−Removed: Market for Common Equity, and Related Stockholder Matters and Small Business Issuer Purchases of Equity Securities
−Removed: Market Information
−Removed: Since June 1, 2015, our common stock has been listed on the NYSE American under the symbol “MLSS”.
−Removed: The following table sets forth the high and low sales prices of Milestone’s common stock for the periods presented.
+Added: Market for Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities
+Added: common stock has been listed on the NYSE American under the symbol “MLSS” since June 1, 2015.
+Added: The trading prices of our common
+Added: stock have historically been volatile and may continue to fluctuate significantly, as discussed in “Item 1A.
+Added: Risk Factors”
+Added: Management’s Discussion and Analysis of Financial Condition and Results of Operations.”
+Added: following table sets forth the quarterly high and low sales prices of our common stock as reported on the NYSE American for the periods
First Quarter
6 unchanged sentences
Fourth Quarter
−Removed: As of March 27, 2024, we had approximately 97 stockholders of record of our common stock.
−Removed: We believe that, in addition to the record owners, we have approximately 3,488 beneficial owners of our common stock.
−Removed: The holders of common stock are entitled to receive such dividends as may be declared by Milestone Scientific’s Board of Directors.
−Removed: Milestone Scientific has not paid and does not expect to declare or pay any dividends in the foreseeable future.
−Removed: Sales of Unregistered Securities
−Removed: Not applicable.
+Added: market price of our common stock may be influenced by factors discussed elsewhere in this Annual Report, including our operating results,
+Added: liquidity position, capital-raising activities, product commercialization progress, regulatory developments, and general market conditions.
+Added: of March 31, 2026, there were approximately 92 holders of record of our common stock.
+Added: We believe there were approximately 3,507 beneficial
+Added: owners of our common stock at that date.
+Added: Because brokers and other nominees hold many shares, the number of beneficial owners may differ
+Added: from the number of holders of record.
+Added: have never declared or paid cash dividends on our common stock.
+Added: We do not currently intend to declare or pay dividends in the near future.
+Added: We anticipate that any future earnings, if any, will be retained to support our operations, fund product development and commercialization
+Added: efforts, and strengthen our financial position.
+Added: The payment of dividends, if any, will be at the discretion of our Board of Directors
+Added: and will depend on our operating results, financial condition, capital requirements, and other factors deemed relevant by the Board.
+Added: of Unregistered Securities
+Added: Purchases of Equity Securities
Selected Financial Data
−Removed: Milestone Scientific is a “smaller reporting company” as defined by Regulations S-K and as such, is not required to provide the information contained in this item pursuant to Regulation S-K.
−Removed: Management ’ s Discussion and Analysis of Financial Condition and Results of Operations
−Removed: The following discussions of the financial condition and results of operations should be read in conjunction with the financial statements and the notes to those statements included elsewhere in this annual report.
−Removed: Certain statements in this discussion and elsewhere in this report constitute forward-looking statements, within the meaning of section 21E of the Exchange Act, which involve risks and uncertainties.
−Removed: The actual results may differ materially from those anticipated in these forward-looking statements.
−Removed: See "Risk Factors" elsewhere in this Form 10-K.
−Removed: Milestone Scientific is a biomedical technology company that patents, designs, develops and commercializes innovative diagnostic and therapeutic injection technologies and devices for medical and dental use.
−Removed: Since our inception, we have engaged in pioneering proprietary, innovative, computer-controlled injection technologies, and solutions for the medical and dental markets.
−Removed: We believe our technologies are proven and well established.
−Removed: Our common stock was initially listed on the NYSE American on June 1, 2015, and trades under the symbol “MLSS".
−Removed: We have focused our resources on redefining the worldwide standard of care for injection techniques by making the experience more comfortable for the patient by reducing the anxiety and stress of receiving injections from the healthcare provider.
−Removed: Our computer-controlled injection devices make injections precise, efficient, and virtually painless.
−Removed: We have developed a proprietary, revolutionary, computer-controlled anesthetic delivery device, our DPS Dynamic Pressure Sensing Technology® System, to meet the needs of various subcutaneous drug delivery injections and fluid aspiration – enabling healthcare practitioners to achieve multiple unique benefits that cannot currently be accomplished with the 160-year-old manual syringe.
