IDE PMA study of fundamental level aspirate evaluated pearlmatrix versus local autoinjet in unique level TLIF procedures:
– Statistically higher fusion rate;
– He achieved more than twice as fused patients at six months;
-Incluó ~ 60% of high -risk patients
Westminster, Colo., June 23, 2025 / prnewswire /-Cerapedics Inc., A Global, Commercial-Stage OrtWchopedics Company dedicated to redefining the path to bone repair, Today Announced The US Food and Drug Administration (FDA) Premarket Appr. Peptide enhanced bone graft as a class III Drug-Device Combination Product For Use in Single-Level Lumbar transformal surgery Interbody (TLIF) Lumbar surgery in adult patients with degenerative disc disease of the disc (DDD). Despite the availability of more than more than 350 spinal bone grafts, none has demonstrated a substantial improvement in fusion speed so far. Driven by an osteogenic cell binding peptide P-15 patented, pearlmatrix bone graft is the first and only bone growth accelerator (BGA) demonstrated to accelerate lumbar fusion.
TLIF is a complex surgical procedure with the aim of reducing or eliminating pain in the lumbar column due to the degenerative disease of the disk (DDD) by eliminating a damaged disk and then joining (merge) the spinal vertebral bones above and below the damaged disk to create spinal stability along with the dictation of the column. The merger is achieved using a bone graft that, over time, grows along with the vertebrae to form a bone.1 In 2023, it is estimated that 465,000 cases of spinal fusion that use a replacement for bone graft were performed in the US1 in addition, despite recent advances, spinal fusion procedures have become more complex due to an increase in the prevalence of patients with patients with one or more risk.
“As it can take up to 12 months to fuse completely after a TLIF procedure, there is still an unsatisfied critical need for new treatment options that accelerate the merger, especially for high -risk patients who are more prone to complications after surgery,” said Michael Steinmetz, MD, President, Department of Neurosurgerry, Cleveland Clinic and research and research Most patients included in most patients in patients in patients.
The FDA’s approval is supported by aspice data, a fundamental prospective IDE study, of the unique, multiple, randomized and controlled blind, evaluating the safety and efficacy of the pearlmatrix bone graft 33 US centers were included and 293 patients. High risk of non -union (that is, patients with type 2 diabetes, BMI ≥ 30 and/or nicotine users). The study fulfilled the primary final point of the clinical success composed of 24 months (CCS) and demonstrated a statistical superiority versus local autoinjet in CCS that is composed of five components: fusion, function (ODI), neurological, without adverse events related to serious device and without secondary surgical interventions of index level. Aspire is the first study of its kind to show substantially higher fusion rates that reach statistically greater than 24 months with more than twice as many fused patients at six months compared to local autoinjut. The complete results of the Aspire study are expected to be published in the coming months.
“The approval of the FDA of the Pearlmatrix bone graft is a significant achievement for the waxing, since we are the only company with two products approved by PMA for use in spinal fusion. This is a testimony of our dedication to investment in the high quality clinical evidence in our positive persecution in the practice of the surgery of the spine and the life of the patients,” said Valeska Schroeder. Cerapedics Executive. “Differentiated by its only osteogenic cell binding peptide P-15, pearlmatrix bone graft is the first and only bone growth accelerator demonstrated to substantially increase the lumbar fusion speed, giving surgeons a new option to better meet the needs of patients and treat them more efficiently.”
Pearlmatrix’s bone graft was approved through the FDA PMA road and a designation of innovative devices in April 2021 was granted. The FDA offers this designation for a product that could provide a more effective treatment of a potentially deadly disease, is a novel technology or offers significant advantages over approved or clear alternatives. The prior approval to the market is the strictest type of marketing application of devices required by the FDA and the approval is based on an FDA determination that the PMA application contains sufficient valid scientific evidence to provide a reasonable guarantee that the device is safe and effective for its planned use. Of the more than 350 grafts of spinal bones in the US market, Cerapedics has two of only three grafts of spinal bones that have received the approval of PMA.
