Comprehensive Spine Center and lead author of the study.
#IFACTOR CERAPEDICS TRIAL#
"The publication of the two-year results from this Level I clinical trial further validates previous findings that i-FACTOR™ Bone Graft, with P-15 technology, is statistically superior to autograft," said Paul Arnold, M.D., neurosurgeon at the University of Kansas Hospital Marc A. Safety success measured by the absence of re-operation, device explantation, and device-related serious adverse events was observed in 95 percent of i-FACTOR Bone Graft patients and 91 percent of autograft patients (p = 0.1379). Improvement in neurological status was similar in both patient groups (95 percent of i-FACTOR Bone Graft patients and 94 percent of autograft patients, p = 0.6944). A more than 15-point improvement from baseline NDI was reported for 77 percent of i-FACTOR Bone Graft patients and 69 percent of autograft patients (p = 0.1804). This was statistically significant for superiority (p = 0.0302).įusion success was confirmed radiologically for 97 percent of i-FACTOR Bone Graft patients and 94 percent of autograft patients (p = 0.2195). At two-year follow-up, a responder analysis of combined endpoints for overall success demonstrated 70 percent success for patients receiving i-FACTOR Bone Graft versus 56 percent for patients receiving autograft. FDA-mandated success criteria included fusion, improvement in Neck Disability Index (NDI), neurological status, and safety. In the IDE clinical trial, patients received either autograft or i-FACTOR Bone Graft in a cortical ring allograft. "The Neurosurgery publication is a testament to the hard work and dedication of the clinical investigators who continue to pursue advanced treatment options for patients with degenerative cervical disc disease." "We are pleased that the statistical superiority in overall success for i-FACTOR Bone Graft versus autograft in ACDF procedures was maintained over two years in our IDE trial," said Jeffrey Marx, Ph.D., president and COO of Cerapedics. In November 2015, Cerapedics received Premarket Approval (PMA) from the FDA for the use of i-FACTOR Bone Graft in ACDF procedures. I‐FACTOR Bone Graft is based on synthetic small peptide (P-15) technology developed by Cerapedics to support bone growth through cell attachment and activation. The results published in the peer reviewed journal Neurosurgery show i-FACTOR Bone Graft is statistically superior in overall clinical success to autograft in anterior cervical discectomy and fusion (ACDF) procedures.
12, 2017 /PRNewswire/ - Cerapedics, a privately-held orthobiologics company, today announced the publication of two-year follow-up data from an FDA Investigational Device Exemption (IDE) clinical trial of i-FACTOR™ Peptide Enhanced Bone Graft.