−Removed: Our proprietary DPS Dynamic Pressure Sensing technology is our technology platform that advances the development of next-generation devices.
−Removed: 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.
−Removed: It has specific medical applications for epidural space identification in regional anesthesia procedures.
−Removed: Our device, The Wand®, a single use disposable handpiece, is marketed in dentistry under the trademark CompuDent®, and STA Single Tooth Anesthesia System® and is suitable for all dental procedures that require local anesthetic.
−Removed: The dental devices currently are sold in the United States, Canada and in over 41 other countries.
−Removed: Milestone Scientific also has 510(k) marketing clearance from the U.S.
−Removed: Food and Drug Administration (FDA) on the CompuFlo® Epidural Computer Controlled Anesthesia System in the lumbar, thoracic and cervical thoracic junction of the spine region.
−Removed: In addition, Milestone Scientific has obtained CE mark approval and can be marketed and sold in most European countries.
−Removed: Our recent receipt of chronology-Specific CPT Code for the Company's technology by the American Medical Association marks an important milestone, that could increase the potential number of anesthesia pain management clinics adopting the CompuFlo instrument.
−Removed: 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 U.S
−Removed: Milestone Scientific and its subsidiaries currently hold over 317 U.S.
−Removed: and foreign patents, and many patents pending and patent applications.
−Removed: The Company’s patents and patent applications relate to drug delivery methodologies, Peripheral Nerve Block, drug flow rate measurement, pressure/force computer-controlled drug delivery with exit pressure, dynamic pressure sensing, automated rate control, automated charging, drug profiles, audible and visual pressure/force feedback, tissue identification, identification of a target region drug delivery injection unit, drug drive unit for anesthetic, handpiece, and injection device.
−Removed: Milestone Scientific remains focused on advancing efforts to achieve the following three primary objectives:
−Removed: Establishing Milestone’s DPS Dynamic Pressure Sensing technology platform as the standard-of-care in painless and precise drug delivery, providing for the first time, objective visual and audible in-tissue pressure feedback, and continuing to expand platform applications;
−Removed: Following obtaining successful FDA clearance of our first medical device, Milestone Scientific is transitioning from a research and development organization to a commercially focused medical device company;
−Removed: Expanding our global footprint of our CompuFlo Epidural and CathCheck System by utilizing a targeted field sales force and partnering with distribution companies worldwide.
−Removed: Our dental devices have been used to administer over 95 million injections worldwide.
−Removed: Each of our devices has a related single use disposable handpiece, leading to a continuing revenue stream following the sale of the device.
−Removed: At present, we sell disposable handpieces unique to our legacy product (the Wand and CompuDent) to users who have not upgraded to our current dental product, the STA Single Tooth Anesthesia System.
−Removed: Building on the success of our proprietary, core technology platform for dental injections, and desiring to pursue other growth opportunities, we have begun to expand the uses and applications of our proprietary, patented technologies to achieve greater operational efficiencies, enhanced patient safety and therapeutic adherence, patient satisfaction, and improved quality of care across a broad range of medical specialties.
−Removed: We intend to continue to expand the uses and applications of our DPS Dynamic Pressure Sensing technology.
−Removed: We believe that we and our technology solutions are recognized by key opinion leaders (i.e., academics, anesthesiologists and practicing dentists whose opinions are widely respected), industry experts and medical and dental practitioners as a leader in the emerging, computer-controlled injection industry.
−Removed: The Single Tooth Anesthesia System (Dental)
−Removed: 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.
−Removed: The instrument has also been favorably evaluated in numerous peer-reviewed, published clinical studies and associated articles.
−Removed: 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.
−Removed: Medical Market Product
−Removed: In June 2017, we received FDA regulatory clearance to sell the CompuFlo Epidural Computer Controlled Anesthesia System in the United States for epidural injections.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: The approval includes the lumbar, thoracic, and cervical-thoracic junction of the spine.
−Removed: On July 10, 2024, the Company announced that First Coast Service Options Inc.
−Removed: (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).
−Removed: On July 23, 2024 the Company announced that Novitas Solutions, Inc.
−Removed: (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:
−Removed: Jurisdiction L (JL) and Jurisdiction H (JH).
−Removed: JL includes Delaware, District of Columbia, Maryland, New Jersey, and Pennsylvania.
