Wright Medical Group NV's injectable bone graft, named Augment, received premarket approval from the U.S. Food and Drug Administration for use in foot and ankle procedures.
With this decision, the injected formulation can be used for the same procedures as the noninjectable version.
Amsterdam, Netherlands-based Wright Medical will immediately begin finalizing FDA packaging procedures and expects to roll out the product within the next four to six weeks.
Wright projects a $300 million market opportunity in the U.S. for the injectable bone graft, adding in its press release that Augment is the first clinically proven injectable protein therapeutic to come to the U.S. market.