Milestone Scientific Inc. (MLSS) Bundle
How does a company with a mission to eliminate injection pain carve out a niche in the competitive MedTech space, especially when its nine-month 2025 revenue stands at approximately $6.9 million? Milestone Scientific Inc. (MLSS) is doing just that, leveraging its proprietary Dynamic Pressure Sensing Technology (DPS) to deliver computer-controlled, precise fluid delivery in both dental and medical fields.
This biomedical innovator, currently holding a market capitalization around $24.90 million, is seeing its strategy pay off with a 5% year-over-year increase in nine-month revenue through Q3 2025, defintely driven by its high-margin dental segment and key Medicare reimbursement wins for its CompuFlo Epidural System. You need to understand the mechanics of this business-the recurring revenue model and the technology's clinical value-to assess its true long-term potential.
Milestone Scientific Inc. (MLSS) History
You're looking for the foundational story of Milestone Scientific Inc., and the core takeaway is that this company is a decades-long biomedical technology play that pivoted from a corporate shell to a medical device innovator, now focused on capitalizing on a $250 million initial Medicare market opportunity in 2024-2025. The company's trajectory is defined by its proprietary Dynamic Pressure Sensing (DPS) technology, which allows for precise, virtually painless injections, first in dentistry and now in high-value medical procedures like epidurals.
Milestone Scientific Inc.'s Founding Timeline
The company's origin traces back to a corporate entity, which later pivoted to focus on medical device technology under the leadership of its founder.
Year established
The company was incorporated on August 17, 1989, initially under the name U.S. Opportunity Search Inc.. The current focus on medical solutions began around 1994, with the first commercial product launching in 1997.
Original location
The original corporate office was located in Livingston, New Jersey. The current principal executive offices are in Roseland, New Jersey.
Founding team members
The company was founded by Leonard Osser. He is credited with establishing the company's mission to create medical solutions that improve healthcare, and he later served as Vice Chairman and Managing Director of China Operations.
Initial capital/funding
The initial seed capital is not publicly disclosed. However, the first recorded major funding event occurred much later, with a $3 million Post-IPO round raised in March 2005.
Milestone Scientific Inc.'s Evolution Milestones
The company's history is a clear progression from a single dental product to a dual-segment business leveraging its core technology for both dental and medical applications.
| Year | Key Event | Significance |
|---|---|---|
| 1997 | Launched first commercial product, The Wand (later CompuDent/STA) | Established the dental segment; introduced the first computer-controlled local anesthesia delivery (C-CLAD) system to the North American market. |
| 2001 | Issued initial U.S. Patent for CompuFlo® technology | Secured proprietary Dynamic Pressure Sensing (DPS) technology as a platform for future medical devices, controlling injection flow rate and monitoring pressure. |
| 2022 | AMA issued Category III CPT® code (CPT0777T) for CompuFlo Epidural System | Validated the technology for reimbursement by government and commercial payers, effective January 1, 2023. This was a defintely critical step for the medical segment. |
| 2024 | Granted favorable Medicare Part B payment rate in multiple jurisdictions | Secured a major reimbursement pathway, opening an initial addressable market of approximately $250 million among Medicare patients in key states like New Jersey, Texas, and Florida. |
| 2025 | Eric C. Hines appointed CEO; Commercial sales of CompuFlo Epidural System commenced | Signaled a new phase of accelerated commercial execution under new leadership, focusing on translating reimbursement wins into sales, with nine-month revenue reaching approximately $6.9 million. |
Milestone Scientific Inc.'s Transformative Moments
The true turning point for Milestone Scientific was pivoting its core technology from a dental niche to a high-value medical solution.
The decision to apply the DPS technology to the medical field, specifically for epidural procedures with the CompuFlo Epidural System, was the most transformative move. This shifted the company from a dental equipment provider to a biomedical technology company with a much larger potential market.
- Technology Repurposing: They took the same core principle-using pressure sensing to guide a needle precisely-and moved it from local dental anesthesia to the complex, high-risk epidural space identification.
- The Reimbursement Breakthrough: Securing the technology-specific CPT code in 2022, and then the favorable Medicare Part B price assignment in 2024 for the CompuFlo Epidural System, de-risked the medical segment's commercial viability. This allowed them to target an initial addressable Medicare market of around $250 million.
- 2025 Leadership Change: The appointment of Eric C. Hines as CEO in August 2025 was a clear signal of an operational shift, prioritizing commercial execution and accelerated growth, especially in the medical segment, to achieve positive cash flow. The goal is to leverage the strong international dental sales, which more than doubled year-over-year in the second quarter of 2025, and the new medical reimbursement pathways.
