Milestone Scientific Inc. (MLSS): Business Model Canvas [Dec-2025 Updated]

You're looking at Milestone Scientific Inc. right now, and honestly, the story is about a tech pivot: they are trying to lock in high-margin, recurring revenue from their proprietary Dynamic Pressure Sensing Technology platform, even as they navigate a tough near-term financial reality. For the nine months ending September 30, 2025, the company posted $6.9 million in revenue, but that came with an operating loss of about $(4.6) million as they push the CompuFlo and STA systems into pain management and dental markets. To see exactly how they plan to bridge that gap-from instrument sales to sticky consumables and reimbursement wins-dive into the full nine-block breakdown below. It's a clear map of their current strategy, for better or worse.

Milestone Scientific Inc. (MLSS) - Canvas Business Model: Key Partnerships

You're looking at how Milestone Scientific Inc. (MLSS) is structuring its go-to-market strategy through external relationships as of late 2025. This is all about leveraging others' networks to scale the CompuFlo® Epidural System and the STA® Single Tooth Anesthesia System, especially given the company's focus on operational streamlining.

The partnership with Axial Biologics remains central for the CompuFlo® medical segment rollout in key states. This arrangement, established in August 2024, focuses on leveraging Axial Biologics' established clinician relationships specifically in New Jersey, Texas, and Florida. This specialized approach was chosen instead of building out a broad internal sales force to accelerate penetration.

Reimbursement alignment with Jurisdictional Medicare Administrative Contractors (JMACs) is a critical enabler for the medical device segment. The favorable Medicare Part B physician payment rate under CPT code CPT0777T was initially secured with Novitas Solutions, Inc. and First Coast Service Options Inc. (FCSO), covering the initial JMAC states of Florida, New Jersey, and Texas. By the start of 2025, this coverage expanded to include providers in Pennsylvania, Maryland, Delaware, Washington D.C., Colorado, Louisiana, Mississippi, New Mexico, Oklahoma, and Arkansas. Milestone Scientific Inc. is still investing in specialized market analysis and reimbursement strategies to maximize commercial potential in healthcare settings as of October 2025. The medical segment is showing growth, contributing to the nine-month revenue increase to $6.9 million for the period ending September 30, 2025.

The company is actively working with international distributors for its dental device sales, which are proving vital for overall revenue stability. For the nine months ending September 30, 2025, growth in international dental sales was a key driver, helping to offset a decline in domestic dental sales. For the six months ending June 30, 2025, international revenue reached approximately $1.9 million, marking an increase of approximately $500,000 compared to the same period in 2024. The Q1 2025 international revenue was reported at approximately $863,000.

Access to US government facilities is secured through a contract award under the Federal Supply Schedule (FSS). This contract allows eligible federal medical facilities, including the U.S. Department of Veterans Affairs (VA), Department of Defense (DoD), and Indian Health Service (IHS), to procure the CompuFlo® Epidural System. The company was advancing initiatives to drive adoption within these federal systems following the award.

Here's a quick look at how some of these segments performed in the first half of 2025:

The medical revenue for the three months ended June 30, 2025, was approximately $32,019. To be fair, the recurring revenue from the medical segment in Q3 2025 was noted as an offset to lower domestic dental sales, though specific recurring revenue figures aren't isolated from the total Q3 revenue of $2.4 million. Finance: draft 13-week cash view by Friday.

Milestone Scientific Inc. (MLSS) - Canvas Business Model: Key Activities

You're looking at the core actions Milestone Scientific Inc. (MLSS) is taking to drive its business forward as of late 2025, focusing on operational discipline and commercial execution across both medical and dental segments. The focus is definitely on efficiency gains while pushing the CompuFlo® Epidural System into broader adoption.

The company's operational restructuring is a major Key Activity, showing immediate financial impact. Through disciplined cost management, Milestone Scientific reduced third-quarter operating expenses by over half a million dollars compared to the same period last year. Management reported this reduction was over $500,000 for the third quarter ended September 30, 2025. This efficiency drive coincided with a reported 20% reduction in operating expenses in Q3 2025 versus Q3 2024.