−Removed: JH includes Arkansas, Colorado, Louisiana, Mississippi, New Mexico, Oklahoma, and Texas.
−Removed: On July 30, 2024, the Company announced receipt of multiple Notices of Allowance (NOA) for essential patent applications in both the U.S.
−Removed: One NOAs was granted by the U.S.
−Removed: 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
−Removed: On August 7, 2024, the Company announced a strategic partnership with Axial Biologics, a premier medical device company with a vast distribution network.
−Removed: Under the agreement, Axial Biologics will serve as the distributor of Milestone Scientific's CompuFlo® Epidural System in New Jersey, Texas, and Florida jurisdictions.
−Removed: On October 3, 2024, the Company announced that iHeal Pain Center had adopted the CompuFlo® Epidural System following successful epidural steroid injection (ESI).
−Removed: 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.
−Removed: The following table shows a breakdown of Milestone Scientific’s product sales (net), domestically and internationally, by business segment product category:
+Added: are a “smaller reporting company,” as defined by Rule 12b-2 of the Securities Exchange Act of 1934 and Regulation S-K.
+Added: we are not required to provide the selected financial data specified in Item 301 of Regulation S-K.
+Added: Management believes that the consolidated
+Added: financial statements and related disclosures included elsewhere in this Annual Report provide sufficient information to understand our
+Added: financial condition, results of operations, and liquidity.
+Added: Discussion and Analysis of Financial Condition and Results of Operations
+Added: following discussion and analysis of the Company’s financial condition and results of operations should be read in conjunction
+Added: with the consolidated financial statements and related notes included elsewhere in this Annual Report on Form 10-K.
+Added: This discussion contains
+Added: forward-looking statements that involve risks and uncertainties.
+Added: Actual results may differ materially from those anticipated in these
+Added: forward-looking statements as a result of various factors, including those discussed under “Risk Factors” in this Form 10-K.
+Added: Scientific, Inc.
+Added: is a biomedical technology company that patents, designs, develops, and commercializes innovative diagnostic and therapeutic
+Added: injection technologies and devices for medical and dental use.
+Added: Since its inception, the Company has focused on pioneering proprietary,
+Added: computer-controlled injection technologies intended to improve the standard of care by making injections more precise, efficient, and
+Added: more comfortable for patients.
+Added: Company’s proprietary Dynamic Pressure Sensing® (DPS) technology platform enables real-time pressure monitoring and controlled
+Added: fluid delivery during injections.
+Added: This platform serves as the foundation for the Company’s dental and medical product offerings.
+Added: It supports multiple applications, including local anesthesia delivery, subcutaneous drug delivery, fluid aspiration, and epidural space
+Added: identification.
+Added: Scientific’s common stock has been listed on the NYSE American since June 1, 2015, and trades under the symbol “MLSS.”
+Added: Scientific remains focused on advancing the following primary objectives:
+Added: ● Establishing
+Added: the DPS Dynamic Pressure Sensing technology platform as a standard-of-care for precise and
+Added: comfortable drug delivery, with objective visual and audible in-tissue pressure feedback;
+Added: ● Transitioning
+Added: from a research-and-development-focused organization to a commercially oriented medical device
+Added: company following FDA clearance of its medical products, and
+Added: the global footprint of the Company’s CompuFlo® Epidural and CathCheck® systems
+Added: through a targeted sales strategy and strategic distribution partnerships.
+Added: and Technology Platform
+Added: Market Products
+Added: its commercial introduction in early 2007, the STA Single Tooth Anesthesia (STA) System, together with its predecessor C-CLAD devices,
+Added: has been used to administer more than 95 million injections globally.
+Added: The system is designed to provide controlled delivery of local
+Added: anesthetics and has been utilized in a broad range of dental procedures.
+Added: The STA Instrument has been evaluated in multiple peer-reviewed
+Added: clinical studies and published articles.
+Added: Feedback from practitioners and published literature indicates that the technology has been
+Added: incorporated into clinical practice in various markets worldwide.
+Added: Market Products
+Added: of 2025, the CompuFlo® Epidural System has received multiple regulatory clearances and reimbursement milestones in the United States.
+Added: The system initially received FDA 510(k) clearance in 2017 for epidural injections in the lumbar region, with expanded clearance in 2023
+Added: for use in the thoracic region, including the cervicothoracic junction.
