MILESTONE SCIENTIFIC INC.MLSS财报
NYSE · 医疗保健 · 骨科、假肢及手术器械与用品
Boston Scientific Corporation (BSC) is an American biotechnology and biomedical engineering firm and multinational manufacturer of medical devices used in interventional medical specialties, including interventional radiology, interventional cardiology, peripheral interventions, neuromodulation, neurovascular intervention, electrophysiology, cardiac surgery, vascular surgery, endoscopy, oncology, urology and gynecology.
What changed in MILESTONE SCIENTIFIC INC.'s 10-K — 2024 vs 2025
Top changes in MILESTONE SCIENTIFIC INC.'s 2025 10-K
219 paragraphs added · 199 removed · 96 edited across 5 sections
- Item 1A. Risk Factors+205 / −119 · 89 edited
- Item 7. Management's Discussion & Analysis+1 / −62
- Item 1C. Cybersecurity+6 / −9 · 5 edited
- Item 2. Properties+2 / −7 · 2 edited
- Item 5. Market for Registrant's Common Equity+5 / −2
Item 1A. Risk Factors
Risk Factors — what could go wrong, per management
89 edited+116 added−30 removed75 unchanged
Item 1A. Risk Factors
Risk Factors — what could go wrong, per management
89 edited+116 added−30 removed75 unchanged
2024 filing
2025 filing
As a result, we may not be able to compete effectively against these companies or their products. Our ability to commercialize our products will depend in part on the extent to which reimbursement will be available from governmental agencies, health administration authorities, private health maintenance organizations and health insurers and other healthcare payers.
As a result, we may not be able to compete effectively against these companies or their products. Our ability to commercialize our products will depend in part on the extent to which reimbursement will be available from governmental agencies, health administration authorities, private health maintenance organizations, health insurers, and other healthcare payers.
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 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.
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 our business; ● Online security breaches and cyberattacks; ● Poor search engine visibility affects traffic and sales; and ● Unexpected changes in political or regulatory environments.
In addition, because of the concentration of ownership of our shares of common stock, our stockholders may from time to time observe instances where there may be less liquidity in the public markets for our securities.
Because of the concentration of ownership of our shares of common stock, our stockholders may from time to time observe instances where there may be less liquidity in the public markets for our securities.
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.
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. 14 ● 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.
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.
For example, the current 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.
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.
The scope of our patent rights may be limited and may also depend on the availability of meaningful legal remedies. 13 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 frequency of filing qui tam actions has increased significantly in recent years, causing greater numbers of medical device, pharmaceutical and health care companies to have to defend False Claim Act actions. The Affordable Care Act includes provisions expanding the ability of certain relators to bring actions that would have been previously dismissed under prior law.
The frequency of filing qui tam actions has increased significantly in recent years, causing greater numbers of medical device, pharmaceutical, and healthcare companies to have to defend False Claim Act actions. The Affordable Care Act includes provisions expanding the ability of certain relators to bring actions that would have been previously dismissed under prior law.
Our ability to generate revenues from our products will be diminished if the products sell for inadequate prices or hospitals or physicians are unable to obtain adequate levels of reimbursement for the cost they incur in connection with the use of the product. Significant uncertainty exists as to the reimbursement status of newly approved healthcare products.
Our ability to generate revenues from our products will be diminished if the products sell for inadequate prices or hospitals or physicians are unable to obtain adequate levels of reimbursement for the cost they incur in connection with the use of the product. Significant uncertainty exists as to the reimbursement status of legacy and newly approved healthcare products.
Any such failure to perform or a reduction or interruption in supply could have a material adverse effect on Milestone Scientific’s business and operations. Risks Related to Regulatory Compliance and Other Legal Matters We are subject to substantial domestic and international government regulation, including regulatory quality standards applicable to our manufacturing and quality processes.
Any such failure to perform or a reduction or interruption in supply could have a material adverse effect on our business and operations. Risks Related to Regulatory Compliance and Other Legal Matters We are subject to substantial domestic and international government regulation, including regulatory quality standards applicable to our manufacturing and quality processes.
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.
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.
