FDA says “NO” to the new robot system from Globus Medical
FDA JILTS GLOBUS ROBOT SYSTEM (Orthopedics This Week)
The FDA has informed Globus Medical, Inc. that the agency is not granting 510(k) clearance for the company’s ExcelsiusGPS robotic guidance and navigation system.
The company issued an SEC filing on May 17, 2017 regarding the FDA’s notification letter dated two days earlier.
The FDA letter, according to the company’s filing, stated the agency does not believe the company has “sufficiently addressed” the agency’s questions regarding the robotic system “within the FDA review period.”
Globus management says it intends to file a revised 510(k) submission for the system in “an expedited fashion.” Management also stated it remains confident in its ability to adequately satisfy all the issues identified by the FDA. The company said it had previously estimated that it was likely to receive FDA clearance to market the system in the second quarter of 2017. Management no longer expects that to happen.
Citing Globus management, Kyle Rose, an analyst at Canaccord Genuity Group, wrote in a report to clients, “The FDA has not expressed any concern” over the technology “and is confident” it can be approved.
The delay followed FDA requests for “additional testing.” Rose expects FDA seeks more data after testing systems from rival robotics developers Mazor Robotics and Zimmer Biomet.
Mass Device reported on May 18, 2017 that Leerink Partners analysts believes the news is a minor setback for the company, because the robotic system represents “an incremental tailwind.”
“While this is a minor setback, we view it as more of a timing issue than anything else and continue to have confidence in [Globus’] organic revenue growth acceleration prospects even if some (or most) of Globus’ robotic revenue contribution were to get pushed into 2018,” Leerink analysts Richard Newitter and Ravi Misra wrote in the investor note.
They added that Globus management believes addressing the FDA’s questions should only take “a matter of weeks” with the agency providing “a clear roadmap (in mgmt.’s view) as to what additional information is needed.”
“[I]mportantly no new studies or data collection is required,” Newitter and Misra wrote.
“Rather the addt’l info requires more ‘data mining & repackaging’ of existing data according to mgmt.,” they wrote. “Once re-submitted, the 90-day clock re-sets, which we think would likely mean an August approval timeframe, if the FDA takes all 3 months to review the resubmission. It’s possible the FDA could ‘pick-up where it left off’ in which case the review process might not take a full 3 months and approval could potentially come sooner than Aug.”
On January 6, 2017, the company announced it won CE Mark approval in the European Union for the ExcelsiusGPS.
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 Medical implants and instruments, with compatibility with pre- and intra-operative CT and fluoroscopic imaging.
Globus paid an undisclosed amount to acquire Excelsius Surgical in January 2014. At that time, Globus said it expected the ExcelsiusGPS system to win FDA clearance in 2015, with commercialization to follow in 2016.