Wright Medical Augments Ortho Extremities Biz With BioMimetic Purchase
This article was originally published in The Gray Sheet
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.
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The Augment biologic-based device was approved for use in ankle and hindfoot fusions after overcoming multiple regulatory challenges, opening up a $300 million US market opportunity. It's the first indication for a product platform that Wright hopes to extend to use in soft-tissue procedures such as rotator cuff or tennis elbow repair, which represent a $1 billion-plus opportunity.
The Augment biologic-based device was approved for use in ankle and hindfoot fusions after overcoming multiple regulatory challenges.
Wright received an "approvable" letter from FDA about nine months ago for its Augment biologic-device bone graft, but the approval is delayed as the agency performs multiple inspections and has issued two Form-483s to a component supplier for the product.