Biolase (NSDQ:BIOL) won 510(k) clearance from the FDA for its WaterLase iPlus, a laser used for soft-tissue orthopedic procedures.
The clearance opens up a $2.6 billion market opportunity for the WaterLase device, according to a company statement.
WaterLase iPlus is cleared for use in soft tissue incision, excision, resection, ablation, vaporization, coagulation and hemostasis, according to the release.
The Irvine, Calif.-based dental device maker said in a separate release that 1st-quarter 2013 losses widened to $2.6 million, or -8¢ per diluted share, on sales of $14.5 million. That compares with Q1 2012 losses of $1.7 million, or -5 ¢ cents per diluted share, on sales of $12.3 million.
In addition, Biolase received some good news from the U.S. Patent & Trademark Office, which rejected all claims by Utah-based CAO Group. In April 2012, CAO sued Biolase for patent infringement.
“We are very pleased with the results of this latest office action issued by the USPTO, which rejected all 37 claims in the CAO Group’s patent that were subject to reexamination. This clearly supports our assertion that the allegations of patent infringement levied by CAO are totally without merit," said Biolase CEO Federico Pignatelli in prepared remarks.
