MOTH CREATES NOVEL PEPTIDE FOR SPINE FUSION (Orthopedics This Week)
Cerapedics, Inc., a privately-held orthobiologics company located in Westminster, Colorado, has received CE Mark rating in Europe and Therapeutic Goods Administration listing in Australia for the firm’s new i-FACTOR Flex FR biologic bone graft. The new biologic bone graft, designed primarily for spinal fusion surgery, features the company’s proprietary synthetic small peptide bone graft technology with the addition of purified silk fibers. The silk is claimed to provide enhanced cohesion, improved mechanical properties, and handling characteristics.
Jeff Marx, president and chief operating officer of Cerapedics, told OTW that, to the best of his knowledge, though silk has historically been used in medicine, his company is the first to use silk in allografts. The product contains silk from larva of the bombyx mori moth. The silk is purified to remove the protein sericin, which results in biocompatible fibroin fibers that enhance cohesion and mechanical properties.
As Marx explained, while the original product worked well in confined spaces, such as cages, “the addition of silk improved interoperative handling characteristics allowing doctors to use it in a broader array of indications.”
“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 for the United Kingdom’s National Health Service.
“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.
“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. He said that the i-FACTOR Flex FR biologic bone graft is based on original technology developed by Cerapedics to support bone growth through cell attachment and osteoblast differentiation. To date, Kashuba said, more than 60 procedures have been successfully completed using i-FACTOR Flex FR biologic bone graft, primarily in spinal fusion applications.
The company is aggressively pursuing clearance from the U.S. Food and Drug Administration. “We were pleased with the relatively small number of deficiencies with the PMA,” Marx said. “None were show stoppers or unanswerable.” The company anticipates clearance by the end of 2015 or beginning of 2016.