+Added: In 2022, the American Medical Association assigned a technology-specific
+Added: Category III CPT® code (0777T), effective January 1, 2023, to facilitate tracking and reimbursement submissions when the system is
+Added: used in conjunction with primary epidural steroid injection procedures.
+Added: In 2024, Medicare Administrative Contractors in Florida and multiple
+Added: additional jurisdictions established Medicare Part B physician payment determinations for CPT code 0777T.
+Added: The Company also received Notices
+Added: of Allowance in the United States and Europe in 2024 related to its next-generation Dynamic Pressure Sensing® technology.
+Added: following table shows a breakdown of Milestone Scientific’s product sales (net), domestically and internationally, by business
+Added: segment, product category:
Year Ended December 31, 2025
Year Ended December 31, 2024
−Removed: International:
−Removed: Rest of World
−Removed: International:
+Added: International Rest of World
+Added: International China
Total Product Sales
−Removed: Current Product Platform
−Removed: Description of Business.
−Removed: Summary of Critical Accounting Estimates
−Removed: We have identified the accounting estimates below as critical to the understanding of our results of operations and our financial condition.
−Removed: In applying these critical accounting estimates in preparing our financial statements, management must use critical assumptions, estimates and judgments concerning future results or other developments, including the likelihood, timing or amount of one or more future events.
−Removed: Actual results may differ from these estimates under different assumptions or conditions.
−Removed: On an ongoing basis, we evaluate our assumptions, estimates and judgments based upon historical experience and various other information that we believe to be reasonable under the circumstances.
−Removed: Management reviews revenue, and its cash position on regularly basis along with the company inventory needs.
−Removed: We believe that the following discussion addresses our most critical accounting estimates, which are those that are most important to the portrayal of our financial condition and results of operations and require management’s most difficult, subjective and complex judgments.
−Removed: For a detailed discussion of significant accounting policies, see Note C.
−Removed: Going Concern and Liquidity
−Removed: Management has developed and is implementing plans to increase revenues and decrease professional and consulting fees over the next twelve months.
−Removed: The Company has also decided to delay all research and development on the Single Tooth Anesthesia System next generation instrument.
−Removed: The Company believes that our existing cash and cash equivalents along with management plans, and the $800,000 in related party note financing received in April 2025 (See Note P) will be sufficient to enable the Company to fund operations for the twelve months from the issuance of these financial statements and alleviates substantial doubt about the Company’s ability to continue as a going concern.
−Removed: Inventories principally consist of finished goods and component parts stated at the lower cost (first-in, first-out method) or net realizable value.
−Removed: Inventory quantities on hand are reviewed on a quarterly basis and a provision for excess and obsolete inventory is recorded if required based on past and expected future sales, potential technological obsolescence and product expiration requirement and regulations.
−Removed: Results of Operations
−Removed: The following table sets forth the consolidated results of operations for the year ended December 31, 2024 compared to the year ended December 31, 2023.
−Removed: For the year end December 31, 2024, compared to year ended December 31, 2023.
+Added: Product Platform
+Added: Item 1—description of Business.
+Added: of Critical Accounting Estimates
+Added: preparation of the Company’s consolidated financial statements in conformity with accounting principles generally accepted in the
+Added: United States of America (“GAAP”) requires management to make estimates, assumptions, and judgments that affect the reported
+Added: amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the
+Added: reported amounts of revenues and expenses during the reporting period.
+Added: considers an accounting estimate to be critical if it requires significant judgment, is inherently subjective, and if changes in the
+Added: estimate could have a material impact on the Company’s financial condition or results of operations.
+Added: Actual results may differ
+Added: from those estimates under different assumptions or conditions.
+Added: evaluates its estimates and assumptions on an ongoing basis using historical experience, current trends, and other information believed
+Added: to be reasonable under the circumstances.
+Added: Management regularly reviews revenue trends, liquidity and cash position, inventory levels,
+Added: and operating forecasts.
+Added: The estimates discussed below represent those that management believes are the most critical to understanding
+Added: the Company’s financial condition and results of operations.
+Added: a more complete discussion of the Company’s significant accounting policies, see Note C to the consolidated financial statements.
+Added: Concern and Liquidity
+Added: assessment of the Company’s ability to continue as a going concern requires significant judgment and is based on estimates regarding
+Added: future revenues, operating expenses, working capital requirements, timing of cash flows, and access to additional sources of capital.
