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What changed in MILESTONE SCIENTIFIC INC.'s 10-K — 2023 vs 2024

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Paragraph-level year-over-year comparison of MILESTONE SCIENTIFIC INC.'s 2023 and 2024 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2024 report.

+124 added−111 removedSource: 10-K (2025-04-15) vs 10-K (2024-03-29)

Top changes in MILESTONE SCIENTIFIC INC.'s 2024 10-K

124 paragraphs added · 111 removed · 80 edited across 4 sections

Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

49 edited+24 added−8 removed121 unchanged
Biggest changeIf the FDA, the FTC or another regulatory agency determines that Milestone Scientific’s promotional or training material constitutes off-label, false or misleading, unfair or deceptive promotion of its products, it could request that Milestone Scientific modify its training or promotional materials or subject Milestone Scientific to regulatory or enforcement actions, including the issuance of an untitled letter, a warning letter, injunction, seizure, civil fine or criminal penalties. 15 It is also possible that other federal, state or foreign enforcement authorities might act if they consider Milestone Scientific’s promotional or training materials to constitute off-label, false or misleading, unfair or deceptive promotion of its products, which could result in significant fines or penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement, and reputational harm.
Biggest changeIt is also possible that other federal, state or foreign enforcement authorities might act if they consider Milestone Scientific’s promotional or training materials to constitute off-label, false or misleading, unfair or deceptive promotion of its products, which could result in significant fines or penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement, and reputational harm.
Safeguards we implement to discourage improper payments or offers of payments by our employees, consultants, sales agents, or distributors may be ineffective, and violations of the FCPA and similar laws may result in severe criminal or civil sanctions, or other liabilities or proceedings against us, any of which would likely harm our reputation, business, results of operations and financial condition.
Safeguards we implement to discourage improper payments or offers of payments by our employees, consultants, sales agents, or distributors may be ineffective, and violations of the FCPA and similar laws may result in severe criminal or civil sanctions, or other liabilities or proceedings against us, any of which would likely harm our reputation, business, results of operations and financial condition.
Issues with product quality could have a material adverse effect upon our business, subject us to regulatory actions and cause a loss of customer confidence in us or our products. In general, our success depends upon the quality of our products.
Issues with product quality could have a material adverse effect upon our business, subject us to regulatory actions and cause a loss of customer confidence in us or our products. In general, our success depends upon the quality of our products.
Quality management plays an essential role in meeting customer requirements, preventing defects, improving our products and services, and assuring the safety and efficacy of our products. Our future success depends on our ability to maintain and continuously improve our quality management program.
Quality management plays an essential role in meeting customer requirements, preventing defects, improving our products and services, and assuring the safety and efficacy of our products. Our future success depends on our ability to maintain and continuously improve our quality management program.
A quality or safety issue may result in adverse inspection reports, warning letters, product recalls or seizures, monetary sanctions, injunctions to halt manufacture and distribution of products, civil or criminal sanctions, costly litigation, refusal of a government to grant approvals and licenses, restrictions on operations or withdrawal of existing approvals and licenses.
A quality or safety issue may result in adverse inspection reports, warning letters, product recalls or seizures, monetary sanctions, injunctions to halt manufacture and distribution of products, civil or criminal sanctions, costly litigation, refusal of a government to grant approvals and licenses, restrictions on operations or withdrawal of existing approvals and licenses.
An inability to address a quality or safety issue in an effective and timely manner may also cause negative publicity, a loss of customer confidence in us or our current or future products, which may result in the loss of sales and difficulty in successfully launching new products.
An inability to address a quality or safety issue in an effective and timely manner may also cause negative publicity, a loss of customer confidence in us or our current or future products, which may result in the loss of sales and difficulty in successfully launching new products.
We do not have control over third-party manufacturers' compliance with these regulations and standards and our manufacturers may be found to be in noncompliance with certain regulations, which may impact their ability to manufacture our products. ● If any third-party manufacturer makes improvements in the manufacturing process for our products, we may not own, or may have to share, the intellectual property rights to the innovation.
We do not have control over third-party manufacturers' compliance with these regulations and standards and our manufacturers may be found to be in noncompliance with certain regulations, which may impact their ability to manufacture our products. 13 ● If any third-party manufacturer makes improvements in the manufacturing process for our products, we may not own, or may have to share, the intellectual property rights to the innovation.
Our operations are and will continue to be directly, or indirectly through our distributors, customers, and health care professionals, subject to various U.S. federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute, federal False Claims Act, and the Foreign Corrupt Practice Act of 1977 (“FCPA”).
Our operations are and will continue to be directly, or indirectly through our distributors, customers, and health care professionals, subject to various U.S. federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute, federal False Claims Act, and the Foreign Corrupt Practice Act of 1977.
Such awards will have a dilutive effect on outstanding share count which could adversely affect the market price of Milestone Scientific’s common stock. 17 Risks Related to Our Intellectual Property If we are unable to adequately protect our patents, trade secrets and other proprietary rights, if our patents are challenged or if our provisional patent applications do not get approved, our competitiveness and business prospects may be materially damaged.
Such awards will have a dilutive effect on outstanding share count which could adversely affect the market price of Milestone Scientific’s common stock. 19 Risks Related to Our Intellectual Property If we are unable to adequately protect our patents, trade secrets and other proprietary rights, if our patents are challenged or if our provisional patent applications do not get approved, our competitiveness and business prospects may be materially damaged.
Any claim of infringement by a third party, even those without merit, could cause us to incur substantial costs defending against the claim and could distract our management from our business. 18 Furthermore, if any such claim is successful, a court could order us to pay substantial damages, including compensatory damages for any infringement, plus prejudgment interest and could, in certain circumstances, treble the compensatory damages and award attorney fees.
Any claim of infringement by a third party, even those without merit, could cause us to incur substantial costs defending against the claim and could distract our management from our business. 20 Furthermore, if any such claim is successful, a court could order us to pay substantial damages, including compensatory damages for any infringement, plus prejudgment interest and could, in certain circumstances, treble the compensatory damages and award attorney fees.
The scope of our patent rights may be limited and may also depend on the availability of meaningful legal remedies. 11 Our failure to adequately protect our intellectual property rights, through patents or otherwise, or limitations on the use or loss of such rights, could have a material adverse effect on our ability to prevent the commercialization of competing anesthetic delivery systems.
The scope of our patent rights may be limited and may also depend on the availability of meaningful legal remedies. 12 Our failure to adequately protect our intellectual property rights, through patents or otherwise, or limitations on the use or loss of such rights, could have a material adverse effect on our ability to prevent the commercialization of competing anesthetic delivery systems.
Sales of a substantial number of shares of our common stock, or the perception that such sales may occur, may adversely impact the price of our common stock. Raising additional capital by issuing securities or through licensing or lending arrangements may cause dilution to our existing stockholders, restrict our operations, or require us to relinquish proprietary rights.
Sales of a substantial number of shares of our common stock, or the perception that such sales may occur, may adversely impact on the price of our common stock. 10 Raising additional capital by issuing securities or through licensing or lending arrangements may cause dilution to our existing stockholders, restrict our operations, or require us to relinquish proprietary rights.
Even if we do generate profits from operations, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to generate profits from operations, and to become and remain profitable, could impair our ability to raise capital, expand our business, and maintain our commercial efforts or continue our operations.
