The FDA approved Cerapedics premarket approval supplement for i-Factor in anterior cervical discectomy and fusion procedures in patients with degenerative disc disease.
Three things to know:
1. The company requested approval for an updated package insert that includes 24-month follow-up data from subjects in the original clinical study.
2. i-Factor is a peptide enhanced bone graft that Cerapedics commercialized in 2016.
3. The biologic bone graft incorporates a small peptide as an attachment factor to stimulate the natural bone healing process.