Wright Obtains FDA Approvable Letter For Augment Bone Graft; Cuts FY Outlook

(RTTNews) - Wright Medical Group Inc (WMGI), a specialty orthopaedic company, Monday received an approvable letter from the U.S. Food and Drug Administration for its Premarket Approval Application for Augment Bone Graft.

Also the company provided weak sales results for the third quarter, and slashed its guidance for the full year, citing supply planning challenging in its international business, some backorders late in the quarter, as well as foreign currency impact.

Elaborating on the FDA approvable letter, Wright said it will work with the Agency to coordinate any preapproval inspections. Assuming satisfactory completion of this activity and receipt of a final approval order from the FDA, commercial sale and distribution of Augment Bone Graft can begin in the U.S., the company said.

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.

According to Wright, Augment Bone Graft would be the first clinically proven protein therapeutic to come to the U.S. orthopaedics market in over a decade, offering an alternative to autograft in ankle and/or hindfoot fusion procedures, which translates into an estimated market opportunity of about $300 million annually in the U.S.

Coming over to its third quarter results, Wright said sales increased 24% year-over-year to $71.3 million. Analysts polled by Thomson Reuters expected sales of $75.8 million.

The company said results were hurt by weak sales in its core U.S. foot and ankle business and in international business.

Wright now projects full-year sales of $298 million to $302 million, from prior guidance of $308 million to $312 million.

Analysts currently expect sales of $309.2 million for the year.

Wright plans to update its full financial guidance on its third quarter conference call, scheduled for November 5.