France-based EDAP (NSDQ:EDAP) has a lot on its plate the next few weeks, preparing for an inspection ahead of an FDA panel review for its therapeutic ultrasound technology for treatment of prostate cancer.
The company added this week that it’s about to raise $9.3 million through a registered direct offering of 3 million ordinary shares at $3.11 apiece, having already entered into definitive agreements with unnamed "institutional investors." The financing round is scheduled to close on or about June 3, EDAP reported.
EDAP didn’t specify its plans for the funds, but the timing suggests they’re slated for commercial efforts for the company’s Ablatherm-HIFU device, which is getting its day with the FDA in July. The company reported that its factory is scheduled next month for a routine assessment for engineering, manufacturing and quality, concurrent with a clinical validation process of the company’s investigation sites ahead of the company’s meeting with the FDA’s expert advisory panel on July 30.
"Having dates confirmed for these additional milestones is further great news for EDAP, as it demonstrates how quickly the FDA process is moving for our Ablatherm-HIFU PMA application," CEO Marc Oczachowski said in prepared remarks. "EDAP has successfully met the requirements of all of our previous FDA inspections and audits and is professionally organized in compliance with major quality assurance systems."
The company is making swift progress toward its PMA review, and it’s touting every milestone along the way. Earlier this month EDAP announced that it had won a July date with the FDA’s Gastroenterology & Urology Devices Panel, calling that win an "important milestone" as well.
The minimally invasive Ablatherm platform uses high-intensity focused ultrasound to target tumors while leaving surrounding tissue intact. The device is already approved in the European Union, EDAP noted.
EDAP shares closed last night at $3.31, down 5.2% on the day. The stock has gained 12.2% since the start of the year.