#Cerapedics ifactor trial

#Cerapedics ifactor trial

The PMA approval was supported by data from a pivotal clinical trial pitting the I-Factor bone graft against an autograft in ACDF procedures. With our transition to a commercial stage company, all of us at Cerapedics look forward to bringing an important new biologic bone graft option, the only backed by significant level-1 clinical evidence, to surgeons and patients across the U.S.,” COO & prez Jeffrey Marx said in a press release. It is the culmination of years of seamless cooperation with our clinical investigators to support PMA approval. “This is an historic milestone for us at Cerapedics and also for the surgical treatment of cervical disc degeneration. Westminster, Colo.-based Cerapedics said the I-Factor graft is the 1st bone graft approved for use in cervical spine procedures and the 2nd PMA cleared bone graft for the spine. This novel mechanism of action is designed to support safer and more predictable bone formation compared to commercially available bone growth factors.Cerapedics said yesterday it won FDA premarket approval for its I-Factor peptide enhanced bone graft for use in anterior cervical discectomy and fusion procedures for patients with degenerative cervical disc disease. i-FACTOR Peptide Enhanced Bone Graft is the only biologic bone graft in orthopedics that incorporates a small peptide as an attachment factor to stimulate the natural bone healing process. '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.'Ĭerapedics is an orthobiologics company focused on developing and commercializing its proprietary synthetic small peptide (P-15) technology platform. '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. The results published in the peer reviewed journal Neurosurgery show i-FACTOR Bone Graft is statistically superior in overall clinical success to autograft. 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. With i-FACTOR Bone Graft we have that data and can feel confident about both performance and cost advantages.' 'In many cases, available data do not confirm that both performance and costs are in line to deliver optimal outcomes for patients and hospitals. '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.

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. I‐FACTOR Bone Graft is based on proprietary P-15 technology developed by Cerapedics to support bone growth through cell attraction, attachment, and activation. '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.' '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. commercial activities in June 2016 following FDA approval of final IFU labeling and additional product sizes.

Food and Drug Administration (FDA) in late 2015 for use in ACDF procedures in patients with degenerative cervical disc disease. Cerapedics received Premarket Approval (PMA) for i-FACTOR bone graft from the U.S.

hospitals have now adopted use of i-FACTOR™ Peptide Enhanced Bone Graft. 26, 2017 /PRNewswire/ - Cerapedics, a privately-held orthobiologics company, today announced that more than 150 leading U.S.