Since approval, ABM/P-15 has been used in an estimated 500,000 procedures.įrom 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. It remains the only dental bone graft substitute with FDA approved claims of superiority over demineralized bone matrix (DBM) allograft and alloplasts. The product received PMA approval in 1999 based on the results of two prospective multi-center investigations. 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. This novel (ABM/P-15) combination acts as an attachment factor for osteogenic cells. Our lead technology platform (i-FACTOR Peptide Enhanced Bone Graft) is the only biologic bone graft that uses a unique small peptide attachment factor (P-15) bound to anorganic bone mineral (ABM).
WHO OWNS IFACTOR ENGINEERING FREE
i-FACTOR is free of many safety risks seen with other products such as ectopic bone formation and on average costs at least 30% less expensive than other drug-device combination products. One of only two Class III FDA-PMA approved spinal bone grafts, i-FACTOR is the leading evidence-based alternative and is powered by a first of its kind molecule called P-15: Osteogenic Cell Binding Peptide. In this study i-FACTOR demonstrated high fusion rates and statistical superiority vs. in Ceramic Engineering from Missouri University of Science and Technology, Rolla MO.Ĭerapedics is an advanced orthobiologics company with i-FACTOR® Peptide Enhanced Bone Graft.Īmong 400+ spinal bone grafts on the market, spine surgeons can feel confident in choosing i-FACTOR Peptide Enhanced Bone Graft which is backed by Level 1 human clinical data from an IDE study published in Spine and Neurosurgery.
When Orthovita was acquired by Stryker Orthobiologics, Jeff led the team that integrated the two companies he continued as VP Corporate Development at Stryker. His experience includes over 13 years with Orthovita, where he was VP Corporate Development. With some two decades of experience in executive management with medical device companies, he brings considerable expertise in research & development, commercialization, sales management, business development and strategic planning. Jeffrey Marx serves as President & Chief Operating Officer, overseeing regulatory, quality, manufacturing, and R&D efforts for the company.
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