Cerapedics today announced that the Canadian Market would be the first to have the i-FACTOR+ MATRIX surgical implant fully commercially available. The implant will be distributed by Surgi-One.
A small proprietary peptide (p-15), a technology developed by Cerapedics, is used in the iFACTOR+ MATRIX implant. The p-15 product reportedly supports bone growth through cell attraction, attachment, and activation. This implant has both spine and orthopaedic applications.
Glen Kashuba, Chief Executive Officer of Cerapedics, stated, “Canada will be the first market offering the i-FACTOR+ MATRIX product, which leverages the clinically proven P-15 osteogenic cell-binding peptide combined with a collagen carrier for optimized handling.”
The i-FACTOR Peptide Enhanced Bone Graft, Cerapedic’s initial P-15 product, was approved in the European Union and Australia, in 2008 and 2010, respectively. Its approval was for its use in the repair of bony voids or defects in orthopaedic applications throughout the skeletal system.
This initial P-15 product also received premarket approval from the US Food and Drug Administration (FDA) in 2015, however, only for its use in single-level anterior cervical fusion procedures.
The i-FACTOR+ MATRIC is currently being studied for Cerapedic’s FDA investigative device exemption, ASPIRE, targeting lumbar fusions.