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. FDA in 2015 for cervical fusion, and the current U.S. The original i-FACTOR was approved by the U.S. FDA allowing for lower study enrollment, which was previously covered by OTW. The company has had promising news from the U.S. The investigational device exemption (IDE) study, ASPIRE, is currently underway in the U.S., where the biologic is currently known as P-15L. 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). 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.
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