MILESTONE SCIENTIFIC INC.
For the period ended Dec 31, 2025. Filed Mar 31, 2026.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2025 · Filed Mar 31, 2026
MLSS$0.30+1.0%Stored close · as of Nov 6, 2026
What changed in Risk Factors?
Read the current filingPrevious report: 10-K
Period ended 2024-12-31; filed 2025-04-15.
0001437749-25-012050
Item 1A. Risk FactorsCurrent report: 10-K
Period ended 2025-12-31; filed 2026-03-31.
0001493152-26-014117
Item 1A. Risk FactorsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 115 previous paragraphs and 148 current paragraphs.
53 unchanged; 46 reworded; 49 added; 15 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 16 previous and 7 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (49)
Current report
Financial institution instability could adversely affect our operations and financial condition.
Current report
We maintain deposits that may exceed FDIC insurance limits. If our financial institution experiences distress or failure, we could experience delayed access to, or a loss of, uninsured deposits or other financial assets. Although U.S. government agencies provided access to uninsured deposits in connection with the Silicon Valley Bank crisis, there is no assurance that similar actions would occur in the future or occur promptly. We are evaluating our banking relationships to increase the portion of deposits that are fully insured or invested in risk-free instruments. Any non-performance by financial institutions could adversely affect our business operations and financial condition, including through impaired access to cash, loss of deposits, or disruptions affecting our customers or vendors.
Current report
Our financial statements have been prepared on a going concern basis, but there can be no assurance that we will be able to continue as a going concern without raising additional capital.
Current report
Due to our available cash and cash equivalents, recurring losses, accumulated deficit, and the need to raise additional capital to finance operations, there is substantial doubt as to our ability to continue as a going concern without raising additional capital.
Current report
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. International operations expose us to risks including foreign currency fluctuations, limitations on currency conversion and repatriation, compliance with complex laws and regulations, political and economic instability, tariffs and other trade barriers, and challenges in obtaining approvals for significant transactions. These risks could adversely affect our sales and operating results.
Current report
There is no assurance that physicians, hospitals, clinics, and other healthcare providers will accept and use the CompuFlo Epidural System. Market acceptance depends on many factors, including perceived safety and effectiveness, cost-effectiveness relative to competing products, convenience and reliability, patient satisfaction, product availability, warranty and technical support, reimbursement availability, and the effectiveness of our marketing and distribution.,
Current report
If our technology does not perform as expected, or if we fail to successfully develop, commercialize, or sell new or enhanced products or penetrate new markets, our business, financial condition, and operating results could be adversely affected.
Current report
Our ability to compete successfully depends on our ability to design, develop, manufacture, assemble, test, market, and support new products and product enhancements in a timely and cost-effective manner that keeps pace with evolving market needs and customer demands. Our success and competitive position are dependent on the performance, reliability, and continued advancement of the technologies we have developed and may develop in the future. There is a risk that our existing or future technologies may not function as intended, may not achieve anticipated performance levels, or may fail to gain market acceptance.
Current report
The markets in which our customers and we compete are characterized by rapid technological change and frequent product obsolescence. A significant technological shift in our target markets could adversely affect our competitive position. If we fail to anticipate technological developments, develop new technologies, or respond effectively to changes in existing technologies, the attractiveness of our products could be adversely affected, resulting in product obsolescence, reduced revenue, and the loss of customers to competitors.
Current report
Innovation is critical to our long-term success, and we must continue to enhance existing products and develop new products with improved capabilities to maintain our competitive position. The development of new technologies and products requires substantial investment and involves prolonged development, testing and approval cycles before products can be commercially marketed. While we intend to continue investing in the development of new and enhanced products, our ability to do so depends on the availability of sufficient financial resources. As part of our cash management plan, we have delayed all research and development on our Single Tooth Anesthesia System next-generation instrument. We may not be able to develop or acquire new products or enhancements that compete effectively in our target markets or that sufficiently differentiate our offerings based on functionality, performance, or cost. However, difficulties or delays in research, development, or production, failure to achieve market acceptance of new or enhanced products, or an inability to manage the transition from older products to new offerings effectively could adversely affect sales, inventory levels, cash flows, and liquidity. In addition, we may be unable to recover our research and development investments or achieve meaningful revenue from new technologies.