Any curtailment or interruptions of the supply, whether because of termination of the relationship or otherwise, would have a material adverse effect on our financial condition, business, and results of operations. Our business is exposed to risks associated with the economic, environmental, and political conditions in China because the sole manufacturer of our handpieces is in China.
Any curtailment or interruption of the supply, whether because of termination of the relationship or otherwise, would have a material adverse effect on our financial condition, business, and results of operations. Our business is exposed to risks associated with the economic, environmental, and political conditions in China because the sole manufacturer of our handpieces is in China.
Risk Related to Our Dependence on Third Parties Relying exclusively on third parties to manufacture our products, changes in our informal manufacturing arrangements made by the manufacturer of our products and disruptions at the manufacturing facility of our manufacturers and failure to maintain existing supply relationships exposes us to risks that may harm our business.
Risk Related to Our Dependence on Third Parties Relying exclusively on third parties to manufacture our products, changes in our informal manufacturing arrangements made by the manufacturer of our products, disruptions at the manufacturing facility of our manufacturers, and failure to maintain existing supply relationships expose us to risks that may harm our business.
This could potentially impair the liquidity of our securities not only in the number of shares that could be bought and sold at a given price, which may be depressed by the relative illiquidity, but also through delays in the timing of transactions and the potential reduction in media coverage.
This would impair the liquidity of our securities not only in the number of shares that could be bought and sold at a given price, which may be depressed by the relative illiquidity, but also through delays in the timing of transactions and the potential reduction in media coverage.
In addition, we are subject to the Foreign Corrupt Practices Act (“FCPA”) and other countries’ anti-corruption/anti-bribery regimes, such as the U.K. Bribery Act. The FCPA prohibits improper payments or offers of payments to foreign governments and their officials for obtaining or retaining business.
In addition, we are subject to the Foreign Corrupt Practices Act (“ FCPA ”) and other countries’ anti-corruption/anti-bribery regimes, such as the U.K. Bribery Act. The FCPA prohibits improper payments or offers of payments to foreign governments and their officials for obtaining or retaining business.
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.
Russia-related sanctions 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.
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, it 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.
Intellectual property rights, including patents, trade secrets, confidential information, trademarks, trade names and trade address, are important to our business. We will endeavor to protect our intellectual property rights in key jurisdictions in which our products are produced or used and in jurisdictions into which our products are imported.
Intellectual property rights, including patents, trade secrets, confidential information, trademarks, trade names, and trade addresse, are important to our business. We will endeavor to protect our intellectual property rights in key jurisdictions in which our products are produced or used and in jurisdictions into which our products are imported.
In the event that any of its existing supply arrangements are terminated or there is a reduction or interruption of supply under these existing arrangements, Milestone Scientific expects that it will be able to enter into new arrangements with alternative suppliers, but these new arrangements may be on terms that are less favorable, including with respect to price and volume, and it may be costly or cause delays in our manufacturing process to transition to a new supplier, particularly in cases in which we must comply with regulatory requirements relating to qualification of new suppliers.
In the event that any of its existing supply arrangements are terminated or there is a reduction or interruption of supply under these existing arrangements, We expect that we will be able to enter into new arrangements with alternative suppliers, but these new arrangements may be on terms that are less favorable, including with respect to price and volume, and it may be costly or cause delays in our manufacturing process to transition to a new supplier, particularly in cases in which we must comply with regulatory requirements relating to qualification of new suppliers.
The federal Anti-Kickback Statute prohibits persons from knowingly and willfully soliciting, offering, receiving, or providing remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual, or the furnishing or arranging for a good or service, for which payment may be made under a federal health care program such as Medicare or Medicaid.
The federal Anti-Kickback Statute prohibits persons from knowingly and willfully soliciting, offering, receiving, or providing remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual, or the furnishing or arranging for a good or service, for which payment may be made under a federal healthcare program such as Medicare or Medicaid.
Similar reporting requirements have also been enacted on the state level in the United States, and an increasing number of countries worldwide either have adopted or are considering similar laws requiring transparency of interactions with health care professionals. In addition, some states, such as Massachusetts and Vermont, impose an outright ban on certain gifts to physicians.
Similar reporting requirements have also been enacted on the state level in the United States, and an increasing number of countries worldwide either have adopted or are considering similar laws requiring transparency of interactions with healthcare professionals. In addition, some states, such as Massachusetts and Vermont, impose an outright ban on certain gifts to physicians.
