US-based orthopaedics company Cerapedics has secured the US Food and Drug Administration (FDA) premarket approval for its PearlMatrix P-15 Peptide Enhanced Bone Graft.
PearlMatrix P-15 is said to be the first proven bone growth accelerator (BGA) for lumbar fusion.
It is specifically designed for single level transforaminal lumbar interbody fusion (TLIF) surgery in adults with degenerative disc disease (DDD).
TLIF surgery addresses lumbar spine pain caused by DDD by removing a damaged disc and fusing the spinal vertebrae above and below it.
The fusion, achieved using a bone graft, aims to stabilise the spine and alleviate pain.
Powered by the P-15 osteogenic cell binding peptide, PearlMatrix advances the fusion process, marking it as a unique solution in bone growth acceleration.
The active component, P-15 Peptide, is a 15-amino acid sequence found in Type-1 collagen, the primary protein in bone.
It plays a vital role in bone regeneration by attaching and activating osteogenic cells, thus promoting new bone formation.
Cerapedics manufactures the P-15 Peptide, which is bound to calcium phosphate particles, creating a scaffold that enhances cell attachment and bone growth.
Cerapedics CEO Valeska Schroeder said: “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.
“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.”
The FDA’s approval is based on data from the ASPIRE study, a prospective, single-blinded, multi-centre, randomised, controlled PMA IDE trial in 293 patients.
The study compared the safety and efficacy of PearlMatrix Bone Graft against local autologous bone graft and cancellous allograft in TLIF surgery across 33 US centres.
The ASPIRE trial achieved its primary endpoint of 24-month Composite Clinical Success (CCS), showing statistical superiority over local autograft.
CCS comprised five components: fusion, function (ODI), neurological outcomes, absence of serious device-related adverse events, and no index-level secondary surgical interventions.
PearlMatrix Bone Graft received FDA approval through the PMA pathway and was granted a Breakthrough Device designation in April 2021.
ASPIRE Study investigator Michael Steinmetz said: “As it can take up to 12 months for bones to fully fuse following a TLIF procedure, there remains a critical unmet need for new treatment options that accelerate fusion, especially for high-risk patients who are more prone to complications following surgery.
“The majority of patients included in the ASPIRE study had one or more comorbidities, which is rare for these types of trials, although it’s more representative of the patients I see in daily practice.
“The efficacy data of the ASPIRE study demonstrate faster fusion compared to local autograft.”
