Bone Biologics Announces Significant Milestone for Spinal Fusion Surgery Using Recombinant Protein and Demineralized Bone Matrix
Published: Feb 25, 2009
Primate trials validate efficacy of the process
THOUSAND OAKS, Calif., Feb. 24 /PRNewswire/ -- Bone Biologics, Inc. announced today 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(R) 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(R) 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.
About The Musculoskeletal Transplant Foundation
MTF is a non-profit service organization dedicated to providing quality tissue through a commitment to excellence in education, research, recovery and care for recipients, donors and their families. In 2008, MTF distributed over 400,000 tissue grafts.
About Bone Biologics, Inc.
Bone Biologics is a convergence biotechnology company focused in the orthobiologics space. The company was founded in 2004 by the research scientists who had identified and validated the product in the lab over the previous ten years. The acquisition of an exclusive worldwide license and the financing from MTF was the genesis of the development of this recombinant protein.
CONTACT: Bruce A. Hazuka of Bone Biologics, +1-818-324-2742