Cerapedics Inc. announced the US Food and Drug Administration (FDA) premarket approval (PMA) of PearlMatrix™ P-15 Peptide Enhanced Bone Graft as a Class III drug-device combination product for use in single-level transforaminal lumbar interbody fusion (TLIF) surgery in adult patients with degenerative disc disease (DDD).

Despite the availability of over 350+ spinal bone grafts, none have demonstrated a substantial improvement in fusion speed until now. Powered by a proprietary P-15 Osteogenic Cell Binding Peptide, PearlMatrix Bone Graft is the first and only bone growth accelerator (BGA) proven to accelerate lumbar fusion.

TLIF is a complex surgical procedure aiming to reduce or eliminate pain in the lumbar spine because of degenerative disc disease (DDD) by removing a damaged disc and then uniting (fusing) the spinal vertebral bones above and below the damaged disc to create spinal stability along with decompression of the spine. The fusion is achieved using a bone graft which, over time, grows together with the vertebrae to form one bone.1 In 2023, an estimated 465,000 spinal fusion cases utilizing a bone graft replacement were performed in the U.S.

Additionally, despite recent advances, spinal fusion procedures have become more complex due to an increase in the prevalence of patients with one or more risk factors.

"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," said Michael Steinmetz, M.D., Chairman, Department of Neurosurgery, Cleveland Clinic and Study Investigator, ASPIRE Study.* "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."

FDA approval is supported by data from ASPIRE, a prospective, single-blinded, multi-center, randomized, controlled pivotal PMA IDE study, evaluating the safety and efficacy of PearlMatrix Bone Graft compared to use of local autologous bone graft and cancellous allograft when applied in TLIF surgery.3 The ASPIRE trial included 33 U.S. centers and 293 patients, including approximately 60 percent of patients that were considered high risk for non-union (i.e., patients with Type 2 diabetes, BMI ≥ 30 and/or nicotine users).

The study met the primary endpoint of 24-month Composite Clinical Success (CCS) and further demonstrated statistical superiority versus local autograft in CCS which was comprised of five components: fusion, function (ODI), neurological, no serious device-related adverse events, and no index-level secondary surgical interventions.

ASPIRE is the first study of its kind to show substantially higher fusion rates achieving statistically superior fusion speed at 24 months with more than twice as many patients fused at six months versus local autograft. Complete results of the ASPIRE study are expected to be published in the coming months.

"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, Chief Executive Officer 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."