The first P-15 enhanced bone graft substitute was developed for use in the oral cavity by CeraMed Dental – the precursor to Cerapedics – under the leadership of Andrew J. Tofe, PhD. The product received PMA approval in 1999 based on the results of two prospective multi-center investigations. It remains the only dental bone graft substitute with FDA approved claims of superiority over demineralized bone matrix (DBM) allograft and alloplasts. Since approval, ABM/P-15 has been used in an estimated 500,000 procedures.
From these roots, Cerapedics has reformulated the (ABM/P-15) product and branded it i-FACTOR Peptide Enhanced Bone Graft to capture the unique “attachment factor” mechanism of action. Cerapedics is now actively involved in introducing the i-FACTOR Bone Graft technology platform into the rapidly expanding market for osteobiologic products.
i-FACTOR Peptide Enhanced Bone Graft is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7
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