EDAP-TMS received a letter from the US Food and Drug Administration (FDA) indicating that, although their premarket application for the Ablatherm device to treat localized prostate cancer was not approvable in its current form, a path forward is possible.
The letter provides specific guidance and recommendations for modifying the patient population to those prostate cancer patients with a greater risk of morbidity and/or mortality from their disease and for using the company's European registry along with the already existing safety data to support approval for the modified indication. EDAP’s press release provides additional details.
"This response from the FDA reflects the extensive and ongoing discussions between our team and agency staff…We appreciate their constructive and comprehensive recommendations."
– EDAP CEO Marc Oczachowski