CE Mark for Silk-Enhanced Biological Bone Graft

Orthobiologics company Cerapedics, has gained CE Mark approval in Europe and Therapeutic Goods Administration (TGA) listing in Australia for the new i-FACTOR™ Flex FR biologic bone graft. The new system features the company’s proprietary synthetic small peptide (P-15) bone graft technology with the addition of purified silk fibers, intended to provide enhanced cohesion, mechanical properties, and handling characteristics.


Cerapedics is a developer of innovative biologic bone graft products for orthopedic procedures including spinal fusion, traumatic fracture treatment, and joint reconstruction. These products may replace or augment the use of autologous bone grafts, which are harvested from the patient in a secondary operation and can often leading to complications including chronic pain, infection, and fracture.

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 fibers that enhance cohesion and mechanical properties.

Physician comments

“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 Dr. Niall Craig, consultant orthopedic surgeon at NHS Grampian in the United Kingdom.

“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,” said Dr. Gregory Kesteloot, neurosurgeon at Stedelijk Ziekenhuis Roeselare in Belgium.

Company comments

“We are pleased to receive CE Mark approval and TGA listing for the new i-FACTOR™ Flex FR biologic bone graft,” said Glen Kashuba, CEO at Cerapedics. “Silk has been used in medical applications for many years, and by adding purified silk fibers 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.”

Source: PR Newswire

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