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

To the surprise of many, the FDA issued a “not approvable” letter to Wright Medical Group for its Augment biologic bone graft. Now company executives must figure out what to do next to grow in the extremities space.

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.

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