Bone Biologics Corp

Bone Biologics Corp is a U.S.-based clinical-stage medical device company focused on bone regeneration for spinal fusion procedures. Its core technology is NELL-1, a recombinant human protein licensed exclusively from UCLA Technology Development Group and combined with demineralized bone matrix (DBM) to create the NB1 bone graft device. The company’s development program is centered on improving bone growth and fusion outcomes while avoiding the need for autograft harvest from a patient’s hip. Bone Biologics has not yet commercialized its lead product and is pursuing FDA approval through the premarket approval pathway for a combination device/drug product.

13.85

13.85

— Bone Biologics Corp
%
Lead bone graft device0% NB1 combines NELL-1 with DBM to support targeted bone regeneration in spinal fusion.
Recombinant protein platform0% NELL-1 is the underlying biologic technology used to stimulate bone formation.
Clinical development program0% Preclinical and human studies aimed at proving safety and effectiveness for FDA approval.
Licensed intellectual property0% Exclusive worldwide rights to UCLA-licensed NELL-1 patents and know-how.

Bone Biologics’ eventual customers are primarily spine surgeons and the hospitals or surgical centers that use bone...

  • Spine surgeonsprimary

    They would use NB1 in lumbar spinal fusion to improve bone growth and avoid autograft harvest.

  • Hospitals and surgical centersprimary

    They would purchase or stock the product for fusion procedures if it gains approval and surgeon adoption.

  • Patients with spinal degenerative diseaseprimary

    They are the clinical beneficiaries of the product, especially those undergoing transforaminal lumbar interbody fusion.

  • Third-party payorssecondary

    They affect reimbursement and therefore the commercial viability of any approved product.

Bone Biologics is headquartered in the United States and is organized as a Delaware corporation with operations tied to...

  • •United States is the core corporate and regulatory base
  • •FDA approval is required for U.S. commercialization
  • •Pilot clinical study is being conducted in Australia
  • •Worldwide license rights support future non-U.S. expansion
  • •Delaware incorporation and U.S. patent filings anchor the business

The company’s strategy is to advance NELL-1/DBM through clinical development and obtain FDA approval for spinal fusion...

01
Complete clinical development for NB1short-term

Regulatory approval is the main gating factor before any commercialization can begin.

02
Secure FDA PMA pathway approvalmedium-term

The company has been told the product will be regulated as a combination product requiring PMA in the U.S.

03
Protect and extend intellectual propertymedium-term

Exclusive patents and licenses are central to competitive differentiation and future partnering value.

Bone Biologics faces the typical risks of a clinical-stage medtech company: regulatory delay, clinical trial failure,...

critical

Regulatory approval risk

NB1 is expected to require FDA PMA approval before U.S. commercialization, which is time-consuming and uncertain.

Scope
Lead product commercialization
Materiality
high
high

Clinical trial execution risk

The company is still generating evidence in pilot studies, and adverse results could stop or delay development.

Scope
NB1 spinal fusion program
Materiality
high
high

Competitive pressure

Large orthopedic and med-tech companies may launch better-funded or faster-approved alternatives.

Scope
Spinal fusion biologics market
Materiality
high
medium

Key person dependence

The company states it is heavily dependent on its CEO and CFO, making turnover disruptive.

Scope
Corporate execution
Materiality
medium
medium

Supply chain and manufacturing dependence

Third parties provide raw materials and product components, which can constrain trials and future supply.

Scope
Clinical and future commercial supply
Materiality
medium
medium

Healthcare compliance and privacy

Anti-kickback, HIPAA, and related laws can restrict commercialization and create liability.

Scope
Commercial launch and provider relationships
Materiality
medium
Stock option and warrant valuation
Non-cash compensation and derivative-like valuation effects
Income tax valuation allowance
Tax expense and balance sheet deferred tax assets
Clinical-stage expense timing
Quarterly operating loss comparability
Equity financing accounting
Capital structure and per-share metrics

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: 11/08/2026