Even if we do generate profits from operations, we may not be able to achieve, sustain or increase profitability on a quarterly or annual basis. Our failure to generate substantive profits from operations and to become and remain profitable could impair our ability to raise capital, expand our business, and maintain our commercial efforts or continue our operations.
Sales of a substantial number of shares of our common stock, or the perception that such sales may occur, may adversely impact the price of our common stock.
Sales of a substantial number of shares of our common stock, or the perception that such sales may occur, may adversely impact on the price of our common stock.
The market price of our common stock may be volatile and may fluctuate significantly, and stockholders could lose all or part of their investment in Milestone Scientific Our stock price may experience substantial volatility because of many factors, including: ● our failure to meet analysts’ expectations; ● sales or potential sales of substantial amounts of our common stock; ● delay or failure in initiating our strategy to commercialize our CompuFlo Epidural System; ● the success of our strategy to commercialize our CompuFlo Epidural System; ● announcements about us or about our competitors, including clinical trial results, regulatory approvals or new product introductions that could adversely impact the market acceptance or competitive advantages of our CompuFlo Epidural System; ● developments concerning our licensors or product manufacturers; ● litigation and other developments relating to our patents or other proprietary rights or those of our competitors; ● our ability to successfully develop and commercialize products and services for the healthcare industry; ● conditions in the medical device industry; ● variations in our anticipated or actual operating results; and ● change in securities analysts’ estimates of our performance, or our failure to meet analysts’ expectations. 16 Many of these factors are beyond our control.
The market price of our common stock may be volatile and may fluctuate significantly, and stockholders could lose all or part of their investment in Milestone Scientific Our stock price may experience substantial volatility because of many factors, including: ● our failure to meet analysts’ expectations; ● sales or potential sales of substantial amounts of our common stock; ● delay or failure in initiating our strategy to commercialize our CompuFlo Epidural System; ● the success of our strategy to commercialize our CompuFlo Epidural System; ● announcements about us or about our competitors, including clinical trial results, regulatory approvals or new product introductions that could adversely impact the market acceptance or competitive advantages of our CompuFlo Epidural System; ● developments concerning our licensors or product manufacturers; ● litigation and other developments relating to our patents or other proprietary rights or those of our competitors; ● our ability to successfully develop and commercialize products and services for the healthcare industry; ● conditions in the medical device industry; ● variations in our anticipated or actual operating results; and 18 ● change in securities analysts’ estimates of our performance, or our failure to meet analysts’ expectations.
Because of the risks and uncertainties associated with product acceptance, we are unable to predict the extent of any future losses, whether we will ever generate significant revenues or if we will ever achieve or sustain profitability.
Because of the risks and uncertainties associated with product acceptance and sales expansion, we are unable to predict the extent of any future losses, whether we will ever generate significant revenues or if we will ever achieve or sustain profitability.
Failure by us to comply with these standards could have an adverse effect on our business, financial condition, or results of operations. The FDA regulates the approval, manufacturing and sales and marketing of many of our products in the United States. Significant government regulations also exist in other countries in which we conduct business.
Failure by us to comply with these standards could have an adverse effect on our business, financial condition, or results of operations. The FDA regulates the product approvals manufacturing, and sales and marketing of many of our products in the United States. Significant government regulations also exist in other countries in which we conduct business.
The operating losses were $7.1 million and $8.8 million, for the years ended December 31, 2023, and 2022, respectively. Our losses have had, and are expected to continue to have, an adverse impact on our working capital, total assets, and stockholders' equity.
The operating losses were $6.8 million and $7.1 million, for the years ended December 31, 2024, and 2023, respectively. Our losses have had, and are expected to continue to have, an adverse impact on our working capital, total assets, and stockholders' equity.
We have exposure to risks of operating in many foreign countries, including: ● fluctuations in foreign currency exchange rates, could increase the end user cost for instruments. ● restrictions on, or difficulties and costs associated with, the currency exchange from foreign countries to obtain U.S. dollars; ● difficulties and costs associated with complying with a wide variety of complex laws, treaties, and regulations; ● unexpected changes in political or regulatory environments; ● political and economic instability; ● import and export restrictions and other trade barriers; and ● difficulties in obtaining approval for significant transactions. 10 If physicians do not accept nor use our CompuFlo Epidural System, our ability to generate revenue from sales will be materially impaired.
We have exposure to risks of operating in many foreign countries, including: ● fluctuations in foreign currency exchange rates, could increase the end user cost for instruments; ● restrictions on, or difficulties and costs associated with, the currency exchange from foreign countries to obtain U.S. dollars; ● difficulties and costs associated with complying with a wide variety of complex laws, treaties, and regulations; ● unexpected changes in political or regulatory environments; ● political and economic instability; ● import and export control restrictions and other trade barriers such as tariffs; and ● difficulties in obtaining approval for significant transactions. 11 If physicians neither accept nor use our CompuFlo Epidural System, our ability to generate revenue from sales will be materially impaired.
Compliance with applicable regulatory requirements is subject to continual review and is rigorously monitored through periodic inspections by the FDA. In the European community, we are required to maintain certain ISO certifications to sell our products and must undergo periodic inspections by notified bodies to obtain and maintain these certifications.
Compliance with applicable regulatory requirements is subject to continual review and is rigorously monitored through periodic inspections by the FDA. In the European community, we are required to maintain compliance to ISO, CE marking standards to sell our products and must undergo periodic inspections by notified bodies to obtain and maintain compliance.
Establishing new manufacturing relationships could involve significant expense and delay. Each of these risks could delay the commercialization of our CompuFlo Epidural Computer Controlled Anesthesia System, limit our available supply of The Wand/ STA for dental applications, cause damage to our reputation, result in higher costs and/or deprive us of potential product revenues.
Each of these risks could delay the commercialization of our CompuFlo Epidural Computer Controlled Anesthesia System, limit our available supply of The Wand/ STA for dental applications, cause damage to our reputation, result in higher costs and/or deprive us of potential product revenues.
The termination, reduction or interruption in supply of these raw materials and components could adversely impact Milestone Scientific Scientific’s ability to manufacture and sell certain of its products. 13 Third-party suppliers may encounter problems during manufacturing for a variety of reasons, including failure to follow specific protocols and procedures, failure to comply with applicable regulations, equipment malfunction, component part supply constraints, and environmental factors, any of which could delay or impede their ability to supply the components and raw materials for Milestone Scientific’s products.
Third-party suppliers may encounter problems during manufacturing for a variety of reasons, including failure to follow specific protocols and procedures, failure to comply with applicable regulations, equipment malfunction, component part supply constraints, and environmental factors, any of which could delay or impede their ability to supply the components and raw materials for Milestone Scientific’s products.
As a device manufacturer, we are required to register with the FDA and are subject to periodic inspection by the FDA for compliance with the FDA’s Quality System Regulation requirements, which require manufacturers of medical devices to adhere to certain regulations, including testing, quality control and documentation procedures.
As a device manufacturer, we are required to register with the FDA and are subject to periodic inspection by the FDA for compliance with the FDA’s Quality System Regulation requirements, which require manufacturers of medical devices to adhere to good manufacturing practices .
We have exposure to risks of operating in an E-commerce platform: ● Refunds and customer disputes due to issues like wrong product delivery or defective items can impact your business. ● Online security breaches and cyberattacks ● Poor search engine visibility affects traffic and sales. ● Unexpected changes in political or regulatory environments; If Milestone Scientific is unable to maintain or expand its E-Commerce platform its sales may be negatively affected.