Current report
Healthcare reform laws and regulations significantly affect the U.S. healthcare services industry.
Current report
In recent years, many legislative proposals have been introduced or proposed in Congress and in some state legislatures that would affect major changes in the healthcare system, either nationally or at the state level. At the federal level, Congress has continued to propose or consider healthcare budgets that substantially reduce payments under the Medicare and Medicaid programs. Healthcare legislative reform measures may have a material adverse effect on our business and results of operations.
Current report
Among policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality, and/or expanding access. In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives. In March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively, the “ACA,”) was passed, which substantially changed the way healthcare is financed by both the government and private insurers and significantly impacts the U.S. pharmaceutical industry.
Current report
Since its enactment, there have been judicial, congressional and executive branch challenges and amendments to certain aspects of the ACA. For example, on August 16, 2022, the Inflation Reduction Act of 2022 (“IRA”) was signed into law, which, among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025. The IRA also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary’s maximum out-of-pocket cost through a newly established manufacturer discount program. It is possible the ACA will be subject to judicial or congressional challenges and amendments in the future.
Current report
On July 4, 2025, the annual reconciliation bill, the One Big Beautiful Bill Act (the “OBBBA”) was signed into law which is expected to reduce Medicaid spending and enrollment by implementing work requirements for some beneficiaries, capping state-directed payments, reducing federal funding, and limiting provider taxes used to fund the program. OBBBA also narrows access to the ACA marketplace exchange enrollment and declines to extend the ACA enhanced advanced premium tax credits, which expired in 2025, and which, among other provisions in the law, are expected to reduce the number of Americans with health insurance.
Current report
Also, there has been heightened governmental scrutiny recently over the manner in which drug manufacturers set prices for their marketed products, which have resulted in several congressional inquiries, presidential executive orders, and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products. For example, the IRA, among other things, (1) directs the U.S. Department of Health and Human Services (“HHS”) to negotiate the price of certain high-expenditure, single-source drugs covered under Medicare that have been on the market for at least 7 years (the “Medicare Drug Price Negotiation Program”) and (2) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation. These provisions began to take effect progressively in fiscal year 2023. On August 15, 2024, HHS announced the agreed-upon reimbursement prices of the first ten drugs that were subject to price negotiations, although the Medicare Drug Price Negotiation Program is currently subject to legal challenges. On January 17, 2025, HHS elected up to fifteen additional products covered under Part D for price negotiation in 2025. Each year thereafter, more Part B and Part D products will become subject to the Medicare Drug Price Negotiation Program. On December 8, 2023, the National Institute of Standards and Technology published for comment a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights, which, for the first time, includes the price of a product as one factor an agency can use when deciding to exercise march-in rights. While march-in rights have not previously been exercised, it is uncertain if that will continue under the new framework. New regulation of drugs may also cover new regulation of medical devices.
Current report
Individual states in the United States have also become increasingly active in passing legislation and implementing regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. For example, on January 5, 2024, the FDA approved Florida’s Section 804 Importation Program (“SIP”) proposal to import certain drugs from Canada for specific state healthcare programs. It is unclear how this program will be implemented, including which drugs will be chosen, and whether it will be subject to legal challenges in the United States or Canada. Other states have also submitted SIP proposals that are pending review by the FDA. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. We expect that additional state and federal healthcare reform measures will be adopted in the future.
