Wright Medical (WMGI) Reports FDA Approvable of Augment Bone Graft, Lowers FY14 Sales Guidance (StreetInsider)
Wright Medical Group, Inc. (NASDAQ: WMGI) today announced that its BioMimetic subsidiary has received an Approvable Letter from the U.S. Food and Drug Administration (FDA) for its Premarket Approval Application (PMA) for Augment® Bone Graft. The approvable letter indicates that FDA determined Augment® Bone Graft to be safe and effective as an alternative to autograft for ankle and/or hindfoot fusion indications and is approvable subject to customary preapproval facilities inspections.
Robert Palmisano, president and chief executive officer of Wright Medical, stated, “Today’s positive news on the approvability of Augment Bone Graft is a major milestone that paves the way for commercialization in the U.S. and further underscores our strength in Biologics. Augment will provide clear benefits to patients and physicians and is expected to be a significant catalyst and meaningful new future growth driver for our business. We will work swiftly to address the inspection requirements set forth in the approvable letter and expect our U.S. foot and ankle commercial team to be ready t...
