Cerapedics began its investigational device exemption clinical trial for its P-15L Peptide Enhanced Bone Graft.
Here are five takeaways:
1. The first patient was enrolled in the clinical trial to study the safety and efficacy of the bone graft in transforaminal lumber interbody fusion surgery.
2. Within the prospective, single-blinded, multi-center, randomized, non-inferiority pivotal IDE study, Cerapedics will compare its P-15L Bone Graft with an autologous bone graft.
3. The study will include 364 patients with degenerative disc disease at up to 30 clinical trial sites across the U.S.
4. The P-15L Bone Graft was developed with Cerapedics' biomimetic small peptide technology and is designed to be a substitute for autologous bone.
5. Cerapedics was the first company to earn FDA clearance for a cervical spine bone graft and second to received pre-market approval for a spinal bone graft.