CerapedicsOrtho-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.

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