Here are 1-3 brief analogies for Bone Biologics (BBLG):

• Imagine **Globus Medical**, but for actively growing new bone in spinal fusion procedures using a unique protein.

• Think of them like a specialized **Stryker** or **Zimmer Biomet**, but focused on regenerating bone with a special protein, rather than just providing implants.

• Like an **Amgen** or **Regeneron**, but focused on bone regeneration using a unique protein, applied within medical devices.

• NELL-1/DBX Fusion Device: A combination product utilizing an osteostimulative recombinant protein designed for targeted bone regeneration in spinal fusion procedures.

Based on the provided company description, Bone Biologics (BBLG) is a medical device company developing products for spinal fusion and other surgical specialties. As such, it sells primarily to other companies or healthcare institutions, not directly to individuals.

The background information does not name any specific major customer companies. However, given the nature of its business and product development for surgical procedures, Bone Biologics' major customers would typically be:

• Hospitals
• Surgical Centers
• Medical Device Distributors

Jeffrey Frelick, Chief Executive Officer | President

Jeffrey Frelick assumed the CEO and President role at Bone Biologics Corporation in June 2019, having previously served as Chief Operating Officer since August 2015. He brings over 25 years of experience in the med-tech industry. Prior to Bone Biologics, Mr. Frelick spent 15 years as a sell-side analyst on Wall Street, covering the med-tech industry at investment banks such as Canaccord Genuity, ThinkEquity, and Lazard. His earlier career included strategic planning and market research for diagnostics companies at Boston Biomedical Consultants, and sales and sales management positions at Becton Dickinson's Primary Care Diagnostic Division.

Deina Walsh, Chief Financial Officer

Deina Walsh was appointed CFO of Bone Biologics in October 2014. She is a Certified Public Accountant (CPA) and the owner/founder of DHW CPA, PLLC, a Public Companies Accounting Oversight Board (PCAOB) registered firm since 2014. Before establishing her firm, Ms. Walsh spent 13 years at a public accounting firm, where she led audit engagements for publicly held entities, ensuring compliance with PCAOB standards and SEC regulations, including Sarbanes-Oxley Act Section 404 requirements. Her experience includes working with both start-up and established operating entities and assisting companies with debt and equity capital raises.

Brent Atkinson, Ph.D., R&D Consultant

Dr. Brent Atkinson has 15 years of musculoskeletal research and development experience. He previously served as the R&D Manager for Zimmer Global Biologics. Dr. Atkinson has also worked with several start-up companies and successfully commercialized orthopedic medical devices and combination therapies.

Bruce Stroever, Chairman of the Board

Bruce Stroever possesses forty years of product development and general management experience within the medical device and orthobiologics fields. He joined MTF Biologics in 1988 as General Manager and retired in mid-2018 as President and Chief Executive Officer. Under Mr. Stroever's leadership, MTF Biologics grew into the world's largest tissue bank, distributing over 500,000 grafts annually and generating more than $400 million in revenues.

Phillip Meikle, Independent Director

Phillip Meikle is a seasoned healthcare executive with over 32 years of experience in the orthopedic and spine industry. He founded Biosystems of New England, Inc. in 1992, serving as its CEO and President. Mr. Meikle sold his company to Stryker in 2019 and continued to serve as a consultant for Stryker for five years.

Here are the key risks to Bone Biologics' business:

1. Going Concern and Financing Risk

   Bone Biologics faces substantial financial uncertainty, as evidenced by recurring operating losses and an accumulated deficit of approximately $88.1 million as of December 31, 2025. This has led its auditor to express substantial doubt about the company's ability to continue as a going concern. The company is highly dependent on securing significant additional equity or debt financing to fund its ongoing operations, particularly for larger clinical trials and to meet its obligations under license agreements. Current cash reserves are projected to fund operations only into the fourth quarter of 2026. Failure to raise sufficient capital could severely impede its ability to continue development and achieve commercialization.

2. Product Development, Clinical Trial, and Regulatory Approval Risk

   The company's viability is primarily tied to the successful development, regulatory approval, and commercialization of its lead product candidate, NELL-1/DBX (NB1), for spinal fusion. NB1 is currently in a small pilot clinical trial in Australia, with plans for a future U.S. pivotal study, which is a costly and time-consuming process. The product is classified as a device/drug combination, requiring an FDA-approved pre-market approval (PMA) application for commercialization in the United States. Delays or failures in clinical trials, unexpected regulatory hurdles, or an inability to demonstrate sufficient safety and effectiveness could significantly increase costs, delay or prevent product development, and ultimately hinder market entry.

3. Single Asset and Competition Risk

   Bone Biologics' business model is heavily concentrated on the success of its single lead asset, NELL-1/DBX. This creates a high level of dependence on this one product's ability to gain market acceptance and achieve commercial success. The medical device industry, particularly in spinal fusion, is highly competitive, with numerous larger orthopedic players already established in the market. The company must navigate this competitive landscape while also potentially facing risks associated with single-source supply chains for medical device manufacturing, which can lead to disruptions, quality control issues, and increased costs.