+Added: Company has incurred recurring operating losses and has an accumulated deficit.
+Added: In addition, the Company’s available cash and cash
+Added: equivalents are not sufficient to fund operations for at least twelve months from the issuance date of these financial statements without
+Added: obtaining additional financing.
+Added: has developed plans intended to improve liquidity and operating results, including initiatives to increase revenues, reduce professional
+Added: and consulting expenses, and defer certain discretionary expenditures, including delaying research and development activities related
+Added: to the next-generation Single Tooth Anesthesia System instrument.
+Added: In April 2025, the Company received $800,000 in related party financing
+Added: (see Note H).
+Added: management’s plans are dependent on the Company’s ability to generate additional revenues and/or obtain additional financing,
+Added: and there can be no assurance that such plans will be successful or that additional capital will be available on acceptable terms, or
+Added: Accordingly, management has concluded that substantial doubt exists about the Company’s ability to continue as a going
+Added: concern within one year after the issuance date of these financial statements.
+Added: accompanying financial statements have been prepared assuming the Company will continue as a going concern and do not include any adjustments
+Added: that might result from the outcome of this uncertainty.
+Added: recognition is a critical accounting estimate due to the judgment required in determining the timing of revenue recognition, identifying
+Added: performance obligations, and estimating variable consideration, including returns and discounts.
+Added: Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers.
+Added: Revenue is recognized when control of the
+Added: promised goods transfers to the customer, in an amount that reflects the consideration the Company expects to receive in exchange for
+Added: is derived primarily from the sale of dental and medical instruments and related single-use disposable handpieces.
+Added: Instrument revenue
+Added: is generally recognized upon shipment or delivery, depending on the contractual terms, while disposable handpiece revenue is recognized
+Added: upon transfer of control to the customer.
+Added: Management evaluates whether contracts contain multiple performance obligations and allocates
+Added: consideration based on relative standalone selling prices when applicable.
+Added: is required in estimating expected returns, distributor incentives, and other variable consideration, which are recorded as reductions
+Added: These estimates are based on historical experience, current market conditions, and anticipated future trends.
+Added: assumptions related to these estimates could have a material impact on reported revenue.
+Added: valuation is considered a critical accounting estimate due to the judgment required in assessing excess and obsolete inventory, forecasted
+Added: demand, and the recoverability of inventory carrying values, particularly in light of the Company’s operating losses and liquidity
+Added: considerations.
+Added: are stated at the lower of cost or net realizable value.
+Added: Cost is determined using the first-in, first-out (FIFO) method.
+Added: periodically reviews inventory quantities on hand relative to historical sales, projected future demand, product life cycles, technological
+Added: changes, regulatory developments, and market conditions.
+Added: records reserves for excess, slow-moving, or obsolete inventory based on its assessment of expected future sales and usage.
+Added: This evaluation
+Added: requires significant judgment, particularly with respect to estimating future demand for instruments and related disposable handpieces,
+Added: anticipated product transitions, and distributor purchasing patterns.
+Added: If actual demand is lower than forecasted, or if products become
+Added: obsolete due to technological advancements, regulatory changes, or shifts in market acceptance, additional inventory write-downs may
+Added: write-downs are recorded as a component of cost of goods sold and establish a new cost basis for the inventory.
+Added: Given the Company’s
+Added: current liquidity position and operating results, adverse changes in demand forecasts or market conditions could have a material impact
+Added: on inventory reserves and future operating results.
+Added: of Operations
+Added: following table sets forth the consolidated results of operations for the year ended December 31, 2025, compared to the year ended December
+Added: the year-end December 31, 2025, compared to the year ended December 31, 2024
Operating results:
11 unchanged sentences
Net loss attributable to Milestone Scientific Inc.
−Removed: Net sales for year ended December 31, 2024, compared to year ended December 31, 2023
+Added: sales for the year ended December 31, 2025, compared to the year ended December 31, 2024
Total sales, net
−Removed: Consolidated revenue for the years ended December 31, 2024 and 2023 was approximately $8.6 million and $9.8 million, respectively, a decrease of approximately $1.2 million.
−Removed: As of January 3, 2023, the Company launched an E-Commerce platform, selling and shipping the STA Single Tooth Anesthesia System® (STA) and handpieces directly to end users, including dental offices and dental groups, within the U.S.
