Pre clinical

Attachment factor for anchorage-dependent cells

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 synthetic peptide P-15.

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.

The Synthetic P-15 Peptide In I-FACTOR Peptide Enhanced Bone Graft Results in Early Bone Formation and Fusion in a Pre-Clinical Spine Model.

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.

The Synthetic P-15 Peptide in i-FACTOR Peptide Enhanced Bone Graft Results in Greater Tissue Volume Fraction and Thicker Trabeculae Compared to Allograft in the Sheep Femur.

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.

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The Synthetic P-15 Peptide in i-FACTOR Peptide Enhanced Bone Graft Accelerates Bone Regeneration in a Preclinical Osteoporotic Rat Model.

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.

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The Synthetic P-15 Peptide in i-FACTOR Peptide Enhanced Bone Graft Enhances Bone Formation Compared to Non-Treated Anorganic Bone (Hydroxyapatite) in Posterolateral Fusion.

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.

The Synthetic P-15 peptide in i-FACTOR Peptide Enhanced Bone Graft Enhances Bone-to-Implant Contact and Osseointegration of Titanium Implants in Preclinical Animal Models.

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).

The Synthetic P-15 peptide in i-FACTOR Peptide Enhanced Bone Graft Enhances Osseointegration and Mechanical Pull-out Strength (2x) of Titanium Implants in a Porcine Animal Model.

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).

 

The Synthetic P-15 Peptide in i-FACTOR Peptide Enhanced Bone Graft Results in Significantly Faster Bone Formation in Preclinical Long-Bone Defects.

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.

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The Synthetic P-15 Peptide in i-FACTOR Peptide-Enhanced Bone Graft Results in Significantly Faster Bone Formation And Fusion in a Preclinical Cranial Model.

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 synthetic 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).

The Synthetic P-15 Peptide in i-FACTOR Peptide Enhanced Bone Graft Results in More Bone Growth Compared to Non-treated Anorganic Bone (Hydroxyapatite) in a Rabbit Osseous Defect.

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.

 

The Synthetic P-15 Peptide in i-FACTOR Peptide Enhanced Bone Graft Results in Equivalent Fusion Rates to Autologous Bone in an Ovine Lumbar Fusion Model.

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.

 

The Synthetic P-15 Peptide in i-FACTOR Peptide Enhanced Bone Graft Results in Superior Fusion Rates Compared to Autograft in a Goat Cervical Fusion Model.

Cheng BC, Moore DK, Zdeblick T. P-15: An Osteoconductive Protein to Enhance Healing of Interbody Cages. ORS 1998 Annual Meeting, Poster # 636.

The Synthetic P-15 Peptide in i-FACTOR Peptide Enhanced Bone Graft Results in Optimum Healing of Segmental Cortical Bone Defects in a Rat Model.

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.

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The Synthetic P-15 Peptide in i-FACTOR Peptide Enhanced Bone Graft Results in Enhanced New Bone Formation in Cortical Defects in a Rabbit Model.

Scarano A, Iezzi G, Petrone G, Orsini G, Degidi M, Strocchi R, Piateelli A. Cortical bone regeneration with a synthetic cell-binding peptide: a histologic and histomorphometric pilot study. Implant Dent 2003;12(4):318-24.

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The Synthetic P-15 Peptide in i-FACTOR Peptide Enhanced Bone Graft Results in Faster New Bone Formation in Maxillary Sinus Defects Compared to Allograft.

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.

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The Synthetic P-15 Peptide in i-FACTOR Peptide Enhanced Bone Graft Enhances Fusion in the Mechanically Demanding Periodontal Environment.

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.

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Scarano A, Iezzi G, Petrone G, Orsini G, Degidi M, Strocchi R, Piatelli A. Cortical bone regeneration with a synthetic cell-binding peptide a histologic and histomorphometric pilot study. Implant Dentistry 2003; 12(4): 318-24.

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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.

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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.

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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-synthetic 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).

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Mechanism of Action

Key to choosing the appropriate graft material is an understanding of how it works. Learn more about the natural process and what to expect from i-FACTOR Bone Graft.

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Clinical

Research needs to translate into patient outcomes. Learn more about how i-FACTOR is transforming patients lives by providing clinicals with Level-1 data demonstrating the safety and efficacy of this new category of bone graft

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The proof you require, the safety you demand.

Clinical Superiority

Clinical Superiority

Level 1 data supports your evidence based clinical decision making.

Peptide Power

Peptide Power

The only bone graft to harness the intense biological activity of a peptide (P-15).

Ready to use

Ready to use

Store at room temperature. Ready to use without mixing.

Fill and forget

Fill and forget

Don’t assume your bone graft will perform. Know it will.

Tried and trusted

Tried and trusted

FDA PMA approved (2015) drug device combination and has been CE Marked since 2008.

Safety by design

Safety by design

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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