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Summary of Conference Call: Wright Medical Announces Receipt of FDA Not Approvable Letter for Augment Bone Graft

  • FDA concerned that patient population enrolled was predominantly low risk, may not have warranted use of either autograft or Augment Bone Graft
  • FDA believes that a new clinical study would be required to evaluate use of Augment as a substitute for autograft in hindfoot and ankle fusion procedures in a well-defined high-risk target population, where use of autograft would be clinically warranted
  • WMGI believed that all FDA concerns as outlined in their previous Non Approvable Letter from December 2011 were fully addressed in the PMA amendment that BioMimetic submitted in June 2012
  • Company must determine next steps in ex-U.S. markets with opportunity for CE Mark
  • Product selling robustly in Australia, also has business in Canada which is “pretty much business as usual”
  • Doesn't expect announcement to impact stated 2013 guidance
  • Other ongoing clinical projects in earlier stages unaffected (e.g., Augment Injectable)

 

Sources: Company press release; Corporate conference call/Thomson Reuters

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