Cerapedics, a privately-held orthobiologics company, today announced that more than 150 leading U.S. hospitals have now adopted use of i-FACTOR Peptide Enhanced Bone Graft. Cerapedics received Premarket Approval (PMA) for i-FACTOR bone graft from the U.S. Food and Drug Administration (FDA) in late 2015 for use in ACDF procedures in patients with degenerative cervical disc disease. The company had initiated U.S. commercial activities in June 2016 following FDA approval of final IFU labeling and additional product sizes.
“The available options including bone morphogenetic protein therapies present both safety risks and significant costs,” said Dan Peterson, MD, FAANS & FACS, neurosurgeon at Austin Brain and Spine. “Increasingly surgeons and hospitals are recognizing the advantages of the i-FACTOR Bone Graft’s synthetic small peptide (P-15) technology in helping to improve safety and outcomes.”
i‐FACTOR Bone Graft is based on proprietary P-15 technology developed by Cerapedics to support bone growth through cell attraction, attachment, and activation. It is the first bone graft to be approved for use in the cervical spine and only the second PMA-approved bone graft in the spine backed by Level 1 human clinical data.
“We are continually hearing about development of new options to support bone regrowth and repair, including use of stem cell technologies,” said Neill Wright, MD, FAANS, Herbert Lourie Professor of Neurological Surgery at Washington University School of Medicine. “In many cases, available data do not confirm that both performance and costs are in line to deliver optimal outcomes for patients and hospitals. With i-FACTOR Bone Graft we have that data and can feel confident about both performance and cost advantages.”
In September 2017, Cerapedics announced publication of two-year follow-up data from an FDA Investigational Device Exemption (IDE) clinical trial of i-FACTOR Bone Graft. The results published in the peer reviewed journal Neurosurgeryshow i-FACTOR Bone Graft is statistically superior in overall clinical success to autograft.
“Our national commercialization and sales strategy is well positioned to meet the rapidly expanding interest in i-FACTOR Bone Graft,” said Glen Kashuba, CEO of Cerapedics. “We fully expect the rate of adoption to continue to grow rapidly in 2018 with over 100 additional hospital approvals pending as more surgeons and hospitals recognize the clear advantages of our technology over currently available options.”
WESTMINSTER, Colo., Oct. 26, 2017