIFU prostate cancer device, saying it needs to address 4 points raised by the federal safety watchdog before the process can resume.

The news, following the French firm’s March announcement that it would abandon its pre-market approval application, sent EDAP shares up 7.5% to $3.75 apiece in pre-market trading today. The stock opened at $3.52 per share and was trading at $3.47 shortly after trading commenced.

Last fall the FDA issued a “not approvable” letter to Edap on the Ablatherm device, a computer-controlled high-intensity focused ultrasound device designed to ablate the entire prostate gland, after an FDA advisory panel recommended against approval. But the FDA said Edap had until the end of this April to amend the PMA application for a narrower indication.

Today Edap said the FDA sent it a letter detailing a 4-item “deficiency list,” putting the de novo process for Ablatherm on hold until the issues are addressed.

The agency wants the results of Edap’s reprocessing validation tests “which are ongoing and expected to be completed in the near future,” the company said. The FDA also wants more details on Edap’s physician training program and changes to Ablatherm HIFU’s draft labeling and user manual, the company said.

“We are very pleased with the FDA feedback to our de novo 510(k) submission. We believe we can address each of the issues raised and we look forward to continuing to work closely with FDA to move the process forward,” CEO Marc Oczachowski said in prepared remarks.

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