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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K

(Mark One)

☒	ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, ~~2024~~ 2025

☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission file number 001-14053

Milestone Scientific Inc.

(Exact name of registrant as specified in its charter)

Delaware

13-3545623

State or other jurisdiction

of Incorporation or organization

(I.R.S. Employer

Identification No.)

425 Eagle Rock Avenue, Roseland, NJ 07068

(Address of principal executive offices)

Registrant’s telephone number, including area code: 973-535-2717.

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	~~Symbol~~	~~Name of each exchange on which registered.~~Symbol	Name of each exchange on which registered.
Common Stock, par value $.001 per share	MLSS	NYSE American
Common Stock, par value $0.001 per share		MLSS	NYSE American

Securities registered pursuant to section 12(g) of the Act: NONE.

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. ☐ Yes ☑ ☒ No

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. ☐ Yes ☑ ☒ No

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☑ ☒ Yes ☐ No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☑ ☒ Yes ☐ No

Indicate by check mark whether the registrant is a large, accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large, accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large, accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☑☒ Smaller reporting company ☑☒ Emerging Growth Company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley ~~act~~Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

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As of June 30, ~~2024~~2025, the last business day of the registrants most recently completed second fiscal quarter, the aggregate market value of the common stock held by non- affiliates of the issuer was $5839,~~221~~730,~~401,~~ 497 This amount is based on the closing price of $0.6864 per share of the registrant'’s common stock as of such date, as reported on the NYSE American.

As of ~~April~~March 1531, ~~2025~~2026, the registrant has a total of 78 80,~~379~~453,~~633~~ 116 shares of Common Stock, par value $0.001 per share outstanding.

DOCUMENTS INCORPORATED BY REFERENCE

None

MILESTONE SCIENTIFIC INC.

Form 10-K Annual Report

TABLE OF CONTENTS

PART I
Item 1.	Business	34
Item 1A.	Risk Factors	109
Item 1B.	Unresolved Staff Comments	2124
Item 1C	Cybersecurity	2225
Item 2.	Description of Property	2225
Item 3.	Legal Proceedings	2225
Item 4.	Mine Safety Disclosure	2125
PART II
Item 5.	Market for Common Equity, Related Stockholder Matters, and Small Business Issuer Purchases of Equity Securities	2326
Item 6.	~~Reserved~~Selected Financial Data	2326
Item 7.	Management'’s Discussion and Analysis or Plan of Operations	2427
Item 7A.	Quantitative and Qualitative Disclosure about Market Risk	3033
Item 8.	Financial Statements	3033
Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	3033
Item 9A.	Controls and Procedures	3134
Item 9B.	Other Information	3134
Item 9C.	Disclosure regarding Foreign Jurisdiction that ~~Prevent~~Prevents inspections	3134
PART III
Item 10.	Directors, Executive Officers, Promoters, and Control Persons and Corporate Governance; Compliance with Section 16 (a) of the Exchange Act	3235
Item 11.	Executive Compensation	3741
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	4247
Item 13.	Certain Relationships and Related Transactions, and Director Independence	4348
Item 14.	Principal Accounting Fees and Services	4450
PART IV
Item 15.	Exhibits and Financial Statement Schedules	4651
Item 16.	Form 10-K Summary	4751
SIGNATURES		4852
EXHIBITS

FORWARD-LOOKING STATEMENTS

When used in this Annual Report on Form 10-K, the words “may”, “will”, “should”, “expect”, “believe”, “anticipate”, “continue”, “estimate”, “project”, “intend” and similar expressions are intended to identify forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) regarding events, conditions and financial trends that may affect Milestone Scientific’s future plans of operations, business strategy, results of operations and financial condition. Milestone Scientific wishes to ensure that such statements are accompanied by meaningful cautionary statements pursuant to the safe harbor established in the Private Securities Litigation Reform Act of 1995. The forward-looking statements included herein are based on current expectations that involve numerous risks and uncertainties. Milestone Scientific’s plans and objectives are based, in part, on assumptions involving the continued expansion of its business. Assumptions relating to the foregoing involve judgments with respect to, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the control of Milestone Scientific. Although Milestone Scientific believes that its assumptions underlying the forward-looking statements are reasonable, any of the assumptions could prove inaccurate. Considering the significant uncertainties inherent in the forward-looking statements included herein, our history of operating losses that are expected to continue, requiring additional funding which we may be unable to raise capital when needed (which may force us to delay, curtail or eliminate commercialization efforts of our CompuFlo Epidural Computer Controlled Anesthesia System), the early stage operations of and relative lack of acceptance of our medical products, relying exclusively on two third parties to manufacture our products, changes to our distribution arrangements exposes us to risks of interruption of marketing efforts and building new marketing channels, changes in our informal manufacturing arrangements made by the manufacturer of our products and disruptions at the manufacturing facility of our manufacturers, including shortages of or delays in obtaining chips and other components, exposes us to risks that may harm our business, raising additional funds by issuing securities or through licensing or lending arrangements may cause dilution to our existing stockholders, restrict our operations or require us to relinquish proprietary rights, if physicians do not accept nor use our CompuFlo Epidural Computer Controlled Anesthesia System, our ability to generate revenue from sales will be materially impaired, exposure to the risks inherent in international sales and operations, including China, and developments by competitors may render our products or technologies obsolete or non-competitive, changes in United States policy regarding international trade, including the imposition of tariff and export controls on certain goods and products imported from China and other countries, which has resulted in retaliatory tariffs and other trade measures by China, the United States and other countries that will result in an increase in costs that we may not be able to offset or that otherwise adversely impact our results of operations, the inclusion of such information should not be regarded as a representation by Milestone Scientific or any other person that the objectives and plans of Milestone Scientific will be achieved. Prospective investors are cautioned that any forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties and the actual results may differ materially from those included within the forward-looking statements because of various factors. Except as required by the federal securities laws, Milestone Scientific undertakes no obligation to revise or update any forward-looking statements, whether as a result of new information, future events or otherwise, to reflect events or circumstances occurring after the date of this Annual Report on Form 10-K. Milestone Scientific is the owner of the following registered U.S. trademarks: CompuDent®; CompuMed®; CompuFlo®; DPS Dynamic Pressure Sensing technology®; Milestone Scientific ®; CathCheck®; the Milestone logo ®; SafetyWand®; STA Single Tooth Anesthesia Device®; and The Wand ®.

~~PART I~~ FORWARD-LOOKING STATEMENTS

~~All~~When used ~~references~~ in this ~~report~~Annual toReport on Form 10-K, the words “~~Milestone~~may”, ~~Scientific~~“will”, “should”, ~~the~~“expect”, “~~Company~~believe”, or“anticipate”, “~~Milestone~~continue”, ~~refer~~“estimate”, “project”, “intend” and similar expressions are intended to identify forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) regarding events, conditions and financial trends that may affect Milestone Scientific’s ~~Inc.~~plans of operations, business strategy, results of operations and ~~its~~financial ~~consolidated~~condition. ~~subsidiaries~~Milestone Scientific wishes to ensure that such statements are accompanied by meaningful cautionary statements pursuant to the safe harbor established in the Private Securities Litigation Reform Act of 1995. The forward-looking statements included herein are based on current expectations that involve numerous risks and uncertainties. Milestone Scientific’s plans and objectives are based, ~~Wand~~in ~~Dental~~part, ~~Inc~~on assumptions involving the continued expansion of its business. Assumptions relating to the foregoing involve judgments with respect to, among other things, future economic, competitive, and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the control of Milestone ~~Innovation Inc~~Scientific. Although Milestone Scientific believes that its assumptions underlying the forward-looking statements are reasonable, ~~unless~~any of the ~~context~~assumptions could prove inaccurate. Considering the significant uncertainties inherent in the forward-looking statements included herein, our history of operating losses that are expected to continue, requiring additional funding which we may be unable to raise capital when needed (which may force us to delay, curtail or eliminate commercialization efforts of our CompuFlo Epidural Computer Controlled Anesthesia System), the early stage operations of and relative lack of acceptance of our medical products, relying exclusively on two third parties to manufacture our products, changes to our distribution arrangements exposes us to risks of interruption of marketing efforts and building new marketing channels, changes in our informal manufacturing arrangements made by the manufacturer of our products and disruptions at the manufacturing facility of our manufacturers, including shortages of or delays in obtaining chips and other components, exposes us to risks that may harm our business, raising additional funds by issuing securities or through licensing or lending arrangements may cause dilution to our existing stockholders, restrict our operations or require us to relinquish proprietary rights, our ability to generate revenue from sales will be materially impaired if physicians do not accept nor use our CompuFlo Epidural Computer Controlled Anesthesia System, exposure to the risks inherent in international sales and operations, including China, several legislative and regulatory changes and proposed changes regarding the healthcare system, including changes to reimbursement coverage of our products, that could prevent or delay marketing approval of product candidates, restrict or regulate post-approval activities, and affect our ability to profitably sell any product candidates for which we obtain marketing approval, and developments by competitors may render our products or technologies obsolete or non-competitive, changes in United States policy regarding international trade, including the imposition of tariff and export controls on certain goods and products imported from China and other countries, which has resulted in retaliatory tariffs and other trade measures by China, the United States and other countries that will result in an increase in costs that we may not be able to offset or that otherwise ~~indicates~~adversely impact our results of operations, the inclusion of such information should not be regarded as a representation by Milestone Scientific or any other person that the objectives and plans of Milestone Scientific will be achieved. Prospective investors are cautioned that any forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties. The actual results may differ materially from those included within the forward-looking statements because of various factors. Except as required by the federal securities laws, Milestone Scientific undertakes no obligation to revise or update any forward-looking statements, whether as a result of new information, future events, or otherwise, to reflect events or circumstances occurring after the date of this Annual Report on Form 10-K. Milestone Scientific is the owner of the following registered U.S. trademarks: CompuDent®; CompuMed®; CompuFlo®; DPS Dynamic Pressure Sensing technology®; Milestone Scientific ®; CathCheck®; the Milestone logo ®; SafetyWand®; STA Single Tooth Anesthesia ~~System~~ Device®; and The Wand ®.

Item 1. Business

Overview

Milestone Scientific Inc. was incorporated in the State of Delaware in August 1989. ~~Milestone~~The ~~Scientific~~Company ~~has~~develops ~~developed~~and acommercializes proprietary, ~~revolutionary,~~ computer-controlled drug ~~anesthetic~~ delivery ~~device,~~systems ~~its DPS~~designed ~~Dynamic Pressure Sensing Technology® System,~~ to ~~meet~~enhance the ~~needs~~safety, ofprecision, ~~various subcutaneous drug delivery injections~~ and ~~fluid~~patient ~~aspiration~~experience –associated ~~enabling healthcare practitioners to achieve multiple unique benefits that cannot currently be accomplished~~ with the 160-year-old manual syringe. The Company’s proprietary DPS Dynamic Pressure Sensing Technology is the Company’s technology platform that advances the development of next-generation devices. It regulates flow rate and monitoring pressure from the tip of the needle, through platform extensions for local anesthesia for subcutaneous ~~drug delivery, used in various dental and medical~~ injections. ~~It has specific medical applications for epidural space identification in regional anesthesia procedures~~ and ~~intra-articular~~fluid aspiration ~~joint injections~~procedures.

The Company’s ~~device,~~core ~~using~~technology ~~The Wand®~~platform, aDynamic ~~single~~Pressure ~~use~~Sensing® ~~disposable~~(“DPS”) ~~handpiece~~Technology, iscontrols ~~marketed~~flow inrate ~~dentistry under the trademarks CompuDent®~~ and ~~STA~~measures pressure ~~Single~~at ~~Tooth Anesthesia System®, and is suitable for all dental procedures that require local anesthetic. The dental devices are currently sold in~~ the ~~United~~needle ~~States,~~tip ~~Canada and~~ in ~~over~~real ~~41 other countries~~time. ~~Milestone~~ ~~Scientific~~DPS ~~also~~Technology ~~has~~is ~~510(k)~~incorporated ~~marketing~~into ~~clearance~~both ~~from~~ the ~~U.S.~~Company’s ~~Food~~dental and ~~Drug~~medical ~~Administration~~products ~~(FDA)~~and supports onclinical ~~the~~applications, ~~CompuFlo®~~including ~~Epidural~~local ~~Computer~~anesthesia ~~Controlled~~delivery, ~~Anesthesia~~epidural ~~System~~space identification in ~~the~~regional ~~lumbar~~anesthesia ~~thoracic~~ procedures, and ~~cervical~~intra-articular ~~thoracic~~joint ~~junction of the spinal region~~injections.

~~The~~In the dental market, the Company’s ~~current~~products ~~marketing~~are ~~focus~~marketed isunder ~~distribution~~the ~~using~~CompuDent® ~~its~~and ~~E-Commerce~~STA ~~platform;~~Single ~~however,~~Tooth itAnesthesia isSystem® ~~also~~trademarks and inutilize ~~the~~The ~~process~~Wand®, ~~of meeting with~~a ~~medical~~single-use ~~facilities~~disposable ~~and~~handpiece. ~~device~~These ~~distributors~~products ~~within~~are sold in the United States, ~~Middle~~Canada, ~~East~~ and ~~Europe~~more sothan as40 other tocountries. ~~develop~~In ~~other~~the ~~channels~~medical ofmarket, ~~distribution~~the Company has received U. ~~Certain~~S. ofFood ~~our~~and ~~medical~~Drug ~~instruments~~Administration ~~have~~(“FDA”) ~~obtained~~510(k) ~~European~~clearance for CEits ~~mark~~CompuFlo® ~~approval~~Epidural ~~and~~Computer ~~can~~Controlled beAnesthesia ~~marketed~~System ~~and~~for ~~sold~~use in ~~most~~specified ~~European~~regions ~~countries~~of the spine.

The Company continues to evaluate opportunities to expand its distribution channels, including e-commerce and third-party distributor relationships, and to pursue additional regulatory clearances and commercial opportunities in domestic and international markets.

DPS Dynamic Pressure Sensing Technology; Our Proprietary Core Technology Platform

Given our experience and established brand awareness within the dental industry beginning with our first commercial product, the first computer-controlled local anesthesia delivery (C-CLAD) system marketed as the Wand® and re-branded as the CompuDent® System, now the market leader in dental injection technology, we elected to focus our product development efforts on improving the patient experience and making the device more versatile and precise for the practitioner.

Our next significant intellectual property advancement was an improvement over our CompuDent® System – the development of our proprietary CompuFlo® Computer-Controlled Drug Delivery System with DPS Dynamic Pressure Sensing Technology, an advanced ~~and FDA-approved~~ technology for the painless and accurate delivery of drugs, anesthetics, and other medicaments into all tissue types, as well as for the aspiration of bodily fluids or previously injected substances. Its regulation and control of the flow rate ~~continues~~continue to provide painless delivery benefits,. ~~while~~In contrast, its innovative dynamic pressure sensing capability provides visual and audible in-tissue pressure feedback, identifying tissue types to the healthcare provider. This pressure feedback extends the benefit of painlessness from anesthetics with known viscosities to a wide range of liquid drugs and other medicaments with varying viscosities and flow rates. Such pressure feedback, part of our DPS Dynamic Pressure Sensing Technology, also allows the healthcare provider to know when certain types of tissues have been penetrated and permits the healthcare provider to inject medicaments precisely at the desired location. Thus, real-time continuous pressure feedback can prevent the injection of tissue outside the intended target area, an important characteristic in the injection of chemotherapeutics and other toxic substances. In addition to the ability to determine exit pressure in-situ (in the injection site tissue) at the tip of the needle, minimizing tissue damage (and eliminating the pain of the injection) because the flow rate and pressure of the injection are precisely controlled, CompuFlo® computer-controlled Drug Delivery Systems features a proprietary algorithm, which allow for the measurement of the exit pressure. CompuFlo® technology also enables devices to provide a digital record of the time and volume of anesthetic or medicament injected.

In 3addition to the ability to determine exit pressure in situ (in the injection site tissue) at the tip of the needle, minimizing tissue damage (and eliminating the pain of the injection) because the flow rate and pressure of the injection are precisely controlled, CompuFlo® computer-controlled Drug Delivery Systems features a proprietary algorithm, which allow for the measurement of the exit pressure. CompuFlo® technology also enables devices to provide a digital record of the time and volume of anesthetic or medicament injected. Each Wand/STA System also includes a disposable injection handpiece that is extremely comfortable, light, and easy to use, providing for precise tactile control during the injection, an electro-mechanical (computer-controlled) fluid delivery instrument, and the ability to record data from the injection event.

Each Wand/STA System also includes a disposable injection handpiece that is extremely comfortable, light, and easy to use, providing for precise tactile control during the injection, an electro-mechanical (computer-controlled) fluid delivery instrument and the ability to record data from the injection event. The pencil grip used with the handpieces provides the practitioner with enhanced tactile sense and accurate control and allows bi-directional rotation, eliminating needle deflection, resulting in greater accuracy and success. The handpiece is vibration-free because it does not have a motor or electrical component in it, and, since the handpiece does not look like a typical syringe, we believe it also reduces patient anxiety and offers the possibility of curing dental phobia, of which an estimated 40 million Americans suffer.

As confirmed by numerous noted medical and dental experts within academia and the clinical practice arenas, CompuFlo Systems using DPS Dynamic Pressure Sensing technology have the potential to greatly increase the safety and efficacy of many drug delivery procedures that currently rely upon the over 160-year-old hypodermic syringe technology and the tactile senses and delivery expertise of the administrator.

Devices using DPS Dynamic Pressure Sensing Technology, such as the CompuFlo System, can be used to inject a wide variety of liquid medicaments as well as anesthetics. We believe our CompuFlo System avoids the negative side effects from the use of traditional hypodermic drug delivery injection devices, which are well documented in dental and medical literature and include risk of death, transient or permanent paralysis, pain, tissue damage, and post-operative complications. Pain and tissue damage often result from uncontrolled flow rates and pressure created during the administration of drug solutions into human tissue. While several technologies can control the flow rate, we believe our patented DPS Dynamic Pressure Sensing technology and CompuFlo Systems provide the control of pressure during the injection as well as accurately and precisely ~~delivery~~deliver the drug.

CompuFlo Epidural Computer Controlled Anesthesia System

The CompuFlo Epidural Computer Controlled Anesthesia System (or the CompuFlo Epidural System) is one such platform extension of our DPS Dynamic Pressure Sensing Technology platform, providing anesthesiologists and other healthcare providers the ability, for the first time, to quantitatively determine and document the pressure at the needle tip in real-time for proper needle placement in epidural procedures used for labor/delivery and back pain management. Our proprietary DPS Dynamic Pressure Sensing Technology allows the CompuFlo Epidural System to provide objective visual and audible in-tissue pressure feedback that allows anesthesiologists to identify and confirm placement in the epidural space.

Our CompuFlo Epidural System provides an objective tool that we believe consistently and accurately identifies the epidural space by detecting the difference in pressure between the ligamentum flavum and the ~~intrafilamentary~~intradural tissue. In studies, the CompuFlo Epidural System with DPS Dynamic Pressure Sensing Technology has been shown to be effective in correctly identifying the epidural space. Knowing the precise location of a needle tip during an epidural injection procedure provides a measure of safety not presently available to doctors using conventional syringes. In the absence of fluoroscopy, identifying the epidural space by relying on the subjective perception of loss of resistance to saline requires a very long education period and learning curve. ~~and~~It could result in morbidity and lack of efficacy. During back pain management epidural procedures, where fluoroscopy is commonly used, the CompuFlo Epidural System allows the clinician to locate the epidural space, without using fluoroscopy, thereby protecting the patient and clinician from unnecessary exposure to radiation, along with significantly reducing capital and operating costs.

Wand/STA Dental Product

Since its ~~market~~commercial introduction in early 2007, the STA Single Tooth Anesthesia (STA) System ~~and~~, ~~prior~~together with its predecessor C-CLAD devices, has ~~have~~ been used to ~~deliver~~administer ~~over~~more than 95 million ~~safe, effective, and comfortable~~ injections globally. The ~~instrument~~system ~~has~~is ~~also~~designed ~~been~~to ~~favorably~~provide ~~evaluated~~controlled indelivery ~~numerous~~of ~~peer-reviewed,~~local anesthetic ~~published~~and ~~clinical~~has ~~studies~~been ~~and~~utilized ~~associated~~in ~~articles.~~a ~~Moreover,~~broad ~~there~~range ~~appears~~of todental beprocedures. aThe ~~growing~~STA ~~consensus~~Instrument ~~among~~has ~~users~~been ~~that~~evaluated ~~the~~in ~~STA~~multiple ~~Instrument~~peer-reviewed clinical isstudies ~~proving~~and topublished bearticles. aFeedback ~~valuable~~from practitioners and ~~beneficial~~published ~~instrument~~literature indicate that isthe ~~positively~~technology ~~impacting~~has ~~the~~been incorporated into clinical practice ofin ~~dentistry~~various markets worldwide.

Patents and Intellectual Property

Milestone Scientific and its subsidiaries currently hold approximately 305 issued U.S. and foreign patents, along with numerous pending patent applications. These patents and applications relate to a wide range of proprietary technologies, including drug delivery methodologies; drug flow-rate measurement; pressure- and force-based computer-controlled drug delivery with exit pressure; dynamic pressure sensing; automated rate control and charging; drug delivery profiles; audible and visual feedback; tissue identification; injection units; drug drive units for anesthetics; handpieces; and injection devices.

Medical Market Product

InAs of ~~June 2017~~2025, wethe CompuFlo® Epidural System has received ~~FDA~~multiple regulatory clearances and reimbursement milestones in the United States. The system initially received FDA 510(k) clearance in 2017 for epidural injections in the lumbar region, with expanded clearance in 2023 for use in the thoracic region, including the cervicothoracic junction. In 2022, the American Medical Association assigned a technology-specific Category III CPT® code (0777T), effective January 1, 2023, to ~~sell~~facilitate tracking and reimbursement submissions when the ~~CompuFlo~~system ~~Epidural~~is used ~~Computer~~in ~~Controlled~~conjunction ~~Anesthesia~~with ~~System~~primary epidural steroid injection procedures. In 2024, Medicare Administrative Contractors in Florida and multiple additional jurisdictions established Medicare Part B physician payment determinations for CPT code 0777T. The Company also received Notices of Allowance in the United States ~~for~~and ~~epidural~~Europe ~~injections~~in 2024 related to its next-generation Dynamic Pressure Sensing® technology.

In May, 2022, the Company received a chronology-specific CPT Code for the Company’s technology by the American Medical Association, which marks an important milestone that could increase the potential number of anesthesia pain management clinics adopting the CompuFlo instrument. Effective January 1, 2023, this temporary tracking code allows clinicians to submit claims to healthcare insurance providers using the Company’s technology for Epidural Sterile Injections in the lumbar, thoracic, and cervical thoracic junction of the spinal region for reimbursement. A CPT code expands the potential for reimbursement of epidural procedures in pain management utilizing the CompuFlo Epidural System, which should help accelerate the commercial roll-out of CompuFlo in the United States.

On February 27, 2023, the Company announced that its CompuFlo® Epidural System has received 510(k) FDA clearance for use in the thoracic region of the spine, including the cervical thoracic junction. This approval expands upon the Company’s prior approval of CompuFlo for use within the lumbar region of the spine, where the focus has been epidural analgesia during labor and delivery procedures.

On June 18, 2024, the Company announced that it has received regulatory approval from Brazil's National Health Surveillance Agency (ANVISA) to market and sell its CompuFlo® Epidural System in Brazil. The approval includes the lumbar, thoracic, and cervical-thoracic junction of the spine.

On July 10, 2024, the Company announced that First Coast Service Options Inc. (FCSO), a Jurisdictional Medicare Administrative Contractor (“JMAC”), has granted favorable Medicare Part B physician price assignment across Florida for use of the Company’s CompuFlo® Epidural System under the American Medical Association’s (AMA) technology-specific Category III CPT® code CPT0777T (real-time pressure-sensing epidural guidance system when used in conjunction with a primary ESI procedure).

On July 23, 2024, the Company announced that Novitas Solutions, Inc. (Novitas), a Jurisdictional Medicare Administrative Contractor (JMAC), had granted a Medicare Part B Physician payment rate for the Company’s CompuFlo® Epidural System under the American Medical Association’s (AMA) technology-specific Category III CPT® code CPT0777T (real-time pressure-sensing epidural guidance system when used in conjunction with a primary ESI procedure).This new price assignment applies to two Medicare regions: Jurisdiction L (JL) and Jurisdiction H (JH). JL includes Delaware, District of Columbia, Maryland, New Jersey, and Pennsylvania. JH includes Arkansas, Colorado, Louisiana, Mississippi, New Mexico, Oklahoma, and Texas.

On July 30, 2024, the Company announced receipt of multiple Notices of Allowance (NOA) for essential patent applications in both the U.S. and Europe. One NOAs was granted by the U.S. Patent and Trademark Office and one NOA was granted by the European Patent Office for a new patent titled “Device and Method for Needle/Catheter Location Utilizing Correlation Analysis.” These patent applications cover Milestone Scientific’s next-generation Dynamic Pressure Sensing® (DPS) technology for real-time pressure-sensing guidance in manual injection systems

On August 7, 2024, the Company announced a strategic partnership with Axial Biologics, a premier medical device company with a vast distribution network. Under the agreement, Axial Biologics will serve as the distributor of Milestone Scientific's CompuFlo® Epidural System in New Jersey, Texas, and Florida jurisdictions.

On October 3, 2024, the Company announced that iHeal Pain Center had adopted the CompuFlo® Epidural System following successful epidural steroid injection (ESI) procedure.

On November 26,2024, the Company announced its approval on contract for the Federal Supply Schedule (FSS), also known as the GSA Schedule, for the CompuFlo® Epidural System.

Other Possible Product Applications

The Company is ~~reviewing~~exploring ~~the~~additional ~~use~~potential ofapplications ~~CompuFlo’s~~for ~~DPS~~its Dynamic Pressure Sensing® ~~Technology~~(“DPS”) ~~for~~technology ~~less painful injections for use~~ platform in ~~rhinoplasty,~~various ~~colorectal~~medical ~~surgery, podiatry, and other disciplines~~settings. InThese ~~the~~areas ~~self-injectable~~may ~~market,~~include ~~there~~certain ~~are~~surgical many injectable drugs routinely self-administered in a home or office setting using spring loaded automatic injection devices by people who suffer from long-term chronic conditions such as multiple sclerosis, rheumatoid arthritis, and ~~other~~procedural ~~diseases of the auto immune system. We believe CompuFlo’s DPS Dynamic Pressure Sensing Technology~~specialties, ~~using~~as ~~pressure~~well ~~sensing capabilities, can serve~~ as apotential ~~less~~applications ~~painless~~in the ~~subcutaneous injection method for these~~ self-~~administered~~injection ~~drugs.~~drug ~~However, there can be no assurance that we will be able to successfully develop any such products, or that if developed, that we will be able to obtain FDA approval to~~ market ~~any such products~~, orwhere ~~even~~patients ifadminister weinjectable dotherapies ~~obtain~~for ~~such~~chronic ~~FDA~~conditions ~~approval,~~at ~~that~~home ~~any such products will generate any revenue for us~~ or bein aclinical ~~commercial success~~environments.

Development ~~Patents~~of new product applications is subject to significant technical, clinical, regulatory, and ~~Intellectual~~commercial ~~Property~~risks. Any new application of DPS technology would require substantial research and development, potential clinical evaluation, regulatory review and clearance or approval, and the establishment of manufacturing and distribution capabilities. The regulatory pathway for new indications or product configurations may be lengthy, uncertain, and costly.

~~Milestone~~There can ~~Scientific~~be ~~and~~no ~~its~~assurance ~~subsidiaries~~that ~~currently~~the ~~hold approximately 317 U.S. and foreign patents, and many patent applications. The~~ Company’s ~~patents~~will ~~and~~successfully ~~patent~~develop ~~applications~~additional ~~relate~~products toor ~~drug delivery methodologies~~indications, ~~drug~~obtain ~~flow~~necessary ~~rate~~regulatory ~~measurement,~~clearances or ~~pressure/force~~approvals ~~computer-controlled~~from ~~drug~~the ~~delivery~~U.S. ~~with~~Food ~~exit~~and ~~pressure,~~Drug ~~dynamic~~Administration ~~pressure~~(“FDA”) ~~sensing,~~or ~~automated~~other ~~rate~~regulatory ~~control~~authorities, ~~automated~~secure ~~charging,~~reimbursement ~~drug profiles~~coverage, achieve ~~audible~~market ~~and visual pressure/force feedback~~acceptance, ~~tissue~~or ~~identification,~~generate ~~drug~~revenue ~~delivery~~from ~~injection~~any ~~unit,~~such ~~drug drive unit for anesthetic, handpiece, and injection device~~initiatives. ~~Milestone~~Failure ~~Scientific~~to ~~and~~successfully ~~its~~develop ~~subsidiaries also currently hold approximately 21 registered U.S.~~ and ~~foreign~~commercialize ~~trademarks,~~new ~~including~~applications could ~~CompuDent®,~~adversely ~~CompuFlo®,~~affect ~~DPS~~the ~~Dynamic~~Company’s ~~Pressure~~future ~~Sensing~~growth ~~technology®, Safety Wand®, STA Single Tooth Anesthesia System®, and The Wand®~~prospects.

Milestone Scientific ~~relies on a combination of patent, copyright, trade secret~~ and ~~trademark~~its ~~laws~~subsidiaries ~~and~~also ~~employee~~hold ~~and~~approximately ~~third-party~~10 ~~non-disclosure~~registered ~~agreements to protect its intellectual property rights~~U.S. ~~Despite~~and ~~the~~foreign ~~precautions taken by Milestone Scientific to protect its IP rights~~trademarks, ~~unauthorized~~including ~~parties may attempt to reverse engineer~~CompuDent®, ~~copy~~CompuFlo®, DPS orDynamic ~~obtain~~Pressure ~~and~~Sensing® ~~use~~technology, ~~products~~Safety ~~and information that Milestone Scientific regards as proprietary~~Wand®, orSTA ~~may~~Single ~~design~~Tooth ~~products~~Anesthesia serving similar purposes that do not infringe on Milestone Scientific’s patents. Milestone Scientific’s failure to protect its proprietary information and the expenses of doing so could have a material adverse effect on our businessSystem®, ~~financial condition,~~ and ~~results~~The ~~of operations~~Wand®.

IfThe Company ~~Milestone~~relies ~~Scientific’s~~on ~~products~~a ~~infringe~~combination ~~upon~~of patent, orcopyright, ~~proprietary~~trade secret, and trademark laws, as well as employee and third-party nondisclosure agreements, to protect its intellectual property rights. ofDespite ~~others~~these efforts, weunauthorized parties may beattempt ~~required~~ to ~~modify~~reverse ~~processes~~engineer, copy, or tootherwise obtain ~~licenses.~~and ~~There~~use ~~can~~technologies beor noinformation ~~assurance~~ that ~~Milestone~~the ~~Scientific~~Company ~~would~~considers beproprietary, ~~able~~or tomay dodevelop socompeting inproducts that aserve ~~timely~~similar ~~manner,~~purposes onwithout ~~acceptable~~infringing ~~terms~~the ~~and~~Company’s ~~conditions~~patents. Failure to adequately protect the Company’s proprietary information, oras atwell ~~all.~~as ~~The~~the ~~failure~~costs toassociated dowith sosuch protection, could have a material adverse effect on ~~our~~the Company’s business, financial condition, and results of operations.

In addition, if the Company’s products are found to infringe upon the patent or proprietary rights of others, the Company may be required to modify its products or processes or obtain licenses from third parties. There can be no assurance that any such licenses would be available on commercially reasonable terms, promptly, or at all. Failure to do so could have a material adverse effect on the Company’s business, financial condition, and results of operations.

Manufacturing

~~Milestone~~The Company ~~Scientific~~relies ~~has~~on ~~informal~~third-party ~~arrangements~~manufacturers ~~with~~for anthe ~~U.S.~~production ~~manufacturer~~ of ~~the~~its products. The Wand®/STA® System, and epidural devices are manufactured by a U.S.-based ~~Pursuant~~supplier pursuant to ~~these~~individual ~~informal~~purchase ~~arrangements,~~orders ~~our~~without ~~third-party~~minimum ~~manufacturer~~volume ~~manufactures~~commitments. ~~the~~Dental ~~Wand/STA~~handpieces ~~System~~are sourced ~~under~~from ~~specific~~a ~~purchase~~manufacturer ~~orders~~located ~~without~~in ~~minimum~~the ~~purchase~~People’s ~~commitments,~~Republic ~~and~~of atChina ~~prices~~under toan beagreement ~~agreed~~that ~~upon~~includes inpricing ~~each~~terms. ~~such~~The ~~purchase~~Company has ~~order~~maintained long-standing relationships with these manufacturers.

~~Our~~The Company’s ~~agreement~~dependence ~~with~~on ~~the~~a ~~principal~~limited ~~manufacturer~~number of ~~dental~~suppliers ~~handpieces~~exposes ~~includes~~it ~~pricing~~to ~~terms.~~risks, ~~Milestone~~including ~~Scientific~~pricing ~~has~~changes, ~~been~~supply ~~supplied by the manufacturer of the Wand/STA System and its predecessor~~disruptions, ~~the CompuDent System~~quality issues, ~~since~~geopolitical ~~the commencement of production in 1998~~factors, and bytermination ~~the~~of ~~manufacturer~~manufacturing ofrelationships. ~~its~~Any ~~dental~~interruption ~~handpieces~~or ~~since~~inability ~~2003.~~to ~~The~~obtain ~~manufacturer~~an ofadequate ~~our~~supply could ~~dental~~materially ~~handpieces~~and isadversely inaffect the ~~People~~Company’s ~~Republic~~business, offinancial ~~China~~condition, and ~~the~~results ~~manufacturer~~ of ~~the Wand/STA System is in the United States~~operations. ~~Refer~~See to Item 1A., “Risk Factors. ”

Changes to pricing of the Wand/STA System instruments by the manufacturer could have a material adverse effect on our financial condition, business, and results of operations. Termination of the manufacturing relationship with any of these third-party manufacturers could significantly and adversely affect our ability to produce and sell the products.

Though other alternate sources of supply for dental handpieces exist, Milestone Scientific would need to establish relationships with new suppliers, and with respect to the Wand/STA System recover its existing tools or have new tools produced and “burn in” and other manufacturing and quality control software re-produced. Establishing new manufacturing relationships could involve significant expense and delay. Any curtailment or interruptions of supply, whether because of the inability of a supplier to meet our product delivery needs or termination of the relationship, would have a material adverse effect on our financial condition, business, and results of operations.

Distribution and Marketing

Dental Products

The Company ~~uses~~markets and sells its dental products worldwide through a combination of exclusive and non-exclusive ~~distributors~~distribution ~~to sell its dental products throughout the world~~arrangements.

~~The~~In the United States, the Company sells its STA Single Tooth Anesthesia Systems® ~~(STA)~~ and related handpieces directly to dental offices and dental groups ~~within~~through ~~the United States via~~ an online sales portal. The Company'’s Ee-~~Commerce portal~~commerce platform accepts ~~online~~electronic payments, ~~via~~including credit ~~and~~ and debit cards. ~~The~~Shipping ~~cost~~costs ofare ~~delivery~~billed ~~is charged~~ to ~~the~~customers, ~~customer~~and ~~along~~applicable ~~with the collection of sales tax for appropriate~~ state and local ~~taxing jurisdictions. The Company recognizes revenue from product~~ sales at ~~the~~taxes ~~time~~are ~~the product ships to a customer via a third party carrier~~collected.

On Internationally, the ~~global~~Company ~~front,~~has ~~we have~~ granted exclusive marketing and distribution rights for the Wand STA System to select dental suppliers in ~~various~~certain regions of ~~within~~ Asia, Africa, South America, and Europe. ~~Additionally,~~The ~~the~~ Company isperiodically inevaluates ~~the~~its ~~process~~international ofdistribution ~~evaluating~~arrangements ~~its~~and ~~current~~may ~~international~~add, replace, ~~distributors~~or expand distributor relationships based on commercial and ~~adding~~regional ~~new~~economic ~~distributors~~considerations. ~~globally~~The asCompany ~~required~~continues ~~based~~to onassess opportunities ~~the~~to ~~economics~~appoint ofadditional ~~the~~distributors ~~region~~globally as market conditions warrant.

Medical Products

The Company ~~markets~~is ~~and~~engaged ~~sells~~in ~~its~~the ~~medical~~marketing ~~products~~and insale ~~the~~of ~~international~~medical ~~markets,~~products ~~including~~to ~~Italy,~~customers ~~Switzerland,~~in ~~Greece,~~domestic ~~Canada~~ and ~~the~~international ~~Middle~~markets. ~~East,~~The ~~through~~Company’s commercialization ~~exclusive~~strategy ~~distributors.~~is Indesigned ~~the~~to ~~United~~support ~~States~~broad ~~the~~market ~~medical~~access ~~products~~while ~~are~~maintaining ~~sold~~operational byefficiency aand ~~direct~~includes ~~sales~~a ~~team~~ combination of ~~one full~~direct ~~time~~sales ~~employee~~efforts and athird-party ~~partnership~~distribution ~~with distributor~~arrangements.

In the United States, the Company sells its medical products through a direct sales organization, supplemented by distribution arrangements with independent agents. This hybrid approach allows the Company to maintain direct relationships with customers while leveraging external sales resources to expand market reach.

Internationally, the Company markets and sells its medical products through third-party distributors, including both exclusive and non-exclusive arrangements, depending on the region. In certain markets, including Italy, the Company has entered into exclusive distribution agreements to support localized sales, marketing, and customer support. The Company periodically evaluates its distribution strategy and may modify its sales channels or distributor relationships based on market conditions, regulatory considerations, and commercial performance.

Competition

Milestone Scientific, Inc. was the first company to ~~market~~commercialize a product ~~that~~designed ~~performed~~to deliver a virtually painless subcutaneous injection, ~~back~~which it introduced in 1997. ~~The~~ ~~company~~With ~~defined~~the alaunch ~~new~~of ~~category~~this oftechnology, ~~drug~~the ~~delivery~~Company ~~systems~~established ~~with~~a ~~the~~new ~~introduction~~category of ~~its~~computer-controlled ~~technology~~drug delivery systems. ~~Over~~ ~~the~~Since ~~years~~that ~~there~~time, ~~have been~~ competing products ~~that~~ have ~~come~~entered tothe market; ~~but~~however, ~~none~~the toCompany ~~them~~believes tothat ~~date~~its products have been more extensively studied and ~~accepted~~adopted asthan ~~widely~~competing alternatives, as ~~the~~evidenced ~~products~~by ~~from Milestone Scientific. Inc. This understanding is based on~~ the ~~sheer~~ number of scientific ~~studies~~and ~~performed~~clinical ~~with~~studies ~~our technologies. A simple internet search proves this point. Milestone Scientific, Inc. continues to be~~ evaluating the ~~leader~~Company’s ~~in this category~~technologies.

Milestone’s Scientific ~~has~~ developed the first subcutaneous drug delivery platform that ~~utilizes~~regulates ~~a novel approach to drug delivery by regulating~~ and ~~monitoring~~monitors both ~~the~~ flow rate and exit- pressure in real- time ~~when~~during ~~performing a subcutaneous~~ injection. This ~~has~~proprietary ~~enabled~~approach anenables ~~injection~~the todelivery beof ~~performed~~anesthetic assolutions in a ~~virtually~~manner ~~painless~~designed ~~injection. In~~to ~~addition,~~minimize ~~this~~patient discomfort. ~~same~~The ~~technology~~Company’s ispatented ~~capable~~Dynamic ofPressure ~~identifying~~Sensing a(“DPS”) ~~specific~~technology ~~target~~further ~~when~~allows ~~performed,~~for ~~this~~the ~~patented~~identification of ~~technology~~specific isanatomical ~~called DPS~~targets ~~technology~~by ~~or Dynamic~~providing ~~Pressure~~real-time ~~Sensing~~feedback ~~technology~~during injection.

~~Milestone Scientific~~The Company’s devices compete ~~based~~primarily on ~~their~~ performance characteristics and the clinical and operational benefits provided to ~~the~~patients and ~~patient,~~practitioners. ~~practitioner,~~Clinical ~~and~~studies ~~their~~evaluating ~~business~~the ~~operations.~~Company’s ~~Numerous clinical~~products ~~studies~~ have ~~shown~~demonstrated ~~that~~reductions ~~our~~in ~~devices~~patient ~~reduce~~ fear, pain, and anxiety associated ~~for~~with ~~many~~injections. ~~patients,~~The ~~and~~Company ~~Milestone Scientific~~ believes ~~that~~these ~~they~~benefits ~~can~~may also reduce practitioner stress ~~levels, as well. Other computer-controlled local anesthesia delivery (C-CLAD) options are the Quicksleeper~~ and ~~SleeperOne,~~improve ~~from~~workflow ~~Dental Hi Tec, Dentapen from Septodant, Anaeject from Septodont, the Calajet from Aseptico, and the Comfort Control Syringe by Dentsply~~efficiency.

~~The~~In the ~~Quicksleeper~~dental ~~was~~market, ~~invented~~the inCompany ~~France~~competes bywith ~~Dr.~~other ~~Alain~~computer-controlled ~~Villette in 1991. It is marketed as the only~~ local ~~anesthetic~~anesthesia delivery ~~device~~(“C-CLAD”) insystems, ~~France that allows~~ including the ~~ability to perform all intraoral local anesthetic injection techniques~~Soan, ~~including osteocentral anesthesia~~Quicksleeper, ~~quickly~~ and ~~without~~SleeperOne ~~failure.~~devices ~~The~~manufactured ~~extra~~by ~~feature~~Dental ~~that~~Hi ~~gives~~Tec, ~~the~~Dentapen ~~Quicksleeper~~by ~~this~~Septodont, ~~ability~~Anaeject isby aSeptodont, ~~built-in motor in~~ the ~~syringe/handpiece~~Calaject system ~~that~~by ~~renders~~Aseptico, ~~the syringe both an injector~~ and ~~a perforator of bone. That is,~~ the ~~handpiece~~Comfort ofControl ~~the~~Syringe ~~Quicksleeper~~by ~~can~~Dentsply ~~perform an intraosseous injection via a motor driven perforation of the cortical plate of bone~~Sirona. AThese ~~standard~~competing ~~dental~~systems ~~needle~~vary ~~that~~in ~~attaches to the syringe spins as the motor rotates the handpiece thus acting as a perforator. However~~design, ~~the handpiece is relatively heavy~~functionality, ~~weighing 240 g. as compared to a standard syringe that weighs 80 g. Injection speed increases during the injection~~price, and ~~but~~market ~~the operator cannot control when the injection speed increases~~penetration.

~~The~~Certain competing ~~Calajet~~devices ~~instrument, manufactured~~incorporate inmotor-driven ~~Europe,~~mechanisms ~~has~~to ~~been~~facilitate ~~very~~intraosseous ~~slow~~injections toor ~~grow~~bone ~~market acceptance~~perforation. ItFor ~~recently~~example, ~~began marketing in~~ the ~~United~~Quicksleeper system, ~~States~~originally ~~with~~developed ~~similar~~in ~~slow~~France, ~~acceptance.~~integrates ~~The~~a ~~instrument~~motorized ishandpiece athat ~~does~~allows ~~not~~both ~~provide~~injection ~~dynamic~~and ~~pressure~~bone ~~sensing~~perforation ~~technology~~but tois ~~identify~~heavier than a ~~specific~~standard ~~target~~dental bysyringe ~~providing~~and ~~real-time~~provides ~~audible~~limited ~~feedback~~operator ~~when~~control ~~the~~over ~~actual~~injection ~~target~~speed. isOther ~~identified~~devices .emphasize ~~Although~~specific ause ~~competitor~~cases, such weas ~~believe~~pediatric ~~that~~intraosseous ~~without~~injections, aor ~~substantial~~have ~~distribution~~experienced ~~network this~~limited ~~instrument~~market ~~will~~adoption ~~have~~due ~~a difficult time~~ to bedistribution ~~successful~~constraints inor ~~the~~clinical ~~United States~~preference.

~~The~~In the ~~Dentapen~~medical ~~from~~market, ~~Septodent~~the ~~is one~~Company’s ofproducts ~~the~~compete ~~more~~with ~~recent~~devices ~~competitor~~designed to assist clinicians in ~~the~~identifying ~~market~~anatomical targets during procedures such as epidural placement. ~~This~~Recent ~~device~~competitors isinclude ~~manufactured~~the inEpiFaith ~~Europe~~syringe, ~~and~~Episure ~~began~~syringe, ~~marketing~~Epidrum indevice, and the EpiFinder ~~United~~system, ~~States~~which received U.S. FDA clearance in ~~2018~~2023. ~~This~~These ~~device is~~devices ~~priced~~employ ~~like~~varying ~~the Wand/STA~~technologies ~~device~~and approaches, ~~but~~including ~~currently,~~loss-of-resistance methods toand ~~our~~sensor-based ~~knowledge,~~detection. itThe ~~has~~Company ~~been~~believes ~~slow~~that toits ~~attract~~DPS ~~viable~~technology ~~distribution~~is indifferentiated by providing continuous real-time audible and visual pressure feedback throughout the ~~United~~entire ~~States~~needle insertion process.

InThe Company’s ~~the~~proprietary ~~medical~~systems ~~segment,~~also ~~for~~compete ~~needle~~with ~~verification~~conventional disposable and ~~placement~~reusable ~~the~~syringes ~~EpiFaith~~that ~~Syringe~~utilize ~~made~~established ~~its~~manual ~~market entry in 2023. The EpiFaith syringe~~ techniques and ~~Episure~~are ~~syringe~~generally ~~both~~offered ~~claim to assist physicians in entering epidural space. The instrument is introduced~~ at a lower price. ~~Another~~points ~~competitor to assist~~ in ~~the~~both ~~identification of~~ the ~~epidural~~dental ~~space is the Epidrum (Exmoor Innovations Ltd., Somerset, UK). Although potential competitors, we believe that our technology is well documented~~ and ismedical ~~the only real-time audible and visual pressure sensor guidance system for epidural analgesia assisting the physician over the entire trajectory of epidural needle placement and catheter verification~~markets.

~~Milestone~~The markets ~~Scientific~~in which the Company operates are subject to technological change and ongoing research and development. Existing new competitors may introduce products with enhanced features or alternative technologies that could reduce the market acceptance of the Company’s products ~~proprietary~~or render them less competitive. Accordingly, ~~patented~~the ~~devices~~Company ~~with~~devotes ~~its~~significant ~~DPS~~resources ~~Dynamic~~to ~~Pressure~~improving ~~Sensing~~existing ~~Technology~~products, ~~platform~~developing new ~~also~~technologies, ~~compete~~expanding ~~with~~into ~~disposable~~adjacent markets, and ~~reusable~~maintaining ~~syringes~~regulatory ~~that~~compliance. ~~generally~~The ~~sell~~Company’s atability ~~lower~~to ~~prices~~compete ~~and~~successfully also ~~that~~depends ~~use~~on ~~established~~maintaining an effective distribution network and ~~well-understood~~executing ~~methodologies~~a incomprehensive ~~both~~marketing strategy. There can be no assurance that the ~~dental~~Company ~~and~~will ~~medical~~successfully ~~marketplaces~~develop new products, obtain required regulatory approvals, or maintain its competitive position in the marketplace.

Technological change and research in the future may affect the market acceptance of our products. Current or new competitors could, at any time, introduce new or enhanced products with features that render our products less marketable or even obsolete. Therefore, Milestone Scientific devoted substantial efforts and financial resources to improve existing products, bring products to market quickly, and develop new products for related markets. In addition, the ability to compete successfully requires that Milestone Scientific maintain an effective distribution network with a strong marketing plan. Any new products must comply with applicable regulatory authorities before they may be marketed. Milestone Scientific cannot assure that it can compete successfully, that competitors will not develop technologies or products that render our products less marketable or obsolete, or, that Milestone Scientific will succeed in improving its existing products, effectively develop new products, or obtain required regulatory approval.

