P-15 Peptide: The Molecular Breakthrough Accelerating Spinal Fusion

In the realm of spinal fusion surgery, the quest for faster, safer, and more reliable bone formation has led to a molecular innovation that is reshaping the standard of care: P-15 Peptide. This naturally occurring 15-amino acid sequence found in type I collagen—the primary protein in bone—plays a pivotal role in initiating and accelerating the bone regeneration process.^1-4

At Cerapedics, P-15 Peptide is pharmaceutically synthesized and stably bound onto calcium phosphate particles, creating a P-15 Peptide enhanced scaffold that provides an abundance of attachment sites for osteogenic cells. ^2-5 These P-15 coated particles leverage the body’s natural bone healing process, unlocking a distinct and proven mechanism of action to attach and activate osteogenic cells to accelerate new bone formation. ^2-4,7-8 The P-15 peptide is redefining how surgeons approach bone graft selection in spinal fusion.

The Science of P-15: A Natural Signal for Bone Growth

Bone healing begins with cellular attachment. Without it, osteogenic cells cannot survive, proliferate, or differentiate. P-15 Peptide addresses this fundamental need by providing a high-affinity surface for osteoblasts and mesenchymal stem cells to bind.^2-4 Once cells attach to the P-15 Peptide, they are activated through a cascade of signaling pathways that stimulate the release of bone-forming enzymes and growth factors. This not only promotes new bone formation but also encourages angiogenesis, creating a vascularized environment conducive to fusion. ^2-4,9-15

This mechanism of action—attach, activate, accelerate—has been validated through extensive preclinical and clinical research.^2-5,7 It is the foundation of two FDA-approved Class III drug-device combination spinal products: i-FACTOR® and PearlMatrix™ P-15 Peptide-Enhanced Bone Grafts.

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PearlMatrix™: Accelerating Lumbar Fusion in Real-World Patients

PearlMatrix P-15 Peptide Enhanced Bone Graft is the first and only proven bone growth accelerator^*16-17 approved for single-level transforaminal lumbar interbody fusion (TLIF). It is a drug-device combination bone graft consisting of P-15 peptide bound to porous calcium phosphate particles and incorporated into a collagen matrix carrier. This structure provides a large surface area for cell attachment and is designed for optimal handling in both open and minimally invasive procedures.

What sets PearlMatrix Bone Graft apart is its demonstrated superiority in time to fusion.^*16-17 In a pivotal Level 1 PMA IDE study involving 293 patients across 33 U.S. sites—60% of whom had comorbidities such as obesity (BMI >= 30), nicotine use, and/or Type 2 diabetes.¹⁶

PearlMatrix Bone Graft demonstrated:¹⁶

• Over 2x more patients fused at 6 months compared to local autograft (57% vs. 27%)
• Statistically superior fusion speed at 24 months and substantially higher fusion rates at 6, 12, and 24 months
• Statistically superior overall clinical success at 24 months, defined by a composite of fusion, function (ODI), neurological status, absence of serious device-related events, and no secondary surgeries

These results underscore the ability of PearlMatrix Bone Graft’s to accelerate fusion, even in patients traditionally considered at higher risk for nonunion, while being as safe as the patient’s own bone.^ƚ5

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i-FACTOR®: 10 Years of Proven Performance in Cervical Spine Fusion

i-FACTOR, the first P-15 Peptide-Enhanced Bone Graft to receive FDA approval, is indicated for single-level anterior cervical discectomy and fusion (ACDF). i-FACTOR is a trusted bone graft replacement that has been commercially available for 10 years and is designed for contained spaces.

In a multicenter, randomized, controlled Level 1 IDE study of 319 patients, i-FACTOR achieved: ^17-20

• 97.3% fusion at two years and 98.6% at six years
• Statistical superiority over local autograft in overall clinical success**
• Comparable safety profile with no increased risk of adverse events or ectopic bone formation^‡

Additionally, i-FACTOR’s Level 1 data included 28.5% high-risk patients.^5-6

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A Platform for Spinal Fusion

Together, PearlMatrix and i-FACTOR represent an evidence-based platform for spinal fusion powered by P-15 peptide. Both products are:

• Class III FDA-approved based on Level 1 human clinical trials
• Proven safe and efficacious, with real-world human clinical data
• Free of human tissue or cells, mitigating the potential of disease transmission related to donor bone
• Sterile, shelf-stable, and ready-to-use, streamlining surgical workflow
• Radiopaque, allowing for easy visualization on X-ray

To learn more about P-15, i-FACTOR and PearlMatrix including U.S. safety information, visit https://www.cerapedics.com/science/p-15.

*Demonstrated statistically superior time to fusion in a single-level TLIF PMA IDE study vs. local autograft.

**Overall success is defined as all four endpoints being met including: fusion, function (NDI), neurological, and safety as demonstrated in the single-level ACDF PMA IDE study¹⁹

^ȽAs demonstrated in a single-level TLIF PMA IDE study vs. local autograft.

^‡No evidence of ectopic bone formation when contained in a bony healing environment in accordance with the IFU.

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