Study: Cerapedics’ i-FACTOR Bone Graft, Autograft Results in Similar Outcomes for ACDF Procedures

Cerapedics has presented preliminary outcomes data from a FDA Investigational Device Exemption clinical trial for i-FACTOR Peptide Enhanced Bone Graft in anterior cervical discectomy and fusion procedures, which indicates that treatment with i-FACTOR does not result in significantly inferior outcomes as compared to treatment with autograft.

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The trial compared the use of i-FACTOR bone graft and autograft for ACDF procedures, and the outcomes were found to be statistically similar. Additionally, i-FACTOR achieved an 89 percent fusion rate whereas the autograft achieved a fusion rate of 85 percent. The data for the IDE and the results are being finalized for submission to the FDA.

 

Cerapedics is an orthobiologics company focused on developing and marketing peptide enhanced bone graft products based on its proprietary synthetic small peptide technology platform.

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