Company: MLSS
Filing Date: 2025-11-13
Form Type: 10-Q
Source: 0001493152-25-022276
Chunk: 34

Company: MILESTONE SCIENTIFIC INC.
Filing Date: 2025-11-13
Form: 10-Q
Item: Part I, Item 1
Chunk 34
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 care for injection techniques by improving precision, efficiency, and
patient comfort while reducing the anxiety associated with traditional injections.

Our proprietary Dynamic Pressure Sensing (DPS®)
Technology System enables controlled flow and real-time pressure monitoring at the needle tip, facilitating safer and more consistent
drug delivery and fluid aspiration. This platform supports multiple medical and dental applications, including accurate epidural space
identification in regional anesthesia procedures.

In dentistry, our Wand® device—marketed
as CompuDent® and STA Single Tooth Anesthesia System®—is a single-use disposable handpiece suitable for all local anesthetic
procedures. The dental systems are marketed in the United States, Canada, and more than 40 other countries. In medicine, our CompuFlo®
Epidural Computer Controlled Anesthesia System has received FDA 510(k) clearance for use in the lumbar, thoracic, and cervical thoracic
junction regions of the spine, as well as CE Mark approval for commercialization across most European countries.

The recent issuance of a chronology-specific CPT code
by the American Medical Association represents a significant advancement, expanding reimbursement potential for epidural procedures using
the CompuFlo® system and supporting broader adoption in anesthesia and pain management practices across the United States. Milestone
Scientific and its subsidiaries hold over 317 U.S. and international patents, with additional applications pending. These patents encompass
innovations in computer-controlled drug delivery, dynamic pressure sensing, automated flow regulation, tissue identification, and anesthetic
injection devices.

Milestone Scientific remains focused on advancing efforts to achieve the
following three primary objectives:

·Establishing Milestone’s DPS Dynamic Pressure Sensing (DPS®) technology platform as the standard of care in painless and
precise drug delivery—providing, for the first time, 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 the successful
FDA clearance of our first medical device.

·Expanding the global footprint of our CompuFlo® Epidural and CathCheck® Systems through a targeted field sales force and
strategic partnerships with distribution companies worldwide.

Our dental devices have been used to administer more than 95 million injections
worldwide. Each of our devices is designed with a corresponding single-use disposable handpiece, providing a recurring revenue stream
following the initial device sale. Currently, we continue to sell disposable handpieces unique to our legacy