Ortho-biologics company Cerapedics announced that it has won FDA breakthrough device designation for its investigational P-15L bone graft to treat degenerative disc disease (DDD).
The company plans to enroll at least 270 DDD patients in the Aspire study, a prospective, single-blinded, multi-center, randomized, non-inferiority pivotal IDE study to evaluate the safety and efficacy of P-15L bone graft compared to the use of an autologous bone graft when applied in spinal fusion surgery. Westminster, Colo.-based Cerapedics plans to file a premarket approval submission with the FDA with the results from this study, which will be conducted across 36 sites in the U.S.
“We are pleased the FDA has granted breakthrough device designation for P-15L bone graft, our next-generation P-15 technology platform candidate, as it underscores the urgent need for more effective treatments for patients suffering with degenerative disc disease,” said Cerapedics CEO Glen Kashuba in a news release. “We look forward to working closely with the FDA through the ongoing clinical trial and review processes for P-15L, with the goal of bringing this important new technology to a patient population with a significant unmet medical need.”