Bone Biologics, Inc. announced that it has successfully completed the initial primate trials validating the efficacy of the proprietary bone growth regeneration UCB-1 (NELL-1) protein in spinal fusion surgery. 100% fusion was obtained in a 3 month period. No cystic lesion was observed. The company is currently preparing Pre-IDE studies.
Bone Biologics has been developing the protein as a Platform Technology since 2004, leveraging the previous ten years of research in the lab performed by the founding scientists at UCLA. This Platform Technology is combined with DBX® demineralized bone matrix to promote bone growth in spinal fusion. Results have exhibited rapid bone growth, high quality of bone, and no ectopic bone growth.
The successful primate surgical outcomes used the DBX® demineralized bone matrix (scaffold) produced by the Musculoskeletal Transplant Foundation (MTF). “The Musculoskeletal Transplant Foundation is a world leader in tissue research and development, and has been both a financial and strategic partner to Bone Biologics over the past four years,” said Bruce A. Hazuka, CEO of Bone Biologics.
“We are very pleased with the progress that Bone Biologics has made in achieving each of their development milestones over the past four years and look forward to their continued progress toward FDA approval and commercialization on the timelines projected by the company,” Bruce Stroever, CEO of MTF said.
The platform technology will be subject to the FDA review and approval process, including clinical trials. It is not currently approved for use in humans.
Source: Bone Biologics Inc.