−Removed: E-commerce revenue for the year ended December 31, 2024 was approximately $5.1 million as compared to $4.8 million for the year ended December 31, 2023.
−Removed: The Company recorded no revenue from Henry Schein for the year ended December 31, 2024, compared to approximately $179,000 recorded for the year ended December 31, 2023.
−Removed: Revenue from other U.S.
−Removed: distributors was approximately $9,000 for the year ended December 31, 2024, a decrease of $476,000 compared to December 31, 2023.
−Removed: The Company terminated all non-exclusive agreements with other distributors in the US in September 2023.
−Removed: For the year ended December 31, 2024, international revenue was approximately $3.4 million, a decrease of $756,000 compared to December 31, 2023.
−Removed: The decrease in international revenue is due low performing markets and shipping delays.
−Removed: For the year ended December 31, 2024, the Company reported zero revenue from China, a decrease of approximately $270,000.
−Removed: For the year ended December 31, 2024, medical revenue increased approximately $37,000 compared to December 31, 2023.
−Removed: Gross Profit for years ended December 31, 2024, and 2023 were as follows:
+Added: For the year ended December 31, 2025, total net sales were approximately
+Added: $8.9 million, an increase of approximately $344,000, or 4%, compared to approximately $8.6 million in 2024.
+Added: Dental sales were approximately $8.8 million,
+Added: compared to $8.5 million in the prior year.
+Added: The increase reflects higher international sales, including sales in China during 2025,
+Added: partially offset by a decline in domestic U.S.
+Added: dental sales.
+Added: International dental sales increased 9% year over year, while domestic
+Added: dental sales decreased 7%.
+Added: Medical sales are approximately $183,000,
+Added: compared to $104,000 in 2024, reflecting higher domestic medical handpiece sales.
+Added: Medical sales continue to represent a small
+Added: portion of total revenue.
+Added: Profit for the years ended December 31, 2025, and 2024 was as follows:
Total gross profit
−Removed: Consolidated gross profit for the year ended December 31, 2024 decreased by approximately $358,000 or 5%, compared to the same period in 2023.
−Removed: Dental gross profit for the years ended December 31, 2024 and 2023 we approximately 74% and 72% respectively.
−Removed: The decrease was due to higher margins in sales associated with the launch of E-Commerce platform offset by lower international sales.
−Removed: The Company recorded approximately $258,000 allowance for medical inventory that was obsolete and or expired for the year ended December 31, 2023.
−Removed: Selling, general and administrative expenses for years ended December 31, 2024, and 2023 were as follows:
−Removed: Total selling, general and administrative expenses
−Removed: Consolidated selling, general and administrative expenses for the years ended December 31, 2024 and 2023 were approximately$12.3 million and $13.1 million, respectively.
−Removed: The decrease of approximately $840,000 is due to several factors.
−Removed: Employee salaries and benefits expenses decreased approximately $654,000 for the year ended December 31, 2024 compared to the same period in 2023.
−Removed: The Company decreased warehousing, marketing, regulatory, royalties’ and travel expenses by approximately $324,000 compared to the same period in 2023.
−Removed: The Company increased professional fees, and quality control by approximately $305,000 compared to the same period in 2023.
−Removed: The Company recorded and decreased in other selling, general and administrative expenses of approximately $167,000 for the year ended December 31, 2024, compared to the same period in 2023 due to the launch of E-Commerce.
−Removed: Research and Development for years ended December 31, 2024, and 2023 were as follows:
+Added: Gross margin was approximately 71% in 2025 compared
+Added: to approximately 75% in 2024.
+Added: The decline in gross margin percentage reflects changes in product mix and cost structure during the period.
+Added: general, and administrative expenses for the years ended December 31, 2025, and 2024 were as follows:
+Added: Total selling, general and administrative expense
+Added: Total selling, general and administrative
+Added: expenses for the year ended December 31, 2025 were approximately $11.6 million, compared to $12.3 million in 2024, representing a
+Added: decrease of approximately $718,000, or 6%.
+Added: As a percentage of net sales, selling, general and administrative expenses decreased to
+Added: approximately 129% of net sales in 2025, compared to approximately 142% of net sales in 2024.
