Globus Robot Cleared for U.S. Sales

Globus Medical, Inc. finally has its own robotic system to market in the U.S.

After asking the company to resubmit its 510(k) clearance application for the ExcelsiusGPS robotic guidance and navigation system back in May, the company announced the FDA granted clearance to market the system in the U.S. on August 17, 2017.

The FDA had told company that its original application did not “sufficiently address” the agency’s questions “within the FDA review period.” Globus execs said in May they were confident in their ability to adequately satisfy all the issues identified by the FDA and immediately filed a revised 510(k) submission.

Wells Fargo analyst, Craig Bijou, said the clearance will allow Globus to perform all of the minimally invasive spine procedures it expected with the robot and gives the company the potential to move into trauma and cranial procedures with the robot in the future. The company said that FDA clearance includes minimally invasive surgeries, as well as open orthopedic and neurosurgical surgeries like screw placement in spinal and orthopedic procedures.

The system is for use in both minimally invasive and open procedures for orthopedics and neurosurgery, including procedures for the spine, long bones and cranium. It’s designed to integrate with Globus implants and instruments, with compatibility with pre- and intra-operative CT and fluoroscopic imaging.

The company had already won CE Mark in the European Union for system in January 2017.

Globus paid an undisclosed amount to acquire Excelsius Surgical in January 2014. At that time, company officials said they expected the system to win FDA clearance in 2015, with commercialization to follow in 2016.

Bijou reported that Globus said that its capital salesforce is ready to start selling. However, wrote Bijou, given the timing of the capital sales cycle, he did not anticipate any placements in the third quarter of 2017. The company had originally suggested around $10 million in robotics revenue for 2017. The company’s 2017 revenue guidance expects around $5 million for robotic revenue in the fourth quarter of 2017.

Bijou added that Globus management believes the clearance gives the company the opportunity to market the robot ahead of the capital spending process for many hospitals.