Commercializing the CompuFlo® Epidural System in pain management is intrinsically tied to securing payment pathways. Milestone Scientific is executing a guided relaunch and reimbursement strategy for CompuFlo in medical markets. A significant enabler is the progress in securing Medicare payment rates, specifically under CPT code 0777T. The initial favorable Medicare Part B physician price assignment by First Coast Service Options Inc. (FCSO) in Florida established an estimated initial addressable market of $125 million among Florida Medicare patients alone. Furthermore, the company is encouraged by an uptick in recurring revenue from CompuFlo disposables.

For the dental segment, Key Activities center on expanding North American direct sales and bolstering the e-commerce channel. The company continued to expand its direct sales programs in North America and enhanced its omnichannel digital marketing strategy to drive recurring e-commerce sales. The STA Single Tooth Anesthesia System has administered over 95 million injections to date. The nine months ended September 30, 2025, saw revenues of approximately $6.9 million, which was an increase of approximately 5% from the $6.6 million reported for the same nine-month period in 2024.

Here's a quick look at some of the financial metrics tied to these activities for the nine months ended September 30, 2025:

On the Research and Development (R&D) front, the company continues to advance its pipeline of next-generation DPS-based injection technologies. For the three months ended September 30, 2025, R&D expenses totaled $16,000. For the nine months ended September 30, 2025, R&D spending was $437,000. That R&D spend is definitely lean, showing the priority is on cost control right now.

Milestone Scientific Inc. (MLSS) - Canvas Business Model: Key Resources

You're looking at the core assets Milestone Scientific Inc. (MLSS) relies on to operate and grow as of late 2025. These aren't just line items; they are the foundation of their value proposition.

• - Proprietary DPS Dynamic Pressure Sensing Technology® platform.
• - Patented CompuFlo® and STA® computer-controlled injection systems.
• - Cash and equivalents of approximately $1.3 million as of September 30, 2025.
• - Regulatory progress, including securing Medicare payment-rate assignments and expanding commercial coverage for CompuFlo®.

The intellectual property is central here. The DPS Dynamic Pressure Sensing Technology® platform is the engine for next-generation devices, regulating flow rate and monitoring pressure right at the needle tip for subcutaneous drug delivery, like local anesthetics. This technology has seen key patent approvals in the U.S. and Europe covering its next-generation application and the CompuPulse System, which identifies pulsatile pressure waveforms.

The CompuFlo® and STA® systems are the commercialized applications of this core tech. The STA® Single Tooth Anesthesia System continues expansion through direct sales programs in North America, and the CompuFlo® disposables are showing growing utilization and recurring revenue in the medical segment.

Here's a quick look at the balance sheet strength as of the third quarter close:

Looking at operational performance for the nine months ended September 30, 2025, the revenue base is supported by these resources:

The regulatory standing is a key enabler for the medical segment. Milestone Scientific Inc. is advancing its reimbursement strategy for CompuFlo®, building on recent progress in securing Medicare payment-rate assignments and expanding commercial coverage. This access alignment with payers is viewed as important for driving the next phase of medical segment growth.

The company's key resources also include its operational structure, which saw a reduction in third-quarter operating expenses by over half a million dollars compared to the same period last year, indicating disciplined cost management.

• Key Q3 2025 Financial Snapshot:
• Q3 2025 Revenue: approximately $2.4 million.
• Q3 2025 Gross Profit Margin: 70%.
• Nine Months 2025 Revenue Growth vs. 2024: approximately 5% increase ($0.3 million).

Finance: draft 13-week cash view by Friday.

Milestone Scientific Inc. (MLSS) - Canvas Business Model: Value Propositions

You're looking at the core reasons why a clinician chooses Milestone Scientific Inc. (MLSS) technology over traditional methods. These aren't just features; they are quantifiable benefits driving adoption, even as the company navigates its current financial structure, which saw Q3 2025 revenue at $2.36 million, beating forecasts.

Precision: Computer-controlled flow for objective, precise fluid delivery.

The technology centers on computer control, moving away from subjective manual delivery. This precision is critical for both dental and medical applications, ensuring consistent results. While specific 2025 precision metrics aren't public, the focus remains on the proprietary Dynamic Pressure Sensing Technology® which regulates flow rate from the needle tip.

Safety: Real-time pressure monitoring to enhance patient safety (e.g., epidurals).

