Westminster, Colo. – October 01, 2026 -- The Centers for Medicare & Medicaid Services has granted New Technology Add-On Payment status to Cerapedics Inc.'s PearlMatrix P-15 Peptide Enhanced Bone Graft, enabling hospitals to recoup up to 65% of the additional cost tied to the device starting October 1, 2026.
CMS approves alternative NTAP pathway tied to FDA Breakthrough Device status
PearlMatrix, a Class III drug-device combination product for skeletally mature patients with degenerative disc disease in the lumbar spine, received NTAP designation under CMS' alternative pathway, which recognizes products holding U.S. FDA Breakthrough Device designation. The reimbursement applies to eligible Medicare beneficiaries treated as inpatients at hospitals paid under the Medicare Inpatient Prospective Payment System.
Pivotal trial shows fusion rates more than double versus autograft at six months
In a Level 1 pivotal premarket approval study conducted under an Investigational Device Exemption, PearlMatrix demonstrated superior fusion results across the full patient cohort, including roughly 60% classified as high-risk -- nicotine users, patients with BMI of 30 or higher, and those with type 2 diabetes. More than twice as many patients achieved fusion at six months compared with those receiving local autograft alone, with the advantage sustained at 12 and 24 months in both overall and high-risk populations.
CEO says reimbursement lowers financial barriers to adoption
"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. The company said the designation could also influence commercial insurers evaluating coverage for the technology.
P-15 Peptide, the active component bound onto calcium phosphate particles in PearlMatrix, is a 15-amino-acid sequence derived from Type-1 collagen designed to attach and activate osteogenic cells. PearlMatrix is intended for single-level use in the lumbar spine (L2-S1) alongside PEEK, titanium alloy, or PEEK/titanium interbody fusion devices across ALIF, TLIF, PLIF, OLIF/ATP, and LLIF surgical approaches.