November 5, 2020
Cerapedics i-FACTOR+ Matrix is now fully available in Canada through distributor Surgi-One and can be used in both spine and general orthopedic applications.
Glen Kashuba, Chief Executive Officer of Cerapedics. “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.”
Cerapedics i-FACTOR+ MATRIX utilizes a small proprietary peptide (P-15) technology developed by Cerapedics to support bone growth through cell attraction, attachment, and activation. 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).
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 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. 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.
CAUTION: In the United States, P-15L Bone Graft (i-FACTOR+ Matrix) is an Investigational Product limited by Federal Law to investigational use only.
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.