Arlington, Tenn.-based Wright said the FDA letter expressed concern that "the population enrolled was predominantly low risk and, therefore, may not have warranted the use of either autograft or Augment Bone Graft" and that "it will be necessary to perform a new clinical study that evaluates the use of Augment Bone Graft as a substitute for autograft in hindfoot and ankle fusion procedures in a well-defined high-risk target population, where the use of autograft would be clinically warranted."
The federal watchdog agency said "the patient population studied in the clinical study, the amount of graft material implanted, and the uncertainty as to whether any graft material would be needed or if the use of no graft material in a fusion procedure of the hindfoot and ankle in the population studied would have achieved similar results," according to a press release.
"Needless to say, we are very disappointed by the FDA’s decision to issue a not approvable letter for our PMA application for Augment bone graft," president & CEO Robert Palmisano said in prepared remarks. "This is not what we expected, as we believed that all of the FDA’s concerns as outlined in their previous not approvable letter from December 2011 had been fully and thoroughly addressed in the PMA amendment that BioMimetic submitted in June 2012. We are continuing to study the FDA’s position and expect we will work collaboratively with the agency to determine an appropriate path forward."
The news sent WMGI shares down 8.6% to $24.73 each as of about 10 a.m. this morning.
Wright acquired BioMimetic Therapeutics in November 2012 for $190 million in cash plus another $190 million in possible milestone payments.
"BioMimetic’s products complement our existing biologics product portfolio, and, if approved by the FDA as we expect, Augment Bone Graft will provide us with a unique solution for the U.S. hindfoot and ankle fusion market that leverages the distribution capabilities of Wright’s dedicated foot and ankle sales organization and our physician training capabilities," Palmisano said at the time.