Current report
The current Trump administration is pursuing policies to reduce regulations and expenditures across government, including at HHS, the FDA, CMS, and related agencies. These actions, presently aimed at executive orders or memoranda from the Office of Management and Budget, may propose policy changes that create additional uncertainty for our business. These actions and proposals include, for example, (1) directives to reduce agency workforce and cut programs; (2) rescinding a Biden administration executive order tasking the Center for Medicare and Medicaid Innovation to consider new payment and healthcare models to limit drug spending; (3) eliminating the Biden administration’s executive order that directed HHS to establish an AI task force and develop a strategic plan; (4) directing HHS and other agencies to lower prescription drug costs through a variety of initiatives, including by improving upon the Medicare Drug Price Negotiation Program and establishing Most-Favored-Nation pricing for pharmaceutical products; (5) imposing tariffs of imported pharmaceutical products; and (6) directing certain federal agencies to enforce existing law regarding hospital and price plan transparency and by standardizing prices across hospitals and health plans. Additionally, Congress may introduce and ultimately pass healthcare-related legislation that could impact the drug approval process and make changes to the Medicare Drug Price Negotiation Program created under the IRA. We expect additional health reform measures may be implemented in the future, particularly given the recent change in administration.
Current report
We expect that healthcare reform measures that may be adopted in the future may result in more rigorous coverage criteria and additional downward pressure on the price that we receive for a medical device. The ultimate content, timing, or effect of any healthcare reform legislation and the impact of potential legislation on us is uncertain and difficult, if not impossible, to predict. Reductions in Medicare and Medicaid reimbursement rates, as well as decreased government spending, for certain drugs and medical devices, may adversely affect demand for our products and services. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. Any such reductions or spending limitations, whether through legislative action, regulatory change, budgetary pressure, or otherwise, could expand over time and materially impact the utilization of our technologies and our overall financial performance. There can be no assurance that future initiatives on reimbursement or coverage policies will not be modified in ways that negatively affect our business, financial condition, results of operations, and/or prospects.
Current report
In a significant regulatory shift, the U.S. Food and Drug Administration (“FDA”) has adopted a new regulatory framework for the domestic medical device industry, replacing the longstanding Quality System Regulation (“QSR”) under 21 C.F.R. Part 820 and aligning U.S. medical device quality requirements more closely with ISO 13485 and the quality management system standards used by regulatory authorities in other jurisdictions. This new framework, finalized as the Quality Management System Regulation (“QMSR”), became effective on February 2, 2026.
Current report
For companies operating in international markets, including the Company, whose international operations already comply with ISO 13485, adoption of the FDA’s QMSR is expected over time to reduce duplication in audits and documentation. The Company has evaluated its quality management system against the requirements of ISO 13485 and the QMSR, and the results of this evaluation have informed updates to standard operating procedures, the quality manual, and related compliance documentation. The Company has substantially implemented the additional controls and process enhancements identified through this evaluation, continues to complete remaining actions to support compliance with the QMSR by its effective date, and is compliant.
Current report
If we or our third party manufacturers are unable to comply with the QMSR, once effective, or with any other applicable FDA requirements or if we or a third party manufacturer later discovers previously unknown problems with our products or manufacturing processes, these could result in, among other things: warning letters or untitled letters; fines, injunctions or civil penalties; suspension or withdrawal of approvals; seizures or recalls of our products; total or partial suspension of production or distribution; administrative or judicially imposed sanctions; the FDA’s refusal to grant pending or future clearances or approvals for our products; clinical holds; refusal to permit the import or export of our products; and criminal prosecution of us, our suppliers, or our employees. Any of these actions could significantly and negatively affect supply of our products. If any of these events occur, our reputation could be harmed, we could be exposed to product liability claims and we could lose customers and experience reduced sales and increased costs.