Government Regulation

The manufacture and sale of medical devices and other medical products are subject to extensive regulation by the Food and Drug Administration ("“FDA"”) pursuant to the U.S. Food, Drug, and Cosmetic Act (“FD&C Act”), and by other federal, state, and foreign authorities. Under the FD&C Act, medical devices must receive FDA clearance before they can be marketed commercially in the United States. Some medical products must undergo rigorous pre-clinical and clinical testing and an extensive FDA approval process before they can be marketed.

These processes can take many years and require the expenditure of substantial resources. The time required for completing such testing and obtaining such approvals is uncertain, and FDA clearance may never be obtained. Delays or rejections may be encountered based upon changes in FDA policy during the period of product development and FDA regulatory review of each product submitted. Similar delays also may be encountered in other countries. Following the enactment of the Medical Device Amendments to the U.S. Food, Drug and Cosmetic Act in May 1976, the FDA classified medical devices in commercial distribution into one of three classes. This classification is based on the controls necessary to reasonably ensure the safety and effectiveness of medical devices. Class I devices are those devices whose safety and effectiveness can reasonably be ensured through general controls, such as adequate labeling, pre-market notification, and adherence to the FDA’s Quality System Regulation (“QSR”), also referred to as “Good Manufacturing Practices” (“GMP”) regulations. Some Class I devices are further exempt from some of the general controls. Class II devices are those devices whose safety and effectiveness reasonably can be ensured using special controls, such as performance standards, post-market surveillance, patient registries, and FDA guidelines. Class III devices are those which must receive pre-market approval by the FDA to ensure their safety and effectiveness. Generally, Class III devices are limited to life-sustaining, life-supporting or implantable devices.7

~~Prior~~These processes tocan ~~Pre-market~~take ~~Notification~~many ~~clearance,~~years and require the ~~manufacturer~~expenditure orof ~~distributor~~substantial ~~may~~resources. ~~not~~The ~~place~~time ~~the~~required ~~device~~for ~~into~~completing ~~commercial~~such ~~distribution~~testing ~~until~~and obtaining ansuch ~~order~~approvals is ~~issued by the FDA. By regulation~~uncertain, ~~the~~and FDA ~~has~~clearance nomay ~~specific~~never ~~time~~be ~~limit~~obtained. byDelays ~~which~~or itrejections ~~must~~may ~~respond~~be toencountered abased ~~510(k)~~upon ~~Pre-market~~changes in ~~Notification. Currently, the~~ FDA ~~typically~~policy ~~responds~~during to the ~~submission~~period of aproduct ~~510(k)~~development ~~Pre-market~~and ~~Notification~~FDA ~~within~~regulatory ~~180~~review ~~days.~~of ~~The~~each ~~FDA~~product ~~response~~submitted. Similar delays may ~~declare~~also ~~that~~be encountered ~~the~~in ~~device~~other iscountries. ~~substantially~~Following ~~equivalent~~the toenactment ~~another~~of ~~legally~~the ~~marketed~~Medical ~~device~~Device ~~and~~Amendments ~~allow~~to the ~~proposed~~U.S. ~~device~~Food, toDrug, beand ~~marketed~~Cosmetic Act in May ~~the United States. However~~1976, the FDA ~~may~~classified ~~determine~~medical ~~that~~devices ~~the~~in ~~proposed~~commercial ~~device~~distribution isinto ~~not~~one ~~substantially~~of ~~equivalent~~three orclasses. ~~may~~This ~~require~~classification ~~further~~is ~~information,~~based ~~such~~on asthe controls ~~additional~~necessary ~~test~~to ~~data,~~ensure ~~before~~ the ~~FDA~~safety isand ~~able~~effectiveness toof ~~decide~~medical ~~regarding~~devices ~~substantial equivalence~~reasonably. ~~Such~~Class aI ~~determination~~devices orare ~~request~~those ~~for~~devices ~~additional~~whose ~~information~~safety and ~~could~~effectiveness ~~delay~~can ~~market~~reasonably ~~introduction~~be ofensured ~~products.~~through Ifgeneral acontrols, ~~device~~such ~~that~~as ~~has~~adequate ~~obtained~~labeling, ~~510(k) Pre~~pre-market ~~Notification~~notification, ~~clearance~~and isadherence to ~~changed~~the orFDA’s ~~modified~~Quality inSystem ~~design,~~Regulation ~~components~~(“QSR”), ~~method~~also ofreferred ~~manufacture,~~to oras ~~intended~~“Good ~~use,~~Manufacturing ~~such~~Practices” ~~that~~(“GMP”) regulations. ~~the~~Some ~~safety~~Class orI ~~effectiveness~~devices ofare ~~the~~further ~~device~~exempt ~~could~~from besome ~~significantly~~of ~~affected,~~the ~~separate~~general ~~510(k)~~controls. ~~Pre-market~~Class ~~notification~~II ~~clearance~~devices ~~must~~are bethose ~~obtained~~devices ~~before~~whose ~~the~~safety and ~~modified~~effectiveness ~~device~~reasonably can be ~~marketed~~ensured inusing ~~the~~special ~~United~~controls, ~~States.~~such Ifas aperformance ~~manufacturer~~standards, orpost-market ~~distributor~~surveillance, ~~cannot~~patient registries, ~~establish~~and ~~that~~FDA aguidelines. ~~proposed~~Class ~~device~~III isdevices ~~substantially~~are ~~equivalent~~those tothat amust ~~legally~~receive ~~marketed device, the manufacturer or distributor will have to seek~~ pre-market approval ofby the ~~proposed~~FDA ~~device,~~to aensure ~~more~~their ~~difficult~~safety ~~procedure requiring extensive data, including pre-clinical~~ and effectiveness. ~~human clinical trial data~~Generally, asClass ~~well~~III asdevices ~~extensive~~are ~~literature~~limited to ~~prove~~life-sustaining, ~~the~~life-supporting, ~~safety~~or ~~and~~implantable ~~efficacy of the device~~devices.

For us to commercialize other medical device products in the United States, Milestone Scientific would have to submit and have cleared additional 510(k) applications to the FDA. In 2017, the FDA reduced the barrier to marketing clearance for certain dental devices, which may enable other manufacturers of injection devices to more readily enter the dental market. While regulatory requirements may affect market entry, we believe that meaningful commercial adoption of new devices is generally dependent on access to established distribution channels within the dental market.

Before Pre-market Notification clearance, the manufacturer or distributor may not place the device into commercial distribution until the FDA issues an order. By regulation, the FDA has no specific time limit by which it must respond to a 510(k) Pre-market Notification. Currently, the FDA typically responds to the submission of a 510(k) Pre-market Notification within 180 days. The FDA response may declare that the device is substantially equivalent to another legally marketed device and allow the proposed device to be marketed in the United States. However, the FDA may determine that the proposed device is not substantially equivalent or may require further information, such as additional test data, before the FDA is able to decide regarding substantial equivalence. Such a determination or request for additional information could delay the market introduction of products. If a device that has obtained 510(k) Pre-market Notification clearance is changed or modified in design, components, method of manufacture, or intended use, such that the safety or effectiveness of the device could be significantly affected, separate 510(k) Pre-market notification clearance must be obtained before the modified device can be marketed in the United States. If a manufacturer or distributor cannot establish that a proposed device is substantially equivalent to a legally marketed device, the manufacturer or distributor will have to seek pre-market approval of the proposed device, a more difficult procedure requiring extensive data, including pre-clinical and human clinical trial data, as well as extensive literature to prove the safety and efficacy of the device.

The FDA cleared the Wand, our CompuDent System, and its disposable handpieces, for marketing in the United States for dental applications in July 1996; the CompuMed® System for marketing in the United States for medical applications in May 2001; the Safety Wand® for marketing in the United States for dental applications in September 2003; the Wand/STA System for dental applications in August 2006; and our CompuFlo Epidural System in June 2017.

~~For~~Though certain usdental toand ~~commercialize~~medical devices have received FDA marketing clearance, there can be no assurance that any of the other ~~products~~medical indevices under development will obtain the ~~United~~required ~~States~~regulatory clearance promptly, ~~Milestone~~or ~~Scientific~~at ~~would~~all. ~~have~~If toregulatory ~~submit~~clearance ~~and~~of ~~have~~a ~~cleared~~product ~~additional~~is ~~510(k)~~granted, such ~~applications~~clearance tomay entail limitations on the ~~FDA~~indicated uses for which the product may be marketed. In ~~2017~~addition, ~~the~~modifications ~~FDA~~may ~~reduced~~be made to the ~~barrier~~products to ~~marketing~~incorporate ~~clearance~~and ~~for~~enhance ~~certain~~their ~~dental~~functionality ~~devices.~~and ~~As a~~performance ~~result,~~based ~~other~~upon ~~manufacturers~~new ofdata ~~injection~~and ~~devices~~design ~~could~~review. ~~more~~There ~~easily~~can be ~~enter~~no assurance that the ~~dental~~FDA ~~market. However,~~will wenot ~~believe~~request additional information relating to product improvements; that any ~~new~~such ~~device~~improvements ~~will~~would not berequire ~~very~~further ~~limited~~regulatory inreview, ~~sales~~thereby ~~volume~~delaying ~~without~~the atesting, ~~significant~~approval, ~~distributor~~and incommercialization ~~the~~of ~~dental~~product ~~market~~improvements; or that ultimately any such improvements will receive FDA clearance.

~~Though~~The FDA’s ~~certain~~regulations ~~dental and~~applicable to manufacturers of medical devices have ~~received~~historically ~~FDA~~included ~~marketing~~Quality ~~clearance~~System Regulation (“QSR”), requiring, ~~there~~among ~~can~~other bethings, nothe ~~assurance~~establishment ~~that~~and ~~any~~maintenance of ~~the~~procedures ~~other~~governing ~~medical~~design ~~devices under~~controls, ~~development~~testing, ~~will~~quality ~~obtain~~control, ~~the~~documentation, and ~~required~~corrective ~~regulatory~~and ~~clearance~~preventive inactions. aFailure ~~timely~~to ~~manner,~~comply orwith atapplicable ~~all.~~QSR Ifrequirements ~~regulatory~~may ~~clearance~~result ofin aenforcement ~~product~~actions isby ~~granted~~the FDA, including ~~such~~warning ~~clearance~~letters, ~~may~~product ~~entail~~recalls, ~~limitations~~suspension onor ~~the~~termination ~~indicated~~of ~~uses~~production, ~~for~~and ~~which~~ the ~~product~~imposition ~~may~~of befines ~~marketed~~or other penalties. Failure Into ~~addition,~~comply ~~modifications~~with applicable QSR requirements may beresult ~~made~~in toenforcement actions by the ~~products~~FDA, toincluding ~~incorporate~~warning ~~and~~letters, ~~enhance~~product ~~their~~recalls, suspension ~~functionality~~or ~~and~~termination ~~performance~~of ~~based~~production, ~~upon~~and ~~new~~the ~~data~~imposition ~~and~~of ~~design~~fines ~~review~~or other penalties. ~~There~~Medical ~~can~~devices must also be nomanufactured ~~assurance~~in establishments that are registered with the FDA ~~will~~and ~~not~~are ~~request~~subject ~~additional~~to ~~information~~periodic ~~relating~~inspection. In addition, labeling and promotional activities are subject to ~~product~~regulation ~~improvements;~~and ~~that~~oversight ~~any~~by ~~such~~the ~~improvements~~FDA ~~would~~and, ~~not~~with ~~require~~respect ~~further~~to ~~regulatory~~advertising ~~review~~and marketing claims, ~~thereby~~in ~~delaying~~certain circumstances by the ~~testing,~~Federal ~~approval,~~Trade ~~and~~Commission. ~~commercialization~~The export of ~~product~~medical ~~improvements;~~devices ~~or that~~is ~~ultimately~~also ~~any~~subject ~~such~~to ~~improvements~~FDA ~~will~~and ~~receive~~other ~~FDA~~applicable ~~clearance~~regulatory requirements in certain circumstances.

In a regulatory shift, the FDA has adopted a new regulatory framework for the domestic medical device industry, replacing the longstanding Quality System Regulation (QSR) under 21 CFR Part 820 and fundamentally aligning U.S. medical device requirements with ISO 13485 and the quality management system (QMS) requirements used by other regulatory authorities from other jurisdictions. The new regulatory framework, finalized as the Quality Management System Regulation (“QMSR”), became effective February 2, 2026.

~~Compliance~~The QMSR ~~with~~is ~~applicable~~less ~~regulatory~~of ~~requirements~~a iswholesale ~~subject~~rewrite toand ~~continual~~more ~~review~~of ~~and~~a strategic refinement of existing quality expectations. A primary change is ~~monitored~~the ~~through~~updating of ~~periodic~~terminology, ~~inspections~~with bythe ISO concept of a Medical Device File replacing the ~~FDA~~QSR’s Device Master Record. ~~Later~~More ~~discovery~~substantively, ofthe new ~~previously~~rule ~~unknown~~makes ~~problems~~risk ~~with~~management a ~~product~~clear, ~~manufacturer~~enforceable orexpectation ~~facility~~across ~~may~~the ~~result~~entire inproduct ~~restrictions~~life oncycle. ~~such~~Similarly, ~~product~~it orstrengthens ~~manufacturer~~supplier and purchasing controls, ~~including~~with ~~fines~~both contract manufacturers and component providers now subject to greater scrutiny and more rigorous oversight. The new framework positions documented evidence, ~~delays~~from ortraining ~~suspensions~~records ofto ~~regulatory~~complaint ~~clearances~~files, ~~seizures~~as orthe ~~recalls~~undisputed cornerstone of ~~products,~~compliance. This ~~operating~~heightened ~~restrictions,~~emphasis on robust and ~~criminal~~accessible ~~prosecution~~documentation underscores the shift towards a more proactive, evidence-based approach to quality.

~~Milestone~~For firms ~~Scientific~~already isoperating ~~subject~~in tointernational ~~pervasive~~markets, ~~and~~including ~~continuing regulation by~~ the ~~FDA~~Company, ~~whose~~their ~~regulations~~international ~~require~~operations ~~manufacturers~~are ofalready ~~medical~~operating ~~devices~~under toISO 13485, ~~adhere~~and tothe ~~certain~~adoption ~~QSR~~of ~~requirements as defined by~~ the ~~FD&C~~QMSR ~~Act.~~is ~~QSR~~expected ~~compliance~~to ~~requires~~reduce ~~testing,~~duplication ~~quality~~in ~~control~~audits and documentation ~~procedures~~. ~~Failure~~However, to ~~comply~~better ~~with~~confirm ~~QSR~~compliance of ~~requirements~~the ~~can~~Company’s ~~result~~domestic inquality ~~the~~control ~~suspension~~procedures orwith ~~termination~~the ofnew ~~production~~QMSR, ~~product~~the ~~recall~~Company orconducted ~~fines~~a ~~and~~gap ~~penalties.~~assessment, ~~Products~~benchmarking QSR-based ~~also~~systems ~~must~~against bethe ~~manufactured~~requirements inof ~~registered~~ISO ~~establishments.~~13485 Inand ~~addition,~~the ~~labeling~~QMSR. ~~and~~This ~~promotional~~analysis ~~activities~~has ~~are~~informed ~~subject~~necessary updates to ~~scrutiny~~domestic standard byoperating procedures, the ~~FDA~~quality manual and, inrelated ~~certain~~compliance ~~circumstances,~~documentation. byThe ~~the~~Company ~~Federal~~has ~~Trade~~implemented ~~Commission.~~the ~~The~~additional ~~export~~controls ofand ~~devices~~process isenhancements ~~also~~identified ~~subject~~through tothis ~~regulation~~evaluation, inand ~~certain~~is ~~instances~~compliant.

Compliance with applicable regulatory requirements is subject to continual review and is monitored through periodic inspections by the FDA. Later discovery of previously unknown problems with a product, manufacturer, or facility may result in restrictions on such product or manufacturer, including fines, delays or suspensions of regulatory clearances, seizures or recalls of products, operating restrictions, and criminal prosecution.

In the European Union, the Company is required to maintain compliance with applicable ISO standards and CE marking requirements in order to market and sell its medical devices and must undergo periodic audits and inspections by notified bodies to obtain and maintain such certifications. The Company’s products, including the Wand® STA System, dental handpieces used with the Wand® and Wand® STA Systems, which are classified as Class IIa medical devices and the CompuFlo® Epidural System, which is classified as a Class IIb medical device, are currently authorized for sale in the European Union under certificates issued pursuant to the former European Medical Devices Directive (“MDD”). The European Union has replaced the MDD with Regulation (EU) 2017/745, commonly referred to as the Medical Device Regulation (“MDR”), which establishes a more stringent regulatory framework for medical devices marketed in the European Union. The MDR imposes enhanced requirements relating to clinical evidence, post-market surveillance, traceability, transparency, and quality system oversight. While certification to ISO 13485 is not a mandatory legal requirement under the MDR, it is the primary internationally recognized quality management system standard used by manufacturers to support compliance with the MDR’s requirements. In this framework, ISO 13485 provides the quality management system structure, while the MDR sets forth the specific legal and regulatory obligations applicable to medical devices in the European Union.

Under the MDR’s transitional provisions, Class IIa and Class IIb medical devices that were certified under the MDD may continue to be marketed in the European Union for a limited period. To continue commercial sales in the European Union beyond the transition period, the Company’s Class IIa and Class IIb devices must obtain certification under the MDR by December 31, 2028. The Company continues to manage its MDR transition activities in coordination with notified bodies; however, failure to successfully obtain MDR certification within the applicable timeframe could adversely affect the Company’s ability to market and sell its products in the European Union. The Company’s products, including the Wand® STA System, dental handpieces used with the Wand® and Wand® STA Systems, which are classified as Class IIa medical devices, and the CompuFlo® Epidural System, which is classified as a Class IIb medical device, will have MDR certification in 2027.

Human Capital

~~The~~As of the most recent reporting period, the Company ~~has~~employed a total of 17 15 full-time employees~~, including one executive officer~~. ~~Milestone~~In ~~Scientific~~addition, ~~also~~the ~~has~~Company employs a consultant who serves as a Director of Clinical Affairs. ~~None~~ ofThe ~~our~~Company’s employees ~~are~~support ~~subject~~key tofunctions aincluding ~~collective~~research ~~bargaining~~and ~~agreement~~development, ~~and~~engineering, regulatory weaffairs, ~~believe~~sales ~~our~~and ~~employee~~marketing, ~~relations~~finance, ~~are~~and ~~good~~operations.

The Company is not a party to any collective bargaining agreements, and a labor union represents none of its employees. The Company has not experienced any material labor disputes or work stoppages.

The Company believes that its future success depends, in part, on its ability to attract, retain, and motivate qualified personnel. Management evaluates workforce needs on an ongoing basis to ensure that human capital resources are aligned with operational requirements and strategic objectives.

Corporate Information

We were organized in August 1989 under the laws of the State of Delaware. Our principal executive office is located at 425 Eagle Rock Avenue, Roseland, New Jersey 07068. Our telephone number is (973) 535-2717.

Item 1A. Risk Factors

You should carefully consider the risks and uncertainties described below, together with the other information included in this Annual Report on Form 10-K. If any of the risks described below occur, our business, financial condition, results of operations, and prospects could be materially and adversely affected. The risks described below are not the only risks we face. Additional risks and uncertainties that we do not currently know about, or that we currently believe are immaterial, also may materially and adversely affect our business, financial condition, results of operations, and/or prospects.

These disclosures reflect the Company’s beliefs and opinions as to factors that could materially and adversely affect the Company and its securities in the future. References to past events are provided by way of example only and are not intended to be a complete listing or a representation as to whether or not such factors have occurred in the past or their likelihood of occurring in the future.

Risks Related to Our Financial Position and Need for Additional Capital

We have incurred significant losses since our inception. These operating losses are expected to continue and we are unable to predict the extent of future losses, whether we will generate significant revenues, or whether we will achieve or sustain profitability.

We are a small, non-diversified medical device company with a history of limited revenue and significant operating losses and our prospects must be evaluated considering the uncertainties, risks, expenses, and difficulties frequently encountered by similarly situated companies. We have generated net losses in all periods since inception, including operating losses of $5.7 million and $6.8 million for the years ended December 31, 2025, and 2024, respectively. These losses have adversely affected, and are expected to continue to affect adversely, our working capital, total assets, and stockholders’ equity.

~~Item~~Because of 1Athe risks and uncertainties associated with product acceptance, sales expansion, and competitive conditions, we cannot predict the extent of future losses, whether we will generate significant revenues, or whether we will achieve or sustain profitability. ~~Risk~~Even ~~Factors~~if we become profitable, we may not be able to maintain or increase profitability on a quarterly or annual basis. If we do not generate sufficient profits from operations and become and remain profitable, our ability to raise capital, expand our business, maintain our commercial efforts, or continue operations could be impaired. In addition, a decline in our valuation could cause stockholders to lose all or part of their investment.

~~You~~We anticipate ~~should~~that ~~consider~~we ~~carefully~~will ~~the~~need ~~risks~~additional ~~and~~funding ~~uncertainties~~for ~~described below, together with all the other information in this Annual Report on Form 10-K. If any of the following risks are realized,~~ our ~~business, financial condition, results of~~ operations and ~~prospects~~may ~~could~~ be ~~materially~~unable ~~and~~to ~~adversely~~raise ~~affected.~~capital ~~The~~when ~~risks~~needed, ~~described~~which ~~below~~may ~~are~~force ~~not the only risks facing~~ us~~. Risks and uncertainties not currently known~~ to usdelay, ~~or that we currently deem to be immaterial also may materially adversely affect our business~~curtail, ~~financial~~or ~~condition,~~eliminate ~~results~~parts of ~~operations~~the ~~and/or~~Company’s ~~prospects~~operations.

~~Risks~~Our operations ~~Related~~have consumed substantial cash since inception. Net cash used in operating activities was approximately $2.9 million for the years ended December 31, 2025, and 2024, respectively. We believe our near-term viability depends on our ability to ~~Our~~raise additional ~~Financial~~capital ~~Position~~to finance operations through public or private equity offerings, collaborations, licensing arrangements, or other sources. Although we intend to pursue additional funding, there can be no assurance that we will obtain sufficient capital on acceptable terms, or at all. If we cannot raise capital when needed, we may be forced to delay, curtail, or eliminate research and development ~~Need~~programs ~~for~~or ~~Additional~~other ~~Capital~~operations. See also the risk factor titled “If we fail to regain compliance with the strict listing requirements of NYSE American, we may be subject to delisting. As a result, our stock price may decline, and our common stock may be delisted. If our stock were no longer listed on NYSE American, the liquidity of our securities likely would be impaired.”

WeSales of ~~have~~a ~~incurred~~substantial ~~significant~~number ~~losses~~of ~~since~~shares of our ~~inception. These~~common ~~operating~~stock, ~~losses~~or ~~are~~the ~~expected~~perception tothat ~~continue,~~such ~~and~~sales wemay ~~are~~occur, ~~unable~~may toadversely ~~predict~~impact the ~~extent~~price of our ~~future~~common ~~losses, whether we will generate significant revenues or whether we will achieve or sustain profitability~~stock.

WeAlmost all ~~are~~our ~~a small~~80,453,116 ~~non-diversified~~outstanding ~~medical~~shares ~~device company with a history~~ of ~~limited~~common ~~revenue~~stock ~~and~~on ~~significant~~December ~~operating~~31, ~~losses~~2025, ~~and~~are ~~our~~available ~~prospects~~for ~~must~~sale bein ~~evaluated considering~~ the ~~uncertainties,~~public ~~risks~~market, ~~expenses,~~either ~~and~~freely or ~~difficulties~~pursuant ~~frequently~~to ~~encountered~~Rule by144 ~~similarly~~under ~~situated~~the ~~companies.~~Securities ~~The~~Act ~~Company~~of ~~has~~1933, ~~generated~~as ~~net~~amended. ~~losses~~Sales inof ~~all~~a ~~periods~~substantial ~~since~~number ~~the~~of ~~commencement~~shares of our ~~operations.~~common ~~The~~stock, ~~operating~~or the ~~losses~~perception ~~were~~that ~~$6.8~~such ~~million~~sales ~~and~~may ~~$7.1 million~~occur, ~~for~~may ~~the~~adversely ~~years~~impact ~~ended~~the ~~December~~price ~~31,~~of ~~2024,~~our ~~and~~common ~~2023, respectively~~stock.

~~Our~~Raising additional ~~losses have had, and are expected to continue to have, an adverse impact on our working~~ capital, ~~total~~by ~~assets,~~issuing ~~and~~securities stockholders' equity. Because of the risks and uncertainties associated with product acceptance and sales expansion, we are unable to predict the extent of any future losses, whether we will ever generate significant revenues or ifthrough welicensing ~~will ever achieve~~ or ~~sustain~~lending ~~profitability.~~arrangements ~~Even if we do generate profits from operations, we~~ may ~~not~~cause bedilution ~~able~~ to ~~achieve, sustain or increase profitability on a quarterly or annual basis. Our failure to generate substantive profits from operations and to become and remain profitable could impair~~ our ~~ability~~existing ~~to raise capital~~stockholders, restrict ~~expand~~ our ~~business~~operations, ~~and maintain our commercial efforts~~ or ~~continue~~require ~~our~~us ~~operations. A decline in the value of our company could also cause our shareholders~~ to ~~lose~~relinquish ~~all~~proprietary ~~or part of their investment~~rights.

WeIf we ~~anticipate that~~raise weadditional capital through the issuance of equity securities, the share ownership of existing stockholders will ~~need~~experience ~~additional~~dilution. Debt ~~funding~~financing ~~for~~could include covenants that restrict our operations, ~~and~~including ~~may~~limitations beon ~~unable~~our ability to incur liens or additional indebtedness, pay dividends, redeem stock, make certain investments, or engage in particular merger, consolidation, or asset sale transactions. If we raise ~~capital~~funds ~~when~~through ~~needed~~licensing arrangements or asset dispositions, ~~which~~we may ~~force~~be usrequired to ~~delay,~~relinquish ~~curtail~~valuable rights to product candidates or ~~eliminate~~grant ~~parts~~licenses ofon ~~the~~terms ~~Company’s~~that ~~operations~~are unfavorable.

~~Our~~Financial institution ~~operations~~instability ~~have~~could ~~consumed~~adversely ~~substantial~~affect amounts of cash since inception. During the years ended December 31, 2024 and 2023, net cash flow used in operations was approximately $2.9 million and approximately $5.3 million, respectively. We believe that our ~~immediate future viability is dependent on our ability to raise additional capital to finance our~~ operations ~~through public or private equity offerings, collaborations~~ and ~~licensing~~financial ~~arrangements or other sources~~condition. Although management plans to pursue additional funding, there is no assurance that we will be successful in obtaining sufficient funding on terms acceptable to us to fund continuing operations, or at all. If we are unable to raise this capital when needed, we may be forced to delay, or eliminate our research and development programs or other operations.

~~Sales~~We maintain ofdeposits athat ~~substantial~~may ~~number~~exceed ofFDIC ~~shares~~insurance oflimits. If our ~~common~~financial ~~stock~~institution experiences distress or failure, we could experience delayed access to, or a loss of, uninsured deposits or other financial assets. Although U.S. government agencies provided access to uninsured deposits in connection with the ~~perception~~Silicon Valley Bank crisis, there is no assurance that ~~such~~similar ~~sales~~actions ~~may~~would occur, ~~may~~in ~~adversely~~the ~~impact~~future onor occur promptly. We are evaluating our banking relationships to increase the ~~price~~portion of deposits that are fully insured or invested in risk-free instruments. Any non-performance by financial institutions could adversely affect our ~~common~~business ~~stock~~operations and financial condition, including through impaired access to cash, loss of deposits, or disruptions affecting our customers or vendors.

~~Almost~~In addition, ~~all~~any ~~our~~further 78deterioration in the macroeconomic economy or financial services industry,~~047,798 outstanding~~ ~~shares~~or delayed access or loss of ~~common~~uninsured deposits ~~stock~~or loss of the ability to draw on ~~December~~ ~~31,~~existing ~~2024,~~credit ~~are~~facilities ~~available~~involving ~~for~~a ~~sale~~troubled inor ~~the~~failed ~~public~~financial ~~market,~~institution ~~either~~by ~~freely~~our customers or ~~pursuant~~vendors, could lead to ~~Rule~~losses ~~144~~or ~~under~~defaults ~~the~~by ~~Securities~~companies ~~Act~~with ofwhom ~~1933~~we do business, aswhich ~~amended. Sales~~in ofturn could have a ~~substantial~~material ~~number~~adverse ofeffect on ~~shares~~our current and/or projected business operations, results of ~~our~~operations ~~common~~and ~~stock~~financial condition. In addition, orother companies could be adversely affected by any of the ~~perception~~liquidity or other risks that ~~such~~are ~~sales~~described ~~may~~above ~~occur,~~as ~~may~~factors ~~adversely~~that ~~impact~~could result in material adverse impacts on ~~the~~us, ~~price~~including but not limited to delayed access or loss of ~~our~~uninsured ~~common~~deposits ~~stock~~or loss of the ability to draw on existing credit facilities involving a troubled or failed financial institution.

Our 10financial statements have been prepared on a going concern basis, but there can be no assurance that we will be able to continue as a going concern without raising additional capital.

~~Raising~~Due to ~~additional~~our ~~capital~~available bycash ~~issuing~~and ~~securities~~cash orequivalents, ~~through~~recurring ~~licensing~~losses, oraccumulated ~~lending~~deficit, ~~arrangements~~and ~~may~~the ~~cause~~need ~~dilution~~ to ~~our~~raise ~~existing~~additional capital ~~stockholders,~~to ~~restrict~~finance ~~our~~ operations, orthere ~~require~~is ussubstantial doubt as to ~~relinquish~~our ~~proprietary~~ability ~~rights~~to continue as a going concern without raising additional capital.

To the extent that we raise additional capital by issuing equity securities, the share ownership of existing stockholders will be diluted. Any future debt financing may involve covenants that restrict our operations, including limitations on our ability to incur liens or additional debt, pay dividends, redeem our stock, make certain investments, and engage in certain merger, consolidation, or asset sale transactions, among other restrictions. In addition, if we raise additional funds through licensing arrangements or the disposition of any of our assets, it may be necessary to relinquish potentially valuable rights to our product candidates or grant licenses on terms that are not favorable to us. 10

~~Changes~~Risks Related ~~in financial~~to ~~institutions~~Sales ~~could adversely affect our current~~ and ~~projected~~Distribution ~~business operations, financial condition and results~~ of ~~operations.~~Our Products

~~The~~Our sales Company currently keeps more than $250,000, the maximum amount insured by the Federal Deposit Insurance Corporation (“FDIC”), in its current bank depositary. The Company may experience delayed access or a loss of its uninsured deposits or other financial assets should its existing financial institution experience financial distress. While the U.S. Department of Treasury, FDIC and ~~Federal~~marketing ~~Reserve~~efforts ~~Board have provided access to uninsured funds~~ in ~~connection with~~ the ~~Silicon~~United ~~Valley~~States ~~Bank~~rely ~~crisis,~~upon there is no guarantee that these institutions will provide access to uninsured funds in the future in the event of the closure of other banks or financial institutions, or that they would do so in a timely fashion. The Company is currently evaluating its ~~banking relationships with the intent of increasing the amount of deposits that are fully insured or invested in risk~~E-~~free~~Commerce ~~instruments~~platform.

~~The~~We believe ~~results of events or concerns~~ that ~~involve non-performance by financial institutions could include~~ a ~~variety~~significant portion of ~~material and adverse impacts on~~ our ~~current~~sales ~~and~~will ~~projected~~continue ~~business~~to ~~operations~~be ~~and~~from ~~our~~its ~~financial~~E-Commerce ~~condition~~platform ~~and~~launched ~~results~~in ofJanuary ~~operations. In addition~~2023, ~~any~~for ~~further deterioration in~~ the ~~macroeconomic~~foreseeable future. ~~economy or financial services industry~~Currently, orsales ~~delayed access or loss~~ of ~~uninsured deposits or loss of~~ the ~~ability~~STA toSingle ~~draw~~Tooth onAnesthesia ~~existing~~Systems® ~~credit~~(STA) ~~facilities~~and ~~involving~~handpieces ~~a troubled or failed financial institution by our customers or vendors, could lead to losses or defaults by companies with whom we do business, which~~ in turn could have a material adverse effect on our current and/or projected business operations, results of operations and financial condition. In addition, other companies could be adversely affected by any of the ~~liquidity~~United orStates ~~other risks that~~ are ~~described~~reliant ~~above as factors that could result in material adverse impacts~~ on ~~us,~~E-Commerce sales. ~~including~~We ~~but~~have ~~not~~exposure ~~limited~~ to ~~delayed~~risks ~~access or loss~~ of ~~uninsured~~operating ~~deposits~~in oran ~~loss~~E-commerce ~~of the ability to draw on existing credit facilities involving a troubled or failed financial institution.~~platform:

~~Risks~~● ~~Related~~Refunds and customer disputes due to ~~Sales~~issues like wrong product delivery or defective items can impact our business; ● Online security breaches and ~~Distribution~~cyberattacks; of● ~~Milestone~~Poor ~~Scientific~~search ~~Products~~engine visibility affects traffic and sales; and ● Unexpected changes in political or regulatory environments.

~~Milestone~~If we ~~Scientific’s~~are ~~sales~~unable ~~and~~to ~~marketing~~maintain ~~efforts~~or inexpand ~~the~~our ~~United Stated rely upon its~~ E-Commerce platform, our sales will be negatively affected.

~~Milestone~~We are ~~Scientific~~exposed ~~believes that a significant portion of its sales will continue~~ to ~~be from its E-Commerce platform launched in January 2023, for~~ the ~~foreseeable~~risks ~~future. Currently,~~inherent ~~sales of the STA Single Tooth Anesthesia Systems® (STA) and handpieces~~ in ~~the~~international ~~United States are reliant on E-Commerce~~ sales. ~~We have exposure to risks of operating in an E-commerce platform:~~

●In ~~Refunds~~2025, export sales outside the United States represented approximately 45% of total sales, and ~~customer~~we ~~disputes~~sold ~~due~~products toin ~~issues~~approximately ~~like~~37 ~~wrong~~countries ~~product~~and ~~delivery~~U.S. orterritories. ~~defective~~International ~~items~~operations ~~can~~expose ~~impact~~us onto ~~our~~risks including ~~business;~~foreign ●currency ~~Online~~fluctuations, ~~security~~limitations ~~breaches~~on ~~and~~currency ~~cyberattacks;~~conversion ●and ~~Poor~~repatriation, ~~search~~compliance ~~engine~~with ~~visibility~~complex ~~affects~~laws ~~traffic~~and regulations, political and ~~sales;~~economic instability, tariffs and ●other ~~Unexpected~~trade ~~changes~~barriers, and challenges in ~~political~~obtaining orapprovals ~~regulatory~~for ~~environments~~significant transactions. These risks could adversely affect our sales and operating results.

If physicians ~~Milestone~~neither ~~Scientific~~accept isnor ~~unable~~use toour ~~maintain~~CompuFlo orEpidural ~~expand~~System, ~~its~~our ~~E-Commerce~~ability ~~platform its~~to generate revenue from sales will be ~~negatively~~ ~~affected~~materially impaired.

WeThere is ~~are~~no ~~exposed~~assurance that physicians, hospitals, clinics, and other healthcare providers will accept and use the CompuFlo Epidural System. Market acceptance depends on many factors, including perceived safety and effectiveness, cost-effectiveness relative to competing products, convenience and reliability, patient satisfaction, product availability, warranty and technical support, reimbursement availability, and the ~~risks~~effectiveness ~~inherent~~of inour ~~international~~marketing ~~sales~~and distribution.,

InBecause we ~~2024,~~expect ~~export~~ sales ~~outside~~ of the ~~United~~CompuFlo ~~States~~Epidural ~~made~~Computer upControlled ~~approximately~~Anesthesia ~~40%~~System ofto generate substantially all our ~~total~~medical ~~sales~~product revenues in the near-term, ~~and~~the wefailure ~~sell~~of ~~our~~this ~~products~~product to ~~customers~~find inmarket ~~approximately~~acceptance 41would ~~countries~~harm ~~and~~our ~~U.S.~~medical ~~territories~~business. We ~~have~~It ~~exposure~~ could require us to ~~risks~~seek additional financing or make such financing difficult to obtain on favorable terms, if at all. Since the Company generates a significant portion of ~~operating~~its innet ~~many~~sales ~~foreign~~from ~~countries~~a single product category, ~~including:~~a decline in demand for that product could significantly impact our net sales and gross margins.

●If our ~~fluctuations~~technology indoes ~~foreign~~not ~~currency~~perform ~~exchange~~as ~~rates~~expected, ~~could increase the end user cost for instruments; ● restrictions on,~~ or ~~difficulties~~if ~~and~~we ~~costs~~fail ~~associated with, the currency exchange from foreign countries~~ to ~~obtain~~successfully ~~U.S. dollars; ● difficulties and costs associated with complying with a wide variety of complex laws~~develop, ~~treaties~~commercialize, ~~and~~or ~~regulations;~~sell ●new ~~unexpected~~or ~~changes~~enhanced inproducts ~~political~~ or penetrate ~~regulatory~~new ~~environments;~~markets, ●our ~~political~~business, ~~and~~financial ~~economic~~condition, ~~instability; ● import~~ and ~~export~~operating ~~control~~results ~~restrictions~~could ~~and~~be ~~other~~adversely ~~trade barriers such as tariffs; and ● difficulties in obtaining approval for significant transactions~~affected.

Our 11ability to compete successfully depends on our ability to design, develop, manufacture, assemble, test, market, and support new products and product enhancements in a timely and cost-effective manner that keeps pace with evolving market needs and customer demands. Our success and competitive position are dependent on the performance, reliability, and continued advancement of the technologies we have developed and may develop in the future. There is a risk that our existing or future technologies may not function as intended, may not achieve anticipated performance levels, or may fail to gain market acceptance.

IfThe markets ~~physicians~~in ~~neither~~which ~~accept~~our ~~nor~~customers ~~use~~and we compete are characterized by rapid technological change and frequent product obsolescence. A significant technological shift in our ~~CompuFlo~~target ~~Epidural~~markets ~~System,~~could adversely affect our ~~ability~~competitive position. If we fail to ~~generate~~anticipate ~~revenue~~technological ~~from~~developments, develop ~~sales~~new ~~will~~technologies, or respond effectively to changes in existing technologies, the attractiveness of our products could be ~~materially~~adversely affected, ~~impaired~~resulting in product obsolescence, reduced revenue, and the loss of customers to competitors.

~~There~~ Innovation is no ~~assurance~~critical ~~that~~to ~~physicians,~~our ~~hospitals,~~long-term ~~clinics~~success, and ~~other~~we ~~health~~must ~~care~~continue ~~providers~~to ~~will~~enhance ~~accept~~existing products and ~~use~~develop ~~the~~new ~~CompuFlo~~products ~~Epidural~~with ~~System~~improved capabilities to maintain our competitive position. ~~Acceptance~~ The development of new technologies and ~~use~~products requires substantial investment and involves prolonged development, testing and approval cycles before products can be commercially marketed. While we intend to continue investing in the development of new and enhanced products, our ability to do so depends on the ~~CompuFlo~~availability ~~Epidural~~of sufficient financial resources. As part of our cash management plan, we have delayed all research and development on our Single Tooth Anesthesia System ~~will~~next-generation ~~depend~~instrument. We may not be able to develop or acquire new products or enhancements that compete effectively in our target markets or that sufficiently differentiate our offerings based on ~~many~~functionality, ~~factors~~performance, ~~including:~~or cost. However, difficulties or delays in research, development, or production, failure to achieve market acceptance of new or enhanced products, or an inability to manage the transition from older products to new offerings effectively could adversely affect sales, inventory levels, cash flows, and liquidity. In addition, we may be unable to recover our research and development investments or achieve meaningful revenue from new technologies.

● perceptions by members of the health care community, including physicians, about the safety and effectiveness of our product. ● cost-effectiveness of our product relative to competing products and systems; ● convenience, ease of use and reliability of our product relative to competing products and systems ● patient satisfaction; ● product availability as well as, manufacturer warranty, maintenance, and customer and technical support; ● availability of reimbursement for our product from government or other healthcare payers; and ● effectiveness of marketing and distribution efforts by us and our licensees and distributors.11

~~Because~~Developments by wecompetitors ~~expect~~may ~~sales~~render ~~of the CompuFlo Epidural Computer Controlled Anesthesia System to generate substantially all~~ our ~~medical~~products ~~product~~or ~~revenues~~technologies inobsolete ~~the near-term, the failure of this product to find market acceptance would harm our business and could require us to seek additional financing~~ or ~~make such financing difficult to obtain on favorable terms, if at all~~non-competitive.

~~Developments~~The medical bydevice ~~competitors~~industry ~~may~~is ~~render~~intensely competitive and subject to rapid and significant technological change. We expect that other companies (or individuals), whether located in the United States or abroad, will pursue the development of alternative injection-based or imaging-based systems that will compete with our products. Many of these potential competitors have substantially greater capital resources, larger research and development staffs and facilities, longer product development history in obtaining regulatory approvals and greater manufacturing and marketing capabilities than we do. These companies also compete with us to attract qualified personnel and parties for acquisitions, joint ventures, or ~~technologies~~other ~~obsolete~~collaborations. As a result, we may not be able to compete effectively against these companies or ~~non-competitive~~their products.

~~The~~Our ability ~~medical device industry is intensely competitive and subject~~ to ~~rapid~~commercialize ~~and~~our ~~significant~~products ~~technological~~will ~~change. We~~depend ~~expect that other companies (or individuals), whether located~~ in ~~the~~part ~~United~~on ~~States or abroad, will pursue~~ the ~~development~~extent ofto ~~alternative~~which ~~injection-based~~reimbursement ~~or imaging-based systems that~~ will ~~compete~~be ~~with~~available ~~our~~from ~~products.~~governmental ~~Many of these potential competitors have substantially greater capital resources~~agencies, health ~~larger~~administration ~~research and development staffs and facilities~~authorities, ~~longer~~private ~~product~~health ~~development~~maintenance history in obtaining regulatory approvals and greater manufacturing and marketing capabilities than we do. These companies also compete with us to attract qualified personnel and parties for acquisitionsorganizations, ~~joint~~health ~~ventures~~insurers, orand other ~~collaborations. As~~healthcare ~~a result, we may not be able to compete effectively against these companies or their products~~payers.

Our ability to ~~commercialize~~generate revenues from our products will ~~depend~~be diminished if the products sell for inadequate prices or hospitals or physicians are unable to obtain adequate levels of reimbursement for the cost they incur in ~~part~~connection onwith the ~~extent~~use of the product. Significant uncertainty exists as to ~~which~~the reimbursement ~~will~~status beof ~~available~~legacy ~~from~~and ~~governmental~~newly ~~agencies,~~approved ~~health~~healthcare ~~administration~~products. ~~authorities~~Healthcare payers, ~~private~~including ~~health~~Medicare, are ~~maintenance~~challenging ~~organizations~~the prices charged for medical products and ~~health~~services. ~~insurers~~Government and other healthcare payers increasingly attempt to contain healthcare costs by limiting both coverage and the level of reimbursement for products. Insurance coverage may not be available, or reimbursement levels may be inadequate to cover the charges for the use of such a product. If the government and other healthcare payers do not provide adequate coverage and reimbursement for any of our products, market acceptance of such products could be reduced.

~~Our~~Prices in ~~ability~~many tocountries, ~~generate~~including ~~revenues~~many ~~from~~in ~~our~~Europe, ~~products will be diminished if the products sell for inadequate prices or hospitals or physicians~~ are ~~unable~~subject to ~~obtain~~local ~~adequate~~regulation ~~levels~~and ofprice ~~reimbursement~~controls. ~~for~~In the ~~cost~~United ~~they~~States, ~~incur~~where inpricing levels ~~connection~~for ~~with~~medical ~~the~~products, ~~use~~procedures ofand ~~the~~services ~~product.~~are ~~Significant~~substantially ~~uncertainty~~established ~~exists~~by asthird-party ~~to the reimbursement status of newly approved healthcare products. Healthcare payers~~payors, including Medicare, ~~are~~if ~~challenging~~payors reduce the ~~prices~~amount ~~charged~~of reimbursement for ~~medical~~a ~~products~~product, ~~and~~it ~~services. Government~~may ~~and~~cause ~~other~~groups ~~healthcare~~or ~~payers~~individuals ~~increasingly~~dispensing ~~attempt~~the product to ~~contain~~discontinue ~~healthcare~~use ~~costs~~of ~~by limiting both coverage and~~ the product, ~~level~~to ofsubstitute ~~reimbursement~~lower ~~for~~cost products~~. Insurance~~ ~~coverage~~even ~~may~~if ~~not~~the bealternatives ~~available,~~are orless ~~reimbursement~~effective ~~levels~~or ~~may be inadequate~~ to ~~cover~~seek ~~the~~additional ~~charges~~price-related ~~for~~concessions. These ~~the~~actions ~~use~~could ofhave ~~such~~ a ~~product. If~~negative ~~the~~effect ~~government~~on ~~and~~our ~~other~~financial ~~healthcare~~results. ~~payers~~The doexistence ~~not~~of ~~provide~~direct ~~adequate coverage~~ and ~~reimbursement~~indirect ~~for~~price ~~any~~controls ofand pressures on our products, ~~market~~could ~~acceptance~~seriously ofaffect ~~such~~our ~~products~~financial ~~could~~prospects beand ~~reduced~~performance.

~~Prices~~Healthcare reform inlaws ~~many countries, including many in Europe, are subject to local regulation~~ and ~~price~~regulations ~~controls.~~significantly Inaffect the United States, where pricing levels for medical products, procedures and services are substantially established by third-party payors, including Medicare, if payors reduce the amount of reimbursement for a product, it may cause groups or individuals dispensing the product to discontinue use of the product, to substitute lower cost products even if the alternatives are less effective or to seek additional price-related concessionsU. ~~These actions could have a negative effect on our financial results~~S. ~~The~~ ~~existence~~healthcare ofservices ~~direct and indirect price controls and pressures on our products could seriously affect our financial prospects and performance~~industry.

WeIn recent ~~could~~years, ~~lose~~many legislative ‎proposals have been introduced or proposed in Congress and in some state legislatures that would affect major changes in the healthcare system, either nationally or at the state level. At the federal level, Congress has continued to propose or ‎consider healthcare budgets that substantially reduce payments under the Medicare and Medicaid programs. Healthcare legislative reform measures may have a material adverse effect on our ~~market~~business ~~advantage~~and ~~earlier~~results ~~than~~of ~~expected~~operations.

WeIn the ~~believe~~United ~~that~~States ~~our~~and ~~products~~some ~~represent~~foreign ajurisdictions, ~~significant~~there ~~improvement~~have ~~over~~been, ~~any~~and ~~existing~~continue ~~drug~~to ~~delivery injection system in use today. However~~be, ~~this~~several ~~competitive~~legislative ~~advantage~~and ~~can~~regulatory ~~evaporate~~changes ~~quickly~~and proposed ifchanges weregarding ~~are~~the ~~not~~healthcare ~~able~~system tothat ~~commercialize~~could ~~our~~prevent ~~products~~or ~~quickly. In~~delay ~~the~~marketing ~~medical~~approval ~~device industry, most~~ of ~~an innovative~~ product’s ~~commercial~~candidates, ~~value~~restrict isor ~~realized~~regulate post-approval ~~during the early stages of commercialization~~activities, ~~before~~and ~~competing~~affect ~~products~~our ~~are~~ability ~~developed.~~to ~~Our~~profitably ~~market~~sell ~~advantage~~any isproduct ~~based,~~candidates ~~in part, on patent rights and the need~~ for ~~new~~which ~~competing~~we ~~products and systems to~~ obtain ~~regulatory~~marketing approval ~~before they can be commercialized~~. ~~The scope of our patent rights may be limited and may also depend on the availability of meaningful legal remedies.~~

Among 12policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality, and/or expanding access. In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives. In March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively, the “ACA,”) was passed, which substantially changed the way healthcare is financed by both the government and private insurers and significantly impacts the U.S. pharmaceutical industry.