We have exposure to risks of operating in an E-commerce platform: ● Refunds and customer disputes due to issues like wrong product delivery or defective items can impact on our business; ● Online security breaches and cyberattacks; ● Poor search engine visibility affects traffic and sales; and ● Unexpected changes in political or regulatory environments.
The stock markets in general, and the market for small, medical device companies have historically experienced extreme price and volume fluctuations. These fluctuations often have been unrelated or disproportionate to the operating performance of these companies. These broad market and industry factors could reduce the market price of our common stock, regardless of our actual operating performance.
Many of these factors are beyond our control. The stock markets in general, and the market for small, medical device companies have historically experienced extreme price and volume fluctuations. These fluctuations often have been unrelated or disproportionate to the operating performance of these companies.
Most states have enacted state false claims laws, and many of those states included laws with qui tam provisions. 14 The Affordable Care Act includes provisions known as the Physician Payments Sunshine Act (section 6002), which require manufacturers of drugs, biologics, devices, and medical supplies covered under Medicare and Medicaid to disclose to the Centers for Medicare and Medicaid Services any transfers of value to physicians and teaching hospitals.
The Affordable Care Act includes provisions known as the Physician Payments Sunshine Act (section 6002), which require manufacturers of drugs, biologics, devices, and medical supplies covered under Medicare and Medicaid to disclose to the Centers for Medicare and Medicaid Services any transfers of value to physicians and teaching hospitals.
In addition, if we raise additional funds through licensing arrangements or the disposition of any of our assets, it may be necessary to relinquish potentially valuable rights to our product candidates or grant licenses on terms that are not favorable to us. 9 Recent developments in financial institutions could adversely affect our current and projected business operations, financial condition and results of operations.
In addition, if we raise additional funds through licensing arrangements or the disposition of any of our assets, it may be necessary to relinquish potentially valuable rights to our product candidates or grant licenses on terms that are not favorable to us.
We may be required to pay fees or other costs for access to such improvements. 12 Though 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 “burned in” and other manufacturing and quality control software re-produced.
Though 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 “burned in” and other manufacturing and quality control software re-produced. Establishing new manufacturing relationships could involve significant expense and delay.
Additional tariffs imposed by the United States on a broader range of imports, or further retaliatory trade measures taken by China or other countries in response, could result in an increase in supply chain costs that Milestone Scientific may not be able to offset or that otherwise adversely impact its results of operations.
Tariffs and other retaliatory measures imposed by the United States on imports, and other retaliatory trade measures taken by the United States, China and other countries, and successive rounds of retaliatory trade measures as part of a trade war or otherwise, will result in an increase in supply chain costs and limit availability of products that Milestone Scientific may not be able to offset or that otherwise adversely impact its operations.
Almost all our 75,881,840 outstanding shares of common stock on December 31, 2023, as well as a substantial number of shares of our common stock underlying outstanding warrants, are available for sale in the public market, either freely or pursuant to Rule 144 under the Securities Act of 1933, as amended.
Almost all our 78,047,798 outstanding shares of common stock on December 31, 2024, are available for sale in the public market, either freely or pursuant to Rule 144 under the Securities Act of 1933, as amended.
We have never paid and do not intend to pay cash dividends in the foreseeable future. As a result, capital appreciation, if any, will be your sole source of gain.
These broad market and industry factors could reduce the market price of our common stock, regardless of our actual operating performance. We have never paid and do not intend to pay cash dividends in the foreseeable future. As a result, capital appreciation, if any, will be your sole source of gain.
These products we obtain from suppliers are subject to fluctuations in price and availability attributable to several factors, including general economic conditions, commodity price fluctuations, the demand by other companies for the same raw materials and the availability of complementary and substitute materials.
These products we obtain from suppliers are subject to fluctuations in price and availability attributable to several factors, including general economic conditions, commodity price fluctuations, the demand by other companies for the same raw materials and the availability of complementary and substitute materials. 14 While Milestone Scientific works with suppliers to ensure continuity of supply, no assurance can be given that these efforts will be successful.
If the FDA disagrees with Milestone Scientific’s determinations and requires it to submit new 510(k) notifications, Milestone Scientific may be required to cease marketing or to recall the modified product until it obtains clearance, and it may be subject to significant regulatory fines or penalties.
If the FDA disagrees with Milestone Scientific’s determinations and requires it to submit new 510(k) notifications, Milestone Scientific may be required to cease marketing or to recall the modified product until it obtains clearance, and it may be subject to significant regulatory fines or penalties. 16 Changes to United States federal and state regulatory agencies may cause disruptions and delays in approval of the government approval processes and regulation relating to our products.
Milestone Scientific Scientific’s principal stockholders, Leonard Osser and Gian Domenico Trombetta control approximately 20% of the issued and outstanding shares of common stock. As a result, they can exercise substantial control over our affairs and corporate actions requiring stockholder approval, including electing directors, selling all or substantially all our assets, merging with another entity, or amending our certificate of incorporation.
As a result, they can exercise substantial control over our affairs and corporate actions requiring stockholder approval, including electing directors, selling all or substantially all our assets, merging with another entity, or amending our certificate of incorporation.
Many states have also adopted laws like the federal Anti-Kickback Statute, some of which apply to the referral of patients for health care items or services reimbursed by any source, not only the Medicare and Medicaid programs.
Many states have also adopted laws like the federal Anti-Kickback Statute, some of which apply to the referral of patients for health care items or services reimbursed by any source, not only the Medicare and Medicaid programs. 15 The federal False Claims Act prohibits persons from knowingly filing, or causing to be filed, a false claim to, or the knowing use of false statements to obtain payment from, the federal government.
These actions could have a negative effect on our financial results. The existence of direct and indirect price controls and pressures on our products could materially adversely affect our financial prospects and performance. We could lose our market advantage earlier than expected.
These actions could have a negative effect on our financial results. The existence of direct and indirect price controls and pressures on our products could seriously affect our financial prospects and performance. We could lose our market advantage earlier than expected. We believe that our products represent a significant improvement over any existing drug delivery injection system in use today.
In the medical device industry, most of an innovative product’s commercial value is realized during the early stages of commercialization, before competing products are developed. Our market advantage is based, in part, on patent rights and the need for new competing products and systems to obtain regulatory approval before they can be commercialized.
Our market advantage is based, in part, on patent rights and the need for new competing products and systems to obtain regulatory approval before they can be commercialized.
Although the FDA has cleared our application to begin marketing the CompuFlo Epidural System, this is no assurance that physicians, hospitals, clinics, and other health care providers will accept and use it.
There is no assurance that physicians, hospitals, clinics, and other health care providers will accept and use the CompuFlo Epidural System.
We are exposed to the risks inherent in international sales. In 2023, export sales outside of the United States made up approximately 45% of our total sales, and we sell our products to customers in approximately 41 countries and U.S. territories.
If Milestone Scientific is unable to maintain or expand its E-Commerce platform its sales will be negatively affected. We are exposed to the risks inherent in international sales. In 2024, export sales outside of the United States made up approximately 40% of our total sales, and we sell our products to customers in approximately 41 countries and U.S. territories.
China’s political and economic systems are very different from most developed countries in many respects, including, the amount of government involvement, the level of development, the control of foreign exchange and the allocation of resources. Uncertainties may arise with changing governmental policies and measures.
China’s political and economic systems are very different from most developed countries in many respects, including, the amount of government involvement, the level of development, the control of foreign exchange and the allocation of resources. The increase in United States tariffs on products from China will impact the price of our goods sold.
