Here are a few brief analogies for Milestone Scientific (MLSS):

1. It's like Dyson for medical injection devices, engineering advanced, computer-controlled systems for precision and patient comfort.

2. Think of it as Becton Dickinson (BD) if they specialized in smart, computer-controlled injection and drug delivery systems designed for accuracy and reduced pain.

• CompuDent: A system used for dental procedures requiring local anesthetic.
• STA Single Tooth Anesthesia System: A system used for all dental procedures that require local anesthetic.
• CompuFlo: A computer-controlled drug delivery system for painless delivery of drugs and aspiration of bodily fluids.
• Disposable injection handpiece: An accessory providing tactile control during injections.
• CompuFlo Epidural: A computer-controlled anesthesia system specifically designed for various medical applications requiring epidural anesthesia.
• CompuMed: A device used in various medical procedures including plastic surgery, hair restoration, podiatry, and dermatology.

Milestone Scientific (MLSS) primarily sells its diagnostic and therapeutic injection technologies and devices to other companies, specifically professional entities within the medical and dental fields, rather than directly to individuals. The company's SEC filings indicate that no single customer accounted for 10% or more of its net revenues, meaning there are no major named corporate customers (such as publicly traded companies) that individually represent a significant portion of its sales.

Therefore, Milestone Scientific serves a broad base of professional customers, which can be categorized as follows:

1. Dental Practices and Clinics: These customers utilize Milestone Scientific's dental products such as the CompuDent and STA Single Tooth Anesthesia System for various dental procedures requiring local anesthetic.
2. Hospitals, Medical Centers, and Pain Management Centers: These institutions are customers for Milestone Scientific's medical systems, including CompuFlo Epidural for anesthesia and other CompuFlo systems for the computer-controlled delivery of drugs and anesthetics in a variety of medical applications.
3. Specialty Medical Clinics and Physicians' Offices: This category encompasses various specialized medical practices such as those in plastic surgery, hair restoration, colorectal surgery, podiatry, dermatology, and orthopedics. These customers use systems like CompuMed and CompuFlo for specific medical procedures and drug delivery.

NPI Medical

PMP Corporation

Eric C. Hines, Chief Executive Officer

Eric C. Hines was appointed Chief Executive Officer of Milestone Scientific, effective August 1, 2025. He brings over 25 years of leadership experience, specializing in scaling sales-driven enterprise software companies. Prior to joining Milestone Scientific, he served as President of North America at Ex Libris, a division of Clarivate, where he successfully doubled the annual revenue from approximately $50 million to over $100 million. At Ex Libris, he was responsible for operations across the U.S., Canada, and Latin America, and played a key role in launching multiple new product lines and managing sales, marketing, and service organizations. Earlier in his career, Mr. Hines held executive positions at NICE Systems, where he led a significant North American security business and oversaw the Customer Experience Management (CEM) division.

Peter Milligan, Chief Financial Officer

Peter Milligan was appointed as Milestone Scientific's Chief Financial Officer on a part-time basis, effective February 1, 2023. Mr. Milligan has extensive experience in finance leadership within various companies. From 2018 to March 2021, he served as Chief Financial Officer of Melinta Therapeutics, LLC, where he guided the company through its Chapter 11 reorganization. Before that, he was the Chief Financial Officer at G&W Laboratories Inc. from 2016 to 2018. Notably, Mr. Milligan was the Senior Vice President and Chief Financial Officer of Exelis Inc., following its spin-off from ITT Inc. in 2011, and continued in this role through the sale of the business to Harris Corp. in 2015. He also served as a fractional Chief Financial Officer for early-stage bio-technology companies, including Travecta Therapeutics Pte. Ltd. (August 2021 to October 2022) and Vinci Pharmaceuticals Inc. (June 2021 to October 2022). His background also includes over a decade at AT&T in various finance roles and prior senior finance positions within ITT Inc.

The key risks to Milestone Scientific's business operations and financial health include significant financial instability, intense competition in the medical and dental device markets, and ongoing regulatory hurdles.

