Overview

Milestone Scientific is a biomedical technology company that patents, designs, develops and commercializes innovative diagnostic and therapeutic injection technologies and devices for medical and dental use. The company has focused its resources on redefining the worldwide standard of care for injection techniques by making the experience more comfortable for the patient by reducing the anxiety and stress of receiving injections.

Milestone Scientific’s key achievements and objectives include:

• Establishing its DPS Dynamic Pressure Sensing technology platform as the standard-of-care in painless and precise drug delivery, providing objective visual and audible in-tissue pressure feedback, and continuing to expand platform applications.
• Transitioning from a research and development organization to a commercially focused medical device company following FDA clearance of its first medical device.
• Expanding the global footprint of its CompuFlo Epidural and CathCheck System by utilizing a targeted field sales force and partnering with distribution companies worldwide.

The company’s dental devices, including the STA Single Tooth Anesthesia System, have been used to administer over 95 million injections worldwide. Milestone Scientific is also expanding the uses and applications of its proprietary, patented technologies to achieve greater operational efficiencies, enhanced patient safety and therapeutic adherence, patient satisfaction, and improved quality of care across a broad range of medical specialties.

Financial Performance

Revenue and Profit Trends

• Consolidated revenue for 2024 was $8.6 million, a decrease of $1.2 million compared to 2023. This was driven by a $1.2 million decrease in dental revenue, partially offset by a $37,000 increase in medical revenue.
• Gross profit decreased by $358,000 or 5% in 2024 compared to 2023, with dental gross profit decreasing by $689,000 and medical gross profit increasing by $331,000.
• The loss from operations decreased by $350,000 in 2024 compared to 2023, driven by increased margins in e-commerce dental sales and lower selling, general and administrative expenses.

Strengths and Weaknesses

Strengths:

• Proprietary, innovative, computer-controlled injection technologies that provide precise, efficient, and virtually painless injections.
• Established patent portfolio with over 317 U.S. and foreign patents.
• Successful commercialization of the STA Single Tooth Anesthesia System, which has been used for over 95 million injections.
• Recent FDA clearance and reimbursement approvals for the CompuFlo Epidural System, which could accelerate its commercial rollout.

Weaknesses:

• Declining revenue in the dental segment, particularly from international and distributor sales.
• Continued losses from operations, although the loss has decreased year-over-year.
• Reliance on a limited number of products and markets, with the dental segment accounting for the majority of revenue.

Outlook

Milestone Scientific is focused on the following key objectives to drive future growth and profitability:

1. Establishing its DPS Dynamic Pressure Sensing technology as the standard-of-care in painless and precise drug delivery.
2. Transitioning from a research and development organization to a commercially focused medical device company.
3. Expanding the global footprint of its CompuFlo Epidural and CathCheck System through targeted sales and distribution partnerships.

The company believes its existing cash and cash equivalents, along with management’s plans and recent financing, will be sufficient to fund operations for the next 12 months and alleviate substantial doubt about its ability to continue as a going concern.

Overall, Milestone Scientific is making progress in commercializing its innovative injection technologies, but faces challenges in maintaining revenue growth and profitability across its dental and medical product lines. The company’s success will depend on its ability to drive adoption of its proprietary technologies and effectively execute its strategic initiatives.