Cerapedics has gained U.S. Food and Drug Administration (FDA) premarket approval for its PearlMatrix P-15 peptide enhanced bone graft for single-level transforaminal lumbar interbody fusion (TLIF) surgery in adult patients with degenerative disc disease (DDD).

PearlMatrix is powered by a proprietary P-15 osteogenic cell binding principle. According to the company, the bone graft is the first, only bone growth accelerator (BGA) proven to accelerate lumbar fusion.

P-15 peptide as a 15-amino acid sequence that’s found naturally in Type-1 collagen, the main protein in bone. It serves an integral role in bone regeneration and as a powerful cell attachment factor. Cerapedics’ pharmaceutically manufactured P-15 peptide is bound onto calcium phosphate particles, creating a P-15-enhanced scaffold that offers attachment sites for osteogenic cells.

PearlMatrix is intended to be used in conjunction with a PEEK TLIF fusion Device and supplemental internal spinal fixation systems cleared by the FDA for use in the lumbosacral spine. The system is to be used in patients who have had at least six months of non-operative treatment.

“The FDA approval of PearlMatrix Bone Graft is a significant achievement for Cerapedics as we’re the only company with two PMA-approved products for use in spinal fusion. This is a testament to our dedication to investing in high-quality clinical evidence in our pursuit to have a positive impact on the practice of spine surgery and the lives of patients,” said Valeska Schroeder, CEO of Cerapedics. “Differentiated by its unique P-15 Osteogenic Cell Binding Peptide, PearlMatrix Bone Graft is the first and only bone growth accelerator proven to substantially increase lumbar fusion speed, giving surgeons a new option to better meet patient needs and treat them more efficiently.”

In September, the company gained FDA approval to expand the indications for use and labeling for its i-FACTOR P-15 peptide enhanced bone graft. The label expansion approves i-FACTOR for single-level anterior cervical discectomy fusion (ACDF) with an allograft bone ring, or in conjunction with an FDA-cleared PEEK, titanium alloy, or PEEK/titanium fusion interbody device for use in the cervical spine, with supplemental anterior plate fixation.