Cerapedics revealed U.S. Food and Drug Administration (FDA) approval to expand the indications for use and labeling for its PearlMatrix P-15 peptide enhanced bone graft.

PearlMatrix is a Class III drug-device combination product meant for adult patients with degenerative disc disease (DDD) in the lumbar spine. With the label expansion, it’s now approved for open or minimally invasive single-level anterior lumbar interbody fusion (ALIF), posterior lumbar interbody fusion (PLIF), oblique lumbar interbody fusion (OLIF), and lateral lumbar interbody fusion (LLIF), in addition to the original approval for transforaminal lumbar interbody fusion (TLIF) surgery.

Further, PearlMatrix is now approved for use with titanium alloy and PEEK/titanium interbody fusion cages cleared by the FDA for use in the lumbosacral spine as well as the original PEEK interbody fusion cages. Cerapedics said that the label expansion means surgeons can use it to help achieve faster fusion, based on the interbody approach that meets their needs.

This news follows PearlMatrix’s initial premarket approval (PMA) in June 2025. It was supported by the ASPIRE study, which compared PearlMatrix to local autograft when applied in TLIF surgery. Results showed statistical superiority in composite clinical success as well as superior fusion speed with comparable safety to local autograft.

“The label expansion for PearlMatrix reflects the strength of our clinical evidence. We strategically selected the TLIF approach for our ASPIRE study due to the complexity of the procedure to create a high bar of evidence before submitting our supplemental application to expand to other lumbar surgical approaches,” said Valeska Schroeder, Ph.D., CEO of Cerapedics. “Now, even more patients have the opportunity to benefit from accelerated lumbar fusion with PearlMatrix.”