~~Our~~Since its ~~failure~~enactment, tothere ~~adequately~~have ~~protect~~been ~~our~~judicial, ~~intellectual~~congressional ~~property~~and ~~rights,~~executive ~~through~~branch ~~patents~~challenges orand ~~otherwise,~~amendments orto ~~limitations~~certain onaspects of the ~~use~~ACA. For orexample, ~~loss~~on ofAugust ~~such~~16, ~~rights~~2022, ~~could~~the ~~have~~Inflation aReduction ~~material~~Act ~~adverse~~of ~~effect~~2022 on(“IRA”) ~~our~~was ~~ability~~signed tointo ~~prevent~~law, ~~the~~which, ~~commercialization~~among ofother things, ~~competing~~extends ~~anesthetic~~enhanced ~~delivery~~subsidies ~~systems. In~~for ~~some~~individuals ~~countries,~~purchasing ~~basic~~health ~~patent~~insurance ~~protections~~coverage ~~for~~in ~~our~~ACA ~~products~~marketplaces ~~may~~through ~~not~~plan ~~exist~~year ~~because~~2025. ~~certain~~The IRA ~~countries~~also ~~did~~eliminates ~~not~~the ~~historically~~“donut ~~offer~~hole” under the ~~right~~Medicare toPart ~~obtain~~D ~~specific~~program ~~types~~beginning ofin ~~patents~~2025 ~~and/or~~by wesignificantly ~~(or~~lowering ~~our~~the ~~licensors)~~beneficiary’s maximum ~~did~~out-of-pocket ~~not~~cost ~~file~~through ina ~~those~~newly ~~markets.~~established Inmanufacturer ~~addition,~~discount ~~the~~program. ~~patent~~It ~~environment~~is ~~can~~possible bethe ~~unpredictable,~~ACA ~~and~~will ~~the~~be ~~validity~~subject ~~and~~to ~~enforceability~~judicial or ofcongressional ~~patents~~challenges ~~cannot~~and beamendments ~~predicted~~in ~~with~~the ~~certainty~~future.

~~Risks~~On July ~~Related~~4, 2025, the annual reconciliation bill, the One Big Beautiful Bill Act (the “OBBBA”) was signed into law which is expected to ~~Employee~~reduce ~~Matters~~ Medicaid spending and enrollment by implementing work requirements for some beneficiaries, capping state-directed payments, reducing federal funding, and limiting provider taxes used to fund the program. OBBBA also narrows access to the ACA marketplace exchange enrollment and declines to extend the ACA enhanced advanced premium tax credits, which expired in 2025, and which, among other provisions in the law, are expected to reduce the number of Americans with health insurance.

~~We may not be able to attract and retain qualified employees.~~12

~~Our~~Also, there ~~future~~has ~~success~~been ~~depends~~heightened ~~upon~~governmental ~~the~~scrutiny ~~services~~recently ofover athe ~~executive~~manner ~~officer.~~in ~~The~~which ~~Company~~drug ismanufacturers ~~currently~~set ~~looking~~prices for atheir ~~new~~marketed products, ~~chief~~which have resulted in several congressional inquiries, presidential executive ~~officer~~orders, and proposed and enacted federal and state legislation designed to, ~~replace~~among ~~Mr.~~other ~~Haverhals~~things, ~~who~~bring ~~retired~~more attransparency to product pricing, review the ~~end~~relationship ofbetween pricing ~~2024~~and manufacturer patient programs, and reform government program reimbursement methodologies for drug products. ~~Currently~~For ~~one~~example, the ofIRA, ~~our~~among ~~directors~~other things, Mr(1) directs the U.S. ~~Goldman,~~Department isof Health and Human Services (“HHS”) to negotiate the ~~Interim~~price ~~Chief~~of ~~Executive~~certain ~~Officer.~~high-expenditure, Wesingle-source ~~also~~drugs ~~rely~~covered under Medicare that have been on ~~other~~the ~~key~~market ~~management~~for ~~and~~at ~~technical~~least ~~personnel,~~7 years (the “Medicare Drug Price Negotiation Program”) and on(2) ~~our~~imposes ~~ability~~rebates under Medicare Part B and Medicare Part D to ~~continue~~penalize price increases that outpace inflation. These provisions began to ~~identify,~~take ~~attract~~effect progressively in fiscal year 2023. On August 15, ~~retain~~2024, ~~and~~HHS ~~motivate~~announced ~~them.~~the ~~Implementing~~agreed-upon ~~our~~reimbursement ~~business~~prices ~~strategy~~of ~~requires~~the ~~specialized~~first ~~territory~~ten ~~managers~~drugs ~~and~~that ~~other~~were ~~talent~~subject to price negotiations, although asthe ~~our~~Medicare ~~revenues~~Drug ~~are~~Price ~~highly~~Negotiation ~~dependent~~Program onis ~~technological~~currently ~~and~~subject ~~product~~to ~~innovations~~legal challenges. ~~The~~On ~~market~~January ~~for~~17, ~~employees~~2025, inHHS ~~our~~elected ~~industry~~up to isfifteen ~~extremely~~additional ~~competitive,~~products ~~several~~covered ~~such~~under ~~competitors~~Part ~~are~~D ~~significantly~~for ~~larger~~price ~~than~~negotiation usin ~~and~~2025. ~~can~~Each ~~offer~~year ~~compensation~~thereafter, more ~~than~~Part ~~what~~B weand ~~are~~Part ~~able~~D products will become subject to ~~offer~~the Medicare Drug Price Negotiation Program. If weOn ~~are~~December ~~unable~~8, to2023, ~~attract~~the National Institute of Standards and ~~retain~~Technology published for comment a ~~new~~Draft ~~chief~~Interagency ~~executive~~Guidance ~~officer~~Framework ~~and~~for ~~other~~Considering ~~qualified~~the ~~employees~~Exercise of March-In Rights, which, for the first time, includes the price of a product as ~~needed~~one factor an agency can use when deciding to exercise march-in rights. While march-in rights have not previously been exercised, ~~our~~it ~~business~~is uncertain if that will continue under the new framework. New regulation of drugs may bealso ~~harmed~~cover new regulation of medical devices.

~~Risk~~Individual states ~~Related~~in the United States have also become increasingly active in passing legislation and implementing regulations designed to ~~Our~~control pharmaceutical ~~Dependence~~product pricing, including price or patient reimbursement constraints, discounts, restrictions on ~~Third~~certain ~~Parties~~product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. For example, on January 5, 2024, the FDA approved Florida’s Section 804 Importation Program (“SIP”) proposal to import certain drugs from Canada for specific state healthcare programs. It is unclear how this program will be implemented, including which drugs will be chosen, and whether it will be subject to legal challenges in the United States or Canada. Other states have also submitted SIP proposals that are pending review by the FDA. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. We expect that additional state and federal healthcare reform measures will be adopted in the future.

~~Relying~~The current ~~exclusively~~Trump onadministration ~~third~~is ~~parties~~pursuing policies to ~~manufacture~~reduce ~~our~~regulations ~~products~~and expenditures across government, ~~changes~~including inat ~~our~~HHS, ~~informal~~the ~~manufacturing~~FDA, ~~arrangements~~CMS, ~~made~~and byrelated agencies. These actions, presently aimed at executive orders or memoranda from the ~~manufacturer~~Office of Management and Budget, may propose policy changes that create additional uncertainty for our ~~products~~business. These actions and ~~disruptions~~proposals atinclude, for example, (1) directives to reduce agency workforce and cut programs; (2) rescinding a Biden administration executive order tasking the ~~manufacturing~~Center ~~facility~~for Medicare and Medicaid Innovation to consider new payment and healthcare models to limit drug spending; (3) eliminating the Biden administration’s executive order that directed HHS to establish an AI task force and develop a strategic plan; (4) directing HHS and other agencies to lower prescription drug costs through a variety of ~~our~~initiatives, ~~manufacturers~~including by improving upon the Medicare Drug Price Negotiation Program and ~~failure~~establishing Most-Favored-Nation pricing for pharmaceutical products; (5) imposing tariffs of imported pharmaceutical products; and (6) directing certain federal agencies to ~~maintain~~enforce existing ~~supply~~law ~~relationships~~regarding ~~exposes~~hospital usand toprice ~~risks~~plan transparency and by standardizing prices across hospitals and health plans. Additionally, Congress may introduce and ultimately pass healthcare-related legislation that could impact the drug approval process and make changes to the Medicare Drug Price Negotiation Program created under the IRA. We expect additional health reform measures may ~~harm~~be ~~our~~implemented ~~business~~in the future, particularly given the recent change in administration.

We expect ~~have~~that ~~limited internal~~healthcare ~~experience~~reform measures that may be adopted in ~~manufacturing~~the ~~operations~~future may result in more rigorous coverage criteria and ~~have~~additional downward ~~not~~pressure ~~historically~~on ~~established~~the ~~our~~price ~~own~~that ~~manufacturing~~we ~~facilities~~receive for a medical device. We ~~currently~~The ~~lack~~‎ultimate ~~the~~content, ~~internal~~timing, ~~resources~~or toeffect ~~manufacture~~of any healthcare reform legislation and the impact of potential legislation on us is ‎uncertain and difficult, if not impossible, to predict. Reductions in Medicare and Medicaid reimbursement rates, as well as decreased government spending, for certain drugs and medical devices, may adversely affect demand for our products and services. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. Any such reductions or spending limitations, ~~including~~whether through legislative action, regulatory change, budgetary pressure, or otherwise, could expand over time and materially impact the utilization of our ~~CompuFlo®~~technologies and ~~Epidural~~our ~~Computer~~overall ~~Controlled~~financial ~~Anesthesia~~performance. ~~System~~There can be no assurance that future initiatives on reimbursement or coverage policies will not be modified in ways that negatively affect our business, financial ‎condition, results of operations, and/or prospects.

Milestone Scientific has been supplied by the manufacturer of the Wand/STA System and its predecessor, the CompuDent System, since the commencement of production in 1998, and by the manufacturer of its handpieces since 2003. The manufacturer of our handpieces is in the People’s Republic of China and the manufacturer of the Wand/STA System is in the United States. At present, we have an informal arrangement with the manufacturers of our products. Our current arrangement with our manufacturers is on a purchase order-by-purchase order basis. As a result, we do not have price protection or a supply commitment for our devices or handpieces. If either manufacturer insists on a material change in terms or determines to discontinue manufacture of our products, it We could ~~have~~lose ~~an adverse effect on~~ our ~~financial~~market ~~condition~~advantage ~~and~~earlier ~~results~~than ~~of operation~~expected.

AnWe believe ~~operational~~that ~~disruption~~our inproducts ~~the~~represent ~~facility~~a ofsignificant ~~the~~improvement ~~manufacturer~~over ~~of,~~any orexisting ~~their~~drug ~~ability~~delivery toinjection ~~ship~~system in use today. However, this ~~our~~competitive ~~handpieces~~advantage orcan ~~devices~~evaporate ~~could~~quickly ~~negatively~~if ~~impact~~we are not able to commercialize our ~~financial~~products ~~results~~quickly. ~~The~~ ~~occurrence~~In ofthe amedical ~~natural~~device ~~disaster~~industry, most ~~such~~of asan ainnovative ~~hurricane,~~product’s ~~tropical~~commercial ~~storm,~~value ~~earthquake,~~is ~~tornado,~~realized ~~severe~~during ~~weather,~~the ~~flood,~~early ~~fire~~stages of commercialization, orbefore ~~epidemic~~competing products are developed. Our market advantage is based, ~~pandemic~~in part, oron ~~other~~patent ~~health~~rights ~~emergency,~~and orthe ~~other~~need ~~unanticipated~~for ~~problems~~new ~~such~~competing asproducts ~~labor~~and ~~difficulties,~~systems ~~equipment~~to ~~failure~~obtain regulatory orapproval ~~unscheduled~~before ~~maintenance,~~they incan ~~each~~be ~~case~~commercialized. ~~could~~The ~~cause~~scope ~~operational~~of ~~disruptions~~our patent rights may be limited and may also depend on the availability of ~~varied~~meaningful ~~duration~~legal remedies.

These types of disruptions could materially adversely affect our financial condition and results of operations to varying degrees dependent upon the facility, the duration of the disruption, our ability to shift business to another facility or find alternative sources of supply. Any losses due to these events may not be covered by our existing insurance policies or may be subject to certain deductibles. Given our current manufacturing relationships, it is possible that our manufacturing requirements may exceed the available supply allotments under our existing agreements. Our anticipated future reliance on third-party manufacturers exposes us to the following additional risks:13

●Our failure Weto ~~may~~adequately beprotect ~~unable~~our tointellectual ~~identify~~property ~~manufacturers~~rights, onthrough ~~acceptable~~patents ~~terms~~ or atotherwise, ~~all~~or ~~because~~limitations on the ~~number~~use ofor ~~potential~~loss ~~manufacturers~~of ~~is limited~~such rights, ~~and~~could ~~the~~have ~~FDA~~a ~~must~~material ~~approve~~adverse ~~any~~effect ~~replacement~~on ~~contractor.~~our ~~This~~ability ~~approval~~to ~~would~~prevent ~~require~~the ~~new~~commercialization ~~testing~~of ~~and~~competing ~~compliance~~anesthetic ~~inspections.~~delivery systems. In ~~addition~~some countries, abasic ~~new~~patent ~~manufacturer~~protections ~~would have to develop substantially equivalent processes~~ for ~~production of~~ our products. ~~● Contract manufacturers~~ may not ~~perform~~exist asbecause ~~agreed~~certain orcountries ~~may~~did not ~~remain~~historically inoffer the ~~contract~~right to ~~manufacturing~~obtain ~~business~~specific ~~for~~types ~~the~~of ~~time~~patents ~~required to successfully produce, store,~~ and/or ~~distribute~~we (or our ~~products.~~licensors) ●did ~~Contract~~not ~~manufacturers~~file ~~are~~in ~~subject~~those tomarkets. ~~ongoing~~In ~~periodic~~addition, ~~unannounced inspections by~~ the ~~FDA~~patent ~~and~~environment ~~corresponding~~can be ~~state~~unpredictable, ~~agencies to ensure strict compliance with current good manufacturing practice~~ and ~~other~~the ~~government~~validity ~~regulations~~ and ~~corresponding~~enforceability ~~foreign~~of ~~standards.~~patents Wecannot ~~do not have control over third-party manufacturers' compliance with these regulations and standards and our manufacturers may~~ be ~~found~~predicted ~~to be in noncompliance~~ with ~~certain regulations, which may impact their ability to manufacture our products~~certainty.

Risks 13 Related to Employee Matters

~~● If any third-party manufacturer makes improvements in the manufacturing process for our products, we~~ We may not ~~own, or may have to share, the intellectual property rights to the innovation. We may~~ be ~~required~~able to ~~pay~~attract ~~fees~~and orretain ~~other~~qualified ~~costs for access to such improvements~~employees.

~~Though~~Our future ~~alternate~~success ~~sources~~depends upon the services of ~~supply~~our ~~for~~executive ~~dental~~officers. ~~handpieces~~The ~~exist,~~Company ~~Milestone~~has ~~Scientific would~~recently ~~need~~appointed toEric ~~establish~~Hines ~~relationships~~as ~~with~~President ~~new~~and ~~suppliers~~Chief Executive Officer, and ~~with~~as ~~respect~~a todirector of the ~~Wand/STA~~Company, ~~System~~replacing ~~recover~~Arjan ~~its~~Haverhals, ~~existing~~who ~~tools~~retired orat ~~have~~the ~~new~~end ~~tools~~of ~~produced~~2024, and ~~“burned~~appointed ~~in”~~Jason Papes as Senior Vice President, Global Head of Sales and Marketing. We also rely on other ~~manufacturing~~key management and ~~quality~~technical ~~control~~personnel, ~~software~~and on ~~re-produced~~our ability to continue to identify, attract, retain, and motivate them. ~~Establishing~~Implementing our business strategy requires specialized territory managers and other talent, as our revenues are highly dependent on technological and product innovations. The market for employees in our industry is extremely competitive; several such competitors are significantly larger than us and can offer compensation more than what we are able to offer. If we are unable to retain our new ~~manufacturing~~chief ~~relationships~~executive ~~could~~officer ~~involve~~and ~~significant~~other ~~expense~~key officers and ~~delay~~attract other qualified employees, as needed, our business may be harmed.

~~Each~~Risk Related ~~of these risks could delay the commercialization of our CompuFlo Epidural Computer Controlled Anesthesia System, limit our available supply of The Wand/ STA for dental applications, cause damage~~ to ~~our~~Our ~~reputation,~~Dependence result in higher costs and/or deprive us of potential product revenues. Any curtailment or interruptions of the supply, whether because of termination of the relationship or otherwise, would have a material adverse effect on ~~our~~Third ~~financial condition, business, and results of operations.~~Parties

~~Our~~Relying exclusively ~~business~~on isthird ~~exposed~~parties to ~~risks~~manufacture ~~associated~~our ~~with~~products, changes in our informal manufacturing arrangements made by the ~~economic~~manufacturer of our products, ~~environmental~~disruptions at the manufacturing facility of our manufacturers, and ~~political~~failure ~~conditions~~to inmaintain ~~China~~existing ~~because~~supply ~~the~~relationships expose ~~sole~~us ~~manufacturer~~to ofrisks ~~our~~that ~~handpieces~~may isharm inour ~~China~~business.

~~Because~~We have ~~the~~limited ~~sole~~internal ~~manufacturer~~experience ~~of our dental handpieces is~~ in ~~China,~~manufacturing ~~our~~operations ~~business~~and ishave ~~disproportionately~~not ~~exposed~~historically toestablished ~~the~~our ~~economic,~~own ~~environmental,~~manufacturing ~~and political conditions of the region~~facilities. We ~~China’s~~currently ~~political~~lack ~~and economic systems are very different from most developed countries in many respects, including,~~ the ~~amount~~internal ~~of government involvement, the level of development, the control of foreign exchange and the allocation of~~ resources. ~~The~~to ~~increase~~manufacture inany ~~United States tariffs on products from China will impact the price~~ of our ~~goods sold. Uncertainties may arise with changing governmental policies and measures. China also faces many social~~products, ~~economic,~~including ~~and~~our ~~political~~CompuFlo® ~~challenges~~Epidural ~~that~~Computer ~~may~~Controlled Anesthesia ~~produce instabilities in both its domestic arena and in its relationship with other countries~~System.

~~These~~We have ~~instabilities~~been ~~may~~supplied ~~significantly~~by ~~and~~the ~~adversely~~manufacturer ~~affect our supply~~ of ~~dental~~the ~~handpieces~~Wand/STA System and ~~our~~its ~~ability~~predecessor, tothe ~~delivery~~CompuDent ~~reasonably~~System, ~~priced~~since ~~products,~~the ~~which~~commencement ~~would~~of production in ~~turn~~1998, ~~adversely~~and ~~affect~~by ~~our~~the ~~financial~~manufacturer ~~performance.~~of Inits ~~addition,~~handpieces assince ~~the~~2003. ~~Chinese~~The ~~legal~~manufacturer ~~system~~of ~~develops,~~our ~~there~~handpieces ~~can~~is bein nothe ~~assurance~~People’s ~~that~~Republic ~~changes~~of China, ~~in laws~~ and ~~regulations~~the ~~and~~manufacturer ~~their~~of ~~interpretation~~the orWand/STA ~~their~~System ~~enforcement~~is ~~will~~in ~~not~~the ~~have~~United aStates. ~~material~~At ~~adverse~~present, ~~effect~~we onhave ~~our~~an ~~business~~informal ~~relationship~~arrangement with the ~~sole manufacturer~~ manufacturers of our ~~dental handpieces~~products. ~~Any~~Our ~~adverse~~current ~~change~~arrangement inwith ~~the~~our ~~economic,~~manufacturers ~~environmental,~~is ~~and~~on ~~political~~a ~~conditions~~purchase inorder-by-purchase ~~China~~order ~~could~~basis. ~~have~~As a ~~material~~result, ~~adverse~~we ~~effect~~do onnot have ~~economic~~price ~~growth~~protection ~~and~~or ~~the~~a ~~level~~supply ofcommitment ~~investments~~for ~~and~~our ~~availability~~devices ofor ~~capital~~handpieces. inIf ~~China,~~either ~~which~~manufacturer ininsists ~~turn~~on ~~could~~a ~~lead~~material tochange ain ~~reduction~~terms or indetermines ~~the~~to ~~supply~~discontinue manufacture of our ~~dental~~products, ~~handpieces~~it ~~and~~could ~~consequently~~ have aan ~~material~~ adverse effect on our ~~businesses~~financial condition and results of operation.

~~Issues~~An operational ~~with~~disruption ~~product~~in ~~quality~~the facility of the manufacturer of, or their ability to ship, our handpieces or devices could ~~have~~negatively impact our financial results. The occurrence of a ~~material~~natural ~~adverse~~disaster, ~~effect~~such ~~upon~~as ~~our~~a ~~business~~hurricane, ~~subject~~tropical usstorm, toearthquake, ~~regulatory~~tornado, ~~actions~~severe ~~and~~weather, flood, ~~cause~~fire, aor ~~loss~~epidemic, ofpandemic, ~~customer~~or ~~confidence~~other inhealth usemergency, or ~~our~~other ~~products~~unanticipated problems such as labor difficulties, equipment failure or unscheduled maintenance, in each case could cause operational disruptions of varied duration.

InThese types ~~general,~~of ~~our~~disruptions ~~success~~could ~~depends~~materially ~~upon~~adversely ~~the~~affect ~~quality of~~ our ~~products. Quality~~financial ~~management~~condition ~~plays~~and anresults ~~essential~~of ~~role~~operations into ~~meeting~~varying ~~customer~~degrees ~~requirements,~~dependent upon ~~preventing~~the ~~defects~~facility, ~~improving~~the ~~our~~duration ~~products~~of ~~and~~the ~~services~~disruption, ~~and assuring the safety and efficacy of~~ our ~~products. Our~~ability ~~future~~to ~~success~~shift ~~depends~~business ~~on our ability~~ to ~~maintain~~another ~~and~~facility ~~continuously~~or ~~improve~~find ~~our~~alternative ~~quality~~sources ~~management~~of ~~program~~supply. A Any ~~quality~~losses ordue ~~safety~~to ~~issue~~these events may ~~result~~not inbe ~~adverse~~covered ~~inspection~~by ~~reports,~~our ~~warning~~existing ~~letters,~~insurance ~~product~~policies ~~recalls~~ or ~~seizures,~~may ~~monetary~~be ~~sanctions,~~subject ~~injunctions~~ to ~~halt~~certain ~~manufacture~~deductibles. ~~and~~Given our ~~distribution~~current ofmanufacturing ~~products~~relationships, ~~civil~~it oris ~~criminal~~possible ~~sanctions,~~that ~~costly~~our ~~litigation,~~manufacturing ~~refusal~~requirements ofmay aexceed ~~government~~the toavailable ~~grant~~supply ~~approvals~~allotments under ~~and~~our ~~licenses, restrictions on operations or withdrawal of~~ existing ~~approvals and licenses~~agreements. An ~~inability~~Our toanticipated ~~address~~future areliance ~~quality~~on orthird-party ~~safety~~manufacturers ~~issue~~exposes ~~in an effective and timely manner may also cause negative publicity, a loss of customer confidence in~~ us orto ~~our current or future products, which may result in~~ the ~~loss~~following ofadditional ~~sales and difficulty in successfully launching new products.~~ risks:

~~The~~● ~~use~~We may be unable to identify manufacturers on acceptable terms or at all because the number of ~~third~~potential ~~parties~~manufacturers is limited, and the FDA must approve any replacement contractor. This approval would require new testing and compliance inspections. In addition, a new manufacturer would have to ~~manufacture~~develop substantially equivalent processes for production of our products. ● Contract manufacturers may ~~increase~~not ~~the~~perform ~~risk~~as ~~that~~agreed weor ~~will~~may not ~~have~~remain ~~enough~~in ofthe contract manufacturing business for the time required to successfully produce, store, and distribute our products. or● ~~such~~Contract ~~quantities~~manufacturers atare ~~acceptable~~subject ~~levels~~to ofongoing ~~cost~~periodic unannounced inspections by the FDA and ~~quality~~corresponding state agencies to ensure strict compliance with current good manufacturing practice and other government regulations and corresponding foreign standards. We do not have control over third-party manufacturers’ compliance with these regulations and standards, and our manufacturers may be found to be in noncompliance with certain regulations, which ~~could~~may ~~impair~~impact ~~our~~their ~~commercialization~~ability ~~efforts~~to manufacture our products.

Milestone Scientific relies on several third parties to supply and manufacture the components and raw materials for its products and its does not have long-term supply agreements with suppliers of these component parts and raw materials, and its arrangements with these suppliers are on a purchase-order basis. These products we obtain from suppliers are subject to fluctuations in price and availability attributable to several factors, including general economic conditions, commodity price fluctuations, the demand by other companies for the same raw materials and the availability of complementary and substitute materials.14

14 ● If any third-party manufacturer makes improvements in the manufacturing process for our products, we may not own or may have to share the intellectual property rights to the innovation. We may be required to pay fees or other costs for access to such improvements. ● Though alternate sources of supply for dental handpieces exist, we would need to establish relationships with new suppliers, and with respect to the Wand/STA System, recover its existing tools or have new tools produced and “burned in” and other manufacturing and quality control software re-produced. Establishing new manufacturing relationships could involve significant expense and delay.

~~While Milestone Scientific works with suppliers to ensure continuity~~ Each of ~~supply, no assurance can be given that~~ these ~~efforts~~risks ~~will~~could bedelay ~~successful. In~~ the ~~event~~commercialization ~~that any~~ of ~~its~~our ~~existing~~CompuFlo ~~supply~~Epidural ~~arrangements~~Computer ~~are~~Controlled ~~terminated~~Anesthesia orSystem, ~~there~~limit isour aavailable supply ~~reduction or interruption~~ of ~~supply~~The ~~under~~Wand/ ~~these~~STA ~~existing~~for ~~arrangements,~~dental ~~Milestone Scientific expects that it will be able to enter into new arrangements with alternative suppliers~~applications, ~~but~~cause ~~these~~damage ~~new arrangements may be on terms that are less favorable, including with respect~~ to ~~price~~our ~~and volume~~reputation, ~~and~~result itin ~~may~~higher becosts ~~costly~~ and/or ~~cause~~deprive ~~delays~~us inof ~~our~~potential product ~~manufacturing~~revenues. ~~process~~Any tocurtailment ~~transition~~or tointerruption aof ~~new~~the ~~supplier~~supply, ~~particularly~~whether inbecause ~~cases in which we must comply with regulatory requirements relating to qualification~~ of ~~new suppliers. The~~ termination, ~~reduction or interruption in supply~~ of ~~these~~the ~~raw~~relationship ~~materials~~or ~~and~~otherwise, ~~components~~would have ~~could~~a ~~adversely~~material ~~impact~~adverse ~~Milestone~~effect ~~Scientific~~on ~~Scientific’s~~our ~~ability~~financial tocondition, ~~manufacture~~business, and ~~sell~~results ~~certain~~ of ~~its products~~operations.

~~Third-party~~Our business ~~suppliers~~is ~~may~~exposed ~~encounter problems during manufacturing for a variety of reasons, including failure~~ to ~~follow~~risks ~~specific~~associated ~~protocols and procedures, failure to comply~~ with ~~applicable~~the ~~regulations~~economic, ~~equipment malfunction~~environmental, ~~component part supply constraints,~~ and ~~environmental~~political ~~factors,~~conditions ~~any~~in ofChina ~~which~~because ~~could delay or impede their ability to supply~~ the ~~components~~sole ~~and~~manufacturer of ~~raw~~our ~~materials~~handpieces ~~for~~is ~~Milestone Scientific’s products. Any such failure to perform or a reduction or interruption~~ in ~~supply could have a material adverse effect on Milestone Scientific’s business and operations~~China.

~~Risks~~Because the ~~Related~~sole manufacturer of our dental handpieces is in China, our business is disproportionately exposed to ~~Regulatory~~the ~~Compliance~~economic, environmental, and ~~Other~~political ~~Legal~~conditions ~~Matters~~of the region. China’s political and economic systems are very different from most developed countries in many respects, including the amount of government involvement, the level of development, the control of foreign exchange, and the allocation of resources. The increase in United States tariffs on products from China have impacted and will continue to impact the price of our goods sold. Uncertainties have arisen and may arise in the future with changing governmental policies and measures. China also faces many social, economic, and political challenges that may produce instabilities in both its domestic arena and in its relationship with other countries.

WeThese instabilities ~~are~~may ~~subject~~significantly toand ~~substantial~~adversely ~~domestic~~affect our supply of dental handpieces and ~~international~~our ~~government~~ability ~~regulation,~~to ~~including~~deliver ~~regulatory~~reasonably ~~quality~~priced ~~standards~~products, which ~~applicable~~would toin ~~our~~turn ~~manufacturing~~adversely ~~and~~affect ~~quality~~our ~~processes~~financial performance. ~~Failure~~In byaddition, usas tothe ~~comply~~Chinese ~~with~~legal ~~these~~system ~~standards~~develops, ~~could~~there can be no assurance that changes in laws and regulations and their interpretation or their enforcement will not have ana material adverse effect on our business relationship with the sole manufacturer of our dental handpieces. Any adverse change in the economic, ~~financial~~environmental, ~~condition~~and political conditions in China could have a material adverse effect on economic growth and the level of investments and availability of capital in China, orwhich in ~~results~~turn could lead to a reduction in the supply of ~~operations~~our dental handpieces and consequently have a material adverse effect on our businesses.

~~The~~Issues with ~~FDA regulates the~~ product ~~approvals~~quality ~~manufacturing,~~could ~~and~~have ~~sales~~a ~~and~~material ~~marketing~~adverse ofeffect ~~many~~upon of our ~~products in the United States. Significant government regulations also exist in other countries in which we conduct~~ business~~. As a device manufacturer~~, wesubject ~~are~~us ~~required~~ to ~~register~~regulatory ~~with~~actions ~~the FDA~~ and ~~are~~cause ~~subject~~a toloss ~~periodic inspection by the FDA for compliance with the FDA’s Quality System Regulation requirements, which require manufacturers~~ of ~~medical~~customer confidence ~~devices~~in ~~to adhere to good manufacturing practices . In addition, the federal Medical Device Reporting regulations require~~ us ~~to provide information to the FDA whenever there is evidence that reasonably suggests that a device may have caused~~ or ~~contributed~~our ~~to a death or serious injury or, if a malfunction were to occur, could cause or contribute to a death or serious injury~~products. ~~Compliance with applicable regulatory requirements is subject to continual review and is rigorously monitored through periodic inspections by the FDA.~~

In general, our success depends upon the ~~European~~quality ~~community,~~of weour ~~are~~products. ~~required~~Quality tomanagement ~~maintain compliance~~plays toan ~~ISO,~~essential CErole ~~marking~~in ~~standards to~~meeting ~~sell~~customer requirements, preventing defects, improving our products and ~~must~~services, ~~undergo~~and ~~periodic~~assuring ~~inspections~~the bysafety ~~notified~~and ~~bodies~~efficacy toof ~~obtain~~our ~~and~~products. ~~maintain~~Our ~~compliance.~~future ~~Failure~~success depends on our ability to ~~comply~~maintain ~~with~~and ~~current~~continuously ~~governmental~~improve ~~regulations~~our ~~and~~quality management program. A quality ~~assurance~~or ~~guidelines~~safety ~~could~~issue ~~lead~~may toresult ~~temporary~~in ~~manufacturing~~adverse ~~shutdowns~~inspection reports, warning letters, product recalls or ~~related~~seizures, ~~field~~monetary ~~actions~~sanctions, ~~product~~injunctions ~~shortages~~to orhalt ~~delays~~manufacture inand ~~product~~distribution ~~manufacturing.~~of ~~Efficacy~~products, civil or ~~safety~~criminal ~~concerns~~sanctions, ancostly ~~increase~~litigation, inrefusal ~~trends~~ of ~~adverse~~a ~~events~~government into ~~the~~grant ~~marketplace,~~approvals and~~/or~~ ~~manufacturing~~licenses, ~~quality~~restrictions ~~issues~~on ~~with~~operations ~~respect~~or withdrawal toof ~~our~~existing ~~products~~approvals ~~could~~and ~~lead~~licenses. An inability to ~~product~~address ~~recalls~~a quality or ~~related~~safety ~~field~~issue ~~actions,~~in ~~withdrawals,~~an effective and/ timely manner may also cause negative publicity, a loss of customer confidence in us or ~~declining~~our current or future products, which may result in the loss of sales and difficulty in successfully launching new products.

WeThe use ~~may~~of bethird ~~subject,~~parties ~~directly, or indirectly,~~ to ~~U.S.~~manufacture ~~federal~~our ~~and~~products ~~state~~may ~~health~~increase ~~care~~the ~~fraud~~risk ~~and~~that ~~abuse~~we ~~and~~will ~~false~~not ~~claims~~have ~~laws~~enough ~~and~~of ~~regulations.~~our ~~Prosecutions~~products ~~under~~or such ~~laws~~quantities at ~~have~~acceptable ~~increased~~levels inof ~~recent~~cost ~~years~~ and ~~we may become subject to such litigation. If we are unable to comply or have not fully complied with such laws~~quality, wewhich could ~~face~~impair ~~substantial~~our ~~penalties~~commercialization efforts.

~~Our~~The Company ~~operations~~relies ~~are~~on ~~and~~several ~~will~~third ~~continue~~parties to besupply ~~directly, or indirectly through our distributors, customers,~~ and ~~health~~manufacture ~~care professionals, subject to various U.S. federal and state fraud and abuse laws, including, without limitation,~~ the ~~federal~~components ~~Anti-Kickback Statute, federal False Claims Act,~~ and ~~the~~raw ~~Foreign~~materials ~~Corrupt~~for ~~Practice~~its ~~Act of 1977. These laws may impact~~products, ~~among other things, our proposed sales,~~ and ~~marketing~~it ~~and~~does ~~education~~not have ~~programs. The federal Anti~~long-~~Kickback~~term ~~Statute~~supply ~~prohibits~~agreements ~~persons~~with ~~from~~suppliers ~~knowingly and willfully soliciting, offering, receiving, or providing remuneration, directly or indirectly, in exchange for or to induce either the referral~~ of anthese ~~individual,~~component orparts ~~the~~and ~~furnishing~~raw ~~or arranging for a good or service~~materials, ~~for~~and ~~which~~its ~~payment~~arrangements ~~may~~with bethese ~~made~~suppliers are ~~under~~on a ~~federal~~purchase-order ~~health care program such as Medicare or Medicaid~~basis. ~~Several~~These ~~courts~~products ~~have~~we ~~interpreted~~obtain ~~the~~from ~~statute’s~~suppliers ~~intent~~are ~~requirement~~subject to ~~mean~~fluctuations ~~that~~in ifprice ~~any~~and ~~one~~availability ~~purpose of an arrangement involving remuneration is~~ attributable to ~~induce~~several ~~referrals of federal health care covered business~~factors, ~~the~~including ~~statute~~general ~~has~~economic ~~been violated. The Anti-Kickback Statute is broad and~~conditions, ~~despite~~commodity aprice ~~series of narrow safe harbors~~fluctuations, ~~prohibits many arrangements and practices that are lawful in businesses outside of~~ the ~~health~~demand ~~care~~by ~~industry.~~other ~~Penalties~~companies for ~~violations of~~ the ~~federal~~same ~~Anti-Kickback Statute include criminal penalties and civil and administrative sanctions such as fines~~raw materials, ~~imprisonment,~~ and ~~possible exclusion from Medicare, Medicaid, and other federal health care programs. An alleged violation of~~ the ~~Anti-Kickback~~availability Statute may be used as a predicate offense to establish liability pursuant to other federal laws and regulations such as the federal False Claims Act. Many states have also adopted laws like the federal Anti-Kickback Statute, some of ~~which~~complementary ~~apply to the referral of patients for health care items or services reimbursed by any source, not only the Medicare~~ and ~~Medicaid~~substitute ~~programs~~materials.

While 15we work with suppliers to ensure continuity of supply, no assurance can be given that these efforts will be successful. In the event that any of its existing supply arrangements are terminated or there is a reduction or interruption of supply under these existing arrangements, We expect that we will be able to enter into new arrangements with alternative suppliers, but these new arrangements may be on terms that are less favorable, including with respect to price and volume, and it may be costly or cause delays in our manufacturing process to transition to a new supplier, particularly in cases in which we must comply with regulatory requirements relating to qualification of new suppliers. The termination, reduction or interruption in supply of these raw materials and components could adversely impact our ability to manufacture and sell certain of its products.

The federal False Claims Act prohibits persons from knowingly filing, or causing to be filed, a false claim to, or the knowing use of false statements to obtain payment from, the federal government. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of the government and such individuals, commonly known as “relators” or “whistleblowers,” may share in any amounts paid by the entity to the government in fines or settlement. The frequency of filing qui tam actions has increased significantly in recent years, causing greater numbers of medical device, pharmaceutical and health care companies to have to defend False Claim Act actions. The Affordable Care Act includes provisions expanding the ability of certain relators to bring actions that would have been previously dismissed under prior law. When an entity is determined to have violated the federal False Claims Act, it may be required to pay up to three times the actual damages sustained by the government, plus civil penalties for each separate false claim. The Deficit Reduction Act of 2005 encouraged states to enact or modify their state false claims act to be at least as effective as the federal False Claims Act by granting states a portion of any federal Medicaid funds recovered through Medicaid-related actions. Most states have enacted state false claims laws, and many of those states included laws with qui tam provisions.15

~~The~~Third-party suppliers ~~Affordable~~may ~~Care~~encounter ~~Act~~problems ~~includes~~during ~~provisions~~manufacturing ~~known~~for asa ~~the~~variety ~~Physician~~of ~~Payments~~reasons, ~~Sunshine~~including ~~Act~~failure ~~(section~~to ~~6002)~~follow specific protocols and procedures, failure ~~which~~to ~~require~~comply ~~manufacturers~~with ofapplicable ~~drugs~~regulations, ~~biologics~~equipment malfunction, ~~devices~~component part supply constraints, and ~~medical~~environmental ~~supplies~~factors, ~~covered~~any of ~~under~~which ~~Medicare~~could ~~and~~delay ~~Medicaid~~or toimpede ~~disclose~~their ability to supply the ~~Centers~~components ~~for~~and ~~Medicare~~raw ~~and~~materials ~~Medicaid~~for ~~Services~~our ~~any~~products. ~~transfers~~Any ofsuch ~~value~~failure to ~~physicians~~perform or ~~and~~a ~~teaching~~reduction ~~hospitals~~or interruption in supply could have a material adverse effect on our business and operations.

~~Manufacturers~~Risks Related ~~must also disclose investment interests held by physicians and their family members. Failure~~ to ~~submit~~Regulatory ~~the~~Compliance ~~required information may result in civil monetary penalties of up to $1 million per year for knowing violations~~ and ~~may~~Other ~~result~~Legal in liability under other federal laws or regulations. Similar reporting requirements have also been enacted on the state level in the United States, and an increasing number of countries worldwide either have adopted or are considering similar laws requiring transparency of interactions with health care professionals. In addition, some states, such as Massachusetts and Vermont, impose an outright ban on certain gifts to physicians. These laws could affect our promotional activities by limiting the kinds of interactions we could have with hospitals, physicians or other potential purchasers or users of our products. Both the disclosure laws and gift bans will impose administrative, cost and compliance burdens on us. If we are found to be in violation of any of the laws described above and other applicable state and federal fraud and abuse laws, we may be subject to penalties, including civil and criminal penalties, damages, fines, or an administrative action of suspension or exclusion from government health care reimbursement programs and the curtailment or restructuring of our operations.Matters

~~In addition, we~~ We are subject to ~~the~~substantial ~~Foreign~~domestic ~~Corrupt Practices Act (“FCPA”)~~ and ~~other~~international ~~countries’~~government ~~anti-corruption/anti-bribery regimes~~regulation, ~~such~~including asregulatory ~~the~~quality ~~U.K.~~standards ~~Bribery~~applicable ~~Act. The FCPA prohibits improper payments or offers of payments~~ to ~~foreign~~our manufacturing ~~governments~~ and ~~their~~quality ~~officials for obtaining or retaining business~~processes. ~~Safeguards~~Failure weby ~~implement~~us to ~~discourage~~comply ~~improper~~with ~~payments~~these orstandards ~~offers~~could ofhave ~~payments~~an byadverse ~~our~~effect ~~employees,~~on ~~consultants,~~our ~~sales agents~~business, ~~or distributors may be ineffective~~financial condition, ~~and violations of the FCPA and similar laws may result in severe criminal~~ or ~~civil sanctions, or other liabilities or proceedings against us, any of which would likely harm our reputation, business,~~ results of operations ~~and financial condition~~.

~~Safeguards~~In a wesignificant ~~implement~~regulatory toshift, ~~discourage~~the ~~improper~~U.S. ~~payments~~Food orand ~~offers~~Drug ofAdministration ~~payments~~(“FDA”) byhas ~~our~~adopted ~~employees,~~a ~~consultants,~~new ~~sales~~regulatory ~~agents,~~framework for orthe ~~distributors~~domestic ~~may~~medical bedevice ~~ineffective~~industry, ~~and~~replacing ~~violations~~the oflongstanding ~~the~~Quality ~~FCPA~~System Regulation (“QSR”) under 21 C.F.R. Part 820 and ~~similar~~aligning ~~laws~~U.S. ~~may~~medical ~~result~~device inquality ~~severe~~requirements ~~criminal~~more orclosely ~~civil~~with ~~sanctions,~~ISO or13485 ~~other~~and ~~liabilities~~the orquality ~~proceedings~~management ~~against~~system ~~us,~~standards used ~~any~~by ofregulatory ~~which~~authorities ~~would~~in ~~likely~~other ~~harm~~jurisdictions. ~~our~~This ~~reputation,~~new ~~business~~framework, ~~results~~finalized ofas ~~operations~~the ~~and~~Quality ~~financial~~Management ~~condition~~System Regulation (“QMSR”), became effective on February 2, 2026.

~~Certain~~For companies ~~modifications~~operating toin ~~Milestone~~international ~~Scientific~~markets, including the Company, whose international operations already comply with ISO 13485, adoption of the FDA’s ~~products~~QMSR ~~may~~is ~~require~~expected ~~new~~over ~~510(k)~~time ~~clearances~~to orreduce ~~other~~duplication ~~marketing~~in ~~authorizations~~audits and documentation. The Company has evaluated its quality management system against the requirements of ISO 13485 and ~~may~~the ~~require~~QMSR, ~~Milestone~~and ~~Scientific~~the results of this evaluation have informed updates to ~~recall~~standard oroperating ~~cease~~procedures, ~~marketing~~the quality manual, and related compliance documentation. The Company has substantially implemented the additional controls and process enhancements identified through this evaluation, continues to complete remaining actions to support compliance with the QMSR by its ~~products~~effective date, and is compliant.

~~Once~~If we aor ~~medical~~our ~~device~~third isparty ~~permitted~~manufacturers toare beunable ~~legally~~to ~~marketed~~comply inwith the ~~United~~QMSR, ~~States~~once ~~pursuant~~effective, toor awith ~~510(k)~~any ~~clearance,~~other applicable FDA requirements or if we or a third party manufacturer ~~may~~later bediscovers ~~required~~previously tounknown ~~notify~~problems with our products or manufacturing processes, these could result in, among other things: warning letters or untitled letters; fines, injunctions or civil penalties; suspension or withdrawal of approvals; seizures or recalls of our products; total or partial suspension of production or distribution; administrative or judicially imposed sanctions; the FDA’s ofrefusal ~~certain~~to ~~modifications~~grant pending or future clearances or approvals for our products; clinical holds; refusal to permit the ~~device~~import or export of our products; and criminal prosecution of us, our suppliers, or our employees. Any of these actions could significantly and negatively affect supply of our products. If any of these events occur, our reputation could be harmed, we could be exposed to product liability claims and we could lose customers and experience reduced sales and increased costs.

~~Manufacturers determine in~~ Under the ~~first~~transitional ~~instance~~provisions, ~~whether~~of athe ~~change~~European toUnion’s aMedical ~~product~~Device ~~requires~~Regulation ~~a new 510~~(k“MDR”), ~~clearance~~To orcontinue ~~premarket~~commercial sales ~~submission,~~in ~~but~~ the ~~FDA~~European ~~may~~Union ~~review~~beyond ~~any~~the ~~manufacturer’s~~transition ~~decision.~~period, ~~The~~the ~~FDA may not agree with Milestone Scientific~~Company’s ~~decisions~~Class ~~regarding~~IIa ~~whether~~and ~~new~~Class ~~clearances~~IIb ~~are~~devices ~~necessary.~~must ~~Milestone~~obtain certification ~~Scientific~~under ~~has~~the ~~made~~MDR ~~modifications~~by toDecember ~~its~~31, ~~products~~2028. inThe ~~the~~Company ~~past~~continues ~~and~~to ~~has~~manage ~~determined based on~~ its ~~review~~MDR oftransition ~~the~~activities ~~applicable~~in ~~FDA~~coordination ~~regulations~~with notified ~~and~~bodies; ~~guidance~~however, ~~that~~failure into ~~certain~~successfully ~~instances~~obtain ~~new~~MDR ~~510(k)~~certification ~~clearances~~within orthe ~~other~~applicable ~~premarket~~timeframe ~~submissions~~could ~~were~~adversely ~~not~~affect the ~~required.~~Company’s ~~Milestone~~ability ~~Scientific~~to ~~may~~market ~~make~~and ~~similar~~sell ~~modifications~~its orproducts ~~add additional features~~ in the ~~future~~European ~~that~~Union. itThe ~~believes~~Company’s doproducts, ~~not~~including ~~require~~the Wand® aSTA ~~new~~System, ~~510(k)~~dental ~~clearance.~~handpieces Ifused ~~the FDA disagrees~~ with ~~Milestone~~the ~~Scientific’s~~Wand® ~~determinations~~ and ~~requires~~Wand® itSTA ~~to submit new 510(k) notifications~~Systems, ~~Milestone~~which ~~Scientific~~are ~~may~~classified beas ~~required~~Class toIIa ~~cease~~medical devices, ~~marketing~~and ~~or to recall~~ the ~~modified~~CompuFlo® ~~product~~Epidural ~~until~~System, itwhich ~~obtains~~is ~~clearance,~~classified ~~and~~as ita ~~may~~Class beIIb ~~subject~~medical todevice, ~~significant~~will ~~regulatory~~have ~~fines~~MDR orcertification ~~penalties~~in 2027.

~~Changes~~We tomay ~~United~~be ~~States~~subject, directly or indirectly, to U.S. federal and state ~~regulatory~~healthcare ~~agencies~~fraud ~~may~~and ~~cause~~abuse ~~disruptions~~and false claims laws and ~~delays~~regulations. inProsecutions ~~approval~~under ofsuch ~~the~~laws ~~government~~have ~~approval~~increased ~~processes~~in recent years and ~~regulation~~we ~~relating~~may become subject to ~~our~~such ~~products~~litigation. If we are unable to comply or have not fully complied with such laws, we could face substantial penalties.