The clear emerging threat for Bone Biologics is the development and increasing clinical application of **stem cell therapies** for spinal indications.

Bone Biologics (NASDAQ: BBLG) operates in several significant addressable markets related to bone regeneration, particularly for spinal fusion procedures. The company's primary product, NELL-1/DBX Fusion Device, targets spinal fusion in patients with degenerative disc disease.

The global market for spinal fusion devices was estimated at USD 7.03 billion in 2023 and is projected to grow to USD 9.75 billion by 2030, with a compound annual growth rate (CAGR) of 4.9% from 2024 to 2030. North America held the largest share of this market, with the U.S. alone accounting for 74.8% of the North American market in 2023. The U.S. spinal fusion devices market was valued at approximately USD 5.5 billion in 2024 and is expected to reach US$ 11.23 billion by 2033.

Within the broader orthobiologics sector, Bone Biologics identifies an established global market opportunity of USD 3 billion for orthobiologics products. The spine biologics market, a component of orthobiologics, where NELL-1/DBX fits, saw North America hold a dominant share, valued at USD 1.56 billion in 2024 and USD 1.67 billion in 2025.

The global bone regeneration market, which encompasses spinal fusion surgeries, was valued at USD 5.2 billion in 2024 and is estimated to reach USD 8.4 billion by 2034, growing at a CAGR of 4.9% from 2025 to 2034. Another estimate places the global bone regeneration market at USD 6.15 billion in 2025, projected to reach around USD 10.31 billion by 2035. Spinal fusion surgeries constituted the largest segment by application in the bone regeneration market in 2024 and 2025.

For degenerative disc disease (DDD) treatment, the global market was valued at USD 24 billion in 2022 and is projected to reach USD 49.7 billion by 2032, with a CAGR of 7.2%. More recent estimates show the global DDD treatment market at USD 34.31 billion in 2025, expected to reach USD 67.71 billion by 2034. North America is a significant region in this market, holding over 57% of the business share in 2022 and an estimated 45% in 2025. The U.S. market for degenerative disc disease treatment was approximately USD 10.93 billion in 2025 and is expected to reach around USD 20.18 billion by 2035.

1. Advancement of NB1 through Clinical Trials and Regulatory Approvals: The successful progression and completion of clinical trials for NB1 (NELL-1/DBX), particularly the ongoing multicenter pilot clinical study in Australia, are critical. This study aims to evaluate the safety and effectiveness of NB1 in spinal fusion procedures. The successful outcome of this pilot study is intended to support the initiation and advancement of a pivotal clinical trial in the United States, ultimately leading towards FDA approval as a Class III medical device. Achieving these regulatory milestones will be the primary enabler for Bone Biologics to commercialize NB1 and generate revenue from its sales.
2. Commercialization and Market Launch of NB1 for Spinal Fusion: Following the anticipated regulatory approvals, the actual market launch of NB1 for spinal fusion procedures will be the direct driver of revenue generation. The company's ongoing efforts to achieve operational and manufacturing readiness, including improvements in supply-chain flexibility and product readiness, such as extending the shelf life of its rhNELL-1 protein to 24 months, are all integral steps towards successful commercialization. These preparatory activities are essential to effectively bring NB1 to market within the domestic and international spine fusion markets.
3. Expansion of NELL-1/DBX Applications into Broader Orthopedic Markets: While the initial focus for NB1 is spinal fusion, Bone Biologics' underlying NELL-1 platform technology has potential applications in a wider array of surgical specialties. These include general orthopedics, trauma, osteoporosis, plastic reconstruction, neurosurgery, interventional radiology, and sports medicine. Successful commercialization of NB1 in spinal fusion could serve as a foundation for strategically expanding the product's indications into these additional, larger markets, thereby unlocking significant future revenue streams. The company holds rights to develop the technology for trauma and osteoporosis applications, indicating a pathway for future market expansion.

Share Repurchases

No information is available regarding share repurchases or authorized future share repurchases for Bone Biologics within the last 3-5 years.

Share Issuance

• Bone Biologics announced a public offering in June 2025, closing a $5.0 million transaction that included shares of common stock and warrants.
• The company conducted a public offering in March 2024, raising $1.5 million, and a warrant inducement in August 2024, which generated $1.8 million in proceeds.
• As of March 2026, Bone Biologics updated its at-the-market (ATM) equity offering program, allowing for the sale of up to an additional $1,064,000 of common stock. The company had previously sold approximately $1.7 million of common stock under a similar earlier program.

Inbound Investments

No information is available regarding large inbound investments made in the company by third-parties within the last 3-5 years, beyond capital raised through public offerings and warrant exercises.

Outbound Investments

No information is available regarding outbound investments made by Bone Biologics in other companies within the last 3-5 years.

Capital Expenditures

No specific dollar value of capital expenditures or expected capital expenditures for the upcoming year is consistently available for Bone Biologics within the last 3-5 years, with some reports indicating "n/a" for this category.