Real-time pressure monitoring is the safety net. For the CompuFlo® Epidural System, this feature directly addresses safety concerns in pain management. Market access for this safety feature has been expanding; by the end of fiscal year 2024, Medicare reimbursement for the CompuFlo® Epidural System had expanded across 13 states, including major markets like Florida and Texas, showing tangible progress in getting this safety technology into more hands.

Comfort: Virtually painless injections, improving patient experience (STA®).

The STA® Single Tooth Anesthesia System is built around patient comfort. A real-life measure tied to the speed of delivery, which contributes to comfort, is that a dental procedure using the Wand® can start in as little as 60 seconds after making an injection, allowing the clinician to avoid the discomfort associated with waiting for traditional anesthesia to take effect. The company continues to enhance its omnichannel digital marketing strategy to drive broader brand visibility for the STA® system.

Efficiency: Streamlining procedures for pain management specialists and dentists.

Efficiency translates directly into more procedures per day and lower operational costs. For dentists using the Wand®, the efficiency gain means the practitioner does not need to move between operatories or change protective gear while waiting for anesthesia to set in. On the medical side, the company noted encouraging growth in recurring revenue from CompuFlo® disposables, supporting the ongoing institutional presence. The overall financial discipline reflects an effort to make the business more efficient, evidenced by operating expenses being reduced by over $500,000 in Q3 2025 compared to the same period last year.

Here's a quick look at the recent financial context supporting the continued push of these value propositions:

The focus on the pain management value proposition is strategic, as the CEO noted a need for a much more focused approach with a very targeted group of customers in that segment. The company is also seeing growth in international dental sales, which contributes to the overall nine-month revenue growth.

• U.S. e-commerce revenue for dental products reached $5.1 million in 2024.
• The company reported an EPS loss of $0.01 for Q3 2025, better than the forecasted loss of $0.02.
• The nine-month operating loss narrowed to approximately $(4.6) million in 2025 from approximately $(4.7) million in 2024.

Finance: draft 13-week cash view by Friday.

Milestone Scientific Inc. (MLSS) - Canvas Business Model: Customer Relationships

You're looking at how Milestone Scientific Inc. (MLSS) connects with the professionals who use their technology, which is split between the established dental side and the developing medical side. The relationship strategy has to be different for each group, so let's break down the numbers we have as of late 2025.

The dental segment relies heavily on direct engagement. The company completed the shift away from U.S. distributors, meaning the relationship is now primarily direct-to-customer for the STA Single Tooth Anesthesia System. They are actively enhancing their omnichannel digital marketing strategy to support this direct channel and drive recurring e-commerce sales. For the first nine months of 2025, the revenue from the U.S. e-commerce and dental service channel was approximately $3.9 million.

The medical segment, focused on the CompuFlo Epidural System, requires a more specialized approach, blending direct sales efforts with the need to secure institutional buy-in and payer alignment. Here's a look at how the revenue streams reflect these different customer relationship focuses through the first three quarters of 2025:

For the medical segment, the customer relationship is evolving. Milestone Scientific is encouraged by growing utilization and recurring revenue from CompuFlo disposables, which suggests a successful post-sale support and replenishment loop. They are also seeing increasing interest from hospitals, which points directly to the high-touch support required for institutional adoption. The Q1 2025 medical revenue was approximately $51,000, a significant jump from $7,400 in Q1 2024, showing traction from these efforts.

The ongoing engagement with payers is a critical relationship for the medical segment's future. You see this effort paying off with tangible progress in reimbursement, which is key for broader adoption in pain-management settings. Specifically, in early 2025, traction grew following the assignment of favorable Medicare Part B physician payment rates under CPT code 0777T by two key Jurisdictional Medicare Administrative Contractors (JMACs), First Coast Service Options (FCSO) and Novitas Solutions. Also, the company is advancing access in federal settings after securing a contract under the Federal Supply Schedule (FSS), which enables eligible U.S. government medical facilities to procure CompuFlo.

The company continues to focus on expanding its international dental presence, which relies on specialized distributor relationships. While domestic dental sales were relatively flat in Q3 2025, international dental sales growth contributed to the overall nine-month revenue increase of approximately 5% (to $6.9 million from $6.6 million year-over-year for the nine months ended September 30, 2025). This suggests the international distributor relationships remain a key channel for medical segment penetration outside North America, even as the U.S. dental channel moves direct.

