Bone Biologics Reports Progress With NB1 Clinical Program
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Insights
The progression of Bone Biologics Corporation's NB1 into human clinical trials marks a significant milestone in the development of orthobiologic treatments for spinal fusion. The focus on Transforaminal Lumbar Interbody Fusion (TLIF) to treat degenerative disc disease (DDD) addresses a substantial market need, as DDD is a common cause of chronic lower back pain affecting a large patient population. The inclusion of patients with Grade 1 spondylolisthesis or retrolisthesis expands the potential therapeutic scope of NB1.
From a research perspective, the trial's design, which has been agreed upon by the Division of Orthopedic Devices, suggests a rigorous approach to establishing safety and efficacy. The outcome of this pilot trial will be critical in determining the viability of NB1 for a larger pivotal clinical trial in the U.S., which could pave the way for FDA approval and commercialization. The long-term impact on Bone Biologics Corporation's business hinges on the success of these clinical trials, as positive results could lead to increased investor confidence and potential partnerships or funding opportunities.
Engaging three hospital sites for the pilot clinical trial of NB1 represents a tangible step forward in Bone Biologics's operational execution, which may resonate positively with investors. The investment community often views the initiation of human trials as a de-risking event, potentially leading to an uptick in stock valuation, assuming the market perceives the trial to have a reasonable chance of success. It is important to note that the costs associated with clinical trials are substantial and the company's financial health must be robust enough to sustain these expenses through to the trial's completion and beyond.
Additionally, the strategic decision to conduct the initial trial in Australia, where the regulatory environment might be more conducive to early-stage clinical research, could be a cost-effective approach. However, investors should monitor the company's burn rate and capital-raising activities, as these factors will be crucial in maintaining momentum towards the pivotal U.S. trial and eventual market entry.
The orthobiologic products market is competitive, with several established players and emerging technologies. Bone Biologics's advancement to human trials positions the company within a niche segment of the spine fusion market, potentially offering a novel solution for DDD. The success of NB1 could disrupt current treatment paradigms and capture market share from traditional bone graft substitutes.
Market acceptance will depend on the clinical outcomes relative to existing treatments. Should NB1 demonstrate superior or equivalent safety and effectiveness, it could command premium pricing and adoption among spine surgeons. However, market penetration will also be influenced by reimbursement policies, which hinge on the demonstration of cost-effectiveness and long-term patient benefit. It is crucial for Bone Biologics to engage with payers early on to ensure alignment on these fronts.
This pilot clinical trial 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 and agreed upon by the Division of Orthopedic Devices in a Pre-submission to support progression to a pivotal clinical trial in
About NB1
rhNELL-1 is a recombinant human protein that is combined with demineralized bone matrix to form the Company’s product candidate NB1. NELL-1 has unique properties that suggest it will be ideal in treating spinal fusion, trauma, osteoporosis and other bone-related indications, and may be especially useful among so-called “hard healers.” This potential lies in its ability to provide rapid, specific and guided control over bone regeneration.
For the NB1 bone graft device, the inclusion of rhNELL-1 provides an ancillary osteopromotive effect that is expected to increase the incidence. The proposed mechanism of action for rhNELL-1 to improve bone formation is based on published research and involves classic receptor binding and intracellular signaling transduction to the nucleus to promote osteogenic gene expression and bone formation.
There is a large and established opportunity for NB1 with an estimated global market of
About Bone Biologics
Bone Biologics was founded to pursue regenerative medicine for bone. The Company is working with select strategic partners to build on the foundation of preclinical research on rhNELL-1. Bone Biologics is focusing development efforts for its NB1 bone graft device in spinal fusion procedures, while additionally having rights to trauma and osteoporosis applications. For more information, please visit www.bonebiologics.com.
Forward-Looking Statements
Certain statements contained in this press release, including, without limitation, statements regarding the timing, implementation, and success of our pilot clinical trial of NB1 in human subjects with DDD, as well as statements containing the words “plan,” “will,” “expected” and words of similar import, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including, but not limited to, market and other conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.
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LHA Investor Relations
Kim Sutton Golodetz
212-838-3777
kgolodetz@lhai.com
Source: Bone Biologics Corporation
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