NYSE: MLSS

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 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 continue to provide painless delivery benefits. 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. 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 deliver the drug.

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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 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. 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 commercial introduction in early 2007, the STA Single Tooth Anesthesia (STA) System, together with its predecessor C-CLAD devices,
has been used to administer more than 95 million injections globally. The system is designed to provide controlled delivery of local
anesthetic and has been utilized in a broad range of dental procedures. The STA Instrument has been evaluated in multiple peer-reviewed
clinical studies and published articles. Feedback from practitioners and published literature indicate that the technology has been incorporated
into clinical practice in 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

As
of 2025, the CompuFlo® Epidural System has received 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 facilitate tracking and reimbursement submissions when the system is
used in conjunction with 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 and Europe in 2024 related to its next-generation Dynamic Pressure Sensing® technology.

Other
Possible Product Applications

The
Company is exploring additional potential applications for its Dynamic Pressure Sensing® (“DPS”) technology platform
in various medical settings. These areas may include certain surgical and procedural specialties, as well as potential applications in
the self-injection drug market, where patients administer injectable therapies for chronic conditions at home or in clinical environments.

Development
of new product applications is subject to significant technical, clinical, regulatory, and commercial 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.

There
can be no assurance that the Company will successfully develop additional products or indications, obtain necessary regulatory clearances
or approvals from the U.S. Food and Drug Administration (“FDA”) or other regulatory authorities, secure reimbursement coverage,
achieve market acceptance, or generate revenue from any such initiatives. Failure to successfully develop and commercialize new applications
could adversely affect the Company’s future growth prospects.

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Milestone
Scientific and its subsidiaries also hold approximately 10 registered U.S. and foreign trademarks, including CompuDent®, CompuFlo®,
DPS Dynamic Pressure Sensing® technology, Safety Wand®, STA Single Tooth Anesthesia System®, and The Wand®.

The
Company relies on a combination of patent, copyright, trade secret, and trademark laws, as well as employee and third-party nondisclosure
agreements, to protect its intellectual property rights. Despite these efforts, unauthorized parties may attempt to reverse engineer,
copy, or otherwise obtain and use technologies or information that the Company considers proprietary, or may develop competing products
that serve similar purposes without infringing the Company’s patents. Failure to adequately protect the Company’s proprietary
information, as well as the costs associated with such protection, could have a material adverse effect on 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

The
Company relies on third-party manufacturers for the production of its products. The Wand®/STA® System and epidural devices are
manufactured by a U.S.-based supplier pursuant to individual purchase orders without minimum volume commitments. Dental handpieces are
sourced from a manufacturer located in the People’s Republic of China under an agreement that includes pricing terms. The Company
has maintained long-standing relationships with these manufacturers.

The
Company’s dependence on a limited number of suppliers exposes it to risks, including pricing changes, supply disruptions, quality
issues, geopolitical factors, and termination of manufacturing relationships. Any interruption or inability to obtain an adequate supply
could materially and adversely affect the Company’s business, financial condition, and results of operations. See Item 1A, “Risk
Factors.”

Distribution
and Marketing

Dental
Products

The
Company markets and sells its dental products worldwide through a combination of exclusive and non-exclusive distribution arrangements.

In
the United States, the Company sells its STA Single Tooth Anesthesia Systems® and related handpieces directly to dental offices and
dental groups through an online sales portal. The Company’s e-commerce platform accepts electronic payments, including credit and
debit cards. Shipping costs are billed to customers, and applicable state and local sales taxes are collected.

Internationally,
the Company has granted exclusive marketing and distribution rights for the Wand STA System to select dental suppliers in certain regions
of Asia, Africa, South America, and Europe. The Company periodically evaluates its international distribution arrangements and may add,
replace, or expand distributor relationships based on commercial and regional economic considerations. The Company continues to assess
opportunities to appoint additional distributors globally as market conditions warrant.

Medical
Products

The
Company is engaged in the marketing and sale of medical products to customers in domestic and international markets. The Company’s
commercialization strategy is designed to support broad market access while maintaining operational efficiency and includes a combination
of direct sales efforts and third-party distribution 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.

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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 commercialize a product designed to deliver a virtually painless subcutaneous injection, which
it introduced in 1997. With the launch of this technology, the Company established a new category of computer-controlled drug delivery
systems. Since that time, competing products have entered the market; however, the Company believes that its products have been more
extensively studied and adopted than competing alternatives, as evidenced by the number of scientific and clinical studies evaluating
the Company’s technologies.

Milestone
Scientific developed the first subcutaneous drug delivery platform that regulates and monitors both flow rate and exit pressure in real
time during injection. This proprietary approach enables the delivery of anesthetic solutions in a manner designed to minimize patient
discomfort. The Company’s patented Dynamic Pressure Sensing (“DPS”) technology further allows for the identification
of specific anatomical targets by providing real-time feedback during injection.

The
Company’s devices compete primarily on performance characteristics and the clinical and operational benefits provided to patients
and practitioners. Clinical studies evaluating the Company’s products have demonstrated reductions in patient fear, pain, and anxiety
associated with injections. The Company believes these benefits may also reduce practitioner stress and improve workflow efficiency.