To understand the strategic intent behind these decisions, you should review the Mission Statement, Vision, & Core Values of Milestone Scientific Inc. (MLSS).
Milestone Scientific Inc. (MLSS) Ownership Structure
Milestone Scientific Inc. (MLSS) operates with a typical public company ownership structure, where a significant majority of shares are held by the retail public, but strategic direction is heavily influenced by a core group of insiders and a small, concentrated institutional base.
This distribution means that while the public float drives daily trading volatility, key decisions often hinge on the alignment between the executive team, the board, and the largest individual shareholders. Exploring Milestone Scientific Inc. (MLSS) Investor Profile: Who's Buying and Why?
Milestone Scientific Inc.'s Current Status
Milestone Scientific Inc. is a publicly traded biomedical technology company. It is listed on the NASDAQ stock exchange under the ticker symbol MLSS. This public status means the company is subject to the Securities and Exchange Commission (SEC) reporting requirements, providing you with quarterly and annual financial transparency.
As of November 2025, the company has approximately 78.63 million shares outstanding, with a market capitalization of around $24.90 million, reflecting its status as a micro-cap stock. The stock price as of November 17, 2025, was approximately $0.31 per share.
Milestone Scientific Inc.'s Ownership Breakdown
The ownership structure shows that the vast majority of the company's shares are held by the general public, while insiders maintain a substantial stake, which is defintely a key factor in governance. Here's the quick math based on 2025 fiscal year data, showing how the shares are allocated:
| Shareholder Type | Ownership, % | Notes |
|---|---|---|
| Retail and Public Float | 83.45% | Calculated as the remainder of shares not held by institutions or insiders. |
| Insiders | 10.88% | Includes key executives, directors, and their affiliated entities, giving them a strong voice. |
| Institutional Investors | 5.67% | Held by funds like Vanguard Group Inc. and Geode Capital Management, Llc. |
Milestone Scientific Inc.'s Leadership
The company's strategic direction is steered by a leadership team that saw key appointments in 2025, focusing on commercialization and growth, especially for the CompuFlo® Epidural System. This new structure is meant to accelerate market penetration.
- Eric C. Hines: Chief Executive Officer (CEO). Appointed in August 2025, Mr. Hines is tasked with leading the company's operational execution and growth initiatives.
- Neal I. Goldman: Chairman of the Board. Mr. Goldman previously served as Interim CEO following the retirement of Arjan Haverhals.
- Jason Papes: Senior Vice President, Global Head of Sales and Marketing. Appointed in August 2025, his role is crucial for expanding the commercial reach of the dental and medical product lines.
- Leonard A. Osser: Vice Chairman of the Board. A long-standing director, Mr. Osser provides historical context and continuity to the board's strategic discussions.
- Joseph D'Agostino: Vice President of Clinical Affairs. He is responsible for managing the clinical trials and affairs that support the company's technology, particularly in the medical segment.
The appointment of a new CEO and a dedicated head of global sales in Q3 2025 signals an organizational pivot toward a more aggressive commercial strategy, a critical action for a company with a small institutional base.
Milestone Scientific Inc. (MLSS) Mission and Values
Milestone Scientific Inc. is driven by a core purpose to revolutionize drug delivery by replacing outdated injection methods with precise, computer-controlled technology, ultimately prioritizing patient comfort and safety. Their cultural DNA is built on innovation and a commitment to transforming the patient experience in both dental and medical settings.
Milestone Scientific's Core Purpose
The company's fundamental purpose centers on leveraging its proprietary technology to enhance the standard of care for injections. This is not just about a better needle; it's about a systemic change in how local anesthetics and other subcutaneous drugs are delivered, making the process less painful and more predictable for millions of patients.
Official Mission Statement
The mission of Milestone Scientific is to be the leading developer of computerized drug delivery instruments that provide painless and precise injections, increasing overall patient comfort and safety across medical and dental applications. This focus on the patient experience is the engine for their commercial strategy, which in 2025 saw nine-month revenue reach approximately $6.9 million.
- Replace dated injection technology with 21st-century computer control.
- Ensure injections are precise, efficient, and highly effective.
- Advance the proprietary DPS Dynamic Pressure Sensing Technology® platform.
