Cerapedics receives CE mark and TGA listing for i-FACTOR Flex FR biologic bone graft

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Cerapedics has received CE mark in Europe and Therapeutic Goods Administration listing in Australia for the i-FACTOR Flex FR biologic bone graft, which features the company’s proprietary synthetic small peptide (P-15) bone graft technology with the addition of purified silk fibres to provide enhanced cohesion, mechanical properties, and handling characteristics.

“Silk has been used in medical applications for many years, and by adding purified silk fibres to the proven efficacy and safety of our P-15 bone graft technology we are now able to pursue exciting new applications for this platform,” said Glen Kashuba, Cerapedics chief executive officer.  

 

The i-FACTOR Flex FR biologic bone graft 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 larva of the bombyx mori moth that is purified to remove the protein sericin, resulting in biocompatible fibroin fibres that enhance cohesion and mechanical properties.

Cerapedics has conducted a limited market release for i-FACTOR Flex FR biologic bone graft in order to obtain feedback from surgeons on a range of product enhancements. The company says that to date, more than 60 procedures have been successfully completed using i-FACTOR Flex FR biologic bone graft, primarily in spinal fusion applications.

“Based on our clinical experience thus far, the new i-FACTOR Flex FR biologic bone graft appears to offer significant advantages in handling while maintaining the safety and efficacy of the first generation i-FACTOR with P-15 technology,” said Niall Craig, consultant orthopaedic surgeon at NHS Grampian, UK.

“The out-of-package handling and in vivo cohesive properties of i-FACTOR Flex FR biologic bone graft are impressive enhancements and can help improve performance in a number of surgical indications,” commented Gregory Kesteloot, neurosurgeon at Stedelijk Ziekenhuis Roeselare in Belgium.