Bone Biologics Corp (NASDAQ: BBLG) is a clinical-stage medical device and biologics company developing a target-specific growth factor for bone regeneration. The company has no approved products and generates no product revenue, relying on capital raises to fund operations. Its lead product candidate, NELL-1/DBM (designated NB1), combines the NELL-1 growth factor with demineralized bone matrix and is intended for lumbar spinal fusion applications. NB1 is expected to require a Class III medical device designation and premarket approval (PMA) from the FDA, per a specific FDA communication referenced in the company's 10-K filed March 2, 2026. The underlying NELL-1 technology is licensed from the Regents of the University of California under an amended license agreement. DBM Putty, a matrix of processed human cortical bone mixed with sodium hyaluronate, serves as the carrier component. The company competes against major multinational orthopedic and med-tech companies in a market where autografts are the current clinical gold standard for spine fusion.

Revenue model

Pre-revenue clinical-stage company. Operations are funded through equity raises, including an at-the-market offering agreement with H.C. Wainwright & Co., LLC dated September 27, 2024, and securities purchase agreements. No product revenue is disclosed in the 10-K filed March 2, 2026.

Products and services

Lead product candidate: NELL-1/DBM Fusion Device (NB1), a NELL-1 growth factor combined with demineralized bone matrix, targeting lumbar spinal fusion. DBM Putty: processed human cortical bone granules mixed with sodium hyaluronate, tested for osteostimulation via athymic mouse model or alkaline phosphatase assay. Both are pre-commercialization as of the 10-K filed March 2, 2026.

Customers and end markets

Target end market is spine surgery, specifically lumbar spinal fusion procedures. End customers would be hospitals, surgical centers, and spine surgeons. No commercial customers as of the filing date; product candidates are in clinical development.

Value-chain role

Drug and medical device developer operating upstream of commercialization. Relies on third-party manufacturers for drug products and on the Musculoskeletal Transplant Foundation under a Supply and Development Support Agreement dated March 3, 2022. Technology is in-licensed from UCLA Technology Development Group under an amended license agreement.

Geographic exposure

United States-focused regulatory and development activity, subject to FDA oversight. No geographic revenue breakdown disclosed, as the company has no product revenue.

Competitors

Major multinational orthopedic companies (unnamed in filing), Major multinational med-tech companies (unnamed in filing)

Source: SEC 10-K, filed 2026-03-02

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