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Edap bails on Ablatherm PMA, to seek de novo clearance from FDA

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Edap bails on Ablatherm PMA, to seek de novo clearance from FDA

Edap (NSDQ:EDAP) shares ticked up today after the French firm said it’s abandoning the pre-market approval bid for its Ablatherm HIFU prostate cancer device and plans instead to seek de novo clearance from the FDA.

Edap said is made the call after a recent meeting with the FDA in which the safety agency indicated that although it would require a PMA for claims covering prostate cancer treatment, it would allow a de novo application for claims covering prostate tissue ablation.

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 the company said it will shelve pursuit of an amended PMA for Ablatherm and go the less-rigorous de novo route.

“We are pleased with the outcome of our most recent meeting with FDA and the ongoing, open dialogue we have maintained with the agency throughout the regulatory process. We believe pursuing a direct de novo 510(k) petition is an opportunity for more expeditious clearance of Ablatherm HIFU technology in the United States," CEO Marc Oczachowski said in prepared remarks. "Our team is now diligently focused on preparing the de novo application."

EDAP shares ticked up 1.8% to $4 apiece today in mid-morning trading.

In January the company got a boost after Health Canada approved its Focal One HIFU device for treating prostate cancer.

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