Cerapedics receives CE mark and TGA listing for new bone graft
Cerapedics recently announced it has received CE mark in Europe and Therapeutic Goods Administration listing in Australia for its new i-FACTOR Flex FR biologic bone graft.
The new biologic bone graft features the company’s proprietary synthetic small peptide (P-15) bone graft technology with the addition of purified silk fibers, according to a company press release.
The i-FACTOR Flex FR is based on original P-15 technology developed by Cerapedics to support bone growth through cell attachment and osteoblast differentiation. The new product includes silk from bombyx mori moth larva that is purified to remove the protein sericin, which results in biocompatible fibroin fibers that enhance cohesion and mechanical properties, according to the release.
More than 60 procedures have been successfully completed thus far using i-FACTOR Flex FR biologic bone graft, primarily in spinal fusion applications. The company introduced the product in a limited market release in order to obtain feedback from surgeons, according to the release.