Cerapedics Inc. announced that the U.S. Food and Drug Administration has granted premarket approval (PMA) for PearlMatrix P-15 Peptide Enhanced Bone Graft as a Class III drug-device combination product for single-level transforaminal lumbar interbody fusion (TLIF) surgery in adult patients with degenerative disc disease. The approval marks a significant milestone as PearlMatrix becomes the first and only bone growth accelerator proven to accelerate lumbar fusion, despite the availability of over 350 spinal bone grafts currently on the market.
Clinical Trial Results Demonstrate Superior Fusion Speed
FDA approval is supported by data from the ASPIRE study, a prospective, single-blinded, multi-center, randomized, controlled pivotal PMA IDE study that evaluated the safety and efficacy of PearlMatrix Bone Graft compared to local autologous bone graft and cancellous allograft in TLIF surgery. The trial included 33 U.S. centers and 293 patients, with approximately 60 percent of participants considered high risk for non-union, including patients with Type 2 diabetes, BMI ≥ 30, and/or nicotine users.
The study met its primary endpoint of 24-month Composite Clinical Success (CCS) and demonstrated statistical superiority versus local autograft. The CCS comprised five components: fusion, function (ODI), neurological outcomes, no serious device-related adverse events, and no index-level secondary surgical interventions. Notably, ASPIRE achieved more than twice as many patients fused at six months versus local autograft, representing substantially higher fusion rates and statistically superior fusion speed at 24 months.
"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 for the 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."
Breakthrough Technology and Regulatory Pathway
PearlMatrix Bone Graft was approved through the FDA PMA pathway and received Breakthrough Device designation in April 2021. This designation is offered by the FDA for products that could provide more effective treatment of life-threatening diseases, represent novel technology, or offer significant advantages over existing approved alternatives. Premarket approval represents the most stringent type of device marketing application required by the FDA, with approval based on sufficient valid scientific evidence providing reasonable assurance that the device is safe and effective for its intended use.
Of the more than 350 spinal bone grafts in the U.S. market, Cerapedics now has two of only three spinal bone grafts that have received PMA approval, highlighting the rigorous clinical evidence required for this regulatory pathway.
Mechanism of Action and Clinical Applications
PearlMatrix is powered by a proprietary P-15 Osteogenic Cell Binding Peptide, which provides a distinct mechanism of action to attach and activate osteogenic cells to accelerate new bone formation. P-15 Peptide is a 15-amino acid sequence found naturally in Type-1 collagen, the predominant protein in bone, serving a crucial role in the bone regeneration process 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 provides an abundance of attachment sites for osteogenic, bone-forming cells. Cell attachment activates pathways that release cell-signaling growth factors and allow bone growth through natural cellular processes.
Market Impact and Clinical Need
TLIF is a complex surgical procedure aimed at reducing or eliminating pain in the lumbar spine caused by degenerative disc disease by removing a damaged disc and fusing the spinal vertebral bones above and below the damaged disc to create spinal stability and decompression. In 2023, an estimated 465,000 spinal fusion cases utilizing a bone graft replacement were performed in the U.S. Additionally, spinal fusion procedures have become more complex due to an increase in the prevalence of patients with one or more risk factors.
"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," 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."
Safety Profile and Clinical Considerations
PearlMatrix is indicated for intervertebral body fusion of the spine in skeletally mature patients and is intended for use 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 indicated for patients who have had at least six months of non-operative treatment and is intended for use at one level in the lumbar spine (L2-S1) for the treatment of degenerative disc disease with up to Grade I spondylolisthesis.
The clinical trial data indicated that PearlMatrix in a TLIF procedure was associated with a higher rate of secondary surgical interventions compared to local autograft. The product should only be used by physicians experienced with TLIF procedures and in surgical procedures where it can be adequately contained at the bony void or defect.
