Cerapedics has achieved a major clinical and commercial milestone with the first U.S. patient treated using PearlMatrix™ P-15 Peptide Enhanced Bone Graft following its recent FDA premarket approval (PMA) in June 2025. PearlMatrix is the first and only bone graft approved through the PMA pathway that is specifically proven to  FDA premarket approval (PMA). Classified as a Class III drug-device combination, PearlMatrix represents a significant innovation in spinal surgery by utilizing a synthetic P-15 peptide to promote natural bone growth and fusion, setting a new standard in biologic graft performance for patients with degenerative disc disease (DDD).

The first post-approval procedure was successfully performed by Dr. Sharad Rajpal, a leading neurosurgeon and Medical Director of the Advanced Spine Program at AdventHealth Avista in Colorado. The patient, diagnosed with lumbar DDD, underwent Transforaminal Lumbar Interbody Fusion (TLIF)—a complex surgical procedure requiring reliable bone graft material to achieve long-term spinal stability. PearlMatrix, used during the TLIF, offers a highly bioactive scaffold that enhances cellular activity, enabling faster and more predictable fusion outcomes. This innovation is particularly critical given the growing complexity of spinal fusion cases and the increasing number of patients presenting with multiple comorbidities.

With over 465,000 spinal fusion procedures performed annually in the U.S., the need for reliable, effective bone graft solutions is more pressing than ever. PearlMatrix stands out among more than 350 spinal grafts on the market as one of only three with FDA PMA approval, reinforcing its unique clinical value. Cerapedics’ success with this launch not only reflects the company’s dedication to evidence-based innovation but also promises improved recovery timelines and outcomes for patients. As the company continues to scale access to PearlMatrix, it marks a defining moment in spine care—delivering safer, faster, and more effective fusion options to surgeons and patients nationwide.

MedTech Spectrum's Summary

First-in-Class FDA-Approved Bone Graft: PearlMatrix™ is the first and only P-15 peptide enhanced bone graft to receive FDA premarket approval for accelerating lumbar spinal fusion in degenerative disc disease (DDD), marking a major regulatory and clinical milestone.

Successful First U.S. Use Post-Approval: The inaugural post-approval procedure, performed during a TLIF surgery, demonstrates the real-world application and potential of PearlMatrix to improve fusion outcomes and patient recovery.

Transforming Spine Surgery Standards: With its bioactive, drug-device design, PearlMatrix offers a new standard in spinal fusion by enhancing bone growth predictability—positioning Cerapedics at the forefront of innovation in orthobiologics.