#IFACTOR BIOLOGIC FREE#

At a mean of 24 months of follow-up (range 15-43 months), 97.5%, 81%, and 100% of patients, respectively, who had undergone single-, double-, and triple-level surgery exhibited fusion at all treated levels. Fine-cut CT scans were used to evaluate the progression to fusion.Īll patients who received i-FACTOR demonstrated radiographic evidence of bony induction and early incorporation of bone graft. Patient's clinical outcomes were assessed using the Oswestry Disability Index for low-back pain, the 12-Item Short Form Health Survey, Odom's criteria, and a visual analog scale for pain. One hundred ten patients with degenerative spinal disease underwent single or multilevel ALIF using the ABM/P-15 bone graft composite with a mean of 24 months (minimum 15 months) of follow-up were enrolled in the study. The authors' goal was to determine the safety and efficacy of i-FACTOR bone graft composite used in patients who underwent ALIF by evaluating fusion rates and clinical outcomes.Ī nonblinded cohort of patients who were all referred to a single surgeon's practice was prospectively studied. Although preclinical studies have documented its usefulness, the role of i-FACTOR in ALIF procedures remains unknown. In particular, i-FACTOR, a novel bone graft substitute composed of anorganic bone matrix (ABM) with P-15 small peptide, is one example currently used widely in the dental community. The search for alternative grafts yielding comparable or superior fusion outcomes with fewer complications continues. Cerapedics is now actively involved in introducing the i-FACTOR Bone Graft technology platform into the rapidly expanding market for osteobiologic products.Despite limited availability and the morbidity associated with autologous iliac crest bone graft (ICBG), its use in anterior lumbar interbody fusion (ALIF) procedures remains the gold standard to achieve arthrodesis. 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).

#IFACTOR BIOLOGIC 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.

Ifactor biologic