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.
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 retain our new chief executive officer and other key officers and attract other qualified employees, as needed, our business may be harmed.
If we are found to be in violation of any of the laws described above and other applicable state and federal fraud and abuse laws, we may be subject to penalties, including civil and criminal penalties, damages, fines, or an administrative action of suspension or exclusion from government health care reimbursement programs and the curtailment or restructuring of our operations.
If we are found to be in violation of any of the laws described above and other applicable state and federal fraud and abuse laws, we may be subject to penalties, including civil and criminal penalties, damages, fines, or an administrative action of suspension or exclusion from government healthcare reimbursement programs and the curtailment or restructuring of our operations.
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.
It is also possible that other federal, state or foreign enforcement authorities might act if they consider the Company’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.
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.
These instabilities may significantly and adversely affect our supply of dental handpieces and our ability to deliver reasonably priced products, which would in turn adversely affect our financial performance.
In the future, your percentage ownership in Milestone Scientific may be diluted because of equity issuances for acquisitions, capital market transactions or otherwise, including any equity awards that Milestone Scientific will grant to its directors, officers, employees and consultants.
In the future, your percentage ownership in the Company may be diluted because of equity issuances for acquisitions, capital market transactions or otherwise, including any equity awards that the Company will grant to its directors, officers, employees and consultants.
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.
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 have impacted and will continue to impact the price of our goods sold.
Several courts have interpreted the statute’s intent requirement to mean that if any one purpose of an arrangement involving remuneration is to induce referrals of federal health care covered business, the statute has been violated.
Several courts have interpreted the statute’s intent requirement to mean that if any one purpose of an arrangement involving remuneration is to induce referrals of federal healthcare covered business, the statute has been violated.
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.
If the FDA, the FTC or another regulatory agency determines that The Company’s promotional or training material constitutes off-label, false or misleading, unfair or deceptive promotion of its products, it could request that the Company modify its training or promotional materials or subject it to regulatory or enforcement actions, including the issuance of an untitled letter, a warning letter, injunction, seizure, civil fine or criminal penalties.
Milestone Scientific relies on several third parties to supply and manufacture the components and raw materials for its products and its does not have long-term supply agreements with suppliers of these component parts and raw materials, and its arrangements with these suppliers are on a purchase-order basis.
The Company relies on several third parties to supply and manufacture the components and raw materials for its products, and it does not have long-term supply agreements with suppliers of these component parts and raw materials, and its arrangements with these suppliers are on a purchase-order basis.
This control could delay, deter, or prevent a change in control and could adversely affect the price that investors might be willing to pay in the future for Milestone Scientific’s securities.
This control could delay, deter, or prevent a change in control and could adversely affect the price that investors might be willing to pay in the future for the Company’s securities.
Most states have enacted state false claims laws, and many of those states included laws with qui tam provisions.
Most states have enacted state false claims laws, and many of those states include laws with qui tam provisions.
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.
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.
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.
Our operations are and will continue to be directly, or indirectly through our distributors, customers, and healthcare 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 Practices Act of 1977.
Milestone Scientific may make similar modifications or add additional features in the future that it believes do not require a new 510(k) clearance.
The Company may make similar modifications or add additional features in the future that it believes do not require a new 510(k) clearance.
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.
In addition, a decline in our valuation could cause stockholders 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.
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.
Uncertainties have arisen and may arise in the future 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.
Item 1A. Risk Factors You should consider carefully the risks and uncertainties described below, together with all the other information in this Annual Report on Form 10-K. If any of the following risks are realized, our business, financial condition, results of operations and prospects could be materially and adversely affected.
Item 1A. Risk Factors You should carefully consider the risks and uncertainties described below, together with the other information included in this Annual Report on Form 10-K. If any of the risks described below occur, our business, financial condition, results of operations, and prospects could be materially and adversely affected.
We cannot be certain that the conduct of our business does not and will not infringe intellectual property or other proprietary rights of others in the U.S. and in foreign jurisdictions.
We cannot be certain that the conduct of our business does not and will not infringe intellectual property or other proprietary rights of others in the United States and in foreign jurisdictions.
