Cerapedics Gains IDE for P-15L Peptide Enhanced Bone Graft Clinical Trial

The FDA granted Cerapedics an investigational device exemption for a clinical trial evaluating the safety and effectiveness of its P-15L Peptide Enhanced bone graft.

In the trial, the company will explore the bone graft’s use as it compares to autografts in transforaminal lumbar interbody fusion procedures meant for treating degenerative disk disease. The trial aims to enroll 364 patients with the disease at 30 U.S. clinical trial sites, with patients assessed prior to surgery and at six weeks, three months, one year and two years post-surgery.

Its primary endpoint is a composite of clinical success at two years based on factors such as radiographic fusion, no new or worsening persisting neurological deficits and no subsequent surgical interventions at the index level.