2 With P-15 as the active component, i-FACTOR Peptide Enhanced Bone Graft is challenging the gold standard in bone grafting and revolutionising expectations for spinal fusion. 1 Radiographic evidence has also shown i-FACTOR Bone Graft to be statistically superior to autologous bone in facilitating the formation of bridging bone in posterior lumbar interbody fusion. Recently-published Level I evidence has demonstrated that i-FACTOR Bone Graft yields significantly superior overall outcomes over the gold standard autograft bone. I-FACTOR Peptide Enhanced Bone Graft is a clinically proven, biologic bone graft that was developed to be an alternative to expensive engineered growth factors (rhBMPs) with documented safety issues, and experimental cell-based allografts with no objective data. The P-15 within i-FACTOR Bone Graft amplifies the natural bone healing process resulting in rapid bone formation that is safe and predictable. This surface bound method of action reduces the risk of bone formation away from the graft site, and ensures growth factors are produced and regulated by the cells in physiological concentrations. Cells have a naturally high affinity for P-15, and once attached, are activated to begin the production of essential growth factors. This combination provides a proven osteoconductive scaffold with an abundance of P-15 attachment sites, allowing for increased cell binding at the fusion site. i-FACTOR Bone Graft combines a synthetic version of this peptide, known as P-15, with a hydroxyapatite, anorganic bone mineral (ABM). This protein segment is responsible for the attachment and proliferation of osteogenic cells that produce bone. Unlike other biologic bone grafts, i-FACTOR Bone Graft has a unique and powerful mechanism of action that is based upon the biological activity of a 15-amino acid peptide sequence naturally found in human Type I collagen. These potent exogenous growth factors stimulate stem cells to differentiate down the osteogenic lineage, but the enhanced fusion potential comes with high costs and the risk of increased complication rates. Biologic bone grafts are often classified as drug/device combinations, of which recombinant human bone morphogenetic proteins (rhBMPs) are the primary example.

In recent years, a number of products have been introduced that incorporate an active component to positively influence the fusion process.

Whether natural (allograft, simple demineralised bone matrix ) or synthetic (hydroxyapatite, calcium phosphate), the majority of materials are simple osteoconductive substitutes offering a scaffold for fusion that is gradually resorbed over time, but does not actively promote bone growth. This has stimulated the search for substitute biomaterials that offer an equivalent level of performance. However, its use is often associated with donor site morbidity, and does not offer reliable levels of quality or volume. i-FACTOR Bone Graft offers a powerful and safe mechanism of action, proven by the highest quality of evidence which is demanded by surgeons, administrators and payers to support therapeutic and coverage decisions.Īutograft bone has long been considered the gold standard for spinal fusion as it has osteoconductive, osteoinductive and osteogenic properties. Amongst the many bone graft substitutes available, i-FACTOR Bone Graft (Cerapedics, Inc.) is the only synthetic bone graft to demonstrate superiority to autograft according to independent radiographic evidence and patient-reported outcomes from a prospective, randomised Level I clinical study. Today’s market is flooded with a variety of different products, all aiming to replicate the performance and safety of autograft bone which clinicians still regard as the “gold standard”. This article is sponsored by Cerapedics, Inc.Ī FAST, RELIABLE AND PROVEN ALTERNATIVE TO AUTOGRAFT i-FACTOR peptide-enhanced bone graft is challenging the gold standard in bone grafting and revolutionising expectations for spinal fusion.īone graft substitutes are used extensively in spinal surgery as a means to encourage bone healing and fusion.

Ifactor bone graft