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.
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; 21 ● 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.
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.
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.
Milestone Scientific has been supplied by the manufacturer of the Wand/STA System and its predecessor, the CompuDent System, since the commencement of production in 1998, and by the manufacturer of its handpieces since 2003. The manufacturer of our handpieces is in the People’s Republic of China and the manufacturer of the Wand/STA System is in the United States.
We have been supplied by the manufacturer of the Wand/STA System and its predecessor, the CompuDent System, since the commencement of production in 1998, and by the manufacturer of its handpieces since 2003. The manufacturer of our handpieces is in the People’s Republic of China, and the manufacturer of the Wand/STA System is in the United States.
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.
Even if we become profitable, we may not be able to maintain or increase profitability on a quarterly or annual basis. If we do not generate sufficient profits from operations and become and remain profitable, our ability to raise capital, expand our business, maintain our commercial efforts, or continue operations could be impaired.
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.
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.
Certain modifications to Milestone Scientific ’ s products may require new 510(k) clearances or other marketing authorizations and may require Milestone Scientific to recall or cease marketing its products.
Certain modifications to the Company ’ s products may require new 510(k) clearances or other marketing authorizations and may require the Company to recall or cease marketing its products.
If we fail to adhere to the strict listing requirements of NYSE American, we may be subject to delisting. As a result, our stock price may decline, and our common stock may be de-listed. If our stock were no longer listed on NYSE American, the liquidity of our securities likely would be impaired.
See, “ If we fail to regain compliance with the strict listing requirements of NYSE American, we may be subject to delisting. As a result, our stock price may decline, and our common stock may be de-listed. If our stock were no longer listed on NYSE American, the liquidity of our securities likely would be impaired ,” above.
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.
Almost all our 80,453,116 outstanding shares of common stock on December 31, 2025, are available for sale in the public market, either freely or pursuant to Rule 144 under the Securities Act of 1933, as amended.
We are a small, non-diversified medical device company with a history of limited revenue and significant operating losses, and our prospects must be evaluated considering the uncertainties, risks, expenses, and difficulties frequently encountered by similarly situated companies. The Company has generated net losses in all periods since the commencement of our operations.
We are a small, non-diversified medical device company with a history of limited revenue and significant operating losses and our prospects must be evaluated considering the uncertainties, risks, expenses, and difficulties frequently encountered by similarly situated companies.
Milestone Scientific may be subject to enforcement actions if it engages in improper marketing or promotion of its products. Milestone Scientific’s promotional materials and training methods must comply with applicable laws, regulations and regulatory authority’s rules and guidelines, including the FDA and the Federal Trade Commission (the “FTC”).
The Company may be subject to enforcement actions if it engages in improper marketing or promotion of its products. The Company’s promotional materials and training methods must comply with applicable laws, regulations, and regulatory authorities’ rules and guidelines, including the FDA and the Federal Trade Commission (the “ FTC ”).
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.
The termination, reduction or interruption in supply of these raw materials and components could adversely impact our ability to manufacture and sell certain of its products. 15 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 our products.
If any of our computer-controlled anesthesia systems are found to infringe third party patent rights, we could be prohibited from manufacturing and commercializing the infringing technology unless we obtain a license under the applicable third-party patent and pay royalties or are able to design around such patent.
If any of our computer-controlled anesthesia systems are found to infringe third party patent rights, we could be prohibited from manufacturing and commercializing the infringing technology unless we obtain a license under the applicable third-party patent and pay royalties or are able to design around such patent. 23 We may be unable to obtain a license on terms acceptable to us, or at all, and we may not be able to redesign the system to avoid infringement.
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.
It is possible that the Trump administration could institute significant changes to certain regulatory agencies and task the “Department of Government Efficiency,” or “ DOGE ,” or any successor or similar initiative or agency, with making further changes to eliminate regulations, cut expenditures, and restructure federal agencies, some of which could impact public companies.
Milestone Scientific has made modifications to its products in the past and has determined based on its review of the applicable FDA regulations and guidance that in certain instances new 510(k) clearances or other premarket submissions were not required.
The FDA may not agree with the Company’s decisions regarding whether new clearances are necessary. The Company has made modifications to its products in the past and has determined, based on its review of the applicable FDA regulations and guidance, that in certain instances, new 510(k) clearances or other premarket submissions were not required.
