ASPIRE pivotal U.S. IDE study results demonstrated PearlMatrix achieved superior clinical success and superior time-to-fusion at 24 months compared to local autograft. The rigor of the ASPIRE study reflects unmatched clinical design and results including:
- More than twice as many patients fused at 6 months 
- Approximately 60% high-risk patients 
- As safe as local autograft

WESTMINSTER, Colo., Dec. 17, 2025 /CNW/ -- Cerapedics Inc., a global, commercial-stage orthopedics company dedicated to redefining the path to bone repair, today announced the publication of two back-to-back papers in Spine detailing 24-month outcomes from the ASPIRE pivotal U.S. Investigational Device Exemption (IDE) study of PearlMatrix P-15 Peptide Enhanced Bone Graft. These results demonstrated PearlMatrix achieved statistically superior clinical success and statistically faster time-to-fusion 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-blinded, multicentre, randomized, controlled pivotal U.S. IDE study, that evaluated the safety and efficacy of PearlMatrix compared to use of local autograft bone graft when applied in TLIF surgery. The ASPIRE study involved 33 U.S. participating centers and enrolled 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 publication of the ASPIRE study results in Spine underscores the strength of our clinical data for PearlMatrix as the first and only drug-device spinal bone graft product proven to accelerate lumbar fusion in patients with degenerative disc disease," said Valeska Schroeder, PhD, Chief Executive Officer of Cerapedics. "Cerapedics is dedicated to 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 paper 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 is comprised of five components: fusion, function gains (ODI), neurological success, no serious device-related adverse events, and no index-level secondary surgical interventions. 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 versus 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 serious device-related adverse events (AEs).

"The ASPIRE study not only demonstrated higher fusion rates for PearlMatrix, as compared to local autograft in TLIF procedures, but it did so in a patient population reflective of typical higher risk patients," said James S. Harrop, M.D., Professor, Neurological Surgery and Orthopedic Surgery, Division Chief, Spine and Peripheral Nerve Surgery, Thomas Jefferson University.* "Unfortunately, in general, there is a lack of high-quality clinical data to support a majority of bone grafting products, especially for patients with comorbidities, which are known to have a significant impact on fusion and clinical success. This study adds literature to support a treatment option."

Superior Time-to-Fusion 
The second paper published in Spine evaluated secondary endpoints of PearlMatrix compared to local autograft through 24 months following TLIF procedure, including time-to-fusion using Kaplan-Meier survival analysis, back and leg pain measured by 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 time-to-fusion rates continued through to 12 months and 24 months resulting in statistically faster time-to-fusion. PearlMatrix also produced significant improvements compared to baseline in pain reduction and quality of life 24 months after single-level TLIF surgery, with outcomes 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 typically a long journey, so the faster fusion happens, the faster patients can resume their activities," said John O'Toole, M.D., Neurosurgeon, Rush University Medical Center.** "No other Level 1 study has specifically analyzed or demonstrated an improvement in time-to-fusion. These findings, combined with maintaining safety in both the overall and high-risk patient populations, provide reassurance that PearlMatrix is a viable alternative for use in single-level TLIF procedures."

*Dr. Harrop has not been paid for any media work.
**Dr. O'Toole 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 intended to fill bony voids or gaps in the extremities and spine that are not intrinsic to the stability of the bony structure. Sufficient internal or external fixation is required. PearlMatrix may be mixed with autogenous bone and/or autogenous bone marrow aspirate (BMA). PearlMatrix is a bone graft substitute material for use only by a qualified orthopedic surgeon, neurosurgeon, or spine surgeon.

PearlMatrix should not be used in situations where there is an absence of load bearing structural support at the graft site; sensitivity to components of the product; active infection at the operative site; operative site is subject to excessive impact for stress; significant vascular impairment near the graft site; in direct contact with articular spaces; presence of segmental defects; metabolic or systemic bone disorders that affect bone or wound healing; compromised renal function; in uncooperative patient who will not or cannot follow post operative instructions.

Care should be exercised in treating individuals with preexisting conditions that may affect the success of the surgical procedure. PearlMatrix should only be used in surgical procedures where it can be adequately contained at the bony void or defect. The effect of PearlMatrix on pregnant or nursing patients has not been evaluated. The use of PearlMatrix mixed with other bone graft substitute products has not been evaluated.

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. Cerapedics bone graft products including PearlMatrix™ and i-FACTOR^® Putty are powered by P15 Peptide which provides a distinct and proven mechanism of action to attach and activate osteogenic cells to accelerate new bone formation. With over 15 years of excellence in Advanced Biologics, Cerapedics is headquartered 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.