Tuesday September 15, 2020 0 comments
WESTMINSTER -- Cerapedics, a private ortho-biologics company, today announced Health Canada approval of the company's next-generation bone graft called i-FACTOR+ Matrix, making it the first market to approve the commercial launch of this product.
"We are excited to announce Canadian regulatory approval of our next-generation product, based on P15 osteogenic cell-binding peptide , i-FACTOR+ Matrix," said Glen Kashuba, Cerapedics CEO.
"The matrix product leverages the clinically proven power of the P15 peptide combined with a collagen carrier for optimized interoperative delivery."
"In addition to an anticipated commercial launch in Canada this October, the technology is currently being studied in our FDA IDE study, ASPIRE, targeting lumbar fusions (TLIF), as previously announced,” said Jeffrey Marx, company president and COO.
“ i-FACTOR+ Matrix is the same technology as the P15-L investigational material in the IDE.”
i-FACTOR Peptide Enhanced Bone Graft is based on proprietary small peptide (P-15) technology developed by Cerapedics to support bone growth through cell attraction, attachment, and activation.
In spinal fusion procedures, surgeons use a bone graft to join and stabilize vertebrae. 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).
In the United States, i-FACTOR Peptide Enhanced Bone Graft was approved via a U.S. Food and Drug Administration (FDA) premarket approval (PMA) application in 2015 only for use in single-level anterior cervical fusion procedures.
In 2018, the company enrolled the first patients in an IDE clinical trial, ASPIRE, evaluating the safety and efficacy of its next-generation product, P-15L Peptide Enhanced Bone Graft, for use in patients undergoing TLIF fusion surgery.