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.
As a direct impact of 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. Geopolitical instability, labor unrest, and economic disruptions in certain foreign jurisdictions may indirectly affect our operations.
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.
If we are unable to maintain or expand our E-Commerce platform, our sales will be negatively affected. We are exposed to the risks inherent in international sales. In 2025, export sales outside the United States represented approximately 45% of total sales, and we sold products in approximately 37 countries and U.S. territories.
As a result, an investor might find it more difficult to dispose of our common stock. Any failure at any time to meet the continuing NYSE American listing requirements could have an adverse impact on the value of and trading activity in our common stock. Your percentage of ownership in Milestone Scientific may be diluted in the future.
As a result, an investor might find it more difficult to dispose of our common stock if we are de-listed. Any failure at any time to meet the continuing NYSE American listing requirements would have an adverse impact on the value of and trading activity in our common stock.
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.
We may be required to pay fees or other costs for access to such improvements. ● Though alternate sources of supply for dental handpieces exist, we 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.
As a result, capital appreciation, if any, of our common stock will be your sole source of gain for the foreseeable future. Provisions in our certificate of incorporation, our by-laws and Delaware law might discourage, delay, or prevent a change in control of our company or changes in our management and, therefore, depress the trading price of our common stock.
Provisions in our certificate of incorporation, our by-laws and Delaware law might discourage, delay, or prevent a change in control of our company or changes in our management and, therefore, depress the trading price of our common stock.
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.
Although we intend to pursue additional funding, there can be no assurance that we will obtain sufficient capital on acceptable terms, or at all. If we cannot raise capital when needed, we may be forced to delay, curtail, or eliminate research and development programs or other operations.
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.
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 operating losses are expected to continue, and we are unable to predict the extent of future losses, whether we will generate significant revenues or whether we will achieve or sustain profitability.
Risks Related to Our Financial Position and Need for Additional Capital We have incurred significant losses since our inception. These operating losses are expected to continue and we are unable to predict the extent of future losses, whether we will generate significant revenues, or whether we will achieve or sustain profitability.
The existence of the forgoing provisions and anti-takeover measures could limit the price that investors might be willing to pay in the future for shares of our common stock. They could also deter potential acquirers of our Company, thereby reducing the likelihood that you could receive a premium for your common stock in an acquisition.
The existence of the forgoing provisions and anti-takeover measures could limit the price that investors might be willing to pay in the future for shares of our common stock.
Our common stock currently trades on the NYSE American under the symbol “MLSS”. If we fail to adhere to NYSE American's strict listing criteria, including with respect to stock price, our market capitalization and stockholders’ equity, our stock may be de-listed.
The Company’s management is pursuing options to address the deficiency. If we fail to regain compliance with and adhere to NYSE American’s strict listing criteria, including with respect to stock price, our market capitalization and stockholders’ equity, our stock may be de-listed.
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.
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.
Once a medical device is permitted to be legally marketed in the United States pursuant to a 510(k) clearance, a manufacturer may be required to notify the FDA of certain modifications to the device.
Once a medical device is permitted to be legally marketed in the United States pursuant to a 510(k) clearance, a manufacturer may be required to notify the FDA of certain modifications to the device. 17 Manufacturers determine in the first instance whether a change to a product requires a new 510(k) clearance or premarket submission, but the FDA may review any manufacturer’s decision.
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.
Many states have also adopted laws like the federal Anti-Kickback Statute, some of which apply to the referral of patients for healthcare items or services reimbursed by any source, not only the Medicare and Medicaid programs.
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.
If our stock were no longer listed on NYSE American, the liquidity of our securities likely would be impaired. ” 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.
Any of these events could seriously harm our business, operating results, and financial condition. General Business Risks Our business and operations would suffer in the event of cybersecurity or other system failures.
Any of these events could seriously harm our business, operating results, and financial condition. General Business Risks Cybersecurity incidents, data breaches, or other system disruptions could compromise our products, data, and operations and materially adversely affect our business, financial condition, and results of operations.
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.
If the FDA disagrees with the Company’s determinations and requires it to submit new 510(k) notifications, the Company 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.
