BioMimetic Amends Augment Bone Graft PMA, Expects Approval By 2014
This article was originally published in The Gray Sheet
BioMimetic Therapeutics submits PMA amendment for its Augment bone graft device to address questions raised by FDA in a “not approvable” letter disclosed in January.
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News Briefs: FDA Turns Down Wright’s Augment; Cook Resumes Zilver PTX Shipments; Luminex Restructures
Wright Medical receives not approvable letter for its Augment bone graft asking for another study. Judge rules against Zimmer in favor of Strkyer in patent case. Cook Medical has resolved the problems that triggered a December 2012 recall of its Zilver PTX peripheral stent. Luminex cuts staff, invests in molecular diagnostics efforts.
Firm expects to gain PMA approval in 2013 for BioMimetic’s Augment bone graft as a replacement for autologous bone graft in foot and ankle fusion procedures. Deal includes $190 million down, and up to $190 million more in milestone payments.
Tryptophan-induced somnolence may be a side effect of Thanksgiving dinner, but the business week leading into Thanksgiving was not sleepy, as we were not short of deals to review.