In addition, a responder analysis for overall success in all four primary outcomes demonstrated 69 percent success for i-FACTOR bone graft versus 57 percent for autograft. In the trial, i-FACTOR bone graft met all four pre-specified primary endpoints (fusion rate, NDI score, neurological outcomes, and safety success), demonstrating noninferiority to autograft with p-values of < 0.0005 for each. The PMA approval is driven by data from a pivotal clinical trial comparing i-FACTOR bone graft to autograft in ACDF procedures. It may be used as a substitute for autologous bone in ACDF procedures. I-FACTOR bone graft is based on synthetic small peptide (P-15) technology developed by Cerapedics to support bone growth through cell attachment and activation. With our transition to a commercial stage company, all of us at Cerapedics look forward to bringing an important new biologic bone graft option, the only backed by significant level-1 clinical evidence, to surgeons and patients across the U.S.” “It is the culmination of years of seamless cooperation with our clinical investigators to support PMA approval. ![]() Marx, Ph.D., president and COO of Cerapedics. “This is an historic milestone for us at Cerapedics and also for the surgical treatment of cervical disc degeneration,” said Jeffrey G. ![]() i-FACTOR bone graft is the first bone graft to be approved for use in the cervical spine and only the second PMA-approved bone graft in the spine. ![]() Food and Drug Administration (FDA) has approved the company’s Premarket Approval (PMA) application for i-FACTOR Peptide Enhanced Bone Graft for use in anterior cervical discectomy and fusion (ACDF) procedures in patients with degenerative cervical disc disease. Cerapedics, a privately-held orthobiologics company, announced today the U.S.
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