Cerapedics said today it won FDA investigational device exemption approval to launch a clinical trial examining the safety and efficacy of its P-15L Peptide Enhanced bone graft.
In the trial, the Wesminster, Colo.-based company will explore the use of the P-15L graft as it compares to autografts in transforaminal lumbar interbody fusion procedures meant for treating degenerative disk disease.
“Prior research of this proprietary P-15 technology has demonstrated potential benefits in fusion rates, neurological outcomes and safety in cervical and lumbar fusions. 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,” trial principal investigator Dr. Paul Arnold of the University of Kansas Medical Center said in prepared remarks.
The P-15L graft is designed based on proprietary synthetic small peptide technology the company developed to support bone growth, attachment and activation, and is intended for use as a substitute for autologous bone.
The trial is slated to enroll 364 patients with degenerative disk disease at 30 clinical trial sites in the US, with patients assessed prior to surgery and at six weeks, three months, one year and two years post-surgery.
“We are very pleased to be on the verge of initiating this milestone study. 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,” prez & COO Jeffrey Marx said in a press release.
The trial’s primary endpoint is a composite of clinical success at 2 years based on factors including radiographic fusion, a minimum of a 15-point improvement on the Oswestry Disability Index, no new or worsening persistent neurological deficits and no subsequent surgical interventions at the index level, Cerapedics said.
“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. 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,” CEO Glen Kashuba said in a prepared statement.
In February 2016, Cerapedics released the results from the pivotal FDA investigational device exemption trial of its i-Factor peptide enhanced bone graft for use in anterior cervical discectomy and fusion procedures. Data from the study was published electronically in the journal