Bone is a rigid composite of mineral (hydroxyapatite) and collagen (primarily Type I). The collagen fibers serve to conduct mechanical forces that are crucial to the behavior of bone cells. The relationship between cells and their surrounding three-dimensional network of force conducting native collagen fibers is essential for normal bone physiology, maintenance and repair. In the body, most cells are attached to native collagen by highly specific points of contact. This point of recognition and contact is a fifteen amino acid sequence, which has been replicated in the P-15 Osteogenic Cell Binding Peptide.
Cell migration along the collagen network is an anchorage-dependent process known as haptotaxis. Simply put, cell motility is a grab and release mechanism in which the P-15 domains serve as rungs on a ladder. Incorporation of these P-15 peptides into the microstructure of anorganic bone mineral has been shown to facilitate and expedite ingrowth of bone by promoting the immigration of reparative cells from the surrounding tissue. The following is a subset of the in vivo and in vitro evidence supporting the safety and efficacy of P-15 Osteogenic Cell Binding Peptide.
Sherman BP, Lindley EM, Turner AS, Seim HB 3rd, Benedict J, Burger EL, Patel VV. Evaluation of ABM/P-15 versus autogenous bone in an ovine lumbar interbody fusion model. Eur Spine J. 2010 Dec;19(12):2156-63.
Ding M, Andreasen CM, Dencker ML, Jensen AE, Theilgaard N, Overgaard S. Efficacy of a small cell-binding peptide coated hydroxyapatite substitute on bone formation and implant fixation in sheep. J Biomed Mater Res A. 2015 Apr;103(4):1357-65.
Pedersen RH, Rasmussen M, Overgaard S, Ding M. Effects of P-15 Peptide Coated Hydroxyapatite on Tibial Defect Repair In Vivo in Normal and Osteoporotic Rats. Biomed Res Int. 2015;2015:253858.
Axelsen MG, Jespersen SM, Overgaard S, Ding M. Evaluation of cell binding peptide (P15) with silk fibre enhanced hydroxyapatite bone substitute for posterolateral spinal fusion in sheep. Eurospine 2015 Annual Meeting, Poster # P30.
Coelho P.G., Teixeira H.S., Marin C., Witek L., Tovar N., Janal M.N., Jimbo R. The in vivo effect of P-15 coating on early osseointegration. Journal of Biomedical Materials Research - Part B Applied Biomaterials (2014) 102:3 (430-440).
Lutz R., Srour S., Nonhoff J., Weisel T., Damien C.J., Schlegel K.A. Biofunctionalization of titanium implants with a biomimetic active peptide (P-15) promotes early osseointegration. Clinical Oral Implants Research (2010) 21:7 (726-734).
Nonhoff J., Moest T., Schmitt C.M., Weisel T., Bauer S., Schlegel K.A. Establishment of a new pull-out strength testing method to quantify early osseointegration - An experimental pilot study. Journal of Cranio-Maxillofacial Surgery (2015) 43:10 (1966-1973).
Nonhoff J., Moest T., Schmitt C.M., Weisel T., Bauer S., Schlegel K.A. Establishment of a new pull-out strength testing method to quantify early osseointegration - An experimental pilot study. Journal of Cranio-Maxillofacial Surgery (2015) 43:10 (1966-1973).
Lindley EM, Guerra FA, Krauser JT, Matos SM, Burger EL, Patel VV. Small peptide (P-15) bone substitute efficacy in a rabbit cancellous bone model. J Biomed Mater Res B Appl Biomater. 2010 Aug;94(2):463-8.
Thorwarth M, Schultze-Mosgau S, Wehrhan F, Kessler P, Srour S, Wiltfang J, Andreas Schlegel K. Bioactivation of an anorganic bone matrix by P-15 peptide for the promotion of early bone formation. Biomaterials. 2005 Oct;26(28):5648-57. Epub 2005 Apr 18.
