Bone Biologics reports progress with NB1 clinical program

Bone Biologics reported progress with advancing its product candidate NB1 into human clinical testing for spinal fusion. Following Human Research Ethics Committee, or HREC, approval last year in Australia for the multicenter, prospective, randomized pilot clinical trial, the company reports that three hospital sites have been engaged to participate in the pilot clinical trial. This pilot clinical trial will evaluate the safety and effectiveness of NB1 in 30 adult subjects who undergo transforaminal lumbar interbody fusion to treat degenerative disc disease. 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. The study design was previously reviewed and agreed upon by the Division of Orthopedic Devices in a Pre-submission to support progression to a pivotal clinical trial in the United States.