Vision Statement
Milestone Scientific envisions a future where its DPS Dynamic Pressure Sensing Technology® is the global standard for injection and drug delivery, eliminating patient discomfort and reducing clinical complications. This vision is supported by tangible progress, like securing Medicare payment rate assignments for its CompuFlo® system in three key jurisdictions, including large population states like New Jersey, Texas, and Florida.
- Achieve broad adoption of CompuFlo® in pain management and hospital systems.
- Drive international growth for the STA Single Tooth Anesthesia System.
- Position the company for long-term profitability through a leaner, more focused organization.
Honestly, the vision boils down to making the fear of the needle obsolete.
Milestone Scientific Slogan/Tagline
While an explicit, single tagline is not always formalized in corporate filings, the company's communications consistently emphasize the core benefit of their technology:
- Painless and Precise Injections.
- Taking Drug Delivery from the 1900s to the 21st Century.
The company's commitment to efficiency and cost control is also clear, with operating expenses reduced by over $500 thousand in the third quarter of 2025 compared to the same period in 2024. This operational discipline defintely underpins their ability to pursue their patient-focused mission. You can find more details on their long-term goals here: Mission Statement, Vision, & Core Values of Milestone Scientific Inc. (MLSS).
Milestone Scientific Inc. (MLSS) How It Works
Milestone Scientific Inc. operates by developing and commercializing computer-controlled injection systems that use proprietary pressure-sensing technology to deliver local anesthetics and other fluids with greater precision and less patient discomfort than traditional manual methods. The company generates revenue primarily through the sale of its capital equipment systems and, critically, the recurring sale of single-use disposable handpieces and cartridges required for each procedure.
Milestone Scientific Inc.'s Product/Service Portfolio
The core of Milestone Scientific's business is built on its patented Dynamic Pressure Sensing Technology (DPSTM), which powers its two main product lines in the dental and medical fields. This technology allows for real-time monitoring of tissue pressure at the needle tip, which is the key to their precision.
| Product/Service | Target Market | Key Features |
|---|---|---|
| The Wand (STA Single Tooth Anesthesia System) | Dental Professionals (General Dentists, Hygienists, Specialists) | Computer-controlled anesthetic flow; Dynamic Pressure Sensing Technology (DPSTM); Single Tooth Anesthesia (STA) capability; virtually painless injection. |
| CompuFlo Epidural System | Anesthesiologists, Interventional Pain Management Physicians, Hospitals | Objective, real-time confirmation of epidural space entry; reduces false loss of resistance; improves first-attempt success rate; enhances patient safety. |
Milestone Scientific Inc.'s Operational Framework
The company's operational model is a classic razor-and-blade strategy, but with a high-tech twist. They focus on manufacturing the main capital equipment-the control unit-and then drive sustainable revenue through the required disposables for every procedure. This is defintely the right way to think about their long-term value.
- Technology Platform: The proprietary Dynamic Pressure Sensing Technology (DPSTM) is the central engine, used across both the dental and medical segments to regulate flow rate and monitor pressure from the needle tip.
- Revenue Mix: Revenue for the nine months ended September 30, 2025, totaled approximately $6.9 million, with the majority coming from the dental segment, specifically from the sale of The Wand disposables and e-commerce sales.
- Sales Strategy: Milestone Scientific is actively shifting toward a direct sales model in North America and expanding its omnichannel digital marketing to boost higher-margin e-commerce sales for its dental products. For the medical segment, the focus is on securing reimbursement and institutional adoption, like the recent progress in getting Medicare payment-rate assignments for CompuFlo.
- Cost Management: Management has executed a clear operational transformation, reducing third-quarter 2025 operating expenses by over $500,000 compared to the same period in 2024, aiming for a leaner, more profitable structure.
Milestone Scientific Inc.'s Strategic Advantages
Milestone Scientific's competitive edge is fundamentally rooted in its intellectual property and the clinical superiority of its core technology. You can't just replicate a decade of R&D and clinical validation overnight.
- Patented Core Technology: Dynamic Pressure Sensing Technology (DPSTM) provides an objective, real-time measure of tissue density, which is a significant advantage over the subjective, traditional 'loss of resistance' technique used in epidurals and other injections.
- High-Margin, Recurring Revenue: The business model is structured to capture recurring revenue from the single-use disposables (e.g., The Wand handpieces and CompuFlo cartridges), which helps stabilize cash flow and offers a higher gross margin-around 70% of revenue in Q3 2025.
- Clinical Validation and Patient Comfort: The systems are clinically proven to increase procedural success rates and significantly reduce patient pain and anxiety, especially in dentistry, which is a powerful sales tool for practitioners.