ItOur isoperations ~~possible~~are ~~that~~and ~~the~~will ~~Trump~~continue to ~~administration~~be ~~could~~directly, ~~institute~~or ~~significant~~indirectly ~~changes~~through toour ~~certain~~distributors, ~~regulatory~~customers, ~~agencies~~ and ~~seek~~healthcare professionals, subject to ~~institute~~various ~~the~~U.S. ~~"Department~~federal ofand ~~Government~~state fraud ~~Efficiency,"~~and orabuse ~~"DOGE~~laws," ~~tasked~~including, ~~with~~without ~~making~~limitation, ~~changes~~the tofederal ~~eliminate~~Anti-Kickback ~~regulations~~Statute, ~~cut~~federal ~~expenditures~~False Claims Act, and ~~restructure~~the ~~federal~~Foreign ~~agencies,~~Corrupt Practices ~~some~~Act of ~~which~~1977. ~~could~~These laws may impact, ~~public~~among ~~companies~~other things, our proposed sales, and marketing and education programs. ~~For~~The ~~example~~federal Anti-Kickback Statute prohibits persons from knowingly and willfully soliciting, ~~the~~offering, ~~incoming~~receiving, ~~administration~~or ~~has~~providing ~~discussed~~remuneration, ~~several~~directly or ~~changes~~indirectly, in exchange for or to ~~the~~induce ~~reach~~either ~~and~~the ~~oversight~~referral of an individual, or the ~~Food~~furnishing ~~and~~or ~~Drug~~arranging ~~Administration~~for a good or service, for which ~~could~~payment ~~affect~~may ~~its~~be ~~relationship~~made ~~with~~under ~~the~~a ~~pharmaceutical~~federal ~~industry,~~healthcare ~~transparency~~program insuch ~~decision~~as ~~making~~Medicare ~~and~~or ~~ultimately~~Medicaid. Several courts have interpreted the ~~cost~~statute’s intent ~~and~~requirement ~~availability~~to mean that if any one purpose of ~~prescription~~an ~~drugs~~arrangement involving remuneration is to induce referrals of federal healthcare covered business, asthe ~~well~~statute ashas ~~oversight~~been ~~over~~violated. ~~clinical~~The ~~trials~~Anti-Kickback ~~and~~Statute ~~pharmaceutical~~is ~~development~~broad and, ~~all~~despite a series of ~~which~~narrow ~~could~~safe ~~pose~~harbors, ~~risks~~prohibits many ~~(or~~arrangements ~~opportunities)~~and ~~for~~practices ~~companies~~that are lawful in ~~related~~businesses ~~industries.~~outside ~~Similarly,~~of ~~there~~the ~~have~~healthcare ~~been~~industry. ~~discussions~~Penalties for violations of ~~"reigning~~the ~~in"~~federal Anti-Kickback ~~regulatory~~Statute ~~agencies~~include criminal penalties and civil and administrative sanctions such as ~~the~~fines, ~~Federal~~imprisonment, ~~Trade~~and ~~Commission~~possible exclusion from Medicare, Medicaid, and other federal healthcare programs. An alleged violation of the ~~Federal~~Anti-Kickback ~~Communications~~Statute ~~Commission~~may be used as a predicate offense to establish liability pursuant to other federal laws and regulations, such as the ~~Federal~~federal ~~Energy~~False ~~Regulatory~~Claims ~~Commission~~Act. Many states have also adopted laws like the federal Anti-Kickback Statute, ~~all~~some of which ~~could~~apply ~~impact~~to ~~how~~the ~~companies~~referral doof ~~business~~patients ~~and~~for ~~could~~healthcare ~~pose~~items ~~risks~~or ~~related~~services reimbursed toby ~~business~~any ~~operations~~source, not only the Medicare and ~~financial~~Medicaid ~~outlook~~programs.

~~Milestone~~The federal ~~Scientific~~False ~~may~~Claims Act prohibits persons from knowingly filing, or causing to be ~~subject~~filed, a false claim to, ~~enforcement~~or the knowing use of false statements to obtain payment from, the federal government. Suits filed under the False Claims Act, known as “qui tam” actions, can ifbe itbrought ~~engages~~by any individual on behalf of the government, and such individuals, commonly known as “relators” or “whistleblowers,” may share in ~~improper~~any ~~marketing~~amounts paid by the entity to the government in fines or ~~promotion~~settlement. The frequency of ~~its~~filing ~~products~~qui tam actions has increased significantly in recent years, causing greater numbers of medical device, pharmaceutical, and healthcare companies to have to defend False Claim Act actions. The Affordable Care Act includes provisions expanding the ability of certain relators to bring actions that would have been previously dismissed under prior law. When an entity is determined to have violated the federal False Claims Act, it may be required to pay up to three times the actual damages sustained by the government, plus civil penalties for each separate false claim. The Deficit Reduction Act of 2005 encouraged states to enact or modify their state False Claims Act to be at least as effective as the federal False Claims Act by granting states a portion of any federal Medicaid funds recovered through Medicaid-related actions. Most states have enacted state false claims laws, and many of those states include laws with qui tam provisions.

~~Milestone~~The Affordable ~~Scientific’s~~Care ~~promotional~~Act ~~materials~~includes ~~and~~provisions ~~training~~known ~~methods~~as ~~must comply with applicable laws, regulations and regulatory authority’s rules and guidelines, including~~ the ~~FDA~~Physician ~~and~~Payments ~~the~~Sunshine ~~Federal~~Act ~~Trade Commission~~ (~~the~~section ~~“FTC”~~6002)~~. If the FDA~~, ~~the~~which ~~FTC~~require ormanufacturers ~~another~~of ~~regulatory agency determines that Milestone Scientific’s promotional or training material constitutes off-label~~drugs, ~~false or misleading~~ biologics, ~~unfair or deceptive promotion of its products~~devices, itand ~~could~~medical ~~request~~supplies ~~that~~covered ~~Milestone~~under ~~Scientific~~Medicare ~~modify~~and ~~its~~Medicaid ~~training~~to ordisclose ~~promotional materials or subject Milestone Scientific~~ to ~~regulatory or enforcement actions, including~~ the ~~issuance~~Centers offor anMedicare ~~untitled~~and ~~letter,~~Medicaid aServices any ~~warning~~transfers ~~letter,~~of ~~injunction,~~value ~~seizure,~~to ~~civil~~physicians ~~fine~~and orteaching ~~criminal penalties~~hospitals.

ItManufacturers must is also ~~possible~~disclose ~~that~~investment interests held by physicians and their family members. Failure to submit the required information may result in civil monetary penalties of up to $1 million per year for knowing violations and may result in liability under other federal, laws or regulations. Similar reporting requirements have also been enacted on the state orlevel ~~foreign~~in ~~enforcement~~the ~~authorities~~United ~~might~~States, ~~act~~and ifan ~~they~~increasing ~~consider~~number of ~~Milestone~~countries ~~Scientific’s~~worldwide ~~promotional~~either have adopted or ~~training~~are ~~materials~~considering tosimilar ~~constitute~~laws ~~off-label~~requiring transparency of interactions with healthcare professionals. In addition, ~~false~~some orstates, ~~misleading~~such as Massachusetts and Vermont, ~~unfair~~impose an outright ban on certain gifts to physicians. These laws could affect our promotional activities by limiting the kinds of interactions we could have with hospitals, physicians or ~~deceptive~~other ~~promotion~~potential purchasers or users of ~~its~~our products. Both the disclosure laws and gift bans will impose administrative, ~~which~~cost ~~could~~and ~~result~~compliance burdens on us. If we are found to be in ~~significant~~violation ~~fines~~of orany ~~penalties~~of ~~under~~the laws described above and other ~~statutory~~applicable ~~authorities,~~state ~~such~~and asfederal fraud and abuse laws, ~~prohibiting~~we ~~false~~may ~~claims~~be subject ~~for~~to ~~reimbursement~~penalties, including civil and ~~reputational~~criminal ~~harm~~penalties, damages, fines, or an administrative action of suspension or exclusion from government healthcare reimbursement programs and the curtailment or restructuring of our operations.

~~Changes~~In addition, inwe ~~laws~~are subject to the Foreign Corrupt Practices Act (“FCPA”) and ~~regulations~~other ~~over~~countries’ ~~which~~anti-corruption/anti-bribery regimes, such as the U.K. Bribery Act. The FCPA prohibits improper payments or offers of payments to foreign governments and their officials for obtaining or retaining business. Safeguards we ~~have~~implement noto ~~control~~discourage ~~can~~improper ~~significantly~~payments ~~affect~~or offers of payments by our ~~business~~employees, consultants, sales agents, or distributors may be ineffective, and ~~results~~violations of the FCPA and similar laws may result in severe criminal or civil sanctions, or other liabilities or proceedings against us, any of which would likely harm our reputation, business, results of operations, and financial condition.

~~Any~~Safeguards we ~~governmental~~implement ~~entity~~to ~~that~~discourage ~~regulates~~improper ~~our~~payments ~~operations~~or inoffers ~~the~~of ~~country~~payments inby ~~which~~our ~~they~~employees, ~~are~~consultants, ~~located~~sales ~~may~~agents, ~~enact new legislation~~ or ~~adopt~~distributors ~~new~~may ~~laws~~be ineffective, and ~~regulations~~violations orof ~~policies~~the atFCPA ~~any time,~~ and ~~new~~similar ~~judicial~~laws ~~decisions~~ may ~~change~~result ~~the~~in ~~interpretation~~severe ofcriminal ~~existing~~or ~~legislation~~civil sanctions, or ~~regulations~~other atliabilities ~~any~~or ~~time~~proceedings against inus, any of ~~the countries in~~ which ~~our~~would ~~operations~~likely orharm ~~projects are located. We have no control over any such changes. Any new laws or regulations governing~~ our ~~operations~~reputation, ~~could have an adverse impact on our~~ business, results of operations, and ~~prospects~~financial condition.

~~Changes~~Certain modifications to ~~trade~~the ~~policy,~~Company’s ~~including~~products ~~tariff~~may ~~and~~require ~~import/export~~new ~~regulations,~~510(k) ~~may~~clearances ~~have~~or aother ~~material~~marketing ~~adverse~~authorizations ~~effect~~and onmay require ~~our~~the ~~results~~Company ofto ~~operations,~~recall ~~cash~~or ~~flows~~cease ~~and~~marketing ~~financial~~its ~~condition~~products.

~~Changes~~Once a inmedical ~~United~~device ~~States~~is ~~policy~~permitted ~~regarding~~to ~~international~~be ~~trade,~~legally ~~including~~marketed ~~import and export regulation and international trade agreements, could adversely affect our business. The U.S. government has instituted and proposed further changes~~ in ~~trade policies that include~~ the ~~imposition~~United ofStates ~~higher~~pursuant tariffs on imports into the U.S., the negotiation or termination of trade agreements, economic sanctions on individuals, corporations or countries, and other government regulations affecting trade between the U.S. and other countries where we conduct our business. It may be time-consuming and expensive for us to alter our operations in order to adapt to or comply with any such changes. Tariffs and other changes in U.S. trade policy have triggered retaliatory actions by the affected countries, and certain foreign governments, including China, have instituted or are considering imposing retaliatory measures on certain U.S. goods. We do a ~~significant amount of business that will be impacted by changes to the trade policies of the U.S. and foreign countries~~ 510(~~including governmental action related to tariffs, international trade agreements, or economic sanctions~~k). ~~Tariffs and other retaliatory measures imposed by the United States on imports~~clearance, ~~and other retaliatory trade measures taken by the United States, China and other countries, and successive rounds of retaliatory trade measures as part of~~ a ~~trade~~manufacturer ~~war or otherwise, will result in an increase in supply chain costs and limit availability of products that Milestone Scientific~~ may ~~not~~ be ~~able~~ required to ~~offset~~notify ~~or that otherwise adversely impact its operations. Such changes have~~ the ~~potential~~FDA toof ~~adversely impact the U.S. economy or~~ certain ~~sectors~~modifications ~~thereof,~~to ~~our industry and~~ the ~~global demand for our products, and as a result, could have a material adverse effect on our results of operations, cash flows and financial condition~~device.

In addition, political tensions between the United States and China have escalated in recent years. Rising political tensions could reduce trade, investment and other economic activities between the two major economies. Any of these factors could have a material adverse effect on Milestone Scientific’s business, prospects, financial condition, and results of operations.17

Manufacturers 17determine in the first instance whether a change to a product requires a new 510(k) clearance or premarket submission, but the FDA may review any manufacturer’s decision. The FDA may not agree with the Company’s decisions regarding whether new clearances are necessary. The Company has made modifications to its products in the past and has determined, based on its review of the applicable FDA regulations and guidance, that in certain instances, new 510(k) clearances or other premarket submissions were not required. The Company may make similar modifications or add additional features in the future that it believes do not require a new 510(k) clearance. If the FDA disagrees with the Company’s determinations and requires it to submit new 510(k) notifications, the Company may be required to cease marketing or to recall the modified product until it obtains clearance, and it may be subject to significant regulatory fines or penalties.

~~Turnover at U.S. Department of Health and Human Services, including the FDA, is expected~~ Changes to ~~lead~~United toStates different enforcement objectives. In addition, on June 28, 2024, the U.S. Supreme Court ruled on Loper Bright Enterprises v. Raimondo, thereby overturning the Chevron Doctrine, a Supreme Court ruling from 1984 that provided for deference to U.S. regulatory agency regulations adopted pursuant to general federal ~~statutory authority. This decision~~ and ~~other~~state ~~related~~regulatory ~~decisions~~agencies may ~~create~~cause ~~new~~disruptions ~~legal~~and ~~avenues~~delays ~~to challenge federal regulations, which may create unforeseen uncertainty, especially for businesses that have relied on a settled regulatory environment~~ in ~~their industry. Our historical reliance on an established regulatory environment may be subject to~~ the ~~potential~~approval ~~risks~~processes ofand ~~challenges~~regulations relating to ~~agency rules that regulate~~ our ~~industry~~products.

~~International~~The ability ~~conflict~~of ~~has~~the FDA to review and approve new products can be affected ~~commerce~~by ~~worldwide~~a variety of factors, including government budget and ~~may~~funding levels, ~~have~~the aability ~~material~~to ~~adverse~~hire ~~effect~~and onretain ~~our~~key ~~results~~personnel, the ability to accept the payment of ~~operations~~user fees, ~~cash~~and ~~flows~~statutory, regulatory, and policy ~~financial~~changes. ~~condition~~Average review times at the FDA have fluctuated in recent years as a result. In addition, government funding of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.

~~The~~Disruptions at ~~Ukraine/Russia~~the ~~conflict~~FDA and ~~various~~other ~~Middle~~agencies ~~East~~may ~~conflicts~~also ~~have~~extend ~~received~~the ~~significant~~time ~~media~~necessary ~~coverage.~~for ~~Geopolitical~~new ~~instability~~drug ~~can~~development ~~lead~~and tofor ~~significant~~those ~~disruption~~new indrugs ~~supply~~to ~~chain~~be ~~efficiency,~~reviewed ~~adding~~or ~~cost~~approved by ~~and~~the ~~delays.~~necessary ~~Russia-related~~government ~~sanctions~~agencies, ~~have~~which ~~been~~would ~~instituted~~adversely byaffect ~~the~~our ~~Office~~business, offinancial ~~Foreign~~condition, ~~Assets~~results ~~Control~~of ~~(OFAC)~~operations, ~~are~~and ~~likely~~prospects. For toexample, ~~have~~over ~~unpredictable~~the ~~and~~last ~~wide-ranging~~several ~~effects~~years, on the ~~domestic~~U.S. ~~and~~government ~~global~~has ~~economy~~shut down several times, and ~~financial~~certain ~~markets~~regulatory agencies, ~~which~~such ~~could~~as the FDA, have anhad ~~adverse~~to ~~effect~~furlough oncritical ~~our~~employees ~~business~~ and ~~results~~stop ofcritical ~~operations~~activities. AsIf a ~~direct~~prolonged ~~impact~~government ~~from~~shutdown ~~the~~occurs ~~conflict,~~or wethere ~~have~~are ~~experienced~~other changes athat ~~decrease~~limit inthe ~~international~~FDA’s ~~sales~~ability to ~~Ukraine~~perform ~~and~~its ~~halted~~necessary ~~all~~activities ~~sales~~in toa ~~Russia.~~timely Wemanner, ~~will~~it ~~continue~~could tosignificantly ~~monitor~~reduce the ability ~~situation~~of ~~carefully~~the FDA to review and, ifprocess ~~necessary~~our regulatory submissions, ~~take~~which ~~action~~could tohave ~~protect~~a ~~our~~material ~~business,~~adverse ~~operations,~~effect ~~and~~on ~~financial~~our ~~condition~~business.

~~Risks~~It is ~~Related~~possible that the Trump administration could institute significant changes to ~~Milestone~~certain ~~Scientific~~regulatory ~~Common~~agencies ~~Stock~~ and task the “Department of Government Efficiency,” or “DOGE,” or any successor or similar initiative or agency, with making further changes to eliminate regulations, cut expenditures, and restructure federal agencies, some of which could impact public companies. For example, the current administration has discussed several changes to the reach and oversight of the Food and Drug Administration, which could affect its relationship with the pharmaceutical industry, transparency in decision making and ultimately the cost and availability of prescription drugs, as well as oversight over clinical trials and pharmaceutical development, all of which could pose risks (or opportunities) for companies in related industries. Similarly, there have been discussions of “reigning in” regulatory agencies such as the Federal Trade Commission, the Federal Communications Commission and the Federal Energy Regulatory Commission, all of which could impact how companies do business and could pose risks related to business operations and financial outlook.

~~Milestone~~The Company ~~Scientific~~may isbe ~~effectively~~subject ~~controlled~~to byenforcement aactions ~~limited~~if ~~number~~it engages in improper marketing or promotion of ~~stockholders.~~its products.

~~Milestone Scientific Scientific~~The Company’s ~~principal~~promotional ~~stockholders,~~materials ~~Leonard Osser~~ and ~~BP4,~~training ~~Srl,~~methods ~~control~~must ~~approximately~~comply ~~20%~~with ofapplicable ~~the~~laws, ~~issued~~regulations, and ~~outstanding~~regulatory ~~shares~~authorities’ rules ofand ~~common~~guidelines, ~~stock.~~including Asthe aFDA ~~result,~~and ~~they~~the ~~can~~Federal ~~exercise~~Trade ~~substantial~~Commission ~~control~~(the ~~over~~“FTC”). ~~our~~If ~~affairs~~the ~~and~~FDA, ~~corporate~~the ~~actions~~FTC ~~requiring~~or ~~stockholder~~another regulatory ~~approval,~~agency ~~including~~determines ~~electing~~that ~~directors,~~The ~~selling~~Company’s ~~all~~promotional or ~~substantially~~training ~~all~~material ~~our~~constitutes ~~assets~~off-label, ~~merging~~false ~~with~~or ~~another entity~~misleading, unfair or ~~amending~~deceptive ~~our~~promotion ~~certificate~~ of ~~incorporation.~~its ~~This control could delay~~products, ~~deter,~~it ~~or prevent a change in control and~~ could ~~adversely~~request ~~affect~~that the ~~price~~Company ~~that~~modify ~~investors~~its ~~might~~training beor ~~willing~~promotional tomaterials ~~pay~~or insubject ~~the~~it to ~~future~~regulatory ~~for~~or ~~Milestone~~enforcement ~~Scientific’s securities. In addition~~actions, ~~because~~including of the ~~concentration~~issuance of ~~ownership~~an ofuntitled ~~our~~letter, ~~shares~~a ofwarning ~~common~~letter, ~~stock~~injunction, ~~our~~seizure, ~~stockholders~~civil ~~may~~fine or ~~from~~criminal ~~time to time observe instances where there may be less liquidity in the public markets for our securities~~penalties.

~~Failure~~It is toalso ~~implement~~possible ~~effective~~that ~~internal~~other ~~controls~~federal, ~~required~~state byor ~~the~~foreign ~~Sarbanes-Oxley~~enforcement ~~Act~~authorities ofmight ~~2002~~act ~~could~~if ~~result~~they inconsider ~~material~~the ~~misstatements~~Company’s inpromotional or ~~our~~training ~~financial~~materials ~~statements~~to constitute off-label, ~~cause~~false ~~investors~~or tomisleading, ~~lose~~unfair ~~confidence~~or deceptive promotion of its products, which could result in ~~the~~significant ~~Company’s~~fines ~~reported~~or ~~financial~~penalties ~~information~~under ~~and~~other ~~have~~statutory aauthorities, ~~negative~~such ~~effect~~as onlaws ~~the~~prohibiting ~~trading~~false ~~price~~claims offor ~~our~~reimbursement, ~~common~~and ~~stock~~reputational harm.

~~Section~~Changes in ~~404~~laws ~~of the Sarbanes-Oxley Act of 2002 requires the management of public companies to develop~~ and ~~implement~~regulations ~~internal controls~~ over ~~financial~~which ~~reporting~~we ~~and~~have ~~evaluate~~no ~~the effectiveness thereof. A material weakness is a deficiency, or a combination of deficiencies, in internal~~ control ~~over~~can ~~financial~~significantly ~~reporting~~affect ~~such~~our ~~that~~business ~~there is a reasonable possibility that a material misstatement of the Company’s annual~~ and interim financial statements will not be prevented or detected on a timely basis. Any failure to complete the Company’s assessment of its internal controls over financial reporting or to remediate any material weaknesses that management may identify could harm the Company’s operating results, cause the Company to fail to meet its reporting obligations or result in material misstatements in the Company’s financial statements. Inadequate disclosure controls and procedures and internal controls over financial reporting could also cause investors to lose confidence in the Company’s public disclosures and reported financial information, which could have a negative effect on the trading price of ~~our common stock~~operations.

~~The~~Any governmental ~~market~~entity ~~price~~that ofregulates our ~~common~~operations ~~stock~~in the country in which they are located may beenact ~~volatile~~new legislation or adopt new laws and ~~may~~regulations ~~fluctuate~~or ~~significantly~~policies at any time, and ~~stockholders~~new ~~could~~judicial ~~lose~~decisions ~~all~~may change the interpretation of existing legislation or ~~part~~regulations at any time in any of ~~their~~the ~~investment~~countries in ~~Milestone~~which ~~Scientific~~our operations or projects are located. We have no control over any such changes. Any new laws or regulations governing our operations could have an adverse impact on our business, results of operations, and prospects.

~~Our~~Changes to ~~stock~~trade ~~price~~policy, including tariff and import/export regulations, may ~~experience~~have ~~substantial~~a ~~volatility~~material ~~because~~adverse effect on our results of ~~many~~operations, ~~factors~~cash flows, ~~including:~~and financial condition.

●Changes to U.S. trade policy, including tariffs and import/export regulations, may adversely affect our ~~failure~~operations, tocash ~~meet~~flows, ~~analysts’~~and ~~expectations;~~financial condition.

~~● sales or potential sales of substantial amounts of our common stock;~~18

●Recent and ~~delay~~potential changes in U.S. trade policy—including higher tariffs, revisions or ~~failure~~terminations inof ~~initiating~~trade agreements, new economic sanctions, and other restrictions on international commerce—could materially impact our ~~strategy~~business. Adjusting our operations to ~~commercialize~~comply with such changes may be time-consuming and costly. Retaliatory measures by other countries, including China, have already increased supply-chain costs and reduced product availability, effects that we may not be able to offset. These dynamics could weaken the U.S. economy, dampen industry demand, and negatively affect global markets in which we operate. in addition, political tensions between the United States and China further heighten these risks. Deteriorating relations could reduce trade, investment, and related economic activity, and materially affect our ~~CompuFlo~~business, ~~Epidural~~prospects ~~System;~~and financial results.

●Regulatory uncertainty ~~the~~may ~~success~~increase offollowing ~~our~~recent ~~strategy~~federal ~~to commercialize our CompuFlo Epidural System;~~developments.

●Turnover and ~~announcements~~new ~~about~~policies usat orthe ~~about~~U.S. ~~our~~Department ~~competitors~~of Health and Human Services, including ~~clinical~~the ~~trial results~~FDA, may continue to shift regulatory ~~approvals~~priorities and orenforcement ~~new~~approaches. ~~product~~In ~~introductions~~addition, ~~that~~the ~~could~~U.S. ~~adversely~~Supreme ~~impact~~Court’s 2024 decision in Loper Bright Enterprises v. Raimondo, which overturned the ~~market~~Chevron ~~acceptance~~Doctrine, orreduced ~~competitive~~deference ~~advantages~~to federal agency interpretations of ~~our~~statutory ~~CompuFlo~~authority. ~~Epidural~~This ~~System;~~decision and related rulings may create new avenues to challenge federal regulations, introducing uncertainty for businesses like ours that have historically relied on a stable regulatory framework.

●Federal actions ~~developments~~related ~~concerning~~to ~~our~~tariffs ~~licensors~~and orresearch ~~product~~funding ~~manufacturers;~~may disrupt our business.

●New and ~~litigation~~proposed U.S. tariffs, along with directives to reevaluate federal trade policies, have led to significant uncertainty regarding future trade relationships, treaties, and ~~other~~tariff structures. These developments ~~relating~~may restrict access to suppliers, reduce global demand, and could adversely affect our ~~patents~~operations, orparticularly ~~other~~given ~~proprietary~~our ~~rights~~reliance oron ~~those~~components ofsourced from China and our ~~competitors;~~significant international sales.

●Additionally, changes ~~our~~to ~~ability~~federal toresearch ~~successfully~~funding—including ~~develop~~reductions or restructuring of grants, particularly those involving higher-education institutions—may negatively impact our business and ~~commercialize~~that ~~products~~of our research partners. Tariffs have already increased our cost of doing business and ~~services~~may ~~for~~continue ~~the~~to ~~healthcare~~constrain ~~industry;~~access to imported equipment essential to our operations.

●International conflict ~~conditions~~has inaffected ~~the~~commerce ~~medical~~worldwide ~~device~~and ~~industry;~~may have a material adverse effect on our results of operations, cash flows, and financial condition.

●The Ukraine/Russia ~~variations~~conflict and various Middle East conflicts have received significant media coverage. Geopolitical instability can lead to significant disruption in ~~our~~supply ~~anticipated~~chain orefficiency, ~~actual~~adding ~~operating~~cost and delays. Russia-related sanctions instituted by the Office of Foreign Assets Control (“OFAC”) are likely to have unpredictable and wide-ranging effects on the domestic and global economy and financial markets, which could have an adverse effect on our business and results; of operations. As a direct impact of the conflict, we have experienced a decrease in international sales to Ukraine and halted all sales to Russia. We will continue to monitor the situation carefully and, if necessary, take action to protect our business, operations, and financial condition.

Geopolitical 18 instability, labor unrest, and economic disruptions in certain foreign jurisdictions may indirectly affect our operations.

●Although we ~~change~~do not have direct sales, operations, or customers in ~~securities~~regions ~~analysts’~~experiencing ~~estimates~~significant instability, such as Venezuela, recent labor strikes, political instability, and economic conditions in Venezuela may contribute to broader regional or global disruptions, including impacts on international trade relationships, energy markets, currency volatility, or global logistics networks. In addition, changes in diplomatic relationships, foreign policy positions, or international regulatory frameworks involving countries experiencing political or economic instability could result in new or expanded trade restrictions, sanctions, compliance obligations, or logistical challenges imposed by foreign governments, as well as the United States. Such developments could indirectly affect the availability or cost of certain inputs, transportation services, or third-party suppliers upon which we rely. While we believe our ~~performance~~current supply chain and manufacturing operations are diversified and resilient, we cannot assure investors that future geopolitical developments will not result in increased costs, delays, or other adverse effects on our ~~failure~~business, tofinancial ~~meet~~condition, ~~analysts’~~or ~~expectations~~results of operations.

~~Many~~Risks Related ofCompany’s these factors are beyond our control. The stock markets in general, and the market for small, medical device companies have historically experienced extreme price and volume fluctuations. These fluctuations often have been unrelated or disproportionate to the operating performance of these companies. These broad market and industry factors could reduce the market price of our common stock, regardless of our actual operating performance.Securities

WeThe ~~have~~Company ~~never~~is ~~paid~~effectively ~~and~~controlled doby ~~not intend to pay cash dividends in the foreseeable future. As~~ a ~~result,~~limited number ~~capital appreciation, if any, will be your sole source~~ of ~~gain~~stockholders.

WeOur ~~have~~principal ~~never~~stockholder, ~~paid~~BP4, Srl, ~~cash~~an ~~dividends~~Italian oninvestment ~~any~~vehicle that is currently in liquidation (“BP4”), controls approximately 11.05% of ~~our~~the ~~capital~~Company’s issued and outstanding shares of common stock. As a result, ~~and~~it wecan ~~currently~~exercise ~~intend~~substantial tocontrol ~~retain~~over ~~future~~our ~~earnings~~affairs and corporate actions requiring stockholder approval, ifincluding ~~any~~electing directors, toselling ~~fund~~all ~~the~~or ~~development~~substantially ~~and~~all ~~growth~~our ofassets, merging with another entity, or amending our ~~business~~certificate of incorporation. In ~~addition~~This control could delay, ~~the~~deter, ~~terms~~or ofprevent ~~existing~~a change in control and ~~future~~could ~~debt~~adversely ~~agreements~~affect the ~~may~~price ~~preclude~~that usinvestors ~~from~~might ~~paying~~be ~~dividends.~~willing Asto apay ~~result,~~in ~~capital~~the ~~appreciation,~~future iffor ~~any,~~the Company’s securities. Because of the concentration of ownership of our shares of common stock, ~~will~~our bestockholders ~~your~~may ~~sole~~from ~~source~~time ofto ~~gain~~time ~~for~~observe instances where there may be less liquidity in the ~~foreseeable~~public markets ~~future~~for our securities.

~~Provisions~~We inexpect ~~our~~we ~~certificate~~will ofneed ~~incorporation,~~additional ~~our~~financing ~~by-laws~~to ~~and~~execute ~~Delaware~~our ~~law~~business ~~might~~plan and ~~discourage,~~fund ~~delay~~operations, orand ~~prevent~~additional afinancing ~~change~~may innot ~~control~~be ofavailable ~~our~~on ~~company~~reasonable terms or ~~changes~~at ~~in our management and, therefore, depress the trading price of our common stock~~all.

~~Provisions~~As of ~~our~~December ~~certificate~~31, 2025, we had total assets of ~~incorporation~~approximately $7,800,000 ~~our~~and ~~by-laws~~working capital of approximately $3,300,000 and ~~Delaware~~$1,100,000 ~~law~~of ~~may~~cash ~~have~~and ~~the~~cash ~~effect~~equivalents. We ofbelieve ~~deterring~~we ~~unsolicited~~will ~~takeovers~~need oradditional ~~delaying~~capital orto ~~preventing~~fund aour ~~change~~operations. inWe ~~control~~intend to seek additional funds through various financing sources, including additional sales of our ~~company~~equity orsecurities ~~changes~~and inpossibly warrants to purchase our ~~management,~~equity ~~including~~securities. ~~transactions~~However, inthere ~~which~~can ~~our~~be ~~stockholders~~no guarantees ~~might~~that ~~otherwise~~such ~~receive~~funds awill ~~premium~~be ~~for~~available ~~their~~on ~~shares~~commercially ~~over~~reasonable ~~then~~terms, ~~current~~if ~~market~~at ~~prices~~all. InIf ~~addition,~~such ~~these~~financing ~~provisions~~is ~~may~~not ~~limit~~available ~~the~~on ~~ability~~satisfactory terms, ofwe ~~stockholders~~may be unable to ~~approve~~further ~~transactions~~pursue ~~that~~our ~~they~~business plan and we may ~~deem~~be unable to becontinue operations, in ~~their~~which ~~best~~case ~~interests. These~~you ~~provisions~~may ~~include:~~lose your entire investment.

● the inability of stockholders to call special meetings; ● the ability of our Board of Directors to designate the terms of and issue new series of preferred stock without stockholder approval, which could include the right to approve an acquisition or other change in our control or could be used to institute a rights plan, also known as a poison pill, that would work to dilute the stock ownership of a potential hostile acquirer, likely preventing acquisitions that have not been approved by our Board of Directors; and19

●If we ~~limitations~~fail to regain compliance with the strict listing requirements of NYSE American, we may be subject to delisting. As a result, our stock price may decline, and our common stock may be de-listed. If our stock were no longer listed on ~~filling~~NYSE American, the liquidity of our ~~vacancies~~securities likely would be impaired.

~~All~~Our common ofstock ~~which~~currently ~~could~~trades ~~make~~on itthe ~~more~~NYSE ~~difficult~~American ~~for~~under athe ~~third~~symbol ~~party~~“MLSS”. toOn ~~acquire~~October 8, or2025, ~~discourage~~the aCompany ~~third~~received ~~party~~a letter from ~~seeking~~NYSE toAmerican ~~acquire~~stating that the Company is not in compliance with the continued listing standards as outlined in Section(s) 1003(a)(ii), and ~~control~~(iii) of ~~our~~the ~~company~~NYSE American Company Guide (the “Company Guide”).

~~In addition,~~ Section 1003(a)(ii) ~~203~~requires ofa ~~the~~listed ~~Delaware~~company ~~General~~to ~~Corporation~~have ~~Law~~stockholders’ ~~prohibits~~equity aof ~~publicly~~$4 ~~held~~million ~~Delaware~~or ~~corporation~~more ~~from~~if ~~engaging~~it inhas areported ~~business~~losses ~~combination~~from ~~with~~continuing operations anand/or ~~interested~~net ~~stockholder,~~losses ~~generally~~in athree ~~person~~of ~~which together with~~ its ~~affiliates~~four ~~owns,~~most orrecent ~~within~~fiscal ~~the last three~~ years, ~~has~~and ~~owned~~Section ~~15%~~1003(a)(iii) requires stockholders’ equity of ~~our~~$6 ~~voting~~million ~~stock,~~or ~~for~~more aif ~~period~~it ofhas ~~three~~reported ~~years~~losses ~~after~~from ~~the~~continuing ~~date~~operations ofand/or ~~the~~net ~~transaction~~losses in ~~which~~its ~~the~~five ~~person~~most ~~became~~recent anfiscal ~~interested~~years. ~~stockholder,~~Based on ~~unless~~ the ~~business~~Company’s ~~combination~~Form is10-Q ~~approved~~for inthe aperiod ~~prescribed~~ended ~~manner. The~~June ~~existence~~30, of2025, the ~~forgoing~~Company ~~provisions~~reported ~~and~~stockholders’ ~~anti-takeover~~equity ~~measures~~of ~~could~~approximately $3.3 ~~limit~~million ~~the~~and ~~price~~experienced ~~that~~losses ~~investors~~in ~~might~~such beperiod ~~willing~~and toeach ~~pay~~of inits ~~the~~five ~~future~~prior ~~for~~fiscal ~~shares~~years. ofAs ~~our~~a ~~common~~result, ~~stock. They~~the ~~could~~Company ~~also~~is ~~deter~~not ~~potential~~currently in ~~acquirers~~compliance ofwith ~~our~~Sections ~~Company,~~1003(a)(ii) ~~thereby~~and ~~reducing~~(iii) ~~the~~and ~~likelihood~~is ~~that~~not ~~you~~eligible ~~could~~for ~~receive~~any aexemption ~~premium~~under ~~for~~Section ~~your~~1003(a) ~~common~~of ~~stock~~the inCompany ~~an acquisition~~Guide.

To maintain its listing, the Company submitted a plan of compliance outlining the actions it has taken or will take to regain compliance. The Company will be able to continue its listing but will be subject to periodic reviews by the NYSE American. If the Company fails to comply with the continued listing standards by April 8, 2027, or if the Company does not make progress consistent with the plan, the NYSE American will initiate delisting procedures as appropriate. The Company’s management is pursuing options to address the deficiency. If we fail to regain compliance with and adhere to ~~the~~NYSE American’s strict listing ~~requirements~~criteria, including with respect to stock price, our market capitalization and stockholders’ equity, our stock may be de-listed. This would impair the liquidity of ~~NYSE~~our ~~American~~securities not only in the number of shares that could be bought and sold at a given price, wewhich may be ~~subject~~depressed toby ~~delisting~~the relative illiquidity, but also through delays in the timing of transactions and the potential reduction in media coverage. As a result, ~~our~~an ~~stock~~investor ~~price~~might ~~may~~find it ~~decline,~~more ~~and~~difficult to dispose of our common stock ~~may~~if bewe are de-listed. IfAny ~~our~~failure ~~stock~~at ~~were~~any notime ~~longer~~to ~~listed~~meet onthe continuing NYSE American, listing requirements would have an adverse impact on the ~~liquidity~~value of ~~our~~and ~~securities~~trading ~~likely~~activity ~~would~~in beour ~~impaired~~common stock.

~~Our~~We have ~~common~~relied ~~stock~~heavily ~~currently trades~~ on ~~the~~sales ~~NYSE~~of ~~American~~our ~~under~~common ~~the~~stock ~~symbol “MLSS”. If we fail~~ to ~~adhere~~fund toour ~~NYSE American's strict listing criteria~~operations, ~~including~~and ~~with~~our ~~respect~~ability to ~~stock~~obtain ~~price,~~additional ~~our~~capital ~~market~~through ~~capitalization~~stock ~~and~~sales or ~~stockholders’~~other ~~equity,~~securities ~~our~~offerings ~~stock~~ may be ~~de-listed. This~~more ~~could~~costly ~~potentially~~or ~~impair~~dilutive ~~the~~to ~~liquidity of~~ our ~~securities~~stockholders ~~not~~than ~~only~~ in the ~~number~~past, ofor ~~shares~~may ~~that~~not ~~could~~ be ~~bought~~available ~~and~~to ~~sold~~us at aall. Our ~~given~~ability ~~price,~~to ~~which~~raise additional capital may be ~~depressed~~limited by ~~the~~a ~~relative~~low ~~illiquidity~~trading volume, ~~but~~stock ~~also~~price ~~through delays in the timing of transactions~~ and ~~the~~market ~~potential~~capitalization, ~~reduction~~as inwell ~~media~~as ~~coverage. As a result~~by laws, anregulations ~~investor might find it more difficult to dispose of our common stock. Any failure at any time to meet the continuing NYSE American listing requirements could have an adverse impact on the value of~~ and ~~trading~~market ~~activity in our common stock~~conditions.

~~Your~~We have ~~percentage~~historically relied on, and may continue to rely, the sale of ~~ownership~~shares inof ~~Milestone~~our ~~Scientific~~ common stock to fund our operations and support our business activities. Our ability to raise additional capital through sales of our common stock or other securities offerings will depend on several factors, many of which may not be ~~diluted~~ in our favor, including the trading volume and volatile trading price of our common stock, our relatively low public float and market capitalization, our potential inability maintain compliance with the listing requirements of the NYSE American, unfavorable financial market conditions, and the other risks and uncertainties. If we are unable to raise additional capital through the offering and sale of shares of our common stock, or securities convertible into or exercisable for our common stock, on a timely basis or on acceptable terms, or at all, we may seek additional capital through other third-party sources that require us to relinquish valuable rights in our intellectual property, technologies, product candidates or future revenue streams, or that subject us to restrictive covenants, operational restrictions or security interests in our assets, or we may need to delay, scale back or eliminate some or all of our development programs, reduce other expenses, file for bankruptcy, reorganize, merge with another entity, or cease operations.

InUsing ~~the~~a ~~future~~shelf registration statement to conduct an equity offering to raise capital generally takes less time and is less expensive than other means, ~~your~~such ~~percentage~~as ~~ownership~~conducting inan offering ~~Milestone~~under ~~Scientific~~ a Form S-1 registration statement. Our ability to raise capital under a shelf registration statement is, and may continue to be, ~~diluted~~limited ~~because~~by, among other things, current and future SEC rules and regulations impacting on the eligibility of ~~equity~~smaller ~~issuances~~companies to use Form S-3 for ~~acquisitions~~primary offerings of securities. For example, ~~capital~~if we filed a new shelf registration statement, we would currently be subject to the “baby shelf rule.” This means that we could use a shelf registration statement to raise additional funds only to the extent that the aggregate market ~~transactions~~value of securities sold by us or ~~otherwise~~on our behalf pursuant to Instruction I.B.6. of Form S-3 during the 12 calendar months immediately prior to, and including, ~~any~~the ~~equity~~intended ~~awards~~sale ~~that~~does ~~Milestone~~not ~~Scientific~~exceed ~~will~~one-third ~~grant~~of tothe ~~its~~aggregate ~~directors~~market value of our public float, ~~officers~~calculated in accordance with the instructions to Form S-3. Based on the aggregate market value of our public float, we ~~employees~~would ~~and~~currently ~~consultants~~be unable to raise significant capital under a shelf registration. ~~Such~~If ~~awards~~our ~~will~~ability ~~have~~to offer securities under a ~~dilutive~~shelf registration ~~effect~~statement onis ~~outstanding~~limited, ~~share~~including ~~count~~by ~~which~~the baby shelf rule, we could ~~adversely~~choose ~~affect~~to conduct an offering of our securities under an exemption from registration under the ~~market~~Securities ~~price~~Act or under a Form S-1 registration statement. We would expect either of ~~Milestone~~these ~~Scientific’s~~alternatives to ~~common~~take ~~stock~~more time and be a more expensive method of raising additional capital relative to using our shelf registration statement.

In 19addition, under SEC rules and regulations, our common stock must be listed and registered on a national securities exchange in order to use a Form S-3 registration statement (1) for a primary offering, if our public float is not at least $75 million as of a date within 60 days prior to the date of filing the Form S-3 or a re-evaluation date, whichever is later,

~~Risks Related to Our Intellectual Property~~ 20

There can be no assurance that we can maintain the listing of our common stock on the NYSE American. See, “If we ~~are~~fail ~~unable~~to regain compliance with the strict listing requirements of NYSE American, we may be subject to ~~adequately~~delisting. ~~protect~~As a result, our ~~patents~~stock price may decline, ~~trade~~and our ~~secrets~~common stock may be de-listed. If our stock were no longer listed on NYSE American, the liquidity of our securities likely would be impaired,” above. Our ability to raise capital on a timely basis through the issuance and sale of equity securities may also be limited by NYSE American’s stockholder approval requirement for certain issuances, including certain transactions that are not deemed a public offering (as defined in the Company Guide). For transactions other ~~proprietary~~than ~~rights~~public offerings, the Company Guide requires stockholder approval prior to the issuance or potential issuance of common stock (or securities convertible into or exercisable for common stock) at a price per share that is less than the “Minimum Price” if the issuance (together with sales by our ~~patents~~officers, ~~are~~directors and ~~challenged~~principal shareholders (as defined in Company Guide)) would equal 20% or ifmore of our ~~provisional~~common ~~patent~~stock ~~applications~~outstanding dobefore the issuance. Under the Company Guide, the “Minimum Price” means a price that is the lower of (i) the Official Closing Price immediately preceding the signing of the binding agreement; or (ii) the average Official Closing Price for the five trading days immediately preceding the signing of the binding agreement. For purposes of calculating the Minimum Price, the “Official Closing Price” of the issuer’s common stock means the official closing price on the NYSE American as reported to the consolidated tape immediately preceding the signing of a binding agreement to issue the securities. In addition, certain prior sales of securities by us may be aggregated with any offering we may propose at a price that is less than the Minimum Price and which is not ~~get~~considered ~~approved~~a public offering by the Company Guide, further limiting the amount we could raise in the offering. Under the Company Guide, stockholder approval is also required prior to the issuance of securities when the issuance or potential issuance will result in a change of control of our ~~competitiveness~~company. Even if a public offering under the Company Guide is not subject to the limitations described above, it may involve publicly announcing the proposed transaction, which often has the effect of depressing the market price of a company’s stock and ~~business~~could ~~prospects~~result in a reduced offering price. Accordingly, our existing investors may besuffer greater dilution if we seek to raise additional capital through such a public offering of our securities. Obtaining stockholder approval is a costly and time-consuming process. If we must obtain stockholder approval for a potential transaction, we would expect to spend substantial additional money and resources. In addition, seeking stockholder approval would delay our receipt of otherwise available capital, which may materially ~~damaged~~and adversely affect our ability to execute our business plan, and there is no guarantee our stockholders ultimately would approve a proposed transaction.

~~Intellectual property rights, including patents, trade secrets, confidential information, trademarks, trade names and trade address, are important~~ Failure to ~~our~~implement ~~business. We~~effective ~~will~~internal ~~endeavor~~controls torequired ~~protect~~by ~~our~~the ~~intellectual~~Sarbanes-Oxley ~~property~~Act ~~rights~~of in2002 ~~key~~could ~~jurisdictions~~result in ~~which~~material ~~our~~misstatements ~~products are produced or used and~~ in ~~jurisdictions into which~~ our ~~products~~financial statements, ~~are~~cause ~~imported. Our~~investors ~~success will depend~~ to alose ~~significant~~confidence ~~degree~~in ~~upon~~the ~~our~~Company’s ~~ability~~reported tofinancial ~~protect~~information and ~~preserve~~have ~~our~~a ~~intellectual~~negative effect ~~property~~on ~~rights. However,~~the wetrading ~~may~~price beof ~~unable to obtain or maintain protection for~~ our ~~intellectual~~common ~~property in key jurisdictions~~stock.

~~Although we~~Section 404 ~~own~~of ~~and~~the ~~have~~Sarbanes-Oxley ~~applied~~Act ~~for~~of ~~patents~~2002 ~~and~~requires ~~trademarks throughout~~ the ~~world,~~management weof ~~may~~public ~~have~~companies to ~~rely~~develop onand ~~judicial~~implement ~~enforcement~~internal ofcontrols ~~our~~over ~~patents~~financial reporting and ~~other~~evaluate ~~proprietary~~the ~~rights~~effectiveness thereof. ~~Our~~ ~~patents~~A ~~and~~material ~~other~~weakness ~~intellectual~~is ~~property~~a ~~rights~~deficiency, ~~may~~or bea ~~challenged,~~combination ~~invalidated,~~of ~~circumvented~~deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of the Company’s annual and ~~rendered~~interim ~~unenforceable~~financial statements will not be prevented or ~~otherwise~~detected ~~compromised~~on a timely basis. A Any failure to ~~protect,~~complete ~~defend~~the Company’s assessment of its internal controls over financial reporting or ~~enforce~~to ~~our~~remediate ~~intellectual~~any ~~property~~material weaknesses that management may identify could ~~have~~harm anthe Company’s ~~adverse~~operating ~~effect~~results, oncause ~~our~~the Company to fail to meet its reporting obligations or result in material misstatements in the Company’s financial ~~condition~~statements. Inadequate disclosure controls and ~~results~~procedures ofand ~~operations. Similarly,~~internal ~~third~~controls ~~parties~~over ~~may~~financial ~~assert~~reporting could ~~claims~~also ~~against~~cause usinvestors ~~and~~to ~~our~~lose ~~customers~~confidence in the Company’s public disclosures and ~~distributors~~reported ~~alleging~~financial ~~our~~information, ~~products~~which ~~infringe~~could have ~~upon~~a ~~third~~negative ~~party~~effect ~~intellectual~~on ~~property~~the ~~rights~~trading price of our common stock.

We believe that the intellectual property underlying our products is a competitive advantage. We rely on a combination of patent rights, trade secrets and nondisclosure and non-competition agreements to protect our proprietary intellectual property, and we will continue to do so. There can be no assurance that our patents, trade secret policies and practices or other agreements will adequately protect our intellectual property. Our issued patents may be challenged, found to be over-broad or otherwise invalidated in subsequent proceedings before courts or the U.S. Patent and Trademark Office. Even if enforceable, we cannot provide any assurances that they will provide significant protection from competition. The market ~~processes,~~price ~~systems, and/or security measures we use to preserve the integrity and confidentiality~~ of our ~~data~~common ~~and~~stock ~~trade secrets~~ may be ~~breached,~~volatile and we may ~~not~~fluctuate ~~have adequate remedies resulting from such breaches. In addition~~significantly, ~~our trade secrets may otherwise become known or be independently discovered by competitors. There can be no assurance that the confidentiality, nondisclosure~~ and ~~non-competition~~stockholders ~~agreements~~could ~~with~~lose ~~employees,~~all ~~consultants and other parties with access to our proprietary information to protect our trade secrets, proprietary technology, processes and other proprietary rights,~~ or ~~any~~part ~~other~~of ~~security~~their measures relating to such trade secrets, proprietary technology, processes and proprietary rights, will be adequate, will not be breached, that we will have adequate remedies for any breach, that others will not independently develop substantially equivalent proprietary information or that third parties will not otherwise gain access to our trade secrets or proprietary knowledge. To the extent that our consultants, contractors, or collaborators use intellectual property owned by others investment in ~~their work for us, disputes may arise as to~~ the ~~rights in related or resulting know-how and inventions~~Company.