In addition, political tensions between the United States and China have escalated in recent years. Rising political tensions could reduce trade, investment and other economic activities between the two major economies. Any of these factors could have a material adverse effect on Milestone Scientific’s business, prospects, financial condition, and results of operations.
Rising political tensions could reduce trade, investment and other economic activities between the two major economies. Any of these factors could have a material adverse effect on Milestone Scientific’s business, prospects, financial condition, and results of operations. 17 Turnover at U.S. Department of Health and Human Services, including the FDA, is expected to lead to different enforcement objectives.
The Company currently keeps more than $250,000, the maximum amount insured by the Federal Deposit Insurance Corporation (“FDIC”), in its current bank depositary. The Company may experience delayed access or a loss of its uninsured deposits or other financial assets should its existing financial institution experience financial distress. While the U.S.
The Company may experience delayed access or a loss of its uninsured deposits or other financial assets should its existing financial institution experience financial distress. While the U.S.
China also faces many social, economic, and political challenges that may produce instabilities in both its domestic arena and in its relationship with other countries. These instabilities may significantly and adversely affect our supply of dental handpieces which would in turn adversely affect our financial performance.
Uncertainties may arise with changing governmental policies and measures. China also faces many social, economic, and political challenges that may produce instabilities in both its domestic arena and in its relationship with other countries.
Implementing our business strategy requires specialized territory managers and other talent, as our revenues are highly dependent on technological and product innovations. The market for employees in our industry is extremely competitive, several such competitors are significantly larger than us and can offer compensation more than what we are able to offer.
The market for employees in our industry is extremely competitive, several such competitors are significantly larger than us and can offer compensation more than what we are able to offer. If we are unable to attract and retain a new chief executive officer and other qualified employees, as needed, our business may be harmed.
We have no control over any such changes. Any new laws or regulations governing our operations could have an adverse impact on our business, results of operations and prospects. Risks Related to Milestone Scientific Common Stock Milestone Scientific is effectively controlled by a limited number of stockholders.
We have no control over any such changes. Any new laws or regulations governing our operations could have an adverse impact on our business, results of operations and prospects. Changes to trade policy, including tariff and import/export regulations, may have a material adverse effect on our results of operations, cash flows and financial condition.
We anticipate that we will need additional funding for our operations and may be unable to raise capital when needed, which may force us to delay, curtail or eliminate parts of the commercialization efforts of our CompuFlo Epidural Computer Controlled Anesthesia System. Our operations have consumed substantial amounts of cash since inception.
A decline in the value of our company could also cause our shareholders to lose all or part of their investment. We anticipate that we will need additional funding for our operations and may be unable to raise capital when needed, which may force us to delay, curtail or eliminate parts of the Company ’ s operations.
During the years ended December 31, 2023 and 2022, net cash flow used in operations was approximately $5.3 million and approximately $6.0 million, respectively. We expect to continue to spend substantial amounts on commercialization and marketing activities, including the continued commercialization and marketing of our FDA-approved CompuFlo Epidural Computer Controlled Anesthesia System.
Our operations have consumed substantial amounts of cash since inception. During the years ended December 31, 2024 and 2023, net cash flow used in operations was approximately $2.9 million and approximately $5.3 million, respectively.
Risks Related to Employee Matters We may not be able to attract and retain qualified employees. Our future success depends upon the continued service of our executive officer and other key management and technical personnel, and on our ability to continue to identify, attract, retain, and motivate them.
Risks Related to Employee Matters We may not be able to attract and retain qualified employees. Our future success depends upon the services of a executive officer. The Company is currently looking for a new chief executive officer to replace Mr. Haverhals, who retired at the end of 2024. Currently one of our directors, Mr.
Changes in United States policy regarding international trade, including import and export regulation and international trade agreements, could also negatively impact Milestone Scientific’s business. The United States has imposed tariffs and export controls on certain goods and products imported from China and certain other countries, which has resulted in retaliatory tariffs by China and other countries.
Changes in United States policy regarding international trade, including import and export regulation and international trade agreements, could adversely affect our business.
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A decline in the value of our company could also cause our shareholders to lose all or part of their investment.
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We believe that our immediate future viability is dependent on our ability to raise additional capital to finance our operations through public or private equity offerings, collaborations and licensing arrangements or other sources.
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Until such time, if ever, as we can generate enough product revenue and achieve positive cash flow, we expect to seek to finance future cash needs through equity financings or corporate collaboration and licensing arrangements and may seek the sale of non-medical assets.
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Although management plans to pursue additional funding, there is no assurance that we will be successful in obtaining sufficient funding on terms acceptable to us to fund continuing operations, or at all. If we are unable to raise this capital when needed, we may be forced to delay, or eliminate our research and development programs or other operations.
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Recent events involving limited liquidity, defaults, non-performance and other adverse developments that affect financial institutions have led to market-wide liquidity concerns. For example, on March 10, 2023, Silicon Valley Bank was closed by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation, or FDIC, as receiver.
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Changes in financial institutions could adversely affect our current and projected business operations, financial condition and results of operations. The Company currently keeps more than $250,000, the maximum amount insured by the Federal Deposit Insurance Corporation (“FDIC”), in its current bank depositary.
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On March 12, 2023, Signature Bank and Silvergate Capital Corp. were also placed into receivership. Future increases of the borrowing rate by the Federal Reserve Board, to slow inflation or for other reasons, may expose other financial institutions to greater interest rate risk and exacerbate liquidity and other adverse developments affecting such institutions.
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Currently, sales of the STA Single Tooth Anesthesia Systems® (STA) and handpieces in the United States are reliant on E-Commerce sales.
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We believe that our products represent a significant improvement over any existing drug delivery injection system in use today. However, this competitive advantage can evaporate quickly if we are not able to commercialize our products quickly.
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However, this competitive advantage can evaporate quickly if we are not able to commercialize our products quickly. In the medical device industry, most of an innovative product’s commercial value is realized during the early stages of commercialization, before competing products are developed.
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If we are unable to attract and retain qualified employees, our business may be harmed.
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Goldman, is the Interim Chief Executive Officer. We also rely on other key management and technical personnel, and on our ability to continue to identify, attract, retain, and motivate them. Implementing our business strategy requires specialized territory managers and other talent, as our revenues are highly dependent on technological and product innovations.
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While Milestone Scientific works with suppliers to ensure continuity of supply, no assurance can be given that these efforts will be successful.
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We may be required to pay fees or other costs for access to such improvements.
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The federal False Claims Act prohibits persons from knowingly filing, or causing to be filed, a false claim to, or the knowing use of false statements to obtain payment from, the federal government.
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These instabilities may significantly and adversely affect our supply of dental handpieces and our ability to delivery reasonably priced products, which would in turn adversely affect our financial performance.
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The termination, reduction or interruption in supply of these raw materials and components could adversely impact Milestone Scientific Scientific’s ability to manufacture and sell certain of its products.
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Most states have enacted state false claims laws, and many of those states included laws with qui tam provisions.
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It is possible that the Trump administration could institute significant changes to certain regulatory agencies and seek to institute the "Department of Government Efficiency," or "DOGE," tasked with making changes to eliminate regulations, cut expenditures, and restructure federal agencies, some of which could impact public companies.
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For example, the incoming administration has discussed several changes to the reach and oversight of the Food and Drug Administration, which could affect its relationship with the pharmaceutical industry, transparency in decision making and ultimately the cost and availability of prescription drugs, as well as oversight over clinical trials and pharmaceutical development, all of which could pose risks (or opportunities) for companies in related industries.
