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:

 

Lauweryns P and Raskin Y, Prospective analysis of a new bone graft in lumbar interbody fusion: Results of a 2-year prospective clinical and radiological study, Int J Spine Surg, 2015; 9

Conclusion: This study suggests that ABM/P-15 has equal or greater efficacy [compared to autograft] at 6 and 12 months. Pain improvements exceeded success criteria at all time points. Functional improvement exceeded success criteria at all time points.

Clinical Evidence

+
-

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

i-FACTOR Peptide Enhanced Bone Graft is statistically superior to autologous bone in facilitating formation of bridging bone inside PLIF cages.

i-FACTOR Peptide Enhanced Bone Graft demonstrates a high fusion rate and clinical improvements  comparable to ALIF using autograft of BMP, but a with superior safety profile and lower cost.

i-FACTOR Peptide Enhanced Bone Graft provides a high level of bone consolidation in challenging long-bone non-union and delayed unions.

i-FACTOR Peptide Enhanced Bone Graft provides a higher rate of fusion in transforaminal lumbar interbody fusion compared to Actifuse and Vitoss.

  • Berg AJ, et al. Transforaminal lumbar interbody fusion rates with Actifuse, i-FACTOR and Vitoss BA synthetic bone grafts, ISASS 2014 Annual Meeting and EFORT 2014 Congress (poster)

i-FACTOR Peptide Enhanced Bone Graft provides reliable fusion in cervical interbody fusion (80% fused and 17% progressing to fusion at 26 weeks follow-up).

  • Berg AJ, et al. Cervical interbody fusion rates with i-FACTOR Peptide Enhanced Bone Graft, ISASS 2014 Annual Meeting and EFORT 2014 Congress (poster)

i-FACTOR Peptide Enhanced Bone Graft restores near normal bone porosity and trabecular orientation in ACDF.

  • Kesteloot G, et al. Three dimensional remodeling of i-FACTOR Peptide Enhanced Bone Graft substitute in cervical fusions, Belgian Society of Neurosurgery 2016 Annual Meeting (poster)

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

+
-

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

+
-

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

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

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

The synthetic P-15 peptide in i-FACTOR Bone Graft 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.