In a significant development for the orthopedic surgery market, Globus Medical has received 510(k) clearance from the Food and Drug Administration (FDA) for its ExcelsiusFlex orthopedic robot. The FDA’s approval, confirmed in a recent posting from the agency, marks a crucial step forward for the company as it aims to expand its footprint in the global reconstruction market.
In the May Investor Call, Globus Medical CEO Dan Scavilla indicated that the company was anticipating FDA clearance for the ExcelsiusFlex by the end of the third quarter.The ExcelsiusFlex provides stereotaxic guidance during orthopedic joint or spine surgeries, a feature that could enhance precision and outcomes in these procedures.
Globus Medical has a proven track record in robotic surgery, particularly with its ExcelsiusGPS system used for spine surgeries. The ExcelsiusGPS and its associated imaging platform have been crucial for its growth. In the first quarter, Globus sales from robotic and imaging systems boosted the enabling technology segment by 27% year over year, reaching $32 million. It represented the highest first-quarter performance since its launch. The recent $3.1 billion acquisition of NuVasive further bolstered Globus’s capabilities, bringing the Pulse spine surgery platform into its portfolio.
Now, with the ExcelsiusFlex, Globus is poised to extend its innovative technologies to joint reconstruction procedures, a $15 billion global market. This market includes a significant demand for knee and hip surgeries, which the ExcelsiusFlex could substantially impact.
According to its CEO, the robot will enable Globus to increase sales of its knee and hip implants, bringing considerable benefits and achieving a larger share of the reconstruction market. Without a doubt, their portfolio of imaging, navigation, and robotics will allow them to differentiate themselves in a highly commoditized market and gain a clear competitive advantage.
Additionally, the company has plans to launch a cementless knee later this year, further broadening its product offerings in the orthopedic space.
While the company anticipates a minimal sales contribution from the ExcelsiusFlex in 2024 due to a soft initial launch, it aims to gradually increase its market share in the U.S. reconstruction market over the coming years.
The FDA clearance of the ExcelsiusFlex marks a milestone for Globus Medical, reflecting its continued innovation and expansion in the orthopedic market. As the company prepares for the robot’s market debut, it stands ready to transform the landscape of joint reconstruction procedures.