Globus Medical (NYSE:GMED) said yesterday that the FDA won’t accept the 510(k) clearance bid for its ExcelsiusGPS robot-assisted surgery platform, likely delaying its launch until the 3rd quarter.
Globus said in a regulatory filing that the federal safety watchdog told it that the company hadn’t “sufficiently addressed the FDA’s questions” about its original clearance application. Audubon, Pa.-based Globus said it plans to file a revised application “in an expedited fashion.”
“We remain confident in our ability to adequately satisfy all of the issues identified by the FDA,” the company said in the filing.
The FDA decision means the plan for a 2nd-quarter launch is off, Globus said, but still affirmed its guidance for adjusted earnings per share of $1.27 on sales of $625 million this year.
Leerink Partners analysts said the news is a minor setback for the company, as ExcelsiusGPS 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 GMED’s organic rev growth acceleration prospects even if some (or most) of GMED’s robotic rev contribution were to get pushed into 2018,” Leerink analysts Richard Newitter and Ravi Misra wrote yesterday in a note to investors.
Globus management believes addressing the FDA’s questions should only take “a matter of weeks,” they wrote, 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.”
GMED shares closed down -1.5% yesterday at $31.24 apiece.
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