Current report
Under the transitional provisions, of the European Union’s Medical Device Regulation (“MDR”), To continue commercial sales in the European Union beyond the transition period, the Company’s Class IIa and Class IIb devices must obtain certification under the MDR by December 31, 2028. The Company continues to manage its MDR transition activities in coordination with notified bodies; however, failure to successfully obtain MDR certification within the applicable timeframe could adversely affect the Company’s ability to market and sell its products in the European Union. The Company’s products, including the Wand® STA System, dental handpieces used with the Wand® and Wand® STA Systems, which are classified as Class IIa medical devices, and the CompuFlo® Epidural System, which is classified as a Class IIb medical device, will have MDR certification in 2027.
Current report
The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, the ability to hire and retain key personnel, the ability to accept the payment of user fees, and statutory, regulatory, and policy changes. Average review times at the FDA have fluctuated in recent years as a result. In addition, government funding of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.
Current report
Disruptions at the FDA and other agencies may also extend the time necessary for new drug development and for those new drugs to be reviewed or approved by the necessary government agencies, which would adversely affect our business, financial condition, results of operations, and prospects. For example, over the last several years, the U.S. government has shut down several times, and certain regulatory agencies, such as the FDA, have had to furlough critical employees and stop critical activities. If a prolonged government shutdown occurs or there are other changes that limit the FDA’s ability to perform its necessary activities in a timely manner, it could significantly reduce the ability of the FDA to review and process our regulatory submissions, which could have a material adverse effect on our business.
Current report
Changes to U.S. trade policy, including tariffs and import/export regulations, may adversely affect our operations, cash flows, and financial condition.
Current report
Recent and potential changes in U.S. trade policy—including higher tariffs, revisions or terminations of trade agreements, new economic sanctions, and other restrictions on international commerce—could materially impact our business. Adjusting our operations to comply with such changes may be time-consuming and costly. Retaliatory measures by other countries, including China, have already increased supply-chain costs and reduced product availability, effects that we may not be able to offset. These dynamics could weaken the U.S. economy, dampen industry demand, and negatively affect global markets in which we operate. in addition, political tensions between the United States and China further heighten these risks. Deteriorating relations could reduce trade, investment, and related economic activity, and materially affect our business, prospects and financial results.
Current report
Regulatory uncertainty may increase following recent federal developments.
Current report
Turnover and new policies at the U.S. Department of Health and Human Services, including the FDA, may continue to shift regulatory priorities and enforcement approaches. In addition, the U.S. Supreme Court’s 2024 decision inLoper Bright Enterprises v. Raimondo, which overturned the Chevron Doctrine, reduced deference to federal agency interpretations of statutory authority. This decision and related rulings may create new avenues to challenge federal regulations, introducing uncertainty for businesses like ours that have historically relied on a stable regulatory framework.
Current report
Federal actions related to tariffs and research funding may disrupt our business.
Current report
New and proposed U.S. tariffs, along with directives to reevaluate federal trade policies, have led to significant uncertainty regarding future trade relationships, treaties, and tariff structures. These developments may restrict access to suppliers, reduce global demand, and could adversely affect our operations, particularly given our reliance on components sourced from China and our significant international sales.
Current report
Additionally, changes to federal research funding—including reductions or restructuring of grants, particularly those involving higher-education institutions—may negatively impact our business and that of our research partners. Tariffs have already increased our cost of doing business and may continue to constrain access to imported equipment essential to our operations.
Current report
Geopolitical instability, labor unrest, and economic disruptions in certain foreign jurisdictions may indirectly affect our operations.
Current report
Although we do not have direct sales, operations, or customers in regions experiencing significant instability, such as Venezuela, recent labor strikes, political instability, and economic conditions in Venezuela may contribute to broader regional or global disruptions, including impacts on international trade relationships, energy markets, currency volatility, or global logistics networks. In addition, changes in diplomatic relationships, foreign policy positions, or international regulatory frameworks involving countries experiencing political or economic instability could result in new or expanded trade restrictions, sanctions, compliance obligations, or logistical challenges imposed by foreign governments, as well as the United States. Such developments could indirectly affect the availability or cost of certain inputs, transportation services, or third-party suppliers upon which we rely. While we believe our current supply chain and manufacturing operations are diversified and resilient, we cannot assure investors that future geopolitical developments will not result in increased costs, delays, or other adverse effects on our business, financial condition, or results of operations.
