Bone Biologics Expands Trial Sites

Six Australian hospitals have now agreed to participate in Bone Biologics Corporation’s first-in-human pilot clinical trial of its bone graft product for spinal fusion. The expanded network doubles the number of participating centers and is expected to speed patient screening and surgical scheduling, supporting the company’s expectation of completing enrollment by year’s end, executives said.

The bone graft product—NB1—combines the recombinant human NELL-1 protein (rhNELL-1) with demineralized bone matrix for use in spinal procedures.

“We believe the additional hospital sites in our study meaningfully increase our access to qualified patients and reduces our reliance on patient flow at any individual center,” Bone Biologics CEO Jeff Frelick stated. “This expansion strengthens our anticipation of reaching full enrollment by the end of 2026 and brings us closer to the 12-month follow-up data.”

The pilot study is a multicenter, prospective, parallel-group, randomized trial conducted in Australia that evaluates NB1’s safety and preliminary effectiveness in up to 30 adult subjects with degenerative disc disease (DDD) undergoing transforaminal lumbar interbody fusion (TLIF). Inclusion criteria include patients with DDD at one level from L2-S1 who may also have up to Grade 1 spondylolisthesis or Grade 1 retrolisthesis at the involved level. Primary clinical endpoints include fusion success at 12 and 24 months after surgery, and change from baseline in the Oswestry Disability Index, a standard measure of functional disability. The U.S. Food and Drug Administration’s Division of Orthopedic Devices previously reviewed the study design in a pre-submission, and these pilot study findings are intended to support progression to a U.S. pivotal clinical study.

“Supported by our cash runway through the second quarter of 2027 and our recently announced 32-month validated shelf life for rhNELL-1, we remain focused on disciplined execution of the NB1 clinical program as we prepare for a potential pivotal study,” Frelick added.

Bone Biologics develops regenerative medicine for bone, working with select strategic partners to build on preclinical research on the NELL-1 protein. The firm is focusing its development efforts for the bone graft substitute product on bone regeneration in spinal fusion procedures, while additionally having rights to trauma and osteoporosis applications.