Edap (NSDQ:EDAP) said yesterday that 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 last year 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 this week, uses highhigh-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.
In September, a New York federal judge dismissed the case, ruling that the defendants failed to prove any of their claims.
“Indeed, the complaint’s allegations – that defendants began the U.S. clinical trial in 2007 and consulted with the FDA on numerous occasions about difficulties in conducting a clinical trial – support an inference that defendants worked diligently to comply with FDA requirements and honestly believed that their diligence would lead to approval of their PMA application,” wrote Judge Lorna Schofield of the U.S. District Court for Southern New York on Sept. 14.
Yesterday the Lyon, France-based company said the appeals period ended without a notice of appeal from the plaintiffs, who sought class-action status for the suit.
“We are pleased with the court’s decision last month and believe the ruling supported our position that the suit was without merit, a belief that was reinforced by the lack of an appeal on behalf of the plaintiffs. We look forward to putting this matter behind us and focusing on the growth of the company following the recent receipt of FDA clearance of our Ablatherm robotic HIFU,” CEO Marc Oczachowski said in prepared remarks.
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