“In addition to the commercial launch in Canada, the latest i-FACTOR+ MATRIX generation is currently being studied in our FDA IDE study, ASPIRE, targeting lumbar fusions (TLIF), as previously announced. Food and Drug Administration (FDA) premarket approval (PMA) application in 2015 only for use in single-level anterior cervical fusion procedures. In the United States, i-FACTOR Peptide Enhanced Bone Graft was approved via a U.S. Cerapedics initial P-15 technology product, i-FACTOR Peptide Enhanced Bone Graft, was approved in the European Union in 2008 and Australia in 2010 for use in the repair of bony voids or defects in orthopedic applications throughout the skeletal system (i.e., the spine and extremities). I-FACTOR+ MATRIX utilizes a small proprietary peptide (P-15) technology developed by Cerapedics to support bone growth through cell attraction, attachment, and activation. “ 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.” “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,” said Glen Kashuba, Chief Executive Officer of Cerapedics.
#Ifactor biologics full
Cerapedics, a private ortho-biologics company, today announced the full commercial availability of i-FACTOR+ MATRIX for surgical implantation in Canada.
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