• Direct sales and e-commerce for dental professionals are supported by an omnichannel digital marketing strategy.
• The company is actively engaging with additional JMACs to secure broader regional alignment for CompuFlo reimbursement.
• Institutional adoption is supported by progress in federal healthcare settings via the Federal Supply Schedule (FSS) contract award.
• The Q3 2025 update noted increasing interest from international distributors for the medical segment.

Finance: draft 13-week cash view by Friday.

Milestone Scientific Inc. (MLSS) - Canvas Business Model: Channels

You're looking at how Milestone Scientific Inc. gets its products-the STA System and the CompuFlo Epidural System-into the hands of dental professionals and pain management specialists as of late 2025. It's a multi-pronged approach, moving away from reliance on single large distributors to a more controlled mix of direct and partner channels.

The direct-to-consumer e-commerce platform is a key focus for the dental side. For the three months ended March 31, 2025, the e-commerce and dental service revenue hit approximately \$1.2 million. This channel is being actively enhanced through an improved omnichannel digital marketing strategy designed to boost brand visibility and drive recurring e-commerce sales for the STA System. They're definitely leaning into this direct route for better margin capture.

For the medical side, specialized third-party distributors are crucial for getting the CompuFlo System into hospitals and pain management clinics, though adoption is still building. Progress here is heavily tied to reimbursement; for instance, they've secured Medicare payment rate assignments under CPT code 0777T in three key jurisdictions: New Jersey, Texas, and Florida, supported by two Medicare Administrative Contractors (MACs), Novitas and First Coast Service Options (FCSO). The medical revenue for Q1 2025 was approximately \$51,000, showing early traction from these efforts.

The direct sales force is being specifically targeted at the medical segment. Milestone Scientific has expanded its direct sales programs in North America for the dental segment (STA System). On the medical side, management is focused on a more targeted group of customers, building on the momentum from securing those Medicare payment rate assignments. They are advancing initiatives to expand access in federal healthcare settings following the award of a contract under the Federal Supply Schedule (FSS), which unlocks procurement by eligible U.S. government medical facilities.

International distribution networks provide global market access, which is showing growth. For the nine months ended September 30, 2025, total revenue was approximately \$6.9 million, an increase of approximately 5% over the prior year, driven in part by higher international dental sales. In Q1 2025 alone, international revenue was approximately \$863,000. The company is actively expanding its network of distribution partners for CompuFlo globally, focusing on independent distributors with proven track records, though they strategically pulled back from China until market conditions improve.

Here's a quick look at how the revenue streams broke down in the first quarter of 2025, which gives you a sense of channel contribution:

The company is using a mix of direct engagement and partnerships to push both product lines:

• Expanded direct sales programs in North America for the STA System.
• Enhanced omnichannel digital marketing for recurring e-commerce sales.
• Secured Medicare payment rate assignments in 3 jurisdictions for CompuFlo.
• Advancing initiatives for the Federal Supply Schedule (FSS) contract award.
• Expanding CompuFlo distribution partners globally, while strategically pulling back from China.

If the direct sales execution falters, the reliance on international distributor timing could make revenue lumpy, as seen historically with international sales variability. Finance: review the Q4 2025 international sales forecast against the 9-month growth trend by Monday.

Milestone Scientific Inc. (MLSS) - Canvas Business Model: Customer Segments

You're looking at the customer base for Milestone Scientific Inc. (MLSS) as of late 2025. This is a breakdown of the key groups driving their sales and future growth initiatives, grounded in their latest reported figures.

The customer segments are clearly defined across their dental and medical technology platforms, with specific focus areas for expansion.

• - Dental professionals (general dentists, specialists) using STA® system.
• - Pain management specialists and Ambulatory Surgery Centers (ASCs).
• - US Federal healthcare facilities (VA, DoD) via FSS contract.
• - International medical and dental distributors and end-users.

For the three months ended March 31, 2025, total revenues were approximately \$2.2 million. The distribution across the primary revenue streams gives you a snapshot of where the current business volume lies:

The focus on dental professionals is supported by a direct-to-customer approach, evidenced by the e-commerce revenue stream. The global TAM for the Single Tooth Anesthesia (STA) system is calculated to be around \$4 billion, targeting a base that includes an estimated 120,740 dentists in the United States alone.

