FDA’s Augment Letter May Force Wright to Rewrite Turnaround Story

Wright Medical Group NV’s turnaround story could lose a significant supporting character with the possible death of its Augment bone graft. Wright last week received a “not approvable” letter for premarket approval application of Augment from the Food and Drug Administration. Augment’s demise isn’t definite as the company still may appeal. But analysts aren’t optimistic the firm can change the FDA’s ruling without conducting a new round of clinical trials on the biological bone graft used in foot fusion. Not only would such an endeavor be expensive, the results could limit use of the bone graft to smaller patient populations, cutting significantly into the $300 million annual opportunity the company had anticipated.

To be sure, the decision is a setback, but not a fatal blow. Wright is still one of the fastest growing players in the burgeoning extremities market. Augment, acquired last year in the purchase of BioMimetic Therapeutics Inc., was supposed to accelerate that growth, says Joanne Wuensch, medical device analyst for BMO Capital Markets