What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2025-04-15 compared with 2024-03-29 · 49 added, 26 removed, 157 unchanged (32% of the section changed)

1 unchanged sentence

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.

Our proprietary DPS Dynamic Pressure Sensing technology is our technology platform that advances the development of next-generation devices.

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.

Our 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 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.

1 unchanged sentence

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.

In addition, we have obtained CE mark approval for certain medical devices, which can be marketed and sold in most European countries.

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;

31 unchanged sentences

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, 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 can accelerate the commercial roll-out of CompuFlo in the United States.

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.

Other Possible Products

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.

2 unchanged sentences

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.

European Conflicts

Sanctions imposed by the United States and other western democracies, because of the conflicts throughout Europe, and any expansion thereof, is likely to have unpredictable and wide-ranging effects on the domestic and global economy and financial markets, which could have an adverse effect on our business and results of operations.

As direct impact from the conflict, we have experienced a decrease in international sales to Ukraine and halted all sales to Russia.

We will continue to monitor the situation carefully and, if necessary, take action to protect our business, operations, and financial condition.

Patents and Intellectual Property

26 unchanged sentences

Dental Products

The Company uses a combination of exclusive and non-exclusive distributors to sell its dental products.

In 2022, the Company began a process of identifying, qualifying and signing non-exclusive dental distribution arrangements with dental distributors in specific geographical locations in the United States and Canada.

As of December 31, 2023, there is one non-exclusive dental distributors engaged in Canada and no non-exclusive dental distributors in the United States

As of January 3, 2023, the Company launched an E-Commerce platform, selling and shipping STA Single Tooth Anesthesia Systems® (STA) and handpieces, directly to dental offices and dental groups within the United States.

Our E-commerce portal accepts online payments via credit and debit cards.

The cost of delivery is charged to the customer along with appropriate sales tax.

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

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.

2 unchanged sentences

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 CTI a medical products distributor covering 22 states.

As of this filing, there is no subcutaneous drug delivery platform or device on the market regulating the flow rate and pressure of an injection capable of delivering a painless injection at the desired location like Milestone Scientific’s proprietary, patented devices having our DPS Dynamic Pressure Sensing technology.

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.

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, the Calajet from Aseptico, and the Comfort Control Syringe by Dentsply.

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

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.

9 unchanged sentences

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

The instrument is a higher price than the Wand STA and does not provide dynamic pressure sensing technology.

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 the newest competitor in the market.

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.

The EpiFaith Syringe claims to assist physicians in entering epidural space.

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.

Although a potential competitor, we believe that our technology is well documented and is the only pressure sensor guidance system for epidural analgesia assisting the physician over the entire trajectory of epidural needle placement and catheter verification.

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.

62 unchanged sentences

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