IfThe wemarket ~~must~~price ~~take~~for ~~legal~~our ~~action~~common tostock ~~protect,~~varied ~~defend~~between ora ~~enforce~~high ~~our~~of ~~intellectual~~$1.39 ~~property~~and a ~~rights,~~low ~~any~~of ~~suits~~$0.23 orduring ~~proceedings~~the ~~could~~twelve ~~result~~months inended ~~significant~~December ~~costs~~31, ~~and~~2025. ~~diversion~~Our ofstock ~~our~~price ~~resources~~is ~~and~~likely ~~our~~to ~~management’s~~continue ~~attention,~~to be volatile and wesubject ~~may~~to ~~not~~significant price ~~prevail~~and involume ~~any~~fluctuations ~~such~~in ~~suits~~response orto ~~proceedings. A~~market ~~failure~~and toother ~~protect~~factors, ~~defend~~including orthose ~~enforce~~listed ~~our~~in ~~intellectual~~this ~~property~~“Risk ~~rights~~Factors” ~~could~~section and ~~have~~other, anunknown ~~adverse~~factors. ~~effect~~Our onstock ~~the~~price ~~results~~may experience substantial volatility because of ~~operations.~~many factors, including:

~~Third~~● ~~parties~~our ~~could~~failure ~~obtain~~to ~~patents~~meet ~~that~~analysts’ ~~may~~expectations; ~~require~~● ussales or potential sales of substantial amounts of our common stock; ● delay or failure in initiating our strategy to ~~negotiate~~commercialize ~~licenses~~our CompuFlo Epidural System; ● the success of our strategy to commercialize our ~~technologies~~CompuFlo Epidural System; ● announcements about us or about our competitors, ~~and~~including weclinical ~~cannot~~trial ~~assure~~results, ~~you~~regulatory approvals or new product introductions that could adversely impact the ~~required~~market ~~licenses~~acceptance ~~would~~or becompetitive ~~available~~advantages onof ~~reasonable~~our ~~terms~~CompuFlo Epidural System; ● developments concerning our licensors or atproduct ~~all.~~manufacturers;

~~Third parties may claim that one or more aspects of our technologies or products may infringe on their intellectual property rights.~~ 21

~~Our~~● ~~computer-controlled~~litigation ~~anesthesia systems are complex systems~~ and ~~numerous~~other ~~U.S.~~developments ~~and~~relating ~~foreign patents and pending patent applications owned by third parties exist in fields that relate~~ to ~~the~~our ~~development~~patents ~~and~~or ~~commercialization~~other ofproprietary ~~drug~~rights ~~delivery~~or ~~systems. In~~those ~~addition, many companies have employed intellectual property litigation as a strategy to gain a competitive advantage. It is possible that infringement claims may occur as the number~~ of ~~products~~our ~~and~~ competitors; in● our ~~market~~ability ~~increases. In addition,~~ to ~~the~~successfully ~~extent~~develop ~~that~~and wecommercialize ~~gain~~products ~~greater visibility~~ and ~~market~~services ~~exposure~~for asthe ahealthcare ~~public~~industry; ~~company,~~● weconditions ~~face~~in ~~a greater risk of being~~ the ~~subject~~medical ofdevice ~~intellectual~~industry; ~~property~~● ~~infringement~~variations ~~claims.~~in ~~We cannot be certain that the conduct of~~ our ~~business~~anticipated ~~does not and will not infringe intellectual property~~ or ~~other~~actual ~~proprietary~~operating ~~rights~~results; ofand ~~others~~● inchange ~~the U.S. and~~ in ~~foreign~~securities ~~jurisdictions.~~analysts’ Ifestimates ~~any~~ of our ~~computer-controlled anesthesia systems are found to infringe third party patent rights~~performance, ~~we could be prohibited from manufacturing and commercializing the infringing technology unless we obtain a license under the applicable third-party patent and pay royalties~~ or ~~are~~our ~~able~~failure to ~~design~~meet ~~around~~analysts’ ~~such patent~~expectations.

WeMany of ~~may~~these befactors ~~unable~~are tobeyond ~~obtain~~our acontrol. ~~license~~The onstock ~~terms~~markets ~~acceptable~~in ~~to us~~general, orand atthe ~~all,~~market ~~and~~for wesmall, ~~may~~medical ~~not~~device becompanies ~~able~~have tohistorically experienced ~~redesign~~extreme ~~the~~price ~~system~~and tovolume ~~avoid infringement~~fluctuations. ~~Even~~ ifThese wefluctuations ~~can~~often ~~redesign~~have ~~our~~been ~~products~~unrelated or ~~processes~~disproportionate to ~~avoid an infringement claim, our efforts to design around~~ the ~~patent~~operating performance ~~could~~of ~~require~~these ~~significant~~companies. ~~time,~~These ~~effort~~broad ~~and~~market ~~expense~~ and ~~ultimately~~industry ~~may~~factors ~~lead~~could toreduce anthe ~~inferior~~market orprice ~~costlier product. Any claim~~ of ~~infringement~~our bycommon ~~a third party~~stock, ~~even~~regardless of ~~those without merit, could cause us to incur substantial costs defending against the claim and could distract~~ our ~~management~~actual ~~from~~operating ~~our business~~performance.

We 20have never paid and do not intend to pay cash dividends in the foreseeable future. As a result, capital appreciation, if any, will be your sole source of gain.

~~Furthermore,~~We have ifnever ~~any~~paid ~~such~~cash ~~claim~~dividends ison ~~successful,~~any aof ~~court~~our ~~could~~capital ~~order us to pay substantial damages~~stock, ~~including~~and ~~compensatory~~we ~~damages~~currently ~~for~~intend ~~any~~to ~~infringement,~~retain ~~plus~~future ~~prejudgment interest and could~~earnings, inif ~~certain circumstances~~any, ~~treble~~to fund the ~~compensatory damages~~ development and ~~award~~growth ~~attorney~~of ~~fees. This damage could be substantial and could harm~~ our ~~reputation,~~ business,. ~~financial~~In ~~condition~~addition, ~~and~~the ~~operating~~terms ~~results.~~of Aexisting ~~court~~and ~~also~~future ~~could~~debt ~~enter~~agreements ~~orders~~may ~~that~~preclude ~~temporarily,~~us ~~preliminary,~~from orpaying ~~permanently~~dividends. ~~prohibit~~As usa result, ~~our~~capital ~~licensees~~appreciation, if any, ~~and~~of our ~~customers~~common ~~from~~stock ~~making,~~will ~~using,~~be ~~selling,~~your ~~offering~~sole tosource ~~sell,~~of orgain ~~importing~~for ~~one~~the orforeseeable ~~more~~future. ofWe ~~our~~cannot ~~products~~assure stockholders orthat ~~using~~ our ~~proprietary~~stock ~~technologies~~price orwill ~~processes,~~appreciate or ~~could~~that ~~enter~~they anwill ~~order~~receive ~~mandating~~a ~~that~~positive wereturn ~~undertake~~on ~~certain~~their ~~remedial~~investment ~~activities~~if and when they sell their shares.

~~Any~~Provisions in our certificate of ~~these~~incorporation, ~~events~~our ~~could~~by-laws ~~seriously~~and ~~harm~~Delaware ~~our~~law ~~business~~might discourage, ~~operating results~~delay, or prevent a change in control of our company or changes in our management and, ~~financial~~therefore, ~~condition~~depress the trading price of our common stock.

~~General~~Provisions of ~~Business~~our ~~Risks~~certificate of incorporation, our by-laws and Delaware law may have the effect of deterring unsolicited takeovers or delaying or preventing a change in control of our company or changes in our management, including transactions in which our stockholders might otherwise receive a premium for their shares over then current market prices. In addition, these provisions may limit the ability of stockholders to approve transactions that they may deem to be in their best interests. These provisions include:

~~Our~~● ~~business and operations would suffer in~~ the ~~event~~inability of ~~cybersecurity~~stockholders orto ~~other~~call ~~system~~special ~~failures.~~ meetings;

~~Despite~~● the ~~implementation~~ability of ~~security measures,~~ our ~~internal~~Board ~~computer systems, and those~~ of ~~any~~Directors ~~third parties with which we partner are vulnerable~~ to ~~damage~~designate ~~from~~the ~~computer~~terms ~~viruses,~~of ~~unauthorized access, natural disasters, terrorism, war~~ and ~~telecommunication~~issue ~~and~~new ~~electrical~~series ~~failures.~~of ~~While~~preferred westock ~~have~~without ~~not~~stockholder ~~experienced~~approval, ~~any~~which ~~cybersecurity~~could orinclude ~~system~~the ~~failure,~~right ~~accident or breach~~ to ~~date,~~approve if an ~~event~~acquisition ~~were~~or toother ~~occur,~~change ~~it could result~~ in ~~a material disruption of~~ our ~~operations,~~control ~~substantial costs to rectify~~ or ~~correct~~could ~~the~~be ~~failure,~~used ~~if possible, and potentially violation of HIPAA and other privacy laws applicable~~ to ~~our~~institute ~~operations.~~a Ifrights ~~any~~plan, ~~disruption~~also orknown ~~security~~as ~~breach resulted in~~ a ~~loss~~poison ofpill, orthat ~~damage~~would work to ~~our~~dilute ~~data~~the orstock ~~applications~~ownership ~~or inappropriate disclosure~~ of ~~confidential~~a orpotential ~~protected~~hostile ~~information~~acquirer, welikely ~~could~~preventing ~~incur~~acquisitions ~~liability,~~that ~~further~~have ~~development~~not ofbeen ~~our~~approved ~~products~~by ~~could be delayed, and~~ our ~~operations~~Board ~~could be disrupted, any~~ of ~~which~~Directors; ~~could severely harm our business~~ and ~~financial condition.~~

~~Issues~~● ~~with~~limitations ~~product~~on ~~quality~~filling ~~could have a material adverse effect upon our business, subject us to regulatory actions and cause a loss~~ of ~~customer confidence in us or our products~~vacancies.

~~In general, our success depends upon the quality~~ All of ~~our~~which ~~products.~~could ~~Quality~~make ~~management~~it ~~plays~~more andifficult ~~essential~~for ~~role~~a inthird ~~meeting~~party ~~customer requirements, preventing defects, improving our products and services, and assuring the safety and efficacy of our products. Our future success depends on our ability~~ to ~~maintain and continuously improve our quality management program. A quality or safety issue may result in adverse inspection reports~~acquire, ~~warning letters, product recalls~~ or ~~seizures,~~discourage ~~monetary sanctions, injunctions to halt manufacture and distribution of products, civil or criminal sanctions, costly litigation, refusal of~~ a ~~government~~third toparty ~~grant~~from ~~approvals~~seeking ~~and licenses, restrictions on operations or withdrawal of existing approvals and licenses. An inability~~ to ~~address a quality or safety issue in an effective and timely manner may also cause negative publicity~~acquire, acontrol ~~loss~~ of ~~customer confidence in us or~~ our ~~current or future products, which may result in the loss of sales and difficulty in successfully launching new products~~ company.

~~Insurance~~In addition, ~~coverage~~Section ~~may~~203 beof ~~inadequate~~the Delaware General Corporation Law prohibits a publicly held Delaware corporation from engaging in a business combination with an interested stockholder, generally a person which together with its affiliates owns, or ~~unavailable~~within the last three years, has owned 15% of our voting stock, for a period of three years after the date of the transaction in which the person became an interested stockholder, unless the business combination is approved in a prescribed manner. The existence of the forgoing provisions and anti-takeover measures could limit the price that investors might be willing to ~~cover~~pay ~~any~~in ~~product~~the ~~liability~~future ~~losses~~for weshares ~~incur~~of our common stock. They could also deter potential acquirers of our Company, thereby reducing the likelihood that you could receive a premium for your common stock in an acquisition.

Our business exposes us to potential product liability claims that are inherent in the design, manufacture, testing, inspection, and sale of dental and medical devices. We are subject to product liability lawsuits alleging that component failures, manufacturing flaws, manufacturing defects, negligence in manufacturing, design defects, negligence in design, or inadequate disclosure of product-related risks, warnings, or product-related information resulted in an unsafe condition, injury, or death to customers. The risk of one or more product liability claims or lawsuits may be even greater after we launch new products with new features or enter new markets where we have no prior experience selling our products and rely on newly hired staff or new independent distributors or contractors to provide new customer training and customer support. In addition, the misuse of our products or the failure of customers to adhere to operating guidelines could cause significant harm to customers, including death, which could result in product liability claims. Product liability lawsuits and claims, safety alerts or product recalls, with or without merit, regardless of any available insurance coverage, could cause us to incur substantial costs, and could place a significant strain on our financial resources, divert the attention of management from our core business, harm our reputation and adversely affect our ability to attract and retain customers, any of which could have a material adverse effect on our business, financial condition and operating results.22

~~Item1B.~~Your percentage ~~Unresolved~~of ~~Staff~~ownership ~~Comments~~in the Company may be diluted in the future.

~~None~~In the future, your percentage ownership in the Company may be diluted because of equity issuances for acquisitions, capital market transactions or otherwise, including any equity awards that the Company will grant to its directors, officers, employees and consultants. Such awards will have a dilutive effect on outstanding share count which could adversely affect the market price of the Company’s common stock.

Risks 21 Related to Our Intellectual Property

~~Item~~If we ~~1C.~~are ~~Cybersecurity~~unable to adequately protect our patents, trade secrets and other proprietary rights, if our patents are challenged or if our provisional patent applications do not get approved, our competitiveness and business prospects may be materially damaged.

~~Governance~~Intellectual property ~~Related~~rights, including patents, trade secrets, confidential information, trademarks, trade names, and trade addresse, are important to ~~Cybersecurity~~our ~~Risks~~business. We will endeavor to protect our intellectual property rights in key jurisdictions in which our products are produced or used and in jurisdictions into which our products are imported. Our success will depend to a significant degree upon our ability to protect and preserve our intellectual property rights. However, we may be unable to obtain or maintain protection for our intellectual property in key jurisdictions.

~~Our~~Although we ~~board~~own ofand ~~directors,~~have asapplied afor ~~whole~~patents and ~~through~~trademarks ~~its~~throughout ~~committees~~the world, ~~holds~~we ~~overall~~may ~~oversight~~have ~~responsibility~~to ~~for~~rely ~~our~~on ~~risk~~judicial ~~management~~enforcement ~~processes,~~of ~~including~~our inpatents ~~relation~~and other toproprietary ~~risks from cybersecurity threats~~rights. Our ~~board~~patents ofand ~~directors~~other ~~exercises~~intellectual ~~its~~property ~~oversight~~rights ~~function~~may ~~through~~be ~~the~~challenged, ~~audit~~invalidated, ~~committee~~circumvented, ~~which~~and ~~oversees~~rendered unenforceable ~~the~~or ~~management~~otherwise ofcompromised. ~~risk~~A ~~exposure~~failure ~~across~~to ~~various areas~~protect, ~~including cybersecurity risks~~defend, inor ~~accordance~~enforce ~~with~~our ~~its~~intellectual ~~charter.~~property ~~The~~could ~~audit~~have ~~committee~~an ~~receives~~adverse ~~quarterly~~effect on ~~reports from~~ our ~~Management~~financial oncondition ~~the~~and ~~status~~results of ~~our cybersecurity program~~operations. ~~The~~Similarly, ~~Chair~~third ofparties ~~the~~may ~~audit~~assert ~~committee~~claims ~~provides~~against aus ~~quarterly~~and ~~report~~our tocustomers ~~the~~and ~~board of directors~~distributors, ~~which~~alleging ~~includes~~our ~~any~~products ~~key~~infringe ~~updates~~upon onthird-party ~~cybersecurity~~intellectual ~~matters,~~property ~~as applicable~~rights.

~~Our~~We believe ~~management~~that ~~team~~the intellectual property underlying our products is ~~responsible~~a ~~for~~competitive ~~the~~advantage. ~~day~~We rely on a combination of patent rights, trade secrets, and nondisclosure and non-competition agreements to~~-day~~ ~~administration~~protect our proprietary intellectual property, and ~~management~~we ofwill continue to do so. There can be no assurance that our ~~cybersecurity~~patents, ~~program~~trade secret policies and practices, ~~under~~or other agreements will adequately protect our intellectual property. Our issued patents may be challenged, found to be over-broad or otherwise invalidated in subsequent proceedings before courts or the ~~direct~~U.S. ~~supervision~~Patent ofand Trademark Office. Even if enforceable, we cannot provide any assurances that they will provide significant protection from competition. The processes, systems, and/or security measures we use to preserve the integrity and confidentiality of our ~~Chief~~data ~~Executive~~and ~~Officer~~trade ~~currently~~ secrets may be breached, and we ~~also~~may ~~work~~not have adequate remedies resulting from such breaches. In addition, our trade secrets may otherwise become known or be independently discovered by competitors. There can be no assurance that the confidentiality, nondisclosure and non-competition agreements with ~~external~~employees, ~~security~~consultants ~~service~~and ~~providers~~other parties with access to ~~support~~our proprietary information to protect our ~~security~~trade ~~monitoring~~secrets, proprietary technology, processes and ~~threat~~other ~~detection~~proprietary ~~capabilities~~rights, or any other security measures relating to such trade secrets, proprietary technology, processes and proprietary rights, will be adequate, will not be breached, that we will have ~~implemented~~adequate aremedies ~~process~~for any breach, that others will not independently develop substantially equivalent proprietary information or that third parties will not otherwise gain access to ~~report~~our ~~relevant~~trade ~~findings~~secrets or proprietary knowledge. To the extent that our consultants, contractors, or collaborators use intellectual property owned by others in their work for us, disputes may arise as to the ~~Chair~~rights ofin related ~~audit~~or ~~committee~~resulting ~~where~~know-how ~~appropriate~~and inventions.

~~Cybersecurity~~If we ~~Risk~~must ~~Management~~take legal action to protect, defend or enforce our intellectual property rights, any suits or proceedings could result in significant costs and ~~Strategy~~diversion of our resources and our management’s attention, and we may not prevail in any such suits or proceedings. A failure to protect, defend or enforce our intellectual property rights could have an adverse effect on the results of operations.

WeThird parties ~~maintain~~could aobtain ~~cybersecurity~~patents ~~program,~~that ~~which~~may ~~includes~~require ~~processes~~us ~~for~~to ~~identification,~~negotiate ~~assessment,~~licenses ~~and management of cybersecurity risks. We conduct periodic risk assessments, including with support from external vendors,~~ to ~~assess~~commercialize our ~~cyber program~~technologies, ~~identify potential areas of enhancement,~~ and ~~develop~~we ~~strategies~~cannot ~~for~~assure you that the ~~mitigation~~required oflicenses ~~cyber~~would ~~risks.~~be Weavailable ~~have~~on ~~implemented~~reasonable aterms ~~process~~or toat ~~periodically conduct security awareness training for employees~~all.

~~Our~~Third parties ~~team~~may ~~is informed~~claim ~~about~~that ~~and~~one ~~monitor~~or ~~the~~more ~~prevention,~~aspects ~~detection, mitigation, and remediation~~ of ~~cybersecurity~~our risks through various means, including by leveraging a managed security service provider and other third-party security software and technology services. In addition, we use third-party security solutions, monitoring, and alerting tools and resources, designed to monitor, identify, and address risks from cybersecurity threats. We also have implemented processes and technologies ~~for~~or ~~network~~products ~~monitoring~~may ~~and~~infringe ~~data~~on ~~loss~~their ~~prevention~~intellectual ~~procedures,~~property ~~and from time to time review such processes and technologies~~rights.

~~Item~~Our computer-controlled 2anesthesia systems are complex systems and numerous U.S. ~~Description~~and foreign patents and pending patent applications owned by third parties exist in fields that relate to the development and commercialization of ~~Property~~drug delivery systems. In addition, many companies have employed intellectual property litigation as a strategy to gain a competitive advantage. It is possible that infringement claims may occur as the number of products and competitors in our market increases. In addition, to the extent that we gain greater visibility and market exposure as a public company, we face a greater risk of being the subject of intellectual property infringement claims. We cannot be certain that the conduct of our business does not and will not infringe intellectual property or other proprietary rights of others in the United States and in foreign jurisdictions. If any of our computer-controlled anesthesia systems are found to infringe third party patent rights, we could be prohibited from manufacturing and commercializing the infringing technology unless we obtain a license under the applicable third-party patent and pay royalties or are able to design around such patent.

The headquarters for Milestone Scientific is located at 425 Eagle Rock Avenue, Roseland, New Jersey 07068, and our telephone number is (973) 535-2717. In August 2019, the Company signed a seven-year lease for a facility in Roseland, New Jersey (the “Roseland Facility”). The Roseland Facility carries monthly lease payments of $9,275, commencing April 1, 2021. The Company is also responsible for electric charges equal to $2.00 per square foot, which is equal to $11,130 annually, payable in equal monthly installments of $928. The Company will also be required to pay its proportionate share of certain operating costs and property taxes applicable to the leased premises more than the new base year amounts. A third-party distribution and logistics center in Pennsylvania handles shipping and order fulfillment on a month-to-month basis.23

~~Milestone~~We may ~~Scientific~~be ~~does~~unable ~~not~~to ~~own~~obtain a license on terms acceptable to us, or ~~intend~~at all, and we may not be able to ~~invest~~redesign inthe ~~any~~system ~~real~~to ~~property~~avoid infringement. Even ~~Milestone~~if ~~Scientific~~we ~~currently~~can ~~has~~redesign noour ~~policy~~products ~~with~~or ~~respect~~processes to ~~investments~~avoid oran ~~interests~~infringement inclaim, ~~real~~our ~~estate~~efforts to design around the patent could require significant time, ~~real~~effort ~~estate~~and ~~mortgages~~expense and ultimately may lead to an inferior or ~~securities~~costlier product. Any claim of infringement by a third party, oreven ~~interests~~those inwithout merit, ~~persons~~could ~~primarily~~cause ~~engaged~~us into ~~real~~incur ~~estate~~substantial ~~activities~~costs defending against the claim and could distract our management from our business.

~~Item 3~~Furthermore, if any such claim is successful, a court could order us to pay substantial damages, including compensatory damages for any infringement, plus prejudgment interest and could, in certain circumstances, treble the compensatory damages and award attorney fees. ~~Legal~~This ~~Proceedings~~damage could be substantial and could harm our reputation, business, financial condition, and operating results. A court also could enter orders that temporarily, preliminary, or permanently prohibit us, our licensees, if any, and our customers from making, using, selling, offering to sell, or importing one or more of our products or using our proprietary technologies or processes, or could enter an order mandating that we undertake certain remedial activities.

~~Milestone~~Any of ~~Scientific~~these isevents ~~not~~could ~~involved~~seriously inharm ~~any~~our ~~material~~business, ~~litigation~~operating results, and financial condition.

~~Item 4.~~General Business ~~Mine Safety Disclosure~~ Risks

~~Not~~Cybersecurity ~~applicable~~incidents, data breaches, or other system disruptions could compromise our products, data, and operations and materially adversely affect our business, financial condition, and results of operations.

We rely extensively 22on information technology (“IT”) systems, cloud-based platforms, software, and connected technologies to conduct our operations, develop and manufacture our medical devices, maintain clinical and regulatory data, and support customers and patients who use our connected products.

~~PART~~Cyberattacks are IIbecoming increasingly sophisticated, frequent, and difficult to detect, and threat actors — including criminal groups, nation-states, and insiders — regularly target healthcare and medical technology companies because of the value and sensitivity of the data involved. Vulnerabilities may exist in our own systems, those of our suppliers and manufacturing partners, and in third-party software embedded in our devices. Any actual or perceived vulnerability or breach in the cybersecurity of our products could result in device malfunction, unauthorized access to patient data, or interruptions in device performance. In extreme circumstances, a cybersecurity incident involving one of our connected medical devices could pose risks to patient safety.

~~Item 5.~~A ~~Market~~significant cybersecurity ~~for~~breach ~~Common~~or ~~Equity~~disruption could lead to operational downtime, ~~and~~loss ~~Related~~or ~~Stockholder~~corruption ~~Matters~~of data, delays in manufacturing or product delivery, and ~~Small~~interruptions ~~Business~~in ~~Issuer~~clinical, ~~Purchases~~research, or commercial activities. In addition, such incidents could require costly remediation efforts, including forensic investigations, system restoration, and implementation of ~~Equity~~additional ~~Securities~~security measures.

~~Market~~Compromise of ~~Information~~protected health information, personally identifiable information, or other sensitive data could expose us to substantial liability under U.S. and international data-protection laws, including the Health Insurance Portability and Accountability Act (“HIPAA”), the General Data Protection Regulation (“GDPR”), and various state privacy regulations. We could face regulatory investigations, enforcement actions, penalties, and ongoing compliance costs. We may also experience loss of customer trust, damage to our reputation, increased insurance premiums, and litigation from patients, customers, or business partners.

~~Since~~Although we ~~June~~maintain 1cybersecurity programs and invest in technical and administrative safeguards designed to protect our systems and devices, these ~~2015~~measures may be insufficient to prevent or detect every potential attack or vulnerability. We also rely on third-party service providers who may have weaker security controls than our own, and our ~~common~~ability ~~stock~~to ~~has~~monitor ~~been~~their ~~listed~~security onpractices is limited. Despite the ~~NYSE~~implementation of ~~American~~security ~~under~~measures, ~~the~~our ~~symbol~~internal ~~“MLSS”~~computer systems, and those of any third parties with which we partner are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. ~~The~~While ~~following~~we ~~table~~have not ~~sets~~experienced ~~forth~~any cybersecurity or system failure, accident or breach to date, if an event were to occur, it could result in a material disruption of our operations, substantial costs to rectify or correct the ~~high~~failure, if possible, and ~~low~~potentially ~~sales~~violation ~~prices~~of HIPAA and other privacy laws applicable to our operations. If any disruption or security breach resulted in a loss of ~~Milestone’s~~or ~~common~~damage ~~stock~~to ~~for~~our ~~the~~data ~~periods~~or ~~presented~~applications or inappropriate disclosure of confidential or protected information, we could incur liability, further development of our products could be delayed, and our operations could be disrupted, any of which could severely harm our business and financial condition.

2024	High		Low		2023	High		Low
First Quarter	$	0.78	$	0.52	First Quarter	$	1.00	$	0.46
Second Quarter	$	0.85	$	0.54	Second Quarter	$	1.22	$	0.72
Third Quarter	$	1.10	$	0.58	Third Quarter	$	1.35	$	0.81
Fourth Quarter	$	1.05	$	0.60	Fourth Quarter	$	1.00	$	0.56

Issues with product quality could have a material adverse effect upon our business, subject us to regulatory actions and cause a loss of customer confidence in us or our products.

~~Holders~~In general, our success depends upon the quality of our products. Quality management plays an essential role in meeting customer requirements, preventing defects, improving our products and services, and assuring the safety and efficacy of our products. Our future success depends on our ability to maintain and continuously improve our quality management program. A quality or safety issue may result in adverse inspection reports, warning letters, product recalls or seizures, monetary sanctions, injunctions to halt manufacture and distribution of products, civil or criminal sanctions, costly litigation, refusal of a government to grant approvals and licenses, restrictions on operations or withdrawal of existing approvals and licenses. An inability to address a quality or safety issue in an effective and timely manner may also cause negative publicity, a loss of customer confidence in us or our current or future products, which may result in the loss of sales and difficulty in successfully launching new products.

AsInsurance coverage ofmay ~~March~~be ~~27,~~inadequate ~~2024,~~or weunavailable ~~had~~to ~~approximately~~cover 97any ~~stockholders~~product ofliability ~~record~~losses ~~of our common stock. We believe that, in addition to the record owners,~~ we ~~have approximately 3,488 beneficial owners of our common stock~~incur.

~~Dividends~~Our business exposes us to potential product liability claims that are inherent in the design, manufacture, testing, inspection, and sale of dental and medical devices. We are subject to product liability lawsuits alleging that component failures, manufacturing flaws, manufacturing defects, negligence in manufacturing, design defects, negligence in design, or inadequate disclosure of product-related risks, warnings, or product-related information resulted in an unsafe condition, injury, or death to customers. The risk of one or more product liability claims or lawsuits may be even greater after we launch new products with new features or enter new markets where we have no prior experience selling our products and rely on newly hired staff or new independent distributors or contractors to provide new customer training and customer support. In addition, the misuse of our products or the failure of customers to adhere to operating guidelines could cause significant harm to customers, including death, which could result in product liability claims. Product liability lawsuits and claims, safety alerts or product recalls, with or without merit, regardless of any available insurance coverage, could cause us to incur substantial costs, and could place a significant strain on our financial resources, divert the attention of management from our core business, harm our reputation and adversely affect our ability to attract and retain customers, any of which could have a material adverse effect on our business, financial condition and operating results.

~~The holders of common stock are entitled to receive such dividends as may be declared by Milestone Scientific’s Board of Directors~~Item 1B. ~~Milestone~~Unresolved ~~Scientific~~Staff ~~has not paid and does not expect to declare or pay any dividends in the foreseeable future.~~Comments

~~Sales of Unregistered Securities~~None.

~~Not applicable.~~24

Item 6 1C. ~~Selected Financial Data~~Cybersecurity

~~Milestone~~Governance Related ~~Scientific is a “smaller reporting company” as defined by Regulations S-K and as such, is not required~~ to ~~provide~~Cybersecurity ~~the information contained in this item pursuant to Regulation S-K.~~ Risks

Our 23Board of Directors has oversight responsibility for risk management, including cybersecurity risk. The Board exercises this oversight through the Audit Committee, which oversees management’s risk exposure across various areas, including cybersecurity, in accordance with its charter. Management provides quarterly reports to the Audit Committee regarding the status of our cybersecurity program. The Chair of the Audit Committee reports to the full Board on cybersecurity matters every quarter, as applicable.

~~Item~~Management is 7.responsible ~~Management’s~~for ~~Discussion~~the ~~and~~day-to-day ~~Analysis~~administration of ~~Financial~~our ~~Condition~~cybersecurity program under the supervision of our Chief Executive Officer. We also engage external security service providers to support monitoring and ~~Results~~threat detection and have processes designed to report relevant findings to the Chair of ~~Operations~~the Audit Committee, as appropriate.

~~The~~Cybersecurity Risk ~~following~~Management ~~discussions of the financial condition~~ and results of operations should be read in conjunction with the financial statements and the notes to those statements included elsewhere in this annual report. Certain statements in this discussion and elsewhere in this report constitute forward-looking statements, within the meaning of section 21E of the Exchange Act, which involve risks and uncertainties. The actual results may differ materially from those anticipated in these forward-looking statements. See "Risk Factors" elsewhere in this Form 10-K.Strategy

~~OVERVIEW~~We maintain a cybersecurity program that includes processes to identify, assess, and manage cybersecurity risks. We conduct periodic risk assessments, including with the support of external vendors, to evaluate our cybersecurity program, identify areas for enhancement, and develop mitigation strategies. We also conduct periodic security awareness training for employees.

~~Milestone~~We monitor ~~Scientific~~cybersecurity isrisks through a ~~biomedical~~combination ~~technology~~of ~~company~~internal ~~that~~efforts ~~patents, designs, develops~~ and ~~commercializes~~third-party ~~innovative~~tools ~~diagnostic~~ and ~~therapeutic~~services, ~~injection~~including ~~technologies~~a ~~and~~managed ~~devices~~security service ~~for~~provider ~~medical~~ and ~~dental~~other ~~use.~~security ~~Since~~software ~~our~~designed ~~inception,~~to wedetect ~~have engaged in pioneering proprietary, innovative, computer-controlled injection technologies,~~ and ~~solutions~~respond ~~for~~to ~~the medical and dental markets~~threats. We ~~believe~~have ~~our~~implemented ~~technologies~~processes ~~are proven~~ and ~~well~~technologies for ~~established.~~network ~~Our~~monitoring ~~common~~and ~~stock~~data ~~was~~loss ~~initially listed on the NYSE American on June 1~~prevention, ~~2015,~~ and ~~trades~~periodically ~~under~~review ~~the~~these ~~symbol “MLSS"~~controls.

We have ~~focused~~not ~~our~~identified ~~resources~~any oncybersecurity ~~redefining~~incidents ~~the~~that ~~worldwide~~have ~~standard~~materially ofaffected, ~~care~~or ~~for~~are ~~injection~~reasonably ~~techniques~~likely byto ~~making~~affect ~~the~~materially, ~~experience~~our ~~more~~business strategy, ~~comfortable~~results ~~for~~of ~~the~~operations, ~~patient~~or byfinancial ~~reducing~~condition. ~~the~~However, ~~anxiety~~like other companies, our third-party vendors and ~~stress~~we ofmay ~~receiving~~experience cybersecurity ~~injections~~threats or incidents from ~~the~~time ~~healthcare~~to ~~provider~~time. ~~Our~~For ~~computer-controlled~~additional ~~injection~~discussion ~~devices~~of ~~make~~related ~~injections precise~~risks, ~~efficient,~~see ~~and~~“Item ~~virtually~~1A. ~~painless~~Risk Factors.”

We have developed a proprietary, revolutionary, computer-controlled anesthetic delivery device, our DPS Dynamic Pressure Sensing Technology® System, to meet the needs of various subcutaneous drug delivery injections and fluid aspiration – enabling healthcare practitioners to achieve multiple unique benefits that cannot currently be accomplished with the 160-year-old manual syringeItem 2. ~~Our~~Description ~~proprietary DPS Dynamic Pressure Sensing technology is our technology platform that advances the development~~ of next-generation devices. It regulates flow rate and monitoring pressure from the tip of the needle, through platform extensions for local anesthesia for subcutaneous drug delivery, used in various dental and medical injections. It has specific medical applications for epidural space identification in regional anesthesia procedures.Property

Our headquarters ~~device,~~are ~~The~~located ~~Wand®,~~at a425 ~~single~~Eagle ~~use~~Rock ~~disposable~~Avenue, ~~handpiece~~Roseland, isNew ~~marketed~~Jersey ~~in dentistry under the trademark CompuDent®~~07068, and ~~STA~~our ~~Single~~telephone ~~Tooth~~number ~~Anesthesia System® and~~ is ~~suitable~~(973) ~~for~~535-2717. ~~all~~In ~~dental~~August 2019, ~~procedures~~we ~~that~~entered ~~require~~into ~~local~~a ~~anesthetic.~~seven-year ~~The~~lease ~~dental~~for ~~devices~~our ~~currently~~facility ~~are sold~~ in ~~the United States~~Roseland, ~~Canada~~New ~~and~~Jersey in(the ~~over~~“Roseland ~~41 other countries~~Facility”). ~~Milestone~~Monthly ~~Scientific~~lease payments ~~also~~are ~~has~~$9,275, ~~510(k)~~commencing ~~marketing~~April ~~clearance~~1, ~~from the U~~2021.S. ~~Food~~We ~~and~~are ~~Drug~~also ~~Administration~~responsible ~~(FDA)~~for onelectricity ~~the~~charges ~~CompuFlo®~~of ~~Epidural~~$2.00 ~~Computer~~per ~~Controlled~~square ~~Anesthesia~~foot ~~System~~(approximately $11,130 ~~in the lumbar~~annually), ~~thoracic~~payable ~~and~~in ~~cervical~~equal ~~thoracic~~monthly ~~junction~~installments of ~~the spine region. In addition~~$928, ~~Milestone~~and ~~Scientific~~our ~~has~~proportionate ~~obtained~~share CEof ~~mark~~certain ~~approval~~operating ~~and~~costs ~~can be marketed~~ and ~~sold~~property taxes in ~~most~~excess ~~European~~of ~~countries~~base-year amounts.

~~Our~~We do ~~recent~~not ~~receipt of chronology-Specific CPT Code for the Company's technology by the American Medical Association marks an important milestone~~own, ~~that~~and ~~could~~do ~~increase~~not ~~the~~currently ~~potential~~intend ~~number~~to of anesthesia pain management clinics adopting the CompuFlo instrument. A CPT code expands the potential for reimbursement of epidural procedures in pain management utilizing the CompuFlo Epidural System.acquire, ~~which~~any ~~should~~real ~~help accelerate the commercial roll-out of CompuFlo in the U~~property.S

~~Milestone Scientific and its subsidiaries currently hold over 317 U~~Item 3.S. ~~and~~Legal foreign patents, and many patents pending and patent applications. The Company’s patents and patent applications relate to drug delivery methodologies, Peripheral Nerve Block, drug flow rate measurement, pressure/force computer-controlled drug delivery with exit pressure, dynamic pressure sensing, automated rate control, automated charging, drug profiles, audible and visual pressure/force feedback, tissue identification, identification of a target region drug delivery injection unit, drug drive unit for anesthetic, handpiece, and injection device.Proceedings

~~Milestone~~We are ~~Scientific~~not ~~remains~~involved ~~focused~~in onany ~~advancing~~legal ~~efforts to achieve the following three primary objectives:~~proceedings.

●Item 4. ~~Establishing~~Mine ~~Milestone’s~~Safety DPS Dynamic Pressure Sensing 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;Disclosures

● Following obtaining successful FDA clearance of our first medical device, Milestone Scientific is transitioning from a research and development organization to a commercially focused medical device company; andNot applicable.

~~● Expanding our global footprint of our CompuFlo Epidural and CathCheck System by utilizing a targeted field sales force and partnering with distribution companies worldwide.~~25

PART 24 II

~~Our dental devices have been used to administer over 95 million injections worldwide~~Item 5. ~~Each~~Market offor ~~our~~Common ~~devices has a related single use disposable handpiece~~Equity, ~~leading~~Related toStockholder ~~a continuing revenue stream following the sale of the device. At present~~Matters, ~~we sell disposable handpieces unique to our legacy product (the Wand~~ and ~~CompuDent)~~Issuer toPurchases ~~users~~of ~~who~~Equity ~~have not upgraded to our current dental product, the STA Single Tooth Anesthesia System.~~Securities

Building on the success of our proprietary, core technology platform for dental injections, and desiring to pursue other growth opportunities, we have begun to expand the uses and applications of our 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.Market Information

WeOur common ~~intend~~stock tohas ~~continue~~been tolisted ~~expand~~on the ~~uses~~NYSE ~~and~~American ~~applications~~under ofthe ~~our~~symbol ~~DPS~~“MLSS” ~~Dynamic~~since ~~Pressure~~June ~~Sensing~~1, ~~technology~~2015. We ~~believe~~The ~~that~~trading weprices ~~and~~of our ~~technology~~common stock ~~solutions~~have ~~are~~historically ~~recognized~~been byvolatile ~~key~~and ~~opinion~~may ~~leaders~~continue ~~(i.e.,~~to ~~academics~~fluctuate significantly, ~~anesthesiologists~~as ~~and~~discussed ~~practicing~~in ~~dentists~~“Item ~~whose~~1A. ~~opinions~~Risk ~~are~~Factors” and ~~widely~~“Item ~~respected),~~7. ~~industry~~Management’s ~~experts~~Discussion and ~~medical~~Analysis ~~and~~of ~~dental~~Financial ~~practitioners~~Condition asand aResults ~~leader~~of ~~in the emerging, computer-controlled injection industry~~Operations.”

The following ~~Single~~table ~~Tooth~~sets ~~Anesthesia~~forth ~~System~~the ~~(Dental)~~quarterly high and low sales prices of our common stock as reported on the NYSE American for the periods indicated.

Since its market introduction in early 2007, the STA Single Tooth Anesthesia System and prior C-CLAD devices have been used to deliver over 95 million safe, effective, and comfortable injections. The instrument has also been favorably evaluated in numerous peer-reviewed, published clinical studies and associated articles. Moreover, there appears to be a growing consensus among users that the STA Instrument is proving to be a valuable and beneficial instrument that is positively impacting the practice of dentistry worldwide.

2025	High		Low		2024	High		Low
First Quarter	$	1.39	$	0.87	First Quarter	$	0.78	$	0.52
Second Quarter	$	1.11	$	0.62	Second Quarter	$	0.85	$	0.54
Third Quarter	$	0.73	$	0.38	Third Quarter	$	1.10	$	0.58
Fourth Quarter	$	0.60	$	0.23	Fourth Quarter	$	1.05	$	0.60

~~Medical~~The market ~~Market~~price ~~Product~~of our common stock may be influenced by factors discussed elsewhere in this Annual Report, including our operating results, liquidity position, capital-raising activities, product commercialization progress, regulatory developments, and general market conditions.

~~In June 2017, we received FDA regulatory clearance to sell the CompuFlo Epidural Computer Controlled Anesthesia System in the United States for epidural injections.~~Holders

InAs of ~~May,~~March ~~2022~~31, ~~the Company received a chronology-specific CPT Code for the Company’s technology by the American Medical Association~~2026, ~~which~~there ~~marks~~were anapproximately ~~important~~92 ~~milestone~~holders ~~that~~of ~~could~~record ~~increase the potential number~~ of ~~anesthesia~~our ~~pain~~common ~~management~~stock. ~~clinics~~We ~~adopting~~believe ~~the~~there ~~CompuFlo~~were ~~instrument.~~approximately ~~Effective January 1~~3,507 ~~2023,~~beneficial owners ~~this~~of ~~temporary~~our ~~tracking~~common ~~code~~stock ~~allows~~at ~~clinicians~~that todate. ~~submit~~Because ~~claims~~brokers toand ~~healthcare~~other ~~insurance~~nominees ~~providers~~hold ~~using~~many ~~the~~shares, ~~Company’s technology for Epidural Sterile Injections in~~ the ~~lumbar,~~number ~~thoracic, and cervical thoracic junction~~ of ~~the~~beneficial ~~spinal~~owners ~~region for~~may ~~reimbursement.~~differ from ~~A CPT code expands~~ the ~~potential~~number ~~for reimbursement~~ of ~~epidural~~holders ~~procedures in pain management utilizing the CompuFlo Epidural System, which should help accelerate the commercial roll-out~~ of ~~CompuFlo in the United States~~record.

OnWe have ~~June~~never ~~18,~~declared ~~2024,~~or paid cash dividends on our common stock. We do not currently intend to declare or pay dividends in the ~~Company~~near ~~announced~~future. We anticipate that itany ~~has~~future ~~received~~earnings, ~~regulatory~~if ~~approval~~any, ~~from~~will ~~Brazil's~~be ~~National~~retained ~~Health~~to ~~Surveillance~~support ~~Agency~~our ~~(ANVISA)~~operations, tofund ~~market~~product development and ~~sell~~commercialization efforts, ~~its~~and ~~CompuFlo®~~strengthen ~~Epidural~~our ~~System~~financial ~~in Brazil~~position. The ~~approval~~payment ~~includes~~of dividends, if any, will be at the ~~lumbar~~discretion of our Board of Directors and will depend on our operating results, ~~thoracic~~financial condition, capital requirements, and ~~cervical-thoracic~~other ~~junction~~factors ofdeemed relevant by the ~~spine~~Board.

On July 10, 2024, the Company announced that First Coast Service Options Inc. (FCSO), a Jurisdictional Medicare Administrative Contractor (“JMAC”), has granted favorable Medicare Part B physician price assignment across Florida for use Sales of ~~the~~Unregistered Company’s CompuFlo® Epidural System under the American Medical Association’s (AMA) technology-specific Category III CPT® code CPT0777T (real-time pressure-sensing epidural guidance system when used in conjunction with a primary ESI procedure).Securities

~~On July 23, 2024 the Company announced that Novitas Solutions, Inc~~None. (Novitas), a Jurisdictional Medicare Administrative Contractor (JMAC), had granted a Medicare Part B Physician payment rate for the Company’s CompuFlo® Epidural System under the American Medical Association’s (AMA) technology-specific Category III CPT® code CPT0777T (real-time pressure-sensing epidural guidance system when used in conjunction with a primary ESI procedure).This new price assignment applies to two Medicare regions: Jurisdiction L (JL) and Jurisdiction H (JH). JL includes Delaware, District of Columbia, Maryland, New Jersey, and Pennsylvania. JH includes Arkansas, Colorado, Louisiana, Mississippi, New Mexico, Oklahoma, and Texas.

Issuer 25 Purchases of Equity Securities

~~On July 30, 2024, the Company announced receipt of multiple Notices of Allowance (NOA) for essential patent applications in both the U~~None.S. and Europe. One NOAs was granted by the U.S. Patent and Trademark Office and one NOA was granted by the European Patent Office for a new patent titled “Device and Method for Needle/Catheter Location Utilizing Correlation Analysis.” These patent applications cover Milestone Scientific’s next-generation Dynamic Pressure Sensing® (DPS) technology for real-time pressure-sensing guidance in manual injection systems

~~On August 7, 2024, the Company announced a strategic partnership with Axial Biologics, a premier medical device company with a vast distribution network~~Item 6. ~~Under~~Selected ~~the~~Financial ~~agreement, Axial Biologics will serve as the distributor of Milestone Scientific's CompuFlo® Epidural System in New Jersey, Texas, and Florida jurisdictions.~~Data

OnWe are ~~October~~a 3“smaller reporting company,” ~~2024~~as defined by Rule 12b-2 of the Securities Exchange Act of 1934 and Regulation S-K. Accordingly, we are not required to provide the ~~Company~~selected ~~announced~~financial ~~that~~data ~~iHeal~~specified ~~Pain~~in ~~Center~~Item ~~had~~301 ~~adopted~~of Regulation S-K. Management believes that the ~~CompuFlo®~~consolidated financial ~~Epidural~~statements ~~System~~and ~~following~~related ~~successful~~disclosures ~~epidural~~included ~~steroid~~elsewhere ~~injection~~in ~~(ESI)~~this Annual Report provide sufficient information to understand our financial condition, results of operations, and liquidity.

~~On November~~ 26~~,2024, the Company announced its approval on contract for the Federal Supply Schedule (FSS), also known as the GSA Schedule, for the CompuFlo® Epidural System.~~

~~The~~Item ~~following~~7. ~~table~~Discussion ~~shows~~and aAnalysis ~~breakdown~~ of ~~Milestone~~Financial ~~Scientific’s~~Condition ~~product sales (net), domestically~~ and ~~internationally,~~Results byof ~~business segment product category:~~Operations

	Year Ended December 31, 2024						Year Ended December 31, 2023
Domestic: US	Dental		Medical		Grand Total		Dental		Medical		Grand Total
Instruments	$	806,885	$	4,000	$	810,885	$	1,002,697	$	1,000	$	1,003,697
Handpieces		4,284,952		55,900		4,340,852		4,270,898		12,000		4,282,898
Accessories		49,112		-		49,112		75,285		-		75,285
Grand Total	$	5,140,949	$	59,900	$	5,200,849	$	5,348,880	$	13,000	$	5,361,880
International: Rest of World
Instruments	$	868,169	$	39,000	$	907,169	$	1,251,354	$	25,000	$	1,276,354
Handpieces		2,476,988		3,920		2,480,908		2,845,734		28,000		2,873,734
Accessories		41,002		-		41,002		45,476		-		45,476
Grand Total	$	3,386,159	$	42,920	$	3,429,079	$	4,142,564	$	53,000	$	4,195,564
International: China
Instruments	$	-	$	-	$	-	$	270,000	$	-	$	270,000
Handpieces		-		-		-		-		-		-
Accessories		-		-		-		-		-		-
Grand Total	$	-	$	-	$	-	$	270,000	$	-	$	270,000
Total Product Sales	$	8,527,108	$	102,820	$	8,629,928	$	9,761,444	$	66,000	$	9,827,444

The following discussion and analysis of the Company’s financial condition and results of operations should be read in conjunction with the consolidated financial statements and related notes included elsewhere in this Annual Report on Form 10-K. This discussion contains forward-looking statements that involve risks and uncertainties. Actual results may differ materially from those anticipated in these forward-looking statements as a result of various factors, including those discussed under “Risk Factors” in this Form 10-K.

