Cerapedics has announced that the US Food and Drug Administration (FDA) has informed the company that an advisory committee panel meeting will not be required for the final review of the premarket approval application for i-FACTOR peptide enhanced bone graft.
The company has also filed a response to the last few remaining items from the premarket approval review of i-FACTOR peptide enhanced bone graft, including those from a recently completed pre-approval facility inspection.
“We were pleased to receive notice from the FDA that we can move forward in the review process without a panel meeting. We appreciate the interactive nature of the FDA review process, which has streamlined our application,” said Jeffrey G Marx, president and chief operating officer of Cerapedics.
i-FACTOR is based on P-15 technology developed by Cerapedics to support bone growth through cell attachment and activation. The premarket approval application is supported by data from a pivotal clinical trial comparing i-FACTOR bone graft to autograft in anterior cervical discectomy and fusion (ACDF) procedures. In the trial, i-FACTOR bone graft met all four pre-specified primary endpoints (fusion rate, neck disability index score, neurological outcomes, and safety success), demonstrating non-inferiority to autograft with p-values of
“Leading with this excellent clinical profile and what we believe will become the only biologic bone graft approved for cervical fusion, we think that i-FACTOR bone graft will be an important product for patients and clinicians,” said Glen Kashuba, Cerapedics’ chief executive officer.