Wright Medical issued a press release announcing that they received a not approvable letter from the FDA on their PMA application for Augment Bone Graft. Needless to say, Wright has got to be pissed…and confused.
In the letter, FDA states it is “concerned that the population enrolled was predominantly low risk and, therefore, may not have warranted the use of either autograft or Augment Bone Graft.” FDA went on to state it believes 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.”
In summary, FDA concerns included “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.” FDA provided a number of additional observations about the clinical study design and results.
Wright announced plans on November 19, 2012 to acquire BioMimetic Therapeutics, Inc. for an upfront purchase price of approximately $190 million in cash and stock plus additional milestone payments of up to approximately $190 million in cash, which are payable upon receipt of FDA approval of Augment Bone Graft and upon achieving certain revenue milestones.
BioMimetic’s Augment product line is based on recombinant human platelet-derived growth factor (rhPDGF-BB), a synthetic copy of one of the body’s principal healing agents. In June 2012, BioMimetic submitted a responsive PMA amendment responding to FDA’s request for additional information about the product. Wright has been waiting it’s approval and most insiders were assuming it was a foregone conclusion. Not the case I guess.
In the July 3rd, 2013 issue of JBJS, “the study” (Recombinant Human Platelet-Derived Growth Factor-BB and Beta-Tricalcium Phosphate (rhPDGF-BB/β-TCP): An Alternative to Autogenous Bone Graft) comprised of 494 patents from 37 test sites determined that: patients requiring hindfoot or ankle arthrodesis, treatment with rhPDGF-BB/β-TCP resulted in comparable fusion rates, less pain, and fewer side effects as compared with treatment with autograft. This study involved some of the biggest names in the foot and ankle world, lead by Brown University’s Christopher DiGiovanni MD. A link to the abstract can be found here.
Where does Wright Medical go from here and who is to blame? Medtronics Infuse? How will this impact Wright Medical moving forward? Wright Medical just sold off its total joint line to the Chinese based MicroPort to become a stand alone foot and ankle and biologics company. Did this rejection put an end to a possible behind the scenes acquisition deal from a larger player like Stryker, Smith and Nephew, or Zimmer? The positive is that 3 days ago, Wright reported a 29% growth in foot and ankle. Hopefully this news does not drastically derail plans moving forward. Looks like It’s back to the drawing board in Memphis, hopefully Bob P and the gang figure something out soon or the purchase of BioMimetics could go down as the “Sam Bowie” or “A-ROD contract” or “New Coke” of medical acquisitions.
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