i-FACTOR Peptide Enhanced Bone Graft is based on proprietary synthetic small peptide (P-15) technology developed by Cerapedics to support bone growth through cell attraction, attachment and activation. In spinal fusion procedures, surgeons use bone graft to join and stabilize vertebrae. i-FACTOR Peptide Enhanced Bone Graft was approved in the European Union in 2008 and in Australia in 2010 for use in the repair of bony voids or defects in orthopedic applications throughout the skeletal system (i.e., the spine and extremities). In the United States, i-FACTOR Peptide Enhanced Bone Graft was approved via a U.S. Food and Drug Administration (FDA) premarket approval (PMA) application in 2015 only for use in single level anterior cervical fusion procedures.
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In the single center, double-blind, randomized IVANOS study, 98 patients (240 treated levels) age 60 and older with lumbar spinal stenosis (LSS) and concomitant degenerative olisthesis (DS) were treated with non-instrumented lumbar posterolateral spine surgery and received either i-FACTOR Peptide Enhanced Bone Graft or allograft. Results demonstrated a 50 percent fusion rate (63/126) using i-FACTOR Peptide Enhanced Bone Graft compared to a 20 percent fusion rate (23/114) using allograft at one-year postoperative follow-up. Patients with 1-level DS achieved estimated fusion rates of 40 percent (29/72) with i-FACTOR Peptide Enhanced Bone Graft versus 21 percent (17/80) with allograft. Patients with 2-level DS achieved estimated fusion rates of 63 percent (34/54) with i-FACTOR Peptide Enhanced Bone Graft versus 18 percent (6/34) with allograft.
"In Denmark the current surgical standard is the use of non-instrumented fusion in treating elderly patients with spinal stenosis and concomitant degenerative olisthesis. This patient population presents a challenging environment to obtain fusion due to their mechanical instability and biology," said Mikkel O Andersen M.D., from the Sector for Spine Surgery and Research at Middelfart Hospital in Denmark. "These data indicate that i-FACTOR Peptide Enhanced Bone Graft offers significant potential benefits in fusion rates compared to allograft."
Cerapedics received approval from the FDA to initiate an investigational device exemption (IDE) clinical trial evaluating the safety and efficacy of its proprietary P-15 technology for use in transforaminal lumbar interbody fusion (TLIF) surgery in March 2018. The company is initiating enrollment in the study with the expectation that the results will support an additional PMA application. P-15 currently remains investigational in the United States for use in the lumbar spine.
"This data from the IVANOS study is another significant milestone as we advance on our commitment to increase the level of clinical evidence evaluating our P-15 technology, and we are proud to be leading the effort to address the evidence gap around commercial bone grafts often used in spinal fusion procedures," said Glen Kashuba, CEO of Cerapedics.
Cerapedics is an orthobiologics company focused on developing and commercializing its proprietary synthetic small peptide (P-15) technology platform. i-FACTOR Peptide Enhanced Bone Graft is the only biologic bone graft in orthopedics that incorporates a small peptide as an attachment factor to stimulate the natural bone healing process. This mechanism of action is designed to support safer and more predictable bone formation compared to commercially available bone growth factors.