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Similarly, there have been discussions of "reigning in" regulatory agencies such as the Federal Trade Commission, the Federal Communications Commission and the Federal Energy Regulatory Commission, all of which could impact how companies do business and could pose risks related to business operations and financial outlook.
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If the FDA, the FTC or another regulatory agency determines that Milestone Scientific’s promotional or training material constitutes off-label, false or misleading, unfair or deceptive promotion of its products, it could request that Milestone Scientific modify its training or promotional materials or subject Milestone Scientific to regulatory or enforcement actions, including the issuance of an untitled letter, a warning letter, injunction, seizure, civil fine or criminal penalties.
Added
The U.S. government has instituted and proposed further changes in trade policies that include the imposition of higher tariffs on imports into the U.S., the negotiation or termination of trade agreements, economic sanctions on individuals, corporations or countries, and other government regulations affecting trade between the U.S. and other countries where we conduct our business.
Added
It may be time-consuming and expensive for us to alter our operations in order to adapt to or comply with any such changes. Tariffs and other changes in U.S. trade policy have triggered retaliatory actions by the affected countries, and certain foreign governments, including China, have instituted or are considering imposing retaliatory measures on certain U.S. goods.
Added
We do a significant amount of business that will be impacted by changes to the trade policies of the U.S. and foreign countries (including governmental action related to tariffs, international trade agreements, or economic sanctions).
Added
Such changes have the potential to adversely impact the U.S. economy or certain sectors thereof, our industry and the global demand for our products, and as a result, could have a material adverse effect on our results of operations, cash flows and financial condition. In addition, political tensions between the United States and China have escalated in recent years.
Added
In addition, on June 28, 2024, the U.S. Supreme Court ruled on Loper Bright Enterprises v. Raimondo, thereby overturning the Chevron Doctrine, a Supreme Court ruling from 1984 that provided for deference to U.S. regulatory agency regulations adopted pursuant to general federal statutory authority.
Added
This decision and other related decisions may create new legal avenues to challenge federal regulations, which may create unforeseen uncertainty, especially for businesses that have relied on a settled regulatory environment in their industry. Our historical reliance on an established regulatory environment may be subject to the potential risks of challenges to agency rules that regulate our industry.
Added
International conflict has affected commerce worldwide, and may have a material adverse effect on our results of operations, cash flows and financial condition. The Ukraine/Russia conflict and various Middle East conflicts have received significant media coverage. Geopolitical instability can lead to significant disruption in supply chain efficiency, adding cost and delays.
Added
Russia-related sanctions have been instituted by the Office of Foreign Assets Control (OFAC) are likely to have unpredictable and wide-ranging effects on the domestic and global economy and financial markets, which could have an adverse effect on our business and results of operations.
Added
As a 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.

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Item 2. Properties

Properties — owned and leased real estate

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Biggest changeW e believe that, in addition to the record owners, we have approximately 3,318 beneficial owners of our common stock. Dividends The holders of common stock are entitled to receive such dividends as may be declared by Milestone Scientific’s Board of Directors.
Biggest changeWe believe that, in addition to the record owners, we have approximately 3,488 beneficial owners of our common stock. Dividends The holders of common stock are entitled to receive such dividends as may be declared by Milestone Scientific’s Board of Directors. Milestone Scientific has not paid and does not expect to declare or pay any dividends in the foreseeable future.
Milestone Scientific currently has no policy with respect to investments or interests in real estate, real estate mortgages or securities of, or interests in, persons primarily engaged in real estate activities. Item 3. Legal Proceedings Milestone Scientific is not involved in any material litigation. Item 4. Mine Safety Disclosure Not applicable. 20 PART II Item 5.
Milestone Scientific currently has no policy with respect to investments or interests in real estate, real estate mortgages or securities of, or interests in, persons primarily engaged in real estate activities. Item 3. Legal Proceedings Milestone Scientific is not involved in any material litigation. Item 4. Mine Safety Disclosure Not applicable. 22 PART II Item 5.
The following table sets forth the high and low sales prices of Milestone’s common stock for the periods presented. 2023 High Low 2022 High Low First Quarter $ 1.00 $ 0.46 First Quarter $ 2.20 $ 1.13 Second Quarter $ 1.22 $ 0.72 Second Quarter $ 1.60 $ 0.75 Third Quarter $ 1.35 $ 0.81 Third Quarter $ 1.27 $ 0.71 Fourth Quarter $ 1.00 $ 0.56 Fourth Quarter $ 0.87 $ 0.45 Holders As of March 29, 2024, we had approximate ly 97 stockholders of record of our common stock.
The following table sets forth the high and low sales prices of Milestone’s common stock for the periods presented. 2024 High Low 2023 High Low First Quarter $ 0.78 $ 0.52 First Quarter $ 1.00 $ 0.46 Second Quarter $ 0.85 $ 0.54 Second Quarter $ 1.22 $ 0.72 Third Quarter $ 1.10 $ 0.58 Third Quarter $ 1.35 $ 0.81 Fourth Quarter $ 1.05 $ 0.60 Fourth Quarter $ 1.00 $ 0.56 Holders As of March 27, 2024, we had approximately 97 stockholders of record of our common stock.
Removed
Milestone Scientific has not paid and does not expect to declare or pay any dividends in the foreseeable future. Sales of Unregistered Securities Not applicable.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeItem 5. Market for Common Equity, Related Stockholder Matters and Small Business Issuer Purchases of Equity Securities 21 Item 6. Reserved 21 Item 7. Management's Discussion and Analysis or Plan of Operations 22 Item 7A. Quantitative and Qualitative Disclosure about Market Risk 28 Item 8. Financial Statements 28
Biggest changeItem 5. Market for Common Equity, Related Stockholder Matters and Small Business Issuer Purchases of Equity Securities 23 Item 6. Reserved 23 Item 7. Management's Discussion and Analysis or Plan of Operations 24 Item 7A. Quantitative and Qualitative Disclosure about Market Risk 30 Item 8. Financial Statements 30 Item 9.
Added
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 30 Item 9A. Controls and Procedures 31

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeThis 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. 23 The following table shows a breakdown of Milestone Scientific’s product sales (net), domestically and internationally, by business segment product category: 2023 Domestic: US Dental Medical Grand Total Instruments $ 1,002,697 $ 1,000 $ 1,003,697 Handpieces 4,270,898 12,000 4,282,898 Accessories 75,285 - 75,285 Grand Total $ 5,348,880 $ 13,000 $ 5,361,880 International: Rest of World Instruments $ 1,251,354 $ 25,000 $ 1,276,354 Handpieces 2,845,734 28,000 2,873,734 Accessories 45,476 - 45,476 Grand Total $ 4,142,564 $ 53,000 $ 4,195,564 International: China Instruments $ 270,000 $ - $ 270,000 Handpieces - - - Accessories - - - Grand Total $ 270,000 $ - $ 270,000 Total Product Sales $ 9,761,444 $ 66,000 $ 9,827,444 2022 Domestic: US Dental Medical Grand Total Instruments $ 524,715 $ 7,500 $ 532,215 Handpieces 2,653,914 25,250 2,679,164 Accessories 78,493 78,493 Grand Total $ 3,257,122 $ 32,750 $ 3,289,872 International: Rest of World Instruments $ 1,413,525 $ - $ 1,413,525 Handpieces 3,391,748 20,000 3,411,748 Accessories 60,797 - 60,797 Grand Total $ 4,866,070 $ 20,000 $ 4,886,070 International: China Instruments $ 270,000 $ - $ 270,000 Handpieces 359,964 - 359,964 Accessories - - - Grand Total $ 629,964 $ - $ 629,964 Total Product Sales $ 8,753,156 $ 52,750 $ 8,805,906 24 Current Product Platform See Item 1.