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.
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. This damage could be substantial and could harm our reputation, business, financial condition, and operating results.
Developments by competitors may render our products or technologies obsolete or non-competitive. The medical device industry is intensely competitive and subject to rapid and significant technological change. We expect that other companies (or individuals), whether located in the United States or abroad, will pursue the development of alternative injection-based or imaging-based systems that will compete with our products.
We expect that other companies (or individuals), whether located in the United States or abroad, will pursue the development of alternative injection-based or imaging-based systems that will compete with our products.
The risks described below are not the only risks facing us. Risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition, results of operations and/or prospects. Risks Related to Our Financial Position and Need for Additional Capital We have incurred significant losses since our inception.
The risks described below are not the only risks we face. Additional risks and uncertainties that we do not currently know about, or that we currently believe are immaterial, also may materially and adversely affect our business, financial condition, results of operations, and/or prospects.
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.
These losses have adversely affected, and are expected to continue to affect adversely, our working capital, total assets, and stockholders’ equity. 9 Because of the risks and uncertainties associated with product acceptance, sales expansion, and competitive conditions, we cannot predict the extent of future losses, whether we will generate significant revenues, or whether we will achieve or sustain profitability.
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.
Risks Related to Employee Matters We may not be able to attract and retain qualified employees. Our future success depends upon the services of our executive officers.
Penalties for violations of the federal Anti-Kickback Statute include criminal penalties and civil and administrative sanctions such as fines, imprisonment, and possible exclusion from Medicare, Medicaid, and other federal health care programs.
The Anti-Kickback Statute is broad and, despite a series of narrow safe harbors, prohibits many arrangements and practices that are lawful in businesses outside of the healthcare industry. Penalties for violations of the federal Anti-Kickback Statute include criminal penalties and civil and administrative sanctions such as fines, imprisonment, and possible exclusion from Medicare, Medicaid, and other federal healthcare programs.
There is no assurance that physicians, hospitals, clinics, and other health care providers will accept and use the CompuFlo Epidural System.
If physicians neither accept nor use our CompuFlo Epidural System, our ability to generate revenue from sales will be materially impaired. There is no assurance that physicians, hospitals, clinics, and other healthcare providers will accept and use the CompuFlo Epidural System.
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Item 1C. Cybersecurity
Cybersecurity — threats and controls disclosure
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Item 1C. Cybersecurity
Cybersecurity — threats and controls disclosure
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2024 filing
2025 filing
Our board of directors exercises its oversight function through the audit committee, which oversees the management of risk exposure across various areas, including cybersecurity risks, in accordance with its charter. The audit committee receives quarterly reports from our Management on the status of our cybersecurity program.
Item 1C. Cybersecurity Governance Related to Cybersecurity Risks Our Board of Directors has oversight responsibility for risk management, including cybersecurity risk. The Board exercises this oversight through the Audit Committee, which oversees management’s risk exposure across various areas, including cybersecurity, in accordance with its charter. Management provides quarterly reports to the Audit Committee regarding the status of our cybersecurity program.
We have not identified any cybersecurity incidents or threats that have materially affected us or are reasonably likely to materially affect us, including our business strategy, results of operations or financial condition; however, like other companies in our industry, we and our third-party vendors may, from time to time, experience threats and security incidents relating to our and our third-party vendors’ information systems.
We have not identified any cybersecurity incidents that have materially affected, or are reasonably likely to affect materially, our business strategy, results of operations, or financial condition. However, like other companies, our third-party vendors and we may experience cybersecurity threats or incidents from time to time. For additional discussion of related risks, see “Item 1A. Risk Factors.”
Cybersecurity Risk Management and Strategy We maintain a cybersecurity program, which includes processes for identification, assessment, and management of cybersecurity risks. We conduct periodic risk assessments, including with support from external vendors, to assess our cyber program, identify potential areas of enhancement, and develop strategies for the mitigation of cyber risks.
We conduct periodic risk assessments, including with the support of external vendors, to evaluate our cybersecurity program, identify areas for enhancement, and develop mitigation strategies. We also conduct periodic security awareness training for employees.