Current report
We expect we will need additional financing to execute our business plan and fund operations, and additional financing may not be available on reasonable terms or at all.
Current report
As of December 31, 2025, we had total assets of approximately $7,800,000 and working capital of approximately $3,300,000 and $1,100,000 of cash and cash equivalents. We believe we will need additional capital to fund our operations. We intend to seek additional funds through various financing sources, including additional sales of our equity securities and possibly warrants to purchase our equity securities. However, there can be no guarantees that such funds will be available on commercially reasonable terms, if at all. If such financing is not available on satisfactory terms, we may be unable to further pursue our business plan and we may be unable to continue operations, in which case you may lose your entire investment.
Current report
Our common stock currently trades on the NYSE American under the symbol “MLSS”. On October 8, 2025, the Company received a letter from NYSE American stating that the Company is not in compliance with the continued listing standards as outlined in Section(s) 1003(a)(ii), and (iii) of the NYSE American Company Guide (the “Company Guide”).
Current report
Section 1003(a)(ii) requires a listed company to have stockholders’ equity of $4 million or more if it has reported losses from continuing operations and/or net losses in three of its four most recent fiscal years, and Section 1003(a)(iii) requires stockholders’ equity of $6 million or more if it has reported losses from continuing operations and/or net losses in its five most recent fiscal years. Based on the Company’s Form 10-Q for the period ended June 30, 2025, the Company reported stockholders’ equity of approximately $3.3 million and experienced losses in such period and each of its five prior fiscal years. As a result, the Company is not currently in compliance with Sections 1003(a)(ii) and (iii) and is not eligible for any exemption under Section 1003(a) of the Company Guide.
Current report
We have relied heavily on sales of our common stock to fund our operations, and our ability to obtain additional capital through stock sales or other securities offerings may be more costly or dilutive to our stockholders than in the past, or may not be available to us at all. Our ability to raise additional capital may be limited by a low trading volume, stock price and market capitalization, as well as by laws, regulations and market conditions.
Showing the first 40 of 49 passages. Open the source sections for the rest.
Removed paragraphs (15)
Previous report
Changes in financial institutions could adversely affect our current and projected business operations, financial condition and results of operations.
Previous report
The Company currently keeps more than $250,000, the maximum amount insured by the Federal Deposit Insurance Corporation (“FDIC”), in its current bank depositary. The Company may experience delayed access or a loss of its uninsured deposits or other financial assets should its existing financial institution experience financial distress. While the U.S. Department of Treasury, FDIC and Federal Reserve Board have provided access to uninsured funds in connection with the Silicon Valley Bank crisis, there is no guarantee that these institutions will provide access to uninsured funds in the future in the event of the closure of other banks or financial institutions, or that they would do so in a timely fashion. The Company is currently evaluating its banking relationships with the intent of increasing the amount of deposits that are fully insured or invested in risk-free instruments.
Previous report
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. We have exposure to risks of operating in many foreign countries, including:
Previous report
There is no assurance that physicians, hospitals, clinics, and other health care providers will accept and use theCompuFloEpidural System. Acceptance and use of theCompuFlo Epidural System will depend on many factors including:
Previous report
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.
Previous report
The FDA regulates the product approvals manufacturing, and sales and marketing of many of our products in the United States. Significant government regulations also exist in other countries in which we conduct business. As a device manufacturer, we are required to register with the FDA and are subject to periodic inspection by the FDA for compliance with the FDA’s Quality System Regulation requirements, which require manufacturers of medical devices to adhere to good manufacturing practices . In addition, the federal Medical Device Reporting regulations require us to provide information to the FDA whenever there is evidence that reasonably suggests that a device may have caused or contributed to a death or serious injury or, if a malfunction were to occur, could cause or contribute to a death or serious injury. Compliance with applicable regulatory requirements is subject to continual review and is rigorously monitored through periodic inspections by the FDA.
