LYON, France — EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced that the U.S. Food and Drug Administration (FDA) concluded its routine inspection of EDAP’s manufacturing site with no findings nor issuance of Form 483 observations.
France-based EDAP TMS SA will get its day with the FDA next month, when the agency’s expert advisors will review EDAP’s Ablatherm-HIFU therapeutic ultrasound technology for treatment of prostate cancer.
The French device maker posted year-end losses of $9.7 million, or 55¢ per diluted share, on sales of $33.7 million. That compares with 2011 losses of $1.3 million, or 10¢ per diluted share, on sales of $31.2 million.
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.