Our management team is responsible for the day-to-day administration and management of our cybersecurity program, under the direct supervision of our Chief Executive Officer currently we also work with external security service providers to support our security monitoring and threat detection capabilities and have implemented a process to report relevant findings to the Chair of audit committee where appropriate.
We also engage external security service providers to support monitoring and threat detection and have processes designed to report relevant findings to the Chair of the Audit Committee, as appropriate. Cybersecurity Risk Management and Strategy We maintain a cybersecurity program that includes processes to identify, assess, and manage cybersecurity risks.
In addition, we use third -party security solutions, monitoring, and alerting tools and resources, designed to monitor, identify, and address risks from cybersecurity threats. We also have implemented processes and technologies for network monitoring and data loss prevention procedures, and from time to time review such processes and technologies.
We monitor cybersecurity risks through a combination of internal efforts and third-party tools and services, including a managed security service provider and other security software designed to detect and respond to threats. We have implemented processes and technologies for network monitoring and data loss prevention, and periodically review these controls.
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Item 1C. Cybersecurity. Governance Related to Cybersecurity Risks Our board of directors, as a whole and through its committees, holds overall oversight responsibility for our risk management processes, including in relation to risks from cybersecurity threats.
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The Chair of the Audit Committee reports to the full Board on cybersecurity matters every quarter, as applicable . Management is responsible for the day-to-day administration of our cybersecurity program under the supervision of our Chief Executive Officer .
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The Chair of the audit committee provides a quarterly report to the board of directors, which includes any key updates on cybersecurity matters, as applicable.
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We have implemented a process to periodically conduct security awareness training for employees. Our team is informed about and monitor the prevention, detection, mitigation, and remediation of cybersecurity risks through various means, including by leveraging a managed security service provider and other third -party security software and technology services.
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See Item 1A “Risk Factors” in this Annual Report on Form 10 K for more information.
Item 2. Properties
Properties — owned and leased real estate
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Item 2. Properties
Properties — owned and leased real estate
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2024 filing
2025 filing
Item 2. Description of Property The headquarters for Milestone Scientific is located at 425 Eagle Rock Avenue, Roseland, New Jersey 07068, and our telephone number is (973) 535-2717. In August 2019, the Company signed a seven-year lease for a facility in Roseland, New Jersey (the “Roseland Facility”). The Roseland Facility carries monthly lease payments of $9,275, commencing April 1, 2021.
Item 2. Description of Property Our headquarters are located at 425 Eagle Rock Avenue, Roseland, New Jersey 07068, and our telephone number is (973) 535-2717. In August 2019, we entered into a seven-year lease for our facility in Roseland, New Jersey (the “Roseland Facility”). Monthly lease payments are $9,275, commencing April 1, 2021.
The Company is also responsible for electric charges equal to $2.00 per square foot, which is equal to $11,130 annually, payable in equal monthly installments of $928. The Company will also be required to pay its proportionate share of certain operating costs and property taxes applicable to the leased premises more than the new base year amounts.
We are also responsible for electricity charges of $2.00 per square foot (approximately $11,130 annually), payable in equal monthly installments of $928, and our proportionate share of certain operating costs and property taxes in excess of base-year amounts. We do not own, and do not currently intend to acquire, any real property.
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A third-party distribution and logistics center in Pennsylvania handles shipping and order fulfillment on a month-to-month basis. Milestone Scientific does not own or intend to invest in any real property.
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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.
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Market for Common Equity, and Related Stockholder Matters and Small Business Issuer Purchases of Equity Securities Market Information Since June 1, 2015, our common stock has been listed on the NYSE American under the symbol “MLSS”.
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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.
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We 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.
Item 5. Market for Registrant's Common Equity
Market for Common Equity — stock, dividends, buybacks
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Item 5. Market for Registrant's Common Equity
Market for Common Equity — stock, dividends, buybacks
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2024 filing
2025 filing
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Item 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.
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Item 5. Market for Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities Market Information Our common stock has been listed on the NYSE American under the symbol “MLSS” since June 1, 2015. The trading prices of our common stock have historically been volatile and may continue to fluctuate significantly, as discussed in “Item 1A.
