Cerapedics’ i-FACTOR bone graft clinical trial results published: 5 observations

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.

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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.

 

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