+Added: Total salaries decreased by approximately $653,000, or 17%, primarily reflecting
+Added: lower headcount and related personnel costs during the year.
+Added: Quality and regulatory expenses decreased by approximately $146,400, or 30%,
+Added: primarily due to reduced regulatory consulting and compliance-related activities.
+Added: Marketing expenses decreased by approximately $236,200,
+Added: or 42%, primarily reflecting reduced promotional and advertising activities.
+Added: Insurance costs decreased by approximately $57,900, or 10%,
+Added: and other SG&A expenses decreased by approximately $90,300, or 10%, primarily due to general cost containment efforts.
+Added: These decreases were partially offset by an increase in stock-based compensation included in salaries
+Added: of approximately $234,400, or 17%, primarily related to equity compensation granted during the year.
+Added: Professional fees and consultants
+Added: increased by approximately $223,600, or 7%, primarily due to higher legal, accounting, and consulting expenses.
+Added: Warehouse expenses increased
+Added: by approximately $18,400, or 4%, reflecting higher distribution and logistics costs.
+Added: Rent increased modestly by approximately $4,500,
+Added: or 3%, while royalties increased slightly by approximately $3,000, or 1%.
+Added: and Development for the years ended December 31, 2025, and 2024 were as follows:
Total research and development
−Removed: Consolidated research and development expenses for the years ended December 31, 2024 and 2023 were approximately $859,000 and $701,000 respectively.
−Removed: The increase of approximately $157,000 is related to the Company's development of the next generation STA Single Tooth Anesthesia System, offset by a decrease in medical expenses relating to the epidural consumables development.
−Removed: The Company has also decided to delay all research and development on the STA Single Tooth Anesthesia System next generation instrument
−Removed: Loss from Operations for 2024 and 2023 were as follows:
+Added: Research and development expenses for the year ended December 31, 2025
+Added: were approximately $449,000 compared to $859,000 for the year ended December 31, 2024, representing a decrease of approximately $409,000,
+Added: decrease in research and development expenses was primarily attributable to a reduction in dental-related research and development activities,
+Added: which decreased to $0.4 million in 2025 from $0.8 million in 2024, representing a decrease of $0.4 million.
+Added: This reduction reflects the
+Added: Company’s decision to delay research and development efforts related to the next-generation Single Tooth Anesthesia System instrument
+Added: research and development expenses decreased modestly to $0.02 million in 2025 from $0.02 million in 2024, reflecting limited ongoing
+Added: development activity related to the Company’s medical product platform.
+Added: the decrease in research and development expenses reflects management’s focus on cost containment and prioritization of resources
+Added: toward commercialization and operational activities during 2025.
+Added: Loss from Operations for 2025- and 2024 were as
Total loss from operations
−Removed: The loss from operations was approximately $6.8 million and $7.1 million for the years ended December 31, 2024 and 2023, respectively, a decrease of approximately $350,000.
−Removed: As stated above, the decrease in the loss from operations is driven by increased margins in E-Commerce dentals sales, offset by lower international dental sales and lower selling, general and administrative expenses during period.
−Removed: Liquidity and Capital Resources
−Removed: The following table summarizes our sources and uses of cash for each of the periods presented:
+Added: Loss from operations for the year ended December 31, 2025, was approximately
+Added: $(5,700,000) compared to $(6,800,000) for the year ended December 31, 2024, representing an improvement of approximately $1.06 million,
+Added: As a percentage of net sales, operating loss improved to approximately 63% of net sales in 2025 compared to approximately 78%
+Added: of net sales in 2024.
+Added: year-over-year improvement in operating results primarily reflects lower operating expenses, including reductions in selling, general
+Added: and administrative expenses and research and development expenditures, partially offset by a modest decline in gross margin percentage.
+Added: and Capital Resources
+Added: following table summarizes our sources and uses of cash for each of the periods presented:
Net cash used in operating activities
+Added: $ (2,916,627 )
+Added: $ (2,919,875 )
Net cash provided by (used in) investing activities
Net cash provided by financing activities
−Removed: Operating Activities
−Removed: Cash flows used in operating activities decreased by $2.4 million for the year ended December 31, 2024 compared to December 31, 2023.
−Removed: The decrease was primarily driven by our receipt of approximately $2.0 million, net of expenses, from the sale of New Jersey net operating losses ‘(NOL”), that were eligible for sale under the State of New Jersey’s Economic Development Authority’s New Jersey Technology Business Tax Certificate Transfer program (“NJEDA Program”).
