PearlMatrix is now the only Class III pharmacologic device spinal bone graft approved for all major lumbar interbody surgical approaches in addition to approved expanded cage materials. Now even more patients can benefit from PearlMatrix, the first and only drug-device spinal bone graft proven to accelerate lumbar fusion.
WESTMINSTER, Colorado, Jan. 13, 2026 /PRNewswire/ — Cerapedics Inc., a global commercial-stage orthopedics company dedicated to redefining the path to bone repair, today announced the U.S. Food and Drug Administration (FDA) approval to expand the indications for use and labeling of PearlMatrix™ P-15 peptide-enhanced bone graft, a Class III drug-device combination product, for patients adults with degenerative disc disease. (DDD) in the lumbar spine. With this label expansion, PearlMatrix is now approved for single-level, open or minimally invasive 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. Additionally, PearlMatrix is now approved for use with titanium alloy and FDA-cleared PEEK/titanium interbody fusion cages for use in the lumbosacral spine, as well as the original PEEK interbody fusion cages. Lumbar fusion makes up the majority of the total fusion market, accounting for approximately 2/3 of the procedures. With this label expansion, surgeons can now use PearlMatrix to help patients achieve a faster fusion based on the interbody approach that meets their individual needs.
Today’s news follows the initial premarket approval (PMA) of PearlMatrix by the FDA in June 2025. The initial approval was supported by data from ASPIRE, a prospective, single-blind, multicenter, randomized, controlled PMA IDE pivotal study that evaluated the safety and efficacy of PearlMatrix compared to the use of local autograft when applied in TLIF surgery. Results from the ASPIRE study, now published in Spine, demonstrated statistical superiority with PearlMatrix versus control in Composite Clinical Success, as well as a statistically superior fusion rate with safety comparable to that of local autograft. The ASPIRE study was designed to include rigorous, clinically meaningful results that reflect real-world practice to establish the safety and efficacy of PearlMatrix in single-level TLIF before pursuing expanded indications. FDA approval for an expansion of the indications for use and labeling occurred three months after the supplemental application was submitted.
“The expansion of the PearlMatrix label 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 level of evidence before submitting our supplemental application to expand to other lumbar surgical approaches,” said Valeska Schroeder, PhD, CEO of Cerapedics. “Now, even more patients have the opportunity to benefit from accelerated lumbar fusion with PearlMatrix.”
“PearlMatrix’s expanded label indications, which now include all major lumbar interbody fusion procedures, will provide many more patients the opportunity to benefit from its proven efficacy.” said Isaac L. Moss, MD, Professor and Chair of Orthopedic Surgery at the University of Connecticut.* “The ASPIRE trial provides some of the most rigorous scientific evidence we have for any bone graft substitute on the market, demonstrating safety and improved fusion time in both the general and high-risk patient populations (i.e., patients with type 2 diabetes, BMI ≥ 30, and/or nicotine users).”
*Dr. Moss has provided consulting and speaking services to Cerapedics, Inc.; He has not been paid for any media work.
About PearlMatrix™ P-15 Peptide Enhanced Bone Graft
PearlMatrix P-15 Peptide Enhanced Bone Graft is the first and only bone growth accelerator shown to accelerate lumbar fusion with a statistically superior fusion rate demonstrated in single-level TLIF procedures. P-15 peptide, the active component of PearlMatrix, provides a distinct and proven mechanism of action to bind and activate osteogenic cells to accelerate new bone formation. The P-15 peptide is a 15-amino acid sequence found naturally in type 1 collagen, the predominant protein in bone. It plays a crucial role in the bone regeneration process as a powerful cell binding factor. Cerapedics’ pharmaceutically manufactured P-15 peptide binds to calcium phosphate particles, creating a P-15-enhanced structure that provides a large number of binding sites for bone-forming osteogenic cells. Cell binding activates pathways that release cell signaling growth factors and enable bone growth through natural cellular processes.
Indications for use
PearlMatrix™ Bone Graft is indicated for spinal intervertebral body fusion in skeletally mature patients. The PearlMatrix bone graft is designed to be used in conjunction with a PEEK, titanium alloy or PEEK/titanium interbody fusion device and supplemental internal spinal fixation systems approved by the FDA for use in the lumbosacral spine. The system will be used in patients who have received at least six months of non-surgical treatment. PearlMatrix bone graft is intended for use at one level of the lumbar spine (L2-S1) for the treatment of degenerative disc disease (DDD) with spondylolisthesis up to Grade I. DDD is defined as back and/or radicular pain of discogenic origin with disc degeneration confirmed by history, physical examination, and radiographic studies.
The following open or minimally invasive surgical approaches can be used with PearlMatrix bone graft:
ALIF (anterior lumbar interbody fusion) TLIF (transforaminal lumbar interbody fusion) PLIF (posterior lumbar interbody fusion) OLIF/ATP (oblique/anterior psoas lumbar interbody fusion) LLIF (lateral lumbar interbody fusion)
PearlMatrix should not be used in situations where there is absence of structural load-bearing support at the graft site, sensitivity to components or product, active infection at the operative site, or operative site subject to excessive impact or stress.
Care should be taken when treating people with pre-existing conditions that may affect the success of the surgical procedure, such as people with bleeding disorders of any etiology, long-term steroid therapy, immunosuppressive therapy, or high-dose radiation therapy. The effect of PearlMatrix in pregnant or lactating patients has not been evaluated. PearlMatrix in a TLIF procedure was associated with a higher rate of secondary surgical interventions compared to local autograft.
PearlMatrix should only be used by physicians experienced in lumbar interbody fusion procedures and in surgical procedures where it can be adequately contained in the bone void or defect.
For more information about PearlMatrix, its indications, contraindications, warnings, precautions and possible adverse events, please visit our website at www.cerapedics.com or see the PearlMatrix Instructions for Use for complete safety and risk information.
About cerapedia
Cerapedics is a global, commercial-stage orthopedics company dedicated to redefining the path to bone repair by healing bones faster and at greater rates, so all patients can get back to living their lives to the fullest. Bone grafts, including Cerapedics products, are used in more than four million interventional, orthopedic, trauma and spinal procedures annually worldwide. Cerapedics has two FDA-cleared drug device products powered by Cerapedics’ proprietary P-15 osteogenic cell-binding peptide: the PearlMatrix™ bone graft for all major lumbar interbody surgical approaches and the i-FACTOR® bone graft for single-level anterior cervical discectomy and fusion (ACDF) in the cervical spine. Cerapedics is based in Westminster, CO.
For more information, visit us at www.cerapedics.com and follow us on LinkedIn.
Media Contact: FleishmanHillard
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SOURCE Cerapedics Inc.