Biggest changeThe following table shows a breakdown of Milestone Scientific’s product sales (net), domestically and internationally, by business segment product category: Year Ended December 31, 2024 Year Ended December 31, 2023 Domestic: US Dental Medical Grand Total Dental Medical Grand Total Instruments $ 806,885 $ 4,000 $ 810,885 $ 1,002,697 $ 1,000 $ 1,003,697 Handpieces 4,284,952 55,900 4,340,852 4,270,898 12,000 4,282,898 Accessories 49,112 - 49,112 75,285 - 75,285 Grand Total $ 5,140,949 $ 59,900 $ 5,200,849 $ 5,348,880 $ 13,000 $ 5,361,880 International: Rest of World Instruments $ 868,169 $ 39,000 $ 907,169 $ 1,251,354 $ 25,000 $ 1,276,354 Handpieces 2,476,988 3,920 2,480,908 2,845,734 28,000 2,873,734 Accessories 41,002 - 41,002 45,476 - 45,476 Grand Total $ 3,386,159 $ 42,920 $ 3,429,079 $ 4,142,564 $ 53,000 $ 4,195,564 International: China Instruments $ - $ - $ - $ 270,000 $ - $ 270,000 Handpieces - - - - - - Accessories - - - - - - Grand Total $ - $ - $ - $ 270,000 $ - $ 270,000 Total Product Sales $ 8,527,108 $ 102,820 $ 8,629,928 $ 9,761,444 $ 66,000 $ 9,827,444 Current Product Platform See Item 1.
It has specific medical applications for epidural space identification in regional anesthesia procedures. Our device, using 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.
It has specific medical applications for epidural space identification in regional anesthesia procedures. 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.
Milestone Scientific remains focused on advancing efforts to achieve the following three primary objectives: ● 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; ● 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; and ● Expanding our global footprint of our CompuFlo Epidural and CathCheck System by utilizing a targeted field sales force and partnering with distribution companies worldwide. 22 Our dental devices have been used to administer over 92 million injections worldwide.
Milestone Scientific remains focused on advancing efforts to achieve the following three primary objectives: ● 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; ● 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; and ● Expanding our global footprint of our CompuFlo Epidural and CathCheck System by utilizing a targeted field sales force and partnering with distribution companies worldwide. 24 Our dental devices have been used to administer over 95 million injections worldwide.
Our common stock was initially listed on the NYSE American on June 1, 2015, and trades under the symbol “MLSS”. 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.
Our common stock was initially listed on the NYSE American on June 1, 2015, and trades under the symbol “MLSS". 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.
The Single Tooth Anesthesia System (Dental) Since its market introduction in early 2007, the STA Single Tooth Anesthesia System and prior C-CLAD devices have been used to deliver over 92 million safe, effective, and comfortable injections. The instrument has also been favorably evaluated in numerous peer-reviewed, published clinical studies and associated articles.
The Single Tooth Anesthesia System (Dental) 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.
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 Milestone Scientific and its subsidiaries currently hold over 245 U.S. and foreign patents, and many patents pending and patent applications.
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 Milestone Scientific and its subsidiaries currently hold over 317 U.S. and foreign patents, and many patents pending and patent applications.
Actual results could differ significantly from those estimates. 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.
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.
Revenue from other U.S. distributors was approximately $485,000 for the year ended December 31, 2023, a decrease of $97,000 compared to December 31, 2022. The Company terminated all non-exclusive agreements with other distributors in the US in September 2023.
Revenue from other U.S. distributors was approximately $9,000 for the year ended December 31, 2024, a decrease of $476,000 compared to December 31, 2023. The Company terminated all non-exclusive agreements with other distributors in the US in September 2023.
As stated above, the decrease in the loss from operations is driven by higher dental sales, and increased margins, which offset the higher selling, general and administrative expenses during period.
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.
As of January 3, 2023, the Company launched an E-Commerce platform, selling and shipping the STA Single Tooth Anesthesia System® (STA) and handpieces directly to end users, including dental offices and dental groups, within the U.S. E-commerce revenue for the year ended December 31, 2023 was approximately $4.8 million.
As of January 3, 2023, the Company launched an E-Commerce platform, selling and shipping the STA Single Tooth Anesthesia System® (STA) and handpieces directly to end users, including dental offices and dental groups, within the U.S.
Financing Activities Cash flows provided by financing activities increased $2.6 million for the year ended December 31, 2023, compared to an immaterial amount for the year ended December 31, 2022.
Financing Activities Cash flows provided by financing activities decreased $2.3 million to $0.2 million for the year ended December 31, 2024 compared to $2.6 million for the year ended December 31, 2023.
The Company recorded an increase in other selling, general and administrative expenses of approximately $306,000 for the year ended December 31, 2023, compared to the same period in 2022 due to the launch of E-Commerce.
The Company increased professional fees, and quality control by approximately $305,000 compared to the same period in 2023. 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.
The decrease of approximately $449,000 is related to the Company's near completion in developing the next generation STA Single Tooth Anesthesia System, offset by an increase in medical cost for the epidural consumables.
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.
The increase of approximately $621,000 is due to several factors. Employee salaries and benefits expenses increased approximately $44,000 for the year ended December 31, 2023 compared to the same period in 2022. The Company decreased quality control, regulatory, and travel expenses by approximately $367,000 compared to the same period in 2022.
The decrease of approximately $840,000 is due to several factors. Employee salaries and benefits expenses decreased approximately $654,000 for the year ended December 31, 2024 compared to the same period in 2023. The Company decreased warehousing, marketing, regulatory, royalties’ and travel expenses by approximately $324,000 compared to the same period in 2023.
For the year ended December 31, 2023, international revenue was approximately $4.1 million, a decrease of $724,000 compared to December 31, 2022. For the year ended December 31, 2023, the Company reported approximately $270,000 revenue from China, a decrease of approximately $356,000.
For the year ended December 31, 2024, international revenue was approximately $3.4 million, a decrease of $756,000 compared to December 31, 2023. The decrease in international revenue is due low performing markets and shipping delays. For the year ended December 31, 2024, the Company reported zero revenue from China, a decrease of approximately $270,000.
The decrease was driven by an increase of $0.8 million in cash used in work capital activities offset by employees paid in common stock of $0.1 million. Investing Activities Cash flows used in investing activities increased $3.0 million for the year ended December 31, 2023 compared to an immaterial amount for the year ended December 31, 2022.
Investing Activities 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.
Liquidity and Capital Resources C ash Flows The following table summarizes our sources and uses of cash for each of the periods presented: 2023 2022 Change Cash flows used in operating activities $ (5,326,129 ) $ (6,031,996 ) $ 705,867 Cash flows used in investing activities (2,972,172 ) (8,527 ) (2,963,645 ) Cash flows provided by (used in) financing activities 2,560,735 (8,544 ) 2,569,279 Total $ (5,737,566 ) $ (6,049,067 ) $ 311,501 Operating Activities Cash flows used in operating activities decreased $0.7 million from $6.0 million for the year ended December 31, 2022 compared to $5.3 million for the year ended December 31, 2023.
