Cerapedics, a private ortho-biologics company, today announced the 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, Chief Executive Officer of Cerapedics, “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. i-FACTOR+ Matrix is the same technology as the P15-L investigational material in the IDE.,” said Jeffrey Marx, Ph.D., President and Chief Operating Officer of Cerapedics.
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.
In the United States, i-FACTOR Peptide Enhanced Bone Graft is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space, and corresponding to at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels, after failure of at least 6 weeks of conservative treatment. i-FACTOR Peptide Enhanced Bone Graft must be used inside an allograft bone ring and with supplemental anterior plate fixation.
See Full Press Release at the Source: Cerapedics Announces Canadian Approval of its next-generation bone graft | Cerapedics
Press Release by: Cerapedics
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