Bone Biologics Reports Progress With NB1 Clinical Program
March 01 2024 - 8:00AM
Business Wire
Bone Biologics Corporation (NASDAQ: BBLG), a developer of
orthobiologic products for spine fusion markets, reports progress
with advancing its product candidate NB1 into human clinical
testing for spinal fusion. Following Human Research Ethics
Committee (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 (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 the United States.
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 $3 billion annually for bone graft
substitutes in spine fusion for products such as growth factors,
DBM, synthetic materials, stem cells and allografts. Additional
longer-term market opportunities include the $11 billion annual
market for treating osteoporosis and the $8 billion annual market
for treating trauma.
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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version on businesswire.com: https://www.businesswire.com/news/home/20240229191120/en/
LHA Investor Relations Kim Sutton Golodetz 212-838-3777
kgolodetz@lhai.com
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