Cerapedics announced the company received FDA approval to initiate an investigational device exemption clinical trial evaluating the safety and efficacy of P-15L Peptide Enhanced Bone Graft compared with autograft in transforaminal lumbar interbody fusion surgery for degenerative disc disease.
“With regulatory approval to begin a new IDE study of P-15L Bone Graft in [transforaminal lumbar interbody fusion] TLIF procedures, we are now in position to collect additional level 1 human clinical data on our next-generation advanced drug-device combination bone graft,” Glen Kashuba, chief executive officer of Cerapedics, said in a company press release. “Several hundred thousand people in the U.S. need surgery for degenerative disc disease every year, and it is our goal to offer surgeons a safe and effective alternative to a patient’s own bones as well as address the evidence gap around commercial bone grafts often used in these procedures.”
Based on a proprietary synthetic small peptide technology to support bone growth through cell attraction, attachment and activation, P-15L Bone Graft’s design enables it use as a substitute for autologous bone, according to the release. In the prospective, single-blind, multi-center, randomized, non-inferiority pivotal IDE study, researchers at up to 30 clinical trial sites will assess 364 patients with degenerative disc disease preoperatively and postoperatively at 6 weeks, 3 months, 12 months and 24 months, the release noted. The primary endpoint includes composite clinical success at 24 months based on achievement of radiographic fusion, at least a 15-point improvement in the Oswestry Disability Index, no new or worsening persistent neurological deficit and no subsequent surgical intervention at the index level.
“We are very pleased to be on the verge of initiating this milestone study,” Jeffrey G. Marx, PhD, president and chief operative officer of Cerapedics, said in the release. “We believe the FDA-approved study design should allow for rapid enrollment and clear evaluation of the safety and efficacy of P-15L Bone Graft vs. local autograft. We’re assembling an outstanding team of surgeon investigators whom we are excited to collaborate with.”