Cerapedics said today it launched a new investigational device exemption trial looking to explore the safety and efficacy of its next-gen P-15L peptide enhanced bone graft in transforaminal interbody fusion surgeries.
The Westminster, Colo.-based company said it has enrolled the first patients in the study, which aims to enroll a total of 364 patients with degenerative disk disease at 30 sites across the US.
“We are pleased to announce enrollment of the first patients in our IDE study in TLIF procedures. 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 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,” CEO Glen Kashuba said in a press release.
The trial will compare the company’s P-15L enhanced bone graft against an autologous bone graft during TLIF surgery, Cerapedics said. The P-15L bone graft is based on biomimetic small peptide tech intended to support bone growth through cell attraction, attachment and activation.
“This important first patient enrolled signifies the culmination of substantial efforts on the part of many external and internal collaborators. We are grateful for all of the efforts that have gotten us to this point and are excited about the future of this study and the P-15L Bone Graft technology. We would like to give special thanks to Dr. Small and his clinical research team for enrolling the first patient,” prez & COO Jeffrey Marx said in a prepared statement.
Earlier this month, Cerapedics said that it closed a $22 million round of financing and added three new members to its board of directors