i-FACTOR Peptide Enhanced Bone Graft Technology Platform
i-FACTOR Bone Graft is an advanced biologic that is supported with level I evidence, satisfies the highest regulatory imperatives, and provides a better cost/benefit ratio than engineered growth factors and cellular allografts.
Mechanism of Action
i-FACTOR Bone Graft is the only biologic bone graft made of a synthetic small peptide (P-15) bound to an anorganic bone mineral (ABM). This unique combination creates a surface-bound “Attract, Attach, Activate” mechanism of action that enhances the body’s natural bone healing process. Being surface-bound, all cellular activity resulting from P-15 attachment is restricted to the implant surface so bone cannot grow where it doesn’t belong (ectopic bone growth).
i-FACTOR Bone Graft is not a morphogen so, unlike engineered growth factors, the signals sent following P-15 attachment in a bony site only activate cells that are pre-programmed to become osteoblasts.
i-FACTOR™ Peptide Enhanced Bone Graft is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space, and corresponding to at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels, after failure of at least 6 weeks of conservative treatment. i-FACTOR Peptide Enhanced Bone Graft must be used inside an allograft bone ring and with supplemental anterior plate fixation.
i-FACTOR Bone Graft products are sterilized after packaging (terminally sterilized), can be stored at room temperature and have a three-year shelf life. i-FACTOR Bone Graft is ready to use and thus requires no mixing or other preparation prior to use.FDA Approval
- Remove the syringe cap and dispense i-FACTOR Putty by depressing the syringe plunger.
- i-FACTOR Putty may be dispensed directly into the allograft ring or into a separate sterile receptacle where it can be transferred using traditional surgical instrumentation or by hand.
- The central cavity of the allograft should be filled with i-FACTOR Bone Graft.
IMPORTANT: Do not irrigate once implanted.