Orthobiologic products developer Bone Biologics has received approval from the Human Research Ethics Committee in Australia to start the pilot study of its NB1 bone graft.
Monash Health has been approved as the first site to carry out a planned multi-centre pilot clinical trial for the assessment of the NB1 bone graft.
The safety and effectiveness of the bone graft will be assessed in 30 adult subjects undergoing transforaminal lumbar interbody fusion for the treatment of degenerative disc disease (DDD).
Bone Biologics president and CEO Jeffrey Frelick said: “We are delighted to announce this important step toward beginning our pilot study in humans and look forward to demonstrating the ability of NB1 to support the same or better fusion success rates in hard healers that were generated in our animal studies.
“We believe NB1 is poised to address the problems with existing bone-growth products by providing rapid, controlled and guided bone growth only in the presence of existing bone, not elsewhere in the body.
“Our longer-term goal is to capture a meaningful portion of the $3bn annual global market for spine fusion products.”
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The study will include patients with DDD at one spine level from L2-S1 who may also have up to Grade 1 spondylolisthesis or Grade 1 retrolisthesis at the involved level.
The company already selected Avania to provide contract research organisation services for the pilot clinical study with NB1.
The US Food and Drug Administration’s Division of Orthopaedic Devices previously reviewed the study design in a pre-submission.