Wright Medical's BioMimetic subsidiary received FDA approval for its AUGMENT Bone Graft product following delays earlier this year, while a vendor was challenged with an FDA inspection.
Augment is approved for use in ankle and/or hindfoot fusion, and is expected by management to reach $10 million to $12 million in U.S. sales in its first seven to eight months on the market. The company estimates the potential U.S. market at $300 million, assuming use in 100 percent of procedures.
Management also noted Augment’s potential for off-label use in other extremities and orthopaedic procedures, specifically spine and trauma.
Though the product has indicated strong positive clinical evidence from its pivotal trial, analysts say that price ($2,500 to $3,000 per procedure) may affect its ability to pass through increasingly tough hospital value analysis committees. As such, analysts predict that Augment may be limited to higher-risk patients.
Wright’s news came days before U.S. rights to Tornier’s Salto Talaris® and Salto XT™ ankles and the Futura™ silastic toe were picked up by Integra LifeSciences. Regulators requested divestiture of these Tornier products to finalize the company’s merger with Wright. The merger is expected to close in 3Q15.