Wright Gets FDA Approvable Letter For Augment Bone Graft; Cuts FY Revenue View

(RTTNews) - Wright Medical Group, Inc. (WMGI) Monday said its BioMimetic subsidiary has received an Approvable Letter from the U.S. Food and Drug Administration for its Premarket Approval Application or PMA for Augment Bone Graft. The stock climbed nearly 4 percent in after-market trading.

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. It is approvable subject to customary preapproval facilities inspections.

Robert Palmisano, president and CEO of Wright Medical, said, "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 Bone Graft would be the first clinically proven protein therapeutic to come to the U.S. orthopaedics market in over a decade, providing an alternative to autograft in ankle and/or hindfoot fusion procedures.

This translates into an estimated market opportunity of about $300 million annually in the U.S.

The combination of two components - recombinant human Platelet-Derived Growth Factor or rhPDGF and Beta-tricalcium phosphate or Beta-TCP - is key to the product candidate's activities.

rhPDGF-BB is intended to provide the biological stimulus for the in-growth and proliferation of osteoblasts, cells responsible for the formation of bone, while Beta-TCP provides a framework or scaffold for new bone growth to occur.

The company will work with the FDA to coordinate any preapproval inspections.

Further, the firm said net sales from continuing operations increased 24 percent in the third quarter to $71.3 million.

U.S. foot and ankle revenue grew about 28 percent including the Solana Surgical and OrthoPro acquisitions. International revenue grew 37 percent. Total ankle replacement sales increased 25 percent from last year.

Based on its third quarter 2014 sales results and recent developments, the company updated its full year 2014 revenue guidance to be in the range of $298 million to $302 million from the previous guidance of $308 million to $312 million.

Analysts look for full year revenues of $309.24 million.

The stock, which closed down 0.6 percent on Monday, added 4 percent in the extended trade.