x
Tell a Friend
 
Total
Ankle Replacement

Wright Medical Group, Inc. Announces FDA Approval for AUGMENT® Bone Graft

Wright Medical Group, Inc. Announces FDA Approval for AUGMENT® Bone Graft

First Clinically Proven, Cost – Effective Alternative to Autograft for Ankle and/or Hindfoot Fusion Indications

Company Can Now Initiate Commercial Sale and Distribution of AUGMENT® Bone Graft in the U.S.

MEMPHIS, Tenn. – September 1, 2015 – Wright Medical Group, Inc. (NASDAQ: WMGI) today announced that its BioMimetic subsidiary has received an approval order from the U.S. Food and Drug Administration (FDA) for its Premarket Approval Application (PMA) for AUGMENT® Bone Graft. The approval order indicates that FDA determined that AUGMENT® Bone Graft is safe and effective as an alternative to autograft for ankle and/or hindfoot fusion indications. Wright can now initiate commercial sale and distribution of AUGMENT® Bone Graft in the U.S.

Robert Palmisano, president and chief executive officer, stated, “The FDA approval of AUGMENT marks a capstone achievement that demonstrates the strength of our science and provides a breakthrough therapeutic option as an alternative to autograft in ankle and hindfoot fusion procedures. We will begin commercial sale and distribution of AUGMENT in the U.S. and believe this product, as well as the PDGF technology platform, will be important drivers of the long – term growth of our business for years to come.”

Read more