Preclinical animal study results indicate that Bone Biologics' rhNELL-1 growth factor effectively promoted bone formation in a phylogenetically advanced spine model. The product was well-tolerated, with no signs of inflammation.
In 1Q19, the company received Human Research Ethics Committee approval for the first center of a multicenter pilot clinical trial to evaluate NB1 recombinant human protein growth factor (NELL-1/DBX®) in 30 patients in Australia. That pilot study will examine the treatment of one-level degenerative disc disease in patients who may also have up to Grade 1 spondylolisthesis or Grade 1 retrolisthesis at the involved level who undergo transforaminal lumbar interbody fusion.
NELL-1 is a recombinant human protein growth factor that is essential for normal bone development. Bone Biologics is focusing its present development efforts for its bone graft substitute product on bone regeneration in spinal fusion.