Cerapedics, Inc. has announced that the first patients have been enrolled in an investigational device exemption (IDE) clinical trial of its next-generation P-15L Peptide Enhanced Bone Graft in transforaminal lumbar interbody fusion (TLIF).
The prospective, single-blinded, multicenter, randomized, non-inferiority pivotal IDE study will compare this product to 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 U.S.
According to the company, “…P-15L Bone Graft is based on a biomimetic 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. In 2015, the company’s first-generation bone graft became the first bone graft to be approved for use in the cervical spine and only the second PMA-approved bone graft in the spine.”
“The team at the Foundation for Orthopaedic Research and Education is pleased to participate in this important IDE trial of P-15L Bone Graft. Being involved in the study of a new drug-device combination product for spinal fusion is gratifying. We look forward to this first step in potentially expanding the indications for use of peptide enhanced bone grafts to the lumbar spine,” said Dr. John M. Small, M.D., of Tampa, Florida.
Cerapedics CEO Glen Kashuba told OTW, “We were very pleased that the FDA will allow us to use any FDA-cleared PEEK TLIF device in the study rather than limiting us to specific devices in the study. This combined with TLIF being the most commonly performed lumbar interbody fusion surgery means that we will be addressing a large segment of the market upon eventual approval.”
“We have a significant body of high quality clinical evidence demonstrating the safety and efficacy of our P-15 peptide technology. This IDE study in TLIF will raise the bar further as surgeons, hospitals, and payors continue to move in the direction of evidence-based medicine.”