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Item 1. Business

2026-03-31 compared with 2025-04-15 · 391 added, 196 removed, 10 unchanged (98% of the section changed)

Milestone Scientific was incorporated in the State of Delaware in August 1989.

Milestone Scientific has developed a proprietary, revolutionary, computer-controlled anesthetic delivery device, its 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 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 joint injections.

The Company’s device, using The Wand®, a single use disposable handpiece, is marketed in dentistry under the trademarks CompuDent ® and STA Single Tooth Anesthesia System ®, and is suitable for all dental procedures that require local anesthetic.

The dental devices are currently sold in the United States, Canada and in over 41 other countries.

Milestone Scientific also has 510(k) marketing clearance from the U.S.

Food and Drug Administration (FDA) on the CompuFlo ® Epidural Computer Controlled Anesthesia System in the lumbar thoracic and cervical thoracic junction of the spinal region.

The Company’s current marketing focus is distribution using its E-Commerce platform;

however, it is also in the process of meeting with medical facilities and device distributors within the United States, Middle East and Europe so as to develop other channels of distribution.

Certain of our medical instruments have obtained European CE mark approval and can be marketed and sold in most European countries.

DPS Dynamic Pressure Sensing Technology;

Scientific Inc.

was incorporated in the State of Delaware in August 1989.

The Company develops and commercializes proprietary computer-controlled

drug delivery systems designed to enhance the safety, precision, and patient experience associated with subcutaneous injections and fluid

aspiration procedures.

Company’s core technology platform, Dynamic Pressure Sensing® (“DPS”) Technology, controls flow rate and measures

pressure at the needle tip in real time.

DPS Technology is incorporated into both the Company’s dental and medical products and

supports clinical applications, including local anesthesia delivery, epidural space identification in regional anesthesia procedures,

and intra-articular joint injections.

the dental market, the Company’s products are marketed under the CompuDent® and STA Single Tooth Anesthesia System® trademarks

and utilize The Wand®, a single-use disposable handpiece.

These products are sold in the United States, Canada, and more than 40

other countries.

In the medical market, the Company has received U.S.

Food and Drug Administration (“FDA”) 510(k) clearance

for its CompuFlo® Epidural Computer Controlled Anesthesia System for use in specified regions of the spine.

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.

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 to provide painless delivery benefits, while 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 accurately and precisely delivery 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 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 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 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.

Medical Market Product

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

In May, 2022, the Company received a chronology-specific CPT Code for 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.

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 the use of CompuFlo ’s DPS Dynamic Pressure Sensing Technology for less painful injections for use in rhinoplasty, colorectal surgery, podiatry, and other disciplines.

In the self-injectable market, there are 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 diseases of the auto immune system.

We believe CompuFlo ’s DPS Dynamic Pressure Sensing Technology, using pressure sensing capabilities, can serve as a less painless subcutaneous injection method for these self-administered drugs.

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, or even if we do obtain such FDA approval, that any such products will generate any revenue for us or be a commercial success.

Patents and Intellectual Property

Milestone Scientific and its subsidiaries currently hold approximately 317 U.S.

and foreign patents, and many patent applications.

The Company’s patents and patent applications relate to drug delivery methodologies, 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, drug delivery injection unit, drug drive unit for anesthetic, handpiece, and injection device.

Milestone Scientific and its subsidiaries also currently hold approximately 21 registered U.S.

and foreign trademarks, including CompuDent ® , CompuFlo ® , DPS Dynamic Pressure Sensing technology ® , Safety Wand ® , STA Single Tooth Anesthesia System ® , and The Wand ®

Milestone Scientific relies on a combination of patent, copyright, trade secret and trademark laws and employee and third-party non-disclosure agreements to protect its intellectual property rights.

Despite the precautions taken by Milestone Scientific to protect its IP rights, unauthorized parties may attempt to reverse engineer, copy, or obtain and use products and information that Milestone Scientific regards as proprietary, or may design products 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 business, financial condition, and results of operations.

If Milestone Scientific’s products infringe upon patent or proprietary rights of others, we may be required to modify processes or to obtain licenses.

There can be no assurance that Milestone Scientific would be able to do so in a timely manner, on acceptable terms and conditions, or at all.

The failure to do so could have a material adverse effect on our business, financial condition, and results of operations.

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.

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.

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.

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.

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.

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.

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.

Epidural Computer Controlled Anesthesia System

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.

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

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.

Dental Product

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.

and Intellectual Property

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;

drive units for anesthetics;

and injection devices.

Market Product

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.

Possible Product Applications

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.

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.

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.

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®.

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.

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 Scientific has informal arrangements with an U.S.

manufacturer of the Wand/STA System, and epidural devices.

Pursuant to these informal arrangements, our third-party manufacturer manufactures the Wand/STA System under specific purchase orders without minimum purchase commitments, and at prices to be agreed upon in each such purchase order.

Our agreement with the principal manufacturer of dental handpieces includes pricing terms.

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 dental handpieces since 2003.

The manufacturer of our dental handpieces is in the People’s Republic of China and the manufacturer of the Wand/STA System is in the United States.

Refer 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 a combination of exclusive and non-exclusive distributors to sell its dental products throughout the world.

The Company sells its STA Single Tooth Anesthesia Systems® (STA) and handpieces directly to dental offices and dental groups within the United States via an online portal.

The Company's E-Commerce portal accepts online payments via credit and debit cards.

The cost of delivery is charged to the customer along with the collection of sales tax for appropriate state and local taxing jurisdictions.

The Company recognizes revenue from product sales at the time the product ships to a customer via a third party carrier.

