Cerapedics has announced the publication of two-year follow-up data from a US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) clinical trial of the I-Factor peptide-enhanced bone graft. The results, published in Neurosurgery, show the graft to be statistically superior to autograft in overall clinical success in anterior cervical discectomy and fusion (ACDF) procedures.
I-Factor is based on synthetic small peptide (P-15) technology, developed by Cerapedics, to support bone growth through cell attachment and activation. In November 2015, the company received Premarket Approval (PMA) from the FDA for the use of drug-device combination in ACDF procedures.
“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,” says Jeffrey Marx, president and chief operating officer of Cerapedics. “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.”
In the IDE clinical trial, patients received either autograft or I-Factor in a cortical ring allograft. FDA-mandated success criteria included fusion, improvement in Neck Disability Index (NDI), neurological status, and safety. At two-year follow-up, a responder analysis of combined endpoints for overall success demonstrated 70% success for patients receiving I-Factor bone graft vs. 56%for patients receiving autograft. This was statistically significant for superiority (p=0.0302).
Fusion success was confirmed radiologically for 97% of I-Factor bone graft patients and 94% of autograft patients (p=0.2195). A more than 15-point improvement from baseline NDI was reported for 77% of I-Factor patients and 69% of autograft patients (p=0.1804). Improvement in neurological status was similar in both patient groups (95% of I-Factor patients and 94% of autograft patients, p=0.6944). Safety success measured by the absence of re-operation, device explantation, and device-related serious adverse events was observed in 95% of I-Factor patients and 91% of autograft patients (p=0.1379).
“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,” says Paul Arnold, neurosurgeon at the University of Kansas Hospital Marc A Asher, M.D. Comprehensive Spine Center and lead author of the study. “We are pleased to be able to offer a new advanced biologic bone graft with outstanding safety and efficacy to our patients.”