# Milestone Scientific, Inc

> Clarifo company profile — qualitative business description generated from
> the company's filings. Financial statements, charts and ratios are
> available on Clarifo (https://www.clarifo.com/en/companies/Milestone Scientific, Inc).

## Overview

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.

## Products & services

• STA Single Tooth Anesthesia System for dental injections
• CompuFlo Epidural System for epidural anesthesia
• CathCheck System for catheter placement verification
• Disposable handpieces and consumables for installed devices
• DPS Dynamic Pressure Sensing technology platform
• Legacy Wand and CompuDent dental injection products

- **Dental injection systems** (78%) — Computer-controlled dental anesthesia devices and related service revenue, including STA and legacy systems.
- **Dental disposables and consumables** (16%) — Single-use handpieces and other recurring consumables sold with dental devices.
- **Medical injection systems** (4%) — Medical devices built on the DPS platform, including CompuFlo and CathCheck.
- **Medical disposables and related services** (2%) — Consumables and support revenue tied to medical device usage and installations.

- STA Single Tooth Anesthesia System for dental injections
- CompuFlo Epidural System for epidural anesthesia
- CathCheck System for catheter placement verification
- Disposable handpieces and consumables for installed devices
- DPS Dynamic Pressure Sensing technology platform
- Legacy Wand and CompuDent dental injection products

## 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** (primary) — Buy STA devices and handpieces to improve patient comfort, reduce anxiety, and support repeat consumable purchases.
- **Dental groups and DSOs** (primary) — Purchase devices at scale and drive higher recurring handpiece usage across multiple locations.
- **Medical clinicians** (secondary) — Use CompuFlo and CathCheck for precise pressure-sensing delivery and procedural verification.
- **International distributors** (secondary) — Buy and resell products in foreign markets to expand reach without a large direct sales force.

- Dentists and dental offices buying STA systems for painless injections
- Dental groups seeking standardized injection workflows and recurring consumables
- Anesthesiologists using CompuFlo for pressure-controlled epidural delivery
- Clinicians and hospitals using CathCheck for catheter verification
- International distributors serving end users outside the U.S.

## Geography

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 States** (59%) — Estimated from disclosed U.S. e-commerce, dental service, and medical revenue.
- **International** (41%) — Estimated from disclosed international revenue in the first half of 2025.

- U.S. e-commerce now supports direct sales to dental end users
- International revenue is a major part of the business mix
- China contributed about $110,000 in the first half of 2025
- Global distributor partnerships are used to expand medical sales
- Foreign sourcing and sales create tariff and trade-policy exposure

## 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 platform** (short-term) — Dental products already generate most revenue and recurring handpiece sales support repeat business.
- **Expand international medical and dental distribution** (medium-term) — Foreign markets can broaden the installed base without requiring a large internal sales force.
- **Preserve liquidity and reach operating breakeven** (short-term) — The company remains dependent on external financing until it can generate positive cash flow.

- Grow dental revenue through direct e-commerce and broader adoption
- Expand CompuFlo and CathCheck through targeted field sales and distributors
- Position DPS as a standard-of-care platform for precise drug delivery
- Reduce professional, consulting, and other operating expenses
- Delay next-generation STA R&D to conserve cash

## 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.

- **Going concern and financing dependence** [critical] — The company has recurring operating losses and needs additional capital to fund operations.
- **Tariffs and trade policy changes** [high] — Management says essential elements are sourced from China and the company has significant foreign sales.
- **Commercial adoption of new devices** [high] — Revenue depends on clinicians adopting computer-controlled injection systems over manual methods.
- **Research and development funding constraints** [medium] — Reduced government or partner funding could slow product development and collaboration.

- Going-concern risk due to recurring losses and limited cash
- Need for equity or debt financing may dilute shareholders
- Tariffs and import rules can raise component costs and disrupt supply
- Dependence on China-sourced inputs creates sourcing exposure
- Commercial adoption risk if dentists and clinicians do not switch
- International sales expose the company to foreign demand volatility

## Accounting

Revenue is affected by the mix between device sales, disposable handpieces, and service/e-commerce revenue, which can shift quarter to quarter as adoption changes. The company also has meaningful judgment around going-concern disclosures, financing classification, and expense allocation between dental, medical, and corporate functions. Because it delays some R&D and relies on recurring consumables, investors should watch whether revenue growth is sustainable without one-time financing support.

- **Revenue recognition by product type** — Affects quarterly revenue mix and gross margin
- **Going-concern assessment** — Signals financing risk and affects investor interpretation of liquidity
- **Expense allocation and operating loss presentation** — Can affect perceived profitability of each product line
- **R&D capitalization versus expensing** — Changes reported operating losses and future product investment

- Revenue mix between devices, disposables, and services affects comparability
- Quarterly sales can swing with distributor orders and e-commerce timing
- Going-concern disclosure reflects liquidity and financing assumptions
- Expense allocation across dental, medical, and corporate affects segment view
- R&D deferrals can change near-term expense recognition and future pipeline

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*Last updated: 2026-09-24T12:11:16.000296+00:00*
