Company Summary: Milestone Scientific Inc.

Overview

Milestone Scientific Inc. is a biomedical technology company specializing in the development, patenting, and commercialization of innovative, computer-controlled injection devices for medical and dental applications. The company’s core focus is on making drug delivery injections safer, more precise, and less painful through proprietary technological platforms.

Core Technologies & Products

• DPS Dynamic Pressure Sensing Technology®: A proprietary platform that controls and monitors flow rate and pressure at the needle tip during injections. It enables real-time pressure feedback (visual and audible) to identify tissue types, improve accuracy, and reduce pain.
• The Wand®: Disposable, single-use handpiece for dental injections; used in all dental procedures requiring local anesthetic.
• CompuDent® and STA Single Tooth Anesthesia System®: Dental systems utilizing DPS technology, marketed worldwide, across over 41 countries.
• CompuFlo® Epidural Computer Controlled Anesthesia System: FDA-cleared device for epidural anesthesia, with specific applications in labor/delivery, pain management, and regional anesthesia. It uniquely provides real-time pressure feedback to identify epidural space accurately, reducing the risk compared to traditional methods.
• CompuFlo® for Medical Use: Also approved in Germany and Brazil, with expanded applications for epidural injections in cervical, thoracic, and lumbar spine regions, including recently acquired European patent rights.
• Additional prospective applications: Including injections for rhinoplasty, colorectal surgery, podiatry, and self-injectable drugs for chronic conditions like multiple sclerosis and rheumatoid arthritis.

Regulatory & Market Approvals

• FDA Clearances:
  • 510(k) clearance for CompuFlo® Epidural System (June 2017)
  • Expanded in 2023 for use in the thoracic spine
• European CE mark: For relevant medical devices.
• Brazil ANVISA approval: For the epidural system (June 2024).
• CMS reimbursement codes: CPT code CPT0777T for epidural guidance, with favorable Medicare Part B payments in Florida and other regions.
• Patent portfolio: Over 317 U.S. and international patents, including recent patent allowances related to needle/catheter location algorithms.

Market & Sales

• Dental Market:
  • Over 95 million injections delivered globally using devices from the company.
  • Products sold primarily in the U.S., Canada, and over 41 other countries.
  • Sales channels include direct sales to dental offices and online e-commerce platform (launched in Jan 2023).
• Medical Market:
  • Products sold in Italy, Switzerland, Greece, Canada, and the Middle East through exclusive distributors.
  • Recent FDA approvals have helped expand the medical application segment.
• Sales Revenue (2024, FY):
  • Total product sales: approximately $8.63 million.
  • Dental segment: approx. $8.53 million.
  • Medical segment: approx. $102,820.
• Revenue decline: From 2023 to 2024 (from approx. $9.83 million to $8.63 million), primarily due to lower international sales and discontinuation of sales to Milestone China.
• Employees: 17 full-time employees, including one executive officer.

Financial Highlights

• Operating losses:
  • 2024: $6.76 million
  • 2023: $7.11 million
• Net losses:
  • 2024: $4.71 million
  • 2023: $6.98 million
• Cash position:
  • As of December 31, 2024: approximately $3.26 million.
• Capital structure:
  • 78,379,633 shares outstanding as of April 15, 2025 (down slightly from prior years).

Key Initiatives & Future Outlook

• Transitioning from R&D to a product commercialization focus.
• Expanding global distribution channels, including recent partnerships and government approvals.
• Developing additional products based on DPS technology for various disciplines.
• Managing ongoing regulatory, patent, and market competition risks.

Summary

Milestone Scientific Inc. is a leading innovator in computer-controlled injection systems, with a focus on dental anesthesia and epidural anesthesia for pain management and regional anesthesia. Their devices are designed to improve patient comfort, safety, and accuracy of injections. The company has a broad patent portfolio, active global sales, FDA and international approvals, and a small but focused workforce. Financially, it continues to incur losses but is working toward revenue growth and market expansion.