About Improved P-15 peptide graft pearlmatrixtm
The improved bone graft of the pearlmatrix P-15 peptide is the first and unique bone growth accelerator demonstrated to accelerate lumbar fusion with statistically higher statistically superior fusion speed in the single-level TLIF procedures. The P-15 peptide, the active component of Pearlmatrix, provides a different and proven mechanism of action to join and activate osteogenic cells to accelerate new bone formation. The P-15 peptide is a sequence of 15 amino acids that is naturally found in type 1 collagen, the predominant protein in the bone. It serves a crucial role in the bone regeneration process as a powerful cellular union factor. The P-15 peptide manufactured by Cerapedics is linked to calcium phosphate particles, creating an improved P-15 scaffold that provides an abundance of fixing sites for osteogenic cells, bone forming. The active cellular union roads that release cell signaling growth factors and allow bone growth through natural cellular processes.
Indications for use
The Pearlmatrix ™ bone graft is indicated for the fusion of the intervertebral body of the column in skeletally mature patients. Pearlmatrix is intended to be used together with a TLIF PEEK fusion device and complementary internal spinal fixing systems eliminated by the FDA for use in the lumbosacra column. The system will be used in patients who have had at least six months of non -surgical treatment. Pearlmatrix is intended to use at a level in the lumbar column (L2-S1) for the treatment of degenerative disc disease (DDD) with spondylolistesis to grade I. The DDD is defined as back pain and/or root of the discogenic origin with the degeneration of the disc confirmed by history, physical examination and radiographic studies.
Pearlmatrix is contraindicated in situations in which there is an absence of structural load support on the graft site, sensitivity to the components or the product, active infection on the operating site or an operational site subject to impact or excessive stress.
The effect of the perlmatrix in pregnant or nursing patients has not been evaluated. Attention should be exercised in the treatment of people with pre -existing conditions that may affect the success of the surgical procedure, such as people with hemorrhagic disorders of any etiology, long -term steroidal therapy, immunosuppressive therapy or high dose radiotherapy. The perlmatrix in a TLIF procedure was associated with a higher rate of secondary surgical interventions compared to local autoinje.
Pearlmatrix should only be used by doctors who have experience with TLIF procedures and in surgical procedures in which it can be properly contained in the hole or bone defect.
For more information about Pearlmatrix, its indications, contraindications, warnings, precautions and possible adverse events, visit our website at www.cerapedics.com or consult the instructions of Pearlmatrix for use to obtain complete information and risk information.
On wax
Cerapepedics is a global commercial stage in commercial stage that is dedicated to redefining the path to bone repair when healing the bones faster and higher rates, so that all patients can return to live their most complete lives. Bone grafts, including Cerapedics products, are used in more than four million annual columns, orthopedics, trauma and intervention procedures worldwide. Cerapepedics has two products approved by the FDA: Pearlmatrixtm bone graft for the single level of a single level (TLIF) in the lumbar column and the I-Factor® bone graft for unique level of unique level (ACDF) in the cervical spine. Cerapedics is based in Westminster, co.
For more information, visit us at www.cerapedics.com and follow us on LinkedIn.
Media contact: Fleishmanhillard
fh-corapedics@fleishman.com
* Dr. Michael Steinmetz has provided consulting, advice and speak to Cerapedics, Inc.; He has not been paid for any media work.
1 clarivate | Decision resources group. Bone graft substitutes. December 2022.
2 haik h, et al. Trends based on the population in complexity of hospitalized patients JAMA Intern Med. 2024; 184 (2): 183-192. DOI: 10.1001/JAMINTERNmed.2023.7410
3 clinicaltrials.gov. P-15L bone graft in melting lumbar transformation with instrumentation. Retrieved in August 2024. Available at: https://clinicaltrials.gov/study/nct03438747
Cerapedics Inc.