~~Current Product Platform~~Overview

~~See~~Milestone Scientific, ~~Item~~Inc. 1is a biomedical technology company that patents, designs, develops, and commercializes innovative diagnostic and therapeutic injection technologies and devices for medical and dental use. ~~Description~~Since its inception, the Company has focused on pioneering proprietary, computer-controlled injection technologies intended to improve the standard of ~~Business~~care by making injections more precise, efficient, and more comfortable for patients.

~~Summary~~The Company’s ofproprietary ~~Critical~~Dynamic ~~Accounting~~Pressure ~~Estimates~~Sensing® (DPS) technology platform enables real-time pressure monitoring and controlled fluid delivery during injections. This platform serves as the foundation for the Company’s dental and medical product offerings. It supports multiple applications, including local anesthesia delivery, subcutaneous drug delivery, fluid aspiration, and epidural space identification.

WeMilestone Scientific’s ~~have~~common ~~identified~~stock ~~the~~has ~~accounting~~been ~~estimates~~listed ~~below~~on ~~as critical to~~ the ~~understanding~~NYSE ofAmerican ~~our~~since ~~results~~June ~~of operations and our financial condition. In applying these critical accounting estimates in preparing our financial statements~~1, ~~management must use critical assumptions~~2015, ~~estimates~~ and ~~judgments~~trades ~~concerning future results or other developments, including the likelihood, timing or amount of one or more future events. Actual results may differ from these estimates~~ under different assumptions or conditions. On an ongoing basis, we evaluate our assumptions, estimates and judgments based upon historical experience and various other information that we believe to be reasonable under the ~~circumstances.~~symbol ~~Management reviews revenue, and its cash position on regularly basis along with the company inventory needs~~“MLSS. We believe that the following discussion addresses our most critical accounting estimates, which are those that are most important to the portrayal of our financial condition and results of operations and require management’s most difficult, subjective and complex judgments.”

~~For a detailed discussion of significant accounting policies, see Note C.~~Business Strategy

Milestone 26 Scientific remains focused on advancing the following primary objectives:

~~Going~~● ~~Concern~~Establishing the DPS Dynamic Pressure Sensing technology platform as a standard-of-care for precise and ~~Liquidity~~comfortable drug delivery, with objective visual and audible in-tissue pressure feedback; ● Transitioning from a research-and-development-focused organization to a commercially oriented medical device company following FDA clearance of its medical products, and ● Expanding the global footprint of the Company’s CompuFlo® Epidural and CathCheck® systems through a targeted sales strategy and strategic distribution partnerships.

~~Management has developed~~ Products and isTechnology implementing plans to increase revenues and decrease professional and consulting fees over the next twelve months. The Company has also decided to delay all research and development on the Single Tooth Anesthesia System next generation instrument. The Company believes that our existing cash and cash equivalents along with management plans, and the $800,000 in related party note financing received in April 2025 (See Note P) will be sufficient to enable the Company to fund operations for the twelve months from the issuance of these financial statements and alleviates substantial doubt about the Company’s ability to continue as a going concern.Platform

~~Inventories~~Dental Market Products

~~Inventories~~Since its ~~principally~~commercial ~~consist~~introduction ofin ~~finished~~early ~~goods~~2007, ~~and~~the ~~component~~STA ~~parts~~Single ~~stated~~Tooth atAnesthesia ~~the~~(STA) ~~lower~~System, ~~cost~~together ~~(first~~with its predecessor C-inCLAD devices, has ~~first-out~~been ~~method)~~used orto ~~net~~administer ~~realizable~~more ~~value~~than 95 million injections globally. ~~Inventory~~The ~~quantities~~system onis ~~hand~~designed ~~are~~to ~~reviewed~~provide oncontrolled adelivery ~~quarterly~~of ~~basis~~local anesthetics and has been utilized in a ~~provision~~broad ~~for~~range ~~excess~~of ~~and~~dental ~~obsolete~~procedures. ~~inventory~~The isSTA ~~recorded~~Instrument ifhas ~~required~~been ~~based~~evaluated onin ~~past~~multiple ~~and~~peer-reviewed clinical ~~expected~~studies ~~future~~and ~~sales,~~published ~~potential~~articles. ~~technological~~Feedback ~~obsolescence~~from practitioners and ~~product~~published ~~expiration~~literature ~~requirement~~indicates ~~and~~that ~~regulations~~the technology has been incorporated into clinical practice in various markets worldwide.

~~Results~~Medical Market ~~of Operations~~Products

As of 2025, the CompuFlo® Epidural System has received multiple regulatory clearances and reimbursement milestones in the United States. The ~~following~~system ~~table~~initially ~~sets~~received ~~forth~~FDA 510(k) clearance in 2017 for epidural injections in the ~~consolidated~~lumbar ~~results~~region, ofwith ~~operations~~expanded clearance in 2023 for use in the ~~year~~thoracic ~~ended~~region, ~~December~~including 31the cervicothoracic junction. In 2022, ~~2024~~the ~~compared~~American Medical Association assigned a technology-specific Category III CPT® code (0777T), effective January 1, 2023, to facilitate tracking and reimbursement submissions when the ~~year~~system ~~ended~~is used ~~December~~in 31conjunction with primary epidural steroid injection procedures. In 2024, ~~2023~~Medicare Administrative Contractors in Florida and multiple additional jurisdictions established Medicare Part B physician payment determinations for CPT code 0777T. The Company also received Notices of Allowance in the United States and Europe in 2024 related to its next-generation Dynamic Pressure Sensing® technology.

~~For the year end December 31, 2024, compared to year ended December 31, 2023.~~27

	2024			2023
Operating results:
Product sales, net	$	8,629,928		$	9,827,444
Cost of products sold		2,195,340			3,034,832
Gross profit		6,434,588			6,792,612
Operating expenses:
Selling, general and administrative expenses		12,295,330			13,135,796
Research and development expenses		858,767			701,378
Depreciation and amortization expense		37,448			61,912
Total operating expenses		13,191,545			13,899,086
Loss from operations		(6,756,957	)		(7,106,474	)
Interest income		60,265			125,527
Gain on sale of net operating losses		1,983,095			-
Net loss		(4,713,597	)		(6,980,947	)
Net loss attributable to noncontrolling interests		-			(51,843	)
Net loss attributable to Milestone Scientific Inc.	$	(4,713,597	)	$	(6,929,104	)

The following table shows a breakdown of Milestone Scientific’s product sales (net), domestically and internationally, by business segment, product category:

	Year Ended December 31, 2025						Year Ended December 31, 2024
	Dental		Medical		Grand Total		Dental		Medical		Grand Total
Domestic-US
Instruments	$	652,044	$	18,400	$	670,444	$	653,990	$	4,000	$	657,990
Handpieces		4,105,727		150,850		4,256,577		4,489,521		57,700		4,547,221
Other		42,194		-		42,194		49,120		-		49,120
Grand Total	$	4,799,965	$	169,250	$	4,969,215	$	5,192,631	$	61,700	$	5,254,331

International Rest of World
Instruments	$	781,019	$	-	$	781,019	$	868,169	$	39,000	$	907,169
Handpieces		2,867,180		14,000		2,881,180		2,423,507		3,920		2,427,427
Other		32,568		-		32,568		41,001		-		41,001
Grand Total	$	3,680,767	$	14,000	$	3,694,767	$	3,332,677	$	42,920	$	3,375,597

International China
Instruments	$	310,000	$	-	$	310,000	$	-	$	-	$	-
Handpieces		-		-		-		-		-		-
Other		-		-		-		-		-		-
Grand Total	$	310,000	$	-	$	310,000	$	-	$	-	$	-

Total Product Sales	$	8,790,732	$	183,250	$	8,973,982	$	8,525,308	$	104,620	$	8,629,928

~~Net~~Current Product ~~sales for year ended December 31, 2024, compared to year ended December 31, 2023~~ Platform

	2024		2023		Change
Dental	$	8,527,108	$	9,761,444	$	(1,234,336	)
Medical		102,820		66,000		36,820
Total sales, net	$	8,629,928	$	9,827,444	$	(1,197,516	)

See Item 1—description of Business.

~~Consolidated revenue for the years ended December 31, 2024 and 2023 was approximately $8.6 million and $9.8 million, respectively, a decrease~~ Summary of ~~approximately~~Critical ~~$1.2~~Accounting million. As of January 3, 2023, the Company launched an E-Commerce platform, selling and shipping the STA Single Tooth Anesthesia System® (STA) and handpieces directly to end users, including dental offices and dental groups, within the U.S. E-commerce revenue for the year ended December 31, 2024 was approximately $5.1 million as compared to $4.8 million for the year ended December 31, 2023.Estimates

The preparation ~~Company~~of ~~recorded no revenue from Henry Schein for~~ the ~~year~~Company’s ~~ended~~consolidated ~~December~~financial ~~31,~~statements ~~2024, compared~~in toconformity ~~approximately~~with ~~$179,000~~accounting ~~recorded~~principles ~~for~~generally ~~the~~accepted ~~year~~in ~~ended December 31, 2023. Revenue from other U.S. distributors was approximately $9,000 for~~ the United ~~year~~States ~~ended~~of ~~December~~America ~~31,~~(“GAAP”) ~~2024,~~requires amanagement ~~decrease~~to ofmake ~~$476~~estimates,~~000~~ ~~compared to December 31~~assumptions, ~~2023. The~~and ~~Company~~judgments ~~terminated~~that ~~all~~affect ~~non-exclusive agreements with other distributors in~~ the USreported amounts inof ~~September~~assets ~~2023.~~and ~~For~~liabilities, the ~~year~~disclosure ~~ended December 31, 2024, international revenue was approximately $3.4 million, a decrease~~ of ~~$756,000 compared~~contingent toassets ~~December 31, 2023. The decrease in international revenue is due low performing markets~~ and ~~shipping~~liabilities ~~delays.~~at ~~For~~ the ~~year~~date ~~ended~~of ~~December~~the ~~31,~~financial ~~2024~~statements, ~~the~~and ~~Company~~ the reported ~~zero revenue~~amounts ~~from China, a decrease~~ of ~~approximately~~revenues ~~$270,000.~~and ~~For~~expenses during the ~~year~~reporting ~~ended December 31, 2024, medical revenue increased approximately $37,000 compared to December 31, 2023~~period.

~~Gross~~Management considers ~~Profit~~an ~~for~~accounting ~~years~~estimate ~~ended~~to ~~December~~be 31critical if it requires significant judgment, ~~2024~~is inherently subjective, and ~~2023~~if ~~were~~changes asin ~~follows:~~the estimate could have a material impact on the Company’s financial condition or results of operations. Actual results may differ from those estimates under different assumptions or conditions.

	2024		2023			Change
Dental	$	6,340,966	$	7,030,018		$	(689,052	)
Medical		93,622		(237,406	)		331,028
Total gross profit	$	6,434,588	$	6,792,612		$	(358,024	)

Management evaluates its estimates and assumptions on an ongoing basis using historical experience, current trends, and other information believed to be reasonable under the circumstances. Management regularly reviews revenue trends, liquidity and cash position, inventory levels, and operating forecasts. The estimates discussed below represent those that management believes are the most critical to understanding the Company’s financial condition and results of operations.

~~Consolidated~~For a ~~gross~~more ~~profit~~complete ~~for~~discussion ~~the~~of ~~year ended December 31, 2024 decreased by approximately $358,000 or 5%, compared to~~ the ~~same~~Company’s ~~period~~significant inaccounting ~~2023. Dental gross profit for the years ended December 31~~policies, ~~2024~~see ~~and~~Note ~~2023~~C ~~we approximately 74% and 72% respectively. The decrease was due~~ to ~~higher margins~~ ~~in sales associated with~~ the ~~launch~~ ofconsolidated ~~E-Commerce~~financial ~~platform offset by lower international sales~~statements. ~~The Company recorded approximately $258,000 allowance for medical inventory that was obsolete and or expired for the year ended December 31, 2023.~~

~~Selling, general and administrative expenses for years ended December 31, 2024, and 2023 were as follows:~~28

	2024		2023		Change
Dental	$	3,929,073	$	4,330,219	$	(401,146	)
Medical		2,128,456		3,381,551		(1,253,095	)
Corporate		6,237,801		5,424,026		813,775
Total selling, general and administrative expenses	$	12,295,330	$	13,135,796	$	(840,466	)

Going Concern and Liquidity

~~Consolidated~~Management’s assessment ~~selling, general and administrative expenses for the years ended December 31, 2024 and 2023 were approximately$12.3 million and $13.1 million, respectively. The decrease~~ of ~~approximately $840,000 is due to several factors. Employee salaries and benefits expenses decreased approximately $654,000 for~~ the ~~year ended December 31, 2024 compared to the same period in 2023. The~~ Company ~~decreased warehousing, marketing, regulatory, royalties~~’s ~~and~~ability ~~travel expenses by approximately $324,000 compared~~ to ~~the~~continue ~~same~~as ~~period~~a ingoing ~~2023. The~~concern ~~Company~~requires ~~increased~~significant ~~professional~~judgment ~~fees,~~ and ~~quality~~is ~~control~~based byon ~~approximately $305,000~~estimates ~~compared~~regarding future ~~to the same period in 2023. The Company recorded and decreased in other selling~~revenues, ~~general~~operating ~~and administrative~~ expenses ~~of approximately $167~~,~~000~~ ~~for~~working ~~the~~capital ~~year~~requirements, ~~ended~~timing ~~December~~of ~~31,~~cash ~~2024~~flows, ~~compared~~and toaccess ~~the same period in 2023 due~~ to ~~the~~additional ~~launch~~sources of ~~E-Commerce~~capital.

~~Research~~The Company has incurred recurring operating losses and ~~Development for~~has ~~years~~an ~~ended~~accumulated ~~December~~deficit. ~~31,~~In ~~2024~~addition, the Company’s available cash and ~~2023~~cash equivalents ~~were~~are asnot ~~follows:~~sufficient to fund operations for at least twelve months from the issuance date of these financial statements without obtaining additional financing.

	2024		2023		Change
Dental	$	835,851	$	614,952	$	220,899
Medical		22,916		86,426		(63,510	)
Corporate		-		-		-
Total research and development	$	858,767	$	701,378	$	157,389

Management has developed plans intended to improve liquidity and operating results, including initiatives to increase revenues, reduce professional and consulting expenses, and defer certain discretionary expenditures, including delaying research and development activities related to the next-generation Single Tooth Anesthesia System instrument. In April 2025, the Company received $800,000 in related party financing (see Note H).

However, 28management’s plans are dependent on the Company’s ability to generate additional revenues and/or obtain additional financing, and there can be no assurance that such plans will be successful or that additional capital will be available on acceptable terms, or at all. Accordingly, management has concluded that substantial doubt exists about the Company’s ability to continue as a going concern within one year after the issuance date of these financial statements.

~~Consolidated research and development expenses for the years ended December 31, 2024 and 2023 were approximately $859,000 and $701,000 respectively.~~ The accompanying ~~increase of~~financial ~~approximately~~statements ~~$157,000 is related~~have tobeen ~~the Company's development~~prepared ofassuming the ~~next generation~~ ~~STA~~Company ~~Single~~will ~~Tooth~~continue ~~Anesthesia~~as ~~System, offset by~~ a ~~decrease~~ ingoing ~~medical~~concern ~~expenses~~and ~~relating~~do tonot ~~the~~include ~~epidural~~any ~~consumables~~adjustments that ~~development.~~might ~~The~~result ~~Company~~from ~~has also decided to delay all research and development on~~ the ~~STA~~outcome ~~Single~~of ~~Tooth~~this ~~Anesthesia System next generation instrument~~uncertainty.

~~Loss from Operations for 2024 and 2023 were as follows:~~ Revenue Recognition

	2024			2023			Change
Dental	$	1,576,043		$	2,128,199		$	(552,156	)
Medical		(2,057,751	)		(3,708,170	)		1,650,419
Corporate		(6,275,249	)		(5,526,503	)		(748,746	)
Total loss from operations	$	(6,756,957	)	$	(7,106,474	)	$	349,517

Revenue recognition is a critical accounting estimate due to the judgment required in determining the timing of revenue recognition, identifying performance obligations, and estimating variable consideration, including returns and discounts.

The Company ~~loss~~recognizes ~~from~~revenue ~~operations~~in ~~was~~accordance ~~approximately~~with ~~$6.8~~ASC ~~million and $7.1 million for the years ended December 31~~606, ~~2024~~Revenue ~~and~~from ~~2023,~~Contracts ~~respectively,~~with ~~a decrease of approximately $350,000~~Customers. AsRevenue ~~stated~~is ~~above,~~recognized ~~the~~when ~~decrease~~control inof the promised ~~loss~~goods ~~from~~transfers ~~operations~~to isthe ~~driven~~customer, ~~by increased margins~~ in ~~E-Commerce~~an ~~dentals~~amount ~~sales, offset~~that byreflects ~~lower~~the ~~international dental~~consideration ~~sales and~~the ~~lower~~Company ~~selling,~~expects ~~general~~to ~~and~~receive ~~administrative~~in ~~expenses~~exchange ~~during~~for those ~~period~~goods.

~~Liquidity~~Revenue is derived primarily from the sale of dental and ~~Capital~~medical ~~Resources~~instruments and related single-use disposable handpieces. Instrument revenue is generally recognized upon shipment or delivery, depending on the contractual terms, while disposable handpiece revenue is recognized upon transfer of control to the customer. Management evaluates whether contracts contain multiple performance obligations and allocates consideration based on relative standalone selling prices when applicable.

~~Cash~~Judgment is ~~Flows~~required in estimating expected returns, distributor incentives, and other variable consideration, which are recorded as reductions of revenue. These estimates are based on historical experience, current market conditions, and anticipated future trends. Changes in assumptions related to these estimates could have a material impact on reported revenue.

~~The following table summarizes our sources and uses of cash for each of the periods presented:~~Inventories

Cash flow:	2024			2023			Change
Net cash used in operating activities	$	(2,919,875	)	$	(5,326,129	)	$	2,406,254
Net cash provided by (used in) investing activities		2,966,449			(2,972,172	)		5,938,621
Net cash provided by financing activities		233,771			2,560,735			(2,326,964	)
	$	280,345		$	(5,737,566	)	$	6,017,911

Inventory valuation is considered a critical accounting estimate due to the judgment required in assessing excess and obsolete inventory, forecasted demand, and the recoverability of inventory carrying values, particularly in light of the Company’s operating losses and liquidity considerations.

~~Operating~~Inventories are ~~Activities~~stated at the lower of cost or net realizable value. Cost is determined using the first-in, first-out (FIFO) method. The Company periodically reviews inventory quantities on hand relative to historical sales, projected future demand, product life cycles, technological changes, regulatory developments, and market conditions.

~~Cash~~Management records ~~flows~~reserves ~~used~~for inexcess, ~~operating~~slow-moving, ~~activities~~or ~~decreased~~obsolete byinventory ~~$2.4 million~~based ~~for~~on ~~the~~its ~~year~~assessment ~~ended~~of ~~December~~expected ~~31,~~future ~~2024~~sales ~~compared~~and tousage. ~~December~~This ~~31,~~evaluation requires ~~2023. The~~significant ~~decrease~~judgment, ~~was~~particularly ~~primarily~~with ~~driven~~respect byto ~~our~~estimating ~~receipt~~future ofdemand ~~approximately~~for ~~$2.0~~instruments ~~million,~~and ~~net~~related ofdisposable ~~expenses~~handpieces, anticipated ~~from~~product ~~the~~transitions, ~~sale~~and ofdistributor ~~New~~purchasing ~~Jersey~~patterns. ~~net~~If ~~operating~~actual ~~losses~~demand ~~‘(NOL”),~~is ~~that~~lower ~~were~~than ~~eligible~~forecasted, ~~for~~or ~~sale~~if ~~under~~products ~~the~~become obsolete ~~State~~due ofto ~~New~~technological ~~Jersey’s~~advancements, ~~Economic~~regulatory ~~Development~~changes, ~~Authority’s New~~or ~~Jersey~~shifts ~~Technology~~in ~~Business~~market ~~Tax~~acceptance, ~~Certificate~~additional ~~Transfer program~~inventory ~~(“NJEDA~~write-downs ~~Program”)~~may be required.

~~Investing~~Inventory write-downs ~~Activities~~are recorded as a component of cost of goods sold and establish a new cost basis for the inventory. Given the Company’s current liquidity position and operating results, adverse changes in demand forecasts or market conditions could have a material impact on inventory reserves and future operating results.

Cash flows provided by investing activities was $3.0 million for the year ended December 31, 2024, compared to $3.0 million of cash flows used in investing activities for the year ended December 31, 2023, an increase of $6.0 million. We sold $3.0 million of marketable securities during the year ending December 31, 2024, compared to $5.0 million sold during the year ended December 31, 2023, which increased cash and equivalents by $2.0 million. We purchased approximately $8.0 million in marketable security during the during the year ending December 31, 2023 compared to no purchases made during the year ended December 31, 2024.29

~~Financing~~Results of ~~Activities~~Operations

~~Cash flows provided by financing activities decreased $2.3 million to $0.2 million for the year ended December 31, 2024 compared to $2.6 million for the year ended December 31, 2023.~~ The following ~~decrease~~table insets ~~cash~~forth ~~used in financing activities was~~ the ~~result~~consolidated ofresults ~~gross proceeds~~ of ~~approximately~~operations ~~$3.0~~for ~~million received from a public offering of common stock, offset by $0.4 million of offering costs associated with~~ the ~~public offering during the~~ year ended December 31, ~~2023~~2025, ~~that~~compared ~~did~~to ~~not recur during~~ the year ended December 31, 2024.

For 29 the year-end December 31, 2025, compared to the year ended December 31, 2024

Contractual Obligations

	2025			2024

Operating results:
Product sales, net	$	8,973,982		$	8,629,928
Cost of products sold		2,566,405			2,195,340
Gross profit		6,407,577			6,434,588

Operating expenses:
Selling, general and administrative expenses		11,576,530			12,295,330
Research and development expenses		449,469			858,767
Depreciation and amortization expense		78,195			37,448
Total operating expenses		12,104,194			13,191,545
Loss from operations		(5,696,617	)		(6,756,957	)
Interest income		(25,599	)		60,265
Gain on sale of net operating losses		-			1,983,095
Net loss		(5,722,216	)		(4,713,597	)
Net loss attributable to noncontrolling interests		-			-
Net loss attributable to Milestone Scientific Inc.		(5,722,216	)		(4,713,597	)

~~The~~Net sales ~~impact~~for of the ~~consolidated~~year ~~contractual~~ended ~~obligations on~~ December 31, ~~2024~~2025, ~~expected~~compared onto the ~~liquidity~~year ~~and~~ended ~~cash~~December ~~flows in future periods~~31, ~~is as follows:~~ 2024

Payments Due by Period
	2025		2024		Change
	Total		Less than 1 Year		1-3 Years		3-5 Years
Dental	$	8,790,732	$	8,525,308	$	265,424
Operating lease obligations	$	379,051		150,011		215,606		13,434
Medical		183,250		104,620		78,630
Purchase obligations	$	2,754,160		1,350,420		1,403,740		-
Total sales, net	$	8,973,982	$	8,629,928	$	344,054
Total	$	3,133,211		1,500,431		1,619,346		13,434

~~Recent~~For ~~Accounting~~the ~~Pronouncements~~year ended December 31, 2025, total net sales were approximately $8.9 million, an increase of approximately $344,000, or 4%, compared to approximately $8.6 million in 2024.

~~See~~Dental ~~“Note~~sales ~~C -~~were ~~Summary~~approximately of$8.8 ~~Significant~~million, compared ~~Accounting~~to ~~Policies”~~$8.5 tomillion in the ~~consolidated~~prior ~~financial~~year. ~~statements~~The ~~for~~increase ~~explanation~~reflects ofhigher ~~recent~~international ~~accounting~~sales, ~~pronouncements~~including ~~impacting~~sales ~~Milestone~~in ~~Scientific~~China during 2025, partially offset by a decline in domestic U.S. dental sales. International dental sales increased 9% year over year, while domestic dental sales decreased 7%.

~~Item~~Medical 7Asales are approximately $183,000, compared to $104,000 in 2024, reflecting higher domestic medical handpiece sales. ~~Quantitative~~Medical ~~and~~sales ~~Qualitative~~continue ~~Disclosures~~to ~~about~~represent ~~Market~~a ~~Risk~~small portion of total revenue.

~~Milestone Scientific is a “smaller reporting company” as defined by Regulation S-K and, as such, is not required to provide the information required by this item.~~30

~~Item~~Gross Profit 8.for ~~Financial~~the ~~Statements~~years ended December 31, 2025, and 2024 was as follows:

The financial statements of Milestone Scientific required by this Item are set forth beginning on page F-1.

	2025		2024		Change
Dental	$	6,227,119	$	6,339,166	$	(112,047	)
Medical		180,458		95,422		85,036
Total gross profit	$	6,407,577	$	6,434,588	$	(27,011	)

~~Item~~Gross 9margin was approximately 71% in 2025 compared to approximately 75% in 2024. ~~Change~~The decline in ~~and~~gross ~~Disagreements~~margin ~~with~~percentage ~~Accountants~~reflects onchanges ~~Accounting~~in product mix and ~~Financial~~cost ~~Disclosure~~structure during the period.

~~None~~Selling, general, and administrative expenses for the years ended December 31, 2025, and 2024 were as follows:

	2025		2024		Change
Dental	$	3,873,178	$	3,929,073	$	(55,895	)
Medical		1,593,538		2,128,456		(534,918	)
Corporate		6,109,814		6,237,801		(127,987	)
Total selling, general and administrative expense	$	11,576,530	$	12,295,330	$	(718,800	)

~~Item~~Total 9Aselling, general and administrative expenses for the year ended December 31, 2025 were approximately $11.6 ~~Controls~~million, compared to $12.3 million in 2024, representing a decrease of approximately $718,000, or 6%. As a percentage of net sales, selling, general and ~~Procedures~~administrative expenses decreased to approximately 129% of net sales in 2025, compared to approximately 142% of net sales in 2024.

~~Evaluation~~Total ofsalaries ~~Disclosure~~decreased ~~Controls~~by approximately $653,000, or 17%, primarily reflecting lower headcount and ~~Procedures~~related personnel costs during the year. Quality and regulatory expenses decreased by approximately $146,400, or 30%, primarily due to reduced regulatory consulting and compliance-related activities. Marketing expenses decreased by approximately $236,200, or 42%, primarily reflecting reduced promotional and advertising activities. Insurance costs decreased by approximately $57,900, or 10%, and other SG&A expenses decreased by approximately $90,300, or 10%, primarily due to general cost containment efforts.

~~Our~~These ~~management,~~decreases ~~with~~were ~~the~~partially ~~participation~~offset ofby ~~our~~an ~~Interim~~increase ~~Chief~~in ~~Executive~~stock-based ~~Officer~~compensation ~~and~~included ~~Acting~~in ~~Principal~~salaries of ~~Accounting~~approximately ~~Officer~~$234,400, ~~which~~or ~~positions~~17%, ~~are~~primarily ~~currently~~related ~~carried~~to ~~out~~equity bycompensation ~~the~~granted ~~same~~during ~~person, evaluated~~ the ~~effectiveness~~year. ofProfessional ~~our~~fees ~~disclosure controls~~ and ~~procedures~~consultants increased asby ofapproximately ~~December 31~~$223,600, ~~2023.~~or ~~The~~7%, ~~term~~primarily ~~“disclosure~~due ~~controls~~to ~~and~~higher ~~procedures~~legal,” asaccounting, ~~defined in Rules 13a-15(e)~~ and ~~15d-15(e)~~consulting ~~under~~expenses. ~~the~~Warehouse ~~Securities~~expenses ~~Exchange~~increased by ~~Act~~approximately ~~of 1934~~$18, ~~as amended~~400, or ~~Exchange Act~~4%, ~~means~~reflecting ~~controls~~higher distribution and ~~other~~logistics ~~procedures~~costs. ofRent aincreased ~~company~~modestly ~~that are designed to ensure that information required to be disclosed~~ by aapproximately ~~company in the reports that it files~~ $4,500, or ~~submits~~3%, ~~under~~while ~~the~~royalties ~~Exchange~~increased ~~Act~~slightly isby ~~recorded,~~approximately ~~processed~~$3, ~~summarized~~000, ~~and~~or ~~reported within the time periods specified in the SEC’s rules and forms~~1%.

~~Disclosure controls~~ Research and ~~procedures~~Development ~~include,~~for ~~without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in~~ the ~~reports~~years ~~that~~ended it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate, to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, as ours are designed to do, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on such evaluation, our Interim Chief Executive Officer and Acting Principal Accounting Officer concluded that, As of December 31, ~~2024~~2025, ~~our disclosure controls~~ and ~~procedures~~2024 were ~~effective~~as ~~at a reasonable assurance level.~~follows:

Management’s Annual Report on Internal Control over Financial Reporting

	2025		2024		Change
Dental	$	430,676	$	835,851	$	(405,175	)
Medical		18,793		22,916		(4,123	)
Corporate		-		-		-
Total research and development	$	449,469	$	858,767	$	(409,298	)

Management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Rule 13a-15(f) under the Exchange Act. Our management assessed the effectiveness of our internal control over financial reporting based on the criteria set forth in “Internal Control-Integrated Framework (2013)” issued by the Committee of Sponsoring Organization of the Treadway Commission. Based on this assessment, management concluded that, As of December 31~~, 2024, our internal control over financial reporting was effective.~~

~~Changes~~Research inand ~~Internal~~development ~~Control~~expenses ~~over~~for ~~Financial~~the ~~Reporting~~year ended December 31, 2025 were approximately $449,000 compared to $859,000 for the year ended December 31, 2024, representing a decrease of approximately $409,000, or 48%.

WeThe decrease ~~routinely~~in ~~review~~research ~~our internal control over financial reporting~~ and ~~from~~development ~~time~~expenses towas ~~time~~primarily ~~make~~attributable ~~changes intended~~ to ~~enhance~~a ~~the~~reduction ~~effectiveness~~in ofdental-related ~~our~~research ~~internal~~and ~~control~~development ~~over financial reporting. For the year ended December 31~~activities, which ~~2024 we~~decreased ~~made~~to no$0.4 ~~changes~~million toin ~~our~~2025 ~~internal~~from ~~control~~$0.8 ~~over~~million ~~financial~~in ~~reporting~~2024, asrepresenting ~~such~~a ~~term~~decrease isof ~~defined~~$0.4 inmillion. ~~Rules~~This ~~13a-15(f)~~reduction ~~and~~reflects ~~15d-15(f) under~~ the Company’s ~~Exchange~~decision ~~Act,~~to ~~that~~delay weresearch ~~believe~~and ~~materially~~development ~~affected,~~efforts orrelated ~~are reasonably likely~~ to ~~materially~~the ~~affect,~~next-generation ~~our~~Single ~~internal~~Tooth ~~control~~Anesthesia ~~over~~System ~~financial~~instrument during ~~reporting~~2025.

~~Item~~Medical research 9Band development expenses decreased modestly to $0.02 ~~Other~~million ~~Information~~in 2025 from $0.02 million in 2024, reflecting limited ongoing development activity related to the Company’s medical product platform.

~~None~~Overall, the decrease in research and development expenses reflects management’s focus on cost containment and prioritization of resources toward commercialization and operational activities during 2025.

~~Item~~Loss ~~9C.~~from ~~Disclosure~~Operations ~~regarding~~for ~~Foreign~~2025- ~~Jurisdiction~~and ~~that~~2024 ~~Prevent~~were ~~Inspections.~~as follows:

Note applicable

	2025			2024			Change
Dental	$	1,923,265		$	1,574,242		$	349,023
Medical		(1,431,873	)		(2,055,950	)		624,077
Corporate		(6,188,009	)		(6,275,249	)		87,240
Total loss from operations	$	(5,696,617	)	$	(6,756,957	)	$	1,060,340

Loss from operations for the year ended December 31, 2025, was approximately $(5,700,000) compared to $(6,800,000) for the year ended December 31, 2024, representing an improvement of approximately $1.06 million, or 16%. As a percentage of net sales, operating loss improved to approximately 63% of net sales in 2025 compared to approximately 78% of net sales in 2024.

~~PART~~The year-over-year ~~III Item~~improvement ~~10. Directors,~~in ~~Executive~~operating ~~Officers~~results primarily reflects lower operating expenses, ~~Promoters~~including reductions in selling, general and ~~Control~~administrative ~~Persons~~expenses and ~~Corporate~~research ~~Governance;~~and ~~Compliance~~development ~~with~~expenditures, ~~Section~~partially 16offset (by a) ofmodest ~~the~~decline ~~Exchange~~in ~~Act~~gross margin percentage.

NAME	AGE	POSITION	DIRECTOR SINCE
Neal Goldman	81	Interim Chief Executive Officer, Chairman of the Board	2019
Leonard Osser	77	Vice Chairman of the Board	1991
Jan Adriaan (Arjan) Haverhals	62	Director	2023
Benedetta Casamento (1) (2) (3)	55	Director	2022
Michael McGeehan (1) (2) (3)	58	Director	2017
Dr. Didier Demesmin (1) (2) (3)	56	Director	2023

Liquidity and Capital Resources

1. Member of the Audit Committee. Mr. Goldman ceased to be on the Audit Committee effective January 1, 2025 when he became Interim CEO upon the retirement of Arjan Haverhals effective December 31, 2024. Dr. Demesmin replaced Mr. Goldman.Cash Flows

2.The following ~~Member~~table ofsummarizes ~~the~~our ~~Compensation~~sources ~~Committee. Mr.~~and ~~Goldman~~uses ~~ceased~~of tocash befor oneach ~~the~~of ~~Compensation Committee effective January 1, 2025 when he became Interim CEO upon~~ the ~~retirement~~periods ~~of Arjan Haverhals. Dr. Demesmin replaced Mr. Goldman.~~presented:

3. Member of the Nominating and Corporate Governance Committee. Mr. Goldman ceased to be on the Nominating and Corporate Governance Committee effective January 1, 2025 when he became Interim CEO upon the retirement of Arjan Haverhals. Dr. Demesmin replaced Mr. Goldman.

Cash flow:	2025			2024			Change
Net cash used in operating activities	$	(2,916,627	)	$	(2,919,875	)	$	3,248
Net cash provided by (used in) investing activities		(15,124	)		2,966,449			(2,981,573	)
Net cash provided by financing activities		786,335			233,771			552,564
	$	(2,145,416	)	$	280,345		$	(2,425,761	)

~~Neal Goldman, Interim Chief Executive Officer and Chairman of the Board~~Operating Activities

~~Neal~~Net cash ~~Goldman~~used ~~has~~in ~~been~~operating aactivities ~~director~~for ~~of Milestone Scientific since 2019 and has served as Chairman of~~ the ~~Board~~year ~~since~~ended ~~January~~December ~~2023. Effective January 1~~31, 2025, heand ~~became Interim CEO upon the retirement of Arjan Haverhals effective December 31,~~ 2024~~. Mr.~~ ~~Goldman~~was ~~is the President and Founder of Goldman Capital Management, Inc~~$2.,9 ~~a family office since 2018~~million, which was ~~previously~~substantially consistent anyear ~~investment~~over ~~advisory firm founded in 1985~~year. He was First Vice President of Research at Shearson Lehman Hutton. He has also held senior positions as a money manager and research analyst with a variety of firms including Neuberger Berman, Moseley Hallgarten Estabrook and Weeden, Bruns Nordeman, and Russ and Company. Mr. Goldman serves as Chairman of Charles & Colvard, Ltd. since 2016 and served on the board of Imageware Systems, Inc. until November 2020. He also serves on the board of Deep-Down Inc. Prior to their respective acquisitions, he served on the boards of Blyth Industries and IPASS Corporation. Mr. Goldman received his B.A. degree in Economics from The City University of New York (City College). Mr. Goldman’s professional experience and financial background have given him the expertise needed to serve as one of our directors.

~~Leonard~~Cash used ~~Osser~~in operating activities during both periods primarily reflects net losses, ~~Vice~~partially ~~Chairman~~offset ofby non-cash charges and changes in working capital. Although loss from operations improved in 2025, operating cash usage remained comparable to the ~~Board~~prior year due to changes in working capital accounts, including the timing of customer collections and vendor payments.

~~Leonard Osser has been a director of Milestone Scientific since 1991 and has served as Milestone Scientific’s Vice Chairman of~~ For the ~~Board~~year ~~since~~ended ~~May 2021. Mr. Osser had been Interim Chief Executive Officer from~~ December ~~2017 until May 2021. From July 2017 to December 2017~~31, ~~he had been Managing Director –China Operations. Prior to that~~2024, hethe ~~served~~Company asreceived ~~Milestone~~approximately ~~Scientific’s Chairman from 1991 until September 2009, and during that time, from 1991 until 2007, was also Chief Executive Officer of Milestone Scientific~~$2.0 ~~In September 2009~~million, henet ~~resigned as Chairman~~ of ~~Milestone~~related ~~Scientific~~expenses, ~~but~~from ~~remained director, and assumed~~ the ~~position~~sale of ~~Chief~~New ~~Executive~~Jersey net ~~Officer.~~operating ~~From~~losses ~~1980~~under ~~until~~ the ~~consummation of Milestone Scientific’s public offering in November 1995, Mr. Osser is the Managing Member of U.S. Asian Consulting Group, LLC, a~~ New Jersey~~-based~~ ~~provider~~Economic ofDevelopment consulting services specializing in distressed or turnaround situations in both the public and private markets. Mr. Osser also serves as a special consultant to the board of directors of Nexalin Technology, Inc. where he is also Managing Director of China Operations. Mr. OsserAuthority’s ~~knowledge~~Technology ofBusiness ~~our~~Tax ~~business~~Certificate ~~and~~Transfer ~~background with us since 1980 provides the Board with valuable leadership skills and insight into our business and accordingly, the expertise needed to serve as one of our directors~~Program.

~~Jan Adriaan (Arjan) Haverhals, Director~~32

Arjan Haverhals was Milestone Scientific's President from September 2020 to the end December 2024 and Chief Executive Officer from May 2021 to the end of December 2024 and served as the President and Chief Executive Officer of Milestone Scientific’s Dental Division (Wand Dental Inc.) from June 2020 to the end of December 2024. Mr. Haverhals is currently a consultant to Milestone Scientific. In January 2023, Mr. Haverhals was appointed to the Board and continues as a director. He brings more than 30 years of sales, marketing, product development, and international expansion experience within the medical device, pharmaceutical, and other industries. Prior to joining Wand Dental and Milestone Scientific, Mr. Haverhals was senior vice president of sales at Xcentric Mold & Engineering from 2019 until 2020 where he was instrumental in increasing sales productivity and efficiency for the company's prototype injection molding services, which included leading healthcare company clients.Investing Activities

Net 32cash used in investing activities for the year ended December 31, 2025, was approximately $0.02 million, compared to net cash provided by investing activities of approximately $3.0 million in 2024. However, the cash provided by investing activities in 2024 was primarily attributable to proceeds from the sale of net operating losses. Investing activity in 2025 was minimal and consisted primarily of routine capital expenditures.

From 2012 until 2018, Mr. Haverhals worked at Straumann, LLC, a global leader in manufacturing medical and dental devices, where he held a series of senior sales and marketing roles including vice president of customer marketing & education, where he oversaw all product franchises and led the launch of more than 30 products in the North American market. He also served as senior vice president for the Nordic Region at Straumann AB, senior vice president of global sales digital solutions, which included oversight of the strategic acquisition of Etkon; and served as vice president of the Prosthetics Business Unit, where he introduced a new implant and prosthetics product line within a new market segment. Financing Activities

HeNet cash ~~also~~provided ~~served~~by asfinancing ~~senior~~activities ~~vice president~~ for the ~~Nordic~~year ~~Region~~ended atDecember ~~Straumann AB~~31, ~~senior vice president of global sales digital solutions~~2025, ~~which~~was ~~included~~approximately oversight of the strategic acquisition of Etkon; and served as vice president of the Prosthetics Business Unit, where he introduced a new implant and prosthetics product line within a new market segment$0.8 ~~He also served as vice president of global marketing & sales at Elkem AS~~million, ~~one~~compared ofto ~~Norway's largest industrial companies~~$0.2 ~~Previously,~~million in Mr2024. ~~Haverhals~~The ~~served~~increase asin ~~executive~~cash ~~vice~~provided ~~president~~by offinancing ~~marketing~~activities &during ~~sales~~2025 atprimarily ~~Cresco~~reflects Tifinancing ~~Systems Sàrl~~proceeds, aincluding ~~global dental implant company~~related-party financing, ~~where~~partially heoffset ~~was~~by ~~responsible~~repayments ~~for turning around~~ and ~~managing~~other ~~global sales, marketing, international business. Mr. Haverhals holds an MS in Pharmacy from the University of Leyden in the Netherlands. Mr. Haverhals’ knowledge of Milestone Scientific’s day~~financing-~~to-day~~related ~~operations gives him the expertise needed to serve as one of our directors~~outflows.

~~Benedetta~~Management continues Ito monitor liquidity and implement cost-containment initiatives. ~~Casamento~~The Company’s ability to meet its future operating requirements will depend on its operating performance and its ability to obtain additional financing, ~~Director~~as discussed in the going concern disclosure.

Benedetta Casamento has served as a director of the Company since April 2022. Since August 2017, Ms. Casamento has served as a Retail Consultant specializing in finance, business operations, and financial planning and analysis. Ms. Casamento previously served as Chairman and President of Allyke, Inc., an artificial intelligence company creating digital imagery insights for retail and other industries, from June 2016 to August 2017. From December 2014 to April 2016, she served as Chief Executive Officer of Calypso St. Barth, a luxury boutique retailer of women’s apparel and accessories. Prior to her role as CEO at Calypso St. Barth, Ms. Casamento served as a consultant to private equity firms with portfolio interests in retail and fashion from July 2012 to December 2014. Ms. Casamento previously served as Executive Vice President, Finance & Operations of The Talbots, Inc. (“Talbots”), a specialty retailer and direct marketer of women’s apparel, accessories, and shoes, from March 2009 to July 2012. Prior to joining Talbots, Ms. Casamento served in various leadership roles within Liz Claiborne Inc. from February 1999 to November 2008, culminating in her position as President of Liz Claiborne Brands. Ms. Casamento started her career at Saks Fifth Avenue. Our Board has determined that Ms. Casamento’s extensive business experience, as well as her background in accounting and finance, qualifies her to serve on the Board. Contractual Obligations

~~Michael~~The impact ~~McGeehan~~of the consolidated contractual obligations on December 31, ~~Director~~ 2025, on the liquidity and cash flows in future periods, is as follows:

Michael McGeehan has been a director of Milestone Scientific since October 2017. Mr. McGeehan is a business consultant with 30 years of experience in a variety of business domains, including financial services, medical and healthcare products, consumer package goods and the software technology industry. Mr. McGeehan started his career at Metaphor Computer Systems in 1988 and then went to work at Microsoft Corporation in 1991. In 1995, Mr. McGeehan left Microsoft and founded Forefront Information Strategies, an information technology consulting firm. In 2002, Mr. McGeehan returned to Microsoft where he worked until 2017, when he returned to and re-started Forefront. Mr. McGeehan was on the Board of Directors of Wand Dental. Mr. McGeehan has a master’s in business administration from Pace University and a Bachelor of Science in Electrical Engineering and Computer Science from Marquette University. Mr. McGeehan’s professional experience and background have given him the expertise needed to serve as one of our directors.

Payments Due by Period
	Total		Less than 1 Year		1-3 Years
Operating lease obligations	$	229,274		152,793		76,481

Purchase obligations	$	2,313,252		1,506,101		807,151

Total	$	2,542,526		1,658,894		883,632

~~Dr. Didier Demesmin,~~Recent Accounting ~~Director~~Pronouncements

~~Dr.~~See “Note ~~Demesmin~~C is- ~~currently~~Summary ~~the Chief Executive Officer and Medical Director~~ of ~~University~~Significant ~~Pain~~Accounting ~~Medicine~~Policies” Center, a position he has held since 2007. Since March 2006, Dr. Demesmin has held the position of Director of the Pain Management Department at St. Peter’s University Hospital. He is also a physician in the Departments of Pain Medicine at JFK Medical Center (since March 2007), Robert Wood Johnson University Hospital (since January 2008), Somerset Medical Center (since February 2009), Hudson Regional Hospital (since December 2010), and Saint Barnabas Hospital (since November 2013). Dr. Demesmin is also a Clinical Instructor in the Department of Medicine at Rutgers Robert Wood Johnson Medical School (since August 2006), a Clinical Assistant Professor in the Department of Physical Medicine and Rehabilitation at Rutgers Robert Wood Johnson Medical School (since July 2013), the Medical Director in the Physical Medicine and Rehabilitation and Sports Medicine Institute at St. Peter’s University Hospital (since (December 2013), and an Assistant Fellowship Program Director in the Multidisciplinary Interventional Pain Medicine Fellowship at JFK Johnson Rehabilitation Institute (since November 2013). Dr. Demesmin has been a member of the Board of Trustees of the New Jersey Society of Interventional Pain Physicians, since September 2010, and the Middlesex County Medical Society of New Jersey, since January 2010, where he held the positions of President Elect, from June 2011 to ~~June 2012, and President, from June 2012 to June 2014. Dr. Demesmin received a BA in Psychology from Rutgers University in 1994, a Medical Degree from~~ the ~~University~~consolidated offinancial ~~Medicine~~statements ~~and~~for ~~Dentistry of New Jersey in 2000, and~~ an ~~MBA~~explanation ~~from the Kellogg School~~ of ~~Management~~recent accounting ofpronouncements ~~Northwestern~~impacting ~~University~~Milestone ~~in 2018~~Scientific. ~~Mr. Demesmin’ s medical healthcare background in the field of interventional pain management and business background has given him the expertise needed to serve as one of our directors.~~

Item 33 7A. Quantitative and Qualitative Disclosures about Market Risk

~~Board~~Milestone Scientific ~~Leadership~~is ~~Structure~~a “smaller reporting company” as defined by Regulation S-K and, as such, is not required to provide the information required by this item.

The Board believes that the segregation of the roles of Board Chairman and the Chief Executive Officer ensures better overall governance of the Company and provides meaningful checks and balances regarding its overall performanceItem 8. ~~This~~Financial structure allows our Chief Executive Officer to focus on developing and implementing the Company’s business plans and supervising the Company’s day-to-day business operations and allows our chairman to lead the Board in its oversight and advisory roles. Because of the many responsibilities of the Board and the significant time and effort required by each of the Chairman and the Chief Executive Officer to perform their respective duties, the Company believes that having separate persons in these roles enhances the ability of each to discharge those duties effectively and enhances the Company’s prospects for success. The Company also believes that having separate positions provides a clear delineation of responsibilities for each position and fosters greater accountability of management. For the foregoing reasons, the Board has determined that its leadership structure is appropriate and in the best interest of stockholders. Statements

The financial ~~Board’s~~statements ~~Oversight~~ of ~~Risk~~Milestone ~~Management~~Scientific required by this Item are set forth beginning on page F-1.

