13 April 2023 | Thursday | News
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Bone Biologics Corporation (NASDAQ: BBLG), a developer of orthobiologic products for spine fusion markets, announces that the Human Research Ethics Committee (HREC) has approved Monash Health as the first of a planned multicenter pilot clinical trial to evaluate the Company’s NB1 bone graft in Australia.
This pilot study will evaluate the safety and effectiveness of NB1 in 30 adult subjects who undergo transforaminal lumbar interbody fusion (TLIF) to treat degenerative disc disease (DDD). 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 by the U.S. Food and Drug Administration’s Division of Orthopedic Devices in a Pre-submission and is intended to support progression to a pivotal clinical study in the United States.
“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 was generated in our animal studies,” said Jeffrey Frelick, Bone Biologics’ president and chief executive officer.
Lumbar DDD is one of the most common causes of low back pain. DDD also leads to substantial disability, with many patients suffering from decreased ability to walk, sit, stand and/or sleep. For some people, DDD is part of the natural process of growing older and is a significant medical issue that is increasing as the global population ages.
“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 $3 billion annual global market for spine fusion products,” added Mr. Frelick.
Bone Biologics previously announced the engagement of Avania as the contract research organization for this pilot clinical trial with NB1.