Cerapedics has announced that the US Food and Drug Administration (FDA) has approved the company’s Investigational Device Exemption (IDE) supplement, reducing the enrolment requirement for the ongoing clinical trial, ASPIRE, for P-15L Bone Graft in a single level transforaminal lumbar interbody fusion (TLIF) surgery.
“We are pleased to announce FDA approval of an IDE supplement resulting in a reduction of the total number of patients required to be enrolled in our IDE study for P15-L cell-binding peptide technology in the TLIF application,” said Jeffrey Marx, president and chief operating officer of Cerapedics. “The enrolment requirement has been reduced from 364 to 270 patients.”
The prospective, single-blinded, multicentre, randomised, non-inferiority pivotal IDE study will evaluate the safety and efficacy of P-15L Bone Graft compared to the use of an autologous bone graft when applied in TLIF surgery. “The reduction in requirement will help us significantly reduce the enrolment period of the IDE Study and lead to an earlier PMA submission,” said Glen Kashuba, chief executive officer of Cerapedics.
In TLIF procedures, surgeons historically obtained bone graft from the patient’s pelvis and placed it in the interbody space to promote fusion when joining and to stabilise one or more vertebrae. P-15L Bone Graft is based on a small biomimetic peptide (P-15) technology developed by Cerapedics to support bone growth, and is designed to be used as a substitute for autologous bone. In 2015, the company’s first-generation bone graft became the first bone graft to be approved for use in the cervical spine and only the second PMA-approved bone graft in the spine.