Results from the pivotal ASPIRE IDE study demonstrated that PearlMatrix achieved superior clinical success and a longer fusion time of 24 months compared to local autograft. The rigor of the ASPIRE study reflects unmatched clinical design and results, including:
– More than double the number of patients fused after 6 months
– Approximately 60% of high-risk patients
– As safe as local autograft
WESTMINSTER, Colorado, Dec. 17, 2025 /PRNewswire/ — Cerapedics Inc., a global commercial-stage orthopedic company dedicated to redefining the path to bone repair, today announced the publication of two consecutive articles in Spine detailing 24-month results from the pivotal ASPIRE investigational device exemption (IDE) study of PearlMatrix P-15 peptide-enhanced bone graft. These results demonstrated that PearlMatrix achieved statistically superior clinical success and statistically faster fusion time compared to local autograft when used in single-level transforaminal lumbar interbody fusion (TLIF) surgery in adult patients with degenerative disc disease (DDD).
ASPIRE was a prospective, single-blind, multicenter, randomized, controlled, pivotal IDE study that evaluated the safety and efficacy of PearlMatrix compared to the use of local autograft bone graft when applied in TLIF surgery. The ASPIRE study involved 33 participating U.S. centers and enrolled 293 patients, including approximately 60 percent of patients who were considered at high risk for nonunion (i.e., patients with type 2 diabetes, BMI ≥ 30, and/or nicotine users).
“The publication of the ASPIRE study results in Spine underscores the strength of our clinical data on PearlMatrix as the first and only drug-device spinal bone graft product shown to accelerate lumbar fusion in patients with degenerative disc disease,” said Valeska Schroeder, PhD, CEO of Cerapedics. “Cerapedics is dedicated to obtaining robust human clinical evidence to help surgeons provide safe and effective treatment options for their patients.”
Superior clinical success and significantly higher fusion rates
The first article published in Spine evaluated the safety and efficacy of PearlMatrix compared to local autograft when applied in TLIF surgery using the primary outcome of Composite Clinical Success (CCS) at 24 months, which consists of five components: fusion, gains of function (ODI), neurological success, no device-related serious adverse events, and no secondary surgical intervention at the index level. To be considered an overall clinical success for an individual patient, all five components must be met.
PearlMatrix met the primary endpoint of CCS at 24 months and further demonstrated statistical superiority over local autograft in CCS. Additionally, PearlMatrix was associated with substantially higher fusion rates compared to local autograft at 24 months. There were no significant differences between treatment groups with respect to ODI improvement, neurological deficits (motor and sensory), and device-related serious adverse events (AEs).
“The ASPIRE study not only demonstrated higher fusion rates for PearlMatrix compared to local autograft in TLIF procedures, but it did so in a patient population that reflects typical higher-risk patients,” said James S. Harrop, MD, Professor of Neurological Surgery and Orthopedic Surgery, Division Chief, Spine and Peripheral Nerve Surgery at Thomas Jefferson University.* “Unfortunately, high-quality clinical data are generally lacking. that support most bone graft products, especially for patients with comorbidities, which are known to have a significant impact on fusion and clinical success.
Superior fusion time
The second article published in Spine evaluated secondary endpoints of PearlMatrix compared to local autograft for 24 months after the TLIF procedure, including time to fusion using Kaplan-Meier survival analysis, back and leg pain measured using the Visual Analog Scale (VAS), and quality of life assessed using the Short Form Survey.
At 6 months, PearlMatrix demonstrated that more than twice as many patients were fused compared to local autograft. Higher fusion time rates continued through 12 and 24 months, resulting in statistically faster fusion time. PearlMatrix also produced significant improvements compared to baseline in pain reduction and quality of life 24 months after single-level TLIF surgery, with results similar to those achieved with local autograft.
“Before a patient undergoes spinal fusion surgery, they have spent time exploring alternatives to manage their pain. This is often a long journey, so the quicker the fusion, the quicker patients can resume activities,” said John O’Toole, MD, a neurosurgeon at Rush University Medical Center.** “No other Level 1 study has specifically looked at or demonstrated an improvement in time to fusion. These findings, combined with maintaining safety in both the general population and in high-risk patients, they provide peace of mind that PearlMatrix is a viable alternative option for use in single-level TLIF procedures.”
*Dr. Harrop has not been paid for any media work.
**Dr. O’Toole 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. PearlMatrix is designed to be used in conjunction with a PEEK TLIF 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 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 radiological studies.
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 the TLIF procedure 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 single-level transforaminal lumbar interbody fusion (TLIF) in the lumbar spine 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
fh-cerapedics@fleishman.com
SOURCE Cerapedics Inc.
