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Cerapedics' i-FACTOR Bone Graft Featured in ISASS Bone Grafting Policy


Cerapedics announced that the International Society for the Advancement of Spine Surgery (ISASS) issued a new bone grafting policy with recommendations on use and payor coverage criterion. This statement features i‑FACTOR™ Peptide Enhanced Bone Graft as one of only two drug/device combination products with Premarket Approval by FDA and support of level 1 clinical data.

i-FACTOR received its PMA in 2015 for use in anterior cervical discectomy and fusion. This represented the first approval of bone graft for use in the cervical spine, and the second PMA-approved bone graft in the spine, following Medtronic's INFUSE. 

i‑FACTOR induces osteoblast cell proliferation and differentiation to accelerate new bone formation in patients with degenerative disc disease. An investigational device exemption clinical trial is evaluating the company's P-15 technology vs. autograft in transforaminal lumbar interbody fusion surgery.  

Source: Cerapedics