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Reimbursement / Regulatory

Cerapedics Receives FDA Approval for i-FACTOR Bone Graft in Cervical Spine Surgery -

FDA approved a Premarket Approval application for Cerapedics' i-FACTOR™ Peptide Enhanced Bone Graft for use as a substitute for autologous bone in anterior cervical discectomy and fusion (ACDF) in patients with degenerative disc disease. This represents the 1st approval of bone graft for use in the cervical spine and the 2nd PMA-approved bone graft in the spine (the 1st being INFUSE). Cerapedics filed its PMA in 3Q14

The approval was supported by pivotal clinical trial data comparing i-FACTOR to autograft in ACDF, during which i-FACTOR met all pre-specified primary endpoints and demonstrated non-inferiority to autograft. The proportion of i-FACTOR bone graft subjects with overall success was noted as significantly higher than that of the autograft subjects.

Cerapedics is ramping up engagement with distributors and direct sales rep recruitment efforts to support U.S. launch of i-FACTOR, in a U.S. market for biologic bone substitutes that it estimates to be ~$500MM.

Source: Cerapedics

Clinical evidence to support use of biologics is repeatedly cited as a surgeon request by the industry panelists who shared viewpoints in ORTHOPRENEUR®, "Growth in Orthobiologics Segment Dependent upon Clinical Data, Cost-effectiveness."

 

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