~~The Board recognizes that companies face a variety of risks, including China operation risk, liquidity/capital accessibility risk, medical product acceptance risk, and operational risk~~Item 9. ~~The~~Change ~~Board~~in ~~believes an effective risk management system will (1) timely identify the material risks that we face; (2) communicate necessary information with respect to material risks to senior executives~~ and, asDisagreements ~~appropriate, to the Board or relevant Board committee; (3) implement appropriate and responsive risk management strategies consistent~~ with ~~the~~Accountants ~~Company’s~~on ~~risk~~Accounting ~~profile;~~ and ~~(4)~~Financial integrate risk management into the Company’s decision-making. The Board encourages, and management promotes, a corporate culture that incorporates risk management into the Company’s corporate strategy and day-to-day business operations. The Board also continually works, with the input of management and executive officers, to assess and analyze the most likely areas of future risk for the Company.Disclosure

Notwithstanding the foregoing, until the Board has located and approved a new Chief Executive Officer, the positions of Board Chairman and Interim Chief Executive Officer are being held by the same person. This person, Mr. Goldman, is also the acting principal accounting officer of the Company. None

~~Committees of the Board~~ 33

~~The~~Item 9A. ~~Board~~Controls ~~has standing audit, compensation,~~ and ~~nominating and corporate governance committees (respectively, the “Audit Committee,” the “Compensation Committee,” and the “Nominating Committee.”)~~Procedures

~~Compensation~~Evaluation of ~~Committee~~ Disclosure Controls and Procedures

The ~~Compensation Committee reviews and recommends to the Board the compensation and benefits of all officers of the~~ Company,’s ~~reviews~~Chief ~~general~~Executive ~~policy~~Officer ~~matters relating to compensation~~ and ~~benefits~~Vice ofPresident ~~employees~~ of ~~the~~Finance ~~Company~~evaluated ~~and administers~~ the ~~issuance~~effectiveness of ~~stock options to~~ the Company’s ~~officers,~~disclosure ~~employees, directors,~~ controls and ~~consultants.~~procedures Itas also provides recommendations to the Board with respect to non-employee director compensation. The Compensation Committee may not delegate its authority to any other person, other than to a subcommittee. The Compensation Committee is comprised of ~~three~~December ~~members~~31, ~~Benedetta Casamento (Chairman), Dr~~2025. Didier Demesmin and Michael McGeehan. A copy of the Compensation Committee Charter has been posted on our website at www.milestonescientific.com. For additional discussion of the Compensation Committee executive compensation objectives, see Item 11, “Objective of Executive Compensation Program.”

~~Audit~~The term ~~Committee~~“disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), refers to controls and other procedures designed to ensure that information required to be disclosed by the Company in reports filed or submitted under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by the Company is accumulated and communicated to management, including the Chief Executive Officer and Vice President of Finance, as appropriate, to allow timely decisions regarding required disclosure.

~~The~~Management recognizes ~~Audit~~that ~~Committee~~any ~~meets with management and the Company’s independent accountants to determine the adequacy of internal~~ controls and other financial reporting matters. The Audit Committee’s purpose is to: (A) assist the Board in its oversight of: (i) the integrity of our financial statements; (ii) our compliance with legal and regulatory requirements; (iii) our independent auditors’ qualifications and independence; (iv) the performance of our internal audit function and independent auditors to decide whether to appointprocedures, ~~retain~~no ormatter ~~terminate~~how ~~our~~well ~~independent~~designed ~~auditors;~~ and ~~(v) the preparation of our Annual Report on Form 10-K For the fiscal year ended December 31~~operated, ~~2024~~can ~~(the~~provide ~~“Annual~~only ~~Report”);~~reasonable ~~and~~assurance ~~(B) to pre-approve all audit, audit-related and other services, if any, to be provided by the independent auditors. The members~~ of ~~the~~achieving their ~~Audit Committee are comprised of Benedetta Casamento (Chairman), Dr~~objectives. Didier Demesmin and Michael McGeehan, all of whom are independent as defined in the listing standards of the NYSE American and Section 10A(m)(3) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). A copy of the Audit Committee Charter has been posted on our website at www.milestonescientific.com.

Based 34on this evaluation, the Chief Executive Officer and Vice President of Finance concluded that, as of December 31, 2025, the Company’s disclosure controls and procedures were effective at the reasonable assurance level.

~~Audit~~Management’s Annual ~~Committee~~Report on Internal Control over Financial ~~Expert~~Reporting

~~The~~Management is ~~Board~~responsible ~~has~~for ~~determined~~establishing ~~that~~and ~~Benedetta~~maintaining ~~Casamento~~adequate isinternal ancontrol ~~“audit~~over ~~committee~~ financial ~~expert~~reporting,” as ~~that term is~~ defined in ~~Item~~Rule ~~407~~13a-15(df)~~(5)~~ ofunder the ~~Regulation~~Exchange ~~S-K,~~Act. ~~and~~Management ~~“independent”~~assessed ~~for~~the ~~purposes~~effectiveness of the ~~listing~~Company’s ~~standards~~internal control over financial reporting as of December 31, 2025, based on the ~~NYSE~~criteria ~~American~~outlined ~~and~~in ~~Section~~Internal ~~10A~~Control—Integrated Framework (m2013)~~(3)~~ issued by the Committee of Sponsoring Organizations of the ~~Exchange~~Treadway ~~Act~~Commission (“COSO”).

~~Nominating~~Based on ~~Committee~~this assessment, management concluded that, as of December 31, 2025, the Company’s internal control over financial reporting was effective.

~~The~~Changes in ~~Nominating~~Internal ~~Committee~~Control ~~identifies~~over ~~potential~~Financial director nominees and evaluates their suitability to serve on the Board. Based on its evaluation, it recommends to the Board the director nominees for Board membership. In addition, the Nominating Committee also evaluates each existing Board member’s suitability for continued service as a director. The members of the Nominating Committee are Michael McGeehan (Chairman), Benedetta Casamento, and Dr. Didier Demesmin. A copy of the Nominating Committee Charter has been posted on our website at www.milestonescientific.com.Reporting

The ~~Nominating Committee believes that the minimum qualifications for service as a director of the~~ Company ~~are~~routinely ~~that~~reviews aits ~~nominee~~internal ~~possess~~control anover ~~ability,~~financial asreporting ~~demonstrated~~and bymay ~~recognized~~make ~~success~~changes infrom ~~his~~time ~~or her field,~~ to ~~make~~time ~~meaningful~~intended ~~contributions~~ to ~~the~~enhance ~~Board’s~~its effectiveness. ~~oversight~~During of the ~~business~~year ~~and~~ended ~~affairs~~December of31, ~~the~~2025, ~~Company~~there ~~and~~were anno ~~impeccable~~changes ~~reputation of integrity and competence~~ in ~~his or her personal or professional activities. The Nominating Committee’s criteria for evaluating potential candidates include~~ the ~~following: an understanding of the~~ Company’s ~~business~~internal ~~environment;~~control ~~and~~over ~~the possession of such knowledge~~financial reporting, ~~skills, expertise and diversity of experience so~~ as todefined ~~enhance~~in ~~the~~Rules ~~Board’s~~13a-15(f) ~~ability to manage~~ and ~~direct~~15d-15(f) ~~the~~under ~~affairs and business of~~ the ~~Company~~Exchange ~~including~~Act, ~~when~~that ~~applicable~~materially affected, toor ~~enhance~~are ~~the~~reasonably ~~ability~~likely ofto affect ~~committees~~materially, of the ~~Board~~Company’s tointernal ~~fulfill~~control ~~their~~over ~~duties~~financial ~~and/or satisfy any independence requirements imposed by law, regulation or listing requirements~~reporting.

~~The Nominating Committee considers director candidates recommended by stockholders~~Item 9B. InOther considering candidates submitted by stockholders, the Committee will take into consideration the needs of the Board and the qualifications of the candidate. The Nominating Committee may also take into consideration the number of shares held by the recommending stockholder and the length of time that such shares have been held. To have a candidate considered by the Nominating Committee, a stockholder must submit the recommendation in writing and must include the following information: the name of the stockholder and evidence of the person’s ownership of Company stock, including the number of shares owned and the length of time of ownership; the name of the candidate, the candidate’s resume or a listing of his or her qualifications to be a director of the Company; and, the person’s consent to be named as a director if selected by the Nominating Committee and nominated by the Board.Information

The Nominating Committee may also receive suggestions from current Board members, the Company’s executive officers or other sources, which may be either unsolicited or in response to requests from the Nominating Committee for such candidatesNone. ~~The Nominating Committee also, from time to time, may engage firms that specialize in identifying director candidates.~~

Once a person has been identified by the Nominating Committee as a potential candidate, it may collect and review publicly available information regarding the person to assess whether the person should be considered furtherItem 9C. IfDisclosure the Nominating Committee determines that the candidate warrants further consideration, the Chairman or another member of the Nominating Committee may contact the person. Generally, if the person expresses a willingness to be considered and to serve on the Board, the Nominating Committee may request information from the candidate, review the person’s accomplishments and qualifications and may conduct one or more interviews with the candidate. The Nominating Committee may consider all such information considering information regarding ~~any~~Foreign ~~other~~Jurisdiction ~~candidates~~ that itPrevents ~~might be evaluating for membership on the Board~~Inspections. In certain instances, Nominating Committee members may contact one or more references provided by the candidate or may contact other members of the business community or other persons that may have greater first-hand knowledge of the candidate’s accomplishments. The Nominating Committee’s evaluation process does not vary based on whether a candidate is recommended by a stockholder, although, as stated above, the Board may take into consideration the number of shares held by the recommending stockholder and the length of time that such shares have been held.

~~Director Independence~~Not applicable

The Board has determined that Michael McGeehan, Benedetta Casamento, and Dr. Didier Demesmin (the “Independent Directors”) are independent, as that term is defined in the listing standards of the NYSE American. In determining director independence, the Board also considered all equity awards, if any, to the Independent Directors for the year ended December 31, 2024, disclosed in “Director Compensation” below, and determined that such awards were compensation for services rendered to the Board and therefore did not impact their ability to continue to serve as Independent Directors. 34

PART 35III

~~Stockholder~~Item 10. ~~Communication~~Directors, ~~with~~Executive ~~the~~Officers, ~~Board~~and Corporate Governance

The Board has established a process to receive communications from stockholders. Stockholders and other interested parties may contact any member (or all members) of the Board, or the non-management directors as a group, any Board committee, or any chair of any such committee by mail or electronically. To communicate with the Board, any individual director or any group or committee of directors, correspondence should be addressed to the Board or any such individual directors or group or committee of directors by either name or title. All such correspondence should be sent “c/o Corporate Secretary” at 425 Eagle Rock Ave., Suite 403, Roseland, New Jersey 07068. All communications received as set forth in the preceding paragraph will be opened by the Corporate Secretary of the Company for the sole purpose of determining whether the contents represent a message to our directors. Any contents that are not in the nature of advertising, promotions of a product or service, patently offensive material or matters deemed inappropriate for the Board will be forwarded promptly to the addressee. In the case of communications to the Board or any group or committee of directors, the Company’s Corporate Secretary will make sufficient copies of the contents to send to each director who is a member of the group or committee to which the envelope is addressed.

NAME	AGE	POSITION	DIRECTOR SINCE
Benedetta Casamento (1) (2) (3)	59	Chairman of the Board	2022
Neal Goldman (1) (2) (3)	82	Vice Chairman of the Board	2019
Eric Hines	58	Chief Executive Officer and Director	2025
Dr. Didier Demesmin	57	Director	2023
Shanth Thiyagalingam (1) (2)	45	Director	2025
Dr. Dawood Sayed	47	Director	2025

~~Section 16(a)~~1. Member ~~Beneficial~~of ~~Ownership~~the ~~Reporting~~Audit ~~Compliance~~Committee

Section 16(a) of the Exchange Act requires our officers and directors, and person who own more than ten percent of a registered class of our equity securities, to file reports of ownership and changes in ownership with the SEC2. Member ~~Officers, directors and greater than ten-percent stockholders are required by SEC regulation to furnish us with copies~~ of ~~all Section 16(a) forms they file. Based solely on review of~~ the ~~copies~~Compensation of such forms furnish to us, or written representations that no Forms 5 were required, we believe that all Section 16(a) filing requirements applicable to our officers and director were complied with during the fiscal year ended December 31, 2024.Committee

~~Insider~~3. Member ~~Trading~~of ~~Arrangements~~the Nominating and ~~Policies~~Corporate Governance Committee

We have adopted an insider trading compliance policy governing the purchase, sale, and/or other dispositions of our securities by our directors, officers, and employees that we believe is reasonably designed to promote compliance with insider trading laws, rules and regulations, and the exchange listing standards applicable to usBenedetta I. ~~The insider trading policy prohibits the use of material non-public information about the Company when making decisions to purchase~~Casamento, ~~sell,~~Chairman give away or otherwise trade in the Company’s securities or to provide such information to others outside the Company. We have established black-out periods to which covered persons are subject related to the filing of ~~our regular reports with~~ the Securities and Exchange Commission. The Company may impose additional black-out periods from time to time as other types of material non-public information occur when material non-public events or disclosures are pending. Covered persons are permitted to trade in the Company’s securities only when there is no black-out period in effect and such trade has been pre-cleared by the appointed Company officer, or when a qualified 10b5-1 plan has been established in accordance with federal securities laws. No covered person has adopted or terminated a Rule 10b5-1 trading plan during the last fiscal quarter of the fiscal year to which this report relates.Board

~~Code~~Benedetta Casamento has been a director of ~~Ethics~~Milestone Scientific since 2022 and has served as Chairman of the Board since December 2025. Since August 2017, Ms. Casamento has served as a Consultant and a board member specializing in strategy, finance, and operations. Ms. Casamento previously served as Chairman and President of Allyke, Inc., an artificial intelligence company creating digital imagery insights for retail and other industries, from June 2016 to August 2017. From December 2014 to April 2016, she served as Chief Executive Officer of Calypso St. Barth, a luxury boutique retailer of women’s apparel and accessories. Before her role as CEO at Calypso St. Barth, Ms. Casamento served as a consultant to private equity firms with portfolio interests in retail and fashion from July 2012 to December 2014. Ms. Casamento previously served as Executive Vice President, Finance & Operations of The Talbots, Inc. (“Talbots”), a specialty retailer and direct marketer of women’s apparel, accessories, and shoes, from March 2009 to July 2012. Before joining Talbots, Ms. Casamento served in various leadership roles within Liz Claiborne Inc. from February 1999 to November 2008, culminating in her position as President of Liz Claiborne Brands. Ms. Casamento started her career at Saks Fifth Avenue. Our Board has determined that Ms. Casamento’s extensive business experience, as well as her background in accounting and finance, qualify her to serve on the Board.

~~Milestone~~Eric Hines, ~~Scientific has adopted a code of ethics that applies to its directors~~President, ~~principal~~Chief ~~executive~~Executive ~~officer~~Officer, ~~principal financial officer~~ and other people performing similar functions. This code of ethics is posted on Milestone Scientific’s web site at www.milestonescientific.com. Milestone Scientific will also provide a copy of the Code of Ethics to any person without charge, upon written request addressed to the Chairman of the Board, Neal Goldman, at the Company’s principal executive office, located at 425 Eagle Rock Avenue Roseland, NJ 07068.Director

~~Clawback~~Mr. Hines ~~Policy~~has been President, Chief Executive Officer, and a director of Milestone Scientific since July 31, 2025. He most recently served as President of North America at Ex Libris Group (September 2014 - June 2021), a global provider of cloud-based solutions for higher education and libraries. From June 2021 to July 2025, Mr. Hines was involved in providing consulting services for Alethea, a technology start-up company, and also invested in commercial and personal real estate ventures. Before his role at Ex Libris Group, Mr. Hines held various roles at NICE Systems (October 2004-June 2014), a multinational company that designs and manufactures smart home security and automation products. Mr. Hines served as Senior Director of Sales at NICE Systems from October 2004 to November 2005. Subsequently, he served as Vice President of several North American divisions of NICE Systems from November 2005 through June 2014. Prior thereto, Mr. Hines served as Regional Director of Sales at AMDOCS Clarify CRM (October 2003- October 2004), a provider of customer relationship management (CRM) solutions to the communications industry. Mr. Hines received a Bachelor of Science in Chemistry from Wake Forest University in 1989 and an MBA in International Business from Xavier University in 1996.

Our Board has adopted a written policy to recover “excess” compensation that is granted, earned, or vested based wholly or in part upon the attainment of a financial reporting measure. The compensation includes both cash-based and equity-based incentives. The compensation covered includes incentive awards awarded to any individuals (including former employees) who served as an executive officer during the three most recently completed fiscal years preceding the date on which the preparation of an accounting restatement is required, provided that the executive officers were awarded more incentive awards than they would have received if the financial statements had been prepared correctly. The recovery will include an executive incentive award even if the executive was not involved in preparing the financial statements or did not commit misconduct that led to the restatement. Restatements attributable to an inadvertent error also will subject executive officers to the recovery of previously received incentive awards.35

Neal 36 Goldman, Director

~~Item~~Neal 11Goldman has served as a director of Milestone Scientific since 2019 and served as Chairman of the Board from 2023 until December 2025. ~~Executive~~Mr. ~~Compensation~~Goldman has been the President and Founder of Goldman Capital Management, Inc., a family office, since 2018. Goldman Capital Management was previously an investment advisory firm founded in 1985. Earlier in his career, Mr. Goldman served as First Vice President of Research at Shearson Lehman Hutton. He has also held senior positions as a money manager and research analyst with several firms, including Neuberger Berman, Moseley Hallgarten Estabrook & Weeden, Bruns Nordeman, and Russ and Company. Mr. Goldman served as Chairman of Charles & Colvard, Ltd. from 2016 until October 2025. He also previously served on the board of ImageWare Systems, Inc. until November 2020 and currently serves on the board of Koil Energy Solutions, Inc. (formerly Deep Down, Inc.). Prior to their respective acquisitions, he served on the boards of Blyth, Inc. and iPass Corporation. Mr. Goldman received a B.A. in Economics from The City University of New York (City College). We believe Mr. Goldman’s extensive experience in investment management and financial analysis qualifies him to serve on our Board of Directors.

~~SUMMARY~~Dr. ~~COMPENSATION~~Didier Demesmin, ~~TABLE~~Director

~~The~~Dr. ~~following~~Demesmin ~~Summary~~is ~~Compensation~~currently ~~Table~~the ~~sets~~Chief ~~forth~~Executive ~~all~~Officer ~~compensation~~and ~~earned~~Medical Director of University Pain and Spine Center, ina ~~all~~position ~~capacities~~he has held since 2007. Since March 2006, ~~during~~Dr. Demesmin has held the ~~fiscal~~position ~~years~~of ~~ended~~Director ~~December~~of ~~31,~~the ~~2024~~Pain ~~and~~Management ~~2023~~Department byat ~~Milestone~~St. ~~Scientific~~Peter’s University Hospital. He is also a physician in the Departments of Pain Medicine at JFK Medical Center (isince March 2007), ~~chief~~Robert ~~executive~~Wood ~~officer~~Johnson University Hospital (since January 2008), Somerset Medical Center (since February 2009), Hudson Regional Hospital (since December 2010), and Saint Barnabas Hospital (iisince November 2013). ~~two~~Dr. ~~most~~Demesmin ~~highly~~is ~~compensated~~also ~~executive~~a ~~officers~~Clinical Instructor in the Department of Medicine at Rutgers Robert Wood Johnson Medical School (since August 2006), ~~other~~a ~~than~~Clinical Assistant Professor in the ~~chief~~Department ~~executive~~of ~~officer~~Physical Medicine and Rehabilitation at Rutgers Robert Wood Johnson Medical School (since July 2013), ~~who~~the ~~were~~Medical ~~serving~~Director asin ~~executive~~the ~~officers~~Physical Medicine and Rehabilitation and Sports Medicine Institute at St. Peter’s University Hospital (since (December 2013), and an Assistant Fellowship Program Director in the Multidisciplinary ~~end~~Interventional Pain Medicine Fellowship at JFK Johnson Rehabilitation Institute (since November 2013). Dr. Demesmin has been a member of the ~~2023 fiscal~~Board ~~year~~of Trustees of the New Jersey Society of Interventional Pain Physicians, since September 2010, and ~~whose~~the Middlesex ~~salary~~County asMedical ~~determined~~Society byof ~~Regulation~~New ~~S-K~~Jersey, ~~Item~~since ~~402~~January 2010, ~~exceeded~~where ~~$100~~he held the positions of President Elect,~~000~~ (from June 2011 to June 2012, and President, from June 2012 to June 2014. He also currently serves on the ~~individuals~~Board ~~falling~~of ~~within~~Directors ~~categories~~for the Latin American Pain Society (iLAPS) and the World Institute of Regenerative Medicine (iiWIRM). ~~are~~Dr. ~~collectively~~Demesmin ~~referred~~received a BA in Psychology from Rutgers University in 1994, a Medical Degree from the University of Medicine and Dentistry of New Jersey in 2000, and an MBA from the Kellogg School of Management of Northwestern University in 2018. Mr. Demesmin’ s medical healthcare background in the field of interventional pain management and business background has given him the expertise needed to serve as ~~the~~one ~~“Named~~of ~~Executive~~our ~~Officers”)~~directors.

Name and Principal Position	Year	Salary		Bonuses		Option Awards		Other Compensation		Total
Jan Adriaan (Arjan) Haverhals (1) (3)
Chief Executive Officer - Wand Dental Inc	2024	$	350,000	$	478,000	$	-	$	53,422	$	881,422
President of Milestone Scientific Inc.	2023	$	350,000	$	281,853	$	-	$	48,412	$	680,265
Peter Milligan (2)
Chief Financial Officer	2023	$	70,000	$	100,000	$	-	$	-	$	170,000

Shanth Thiyagalingam Director

1Mr. Thiyagalingam ~~During~~currently ~~2024~~serves heas ~~was~~Chief ~~awarded~~Executive ~~$478,000~~Officer inof PainTEQ, a ~~discretionary~~disruptive ~~performance~~technology ~~bonus~~serving ~~for~~patients suffering from sacroiliac joint dysfunction and supporting the ~~year~~interventional ~~ended~~pain ~~December~~market. 31From 2020 through 2025, ~~2024.~~he ~~Other~~held ~~compensation~~successive ~~represents~~leadership ~~payments~~roles ~~made~~at ~~for~~the ~~health~~company—from Chief ~~insurance~~Commercial ~~coverage~~Officer ofto ~~approximately~~Chief ~~$39~~Operating Officer,~~000~~ and ~~car~~ultimately ~~allowance~~as ofCEO. ~~approximately~~During ~~$14~~his tenure,~~000~~ he led the company’s transformation from early-stage startup to hyper-growth innovator in the interventional pain space. ~~Arjan~~He ~~Haverhals~~also led M&A initiatives and was ~~awarded~~instrumental in ~~$281~~securing a Category 1 CPT code for the LinQ procedure—a new therapy in the interventional pain market. Under his leadership,~~000~~ PainTEQ was recognized three years in a ~~discretionary~~row ~~performance~~by ~~bonus~~the ~~for~~INC 5000 and named a “Best Place to Work” by the ~~year~~Tampa ~~ended~~Bay ~~December~~Business 31Journal. Prior to this he worked in senior leadership roles across reputable companies such as Abbott, ~~2023~~Nevro and Stryker. ~~Other~~He ~~compensation~~holds ~~represents~~a ~~payments~~Bachelor of ~~made~~Medical ~~for~~Science ~~health~~from ~~insurance~~the ~~coverage~~University of ~~approximately~~Sydney, ~~$34~~a master’s in marketing management,~~000~~ and ~~car~~an ~~allowance~~MBA from Macquarie Graduate School of ~~approximately~~Management ~~$14,000~~(MGSM). He is also a certified Gallup Strengths Coach and is passionate about fostering high-performance cultures and mentoring emerging leaders in the medtech industry.

	2.	Peter Milligan was appointed as the Chief Financial Officer of the Company February 1, 2023. He was awarded a $100,000 bonus for joining the company to be paid in shares of stock. On August 24, 2023 the Company announced that Peter Milligan resigned from the Company effective September 1, 2023.
	3.	Mr. Haverhals resigned as the Chief Executive Officer of the Company as of December 31, 2024.

Dawood Sayed, M.D., Director

~~Pay~~Dr. Sayed ~~versus~~is ~~Performance~~a ~~Table~~Professor of Anesthesiology and Pain Medicine at the University of Kansas Medical Center and currently serves as Division Chief of Pain Medicine, Director of Interventional Spine Services, and Director of the Center for Neuromodulation. With a robust clinical, academic, and policy background, he brings over a decade of leadership in pioneering minimally invasive pain therapies, neuromodulation, and health system innovation. Dr. Sayed also serves as Vice Chairman and Co-Founder of the American Society of Pain and Neuroscience (ASPN), where he works closely with key stakeholders, including commercial payers, regulators, and medical device manufacturers, to advance access to innovative pain relief technologies. His leadership has earned him multiple honors, including the 2025 Presidential Award from the North American Neuromodulation Society (NANS). Dr. Sayed has authored over 100 peer-reviewed publications, contributed to national guidelines in pain medicine, and currently leads multiple clinical trials evaluating neuromodulation and spinal therapies. He also serves as a medical advisor to several leading medtech innovators and participates on national AMA CPT® and NANS advocacy committees.

As required by Section 953(a) of the Dodd-Frank Wall Street Reform and Consumer Protection Act, and Item 402(v) of Regulation S-K, we are providing the following information about the relationship between executive compensation actually paid (as defined by SEC rules) and certain financial performance metrics of the Company. For further information concerning the Company’s compensation philosophy and how the Company aligns executive compensation with the Company’s performance, refer to “—Compensation Philosophy and Objectives” and “—Compensation Elements”.36

	(a)		(b)		(c)		(d)		(e)
									Value of Initial Fixed $100 Investment Based on:
Year	Summary Compensation Table Total for PEO($)		Compensation Actually Paid to PEO($)		Average Summary Compensation Table Total for Non-PEO NEO's($)		Average Compensation Actually Paid to Non-PEO NEO's($)		Total Shareholder Return ($)		Net Income ($)
2024		881,422		881,422		n/a		n/a		137.14		(4,713,597	)
2023		680,265		680,265		n/a		n/a		150.00		(6,929,104	)

Board Leadership Structure

Calculation of Compensation Actually Paid to PEO (column b)	2024		2023
Total Summary Compensation Paid Table (SCT) - column (a)		881,422		680,265
Less: value reported under stock awards in the SCT		-		-
Add: FV of unvested equity awards at year end 2021		-		-
Add: FV of vested awards as of the vesting date		-		-
Compensation actually paid		881,422		680,265

The Board of Directors believes that the separation of the roles of Chairman of the Board and Chief Executive Officer provides for effective corporate governance and appropriate checks and balances with respect to the Company’s leadership and oversight. Under this structure, the Chief Executive Officer is responsible for developing and implementing the Company’s business strategies and overseeing the Company’s day-to-day operations. At the same time, the Chairman of the Board leads the Board in its oversight, governance, and advisory functions. The Board believes that separating these roles allows each individual to focus on their respective responsibilities and devote the appropriate time and attention required to perform those duties effectively.

The 37Board further believes that this leadership structure promotes clear accountability, enhances management oversight, and supports effective decision-making. For these reasons, the Board has determined that its current leadership structure is appropriate and in the best interests of the Company and its stockholders.

~~(a)~~ The amounts reported in this column are the amounts of total compensation reported for Mr. Haverhals, Chief Executive Officer, for each corresponding year in the "Total" column of the Summary Compensation Table (“SCT Board’)s onOversight ~~page 12~~ of ~~this~~Risk ~~proxy statement.~~Management

~~(b)~~ The Board ~~amounts~~of ~~reported~~Directors inrecognizes ~~this~~that ~~column represent~~ the ~~amount~~Company offaces ~~compensation~~a ~~actually~~variety ~~paid (“CAP”) Mr. Haverhals as computed in accordance with Item 402(v)~~ of ~~Regulation~~risks, ~~S-K~~including, ~~but~~among doothers, ~~not~~risks ~~reflect~~related ~~the actual amount of compensation earned by or paid~~ to ~~Mr.~~operations ~~Haverhals during the applicable year. The determination of CAP begins with the total compensation reported~~ in ~~the SCT~~China, liquidity ~~which is then adjusted by equity-based~~ and ~~other~~access ~~compensation~~to ~~as set forth in the following table. For equity-based awards made during the year~~capital, ~~the~~market ~~recorded~~acceptance grant date value is replaced with the estimated year-end value. For equity-based awards made in prior years that remain unvested at year-end, the estimated change in value from the beginning to the end of ~~the~~medical ~~year is included. For equity-based awards made in prior years~~products, ~~but~~regulatory ~~vested during the year~~matters, ~~the~~and ~~estimated~~general ~~change~~operational ~~in value from the beginning of the year to the date of vesting is included:~~risks.

~~(c)~~ The Board ~~amounts~~believes ~~reported~~that inan ~~this~~effective ~~column~~risk ~~represent~~management ~~the~~framework ~~average~~is ofdesigned the amounts reported for the Company's Non-CEO named executive officer’s (“NEOs”) as a group in the "Total" column of the SCT in each applicable year. There were no NEO’s at the company during 2024 and 2023, respectively.to:

~~(d)~~● ~~The~~Identify ~~amounts~~and ~~reported~~assess material risks in ~~this~~a ~~column~~timely ~~represent~~manner ~~the~~● ~~average~~Communicate ~~amount~~material ofrisk ~~CAP~~information to ~~the~~senior ~~Non-CEO~~management ~~NEOs~~and, as ~~a group~~appropriate, asto ~~computed~~the inBoard ~~accordance~~and ~~with~~its ~~Item~~committees ~~402(v)~~● ofDevelop ~~Regulation~~and ~~S-K.~~implement ~~Since~~appropriate ~~there~~risk ~~were~~mitigation nostrategies ~~adjustments~~● toIntegrate berisk ~~made~~considerations ~~for~~into ~~these~~the ~~NEO~~Company’s, ~~the~~strategic ~~amounts~~planning ~~actually~~and ~~paid~~decision-making ~~are equal to the SCT amounts calculated in the previous column.~~processes

~~(e)~~The Board ~~This~~oversees ~~represents~~the Company’s overall risk management processes, while management is responsible for the ~~year~~day-~~end~~to-day ~~value~~management of risk. anThe ~~initial~~Chief ~~$100~~Executive ~~investment~~Officer, ~~made~~together atwith senior management, identifies, evaluates, and manages the ~~beginning~~Company’s ofrisk exposures and implements risk management strategies approved by the ~~period~~Board.

~~Employment~~The Board receives regular reports from management regarding the Company’s risk profile and ~~Consulting~~engages ~~Contracts~~in periodic discussions concerning significant risk exposures and mitigation efforts. The Board believes this structure promotes a culture of risk awareness and supports the Company’s long-term strategic objectives and the interests of its stockholders.

~~On March 2, 2021, the Company entered into a Royalty Sharing Agreement with Leonard Osser, pursuant to which Mr. Osser sold, transferred and assigned to the Company all~~ Committees of ~~his rights in and to a certain patent application as to which he is a co-inventor with Mark Hochman, a consultant to~~ the Company, and the Company agreed to pay to Mr. Osser, beginning May 9, 2027, half of the royalty (2.5%) on net sales that would otherwise be payable to Mark and Claudia Hochman under their existing Technology Sale Agreement, dated January 1, 2005 and amended from time to time, with the Company. In connection with the Royalty Sharing Agreement, the Hochman's agreed with the Company, pursuant to an addendum to such Technology Sale Agreement dated February 25, 2021, to reduce from 5% to 2.5% the payments due to them under their Technology Sale Agreement beginning on May 9, 2027, and thereafter with respect to dental products embodying the invention.Board

AsThe Board ~~part~~ of ~~the~~Directors ~~Succession~~has ~~Plan~~three ofstanding ~~the~~committees: ~~Company, Mr. Osser agreed, pursuant to an agreement dated April 6, 2021 (~~the ~~“Succession~~Audit ~~Agreement”)~~Committee, ~~to restructure certain of his existing agreements with~~ the ~~Company,~~Compensation ~~which provide for additional and broader executive support~~Committee, and ~~at such time as he elects to step down as Interim Chief Executive Officer of~~ the ~~Company,~~Nominating toand ~~become~~Corporate ~~the Vice Chairman of the Board of the Company~~Governance Committee. ~~With~~Each ~~respect~~committee tooperates ~~Mr. Osser’s July 2017 Employment Agreement and July 2017 Consulting Agreement (each as previously disclosed), the compensation~~ under ~~the Employment Agreement was modified to reduce the overall compensation by $100,000 to $200,000, split equally between~~ a ~~cash~~written ~~amount~~charter ~~and~~approved ~~an amount in shares, and the compensation under the Consulting Agreement was increased~~ by ~~$100,000 to $200,000, equally split between a cash amount and an amount in shares, which shares were formerly payable under~~ the Employment Agreement. If the Company terminates Mr. Osser’s employment “Without Cause,” other than due to his death or disability, or if Mr. Osser terminates his employment for “Good Reason” (both as defined in the agreement), Mr. Osser is entitled to be paid in one lump sum payment as soon as practicable following such termination: an amount equal to the aggregate present value (as determined in accordance with Section 280G(d)(4) of the Code) of all compensation pursuant to this agreement from the effective date of termination hereunder through the remainder of the Employment Term. In connection with his acceptance of the Vice Chairman position and in consideration of his services as a member of the Board ~~and agreement to provide certain additional general consulting services, Mr~~. Osser was granted options to purchase 2,000,000 shares of common stock, exercisable at the fair market value of the common stock on the date of grant, vesting over the five-year period after he steps down as Interim Chief Executive Officer of the Company or ten years from the date of grant, whichever shall end first. The Company believes that the effect of such existing agreements and the Succession Agreement, all of which relate to the period after such time Mr. Osser steps down as Interim Chief Executive Officer of the Company, collectively expand Mr. Osser’s consulting to and support of the Company beyond its Chinese operations to also include its medical and other products, while enhancing the retention aspects of the Company’s relationship with Mr. Osser. On May 19, 2021, Mr. Osser resigned as Interim Chief Executive Officer of the Company and assumed the role of Vice Chairman of the Board.

~~Compensation~~● ~~under~~Audit ~~the~~Committee ~~Employment~~– ~~Agreement~~Oversees ~~and~~risks ~~the~~related ~~Consulting~~to ~~Agreement~~financial isreporting, ~~payable~~internal ~~for~~controls, ~~9.5 years from May 19~~compliance, ~~2021. The Company recorded expenses of $200~~liquidity,~~000 related~~ toand ~~the~~cybersecurity. ~~Employment~~● ~~Agreement~~Compensation ~~for~~Committee ~~each~~– ~~of the~~Oversees ~~years~~risks ~~ended~~associated ~~December~~with ~~31,~~compensation ~~2024~~policies and ~~2023~~practices, ~~respectively~~including ~~. The~~whether ~~Company~~such ~~recorded~~programs ~~expenses~~encourage ofexcessive ~~$200,000~~risk-taking. ~~and~~● ~~$200,000 related~~Nominating toand ~~the~~Corporate ~~Consulting~~Governance ~~Agreement~~Committee ~~for~~– ~~each~~Oversees ~~of the~~risks ~~years~~related ~~ended~~to ~~December~~corporate ~~31,~~governance ~~2024 and 2023~~practices, ~~respectively.Mr.~~Board ~~Osser also owns 2~~composition,~~717,765 of~~ ~~the Company's stock,~~ and ~~2,481,048~~director ~~shares to be issued at the termination of his employment agreement~~independence.

The 38Board believes that its committee structure enhances its ability to effectively oversee the Company’s risk management processes in accordance with NYSE American corporate governance standards.

Mr. Arjan Haverhals retired as the Chief Executive Officer and other officer positions with the Company on December 31, 2024. The Company entered into a consulting agreement with Mr. Arjan Haverhals that commenced on January 1, 2025, and continues for an indefinite period, subject to the Company having the right to terminate the Consulting Agreement on 30 days advance notice in the event of his disability to provide services and either party having the right to terminate the Consulting Agreement on 90 days’ advance notice. Mr. Haverhals will be paid an annual fee at the rate of $350,000, at the at the rate of $150,000 in respect of the first calendar quarter of 2025, and at the rate of $66,666, in respect of each subsequent calendar quarter of 2025, payable monthly in arrears, in each case in equal monthly installments on the last day of each month of such quarter. The Company will reimburse Mr. Haverhals for reasonable expenses in providing the services. Mr. Haverhals will be an independent contractor and will not be provided with health and accident insurance, life insurance, paid sick leave and/or paid vacation time. In connection with the Consulting Agreement, he has also entered into a Company-standard form of non-disclosure, non-solicitation, non-competition and invention agreement Mr. Haverhals continues as a director of Milestone Scientific. Mr. Haverhals will be issued 638,023 shares of the Company's stock ninety days after his resignation as CEO.37

~~Objective of Executive Compensation Program~~ Audit Committee

The Audit ~~primary~~Committee ~~objective~~meets ofregularly ~~the~~with ~~executive~~management ~~compensation program is to attract~~ and ~~retain qualified, energetic managers who are enthusiastic about~~ the ~~mission~~Company’s ~~and~~independent ~~culture~~registered ofpublic ~~Milestone~~accounting ~~Scientific.~~firm ~~A further objective of the compensation program is~~ to ~~provide~~review ~~incentives~~ and ~~reward~~discuss matters ~~each~~related ~~manager~~to ~~for~~the ~~their~~Company’s ~~contribution.~~financial ~~In addition~~reporting, ~~Milestone~~internal ~~Scientific~~control ~~strives~~over tofinancial ~~promote~~reporting, ~~an ownership mentality among key leadership~~ and ~~the~~audit ~~Board of Directors~~process.

The primary ~~Compensation~~purpose ~~Committee~~of ~~reviews~~the ~~and~~Audit ~~approves,~~Committee oris into ~~some~~assist ~~cases recommends for~~ the ~~approval~~Board of ~~the~~Directors ~~full~~in ~~Board,~~its ~~the~~oversight ~~annual compensation procedures for the Named Executive Officers.~~of:

● The ~~compensation~~integrity ~~program~~of isthe ~~designed to reward teamwork, as well as each manager~~Company’s ~~individual~~financial ~~contribution.~~statements In● ~~measuring~~The ~~the Named Executive Officers~~Company’s ~~contribution,~~compliance ~~the~~with ~~Compensation~~legal ~~Committee considers numerous factors including the growth strategic business relationships~~ and ~~financial~~regulatory ~~performance.~~requirements ~~Regarding~~● ~~most~~The ~~compensation~~qualifications, ~~matters~~independence, ~~including executive~~ and ~~director compensation,~~performance ~~management~~of ~~provides recommendations to~~ the ~~Compensation~~Company’s ~~Committee;~~independent ~~however,~~registered ~~the~~public ~~Compensation~~accounting ~~Committee~~firm ~~does~~● ~~not~~The ~~delegate~~preparation ~~any~~and filing of ~~its~~the ~~functions~~Company’s toAnnual ~~others~~Report inon ~~setting~~Form ~~compensation.~~10-K ~~Milestone~~for ~~Scientific~~the ~~does~~fiscal ~~not~~year ~~currently~~ended ~~engage~~December ~~any~~31, ~~consultant to advise on executive and/or director compensation matters.~~2025

~~Stock~~The Audit ~~price~~Committee ~~performance~~is ~~has~~directly ~~not~~responsible ~~been~~for athe ~~factor~~appointment, inretention, ~~determining annual~~ compensation, ~~because~~evaluation, ~~the~~and ~~price~~oversight of ~~Milestone~~the ~~Scientific~~Company’s independent ~~common~~registered ~~stock~~public isaccounting ~~subject to a variety of factors outside of Milestone Scientific’s control~~firm. ~~Milestone~~The ~~Scientific~~Committee ~~does~~also ~~not~~pre-approves ~~have~~all anaudit ~~exact~~and ~~formula~~permitted ~~for~~non-audit ~~allocating~~services ~~between~~provided ~~cash~~by the ~~and~~independent ~~non-cash compensation~~auditors.

~~Annual~~The Audit ~~CEO~~Committee ~~compensation~~is ~~consists~~currently comprised of aBenedetta ~~base~~Casamento ~~salary component~~(Chair), aNeal ~~bonus~~Goldman, ~~component (payable in a mix of cash~~ and ~~stock)~~Shanth ~~and periodic stock option grants~~Thiyagalingam. ItThe isBoard ~~the~~has ~~Compensation Committee’s intention to set totals for the CEO for cash compensation sufficiently high enough to attract and retain a strong motivated leadership team, but not so high~~ determined that iteach ~~creates~~member aof ~~negative perception with~~ the ~~other~~Audit ~~stakeholders.~~Committee ~~The~~is ~~CEO~~independent ~~receives stock option grants~~ under the ~~stock~~listing ~~option~~standards ~~plan. The number~~ of ~~stock~~NYSE ~~options~~American ~~granted~~and tosatisfies the ~~executive~~independence ~~officer~~requirements of isSection ~~made~~10A(m)(3) onof athe ~~discretionary~~Securities ~~rather~~Exchange ~~than~~Act aof ~~formula~~1934, ~~basis~~as ~~by the Compensation Committee~~amended.

~~The~~A copy ~~CEO’s~~of ~~current~~the ~~and~~Audit ~~prior~~Committee ~~compensation~~Charter is ~~considered~~available ~~in setting future compensation. To some extent, the compensation plan is based~~ on the ~~market~~Company’s ~~and~~website ~~the~~at ~~companies that compete for executive management~~www. ~~The elements of the plan (e~~milestonescientific.gcom., base salary, bonus, and stock options) are like the elements used by many companies. The exact base pay, stock option grant, and bonus amounts are chosen to balance the competing objectives of fairness to all stakeholders and attracting and retaining executive managers.

Audit 39 Committee Financial Expert

~~Outstanding~~The Board ~~Equity~~of ~~Awards~~Directors ~~on December~~has 31determined that Benedetta Casamento is an “audit committee financial expert” as defined in Item 407(d)(5) of Regulation S-K. In addition, ~~2024~~the Board has determined that Ms. Casamento is independent within the meaning of the listing standards of NYSE American and the applicable rules of the Securities and Exchange Commission, including Section 10A(m)(3) of the Securities Exchange Act of 1934, as amended.

Name	Number of Securities Underlying Unexercised Options (#) Exercisable (1)		Number of Securities Underlying Unexercised Options (#) Unexercisable (1)		Option Exercise Price ($)		Option Expiration Date	Number of Shares or Units of Stock that have not vested (#) (2)		Market Value of Number of Shares or Units of Stock that have not vested (#) (3)
Jan Adriaan (Arjan ) Haverhals
		167,739		48,557	$	1.52	3/30/2025		638,024	$	612,503
Total		167,739		48,557					638,024	$	612,503
Leonard Osser		703,518		-	$	1.99	12/22/2025		2,481,046	$	2,381,804
		1,200,000		800,000		2.47	4/23/2031
		32,175		-	$	3.11	2/9/2026
Total		1,935,693		800,000					2,481,046	$	2,381,804
Total		2,103,432		848,557					3,119,070		2,994,307

Compensation Committee

The Compensation ~~following~~Committee ~~table~~reviews ~~includes~~and ~~certain~~recommends ~~information~~to ~~with~~the ~~respect~~Board of Directors the compensation and benefits of the Company’s executive officers. The Committee also reviews general policies relating to ~~all~~employee ~~unexercised~~compensation and benefits and administers the Company’s equity compensation plans, including the grant of stock options and ~~unvested~~other ~~shares~~equity ofawards ~~common~~to ~~stock~~officers, ofemployees, ~~Milestone~~directors, ~~Scientific~~and ~~outstanding~~consultants. In ~~owned~~addition, bythe Compensation Committee reviews and makes recommendations to the ~~Named~~Board ~~Executive~~regarding ~~Officers~~compensation onfor ~~December~~non-employee 31directors. The Compensation Committee may not delegate its authority to any other person, ~~2024~~except to a subcommittee established in accordance with applicable law and the Committee’s charter.

1.The Compensation ~~Represents~~Committee ~~stock~~is ~~option~~currently ~~grants~~comprised atof ~~fair~~Neal ~~market~~Goldman ~~value~~(Chair), onBenedetta ~~the~~Casamento, ~~date~~and ofShanth ~~grant.~~Thiyagalingam

2.A copy ~~Issuance~~ of the ~~shares~~Compensation ofCommittee ~~common~~Charter ~~stock~~is ~~have~~available ~~been~~on ~~deferred until~~ the ~~termination~~Company’s ofwebsite ~~employment~~at ~~with~~www.milestonescientific.com. ~~Milestone~~For ~~Scientific~~additional discussion inof ~~accordance~~executive ~~with~~compensation ~~the~~objectives, ~~terms~~see ofItem ~~respective~~11, ~~employment~~“Executive ~~arrangements~~Compensation.”

3.Nominating and ~~Based~~Corporate onGovernance ~~the closing price per share of $0.96 as reported on the NYSE American on December 31, 2024~~Committee

~~Director~~The Nominating ~~Compensation~~ and Corporate Governance Committee identifies, evaluates, and recommends individuals qualified to serve as directors of the Company and assesses the suitability of incumbent directors for continued service on the Board.

	Fees Earned paid in cash$		Stock Awards $		Options Award $		Non-Equity Incentive Plan Compensation $		Change in pension value and nonqualified deferred compensation earnings $		All other Compensation		Fees Earned paid in cash$		Total $
Neal Goldman		-		120,000		-		-		-		-		-		120,000
Benedetta Casamento		-		120,000		-		-		-		-		-		120,000
Leonard Osser		-		100,000		-		-		-		-		-		100,000
Dr. Didier Demesmin		-		100,000		-		-		-		-		-		100,000
Michael McGeehan		-		110,000		-		-		-		-		-		110,000
Gian Domenico Trombetta (1)		-		100,000		-		-		-		-		-		100,000

The Committee is currently comprised of Benedetta Casamento (1Chair) ~~Resigned~~and asNeal Goldman. A copy of ~~January~~the ~~12,~~Nominating ~~2025~~and Corporate Governance Committee Charter is available on the Company’s website at www.milestonescientific.com.

In 40evaluating director candidates, the Committee considers a variety of factors, including integrity, professional experience, judgment, independence, understanding of the Company’s business and industry environment, and the ability to make meaningful contributions to the Board’s oversight responsibilities. The Committee also evaluates whether a candidate’s skills, expertise, and experience complement the existing composition of the Board and its committees and satisfy applicable independence and regulatory requirements.

~~Item~~The Committee 12considers director candidates recommended by stockholders. ~~Security~~Stockholders ~~Ownership~~wishing ofto ~~Certain~~recommend ~~Beneficial~~a ~~Owners~~candidate ~~and~~for ~~Management~~consideration must ~~and~~submit ~~Related~~a ~~Stockholders~~written ~~Matters~~recommendation that includes:

● The ~~following~~stockholder’s ~~table,~~name ~~together~~and ~~with~~evidence ~~the~~of ~~accompanying~~stock ~~footnotes~~ownership, ~~sets~~including ~~forth~~the ~~information,~~number asof ~~March~~shares ~~15,~~held ~~2025 regarding~~and ~~stock~~the ~~ownership~~duration of ~~all~~ownership ~~persons~~● ~~known~~The bycandidate’s ~~Milestone~~name ~~Scientific~~and toa ~~own~~résumé ~~beneficially~~or ~~more~~summary ~~than~~of 5%qualifications of● ~~Milestone~~The ~~Scientific~~candidate’s ~~outstanding~~ ~~common~~written ~~stock,~~consent ~~Named~~to ~~Executives,~~be ~~all~~named ~~directors,~~as ~~and~~a ~~all~~nominee ~~directors~~ and ~~executive~~to ~~officers~~serve ~~of Milestone Scientific~~ as a ~~group:~~director if elected

Names of Beneficial Owner (1)	Shares of Common Stock Beneficially Owned (2)		Percentage
Executive Officers and Directors
Jan Adriaan (Arjan) Haverhals (3)		638,023		0.83	%
Neal Goldman (4)		2,325,856		3.01	%
Benedetta Casamento (5)		404,490		0.52	%
Michael McGeehan (6)		584,744		0.76	%
Leonard Osser (7)		5,198,813		6.73	%
Dr. Didier Demesmin (8)		112,356		0.15	%
All directors & executive officers as group (6 persons)		9,264,282		12.00	%
5% and Greater Shareholders
BP4 S.R.L (9)		9,672,192		12.52	%

The Committee may also consider candidates suggested by current directors, executive officers, or other sources and may retain third-party search firms to assist in identifying qualified candidates. The evaluation process does not vary based on the source of the nomination.

