Cerapedics Receives CE Mark for New Bone Graft

Cerapedics Inc., a privately-held, Westminster, Colo.-based orthobiologics company, announced today it has received CE mark in Europe and Therapeutic Goods Administration (TGA) listing in Australia for the new 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 fibers to—according to the company—provide enhanced cohesion, mechanical properties, and handling characteristics.

“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.”

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.

Cerapedics 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. To date more than 60 procedures have been successfully completed using the 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, M.D., 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 Gregory Kesteloot, M.D., neurosurgeon at Stedelijk Ziekenhuis Roeselare in Belgium.

Cerapedics is working to identify and develop 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 often can lead to complications including chronic pain, infection and fracture.
The company is focused on developing and commercializing its proprietary synthetic small peptide (P-15) technology platform.

Cerapedics is currently enrolling patients in a clinical trial in the United States on the use of P-15 Bone Putty for single level anterior cervical discectomy and fusion procedures.