MLSSNYSEOrthopedic, Prosthetic & Surgical Appliances & SuppliesUS GAAP · USD

Milestone Scientific, Inc

Milestone Scientific Inc. designs and commercializes computer-controlled injection systems for dental and medical use, centered on its Dynamic Pressure Sensing (DPS) platform. The company’s products are intended to make injections more precise, more comfortable, and in some cases virtually painless, while creating recurring revenue from disposable handpieces and related consumables.

Revenue9.0m USD
+4.0 %y/y
Operating profit (EBIT)-5.7m USD
+15.7 %y/y
EBIT margin-63.5%
+14.8 ppy/y
Net income-5.7m USD
−21.4 %y/y
Free cash flow-2.9m USD
−0.1 %y/y

Fiscal year 2025 · change from previous year

Development 2020–2025

-10-5051015m USD2020: 5.4 m USD2020: EBIT -7.5 m USD20202021: 10 m USD2021: EBIT -7.4 m USD20212022: EBIT -8.8 m USD20222023: 9.8 m USD2023: EBIT -7.1 m USD20232024: 8.6 m USD2024: EBIT -6.8 m USD20242025: 9.0 m USD2025: EBIT -5.7 m USD20259.0-5.7
RevenueOperating profit (EBIT)

Business

Share of revenue
Dental injection systems78 %

Computer-controlled dental anesthesia devices and related service revenue, including STA and legacy systems.

Dental disposables and consumables16 %

Single-use handpieces and other recurring consumables sold with dental devices.

Medical injection systems4 %

Medical devices built on the DPS platform, including CompuFlo and CathCheck.

Medical disposables and related services2 %

Consumables and support revenue tied to medical device usage and installations.

Customers

Customers are primarily dentists, dental groups, and dental offices that buy the STA system to improve patient comfort and standardize injection delivery. The medical side serves anesthesiologists and other clinicians using the CompuFlo and CathCheck systems for precise pressure-controlled delivery and verification. The company also sells through distributors internationally, which broadens access to smaller practices and foreign markets.

Dental practices

Buy STA devices and handpieces to improve patient comfort, reduce anxiety, and support repeat consumable purchases.

Dental groups and DSOs

Purchase devices at scale and drive higher recurring handpiece usage across multiple locations.

Medical clinicians

Use CompuFlo and CathCheck for precise pressure-sensing delivery and procedural verification.

International distributors

Buy and resell products in foreign markets to expand reach without a large direct sales force.

Strategy

Management is trying to shift Milestone from a research-heavy organization toward a more commercially focused medical device company. Near-term priorities are to grow dental revenue, expand international medical sales, and reduce operating expenses while preserving cash. The company is also emphasizing its DPS platform as a broader technology base for future applications beyond dentistry.

Commercialize the core dental platformShort term

Dental products already generate most revenue and recurring handpiece sales support repeat business.

Expand international medical and dental distributionMedium term

Foreign markets can broaden the installed base without requiring a large internal sales force.

Preserve liquidity and reach operating breakevenShort term

The company remains dependent on external financing until it can generate positive cash flow.

Geography

2025

Milestone sells in the United States and internationally, with management highlighting global expansion as a core objective. In the first half of 2025, international revenue was about $1.9 million and included roughly $110,000 from China, showing that overseas demand is a meaningful part of the mix. The company also launched U.S. e-commerce direct-to-end-user sales, which changed its domestic route to market and reduced reliance on prior distribution arrangements.

United States55 %
Other countries (US filing)41 %
China3.5 %

Share of the revenue the company reports by geography.

Risks

Milestone remains a going-concern story, with recurring losses and a continuing need for external capital until profitability is achieved, if ever. Its business is also exposed to tariff and import restrictions because it sources essential components from China and sells into foreign markets. Execution risk is high because growth depends on converting a niche technology platform into broader commercial adoption across dental and medical channels.

Sorted by severity
LowMediumHighLowMediumHighImpact →Likelihood →Going concern and financing dependence1Tariffs and trade policy changes2Commercial adoption of new devices3Research and development funding constraints4
Impact is the risk’s severity and likelihood how probable it is over the next few years, both assessed from the company’s reports. Numbers match the list.
  1. Going concern and financing dependenceImpact: CriticalLikelihood: High

    The company has recurring operating losses and needs additional capital to fund operations.

    Exposure: Cash runway and dilution risk

  2. Tariffs and trade policy changesImpact: HighLikelihood: High

    Management says essential elements are sourced from China and the company has significant foreign sales.

    ExposureCost of goodsSupply chainInternational demand
  3. Commercial adoption of new devicesImpact: HighLikelihood: High

    Revenue depends on clinicians adopting computer-controlled injection systems over manual methods.

    Exposure: Dental and medical product uptake

  4. Research and development funding constraintsImpact: MediumLikelihood: Medium

    Reduced government or partner funding could slow product development and collaboration.

    Exposure: Pipeline and future product expansion

Accounting

Judgemental items
Revenue recognition by product type

Device sales, disposable handpieces, and service revenue may be recognized at different points in time.

Impact: Affects quarterly revenue mix and gross margin

Going-concern assessment

Management concluded there is substantial doubt about continuing as a going concern.

Impact: Signals financing risk and affects investor interpretation of liquidity

Expense allocation and operating loss presentation

SG&A is split across dental, medical, and corporate, influencing how each business line appears.

Impact: Can affect perceived profitability of each product line

R&D capitalization versus expensing

The company is delaying some development work, which affects current-period expense levels.

Impact: Changes reported operating losses and future product investment

Publicly listed companies with a comparable business focus.

Last updated: 24/09/2026

Milestone Scientific, Inc (MLSS) Revenue, Earnings & Financials 2025 – Clarifo