Charles Sternberg, Associate Editor01.05.24
Cerapedics Inc., a commercial-stage orthopedics company dedicated to redefining the standard of care for bone repair, has filed the final module in the Pre-Market Approval (PMA) application with the U.S. Food and Drug Administration (FDA) for its investigational P-15 Peptide Enhanced Bone Graft.
Cerapedics was able to advance to this submission earlier than anticipated due to the use of a rigorous statistical analysis known as the Bayesian Multiple Imputation. If approved, this will be the latest bone graft product in Cerapedics’ portfolio to leverage its powerful, proprietary P-15 Osteogenic Cell Binding Peptide, which has a proven mechanism of action not found in any other category of bone graft materials.
“We are proud to submit our PMA application, and to be closer to introducing our innovative P-15 Peptide Enhanced Bone Graft to the large population of patients undergoing TLIF procedures in the U.S.,” said Valeska Schroeder, Chief Executive Officer of Cerapedics. “With substantial Level 1 human clinical data supporting the product, we look forward to our continued collaboration with the FDA in the upcoming review process.”
The PMA application is based on data from the ASPIRE study, a prospective, single-blinded, multi-center, randomized, non-inferiority pivotal IDE study to evaluate the safety and efficacy of P-15 Bone Graft compared to use of an autologous bone graft when applied in TLIF surgery. The ASPIRE trial included 33 U.S. centers and 290 patients, many of which were considered high risk for non-union (diabetics, obese patients, and nicotine users).
The primary endpoint of the study looked at a 24-month composite clinical success defined as meeting fusion (assessed via thin cut CT at 6, 12 and 24-months), function (ODI), neurological, index level secondary surgery intervention, and serious device-related adverse event endpoints. Based on meeting the requirements of a Bayesian analysis, Cerapedics submitted the final PMA module before all patients reached the month 24 follow-up visit.
Cerapedics was able to advance to this submission earlier than anticipated due to the use of a rigorous statistical analysis known as the Bayesian Multiple Imputation. If approved, this will be the latest bone graft product in Cerapedics’ portfolio to leverage its powerful, proprietary P-15 Osteogenic Cell Binding Peptide, which has a proven mechanism of action not found in any other category of bone graft materials.
About the P-15 Bone Graft
The new P-15 Bone Graft is designed for use in transforaminal lumbar interbody fusion (TLIF) surgery in patients with degenerative disc disease. In April 2021, the FDA granted breakthrough device designation for the new P-15 Bone Graft intended for use in the treatment of a single-level TLIF in patients with degenerative disc disease. The designation offers an opportunity to interact with FDA experts to address regulatory topics efficiently and allows for prioritized review of regulatory submissions.“We are proud to submit our PMA application, and to be closer to introducing our innovative P-15 Peptide Enhanced Bone Graft to the large population of patients undergoing TLIF procedures in the U.S.,” said Valeska Schroeder, Chief Executive Officer of Cerapedics. “With substantial Level 1 human clinical data supporting the product, we look forward to our continued collaboration with the FDA in the upcoming review process.”
The PMA application is based on data from the ASPIRE study, a prospective, single-blinded, multi-center, randomized, non-inferiority pivotal IDE study to evaluate the safety and efficacy of P-15 Bone Graft compared to use of an autologous bone graft when applied in TLIF surgery. The ASPIRE trial included 33 U.S. centers and 290 patients, many of which were considered high risk for non-union (diabetics, obese patients, and nicotine users).
The primary endpoint of the study looked at a 24-month composite clinical success defined as meeting fusion (assessed via thin cut CT at 6, 12 and 24-months), function (ODI), neurological, index level secondary surgery intervention, and serious device-related adverse event endpoints. Based on meeting the requirements of a Bayesian analysis, Cerapedics submitted the final PMA module before all patients reached the month 24 follow-up visit.