Bone Biologics has doubled the number of Australian hospital sites participating in its first-in-human pilot clinical trial of NB1, its bone graft product for spinal fusion.
Six hospital sites are now under agreement to participate in the trial. The company expects the expanded network to accelerate patient screening and surgical scheduling as it works to complete enrollment by year-end 2026, according to a Sept. 8 news release.
The randomized trial is evaluating the safety and preliminary effectiveness of NB1 in up to 30 adults with degenerative disc disease undergoing transforaminal lumbar interbody fusion. Researchers will assess fusion success at 12 and 24 months after surgery and changes in functional disability.
The FDA’s Division of Orthopedic Devices previously reviewed the study design in a pre-submission. Bone Biologics intends to use findings from the Australian pilot study to support progression to a potential pivotal clinical study in the U.S., according to the release.
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