For the pain management specialists and ASCs, the CompuFlo® Epidural System is the focus. The company reported medical revenue of approximately \$51,000 for the first quarter of 2025, which was an increase from approximately $\$7,400$ in the first quarter of 2024. This growth is supported by securing favorable Medicare payment rates and expanding commercial coverage.

Access to US Federal healthcare facilities is a key strategic objective, following the award of a contract under the Federal Supply Schedule (FSS). This contract enables eligible U.S. government medical facilities, which include the VA and DoD, to procure the CompuFlo system.

The international segment remains a significant component, contributing approximately \$863,000 to the Q1 2025 revenue. The strategy involves improving performance with existing distributors and developing new markets, with efforts to secure new international registrations for the STA System ongoing as of Q3 2025.

As of June 30, 2025, the trailing twelve-month revenue stood at \$9.1 million.

Milestone Scientific Inc. (MLSS) - Canvas Business Model: Cost Structure

You're looking at the hard numbers behind Milestone Scientific Inc.'s (MLSS) operations as of late 2025. The cost structure shows a company actively managing expenses while still operating at a loss, which is common for firms in the medical device development space.

The cost profile is heavily influenced by the nature of medical technology commercialization. Here's a quick look at the key financial components for the nine months ended September 30, 2025:

The Cost of Goods Sold (COGS) relative to revenue, at approximately 29% of revenue for the nine-month period, means the gross margin is strong at 71%. Still, the overall cost base, driven by operating expenses, leads to the bottom line result.

Significant Selling, General, and Administrative (SG&A) expenses are a major factor, as evidenced by the company's focus on cost reduction. Milestone Scientific Inc. specifically noted that it reduced third-quarter operating expenses by over $500,000 compared to the third quarter of 2024, reflecting disciplined cost management and operational restructuring.

Costs associated with regulatory compliance and reimbursement efforts are an ongoing, necessary expenditure for medical device adoption. Milestone Scientific Inc. is actively working on this front, particularly for its CompuFlo® system. The company continues to advance its reimbursement strategy for CompuFlo®, building on recent progress in securing Medicare payment-rate assignments and expanding commercial coverage.

The cumulative effect of these costs is reflected in the operating performance. The operating loss for the nine months ended September 30, 2025, was approximately $(4.6) million. This compares to an operating loss of approximately $(4.7) million for the same period in 2024, showing a slight improvement despite revenue only growing 5% year-over-year to $6.9 million.

You can see the quarterly impact of cost control, too:

• Operating loss for Q3 2025 was approximately $(1.1) million.
• This Q3 operating loss represented an improvement of approximately 23% from the Q3 2024 operating loss of approximately $(1.5) million.
• The net loss for the nine months ended September 30, 2025, was approximately $(4.6) million, or $(0.06) per share.

Milestone Scientific Inc. (MLSS) - Canvas Business Model: Revenue Streams

You're looking at how Milestone Scientific Inc. (MLSS) brings in cash as of late 2025. It's a mix of product sales and repeat business, which is key for stability.

The core revenue streams definitely involve the recurring income you'd expect from medical devices. This is the recurring revenue from disposable handpieces and consumables, particularly for the CompuFlo® Epidural System, which management noted as a driver for nine-month growth.

Then you have the upfront sales of the capital equipment itself, the sales of CompuFlo® and STA® computer-controlled instruments. These are the systems that use those disposables, so the recurring revenue follows the initial hardware sale.

We can see the geographic and segment breakdown in the latest figures. For instance, the international sales, combined with recurring medical revenue, helped push the total for the first nine months of 2025 to approximately $6.9 million. That's up from $6.6 million for the same nine-month period in 2024.

Domestically, the dental side shows a clear channel. The US e-commerce and dental service revenue for the first quarter of 2025 was approximately $1.2 million. That figure held steady compared to Q1 2024.

Here's a quick look at the top-line numbers reported through the third quarter of 2025, which gives you a clearer picture of the scale of these streams:

Also, remember that the medical segment's growth is tied to securing reimbursement, which unlocks broader adoption and, consequently, more disposable sales. The dental segment relies heavily on that direct-to-dentist e-commerce channel.

The revenue sources break down into these primary buckets:

• Recurring revenue from CompuFlo® disposables.
• Sales of STA® Single Tooth Anesthesia System instruments.
• International dental sales through distributors.
• US e-commerce and direct dental service sales.