Cerapedics Inc. has received U.S. FDA premarket approval (PMA) for its PearlMatrix™ P-15 Peptide Enhanced Bone Graft, a Class III drug-device combination product.
It is approved for use in single-level transforminal lumbar interbody fusion (TLIF) surgeries in adult patients with degenerative disc disease (DDD).
PearlMatrix is the first and only bone growth accelerator shown to significantly speed up lumbar fusion. It uses a synthetic P-15 peptide, derived from type-1 collagen, to stimulate bone-forming cell attachment and activation, enhancing new bone growth.
The approval is based on the ASPIRE study, a multi-centre, randomised trial involving 293 patients, 60% of whom had high-risk factors like obesity, diabetes, or nicotine use.
The study demonstrated superior fusion speed and higher success rates compared to local autograft, meeting the 24-month Composite Clinical Success endpoint.
PearlMatrix received FDA Breakthrough Device designation in 2021. It is now one of only three PMA-approved spinal bone grafts in the U.S., and the second from Cerapedics.
The product is indicated for use at a single lumbar level (L2–S1) with a PEEK TLIF device and FDA-cleared internal fixation systems, following at least six months of non-surgical treatment.
It is contraindicated in cases of infection, lack of structural support, or hypersensitivity to components, and is not evaluated in pregnant or breastfeeding patients.
