Full Press Release Details
Two Patients Treated in Pilot Clinical Study with Bone Biologics' NB1 Bone Graft Device in Spine Fusion
Management "CEO Chat" with Zacks Small-Cap Research Analyst Begins Today at 11 a.m. Eastern Time
Mass. (June 20, 2024) - Bone Biologics Corporation ("Bone Biologics" or the "Company")
(Nasdaq: BBLG, BBLGW), a developer of orthobiologic products for spine fusion markets, announces that the first two patients
have been treated in the multicenter, prospective, randomized pilot clinical study of the Company's NB1 bone graft device. NB1
is NELL-1 protein combined with demineralized bone matrix (DBM) to provide rapid, specific and guided control over bone regeneration.
pilot clinical study will evaluate NB1 in 30 adult subjects who undergo transforaminal lumbar interbody fusion (TLIF) to treat degenerative
disc disease (DDD) and will evaluate safety and effectiveness, fusion success, pain, function improvement and adverse events. To be enrolled
in the study, patients must have DDD at one level from L2-S1 and may also have up to Grade 1 spondylolisthesis or Grade 1 retrolisthesis
at the involved level. These two patients were treated in Australia. The study design was previously reviewed and agreed upon by the
U.S. Food and Drug Administration's Division of Orthopedic Devices in a Pre-submission to support progression to a pivotal clinical
trial in the United States.
have worked diligently to prepare for this important milestone and are delighted that the first patients have been treated in our pilot
clinical study," said Jeffrey Frelick, president and chief executive officer of Bone Biologics. "Preclinical animal studies
demonstrated a strong safety profile, fusion success and bone healing of NB1, and we are optimistic that we will show fusion success
is clear need for a product that creates rapid, controlled and guided bone growth only in the presence of existing bone and not elsewhere
in the body. We aim to demonstrate that NB1 will address this opportunity and compete in the $3 billion annual global market for spine
fusion products," he added.
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.
Biologics reminds investors that Jeffrey Frelick, the Company's president and chief executive officer, and Deina Walsh, chief financial
officer, will be interviewed by Zacks Small-Cap Research analyst Brad Sorensen, CFA in a "CEO Chat" today at the Life Science
Investor Forum with Virtual Investor Conference hosted by VirtualInvestorConferences.com.
interview will begin at 11:00 a.m. Eastern time and can be viewed here. Investors are encouraged to preregister to expedite participation
and receive event updates, and are invited to ask questions during the event via a chat function.
Company's product candidate NB1 combines the recombinant human NELL-1 (rhNELL-1) protein with demineralized bone matrix. 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.
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.
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.
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.
statements contained in this press release, including, without limitation, statements regarding the timing, implementation, and success
of the company's pilot clinical study, 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, as well
as statements containing the words "will," "expect," 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.