- Reimbursement Focus: Strategic efforts to secure favorable Medicare and commercial reimbursement for the CompuFlo Epidural System are crucial. This expands the total addressable market in interventional pain management, making the system a viable option for hospitals and ambulatory surgery centers. Exploring Milestone Scientific Inc. (MLSS) Investor Profile: Who's Buying and Why?
Milestone Scientific Inc. (MLSS) How It Makes Money
Milestone Scientific Inc. generates revenue primarily through a classic 'razor-and-blade' model, selling its proprietary computer-controlled injection systems, like the STA System and CompuFlo System, and then generating high-margin, recurring revenue from the single-use disposable handpieces and kits required for every procedure. This model creates a predictable revenue stream tied directly to the utilization of their installed base of equipment in dental and medical practices.
Milestone Scientific Inc.'s Revenue Breakdown
The business is split into two reporting segments: Dental and Medical. As of the third quarter of 2025 (Q3 2025), the Dental segment remains the dominant revenue driver, but the Medical segment is the strategic focus for recurring, high-growth revenue. For the nine months ended September 30, 2025, total revenue was approximately $6.9 million. [cite: 2, 6 from first search]
| Revenue Stream | % of Total (Q3 2025) | Growth Trend |
|---|---|---|
| Dental Sales (International) | ~41.7% | Increasing |
| Dental Sales (Domestic E-commerce/Service) | ~41.7% | Decreasing |
| Medical Segment (CompuFlo Disposables/System) | ~1.7% | Increasing |
Here's the quick math: Based on Q3 2025 total revenue of approximately $2.4 million, the domestic dental sales were about $1.0 million, and the medical segment revenue was a small but growing $41,000. [cite: 3 from first search] International dental sales are a key growth engine, with management noting that higher international sales helped offset lower domestic dental sales in Q3 2025. [cite: 2, 5 from first search]
Business Economics
The core economic engine of Milestone Scientific is the high-margin disposable component of its products, a strategy that drives financial health far more than the initial sale of the hardware. The company's patented Dynamic Pressure Sensing (DPS) technology is the key differentiator, enabling a premium price point for the disposables.
- Razor-and-Blade Model: The STA Single Tooth Anesthesia System and the CompuFlo Epidural System are the 'razors,' sold to establish a footprint. The 'blades' are the proprietary, single-use handpieces and disposable kits, which are required for every procedure and generate a consistent, recurring revenue stream. [cite: 1, 5 from second search]
- High Gross Margin: The gross profit margin for the nine months ended September 30, 2025, was approximately 71% of revenue. [cite: 2, 6 from first search] This high margin, typical of a disposables-driven medical device company, provides significant operating leverage as sales volume increases.
- Strategic Reimbursement: The medical segment's growth is heavily tied to securing reimbursement. Milestone Scientific has made crucial progress by obtaining Medicare Part B physician payment rate assignments for the CompuFlo Epidural System in key jurisdictions. This represents an initial addressable market of approximately $250 million among Medicare patients in those regions alone, which is a massive opportunity for the low-percentage Medical segment. [cite: 7 from second search]
- Direct-to-Consumer Shift: The company is strategically moving toward direct sales and e-commerce for its dental products in North America. This shift is designed to capture higher margins by cutting out distributors, even as total domestic dental sales softened slightly in Q3 2025. [cite: 2, 4 from second search]
To be fair, the company's long-term success hinges on converting that $250 million addressable market into realized revenue. You can read more about the company's long-term goals in its Mission Statement, Vision, & Core Values of Milestone Scientific Inc. (MLSS).
Milestone Scientific Inc.'s Financial Performance
While the business model is sound, the company's near-term financials reflect a business in a growth and transformation phase, prioritizing market penetration and cost control over immediate profitability.
