Spinal fusion procedures such as TLIF involve joining and stabilizing one or more vertebrae to reduce pain and nerve irritation. A bone graft, which has historically been obtained from the patient's pelvis, is placed in the interbody space to promote fusion. P-15L Bone Graft is based on proprietary synthetic small peptide (P-15) technology developed by Cerapedics to support bone growth through cell attraction, attachment and activation, and is designed to be used as a substitute for autologous bone.
"With regulatory approval to begin a new IDE study of P-15L Bone Graft in TLIF procedures, we are now in position to collect additional Level 1 human clinical data on our next-generation advanced drug-device combination bone graft," said Glen Kashuba, CEO of Cerapedics. "Several hundred thousand people in the U.S. need surgery for degenerative disk disease every year, and it is our goal to offer surgeons a safe and effective alternative to a patient's own bone as well as address the evidence gap around commercial bone grafts often used in these procedures."
The prospective, single-blinded, multi-center, randomized, non-inferiority pivotal IDE study will evaluate the safety and efficacy of P-15L Bone Graft compared to use of an autologous bone graft when applied in TLIF surgery. The study will include 364 patients with degenerative disk disease at up to 30 clinical trial sites across the United States. Patients will be assessed prior to surgery and six weeks, three months, 12 months, and 24 months post-surgery. The primary endpoint for the study is composite clinical success at 24 months based on several factors including the achievement of radiographic fusion (assessed by CT), at least a 15-point improvement in the Oswestry Disability Index (ODI), no new or worsening persistent neurological deficit, and no subsequent surgical intervention at the index level. Clinical investigators are permitted to use any FDA cleared static PEEK interbody device and any FDA cleared pedicle fixation system delivered through either an open or minimally invasive TLIF technique.
"We are very pleased to be on the verge of initiating this milestone study," said Jeffrey G. Marx, Ph.D., president and chief operating officer of Cerapedics. "We believe the FDA approved study design should allow for rapid enrollment and clear evaluation of the safety and efficacy of P-15L Bone Graft versus local autograft. We're assembling an outstanding team of surgeon investigators whom we are excited to collaborate with."
"Prior research of this proprietary P-15 technology has demonstrated potential benefits in fusion rates, neurological outcomes and safety in cervical and lumbar fusions," said Paul M. Arnold, M.D., neurosurgeon and vice chair of research in the Department of Neurosurgery at the University of Kansas Medical Center and principal investigator of the IDE study. "We are pleased to participate in a new study evaluating whether similar results can be achieved in a wider range of patients with degenerative disk disease utilizing the next generation P-15L product."
In November 2015, Cerapedics received premarket approval (PMA) from the FDA for the use of i-FACTOR Bone Graft in anterior cervical discectomy and fusion (ACDF) procedures, becoming only the second PMA-approved bone graft in the spine. The company is initiating enrollment in the newly approved TLIF IDE study with the expectation that the results from the study will support a PMA application.
Cerapedics is an orthobiologics company focused on developing and commercializing its proprietary synthetic small peptide (P-15) technology platform. 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. This novel mechanism of action is designed to support safer and more predictable bone formation compared to commercially available bone growth factors.