Cerapedics' PearlMatrix P-15 Peptide Enhanced Bone Graft, The First and Only Proven Bone Growth Accelerator, Now Approved for Expanded Indications for Use

• PearlMatrix is now the only Class III drug-device spinal bone graft approved for all major lumbar interbody surgical approaches in addition to expanded approved 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, Colo., Jan. 13, 2026 /PRNewswire/ -- Cerapedics Inc., a global, commercial-stage orthopedics company dedicated to redefining the path to bone repair, today announced U.S. Food and Drug Administration (FDA) approval for an expansion to the indications for use and labeling for PearlMatrix™ P-15 Peptide Enhanced Bone Graft, a Class III drug-device combination product, for adult patients with degenerative disc disease (DDD) in the lumbar spine. With this label expansion, PearlMatrix is 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. Moreover, 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. Lumbar fusion makes up the majority of the total fusion market, representing about 2/3 of the procedures. With this label expansion, surgeons can now use PearlMatrix to help patients achieve faster fusion based on the interbody approach that meets their individual needs.

Today's news follows the initial FDA premarket approval (PMA) of PearlMatrix in June 2025. Initial approval was supported by data from ASPIRE, a prospective, single-blinded, multicenter, randomized, controlled pivotal PMA IDE study, that evaluated the safety and efficacy of PearlMatrix compared to use of local autograft when applied in TLIF surgery. Results from the ASPIRE study, now published in Spine, demonstrated statistical superiority with PearlMatrix versus the control in Composite Clinical Success as well as statistically superior fusion speed with comparable safety to local autograft. The ASPIRE study was designed to include rigorous and clinically meaningful outcomes reflecting real-world practice to establish the safety and efficacy of PearlMatrix in single-level TLIF prior to pursuing expanded indications. FDA approval for an expansion to the indications for use and labeling came within three months of submitting the supplemental application.

"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," noted Valeska Schroeder, PhD, Chief Executive Officer of Cerapedics. "Now, even more patients have the opportunity to benefit from accelerated lumbar fusion with PearlMatrix."

"The expanded on-label indications for PearlMatrix, now including all major lumbar interbody fusion procedures, will give many more patients the opportunity to benefit from its proven efficacy." said Isaac L. Moss, M.D., Professor and Chair of Orthopedic Surgery, University of Connecticut.* "The ASPIRE trial provides some of the most rigorous scientific evidence we have for any bone graft substitute on the market, as it demonstrated safety and improved time-to-fusion in both the overall and high risk-patient populations (i.e., patients with Type 2 diabetes, BMI ≥ 30 and/or nicotine users)."

*Dr. Moss has provided advisory 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 proven to accelerate lumbar fusion with demonstrated statistically superior fusion speed in single-level TLIF procedures. P-15 Peptide, the active component of PearlMatrix, provides a distinct and proven 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. It serves 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.

Indications for Use
PearlMatrix™ Bone Graft is indicated for intervertebral body fusion of the spine in skeletally mature patients. PearlMatrix Bone Graft is intended to be used in conjunction with a PEEK, titanium alloy, or PEEK/titanium interbody fusion device and supplemental internal spinal fixation systems cleared by the FDA for use in the lumbosacral spine. The system is to be used in patients who have had at least six months of non-operative treatment. PearlMatrix Bone Graft is intended for use at one level in the lumbar spine (L2-S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back and/or radicular pain of discogenic origin with degeneration of the disc confirmed by history, physical exam, and radiographic studies.

The following open or minimally invasive surgical approaches may be used with PearlMatrix Bone Graft:

• ALIF (anterior lumbar interbody fusion)
• TLIF (transforaminal lumbar interbody fusion)
• PLIF (posterior lumbar interbody fusion)
• OLIF/ATP (oblique lumbar interbody fusion/anterior to psoas)
• LLIF (lateral lumbar interbody fusion)

PearlMatrix should not be used in situations where there is an absence of load-bearing structural support at the graft site, sensitivity to components or the product, active infection at the operative site, or operative site subject to excessive impact or stress.

Care should be exercised in treating individuals with preexisting conditions that may affect the success of the surgical procedure such as individuals with bleeding disorders of any etiology, long-term steroidal therapy, immunosuppressive therapy or high dosage radiation therapy. The effect of PearlMatrix on pregnant or nursing 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 who are experienced with lumbar interbody fusion procedures and in surgical procedures where it can be adequately contained at the bony void or defect.

To learn more about PearlMatrix, its indications, contraindications, warnings, precautions and potential adverse events, visit our website at www.cerapedics.com or refer to the PearlMatrix Instructions for Use for complete safety and risk information.

About Cerapedics
Cerapedics is a global, commercial-stage orthopedics company that is dedicated to redefining the path to bone repair by healing bones faster and at higher rates, so all patients can get back to living their fullest lives. Bone grafts, including Cerapedics' products, are used in over four million annual spine, orthopedics, trauma, and interventional procedures worldwide. Cerapedics has two drug-device products approved by the FDA powered by Cerapedics' proprietary P-15 Osteogenic Cell Binding Peptide: PearlMatrix™ Bone Graft for all major lumbar interbody surgical approaches and i-FACTOR^® Bone Graft for single-level anterior cervical discectomy and fusion (ACDF) in the cervical spine. Cerapedics is headquartered in Westminster, CO. 

For more information, visit us at www.cerapedics.com and follow us on LinkedIn.

Media contact: FleishmanHillard 
[email protected] 

SOURCE Cerapedics Inc.