Spine published the FDA Investigational Device Exemption clinical trial results for Cerapedics' i-FACTOR Peptide Enhanced Bone Graft in anterior cervical discectomy and fusion procedures, according to News-Medical.
Cerapedics is a Broomfield, Colo.-based orthobiologics company.
Here are five observations:
1. Michael Janssen, DO, of Denver-based Spine Education Research Institute, led the research.
2. The trial demonstrated the i-FACTOR bone graft was safe and effective. It met FDA-mandated non-inferiority success criteria in comparison to local autograft in single-level ACDF for cervical radiculopathy.
3. The i-FACTOR bone graft and autograft had high fusion rates in the study and showed improvements in neck disability index.
4. The i-FACTOR bone graft exhibited a 69 percent success rate in all four primary outcomes, while the autograft demonstrated a 57 percent success rate.
5. The researchers concluded the i-FACTOR bone graft is a strong alternative to autograft bone for ACDF procedures.