−Removed: Investing Activities
−Removed: Cash flows provided by investing activities was $3.0 million for the year ended December 31, 2024, compared to $3.0 million of cash flows used in investing activities for the year ended December 31, 2023, an increase of $6.0 million.
−Removed: We sold $3.0 million of marketable securities during the year ending December 31, 2024, compared to $5.0 million sold during the year ended December 31, 2023, which increased cash and equivalents by $2.0 million.
−Removed: We purchased approximately $8.0 million in marketable security during the during the year ending December 31, 2023 compared to no purchases made during the year ended December 31, 2024.
−Removed: Financing Activities
−Removed: Cash flows provided by financing activities decreased $2.3 million to $0.2 million for the year ended December 31, 2024 compared to $2.6 million for the year ended December 31, 2023.
−Removed: The decrease in cash used in financing activities was the result of gross proceeds of approximately $3.0 million received from a public offering of common stock, offset by $0.4 million of offering costs associated with the public offering during the year ended December 31, 2023, that did not recur during the year ended December 31, 2024.
−Removed: Contractual Obligations
−Removed: The impact of the consolidated contractual obligations on December 31, 2024, expected on the liquidity and cash flows in future periods, is as follows:
+Added: $ (2,145,416 )
+Added: $ (2,425,761 )
+Added: cash used in operating activities for the year ended December 31, 2025, and 2024 was $2.9 million, which was substantially
+Added: consistent year over year.
+Added: used in operating activities during both periods primarily reflects net losses, partially offset by non-cash charges and changes in working
+Added: Although loss from operations improved in 2025, operating cash usage remained comparable to the prior year due to changes in
+Added: working capital accounts, including the timing of customer collections and vendor payments.
+Added: the year ended December 31, 2024, the Company received approximately $2.0 million, net of related expenses, from the sale of New Jersey
+Added: net operating losses under the New Jersey Economic Development Authority’s Technology Business Tax Certificate Transfer Program.
+Added: cash used in investing activities for the year ended December 31, 2025, was approximately $0.02 million, compared to net cash provided
+Added: by investing activities of approximately $3.0 million in 2024.
+Added: However, the cash provided by investing activities in 2024 was
+Added: primarily attributable to proceeds from the sale of net operating losses.
+Added: Investing activity in 2025 was minimal and consisted primarily
+Added: of routine capital expenditures.
+Added: cash provided by financing activities for the year ended December 31, 2025, was approximately $0.8 million, compared to $0.2 million
+Added: The increase in cash provided by financing activities during 2025 primarily reflects financing proceeds, including related-party
+Added: financing, partially offset by repayments and other financing-related outflows.
+Added: continues to monitor liquidity and implement cost-containment initiatives.
+Added: The Company’s ability to meet its future operating requirements
+Added: will depend on its operating performance and its ability to obtain additional financing, as discussed in the going concern disclosure.
+Added: impact of the consolidated contractual obligations on December 31, 2025, on the liquidity and cash flows in future periods, is as follows:
Payments Due by Period
−Removed: Less than 1 Year
−Removed: Operating lease obligations
+Added: Operating lease
Purchase obligations
−Removed: Recent Accounting Pronouncements
−Removed: See “Note C - Summary of Significant Accounting Policies” to the consolidated financial statements for explanation of recent accounting pronouncements impacting Milestone Scientific.
+Added: Accounting Pronouncements
+Added: “Note C - Summary of Significant Accounting Policies” to the consolidated financial statements for an explanation of recent
+Added: accounting pronouncements impacting Milestone Scientific.
Quantitative and Qualitative Disclosures about Market Risk
−Removed: Milestone Scientific is a “smaller reporting company” as defined by Regulation S-K and, as such, is not required to provide the information required by this item.
+Added: Scientific is a “smaller reporting company” as defined by Regulation S-K and, as such, is not required to provide the information
+Added: required by this item.
Financial Statements
−Removed: The financial statements of Milestone Scientific required by this Item are set forth beginning on page F-1.
+Added: financial statements of Milestone Scientific required by this Item are set forth beginning on page F-1.
Change in and Disagreements with Accountants on Accounting and Financial Disclosure
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.