Previous report
In the European community, we are required to maintain compliance to ISO, CE marking standards to sell our products and must undergo periodic inspections by notified bodies to obtain and maintain compliance. Failure to comply with current governmental regulations and quality assurance guidelines could lead to temporary manufacturing shutdowns, product recalls or related field actions, product shortages or delays in product manufacturing. Efficacy or safety concerns, an increase in trends of adverse events in the marketplace, and/or manufacturing quality issues with respect to our products could lead to product recalls or related field actions, withdrawals, and/or declining sales.
Previous report
Changes in United States policy regarding international trade, including import and export regulation and international trade agreements, could adversely affect our business. The U.S. government has instituted and proposed further changes in trade policies that include the imposition of higher tariffs on imports into the U.S., the negotiation or termination of trade agreements, economic sanctions on individuals, corporations or countries, and other government regulations affecting trade between the U.S. and other countries where we conduct our business. It may be time-consuming and expensive for us to alter our operations in order to adapt to or comply with any such changes. Tariffs and other changes in U.S. trade policy have triggered retaliatory actions by the affected countries, and certain foreign governments, including China, have instituted or are considering imposing retaliatory measures on certain U.S. goods. We do a significant amount of business that will be impacted by changes to the trade policies of the U.S. and foreign countries (including governmental action related to tariffs, international trade agreements, or economic sanctions). Tariffs and other retaliatory measures imposed by the United States on imports, and other retaliatory trade measures taken by the United States, China and other countries, and successive rounds of retaliatory trade measures as part of a trade war or otherwise, will result in an increase in supply chain costs and limit availability of products that Milestone Scientific may not be able to offset or that otherwise adversely impact its operations. Such changes have the potential to adversely impact the U.S. economy or certain sectors thereof, our industry and the global demand for our products, and as a result, could have a material adverse effect on our results of operations, cash flows and financial condition.
Previous report
In addition, political tensions between the United States and China have escalated in recent years. Rising political tensions could reduce trade, investment and other economic activities between the two major economies. Any of these factors could have a material adverse effect on Milestone Scientific’s business, prospects, financial condition, and results of operations.
Previous report
Turnover at U.S. Department of Health and Human Services, including the FDA, is expected to lead to different enforcement objectives. In addition, on June 28, 2024, the U.S. Supreme Court ruled on Loper Bright Enterprises v. Raimondo, thereby overturning the Chevron Doctrine, a Supreme Court ruling from 1984 that provided for deference to U.S. regulatory agency regulations adopted pursuant to general federal statutory authority. This decision and other related decisions may create new legal avenues to challenge federal regulations, which may create unforeseen uncertainty, especially for businesses that have relied on a settled regulatory environment in their industry. Our historical reliance on an established regulatory environment may be subject to the potential risks of challenges to agency rules that regulate our industry.
Previous report
Risks Related to Milestone Scientific Common Stock
Previous report
Your percentage of ownership in Milestone Scientific may be diluted in the future.
Previous report
Our business and operations would suffer in the event of cybersecurity or other system failures. *** ***
Reworded paragraphs (46)
Previous wording
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. 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.
Current wording
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. 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.
Previous wording
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. The operating losses were $6.8 million and $7.1 million, for the years ended December 31, 2024, and 2023, respectively.
Current wording
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. We have generated net losses in all periods since inception, including operating losses of $5.7 million and $6.8 million for the years ended December 31, 2025, and 2024, respectively. These losses have adversely affected, and are expected to continue to affect adversely, our working capital, total assets, and stockholders’ equity.
Previous wording
Our losses have had, and are expected to continue to have, an adverse impact on our working capital, total assets, and stockholders' equity. 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. 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. A decline in the value of our company could also cause our shareholders to lose all or part of their investment.
