Milestone Scientific Inc (NYSE American: MLSS) is a medical device company that develops and commercializes computer-controlled drug delivery systems for dental and medical applications. Revenue is generated through the sale of electro-mechanical instruments and proprietary disposable handpieces used in conjunction with those instruments. The company's core products are the Wand/STA Single Tooth Anesthesia System for dental injections and the CompuFlo Epidural System for epidural space identification, both built on its proprietary CompuFlo and DPS Dynamic Pressure Sensing technology. The STA System and its predecessor C-CLAD devices have been used in more than 95 million injections globally as of the FY2025 10-K filing. Milestone Scientific carries substantial doubt about its ability to continue as a going concern without raising additional capital, citing recurring losses, accumulated deficit, and reliance on external financing as of December 31, 2025. The company does not pay dividends and had approximately 3,507 beneficial owners of common stock as of March 31, 2026.

Revenue model

Transactional sales of computer-controlled drug delivery instruments and proprietary single-use disposable handpieces. Each procedure using the system requires a new disposable handpiece, creating a recurring consumables revenue stream tied to installed instrument base.

Products and services

Wand/STA Single Tooth Anesthesia System (dental computer-controlled local anesthetic delivery); CompuFlo Epidural System with DPS Dynamic Pressure Sensing Technology (epidural space identification for pain management and anesthesia); proprietary disposable injection handpieces; registered trademarks including CompuDent, CompuFlo, DPS Dynamic Pressure Sensing, Safety Wand, STA Single Tooth Anesthesia System, and The Wand.

Customers and end markets

Dental practitioners (primary installed base); anesthesiologists and pain management physicians using the CompuFlo Epidural System. End markets include outpatient dental offices and hospital or clinic-based epidural procedures.

Value-chain role

Medical device developer and commercial seller. The company holds patents, trademarks, and trade secrets on its DPS and CompuFlo technology. Products are subject to FDA clearance domestically and CE marking and ISO 13485 compliance for European Union markets. Manufacturing and distribution capabilities are referenced as required for any new product development.

Geographic exposure

United States (primary market, FDA-regulated) and international markets including the European Union (ISO 13485 and CE marking compliance maintained as of the FY2025 filing).

Source: SEC 10-K, filed 2026-03-31

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