1. Financial Instability and Going Concern Risk

Milestone Scientific faces substantial financial challenges, including a history of consistent net losses over its five most recent fiscal years. The company's stockholders' equity of approximately $3.3 million is significantly below the NYSE American's continued listing standards, which require $4 million or $6 million depending on the number of loss-making years, leading to a notice of non-compliance and potential delisting. Furthermore, the company's Altman Z-Score of -18.64 indicates a potential risk of bankruptcy within the next two years. Milestone Scientific operates with negative cash flow and relies on external financing to sustain its operations, and it has less than one year of cash runway with no forecast of profitability over the next three years.

2. Intense Competition and Commercialization Challenges

Operating in the highly competitive medical and dental device landscape, Milestone Scientific, as a micro-cap company, struggles against larger competitors such as Dentsply Sirona and Straumann Group AG. These larger entities possess superior sales and marketing infrastructure, established distribution channels, and brand recognition, allowing them to outspend MLSS, bundle products, and leverage long-standing relationships with practitioners. The company faces significant challenges in translating its proprietary Dynamic Pressure Sensing® (DPS) technology into widespread commercial success and achieving financial stability. The effectiveness of its direct sales model relies heavily on successful marketing, customer acquisition, and retention. Additionally, healthcare cost pressures and premium pricing for its products could hinder market adoption and restrict future revenue, particularly as hospitals limit capital expenditures.

3. Regulatory Hurdles and Product Approval Risks

As a medical device company, Milestone Scientific is subject to rigorous regulatory challenges. There is a risk that the U.S. Food and Drug Administration (FDA) could disagree with the company's assessments regarding the necessity of new 510(k) clearances for product modifications. Such a disagreement could force Milestone Scientific to cease marketing or recall modified products until new clearances are obtained, potentially leading to significant regulatory fines or penalties. Furthermore, any changes in federal and state regulatory agencies could introduce disruptions and delays in the product approval processes.

Milestone Scientific Inc. (MLSS) designs, develops, and commercializes diagnostic and therapeutic injection technologies and devices for medical, dental, and cosmetic use. The addressable markets for its main products and services are substantial across various regions.

Dental Segment (CompuDent and STA Single Tooth Anesthesia System)

• The global dental anesthetics market was valued at approximately USD 2.42 billion in 2025 and is projected to increase to about USD 3.94 billion by 2035, growing at a Compound Annual Growth Rate (CAGR) of 4.99% from 2026 to 2035.
• Another estimate places the global dental anesthetics market at USD 1.73 billion in 2025, with a projected growth to USD 2.33 billion by 2031 at a CAGR of 5.07%.
• Computer-controlled local anesthetic delivery systems are a growing sub-segment, expected to expand at a 7.78% CAGR through 2031.
• North America represented the largest share of the dental anesthetics market, holding 41.72% of the revenue in 2025. The Asia-Pacific region is also a significant market, with an estimated size of USD 943.80 million in 2025 and a projection to reach around USD 1,574.20 million by 2035, at a CAGR of 5.25%.

Medical Segment (CompuFlo, CompuFlo Epidural, and CompuMed)

CompuFlo (Computer-controlled drug delivery systems)

• The global electronic drug delivery systems market was valued at USD 13.80 billion in 2025 and is projected to reach USD 30.22 billion by 2034, demonstrating a CAGR of 9.1%.
• The global smart drug delivery systems market was estimated at USD 10.5 billion in 2023 and is anticipated to grow to USD 48.3 billion by 2034, with a CAGR of 17% from 2025.
• The global controlled release drug delivery market, another related market, was estimated at USD 59.8 billion in 2024 and is projected to reach USD 148.6 billion by 2033, growing at a CAGR of 10.7%.
• North America held approximately 44.7% of the electronic drug delivery systems market in 2024.

CompuFlo Epidural (Epidural anesthesia systems)

• Approximately 11 million epidural procedures are performed annually in the U.S.
• The global epidural anesthesia disposable device market is expected to grow from USD 1.76 billion in 2025 to USD 2.79 billion in 2030, at a CAGR of 9.7%.
• The global epidural anesthesia system market is projected to grow from USD 3.22 billion in 2025 to USD 5.31 billion by 2032, at a CAGR of 7.40%.
• The global epidural and spinal anesthesia drug market was valued at USD 1.25 billion in 2025 and is expected to reach USD 1.76 billion by 2034, with a CAGR of 5.1%.
• North America was the largest regional market for epidural anesthesia disposable devices in 2025. Specifically, the addressable market for the CompuFlo Epidural System among Florida Medicare patients alone is an estimated USD 125 million.