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Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 30 Item 9A. Controls and Procedures 31
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Management’s Discussion and Analysis of Financial Condition and Results of Operations.” The following table sets forth the quarterly high and low sales prices of our common stock as reported on the NYSE American for the periods indicated. 2025 High Low 2024 High Low First Quarter $ 1.39 $ 0.87 First Quarter $ 0.78 $ 0.52 Second Quarter $ 1.11 $ 0.62 Second Quarter $ 0.85 $ 0.54 Third Quarter $ 0.73 $ 0.38 Third Quarter $ 1.10 $ 0.58 Fourth Quarter $ 0.60 $ 0.23 Fourth Quarter $ 1.05 $ 0.60 The market price of our common stock may be influenced by factors discussed elsewhere in this Annual Report, including our operating results, liquidity position, capital-raising activities, product commercialization progress, regulatory developments, and general market conditions.
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Holders As of March 31, 2026, there were approximately 92 holders of record of our common stock. We believe there were approximately 3,507 beneficial owners of our common stock at that date. Because brokers and other nominees hold many shares, the number of beneficial owners may differ from the number of holders of record.
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Dividends We have never declared or paid cash dividends on our common stock. We do not currently intend to declare or pay dividends in the near future. We anticipate that any future earnings, if any, will be retained to support our operations, fund product development and commercialization efforts, and strengthen our financial position.
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The payment of dividends, if any, will be at the discretion of our Board of Directors and will depend on our operating results, financial condition, capital requirements, and other factors deemed relevant by the Board. Sales of Unregistered Securities None. Issuer Purchases of Equity Securities None.
Item 7. Management's Discussion & Analysis
Management's Discussion & Analysis (MD&A) — revenue / margin commentary
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Item 7. Management's Discussion & Analysis
Management's Discussion & Analysis (MD&A) — revenue / margin commentary
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2024 filing
2025 filing
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Item 7. Management ’ s Discussion and Analysis of Financial Condition and Results of Operations 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.
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Item 7. Management’s Discussion and Analysis or Plan of Operations 27 Item 7A. Quantitative and Qualitative Disclosure about Market Risk 33 Item 8. Financial Statements 33 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 33 Item 9A. Controls and Procedures 34
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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. The actual results may differ materially from those anticipated in these forward-looking statements. See "Risk Factors" elsewhere in this Form 10-K.
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OVERVIEW 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. Since our inception, we have engaged in pioneering proprietary, innovative, computer-controlled injection technologies, and solutions for the medical and dental markets. We believe our technologies are proven and well established.
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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.
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Our computer-controlled injection devices make injections precise, efficient, and virtually painless. 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.
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Our proprietary DPS Dynamic Pressure Sensing technology is our technology platform that advances the development of next-generation devices. It regulates flow rate and monitoring pressure from the tip of the needle, through platform extensions for local anesthesia for subcutaneous drug delivery, used in various dental and medical injections.
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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.
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The dental devices currently are sold in the United States, Canada and in over 41 other countries. Milestone Scientific also has 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) on the CompuFlo® Epidural Computer Controlled Anesthesia System in the lumbar, thoracic and cervical thoracic junction of the spine region.
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In addition, Milestone Scientific has obtained CE mark approval and can be marketed and sold in most European countries. 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.
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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.
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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.
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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.
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Each of our devices has a related single use disposable handpiece, leading to a continuing revenue stream following the sale of the device. 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.
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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.
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We intend to continue to expand the uses and applications of our DPS Dynamic Pressure Sensing technology. 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.
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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.
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Moreover, there appears to be a growing consensus among users that the STA Instrument is proving to be a valuable and beneficial instrument that is positively impacting the practice of dentistry worldwide. Medical Market Product In June 2017, we received FDA regulatory clearance to sell the CompuFlo Epidural Computer Controlled Anesthesia System in the United States for epidural injections.
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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.
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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.
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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.
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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.
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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.
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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.
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(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).
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On July 23, 2024 the Company announced that Novitas Solutions, Inc.
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(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).
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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.
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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.
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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).
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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.
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The 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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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For the year ended December 31, 2024, medical revenue increased approximately $37,000 compared to December 31, 2023.
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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.
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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.
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The Company recorded approximately $258,000 allowance for medical inventory that was obsolete and or expired for the year ended December 31, 2023.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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”).
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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.
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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.
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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.
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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.
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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.