Liquidity and Capital Resources C ash Flows The following table summarizes our sources and uses of cash for each of the periods presented: Cash flow: 2024 2023 Change Net cash used in operating activities $ (2,919,875 ) $ (5,326,129 ) $ 2,406,254 Net cash provided by (used in) investing activities 2,966,449 (2,972,172 ) 5,938,621 Net cash provided by financing activities 233,771 2,560,735 (2,326,964 ) $ 280,345 $ (5,737,566 ) $ 6,017,911 Operating Activities Cash flows used in operating activities decreased by $2.4 million for the year ended December 31, 2024 compared to December 31, 2023.
December 31, 2023 December 31, 2022 Operating results: Product sales, net $ 9,827,444 $ 8,805,906 Cost of products sold 3,034,832 3,905,092 Gross profit 6,792,612 4,900,814 Operating expenses: Selling, general and administrative expenses 13,135,796 12,514,323 Research and development expenses 701,378 1,150,209 Depreciation and amortization expense 61,912 63,755 Total operating expenses 13,899,086 13,728,287 Loss from operations (7,106,474 ) (8,827,473 ) Other income, and interest net 125,527 54,607 Net loss (6,980,947 ) (8,772,866 ) Net loss attributable to noncontrolling interests (51,843 ) (66,735 ) Net loss attributable to Milestone Scientific Inc. $ (6,929,104 ) $ (8,706,131 ) Net sales for year ended December 31, 2023, compared to year ended December 31, 2022 2023 2022 Change Dental $ 9,761,444 $ 8,753,156 $ 1,008,288 Medical 66,000 52,750 $ 13,250 Total sales, net $ 9,827,444 $ 8,805,906 $ 1,021,538 Consolidated revenue for the years ended December 31, 2023 and 2022 was approximately $9.8 million and $8.8 million, respectively, an increase of approximately $1.0 million.
For the year end December 31, 2024, compared to year ended December 31, 2023. 2024 2023 Operating results: Product sales, net $ 8,629,928 $ 9,827,444 Cost of products sold 2,195,340 3,034,832 Gross profit 6,434,588 6,792,612 Operating expenses: Selling, general and administrative expenses 12,295,330 13,135,796 Research and development expenses 858,767 701,378 Depreciation and amortization expense 37,448 61,912 Total operating expenses 13,191,545 13,899,086 Loss from operations (6,756,957 ) (7,106,474 ) Interest income 60,265 125,527 Gain on sale of net operating losses 1,983,095 - Net loss (4,713,597 ) (6,980,947 ) Net loss attributable to noncontrolling interests - (51,843 ) Net loss attributable to Milestone Scientific Inc. $ (4,713,597 ) $ (6,929,104 ) 27 Net sales for year ended December 31, 2024, compared to year ended December 31, 2023 2024 2023 Change Dental $ 8,527,108 $ 9,761,444 $ (1,234,336 ) Medical 102,820 66,000 36,820 Total sales, net $ 8,629,928 $ 9,827,444 $ (1,197,516 ) 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.
Selling, general and administrative expenses for years ended December 31, 2023, and 2022 were as follows: 2023 2022 Change Dental $ 4,330,219 $ 3,225,032 $ 1,105,187 Medical 3,381,551 4,183,983 (802,432 ) Corporate 5,424,026 5,105,308 318,718 Total selling, general and administrative expenses $ 13,135,796 $ 12,514,323 $ 621,473 Consolidated selling, general and administrative expenses for the years ended December 31, 2023 and 2022 were approximately $13.1 million and $12.5 million, respectively.
Selling, general and administrative expenses for years ended December 31, 2024, and 2023 were as follows: 2024 2023 Change Dental $ 3,929,073 $ 4,330,219 $ (401,146 ) Medical 2,128,456 3,381,551 (1,253,095 ) Corporate 6,237,801 5,424,026 813,775 Total selling, general and administrative expenses $ 12,295,330 $ 13,135,796 $ (840,466 ) 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.
Gross Profit for years ended December 31, 2023, and 2022 were as follows: 2023 2022 Change Dental $ 7,030,018 $ 5,446,175 $ 1,583,843 Medical (237,406 ) (545,361 ) $ 307,955 Total gross profit $ 6,792,612 $ 4,900,814 $ (1,891,798 ) Consolidated gross profit for the year ended December 31, 2023 increased by approximately 1.9 million or 40%, compared to the same period in 2022.
Gross Profit for years ended December 31, 2024, and 2023 were as follows: 2024 2023 Change Dental $ 6,340,966 $ 7,030,018 $ (689,052 ) Medical 93,622 (237,406 ) 331,028 Total gross profit $ 6,434,588 $ 6,792,612 $ (358,024 ) Consolidated gross profit for the year ended December 31, 2024 decreased by approximately $358,000 or 5%, compared to the same period in 2023.
The increase was due to higher margins in sales associated with the launch of E-Commerce platform. The Company recorded approximately $258,000 and $550,000 allowance for medical inventory that was obsolete and or expired for the years ended December 31, 2023 and 2022, respectively.
The Company recorded approximately $258,000 allowance for medical inventory that was obsolete and or expired for the year ended December 31, 2023.
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. 25 Results of Operations The following table sets forth the consolidated results of operations for the year ended December 31, 2023 compared to the year ended December 31, 2022.
Inventories Inventories principally consist of finished goods and component parts stated at the lower cost (first-in, first-out method) or net realizable value. 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.
The Company ended the agreement with its major United States distributor, Henry Schein, as of December 31, 2022. 26 The Company recorded no revenue from Henry Schein for the year ended December 31, 2023, compared to approximately $2.6 million recorded for the year ended December 31, 2022.
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. 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.
Research and Development for years ended December 31, 2023, and 2022 were as follows: 2023 2022 Change Dental $ 567,357 $ 1,095,523 $ (528,166 ) Medical 86,426 54,686 31,740 Corporate 47,595 - 47,595 Total research and development $ 701,378 $ 1,150,209 $ (448,831 ) Consolidated research and development expenses for the years ended December 31, 2023 and 2022 were approximately $701,000 and $1.2 million respectively.
Research and Development for years ended December 31, 2024, and 2023 were as follows: 2024 2023 Change Dental $ 835,851 $ 614,952 $ 220,899 Medical 22,916 86,426 (63,510 ) Corporate - - - Total research and development $ 858,767 $ 701,378 $ 157,389 28 Consolidated research and development expenses for the years ended December 31, 2024 and 2023 were approximately $859,000 and $701,000 respectively.
Profit (Loss) from Operations for 2023 and 2022 were as follows: 2023 2022 Change Dental $ 2,128,199 $ 1,121,815 $ 1,006,384 Medical (3,708,170 ) (4,788,105 ) 1,079,935 Corporate (5,526,503 ) (5,161,183 ) (365,320 ) Total loss from operations $ (7,106,474 ) $ (8,827,473 ) $ 1,720,999 27 The loss from operations was approximately $7.2 million and $8.8 million for the years ended December 31, 2023 and 2022, respectively, a decrease of approximately $1.7 million.
The Company has also decided to delay all research and development on the STA Single Tooth Anesthesia System next generation instrument Loss from Operations for 2024 and 2023 were as follows: 2024 2023 Change Dental $ 1,576,043 $ 2,128,199 $ (552,156 ) Medical (2,057,751 ) (3,708,170 ) 1,650,419 Corporate (6,275,249 ) (5,526,503 ) (748,746 ) Total loss from operations $ (6,756,957 ) $ (7,106,474 ) $ 349,517 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.
