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Reimbursement / Regulatory

Cerapedics Gains FDA Approval of PMA Supplement for i-FACTOR -

FDA approved Cerapedics' Premarket Approval supplement for i-FACTOR® Peptide Enhanced Bone Graft for use in ACDF to treat degenerative cervical disc disease. The company requested approval for an updated package insert that incorporates 24-month follow-up data from subjects enrolled in the original clinical study. A review of 2-year follow-up data from an FDA Investigational Device Exemption clinical trial of i-FACTOR indicated its statistical superiority in overall clinical success to autograft in ACDF. Analysis of combined endpoints for overall success demonstrated 70% success for patients receiving i-FACTOR vs. 56% for those receiving autograft. Cerapedics launched i‑FACTOR in 2016. The drug/device combination is based on synthetic small peptide technology that accelerates new bone formation. It is in a new category of bone graft technology and is one of only two drug/device combination products approved by FDA, joining Medtronic's Infuse.