Edap (NSDQ:EDAP) said today it inked an agreement with institutional investors for the placement of 3.3 million shares at $3.50 a piece, bringing in an estimated $11.5 million for the company.
Investors in the round will receive warrants to purchase up to 3.3 million shares at an exercise price of $4.50 per share, exchangeable beginning 6 months from the date issued and for a period of 2 years after, Edap said.
The French company said it expects the offering to close on or around April 14. H.C. Wainwright & Co. acted as the exclusive placement agent for the round, according to an SEC filing.
Yesterday, EDAP said it submitted an application for FDA 510(k) clearance for its next-gen high-intensity focused ultrasound Focal One device designed to treat prostate cancer.
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.
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 ultra 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.
