By Brad Perriello
Wright Medical says it now expects its Augment bone graft to win FDA approval in the 2nd half of the year, not next month as previously forecast.
Wright Medical (NSDQ:WMGI) today pushed back the timeline for FDA approval of its Augment bone putty, after the safety watchdog said last month that the vendor that makes Augment must undergo another site inspection.
In early February Memphis-based Wright said that an FDA inspection conducted as part of a review of Augment prompted a Form 483 warning to the vendor. Today Wright, in reporting its 1st-quarter earnings, said it asked the FDA to schedule the follow-up inspection on or after May 4.
“Assuming a satisfactory inspection result, the company believes final approval of Augment bone graft now appears more likely in the 2nd half of 2015,” Wright said.
“We are continuing to work closely with the vendor to resolve the observations following an FDA inspection at the vendor’s facility to receive final FDA approval for Augment bone graft,” president & CEO Robert Palmisano added in prepared remarks.
