Dive Brief:
- Globus Medical received 510(k) clearance from the Food and Drug Administration for its ExcelsiusFlex orthopedics robot, according to a posting from the agency.
- CEO Dan Scavilla said in a May investor call that Globus had filed a submission for a reconstruction robot with the FDA and expected clearance late in the third quarter. A June 14 filing describes ExcelsiusFlex as a device that provides stereotaxic guidance during orthopedic joint or spine surgeries.
- RBC Capital Markets analyst Shagun Singh, who first pointed out the FDA’s notification in an emailed research note, said that Globus hopes to gain share in the roughly $15 billion global reconstruction market with the new robot.
Dive Insight:
Orthopedics firm Globus Medical currently sells a robotic navigation system for spine surgeries, called ExcelsiusGPS, and a related imaging platform. Both products have driven growth for the company. In the first quarter, Scavilla said sales of robotic and imaging systems drove Globus’ enabling technology segment to grow 27% year over year to $32 million, making for the “highest Q1 since launch.”
Globus also acquired a spine surgery platform, called Pulse, with its recent $3.1 billion purchase of Nuvasive.
Now, the company is looking to expand further into joint reconstruction procedures. Discussing the new robot in May, Scavilla told investors that he expected it to be “one of the most exciting things I think we’ll get out the door this year,” adding that the company was building inventory to prepare for a rollout as it awaited FDA authorization.
The robot will be “in a different marketplace that will allow us to have more volume ramp-up of our implants of knees and hips,” Scavilla said. “And so I think that there will be a benefit there to the overall business.”
The earlier-than-expected clearance will allow Globus to expand into the global hip and knee market and provide another enabling technology, Singh wrote. Globus expects its reconstruction robot will stand apart from competitors “as it leverages its imaging, navigation, and robotics expertise in a market where implants are fairly commoditized,” she added.
The company also plans to launch a cementless knee later this year.
A Globus spokesperson confirmed the clearance in an email. Singh wrote that the company expects a minimal sales contribution in 2024 with a soft initial launch and hopes to gain market share annually in the U.S. reconstruction market.