Cerapedics Gains FDA Approval of PMA Supplement for i-FACTOR

By Julie A. Vetalice

Cerapedics Gains FDA Approval of PMA Supplement for i-FACTOR

FDA approved Cerapedics' Premarket Approval (PMA) supplement for i-FACTOR® Peptide Enhanced Bone Graft for use in anterior cervical discectomy and fusion to treat degenerative cervical disc disease. Cerapedics 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.

"We are pleased to receive FDA approval of our PMA supplement, which allows i-FACTOR labeling to reflect longer-term clinical data showing that the statistical superiority to autologous bone in overall clinical success that was observed at one year has been maintained at two-year follow-up," said Jeffrey Marx, Ph.D., President and Chief Operating Officer. "We believe i-FACTOR Bone Graft represents one of the most important technological breakthroughs in this field and are committed to compiling extensive Level I human clinical data to support its use across the U.S. and around the world."

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 the FDA, joining Medtronic's Infuse.

Product Labels: PRP/Cell-Based/Osteoinductive Materials

Tags: ["Premarket Approval","Regulatory"]