Cerapedics, Inc., a Westminster, Colorado-based developer and producer of peptide-based biologics for spine fusion and extremities recently announced the commercial launch of its latest product, the i-FACTOR®+ Matrix across Canada.
The updated Peptide Enhanced Bone Graft product was approved by Health Canada in September 2020 and is an upgraded version of the original i-FACTOR bone graft that has been available since 2008 in the European Union (EU). The investigational device exemption (IDE) study, ASPIRE, is currently underway in the U.S., where the biologic is currently known as P-15L. The company has had promising news from the U.S. FDA allowing for lower study enrollment, which was previously covered by OTW.
The original i-FACTOR was approved by the U.S. FDA in 2015 for cervical fusion, and the current U.S. IDE study is investigating the use of the biologic for “lumbar fusions (TLIF)… i-FACTOR+ Matrix is the same technology as the P15-L investigational material in the IDE,” said company President and COO Jeffrey Marx, Ph.D.
The commercial rollout marks the first widespread availability of the second-generation biologic as explained by Cerapedics CEO Glen Kashuba. “Canada will be the first market offering the i-FACTOR+ MATRIX product, which leverages the clinically proven P-15 osteogenic cell-binding peptide combined with a collagen carrier for optimized handling.” Kashuba added details of the launch, saying, “We are excited to announce that i-FACTOR+ Matrix is now fully available in Canada through our distributor Surgi-One and can be used in both spine and general orthopedic applications.”
The 15-amino acid peptide at the heart of i-FACTOR is a sequence found in type I collagen, that pre-clinical studies showed encouraged bone growth. The sequence, however, is normally hidden within the structure of the collagen protein. By adhering the peptide to the surface of a collagen-based carrier the bioavailability of the osteoinductive peptide is increased by orders of magnitude. The company also markets a silk fiber-enhanced version of i-FACTOR, called IFACTOR FlexFR, in countries that allow CE marking.
