NTAP provides additional Medicare reimbursement to hospitals using PearlMatrix, the first and only bone growth accelerator demonstrating superior lumbar fusion speed

WESTMINSTER, Colo., Oct. 1, 2026 /PRNewswire/ — Cerapedics Inc., a commercial-stage musculoskeletal company dedicated to redefining the path to bone repair, today announced that the Centers for Medicare & Medicaid Services (CMS) has granted New Technology Add-On Payment (NTAP) status for PearlMatrix® P-15 Peptide Enhanced Bone Graft, a Class III drug-device combination product for skeletally mature patients with degenerative disc disease in the lumbar spine. PearlMatrix NTAP status is effective October 1, 2026.

The NTAP designation provides supplemental reimbursement to hospitals and healthcare facilities that utilize novel technologies that represent significant clinical advances. PearlMatrix was granted NTAP status under CMS’ alternative NTAP pathway which recognizes the transformative nature of products that have received U.S. FDA Breakthrough Device designation. Inclusion in the NTAP program highlights the potential to address a critical need for patients requiring faster fusion products backed by strong clinical evidence.

“With the NTAP approval, financial barriers for hospitals may be lowered, allowing more patients access to PearlMatrix,” said Valeska Schroeder, PhD, Chief Executive Officer of Cerapedics. “This supports our commitment to advancing evidence-based solutions that improve patient outcomes. Our P-15 drug-device products are supported by extensive human clinical evidence, including the long-standing proven safety and efficacy of i-FACTOR in the cervical spine. With PearlMatrix, we have a new formulation designed for the lumbar spine that is supported by an unprecedented clinical trial demonstrating superiority in fusion speed versus local autograft.”

PearlMatrix is the first and only bone growth accelerator proven to substantially increase lumbar fusion speed. In a Level 1, pivotal premarket approval (PMA) study conducted under Investigational Device Exemption (IDE), it demonstrated superior results across all patients, including approximately 60% high-risk patients (nicotine users, BMI≥30, and/or type 2 diabetes). The study showed more than twice as many patients achieved fusion at six months compared to those receiving local autograft alone, with substantially higher fusion rates sustained at 12 and 24 months in both overall and high-risk patient populations. 

The NTAP program applies to eligible Medicare beneficiaries receiving inpatient care at hospitals paid under the Medicare Inpatient Prospective Payment System (IPPS). For qualifying inpatient cases involving PearlMatrix, NTAP approval allows for up to 65% reimbursement of the additional cost associated with the technology. This approval can help support patient access to innovative medical technologies during the early stages of adoption and can also influence commercial insurers as they consider recent technology like PearlMatrix.  

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. 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 allows 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 procedures using anterior, lateral, oblique, posterior or transforaminal lumber interbody fusion approaches 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 commercial-stage musculoskeletal 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 and 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 
fh-cerapedics@fleishman.com 

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SOURCE Cerapedics Inc.