The company said the new submission comes following the FDA 510(k) clearance of its Ablatherm Robotic HIFU designed for the ablation of prostate tissue, which it won last November.
“We are pleased to submit our Focal One HIFU device file to the FDA to further our goal of making EDAP’s full range of HIFU products available to both urologists and patients in the U.S. There is a clear, growing demand from the worldwide urology community for non-invasive options for the ablation of prostatic tissue, and we are well positioned to address this market with our complementary Ablatherm and Focal One devices. We believe that HIFU has the potential to become a standard of care tool for prostate ablation. We are extremely excited by the progress of the U.S. commercial launch of Ablatherm Robotic HIFU and look forward to working with the FDA on the clearance process for Focal One,” CEO Marc Oczachowski said in an SEC filing.
Last November, Edap said the appeal deadline lapsed for a shareholders lawsuit filed after an FDA advisory panel recommended against approval for its its Ablatherm device for treating prostate cancer.
EDAP shares plunged in 2014 after the FDA’s Gastroenterology & Urology Devices panel voted that the device did not appear to be effective or safe. Ablatherm, which won 510(k) clearance from the federal safety watchdog earlier in November, uses high-intensity focused ultrasound to ablate prostate tissue.
Shareholders sued in August 2014, accusing Edap of misleading investors by exaggerating Ablatherm’s safety and efficacy and understating adverse events.