Cerapedics Gains FDA Approval of IDE Supplement

FDA approved Cerapedics’ Investigational Device Exemption (IDE) supplement, reducing the enrollment requirement for the ongoing ASPIRE clinical trial for P-15L Bone Graft in a single level transforaminal lumbar interbody fusion (TLIF). Enrollment is reduced from 364 to 270 patients, leading to an earlier premarket approval (PMA) submission.

The prospective, single-blinded, multi-center, randomized, non-inferiority pivotal IDE study will evaluate P-15L Bone Graft vs. autologous bone graft in TLIF.

P-15L Bone Graft is based on a small biomimetic peptide technology developed by Cerapedics to support bone growth, and is designed 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, following Medtronic’s Infuse.