Cerapedics has announced that it has completed enrolment of the ASPIRE study—a pivotal US Food and Drug Administration (FDA) investigational device exemption (IDE) study—which will evaluate the safety and efficacy of P-15L bone graft for use in transforaminal lumbar interbody fusion (TLIF) surgery in patients with degenerative disc disease (DDD). Results from the study are intended to be used in a Premarket Approval (PMA) submission to the FDA.
Principal investigator of the study, Paul Arnold (Carle Illinois College of Medicine, Illinois, USA), said: “This study was designed for non-inferiority in a composite endpoint, but also to determine whether P-15L bone graft provides faster fusion versus autograft and, thus, determine the potential clinical benefits to patients undergoing TLIF procedures. We look forward to the maturation of the data and our ability to present it.”
The P-15L Peptide Enhanced Bone Graft, which has been granted breakthrough device designation by the FDA, is Cerapedics’ next-generation P-15 technology platform candidate. The ASPIRE study is a prospective, single-blinded, multicentre, randomised, 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 in TLIF surgery. The study involves 290 subjects, including high-risk patients, across 36 clinical trial sites in the US.
Medical and economic outcomes will be evaluated at six months and through a two-year follow-up with a Bayesian statistical approach for a composite endpoint of fusion, Oswestry Disability Index, neurological success, and safety success.
Glen Kashuba, chief executive officer of Cerapedics, said: “We want to thank all the patients, investigators, and their research teams who are participating in the ASPIRE study. Their hard work and dedication have resulted in a timely enrolment amid challenging circumstances presented by the COVID-19 pandemic. This speaks volumes about the interest to investigate the potential clinical benefits of the P-15L bone graft.”
“An indication for the use of P-15L bone graft in lumbar spine fusion would unlock a significant addressable market expansion opportunity that represents 80% of the total bone graft market. With the completion of the enrolment phase, we look forward to shifting to the follow-up phase of the study in anticipation of submitting the clinical data to FDA under a PMA application,” added Jeff Marx, president and chief operating officer of Cerapedics.