BURLINGTON, MA, Sept. 08, 2026 (GLOBE NEWSWIRE) -- Bone Biologics Corporation (Nasdaq: BBLG, BBLGW) (“Bone Biologics” or the “Company”), a developer of orthobiologic products for spine fusion markets, today announced that six hospital sites in Australia are now under agreement to participate in its first-in-human pilot clinical trial of NB1, the Company’s rhNELL-1-based bone graft product for spinal fusion. The expanded network doubles the number of participating centers and is expected to accelerate patient screening and surgical scheduling, strengthening the Company’s expectation to complete enrollment by year-end 2026.
Bone Biologics Expands Trial Sites
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orthobiologicsspine fusionBone Biologics CorporationrhNELL-1-based bone graftfirst-in human pilot clinical trial
NB1, the Company’s lead product candidate, combines the recombinant human NELL-1 protein (rhNELL-1) with demineralized bone matrix for use in spinal procedures.
“We believe the additional hospital sites in our study meaningfully increases our access to qualified patients and reduces our reliance on patient flow at any individual center,” said Bone Biologics CEO Jeff Frelick. “This expansion strengthens our anticipation of reaching full enrollment by the end 2026 and brings us closer to the 12-month follow-up data.”
Study design and endpoints
The pilot study is a multicenter, prospective, parallel-group, randomized trial conducted in Australia that evaluates the safety and preliminary effectiveness of NB1 in up to 30 adult subjects with degenerative disc disease (DDD) undergoing transforaminal lumbar interbody fusion (TLIF). 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. Primary clinical endpoints include fusion success at 12 and 24 months following surgery, and change from baseline in the Oswestry Disability Index, a standard measure of functional disability. The U.S. Food and Drug Administration’s Division of Orthopedic Devices previously reviewed the study design in a pre-submission, and these pilot study findings are intended to support progression to a pivotal clinical study in the United States.
“Supported by our cash runway through the second quarter of 2027 and our recently announced 32-month validated shelf life for rhNELL-1, we remain focused on disciplined execution of the NB1 clinical program as we prepare for a potential pivotal study,” added Frelick.
About Bone Biologics
Bone Biologics was founded to pursue regenerative medicine for bone. The Company is undertaking work with select strategic partners that builds on the preclinical research of the NELL-1 protein. Bone Biologics is focusing development efforts for its bone graft substitute product on bone regeneration 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 number and participation of hospital sites in the Company’s pilot clinical study, the expected timing of completion of patient enrollment, the timing, implementation and success of the Company’s pilot clinical study and any interim updates, the Company’s operating runway, the Company’s development of rhNELL-1 and achievement of operational milestones, the ability of the Company’s lead product candidate NB1 to provide rapid, specific and guided control over bone regeneration and show fusion success in humans, the ability of NB1 to compete in global markets, and the Company’s progression toward a potential pivotal clinical study, as well as statements containing the words “may,” “anticipate,” “believe,” “continue,” “expect,” “focus,” “intend,” “will,” 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, 2025 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.
Contacts
CORE IR
(212) 655-0924
investors@bonebiologics.com
Author
TH
TJ Halvorson
The De Angelis Group | Orthopedics This Week | MSK Innovations
Why This Matters
Two Perspectives
MBA Lens: Economic and industry impact
Bone Biologics is expanding its first-in-human pilot clinical trial for NB1, an rhNELL-1-based bone graft for spinal fusion, by doubling trial sites to six in Australia. This strategic move aims to accelerate patient enrollment, strengthening the company's expectation to complete the 30-patient study by year-end 2026. Successful completion is crucial for advancing to a pivotal U.S. clinical study, leveraging their cash runway through Q2 2027.
- The expansion to six Australian sites for the NB1 spinal fusion trial seeks to optimize patient access and reduce reliance on individual centers.
- This strategy supports the company's goal of completing pilot study enrollment by year-end 2026, paving the way for a U.S. pivotal study.
PhD Lens: Clinical and outcomes impact
Bone Biologics' NB1, a bone graft combining recombinant human NELL-1 protein with demineralized bone matrix, is undergoing a first-in-human pilot clinical trial in Australia. This multicenter, randomized study evaluates NB1's safety and preliminary effectiveness in up to 30 adult subjects with degenerative disc disease undergoing TLIF procedures. Primary endpoints include fusion success at 12 and 24 months and Oswestry Disability Index changes.
- NB1 integrates rhNELL-1 with DBM, targeting bone regeneration in L2-S1 spinal fusion for degenerative disc disease.
- The pilot study assesses fusion success at 12/24 months and functional disability via Oswestry Disability Index, with FDA pre-submission review.
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Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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