Company: MLSS
Filing Date: 2025-11-13
Form Type: 10-Q
Source: 0001493152-25-022276
Chunk: 80

Company: MILESTONE SCIENTIFIC INC.
Filing Date: 2025-11-13
Form: 10-Q
Item: Part I, Item 8
Chunk 80
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 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 products—The Wand®
and CompuDent®—to customers who have not yet upgraded to our current dental product, the STA Single Tooth Anesthesia System®.

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The Single Tooth Anesthesia System (Dental)

Since its introduction in early 2007, the STA Single Tooth Anesthesia System®
and earlier computer-controlled local anesthetic delivery (C-CLAD) devices have been used to deliver more than 95 million safe, effective,
and comfortable injections. The instrument has been favorably evaluated in numerous peer-reviewed clinical studies and publications. There
is a growing consensus among users that the STA System is a valuable and beneficial instrument that is positively transforming dental
practice worldwide.

Medical Market Product

In June 2017, Milestone Scientific received FDA clearance to market the
CompuFlo® Epidural Computer Controlled Anesthesia System in the United States for epidural injections.

In May 2022, the Company received a chronology-specific CPT code for its
technology from the American Medical Association, marking an important milestone. Effective January 1, 2023, this temporary