Manage episode 302045181 series 2934477
Jeffrey Marx serves as President & Chief Operating Officer, overseeing regulatory, quality, manufacturing, and R&D efforts for the company. 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. His experience includes over 13 years with Orthovita, where he was VP Corporate Development. When Orthovita was acquired by Stryker Orthobiologics, Jeff led the team that integrated the two companies; he continued as VP Corporate Development at Stryker. He has earned a Ph.D. in Ceramic Engineering from Missouri University of Science and Technology, Rolla MO.
Cerapedics is an advanced orthobiologics company with i-FACTOR® Peptide Enhanced Bone Graft.
Among 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. In this study i-FACTOR demonstrated high fusion rates and statistical superiority vs. autograft in overall clinical success.
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. 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.
ABOUT i-FACTOR Bone Graft
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). This novel (ABM/P-15) combination acts as an attachment factor for osteogenic cells.
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.