Cerapedics Receives Medicare NTAP Status for PearlMatrix P-15 Peptide Enhanced Bone Graft

WESTMINSTER, Colo., Oct. 1, 2026 /CourierPR/ -- Cerapedics Inc., a company dedicated to redefining the path to bone repair, has achieved a significant milestone with the Centers for Medicare & Medicaid Services (CMS) granting New Technology Add-On Payment (NTAP) status for its PearlMatrix® P-15 Peptide Enhanced Bone Graft. This designation is effective October 1, 2026, and it will provide additional Medicare reimbursement to hospitals using the product, thereby accelerating lumbar fusion for patients.

PearlMatrix® P-15 Peptide Enhanced Bone Graft is the first and only bone growth accelerator proven to substantially increase lumbar fusion speed. It has been granted NTAP status under CMS' alternative NTAP pathway, which recognizes the transformative nature of products that have received U.S. FDA Breakthrough Device designation. This approval highlights the potential to address a critical need for patients requiring faster fusion products backed by strong clinical evidence.

The P-15 Peptide, the active component of PearlMatrix, provides a distinct and proven mechanism of action to attach and activate osteogenic cells, accelerating new bone formation. In a Level 1, pivotal premarket approval (PMA) study conducted under Investigational Device Exemption (IDE), PearlMatrix 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.

PearlMatrix is indicated for intervertebral body fusion of the spine in skeletally mature patients. It 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 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 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.

The approval of PearlMatrix® P-15 Peptide Enhanced Bone Graft under the NTAP program is a significant step forward in the field of bone repair, providing hospitals with the financial support needed to offer advanced treatments to patients. Cerapedics remains committed to advancing evidence-based solutions that improve patient outcomes and enhance the quality of life for those suffering from degenerative disc disease.