1. The addresses of the persons named in this table are as follows: Leonard Osser, Jan Adriaan (Arjan) Haverhals, Neal Goldman, Michael McGeehan, Benedetta Casamento and Dr. Didier Demesmin are at 425 Eagle Rock Avenue, Roseland, New Jersey 07068.Director Independence

2.The Board Aof ~~person~~Directors ishas ~~deemed~~determined ~~to be a beneficial owner of securities~~ that ~~can~~Neal ~~be acquired by such person within 60 days from March 15~~Goldman, ~~2025~~Benedetta ~~as applicable~~Casamento, ~~upon~~Shanth ~~the exercise of options and warrants or conversion of convertible securities. Each beneficial owner's percentage ownership is determined by assuming that options~~Thiyagalingam, ~~warrants~~ and ~~convertible~~Dawood ~~securities that are held by such person (but not held by any other person) and that are exercisable or convertible within 60 days from March 15~~Sayed,~~2025,~~ ~~have been exercised or converted~~M.D. ~~Except as otherwise indicated~~(collectively, ~~and subject to applicable community property and similar laws, each of~~ the ~~persons~~“Independent ~~named~~Directors”) ~~has sole voting and investment power with respect to the shares shown as beneficially owned. The percentages for each beneficial owner~~ are ~~determined~~independent ~~based~~within ~~on dividing~~ the ~~number~~meaning of ~~shares~~Section of803A ~~common stock beneficially owned by the sum~~ of the ~~outstanding~~NYSE ~~shares~~American ofCompany ~~common stock on March 15, 2025 and the number of shares underlying options exercisable and convertible securities convertible within 60 days from March 15, 2025 held by the beneficial owner~~Guide.

3.In making ~~Includes~~its ~~638~~independence determinations,~~023~~ ~~shares~~the Board considered all relevant facts and circumstances, including any equity compensation awards granted to bethe ~~issued~~Independent atDirectors during the ~~termination~~year ofended MrDecember 31, 2025, as disclosed under “Director Compensation” below. ~~Haverhals'~~The ~~employment~~Board ~~agreement,~~determined ~~and~~that ~~119,676~~such ~~vested~~awards ~~stock~~were ~~options~~granted toas ~~purchase~~compensation ~~common~~for ~~stock~~services ofrendered in their capacity as directors and do not constitute a material relationship with the Company that would impair their independence under the NYSE American listing standards.

4.Stockholder Communication ~~Includes~~with ~~2,325,856~~the ~~shares~~Board ~~held by Mr. Goldman.~~

5The Board of Directors has established a process for stockholders and other interested parties to communicate with the Board. ~~Includes~~Stockholders and ~~404~~other interested parties may communicate with any member of the Board,~~490~~ ~~shares~~the ~~held~~non-management directors as a group, any Board committee, or the chair of any such committee by ~~Mrs~~directing correspondence to the intended recipient by name or title. ~~Casamento~~All correspondence should be sent “c/o Corporate Secretary” at: 425 Eagle Rock Avenue, Suite 403, Roseland, New Jersey 07068.

6The Company’s Corporate Secretary will review all communications for the sole purpose of determining whether the correspondence is appropriate for delivery to the directors. ~~Includes~~Communications ~~584~~that are unrelated to the duties and responsibilities of the Board,~~744~~ ~~shares~~including advertisements, ~~held~~solicitations, byor ~~Mr.~~patently ~~McGeehan~~offensive material, will not be forwarded.

7.All appropriate ~~Includes~~communications ~~2,717,765~~will ~~shares~~be ~~held~~promptly byforwarded ~~Mr.~~to ~~Osser~~the orintended ~~his~~director ~~family,~~or ~~2,481,048~~directors. ~~shares~~In tothe becase ~~issued~~of atcommunications addressed to the ~~termination~~Board ofor ~~his~~to ~~employment~~a ~~agreement,~~committee ~~and~~or 1group of directors,~~993,279~~ ~~vested~~the ~~stock~~Corporate ~~options~~Secretary towill ~~purchase~~distribute ~~common~~copies ~~stock~~to ofeach ~~the~~applicable ~~Company~~member.

8.Section 16(a) Beneficial ~~Includes~~Ownership ~~112,356~~Reporting ~~shares held by Dr. Demesmin.~~Compliance

9.Section 16(a) ~~Includes~~of ~~9,672,192~~the ~~shares~~Securities ~~held~~Exchange byAct ~~BP4~~of ~~S.R.L.~~1934, as amended (~~"BP4"~~the “Exchange Act”)., ~~Dr.~~requires ~~Pedro~~the ~~Palau,~~Company’s ~~Liquidator~~directors and executive officers, ~~with~~and anpersons ~~address~~who atbeneficially ~~Corso~~own ~~Venezia~~more ~~44,~~than ~~Milan,~~ten ~~Italy~~percent ~~20121,~~of isa ~~deemed~~registered class of the Company’s equity securities, to ~~have~~file ~~voting~~reports of ownership and ~~investment~~changes ~~power~~in ~~over~~ownership ~~the~~of such securities ~~held~~with bythe ~~BP4~~Securities and Exchange Commission (the “SEC”). Such ~~Based~~directors, onexecutive ~~information~~officers, inand ~~the~~greater-than-ten-percent ~~Schedule~~beneficial ~~13D~~owners ~~filed~~are required by ~~BP4~~SEC onregulations ~~February~~to 7,furnish ~~2025~~the Company with copies of all Section 16(a) reports they file.

Based 41solely upon a review of the copies of such reports furnished to the Company and written representations from certain reporting persons that no Form 5 reports were required, the Company believes that all filing requirements applicable to its directors and executive officers under Section 16(a) were timely satisfied during the fiscal year ended December 31, 2025.

~~Securities Authorized for Issuance under Equity Compensation Plans~~39

~~Equity~~Insider Trading ~~Compensation~~Arrangements ~~Plan Information~~and ~~(as of December 31, 2024)~~Policies

Equity compensation plan approved by stockholders	Number of Securities to be issued upon exercise of outstanding options and warrants		Weighted-average exercise price of outstanding options and warrants		Number of securities remaining available for future issuance under equity compensation plan
Grants under our 2021 Stock Option Plan (4)		3,051,985	$	2.12		7,579,778
Total		3,051,985	$	-		7,579,778

The Company has adopted an insider trading policy governing the purchase, sale, and other dispositions of the Company’s securities by its directors, officers, and employees. The Company believes this policy is reasonably designed to promote compliance with applicable insider trading laws, rules, regulations, and exchange listing standards.

1. The policy ~~2020~~prohibits ~~plan,~~trading ~~as amended and restated~~ in ~~2021~~the ~~and~~Company’s ~~amended~~securities ~~during~~while ~~2024,~~in ~~provides~~possession ~~for awards~~ of ~~restricted~~material ~~common~~nonpublic ~~stock~~information and ~~options~~prohibits tothe ~~purchase up to a maximum~~ disclosure of ~~11,500,000~~such ~~shares~~information ofto ~~common~~others ~~stock~~who ~~and expires in December 2030. Options~~ may betrade ~~granted to employees, directors, and consultants of Milestone Scientific for the purchase of shares of common stock at a price not less than the fair market value of common stock~~ on the ~~date~~basis of ~~grant.~~that ~~In general, options become exercisable over a three-year period from the grant date and expire five years after the date of grant~~information. ~~During the year ended December 31, 2024, 7,579,778 options and shares were issued.~~

~~Item~~The Company ~~13.~~has ~~Certain~~established ~~Relationships~~regular ~~and~~blackout ~~Related~~periods ~~Transactions,~~in connection with the preparation and ~~Director~~filing ~~Independence~~of its periodic reports. The Company may also impose special blackout periods from time to time when material nonpublic developments or events are pending.

~~United~~Covered persons ~~Systems~~may trade in the Company’s securities only when no blackout period is in effect, they are not in possession of material non-public information and the transaction has been pre-cleared by the Company’s designated compliance officer, or pursuant to a Rule 10b5-1 trading plan adopted in compliance with applicable SEC rules.

~~Milestone Scientific has a supply agreement with United Systems~~ During the ~~principal~~last ~~supplier~~fiscal quarter of its handpieces, pursuant to which it procures manufactured products under specific purchase orders, but without minimum purchase commitments. Purchases from this supplier were approximately $1.7 million and $2.3 million for the ~~twelve~~fiscal ~~months~~year ~~ended~~covered ~~December~~by ~~31, 2024, and 2023, respectively. As December 31, 2024, and December 31, 2023, Milestone Scientific owed~~ this ~~supplier approximately $664~~report,~~000~~ ~~and~~no ~~$402,000,~~director ~~respectively,~~or ~~which~~officer isadopted ~~included~~or interminated ~~accounts payable and accrued expenses related party on the consolidated balance sheets. In June 2021, the Company signed~~ a ~~ten~~Rule 10b5-~~year~~1 ~~agreement with United Systems for supplier of the handpieces~~trading arrangement.

~~Other~~ Code of Ethics

~~For the year ended December 31, 2023, the~~ The Company ~~had approximately~~has ~~$270,000~~adopted ~~sales~~a toCode ~~Milestone China or agents~~ of ~~Milestone China~~Ethics, anas ~~entity~~defined in ~~which~~Item ~~the~~406 ~~Company~~of ~~formerly~~Regulation ~~had~~S-K, anthat ~~ownership~~applies ~~interest~~to ~~terminating~~its inprincipal ~~2021.~~executive ~~The~~officer, ~~Company~~principal financial ~~reported~~officer, noprincipal ~~sales~~accounting toofficer ~~Milestone~~or ~~China~~controller, or ~~agents~~persons ofperforming ~~Milestone~~similar ~~China~~functions, ~~during~~as ~~the~~well ~~year~~as ~~ended~~its ~~December 31,2024~~directors.

K.The Code ~~Tucker~~of ~~Andersen,~~Ethics ais ~~significant~~publicly ~~stockholder~~available ofon ~~Milestone~~the ~~Scientific,~~Company’s ~~has~~website anat ~~agreement~~www.milestonescientific.com. ~~with~~The ~~Milestone~~Company ~~Scientific~~will to provide ~~financial~~a copy ~~and~~of ~~business~~the ~~strategic~~Code ~~services.~~of ~~Expenses~~Ethics, ~~recognized~~without oncharge, ~~this~~upon ~~agreement~~a ~~were~~written ~~$100,000~~request ~~for year ended~~to: ~~December~~Benedetta 31Casamento, ~~2023.~~Chairman ~~The~~of ~~agreement~~the ~~was~~Board, ~~not~~Milestone ~~renewed~~Scientific Inc, ~~for~~425 ~~the~~Eagle ~~year~~Rock ~~ending~~Avenue, ~~December 31~~Roseland, ~~2024~~New Jersey 07068.

~~Director~~The Company intends to disclose any amendments to, or waivers (including any implicit waiver), from a provision of ~~Clinical~~the ~~Affairs~~Code of Ethics granted to its principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions, on its website or in a Current Report on Form 8-K, as required by applicable SEC rules.

The Director of Clinical Affairs’ royalty fee was approximately $442,000 and $485,000 for the years ended December 31, 2024 and 2023, respectively. Additionally, Milestone Scientific expensed consulting fees to the Director of Clinical Affairs of $156,000 for the year ended December 31, 2024 and 2023, respectively. As of December 31, 2024, and 2023, Milestone Scientific owed the Director Clinical Affairs for royalties of approximately $110,000 and $114,000, respectively, which is included in accounts payable, related party and accrued expense, related party, in the consolidated balance sheet.40

Clawback 42 Policy

~~Employment~~ The Board of Directors has adopted a written compensation recovery policy (the “Clawback Policy”) in accordance with Section 10D of the Securities Exchange Act of 1934, as amended, and ~~Consulting~~the ~~Contracts~~applicable listing standards of NYSE American.

OnThe Clawback ~~March~~Policy 2,provides ~~2021,~~for the ~~Company~~recovery ~~entered into a Royalty Sharing Agreement with Leonard Osser, pursuant to which Mr. Osser sold, transferred and assigned to the Company all~~ of ~~his rights in and to a~~ certain ~~patent application as to which he is a co~~incentive-~~inventor~~based ~~with~~compensation ~~Mark Hochman, a consultant to the Company, and the Company agreed to pay to Mr. Osser, beginning May 9, 2027, half of the royalty (2.5%) on net sales~~ that ~~would~~was ~~otherwise~~erroneously ~~be payable to Mark and Claudia Hochman under their existing Technology Sale Agreement~~awarded, ~~dated January 1~~earned, ~~2005~~or ~~and~~vested ~~amended~~based wholly ~~from~~or ~~time~~in topart ~~time,~~upon ~~with~~ the ~~Company.~~attainment Inof ~~connection~~a ~~with~~financial ~~the~~reporting ~~Royalty Sharing Agreement~~measure, in the ~~Hochman's~~event ~~agreed with~~ the Company, ~~pursuant~~is torequired ~~an addendum~~ to ~~such~~prepare ~~Technology~~an ~~Sale~~accounting restatement ~~Agreement dated February 25, 2021, to reduce from 5% to 2.5% the payments~~ due to ~~them~~material ~~under~~noncompliance ~~their Technology Sale Agreement beginning on May 9, 2027, and thereafter~~ with ~~respect~~any tofinancial ~~dental~~reporting ~~products~~requirement ~~embodying~~under the ~~invention~~federal securities laws.

AsThe policy ~~part~~applies ~~of the Succession Plan of the Company, Mr. Osser agreed, pursuant~~ to ancurrent ~~agreement dated April 6, 2021 (the “Succession Agreement”), to restructure certain of his existing agreements with the Company, which provide for additional~~ and ~~broader~~former executive ~~support,~~officers ~~and~~who atreceived ~~such~~incentive-based time as he elects to step down as Interim Chief Executive Officer of the Company, to become the Vice Chairman of the Board of the Company. With respect to Mr. Osser’s July 2017 Employment Agreement and July 2017 Consulting Agreement (each as previously disclosed), the compensation ~~under~~during the ~~Employment~~three ~~Agreement~~completed ~~was~~fiscal ~~modified~~years immediately topreceding ~~reduce~~ the ~~overall~~date ~~compensation~~on by $100,000 to $200,000, split equally between a cash amount and an amount in shares, and the compensation under the Consulting Agreement was increased by $100,000 to $200,000, equally split between a cash amount and an amount in shares, which ~~shares were formerly payable under~~ the ~~Employment Agreement. If the~~ Company ~~terminates~~is ~~Mr.~~required ~~Osser’s employment “Without Cause,” other than due~~ to ~~his~~prepare ~~death~~an oraccounting ~~disability, or if Mr~~restatement. ~~Osser~~Recovery ~~terminates his employment for “Good Reason” (both as defined in the agreement), Mr. Osser~~ is ~~entitled~~required to ~~be paid in one lump sum payment as soon as practicable following such termination: an amount equal to~~ the ~~aggregate~~extent that ~~present value (as determined in accordance with Section 280G(d)(4) of~~ the ~~Code)~~incentive-based ~~of all~~ compensation ~~pursuant~~received toexceeds ~~this agreement from~~ the ~~effective~~amount ~~date~~that ofwould ~~termination~~have ~~hereunder~~been ~~through~~received ~~the~~had ~~remainder~~it ofbeen ~~the~~determined ~~Employment~~based Term. In connection with his acceptance of the Vice Chairman position and in consideration of his services as a member of the Board and agreement to provide certain additional general consulting services, Mr. Osser was granted options to purchase 2,000,000 shares of common stock, exercisable at the fair market value of the common stock on the ~~date~~restated financial ~~of grant, vesting over the five-year period after he steps down as Interim Chief Executive Officer of the Company or ten years from the date of grant, whichever shall end first~~results.

The Company believes that the effect of such existing agreements and the Succession Agreement, all of which relate to the period after such time Mr. Osser steps down as Interim Chief Executive Officer of the Company, collectively expand Mr. Osser’s consulting to and support of the Company beyond its Chinese operations to also include its medical and other products, while enhancing the retention aspects of the Company’s relationship with Mr. Osser. On May 19, 2021, Mr. Osser resigned as Interim Chief Executive Officer of the Company and assumed the role of Vice Chairman of the Board. Compensation Recovery under the ~~Employment~~Clawback ~~Agreement~~Policy ~~and the Consulting Agreement~~ is ~~payable~~required ~~for~~regardless ~~9.5 years from May 19, 2021. The Company recorded expenses~~ of ~~$200,000 related~~whether to the ~~Employment~~executive ~~Agreement~~officer ~~for~~engaged ~~each~~in ofmisconduct ~~the~~or ~~years~~was ~~ended~~responsible ~~December 31, 2024 and 2023, respectively . The Company recorded expenses of $200,000 related to the Consulting Agreement~~ for ~~each of~~ the ~~years~~error that ~~ended~~resulted ~~December~~in ~~31, 2024 and 2023, respectively. Mr. Osser also owns 2,717,765 of~~ the ~~Company's~~restatement ~~stock,~~ and ~~2,481,048~~applies ~~shares~~ to berestatements ~~issued~~resulting atfrom ~~the~~both ~~termination~~misconduct ofand ~~his~~inadvertent ~~employment agreement~~errors.

~~As of February 2024, the University Pain Medicine Center (STEMMEE), of which Dr~~Item 11. D.Executive Demesmin, a Company board member is the CEO agreed to purchases products from the Company under the same terms and conditions applying to other medical pain clinics in the United States. STEMMEE purchased medical products in the amount of $21,000 for the year ended December 31, 2024Compensation

~~The~~SUMMARY COMPENSATION Company entered into a consulting agreement with Mr. Arjan Haverhals, which commenced on January 1, 2025, and continues for an indefinite period, subject to the Company having the right to terminate the Consulting Agreement on 30 days advance notice in the event of his disability to provide services and either party having the right to terminate the Consulting Agreement on 90 days’ advance notice. Mr. Haverhals will be paid an annual fee at the rate of $350,000, at the at the rate of $150,000 in respect of the first calendar quarter of 2025, and at the rate of $66,666, in respect of each subsequent calendar quarter of 2025, payable monthly in arrears, in each case in equal monthly installments on the last day of each month of such quarter. The Company will reimburse Mr. Haverhals for reasonable expenses in providing the services. Mr. Haverhals will be an independent contractor and will not be provided with health and accident insurance, life insurance, paid sick leave and/or paid vacation time. In connection with the Consulting Agreement, he has also entered into a Company-standard form of non-disclosure, non-solicitation, non-competition and invention agreement. Mr. Haverhals continues as a director of the Company. Mr. Haverhals continues as a director of Milestone Scientific. Mr. Haverhals will be issued 638,023 shares of the Company's stock ninety days after his resignation as CEO.TABLE

The following Summary Compensation Table sets forth 43information concerning all compensation earned by Milestone Scientific’s (i) principal executive officer during the last completed fiscal year, (ii) principal financial officer during the last completed fiscal year, and (ii) the three most highly compensated executive officers other than the principal executive officer and principal financial officer who were serving as executive officers at the end of the fiscal year ended December 31, 2025.

~~April~~The following table provides information regarding unexercised stock options held by the Named Executive Officers as of December 31, 2025 and ~~Financing~~2024.

On April 9, 2025, the Company issued a series of promissory notes in the aggregate amount of $800,000, to Mr. Neal Goldman, Ms. Benedetta Casamento, and Dr. Didier Demesmin, each of whom is a director of the Company. The notes are due April 9, 2028, and bear interest at the annual rate of prime less 2.50%, payable annually. All principal and interest shall be payable in cash and/or shares of common stock at the sole discretion of the Company. The notes are convertible into shares of common stock by the holder at any time and by the Company at maturity. If the Company sells equity securities for gross proceeds in excess of $4,000,000, the holders may request repayment of their note in either cash, shares of common stock or a combination of cash and shares; provided, that the holders would then be entitled to receive only so much cash as the net proceeds to the Company in such sale of equity securities, after payment of other indebtedness and other uses (other than working capital) specified as a use of the proceeds in the relevant offering or disclosure documentation, shall be in excess of $4,000,000. Upon a liquidation event of the Company, as defined in the notes which includes a sale of the Company or assets, a merger, reorganization or combination transaction where the shareholders before the transaction own less than 50% of the Company after the transaction and a liquidation, dissolution or winding-up of the Company, the notes will be repaid in cash or its portion of any non-cash consideration. The conversion rate for any issuance of shares of common stock will be at the then fair value of a share of common stock, with the fair value being determined with reference to the public market price of a share of common stock, but not less than $0.50. The notes are unsecured and have typical default terms.

Name	Position	Year	Salary ($)		Bonus ($)		Option Awards ($)		All Other Compensation ($)		Total ($)
Eric Hines (1)	CEO	2025	$	77,019			$	718,000	$	-	$	795,019
Jan Adriaan (Arjan) Haverhals (2)	CEO	2024	$	350,000	$	478,000	$	-	$	53,422	$	881,422
Jason Papes (3)	Senior VP of Global Sales and Marketing	2025	$	77,596	$	-	$	646,200	$	-	$	723,796
Keisha M. Harcum (4)	Vice President of Finance	2024	$	203,845	$	25,000	$	-	$	-	$	228,845
Keisha M. Harcum (4)	Vice President of Finance	2025	$	220,028	$	50,000	$	-	$	-	$	270,028

~~Item~~1. Mr. Hines was appointed Chief Executive Officer and a member of the Board of Directors effective August 1, 2025. Pursuant to his employment agreement, Mr. Hines was granted an option to purchase 2,000,000 shares of the Company’s common stock on August 1, 2025, at an exercise price of $0.50 per share. The option expires on August 1, 2035 and vests in equal annual installments, subject to continued service. The grant date fair value of this option award, computed in accordance with ASC 718, is reflected in the “Option Awards” column of the Summary Compensation Table for 2025. 2. During 2024, Mr. Haverhals was awarded a discretionary performance bonus of $478,000 for the year ended December 31, 2024. “All Other Compensation” for 2024 includes approximately $39,000 in Company-paid health insurance premiums and approximately $14,000 for a car allowance. ~~Principal~~Mr. ~~Accountant~~Haverhals ~~Fees~~resigned as Chief Executive Officer effective December 31, 2024. 3. Mr. Papes was hired as Senior Vice President of Global Sales and ~~Services~~Marketing effective August 6, 2025. Pursuant to his employment agreement, he was granted an option to purchase 2,000,000 shares of the Company’s common stock on August 6, 2025, at an exercise price of $0.45 per share. The option expires on August 6, 2035 and vests in equal annual installments, subject to continued service. The grant date fair value of this option award, computed in accordance with ASC 718, is reflected in the “Option Awards” column of the Summary Compensation Table for 2025. 4. During 2025 and 2024, Ms. Harcum was awarded performance bonuses of $50,000 and $25,000 respectively.

~~Audit Fees~~41

~~Milestone~~Pay versus ~~Scientific~~Performance incurred aggregate audit and financial statement review fees of approximately $220,000 from Marcum for 2024. Milestone Scientific incurred aggregate audit and financial statement review fees of approximately $295,200 from Marcum for 2023 These fees include fees for professional services rendered for the audit of our annual financial statements and the review of financial statements included in our report on Form 10-Q's or services that are normally provided in connection with statutory and regulatory filings and fees related to registration statements.Table

~~Tax~~As required ~~Fees~~by Section 953(a) of the Dodd-Frank Wall Street Reform and Consumer Protection Act and Item 402(v) of Regulation S-K, the Company provides the following information regarding the relationship between executive compensation actually paid (“CAP”) and certain financial performance measures of the Company for the two most recently completed fiscal years.

~~Milestone~~For additional ~~Scientific~~information ~~incurred~~regarding ~~aggregate~~the ~~tax~~Company’s ~~fees~~compensation ofphilosophy ~~approximately~~and ~~$33,000~~alignment ~~from~~of ~~Marcum~~executive ~~for~~compensation ~~2024.~~with ~~Milestone~~performance, see ~~Scientific~~“Compensation ~~incurred~~Philosophy ~~tax~~and ~~fees~~Objectives” ofand ~~approximately~~“Compensation ~~$42,000 from Marcum for 2023~~Elements.”

Audit Related Fees

Year	SCT Total PEO ($)		CAP PEO ($)		Avg. SCT Total Non-PEO ($)		Avg. CAP Non-PEO ($)		TSR ($100 Base)		Net Loss ($)
	(a)		(b)		(c)		(d)		(e)
2025	$	795,019	$	77,019	$	496,912	$	591,122	$	28.72	$	(5,722,216	)
2024	$	881,422	$	881,422	$	228,846	$	228,846	$	137.14	$	(4,713,597	)

Milestone Scientific did not incur audit related fees from Marcum in either 2024 or 2023.

	2025			2024
Calculation of Compensation Actually Paid to PEO (Column (b))
Total Summary Compensation Table (SCT)	$	795,019		$	881,422
Less: Grant Date Fair Value of Option Awards	$	(718,000	)	$	-
Add: Fair Value of Unvested Option Awards as of 12/31/2025	$	925,800		$	-
Compensation Actually Paid	$	1,002,819		$	881,422

~~All~~(a) The ~~Other~~amounts ~~Fees~~reported in this column represent the total compensation reported for the Company’s principal executive officer (“PEO”) in the “Total” column of the Summary Compensation Table for each applicable fiscal year.

~~Milestone~~(b) The ~~Scientific~~amounts ~~did~~reported ~~not~~in ~~incur~~this ~~other~~column ~~accounting~~represent ~~fees from~~compensation ~~Marcum~~actually paid (“CAP”) to the PEO, as computed in ~~either~~accordance ~~2024~~ with Item 402(v) of Regulation S-K. CAP does not reflect the actual amount of compensation earned by or ~~2023~~ paid to the PEO during the applicable year. In accordance with SEC rules, the calculation of CAP begins with the total compensation reported in the Summary Compensation Table and includes adjustments for equity awards as described below. For the fiscal year 2025, CAP reflects the following adjustments:

Audit Committee Administration of the Engagement

	●	Subtraction of the aggregate grant date fair value of stock option awards granted during 2025, as reported in the Summary Compensation Table; and
	●	Addition of the fair value of unvested stock option awards outstanding as of December 31, 2025.

The fair ~~engagements~~value ~~with~~of ~~Marcum~~unvested asstock ~~the~~option ~~Company’s~~awards ~~principal~~as ~~accountants~~of ~~and~~December ~~tax~~31, ~~compliance~~2025 ~~services~~was ~~were~~determined ~~approved~~using ~~in advance by~~ the ~~Board and the Audit Committee. No non~~Black-~~audit~~Scholes oroption ~~non-audit~~pricing ~~related~~model ~~services~~with ~~were approved by~~ the following ~~Audit Committee in either 2024 or 2023.~~assumptions:

~~Audit~~● ~~Committee~~Stock ~~Pre~~price: $0.27 ● Volatility: 86.95% ● Risk-~~Approval~~free ~~Policies~~interest ~~and~~rate: ~~Procedures~~3.63% ● Expected term: 10 years ● Dividend yield: 0%

~~The~~For fiscal ~~Audit~~years ~~Committee~~2024, ~~charter~~no ~~provides~~equity ~~that~~awards ~~the~~were ~~Audit~~granted Committee will pre-approve audit services and non-audit services to be provided by the independent auditors before the accountant is engaged to render these services. The Audit Committee may consult with management in the decision-making process but may not delegate this authority to management. The Audit Committee may delegate its authority to preapprove services to one or ~~more~~outstanding ~~committee members, provided~~ that ~~the~~required ~~designers~~adjustment ~~present~~under ~~the~~Item ~~pre-approvals~~402(v), ~~to the full committee at the next committee meeting. All audit~~ and ~~non-audit~~therefore, ~~services~~CAP ~~performed by~~ equals the ~~independent~~total ~~accountants~~compensation ~~have~~reported ~~been~~in ~~pre-approved by~~ the ~~Audit~~Summary ~~Committee~~Compensation toTable ~~assure~~for ~~that~~those ~~such services do not impair the auditors’ independence from us~~years.

Because 44the Company’s stock price declined during fiscal year 2025, the year-end fair value of outstanding stock option awards was lower than their grant date fair value, resulting in CAP being lower than total compensation reported in the Summary Compensation Table

~~PART IV~~ 42

~~Item~~(c) The 15amounts reported in this column represent the average of the amounts reported for the Company’s Non-PEO Named Executive Officers (“Non-PEO NEOs”) in the “Total” column of the Summary Compensation Table for each applicable year. ~~Exhibits~~There ~~and~~were no ~~Financial~~Non-PEO ~~Statement~~NEOs ~~Schedules~~during fiscal year 2024.

a. (d) The ~~following~~amounts ~~documents~~reported ~~are~~in ~~filed~~this column represent the average compensation actually paid (“CAP”) to the Company’s Non-PEO NEOs as ~~part~~computed in accordance with Item 402(v) of ~~this~~Regulation ~~Report:~~S-K. For fiscal year 2025, CAP for each Non-PEO NEO reflects the same equity award adjustments described in footnote (b), as applicable. For fiscal year 2024, no adjustments were required.

	1	Financial Statements. See Index to Financial Statements on page F-1.
	2	Financial Statement Schedule
	3	Exhibits
		Certain of the following exhibits were filed as Exhibits to previous filings filed by Milestone Scientific under the Securities Act of 1933, as amended, or reports filed under the Securities and Exchange Act of 1934, as amended, and are hereby incorporated by reference.

(e) Total Shareholder Return (“TSR”) represents the cumulative value of an initial $100 investment in the Company’s common stock beginning of the period.

b.Employment and ~~The~~Consulting ~~following documents are filed as exhibits to this Report:~~Contracts

Exhibit No		Description
3.1		Certificate of Incorporation of Milestone as restated and amended as of March 25, 2025. *
3.2		Amended and Restated By-laws filed April 1, 2019 (1)
4.1		Specimen stock certificate (2)
4.5		Description of Registrant’s Securities (3)
4.6		Form of Promissory Note, dated April 8,2025*
10.1		Lease dated November 25, 1996 between Livingston Corporate Park Associates, L.L.C. and Milestone (4)
10.2		Lease amendment dated April 28, 2004 between Livingston Corporate Park Associates, L.L.C. And Milestone (5)
10.3		2011 Equity Compensation Plan (6)
10.4		Agreement with Mark Hochman, dated July 2015 (7)
10.5		Succession Agreement between Leonard Osser and Milestone Scientific Inc. + (8)
10.6		Amended and Restated 2020 Equity Incentive Plan (9)
10.7		Employment Agreement, dated and effective as of January 1, 2022, between Arjan Haverhals and Milestone Scientific Inc.+ (10)
10.8		Underwriting Agreement, dated as of December 10, 2023, between the Company and Maxim Group LLC (11)
10.10		Amended Employment agreement dated and effective July 5, 2023 between Arjan Haverhals and Milestone Scientific Inc. + (12)
10.11		Consulting Agreement, dated December 18, 2024, between Arjan Haverhals and Milestone Scientific Inc. +* (13)
14.1		Code of Ethics (14)
19.1		Insider Trading Policy(15)
21.1		List of Subsidiaries *
23.1		Consent of Marcum LLP *
31.1		Rule 13a-14(a) Certification-Chief Executive Officer and Principal Financial Officer *
32.1		Section 1350 Certifications-Chief Executive Officer and Principal Financial Officer * / ***
99.1		Clawback Policy, dated 2023 (16)
101.INS		Inline XBRL Instance Document*
101.SCH		Inline XBRL Taxonomy Extension Schema Document*
101.CAL		Inline XBRL Taxonomy Extension Calculation Linkbase Document*
101.LAB		Inline XBRL Taxonomy Extension Label Linkbase Document*
101.PRE		Inline XBRL Taxonomy Extension Presentation Linkbase Document*
101.DEF		Inline XBRL Taxonomy Extension Definition Linkbase Document*
104		Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

Leonard Osser

*Succession Agreement ~~Filed~~and ~~herewith.~~Related +Compensation ~~Indicates management contract or compensatory plan or arrangement.~~Arrangements

As 45part of the Company’s succession planning, on April 6, 2021, Mr. Osser entered into an agreement with the Company (the “Succession Agreement”) pursuant to which he agreed to restructure certain of his existing arrangements with the Company to provide broader executive support beyond the Company’s Chinese operations and, upon stepping down as Interim Chief Executive Officer, to assume the role of Vice Chairman of the Board.

~~***~~In connection ~~Furnished, not filed, in accordance~~ with ~~item~~the ~~601(32)~~Succession ~~(ii) of Regulations-S-K.~~Agreement:

1) Incorporated by reference to Milestone Scientific’s For 10-K filed with SEC on April 1, 2019. Exhibit 3.4.

	●	Compensation under Mr. Osser’s July 2017 Employment Agreement was reduced by $100,000 to $200,000, with the reduction split equally between cash compensation and equity compensation.
	●	Compensation under his July 2017 Consulting Agreement was increased by $100,000 to $200,000, also split equally between cash and equity compensation. The equity component shifted from the Employment Agreement to the Consulting Agreement.

2)Compensation under ~~Incorporated~~the byEmployment ~~reference~~Agreement toand ~~Amendment~~Consulting ~~No1~~Agreement tois ~~Milestone~~payable ~~Scientific’s Registration Statement on Form 10-KSB~~ for ~~the~~9.5 ~~year~~years ~~ended~~from May 1519, ~~1995~~2021.

3)For each ~~Incorporated~~of ~~by reference to Milestone Scientific’s Form 10-K filed with~~ the ~~SEC~~years onended ~~March~~December 31, ~~2022~~2025 and 2024, ~~Exhibit~~the ~~4.6.~~Company recorded:

4) Incorporated by reference to Milestone’s Form 10-KSB for the year ended December 31, 1996.

	●	$200,000 of expenses related to the Employment Agreement; and
	●	$200,000 of expenses related to the Consulting Agreement.

5)If the ~~Incorporated~~Company byterminates ~~reference~~Mr. Osser’s employment without cause (other than due to ~~Milestone~~death ~~Scientific’s~~or ~~Form~~disability), ~~10-KSB~~or ~~filed~~if ~~with~~Mr. Osser terminates his employment for good reason (each as defined in the ~~SEC~~applicable onagreement), ~~April~~he 4is entitled to receive, ~~2005~~in a lump sum, ~~Exhibit~~an 10amount equal to the aggregate present value (determined in accordance with Section 280G(d)(4) of the Internal Revenue Code) of all compensation payable from the termination date through the remainder of the employment term.~~37.~~

~~6) Filed as Appendix A to Milestone Scientific’s Proxy Statement filed with the SEC on May 2, 2011 and incorporated herein by reference.~~43

7)Vice Chairman ~~Incorporated~~Appointment byand ~~reference~~Option ~~to Milestone Scientific’s Form 10-K for the year ended December 31, 2015, Exhibit 10.11.~~Grant

8)Upon stepping ~~Incorporated~~down byas ~~reference~~Interim Chief Executive Officer on May 19, 2021, Mr. Osser assumed the role of Vice Chairman of the Board. In connection with his acceptance of the Vice Chairman position and his agreement to ~~Milestone~~provide ~~Scientific~~additional consulting services, Mr. Osser was granted options to purchase 2,000,000 shares of the Company’s ~~Form~~common ~~8-K~~stock ~~filed~~at ~~with~~an exercise price equal to the ~~SEC~~fair market value on ~~April~~the date of grant. The options vest over the five-year period following his resignation as Interim Chief Executive Officer ten years from the date of grant, whichever period ends first. On November 7, ~~2021~~2025, ~~Exhibit~~Mr. 10Osser resigned as a director of the Company.1.

~~9) Incorporated by reference to Milestone Scientific’s Proxy Statement on Schedule 14A filed with the SEC on April 30, 2021, Appendix A.~~Beneficial Ownership

~~10)~~Mr. Osser ~~Incorporated~~beneficially byowns ~~reference~~2,844,028 toshares ~~Milestone~~of ~~Scientific~~the Company’s ~~Form~~common ~~10-Q~~stock. ~~filed~~In ~~with~~addition, ~~the~~3,221,786 ~~SEC~~shares onare ~~August~~issuable ~~15,~~to ~~2022~~him upon termination of his employment agreement, ~~Exhibit~~subject 10to the terms thereof.1.

11Jan Adriaan (Arjan) ~~Incorporated by reference to Milestone Scientific’s Form 8-K filed with the SEC on December 12, 2023, Exhibit 1.1.~~Haverhals

12The Company entered into a consulting agreement with Jan Adriaan (Arjan) ~~Incorporated~~Haverhals by(the ~~reference~~“Consulting toAgreement”), ~~Milestone~~effective ~~Scientific’s~~January 1, ~~Form~~2025. ~~10Q~~The ~~filed~~Consulting Agreement continues for an indefinite term unless terminated in accordance with its terms. Either party may terminate the ~~SEC~~Consulting onAgreement ~~August~~upon 1590 days’ prior written notice. The Company may terminate the Consulting Agreement upon 30 days’ prior written notice in the event of Mr. Haverhals’ inability to provide services. Under the Consulting Agreement, ~~2022~~Mr. Haverhals is entitled to receive consulting fees at an annual rate of $350,000, ~~Exhibit~~payable 10monthly in arrears.1. For 2025, compensation was structured as follows:

13) Incorporated by reference to Milestone Scientific Form 8K filed with SEC on December 20, 2024. Exhibit 10.1.

	●	$150,000 for the first calendar quarter of 2025; and
	●	$67,000 for each subsequent calendar quarter of 2025.

~~14)~~The Company ~~Incorporated~~recorded byconsulting ~~reference~~expense of approximately $350,000 for the year ended December 31, 2025 related to ~~Milestone~~the ~~Scientific~~Consulting Agreement. Mr. Haverhals is entitled to reimbursement of reasonable expenses incurred in providing services. He serves as an independent contractor and is not eligible for Company-provided health or accident insurance, life insurance, paid sick leave, or paid vacation benefits. In connection with the Consulting Agreement, Mr. Haverhals entered into the Company’s ~~Form~~standard 10form of non-Kdisclosure, ~~for~~non-solicitation, non-competition, ~~the~~and ~~year~~invention ~~ended~~assignment agreement. As of December 31, ~~2023~~2025, ~~Exhibit~~the 10Company owed Mr.14 Haverhals approximately $89,000 under the Consulting Agreement, which is included in accounts payable — related party in the Company’s consolidated balance sheets.

~~15)~~Subsequent to ~~Incorporated~~December by31, ~~reference~~2025, Mr. Haverhals agreed to ~~Milestone~~waive ~~Scientific~~$66,000 of amounts payable to him, which had been included in accounts payable — related party. Pursuant to the Consulting Agreement, Mr. Haverhals is entitled to receive 912,736 shares of the Company’s ~~Form~~common ~~10-K~~stock ~~for~~six months following his resignation as Chief Executive Officer, subject to the ~~year~~terms ~~ended~~of the Consulting Agreement. As of December 31, ~~2023~~2025, ~~Exhibit~~such 19shares had not been issued.1.

~~16)~~Mr. Haverhals ~~Incorporated~~did bynot ~~reference~~stand tofor ~~Milestone~~re-election ~~Scientific~~as a director at Company’s ~~Form~~Annual ~~10-K~~Meeting ~~for~~of ~~the~~Stockholders ~~year~~held ~~ended~~on December 3118, ~~2023~~ 2025, ~~Exhibit~~Mr. 99Haverhals was not re-elected to the Board of Directors.1 and his term as a director expired at the conclusion of the Annual Meeting.

~~Item~~April 2025 ~~16. Form 10-K Summary~~Financing

~~None~~On April 9, 2025, the Company issued a series of promissory notes in the aggregate amount of $800,000 to Mr. Neal Goldman, Ms. Benedetta Casamento, and Dr. Didier Demesmin, each of whom is a director of the Company. The notes are due April 9, 2028, and bear interest at the annual rate of prime less 2.50%, payable annually. All principal and interest shall be payable in cash and/or shares of common stock at the sole discretion of the Company. The notes are convertible into shares of common stock by the holder at any time and by the Company at maturity. If the Company sells equity securities for gross proceeds in excess of $4,000,000, the holders may request repayment of their note in either cash, shares of common stock or a combination of cash and shares; provided, that the holders would then be entitled to receive only so much cash as the net proceeds to the Company in such sale of equity securities, after payment of other indebtedness and other uses (other than working capital) specified as a use of the proceeds in the relevant offering or disclosure documentation, shall be in excess of $4,000,000. Upon a liquidation event of the Company, as defined in the notes which includes a sale of the Company or assets, a merger, reorganization or combination transaction where the shareholders before the transaction own less than 50% of the Company after the transaction and a liquidation, dissolution or winding-up of the Company, the notes will be repaid in cash or its portion of any non-cash consideration. The conversion rate for any issuance of shares of common stock will be at the then fair value of a share of common stock, with the fair value being determined with reference to the public market price of a share of common stock, but not less than $0.50. The notes are unsecured and have typical default terms.

46 44

~~SIGNATURES~~Objective of Executive Compensation Program

InThe primary ~~accordance~~objectives ~~with~~of ~~Section 13~~the orCompany’s ~~15(d)~~executive ofcompensation ~~the~~program ~~Securities~~are ~~Exchange~~to ~~Act~~attract, ofretain ~~1934,~~and ~~the~~motivate ~~registrant~~qualified ~~caused~~and ~~this~~energetic executive ~~report~~officers who are committed to beadvancing ~~signed~~Milestone onScientific’s ~~its~~mission ~~behalf~~and bylong-term ~~the~~strategic ~~undersigned~~goals. The program is also designed to reward individual performance, ~~thereunto~~encourage ~~duly~~teamwork, ~~authorized~~and align management’s interests with those of stockholders by promoting an ownership-oriented culture.

~~Milestone~~The Compensation ~~Scientific~~Committee ~~Inc.~~of ~~By:~~the ~~/s/Neil~~Board ~~Goldman~~of ~~Chairman~~Directors ofis ~~the~~responsible ~~Board~~for reviewing and approving, ~~Interim~~or ~~Chief~~where ~~Executive~~appropriate ~~Officer~~recommending to the full Board for approval, ~~and~~the ~~Acting~~annual ~~Chief~~compensation ~~Accounting~~of ~~Officer~~the ~~(Principal~~Company’s Named Executive ~~and~~Officers ~~Accounting Officer~~(“NEOs”).

~~Date:~~The Company’s ~~April~~compensation ~~15,~~program ~~2025~~seeks to balance:

~~Pursuant~~● toCompetitive ~~the~~base ~~requirements~~compensation ofsufficient ~~the~~to ~~Securities~~attract ~~Exchange~~and ~~Act~~retain ofstrong ~~1934,~~leadership; ~~this~~● ~~report~~Performance-based ~~has~~incentives ~~been~~that ~~signed~~reward ~~below~~individual byand ~~the~~Company ~~following~~performance; ~~persons~~and on● ~~behalf~~Equity-based ofcompensation ~~the~~designed ~~registrant~~to ~~and~~align inexecutive ~~the~~interests ~~capacities~~with stockholders and onpromote ~~the~~long-term ~~dates~~value ~~indicated~~creation.

Signature	Date	Title
/s/ Neal Goldman	April 15, 2025	Chairman of the Board, Interim Chief Executive Officer and Acting Chief Accounting Officer (Principal Executive and Accounting Officer)
Neal Goldman
/s/ Leonard Osser	April 15, 2025	Vice Chairman and Director
Leonard Osser
/s/ Benedetta Casamento	April 15, 2025	Director
Benedetta Casamento
/s/ Michael McGeehan	April 15, 2025	Director
Michael McGeehan
/s/ Dr. Didier Demesmin	April 15, 2025	Director
Dr. Didier Demesmin
/s/ Arjan J. Haverhals	April 15, 2025	Director
Arjan J. Haverhals

In evaluating executive performance and determining compensation levels, the Compensation Committee considers a range of qualitative and quantitative factors, including:

47 ● Financial performance; ● Progress toward strategic objectives; ● Development of strategic business relationships; ● Leadership effectiveness and organizational development; and ● Individual contributions to Company performance.

~~REPORT INDEX~~While management TOmay ~~CONSOLIDATED~~provide ~~FINANCIAL~~recommendations ~~STATEMENTS~~to the Compensation Committee regarding executive compensation matters, the Compensation Committee retains full authority and does not delegate its compensation-setting responsibilities.

~~For~~The Company ~~the~~does ~~Years~~not ~~Ended~~currently ~~December~~engage ~~31,~~a ~~2024 and~~compensation ~~2023~~consultant to advise on executive or director compensation matters.

Report of Independent Registered Public Accounting Firm (PCAOB ID Number 688)	F-2
Consolidated Financial Statements:
Consolidated Balance Sheets	F-3
Consolidated Statements of Operations	F-4
Consolidated Statements of Changes in Stockholders’ Equity	F-5
Consolidated Statements of Cash Flows	F-6
Notes to Consolidated Financial Statements	F-7 -F-24

Annual compensation for the Chief Executive Officer generally consists of:

F● Base salary; ● Performance-1 based bonus (which may be payable in cash and/or equity); and ● Periodic grants of stock options under the Company’s equity incentive plan.

~~Report~~Stock option ofawards ~~Independent~~are ~~Registered~~granted ~~Public~~on ~~Accounting~~a ~~Firm~~discretionary basis, rather than pursuant to a formula, taking into account individual performance, role, market conditions and long-term retention considerations.

ToThe Compensation ~~the~~Committee ~~Shareholders~~considers both current and ~~Board~~prior ofcompensation ~~Directors~~when ofdetermining future compensation adjustments. The Company also considers market practices among companies that compete for executive talent, recognizing that compensation elements such as base salary, bonus and equity awards are commonly used in the marketplace.

~~Milestone~~The Compensation ~~Scientific~~Committee has not historically based annual compensation decisions solely on short-term stock price performance, ~~Inc~~recognizing that the Company’s stock price may be influenced by external factors beyond management’s direct control. However, equity-based compensation is intended to align executive interests with long-term stockholder value. The Company does not employ a fixed formula to determine the allocation between cash and non-cash compensation. Instead, compensation decisions are made based on the Compensation Committee’s judgment, taking into account the Company’s financial condition, market conditions, competitive positioning, and retention objectives.

~~Opinion on the Financial Statements~~45

WeOutstanding Equity ~~have~~Awards ~~audited the accompanying consolidated balance sheets of Milestone Scientific, Inc. (the “Company”) as of~~ on December 31, 2024 and 2023, the related consolidated statements of operations, stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2024, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2024, in conformity with accounting principles generally accepted in the United States of America.2025

Basis for Opinion

Name	Number of Securities Underlying Unexercised Options (#) Exercisable (1)		Number of Securities Underlying Unexercised Options (#) Unexercisable (1)		Option Exercise Price ($)		Option Expiration Date	Number of Shares or Units of Stock that have not vested (#) (2)		Market Value of Number of Shares or Units of Stock that have not vested (#) (3)
Eric Hines		200,000		1,800,000	$	0.50	8/1/2035		-	$	-
Total		200,000		1,800,000					-	$	-
Jason Papes		200,000		1,800,000	$	0.45	8/6/2035		-	$	-
Total		200,000		1,800,000					-	$	-
Leonard Osser		1,600,000		400,000	$	2.47	4/23/2031		3,221,786	$	869,882
		32,175		-	$	3.11	2/9/2026		-	$	-
Total		1,632,175		400,000					3,221,786	$	869,882

Filing Compare · MILESTONE SCIENTIFIC INC.