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Proven Superiority vs. Autograft in Overall Clinical Success 1,2 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 least 30% Less Expensive than Infuse 3 $ 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 formation 3 • IDE Study demonstrated no difference in adverse events vs. autograft 1,2 • 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 Success p= 0.2907 p= 0.8123 p= 0.3085 p= 0.0382 p= 0.2195 p= 0.1804 p= 0.6944 p= 0.1379 p= 0.0302 80% 60% 40% 20% 0% 89 79 94 98 97 77 95 95 86 74 93 95 94 69 69 70 94 91 57 56 STATISTICALLY SUPERIOR % Success FUSION NO EVIDENCE OF ECTOPIC BONE FORMATION TM POWERED BY FDA Approved IDE Study High Fusion Rate 97.3% HIGH FUSION RATES HAS LEVEL 1 DATA
