Cerapedics believes that choosing a bone graft based on educated decision making with reasoned burden of proof requires access to relevant posters, abstracts and peer-reviewed publications. These are organized by clinical study, pre-clinical research and scientific study of the mechanism of action. The “Featured Publication” highlights i-FACTOR Bone Graft in a specific clinical application of interest.

Featured Publication:

 

Arnold PM, et al. Efficacy of i-FACTOR Bone Graft versus autograft in anterior cervical discectomy and fusion. Results of the prospective, randomized, single-blinded Food and Drug Administration Investigational Device Exemption study, Spine (Phila Pa, 1976), 2016; 41(13):1075-83

Conclusion: i-FACTOR has met all four FDA mandated non-inferiority success criteria and has demonstrated safety and efficacy in single-level ACDF for radiculopathy. i-FACTOR and autograft groups demonstrated significant post-surgical improvement and high fusion rates.

Clinical Evidence

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i-FACTOR Peptide Enhanced Bone Graft exhibits superior clinical outcomes compared to autograft (the ‘gold standard’) in anterior cervical discectomy and fusion.

The synthetic P-15 peptide exhibits greater defect fill compared to freeze dried bone allograft and open flap debridement in periodontal osseous defects.

The synthetic P-15 peptide exhibits greater defect fill and superior clinical results compared to anorganic hydroxyapatite bone matrix in periodontal osseous defects.

The synthetic P-15 peptide is effective in the long-term management of infrabony defects after three-year follow-up.

The synthetic P-15 peptide offered significantly improved clinical outcomes compared to open flap debridement.

Pre-Clinical Evidence

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The synthetic P-15 peptide results in early bone formation and fusion in a pre-clinical spine model.

The synthetic P-15 peptide results in greater tissue volume fraction and thicker trabeculae compared to autograft in the sheep femur.

The synthetic P-15 peptide accelerates bone regeneration in a pre-clinical osteoporotic rat model.

The synthetic P-15 peptide enhances bone formation compared to non-treated anorganic bone (hydroxyapatite) in posterolateral fusion.

  • Axelsen MG, et al. Evaluation of cell binding peptide (P15) with silk fibre enhanced hydroxyapatite bone substitute for posterolateral spinal fusion in sheep, Eurospine 2015 Annual Meeting, Poster #30

The synthetic P-15 peptide results in significantly faster bone formation in pre-clinical long bone defects.

The synthetic P-15 peptide results in significantly faster bone formation in pre-clinical cranial model.

The synthetic P-15 peptide results in more bone growth compared to non-treated anorganic bone mineral (hydroxyapatite) in a rabbit osseous defect.

  • Guerra FA, 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 results in equivalent fusion rates to autologous bone in an ovine lumbar fusion model.

  • Patel VV, et al. 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 results in superior fusion rates compared to autograft in a goat cervical fusion model.

  • Cheng BC, et al. P-15: An osteoconductive protein to enhance healing of interbody cages, ORS 1998 Annual Meeting, Poster #636

The synthetic P-15 peptide results in optimal healing of segmental cortical bone defects in a rat model.

The synthetic P-15 peptide results in enhanced new bone formation in cortical defects in a rabbit model.

The synthetic P-15 peptide results in faster new bone formation in maxillary sinus defects compared to allograft.

The synthetic P-15 peptide enhances fusion in the  demanding periodontal environment.

Mechanism of Action

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The synthetic P-15 peptide is bound to the anorganic bone mineral and ensures bone grows where you want it.

The synthetic P-15 peptide causes stem cell differentiation to viable osteogenic cells.

The synthetic P-15 peptide increases the number of viable osteogenic cells attached.

The synthetic P-15 peptide results in the natural production of alkaline phosphatase and bone morphogenic protein leading to early bone formation.

The synthetic P-15 peptide results in higher expression of alkaline phosphatase (an early marker of cell proliferation) compared to other bone graft substitutes.

The synthetic P-15 peptide enhances bone marrow stromal cell attachment, spreading and alignment and the provision of biomimetic microenvironments for osteoblasts leading to bone formation.

The synthetic P-15 peptide stimulates early bone formation at a significantly higher rate compared to non-treated anorganic bone (hydroxyapatite).

The synthetic P-15 peptide results in improved cell viability compared to non-treated anorganic bone (hydroxyapatite) and demineralized bone allograft.