Year end December 31, 2023, compared to year ended December 31, 2022.
For the year ended December 31, 2024, medical revenue increased approximately $37,000 compared to December 31, 2023.
However, the Company’s continued operations will depend on its ability to raise additional capital through various potential sources until it achieves profitability, if ever. 28 Contractual Obligations The impact of the consolidated contractual obligations on December 31, 2023, expected on the liquidity and cash flows in future periods, is as follows: Payments Due by Period Total Less than 1 Year 1-3 Years 3-5 Years Operating lease obligations $ 1,055,975 $ 144,300 $ 911,675 $ - Purchase obligations (1) $ 2,382,630 $ 1,782,333 $ 600,297 $ - Total $ 3,438,605 $ 1,926,633 $ 1,511,972 $ - Recent Accounting Pronouncements See “Note C - Summary of Significant Accounting Policies” to the consolidated financial statements for explanation of recent accounting pronouncements impacting Milestone Scientific.
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. 29 Contractual Obligations The impact of the consolidated contractual obligations on December 31, 2024, expected on the liquidity and cash flows in future periods, is as follows: Payments Due by Period Total Less than 1 Year 1-3 Years 3-5 Years Operating lease obligations $ 379,051 150,011 215,606 13,434 Purchase obligations $ 2,754,160 1,350,420 1,403,740 - Total $ 3,133,211 1,500,431 1,619,346 13,434 Recent Accounting Pronouncements See “Note C - Summary of Significant Accounting Policies” to the consolidated financial statements for explanation of recent accounting pronouncements impacting Milestone Scientific.
Removed
Description of Business. Summary of Critical Accounting Estimates The preparation of these consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities.
Added
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 an on-going basis, Milestone Scientific evaluates its estimates, including those related inventory valuation and cash flow assumptions regarding evaluations for going concern considerations.
Added
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.
Removed
Milestone Scientific bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not clear from other sources. Actual results may differ from those estimates under different assumptions or conditions.
Added
(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
Our accounting policies are more fully described in Note C of the financial statements to this Annual Report on Form 10-K. As disclosed in Note C, the preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions about future events that affect the amounts reported in the financial statements and accompanying notes.
Added
On July 23, 2024 the Company announced that Novitas Solutions, Inc.
Removed
Assessment of our Ability to Continue as a Going Concern In accordance with (“ASC”) 205-40, “Presentation of Financial Statements – Going Concern”, the Company continually evaluates whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company's ability to continue as a going concern within one year after the date that the consolidated financial statements are issued.
Added
(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).
Removed
Milestone Scientific has incurred operating losses and negative cash flows from operating activities in virtually each year since its inception.
Added
JL includes Delaware, District of Columbia, Maryland, New Jersey, and Pennsylvania. JH includes Arkansas, Colorado, Louisiana, Mississippi, New Mexico, Oklahoma, and Texas. 25 On July 30, 2024, the Company announced receipt of multiple Notices of Allowance (NOA) for essential patent applications in both the U.S. and Europe. One NOAs was granted by the U.S.
Removed
The Company has evaluated whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company's ability to continue as a going concern within one year after the date that the consolidated financial statements are issued. The Company has incurred total losses since inception of $123.3 million.
Added
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.
Removed
The operating losses were $7.1 million and $8.8 million, for the years ended December 31, 2023, and 2022, respectively. On December 31, 2023, Milestone Scientific had cash and cash equivalents and marketable securities of approximately $6.0 million and working capital of approximately $7.7 million.
Added
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).
Removed
For the twelve months ended December 31, 2023 and 2022, we had cash flows used in operating activities of approximately $5.3 million and $6.0 million, respectively. Management has prepared cashflow forecasts covering a period of 12 months from the date of issuance of these financial statements.
Added
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
These forecasts include several revenue and operating expense assumptions which indicate that the Company’s current cash and liquidity is sufficient to finance the operating requirements for at least the next 12 months.
Added
Description of Business. Summary of Critical Accounting Estimates We have identified the accounting estimates below as critical to the understanding of our results of operations and our financial condition.
Removed
Additionally, the Company was approved on September 12, 2023 to sell Net Operating Losses through the New Jersey Technology Business Tax Certificate Transfer Program (“NJ NOL Program”), a program administered by the New Jersey Economic Development Authority (“NJEDA”). Management believes this program will generate positive cash flow in the near future.
Added
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. Actual results may differ from these estimates under different assumptions or conditions.
Removed
Milestone Scientific is actively pursuing the generation of positive cash flows from operating activities through an increase in revenue from its dental business worldwide, the generation of revenue from its medical devices and disposables business in the United States and worldwide, and a reduction in operating expenses.
Added
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. Management reviews revenue, and its cash position on regularly basis along with the company inventory needs.
Removed
However, the Company’s continued operations will depend on its ability to raise additional capital through various potential sources until it achieves profitability, if ever. Inventories Inventories principally consist of finished goods and component parts stated at the lower of cost (first-in, first-out method) or net realizable value.
Added
For a detailed discussion of significant accounting policies, see Note C. 26 Going Concern and Liquidity Management has developed and is implementing plans to increase revenues and decrease professional and consulting fees over the next twelve months. The Company has also decided to delay all research and development on the Single Tooth Anesthesia System next generation instrument.
Removed
The Company increased professional fees, and royalties’ expenses by approximately $317,000 compared to the same period in 2022.With the launch of the E-Commerce platform marketing and warehousing expense increased for the year ended December 31, 2023, by approximately $320,000 compared to the same period in 2022.
Added
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
The increase in cash used in investing activities was driven by the Company’s purchase of marketable securities of $7.9 million, offset by the sale of $5.0 million of marketable securities during the current year.
Added
Results of Operations 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
The increase 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 current year. Consideration of Company ’ s ability to continue as a going concern.
Added
Dental gross profit for the years ended December 31, 2024 and 2023 we approximately 74% and 72% respectively. 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 has evaluated whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company's ability to continue as a going concern within one year after the date that the consolidated financial statements are issued. The Company has incurred total losses since inception of $123.3 million.
Added
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
The operating losses were $7.1 million and $8.8 million, for the years ended December 31, 2023, and 2022, respectively. On December 31, 2023, Milestone Scientific had cash and cash equivalents and marketable securities of approximately $6.0 million and working capital of approximately $7.7 million.
Added
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
For the twelve months ended December 31, 2023 and 2022, we had cash flows used in operating activities of approximately $5.3 million and $6.0 million, respectively.
Added
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
Additionally, the Company was approved on September 12, 2023 to sell Net Operating Losses through the New Jersey Technology Business Tax Certificate Transfer Program (“NJ NOL Program”), a program administered by the New Jersey Economic Development Authority (“NJEDA”). Management believes this program will generate positive cash flow in the near future.
Removed
Management has prepared cashflow forecasts covering a period of 12 months from the date of issuance of these financial statements. These forecasts include several revenue and operating expense assumptions which indicate that the Company’s current cash and liquidity is sufficient to finance the operating requirements for at least the next 12 months.
Removed
Milestone Scientific is actively pursuing the generation of positive cash flows from operating activities through an increase in revenue from its dental business worldwide, the generation of revenue from its medical devices and disposables business in the United States and worldwide, and a reduction in operating expenses.

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