- Revenue Growth: For the nine months ended September 30, 2025, total revenue increased by approximately 5% to $6.9 million, compared to the same period in 2024. [cite: 2, 6 from first search]
- Net Loss: Despite revenue growth and high gross margins, the company continues to operate at a loss. The net loss for the nine months ended September 30, 2025, was approximately $(4.6) million, or $(0.06) per share. [cite: 2, 6 from first search]
- Cost Containment: Management is defintely focused on operational efficiency, having reduced third-quarter operating expenses by over $500,000 compared to the same period last year, which helped narrow the quarterly net loss to approximately $1.2 million. [cite: 4 from second search, 5 from first search]
- Liquidity: As of September 30, 2025, the company reported cash and cash equivalents of approximately $1.3 million and working capital of approximately $3.1 million. This low cash position is a key constraint to watch, as sustained operating losses require a reliance on cost reductions and future financing. [cite: 2, 6 from first search]
What this estimate hides is the widening nine-month net loss, which grew from $\$(2.7)$ million in 2024 to $\$(4.6)$ million in 2025, due to factors like increased R&D and SG&A in previous quarters, so the cost-cutting measures are a necessary near-term action. [cite: 2, 6 from first search]
Milestone Scientific Inc. (MLSS) Market Position & Future Outlook
Milestone Scientific Inc. holds a promising, yet small, position in the niche market of computer-controlled injection systems, driven by its patented Dynamic Pressure Sensing Technology (DPS). The company is in a critical transition phase, focusing on operational efficiency, having reduced its third-quarter 2025 operating expenses by over $500,000 compared to the prior year, to capitalize on the medical segment's growth potential.
While nine-month 2025 revenue reached approximately $6.9 million, a 5% increase year-over-year, the company's future trajectory hinges on the successful commercialization and reimbursement expansion of its CompuFlo medical system, moving beyond its established dental base.
Competitive Landscape
Milestone Scientific Inc. operates in two segments-dental and medical-where it competes against large, diversified medical device and pharmaceutical companies. Its market share in the overall dental and epidural device markets is small, but its position is stronger in the specialized Computer-Controlled Local Anesthetic Delivery (CCLAD) niche, which is valued at roughly $250 million.
| Company | Market Share, % | Key Advantage |
|---|---|---|
| Milestone Scientific Inc. | ~3.5% (CCLAD Niche) | Proprietary DPS Dynamic Pressure Sensing Technology for real-time pressure feedback. |
| Dentsply Sirona | ~15% (Broader Dental Market) | Vast, integrated portfolio of dental equipment, consumables, and global distribution network. |
| B. Braun | ~10% (Epidural Device Market) | Dominance in traditional epidural kits and disposable devices, and established hospital contracts. |
Opportunities & Challenges
Our analysis suggests Milestone Scientific Inc. has clear near-term opportunities tied to its medical segment, but these are balanced by significant capital and market adoption risks. The core challenge is translating superior technology into widespread commercial adoption against entrenched, well-capitalized competitors.
| Opportunities | Risks |
|---|---|
| Medicare Reimbursement: Progress in securing Medicare payment-rate assignments for CompuFlo, enabling broader adoption in pain management clinics. | Going Concern Risk: Recurring operating losses, with a nine-month 2025 net loss of approximately $(4.6) million, creating a need for additional capital. |
| Medical Segment Relaunch: Guided relaunch of CompuFlo, targeting the estimated $1.51 billion Epidural Guidance Systems market in 2025. | Slow Domestic Dental Sales: Domestic dental revenue slightly declined in Q3 2025, which suggests market resistance to the higher initial cost of the STA System. |
| International Expansion: Continued growth in international dental sales, which partially offset lower domestic revenue, plus new international registrations for the STA System. | Reimbursement Dependency: Commercial success of CompuFlo is heavily dependent on securing and expanding commercial and Medicare reimbursement coverage. |
Industry Position
Milestone Scientific Inc. is positioned as a technology innovator in the specialized field of computer-controlled drug delivery, not a volume leader in the broader medical device industry. Its DPS technology is defintely a core differentiator, offering a safety and precision advantage over traditional manual injection methods.
The company's strategy is smart: focus on high-margin disposables (CompuFlo) to create recurring revenue after the initial system sale. Here's the quick math: with Q3 2025 revenue at $2.4 million and a market capitalization of only $24.04 million as of November 20, 2025, the market is pricing in significant risk, but also potential upside if the CompuFlo medical relaunch gains traction. The entire medical market for epidural guidance systems alone is projected to be $1.51 billion in 2025, so even a small market share gain there would be transformative.
- Focus on high-growth segment: The Computer-Controlled Local Anesthetic Delivery (CCLAD) market is projected to expand at an 8.13% CAGR through 2030.
- Technology moat: DPS Dynamic Pressure Sensing Technology is a unique selling proposition for patient comfort and procedural safety in both dental and regional anesthesia.
- Actionable insight: Watch the recurring revenue from CompuFlo disposables as the key metric for sustained profitability, as discussed in Breaking Down Milestone Scientific Inc. (MLSS) Financial Health: Key Insights for Investors.

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