Artzi Z, Kozlovsky A, Nemcovsky CE, Moses O, Tal H, Rohrer MD, Prasad HS, Weinreb M. Histomorphometric evaluation of natural mineral combined with a cell-binding peptide (P-15) in critical-size defects in the rat calvaria. Int J Oral Maxillofac Implants. 2008 Nov-Dec;23(6):1063-70.
Tovar N., Jimbo R., Gangolli R., Witek L., Lorenzoni F., Marin C., Manne L., Perez-Troisi L., Baldassarri M., Coelho P.G. Modification of xenogeneic graft materials for improved release of P-15 peptides in a calvarium defect model. The Journal of craniofacial surgery (2014) 25:1 (70-76).
Guerra FA, Krauser JT, Cabrita AM, et al. Small Peptide (P-15) Bone Substitute Efficacy in a Rabbit Cancellous Bone Model. ORS 2005 Annual Meeting, Poster # 0212.
Patel VV, Benedict JJ, Seim HB, Turner AS. Lumbar Spine Fusion in an Ovine Model Comparing P-15/BGS to Autogenous Bone. ORS 2007 Annual Meeting, Poster # 1452.
Cheng BC, Moore DK, Zdeblick T. P-15: An Osteoconductive Protein to Enhance Healing of Interbody Cages. ORS 1998 Annual Meeting, Poster # 636.
Cakmak G, Bolukbasi S, Simsek A, Erdem O, Yilmaz G, Senkoylu A. Effect of synthetic cell-binding peptide on the healing of cortical segmental bone defects. Saudi Medical Journal, Jun 2006;27(6): 777-80.
Scarano A, Iezzi G, Petrone G, Orsini G, Degidi M, Strocchi R, Piateelli A. Cortical bone regeneration with a cell-binding peptide: a histologic and histomorphometric pilot study. Implant Dent 2003;12(4):318-24.
El-Madany I, Emam H, Sharawy M. Comparison of cellular response to anorganic bone matrix/cell binding peptide and allogenic cranial bone after sinus augmentation in rhesus monkeys. J Oral Implantol. 2011 Apr;37(2):233-45.
Vastardis S, Yukna RA, Mayer ET, Atkinson BL. Periodontal regeneration with peptide-enhanced anorganic bone matrix in particulate and putty form in dogs. J Periodontol, 2005; Oct 76(10): 1690-1696.
Scarano A, Iezzi G, Petrone G, Orsini G, Degidi M, Strocchi R, Piatelli A. Cortical bone regeneration with a cell-binding peptide a histologic and histomorphometric pilot study. Implant Dentistry 2003; 12(4): 318-24.
Tehemar S, Hanes P, Sharawy M. Enhancement of osseointegration of implants placed into extraction sockets of healthy and periodontally diseased teeth by using graft material, an ePTFE membrane, or a combination. Clinical Implant Dentistry and Related Research 2003; 5(3): 193-211.
Barboza E, Souza R, Caula A, Neto L, Caula F, Duarte M. Bone regeneration of localized chronic alveolar defects utilizing cell-binding peptide associated with anorganic bovine-derived bone mineral: a clinical and histological study. Journal of Periodontology 2002; 73(10):1153-9.
Suaid F.A., Macedo G.O., Novaes Jr. A.B., Borges G.J., Souza S.L.S., Taba Jr. M., Palioto D.B., Grisi M.F.M. The bone formation capabilities of the anorganic bone matrix cell-binding peptide 15 grafts in an animal periodontal model: A histologic and histomorphometric study in dogs. Journal of Periodontology (2010) 81:4 (594-603).
Level 1 data supports your evidence based clinical decision making.
The only bone graft to harness the intense biological activity of a peptide (P-15).
Store at room temperature. Ready to use without mixing.
Don’t assume your bone graft will perform.
FDA PMA approved (2015) active biologic and has been CE Marked since 2008.
The unique P-15 action is surface bound and unlike growth factors only grows bone where you need it.
i-FACTOR Biologic Bone Graft novel mechanism of action enhances the body’s natural bone healing process, resulting in safe, predictable bone formation. ABM/P-15 has been in human clinical use for more than 17 years in an estimated 500,000 patients worldwide.
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