Cerapedics Announces First U.S. Patient Treated with PearlMatrix™ P-15 Peptide Enhanced Bone Graft following FDA approval

AdventHealth Avista, an Orthopedic and Spine Center of Excellence, conducted the first lumbar fusion procedure with PearlMatrix Bone Graft, the first and only bone growth accelerator for lumbar fusion.

WESTMINSTER, Colo., July 8, 2025 /PRNewswire/ -- Cerapedics Inc., a global, commercial-stage orthopedics company dedicated to redefining the path to bone repair, today announced the successful completion of the first patient treated with PearlMatrix™ P-15 Peptide Enhanced Bone Graft following the recent U.S. Food and Drug Administration (FDA) approval. PearlMatrix Bone Graft is a Class III drug-device combination product for lumbar fusion. The first post-approval procedure on an adult patient with degenerative disc disease (DDD) was performed by neurosurgeon Sharad Rajpal, M.D., Medical Director of the Advanced Spine Program at AdventHealth Avista in Louisville, Colorado.

PearlMatrix Bone Graft received U.S. FDA premarket approval in June 2025 and is the first and only bone growth accelerator proven to accelerate lumbar fusion based on data from the pivotal ASPIRE IDE study. Of the more than 350 spinal bone grafts in the U.S. market, Cerapedics has two of only three spinal bone grafts that have successfully gone through the PMA process.

"My goal is to bring my patients the most innovative and appropriate treatments specific to their needs, so they can regain their quality of life as soon as possible. I am proud to have performed the first post-approval procedure using PearlMatrix Bone Graft, a novel approach to treating degenerative disc disease," said Sharad Rajpal M.D., FAANS, FCNS, with AHMG.* "It's innovation like this that helps surgeons effectively treat patients, and it's particularly gratifying to be able to use a Colorado innovation on a local resident."

TLIF is a complex surgical procedure aimed at reducing or eliminating pain in the lumbar spine as a result of degenerative disc disease by removing the damaged disc and then fusing the spinal vertebral bones above and below the damaged disc to create spinal stability, along with decompression of the affected nerves. The fusion is achieved using a bone graft, which, over time, helps the vertebrae grow together to form one continuous bone.¹ In 2023, an estimated 465,000 spinal fusion cases utilizing a bone graft replacement were performed in the U.S.¹ Despite recent advances, spinal fusion procedures have become more complex due to an increase in the prevalence of patients with one or more risk factors.²

"This first surgery post-approval is a significant milestone for Cerapedics," said Valeska Schroeder, Chief Executive Officer of Cerapedics. "Every single team member behind the development, approval, and distribution of PearlMatrix P-15 Peptide Enhanced Bone Graft worked tirelessly to get this unique drug-device into the hands of surgeons to help them safely and effectively treat their patients. We are proud of the innovation we bring to the market, and we look forward to seeing the positive impact of our devices."

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 in single-level TLIF procedures. 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 allow 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 is intended to be used in conjunction with a PEEK TLIF 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.

PearlMatrix is contraindicated 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 an operative site subject to excessive impact or stress.

The effect of PearlMatrix on pregnant or nursing patients has not been evaluated. 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. 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 TLIF procedures 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 global, commercial-stage orthopedics 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 products approved by the FDA: PearlMatrix™ Bone Graft for single-level transforaminal lumbar interbody fusion (TLIF) in the lumbar spine 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
[email protected]

* Dr. Rajpal has provided consulting, advisory, and speaking services to Cerapedics, Inc.; he has not been paid for any media work.

¹Clarivate | Decision Resources Group. Bone Graft Substitutes. December 2022.
²Haik H, et al. Population-Based Trends in Complexity of Hospital Inpatients JAMA Intern Med. 2024;184(2):183-192. doi:10.1001/jamainternmed.2023.7410

SOURCE Cerapedics Inc.