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Cerapedics has enrolled the first of 364 patients in an Investigational Device Exemption (IDE) clinical trial evaluating next-gen P-15L Peptide Enhanced Bone Graft vs. autograft in transforaminal lumbar interbody fusion (TLIF).
The prospective, single-blinded, multi-center, randomized, non-inferiority pivotal study will enroll patients at up to 30 U.S. sites, with follow-up at 6 weeks, 3 months, 12 months and 24 months. Investigators can use any FDA-cleared static PEEK interbody and any FDA-cleared pedicle fixation system delivered in an open or minimally invasive technique.
P-15L graft, a substitute for autologous bone, is based on synthetic small peptide technology and was developed to spur bone growth via cell attraction, attachment and activation.
“More than 300,000 people in the U.S. suffer from degenerative disk disease that leads to pain and nerve irritation and often requires surgery,” said Cerapedics CEO Glen Kashuba. “Our first-generation bone graft is already approved for anterior cervical discectomy and fusion procedures, and this pivotal study in TLIF procedures will be instrumental in a second premarket approval application for our next-generation P-15 technology in the years ahead.”
Cerapedics received FDA approval to initiate this IDE study in March 2018. At that time, Paul M. Arnold, of the Department of Neurosurgery at the University of Kansas Medical Center, commented, “Prior research of this proprietary P-15 technology has demonstrated potential benefits in fusion rates, neurological outcomes and safety in cervical and lumbar fusions.”
Cerapedics has been active in R&D this year. Last month, the company reported that it closed a $22 million round of financing that will support continued launch of i-FACTOR™ Peptide Enhanced Bone Graft and a second Level I IDE human clinical study.
