Edap (NSDQ:EDAP) said the FDA accepted its pre-market approval application for its Ablatherm ultrasound prostate cancer treatment, backed by data from its Enlight investigational device exemption study.
The Vaulx-en-Velin, France-based medical device company also reported that its losses increased by a whopping 646% during the 2012, on an 8% sales increase.
Edap touts the Ablatherm device as a minimally invasive treatment for localized prostate cancer. The company submitted its PMA for the high intensity ultrasound treatment in early February.
"Receiving FDA filing acceptance for our PMA in less than 2 months is both very timely and a major milestone. We are moving forward in the PMA review process as the agency commences its substantive review. We will continue to work closely with the FDA review team," CEO Marc Oczachowski said in prepared remarks.
The device is already being used in Europe, Canada, Australia, South Africa, Mexico, Taiwan, South Korea, New Zealand, Brazil, Russia and the Philippines. Ablatherm was developed jointly with the French Institute of Medical Research.
Edap posted 2012 losses of $9.7 million, or 55¢ per diluted share, on sales of $33.6 million. That compares with 2011 losses of $1.3 million, or 10¢ per diluted share, on sales of $31.2 million.
For the 4th quarter, losses were $1.4 million, or 8¢ per diluted share, on sales of $12.2 million. That compares with losses of $779,000, or 6¢ per diluted share, on sales of $10.1 million during Q4 2011.