In
the dental market, the Company competes with other computer-controlled local anesthesia delivery (“C-CLAD”) systems, including
the Soan, Quicksleeper, and SleeperOne devices manufactured by Dental Hi Tec, Dentapen by Septodont, Anaeject by Septodont, the Calaject
system by Aseptico, and the Comfort Control Syringe by Dentsply Sirona. These competing systems vary in design, functionality, price,
and market penetration.

Certain
competing devices incorporate motor-driven mechanisms to facilitate intraosseous injections or bone perforation. For example, the Quicksleeper
system, originally developed in France, integrates a motorized handpiece that allows both injection and bone perforation but is heavier
than a standard dental syringe and provides limited operator control over injection speed. Other devices emphasize specific use cases,
such as pediatric intraosseous injections, or have experienced limited market adoption due to distribution constraints or clinical preference.

In
the medical market, the Company’s products compete with devices designed to assist clinicians in identifying anatomical targets
during procedures such as epidural placement. Recent competitors include the EpiFaith syringe, Episure syringe, Epidrum device, and the
EpiFinder system, which received U.S. FDA clearance in 2023. These devices employ varying technologies and approaches, including loss-of-resistance
methods and sensor-based detection. The Company believes that its DPS technology is differentiated by providing continuous real-time
audible and visual pressure feedback throughout the entire needle insertion process.

The
Company’s proprietary systems also compete with conventional disposable and reusable syringes that utilize established manual techniques
and are generally offered at lower price points in both the dental and medical markets.

The
markets 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 or render them less competitive. Accordingly, the Company devotes significant resources to improving existing products, developing
new technologies, expanding into adjacent markets, and maintaining regulatory compliance. The Company’s ability to compete successfully
also depends on maintaining an effective distribution network and executing a comprehensive marketing strategy. There can be no assurance
that the Company will successfully develop new products, obtain required regulatory approvals, or maintain its competitive position in
the marketplace.

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.

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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 may also 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 ensure the safety and effectiveness of medical devices reasonably. 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 that 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.

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.

Though
certain dental and medical devices have received FDA marketing clearance, there can be no assurance that any of the other medical devices
under development will obtain the required regulatory clearance promptly, or at all. If regulatory clearance of a product is granted,
such clearance may entail limitations on the indicated uses for which the product may be marketed. In addition, modifications may be
made to the products to incorporate and enhance their functionality and performance based upon new data and design review. There can
be no assurance that the FDA will not request additional information relating to product improvements; that any such improvements would
not require further regulatory review, thereby delaying the testing, approval, and commercialization of product improvements; or that
ultimately any such improvements will receive FDA clearance.

The
FDA’s regulations applicable to manufacturers of medical devices have historically included Quality System Regulation (“QSR”),
requiring, among other things, the establishment and maintenance of procedures governing design controls, testing, quality control, documentation,
and corrective and preventive actions. Failure to comply with applicable QSR requirements may result in enforcement actions by the FDA,
including warning letters, product recalls, suspension or termination of production, and the imposition of fines or other penalties.
Failure to comply with applicable QSR requirements may result in enforcement actions by the FDA, including warning letters, product recalls,
suspension or termination of production, and the imposition of fines or other penalties. Medical devices must also be manufactured in
establishments that are registered with the FDA and are subject to periodic inspection. In addition, labeling and promotional activities
are subject to regulation and oversight by the FDA and, with respect to advertising and marketing claims, in certain circumstances by
the Federal Trade Commission. The export of medical devices is also subject to FDA and other applicable 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.

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The
QMSR is less of a wholesale rewrite and more of a strategic refinement of existing quality expectations. A primary change is the updating
of terminology, with the ISO concept of a Medical Device File replacing the QSR’s Device Master Record. More substantively, the
new rule makes risk management a clear, enforceable expectation across the entire product life cycle. Similarly, it strengthens supplier
and purchasing controls, with both contract manufacturers and component providers now subject to greater scrutiny and more rigorous oversight.
The new framework positions documented evidence, from training records to complaint files, as the undisputed cornerstone of compliance.
This heightened emphasis on robust and accessible documentation underscores the shift towards a more proactive, evidence-based approach
to quality.

For
firms already operating in international markets, including the Company, their international operations are already operating under ISO
13485, and the adoption of the QMSR is expected to reduce duplication in audits and documentation. However, to better confirm compliance
of the Company’s domestic quality control procedures with the new QMSR, the Company conducted a gap assessment, benchmarking
QSR-based systems against the requirements of ISO 13485 and the QMSR. This analysis has informed necessary updates to domestic
standard operating procedures, the quality manual and related compliance documentation. The Company has implemented the additional controls and process enhancements identified through this evaluation, and is 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

As
of the most recent reporting period, the Company employed a total of 15 full-time employees. In addition, the Company employs a consultant
who serves as Director of Clinical Affairs. The Company’s employees support key functions including research and development, engineering,
regulatory affairs, sales and marketing, finance, and 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.