Globus Medical (NYSE:GMED) said today that it won 510(k) clearance from the FDA for its long-awaited Excelsius robot-assisted surgery platform, which is designed to integrate intra-operative CT and fluoroscopic imaging technologies.
Audubon, Pa.-based Globus said the clearance covers minimally invasive and open orthopedic and neurosurgical surgeries, including screw placement in spinal and orthopedic procedures. The system won CE Mark approval in the European Union in January.
“Excelsius GPS is the culmination of years of research and development efforts and demonstrates Globus Medical’s superior product development capabilities,” robotics, imaging, & navigation VP Norbert Johnson said in prepared remarks. “We believe the Excelsius GPS System will advance patient care and provide tangible benefits for surgeons and hospitals in terms of time, accuracy and reduced radiation exposure through the application of robotic and navigation technology in spine and orthopedic surgery.”
When Globus acquired Excelsius in January 2014 for an estimated $20 million to $40 million, the company said it expected the system to win FDA clearance the next year, with commercialization to follow in 2016. In May Globus said it planned to re-file its 510(k) bid “in an expedited fashion” after the FDA said the company hadn’t “sufficiently addressed the FDA’s questions” about its original clearance application, delaying the launch from the second to third quarter.
At time the company affirmed its full-year guidance for adjusted earnings per share of $1.27 on sales of $625 million; Globus did not update its outlook in today’s release.
GMED shares jumped 5.6% to $30.87 in late-morning trading today.