Tuesday July 31, 2018 0 comments
WESTMINSTER -- Cerapedics, a privately-held orthobiologics company, today announced the first patients have been enrolled in an investigational device exemption (IDE) clinical trial evaluating the safety and efficacy of the next-generation P-15L Peptide Enhanced Bone Graft in transforaminal lumbar interbody fusion (TLIF) surgery.
The prospective, single-blinded, multi-center, randomized, non-inferiority pivotal IDE study will evaluate the safety and efficacy of P-15L Bone Graft compared to use of an autologous bone graft when applied in TLIF surgery, the company said.
The study will include a total of 364 patients with degenerative disk disease at up to 30 clinical trial sites across the U.S. once it is fully enrolled.
"We are pleased to announce enrollment of the first patients in our IDE study in TLIF procedures," said Glen Kashuba, Cerapedics CEO.
"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.
“Our first-generation bone graft is already approved for anterior cervical discectomy and fusion (ACDF) procedures, and this pivotal study in TLIF procedures will be instrumental in a second Premarket Approval (PMA) application for our next-generation P-15 technology in the years ahead."
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 stabilizing one or more vertebrae.
Cerapedics said its P-15L Bone Graft is based on a biomimetic small peptide (P-15) technology developed to support bone growth through cell attraction, attachment, and activation, 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.
"This important first patient enrolled signifies the culmination of substantial efforts on the part of many external and internal collaborators," said Jeffrey G. Marx, Cerapedics president and COO.