On the global front, we have granted exclusive marketing and distribution rights for the Wand STA System to select dental suppliers in various regions within Asia, Africa, South America, and Europe.

Additionally, the Company is in the process of evaluating its current international distributors and adding new distributors globally as required based on the economics of the region.

Medical Products

The Company markets and sells its medical products in the international markets, including Italy, Switzerland, Greece, Canada and the Middle East, through exclusive distributors.

In the United States the medical products are sold by a direct sales team of one full time employee and a partnership with distributor.

Milestone Scientific, Inc.

was the first to market a product that performed a virtually painless subcutaneous injection back in 1997.

The company defined a new category of drug delivery systems with the introduction of its technology.

Over the years there have been competing products that have come to market but none to them to date have been studied and accepted as widely as the products from Milestone Scientific.

This understanding is based on the sheer number of scientific studies performed with our technologies.

A simple internet search proves this point.

Milestone Scientific, Inc.

continues to be the leader in this category.

Milestone’s has developed the first subcutaneous drug delivery platform that utilizes a novel approach to drug delivery by regulating and monitoring both the flow rate and exit-pressure in real-time when performing a subcutaneous injection.

This has enabled an injection to be performed as a virtually painless injection.

In addition, this same technology is capable of identifying a specific target when performed, this patented technology is called DPS technology or Dynamic Pressure Sensing technology.

Milestone Scientific’s devices compete based on their performance characteristics and the benefits provided to the patient, practitioner, and their business operations.

Numerous clinical studies have shown that our devices reduce fear, pain and anxiety for many patients, and Milestone Scientific believes that they can reduce practitioner stress levels, as well.

Other computer-controlled local anesthesia delivery (C-CLAD) options are the Quicksleeper and SleeperOne, from Dental Hi Tec, Dentapen from Septodant, Anaeject from Septodont, the Calajet from Aseptico, and the Comfort Control Syringe by Dentsply.

The Quicksleeper was invented in France by Dr.

Alain Villette in 1991.

It is marketed as the only local anesthetic delivery device in France that allows the ability to perform all intraoral local anesthetic injection techniques, including osteocentral anesthesia, quickly and without failure.

The extra feature that gives the Quicksleeper this ability is a built-in motor in the syringe/handpiece that renders the syringe both an injector and a perforator of bone.

That is, the handpiece of the Quicksleeper can perform an intraosseous injection via a motor driven perforation of the cortical plate of bone.

A standard dental needle that attaches to the syringe spins as the motor rotates the handpiece thus acting as a perforator.

However, the handpiece is relatively heavy, weighing 240 g.

as compared to a standard syringe that weighs 80 g.

Injection speed increases during the injection, but the operator cannot control when the injection speed increases.

The Calajet instrument, manufactured in Europe, has been very slow to grow market acceptance.

It recently began marketing in the United States with similar slow acceptance.

The instrument is a does not provide dynamic pressure sensing technology to identify a specific target by providing real-time audible feedback when the actual target is identified .

Although a competitor, we believe that without a substantial distribution network this instrument will have a difficult time to be successful in the United States.

The Dentapen from Septodent is one of the more recent competitor in the market.

This device is manufactured in Europe and began marketing in the United States in 2018.

This device is priced like the Wand/STA device, but currently, to our knowledge, it has been slow to attract viable distribution in the United States.

In the medical segment, for needle verification and placement the EpiFaith Syringe made its market entry in 2023.

The EpiFaith syringe and Episure syringe both claim to assist physicians in entering epidural space.

The instrument is introduced at a lower price.

Another competitor to assist in the identification of the epidural space is the Epidrum (Exmoor Innovations Ltd., Somerset, UK).

Although potential competitors, we believe that our technology is well documented and is 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.

Milestone Scientific’s proprietary, patented devices with its DPS Dynamic Pressure Sensing Technology platform also compete with disposable and reusable syringes that generally sell at lower prices and that use established and well-understood methodologies in both the dental and medical marketplaces.

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.

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.

has maintained long-standing relationships with these manufacturers.

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

and Marketing

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

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

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.

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.

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.

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

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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 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.

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”)

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.

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.

Prior to Pre-market Notification clearance, the manufacturer or distributor may not place the device into commercial distribution until an order is issued by the FDA.

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.

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 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 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.

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 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 us to commercialize other 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.

As a result, other manufacturers of injection devices could more easily enter the dental market.

However, we believe that any new device will be very limited in sales volume without a significant distributor in the dental market.

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 in a timely manner, 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.

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.

Milestone Scientific is subject to pervasive and continuing regulation by the FDA, whose regulations require manufacturers of medical devices to adhere to certain QSR requirements as defined by the FD&C Act.

QSR compliance requires testing, quality control and documentation procedures.

Failure to comply with QSR requirements can result in the suspension or termination of production, product recall or fines and penalties.

Products also must be manufactured in registered establishments.

In addition, labeling and promotional activities are subject to scrutiny by the FDA and, in certain circumstances, by the Federal Trade Commission.

The export of devices is also subject to regulation in certain instances.

Human Capital

The Company has a total of 17 full-time employees, including one executive officer.

Milestone Scientific also has a consultant who serves as a Director of Clinical Affairs.

None of our employees are subject to a collective bargaining agreement and we believe our employee relations are good.

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.

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.

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;

ultimately any such improvements will receive FDA clearance.

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.

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.

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

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.

with applicable regulatory requirements is subject to continual review and is monitored through periodic inspections by the FDA.

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

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.

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.

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.

Company believes that its future success depends, in part, on its ability to attract, retain, and motivate qualified personnel.

evaluates workforce needs on an ongoing basis to ensure that human capital resources are aligned with operational requirements and strategic

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.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business