Cerapedics filed the final module in the Premarket Approval (PMA) application with FDA for its investigational P-15 Peptide Enhanced Bone Graft. If approved, this will be the latest bone graft product in Cerapedics’ portfolio to leverage its proprietary P-15 Osteogenic Cell Binding Peptide.
The new P-15 Bone Graft is designed for use in transforaminal lumbar interbody fusion (TLIF) in patients with degenerative disc disease. In 2021, 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 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 US centers and 290 patients, many of which were considered high-risk for non-union. The primary endpoint of the study looked at a 24-month composite clinical success defined as meeting fusion, function, 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 followup visit.
“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.”
Cerapedics filed the final module in the Premarket Approval (PMA) application with FDA for its investigational P-15 Peptide Enhanced Bone Graft. If approved, this will be the latest bone graft product in Cerapedics’ portfolio to leverage its proprietary P-15 Osteogenic Cell Binding Peptide.
The new P-15 Bone Graft is designed for use in...
Cerapedics filed the final module in the Premarket Approval (PMA) application with FDA for its investigational P-15 Peptide Enhanced Bone Graft. If approved, this will be the latest bone graft product in Cerapedics’ portfolio to leverage its proprietary P-15 Osteogenic Cell Binding Peptide.
The new P-15 Bone Graft is designed for use in transforaminal lumbar interbody fusion (TLIF) in patients with degenerative disc disease. In 2021, 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 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 US centers and 290 patients, many of which were considered high-risk for non-union. The primary endpoint of the study looked at a 24-month composite clinical success defined as meeting fusion, function, 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 followup visit.
“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.”
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