Proven Superiority vs. Autograft in Overall Clinical Success1,2 Published in SPINE & Neurosurgery
Among 400+ spinal bone grafts on the market, spine surgeons can feel confident in choosing i-FACTOR Peptide Enhanced Bone Graft which is backed by Level 1 human clinical data from an IDE study published in Spine and Neurosurgery. In this study i-FACTOR demonstrated high fusion rates and statistical superiority vs. autograft in overall clinical success.1,2
One of only two Class III FDA-PMA approved spinal bone grafts, i-FACTOR is the leading evidence-based alternative and is powered by a first of its kind molecule called P-15: Osteogenic Cell Binding Peptide. i-FACTOR is free of many safety risks seen with other products such as ectopic bone formation and i-FACTOR is at least 30% less expensive than other drug-device combination products.1,2,3
The FIRST Bone Graft with P-15 Osteogenic Cell Binding Peptide
IS COST EFFECTIVE i-FACTOR is at least30% Less Expensive than Infuse3 $
The P-15 Peptide is bound to the anorganic bone mineral in i-FACTOR and it’s powerful mechanism of action eliminates the risk for heterotopic ossification seen with morphogenetic growth factors.
• Only grows bone in a bony environment; no evidence of ectopic bone formation3
• IDE Study demonstrated no difference in adverse events vs. autograft1,2
• Clinical experience outside US since 2008, in US since 2015• Over 100k procedures worldwide since 2008
i-FACTOR is Safe
100%
p= 0.4220
Fusion Success
i-FACTOR 12 months Autograft 12 months i-FACTOR 24 months Autograft 24 months
NDI Success Neurological Success Safety Success Overall Successp= 0.2907 p= 0.8123 p= 0.3085 p= 0.0382p= 0.2195 p= 0.1804 p= 0.6944 p= 0.1379 p= 0.0302
80%
60%
40%
20%
0%
89
79
949897
77
95 95
86
74
9395
94
69 6970
94 91
57 56
STATISTICALLY SUPERIOR
% S
ucce
ss
FUSIONNO EVIDENCE OFECTOPIC BONE FORMATION
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POWERED BY
FDA Approved IDE Study High Fusion Rate 97.3%
HIGHFUSIONRATESHAS LEVEL 1 DATA
FUSION
Powered by P-15: Osteogenic Cell Binding Peptide
P-15 Peptide
Osteogenic Cell Surface Receptors
i-FACTOR facilitates an abundance of osteogenic cells bound at the fusion site because cells are attracted to and attach to the i-FACTOR P-15 Peptide.4,5,6,7 The attachment activates multiple molecular processes that drive bone formation:
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ML-0618 10/20
References 1. Arnold P, Sasso R. et. al. Spine 2016; 41(13): 1075-83.
2. Arnold P, Sasso R. et. al. Neurosurg 2018; 83(3): 377-84.
3. Internal Data Report
4. Hennessy KM, Pollot BE, et. al. Biomat 2009; 30(10): 1898-909.
15 Amino Acids Chain
5. Nguyen H, Qian JJ. et. al. Biochem Biophys Res Commun 2003; 311(1): 179-86.
6. Yang XB, Bhatnager RS. et. al. Tissue Eng 2004; 10(7-8): 1148-59.
7. Qian JJ, Bhatnager RS. et. al. J Biomed Mater Res 1996; 31(4):545-54.
• Increased Number of Cells Bound at the Fusion Site4,5,6,7
• Increased Cellular Proliferation4,5,6,7
• Increased Protein/Matrix Production4,5,6,7
• Improved Overall Clinical Success Compared to Autograft1,21,2,5,6,7,8
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2797 Internationally available