CompuMed (Devices for various medical procedures)

• Dermatology: The global dermatology devices market size was estimated at USD 13.9 billion in 2023 and is projected to reach USD 34.34 billion by 2030, growing at a CAGR of 12.6%. North America held the largest revenue share of 43.00% in 2023.
• Hair Restoration: The global hair restoration market size was estimated at USD 6,463.0 million in 2023 and is projected to reach USD 18,923.4 million by 2030, growing at a CAGR of 16.6%. North America held a 40.05% share of the hair restoration services market in 2025.
• Colorectal Surgery: The global colorectal surgery market is valued at USD 15.4 billion in 2024 and is projected to reach USD 23.1 billion by 2030, with a CAGR of 6.9%. North America accounted for the largest market share at 39% in 2024. The global colorectal surgical devices market is expected to be worth USD 27,559.70 million by 2029.
• Podiatry: The global podiatry devices market is estimated to be worth approximately USD 6.5 billion in 2024 and is projected to reach around USD 9 billion by 2029, exhibiting a CAGR of approximately 6%. North America is the largest market for podiatry equipment, holding approximately 45% of the global market share.
• Orthopedics: The global orthopedic devices market size is calculated at USD 65.79 billion in 2025 and is predicted to increase to approximately USD 100.33 billion by 2035, expanding at a CAGR of 4.31%. North America dominated the global market with the largest market share of 46% in 2025.

Milestone Scientific (MLSS) is expected to drive future revenue growth over the next 2-3 years through several key initiatives:

1. Expansion of the Dental Segment: The company is focused on expanding its dental sales, both internationally and within North America. This includes pursuing new international registrations for the STA Single Tooth Anesthesia System and strengthening direct sales and omnichannel marketing efforts for the STA system in North America.

2. Commercialization and Reimbursement of the CompuFlo Epidural System: Milestone Scientific is actively working on the commercial rollout of its CompuFlo Epidural System for medical applications. Significant progress has been made in securing Medicare Part B payment coverage and gaining support from commercial insurers. The company is executing a guided relaunch and reimbursement strategy in medical markets, reinforced by the launch of the CompuFlo Advisor Program aimed at accelerating commercial adoption and improving Medicare reimbursement.

3. Growth in Recurring Revenue from CompuFlo Disposables: As the CompuFlo Epidural System gains adoption, there is an expected increase in recurring revenue from the sales of its associated disposable handpieces. The CompuFlo Advisor Program specifically targets increasing this recurring disposable revenue.

4. Enhanced Sales and Marketing Strategies Under New Leadership: With recent changes in leadership, including the appointment of a new CEO, Milestone Scientific is implementing a more focused approach with targeted customer groups and an emphasis on improving sales execution and leadership. This strategic refinement is anticipated to drive overall commercial success.

Share Repurchases

• Milestone Scientific has shown a negative 3-Year Share Buyback Ratio of -4.60% as of September 2025, and consistently negative ratios historically, indicating that the company has been issuing shares rather than repurchasing them over the past three to five years.

Share Issuance

• Milestone Scientific increased its authorized common stock from 100,000,000 to 125,000,000 shares, effective March 10, 2026, after receiving stockholder approval on December 18, 2025. This amendment provides the company with flexibility for future equity financings, stock-based compensation, or strategic transactions.
• The company's outstanding shares have increased from 69.57 million in 2021 to 82.32 million in 2025 and as of February 2026, reflecting consistent share issuances over this period.
• Annual increases in outstanding shares include 5.71% in 2021, 2.01% in 2022, 3.88% in 2023, 8.46% in 2024, and 2.95% in 2025.

Inbound Investments

• On April 8, 2024, Milestone Scientific received $1,983,095 from Comcast Corporation through the sale of its unused Net Operating Losses (NOLs) and Research & Development (R&D) tax credits. These funds are designated for general corporate purposes and working capital.

Capital Expenditures

• Milestone Scientific reported capital expenditures of $120,000 for the nine months ended September 30, 2025, and $112,000 for the nine months ended September 30, 2024.
• For the full year 2024, capital expenditures were $119,000, while in 2023, they amounted to $178,000.
• In 2022, the company's capital expenditures were $80,000, and in 2021, they were $118,000.