Cerapedics Gains Canadian Approval of Next-Gen Bone Graft

By Julie A. Vetalice

Cerapedics Gains Canadian Approval of Next-Gen Bone Graft

Cerapedics announced Health Canada approval of their next-generation bone graft called i-FACTOR®+ Matrix, making it the first market to approve the commercial launch of this product. Product launch will commence in 4Q20.

The technology is currently being studied in an FDA Investigational Device Exemption (IDE) study, ASPIRE, targeting lumbar fusion. i-FACTOR+ Matrix is the same technology as the P15-L investigational material in the IDE.

i-FACTOR Peptide Enhanced Bone Graft is based on proprietary small peptide (P-15) technology developed by Cerapedics to support bone growth through cell attraction, attachment, and activation.

In the U.S., i-FACTOR Peptide Enhanced Bone Graft was approved via an FDA premarket approval application in 2015 only for use in single-level anterior cervical fusion.

"We are excited to announce Canadian regulatory approval of our next-generation product, based on P15 osteogenic cell-binding peptide, i-FACTOR+ Matrix," said Glen Kashuba, Chief Executive Officer of Cerapedics, "The matrix product leverages the clinically proven power of the P15 peptide combined with a collagen carrier for optimized interoperative delivery."

Product Labels: Bone Graft Materials/DBM

Tags: Regulatory