Current wording
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. 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. In addition, a decline in our valuation could cause stockholders to lose all or part of their investment.
Previous wording
Our operations have consumed substantial amounts of cash since inception. During the years ended December 31, 2024 and 2023, net cash flow used in operations was approximately $2.9 million and approximately $5.3 million, respectively. We believe that our immediate future viability is dependent on our ability to raise additional capital to finance our operations through public or private equity offerings, collaborations and licensing arrangements or other sources. 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.
Current wording
Our operations have consumed substantial cash since inception. Net cash used in operating activities was approximately $2.9 million for the years ended December 31, 2025, and 2024, respectively. We believe our near-term viability depends on our ability to raise additional capital to finance operations through public or private equity offerings, collaborations, licensing arrangements, or other sources. 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. See also the risk factor titled “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 delisted. If our stock were no longer listed on NYSE American, the liquidity of our securities likely would be impaired.”
Previous wording
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. 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.
Current wording
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. 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.
Previous wording
To the extent that we raise additional capital by issuing equity securities, the share ownership of existing stockholders will be diluted. Any future debt financing may involve covenants that restrict our operations, including limitations on our ability to incur liens or additional debt, pay dividends, redeem our stock, make certain investments, and engage in certain merger, consolidation, or asset sale transactions, among other restrictions. In addition, if we raise additional funds through licensing arrangements or the disposition of any of our assets, it may be necessary to relinquish potentially valuable rights to our product candidates or grant licenses on terms that are not favorable to us.
Current wording
If we raise additional capital through the issuance of equity securities, the share ownership of existing stockholders will experience dilution. Debt financing could include covenants that restrict our operations, including limitations on our ability to incur liens or additional indebtedness, pay dividends, redeem stock, make certain investments, or engage in particular merger, consolidation, or asset sale transactions. If we raise funds through licensing arrangements or asset dispositions, we may be required to relinquish valuable rights to product candidates or grant licenses on terms that are unfavorable.
Previous wording
The results of events or concerns that involve non-performance by financial institutions could include a variety of material and adverse impacts on our current and projected business operations and our financial condition and results of operations. In addition, any further deterioration in the macroeconomic economy or financial services industry, or delayed access or loss of uninsured deposits or loss of the ability to draw on existing credit facilities involving a troubled or failed financial institution by our customers or vendors, could lead to losses or defaults by companies with whom we do business, which in turn could have a material adverse effect on our current and/or projected business operations, results of operations and financial condition. In addition, other companies could be adversely affected by any of the liquidity or other risks that are described above as factors that could result in material adverse impacts on us, including but not limited to delayed access or loss of uninsured deposits or loss of the ability to draw on existing credit facilities involving a troubled or failed financial institution.
Current wording
In addition, any further deterioration in the macroeconomic economy or financial services industry, or delayed access or loss of uninsured deposits or loss of the ability to draw on existing credit facilities involving a troubled or failed financial institution by our customers or vendors, could lead to losses or defaults by companies with whom we do business, which in turn could have a material adverse effect on our current and/or projected business operations, results of operations and financial condition. In addition, other companies could be adversely affected by any of the liquidity or other risks that are described above as factors that could result in material adverse impacts on us, including but not limited to delayed access or loss of uninsured deposits or loss of the ability to draw on existing credit facilities involving a troubled or failed financial institution.
Previous wording
Risks Related to Sales and Distribution of Milestone Scientific Products
Current wording
Risks Related to Sales and Distribution of Our Products
Previous wording
Milestone Scientific’s sales and marketing efforts in the United Stated rely upon its E-Commerce platform.
Current wording
Our sales and marketing efforts in the United States rely upon its E-Commerce platform.
Previous wording
Milestone Scientific believes that a significant portion of its sales will continue to be from its E-Commerce platform launched in January 2023, for the foreseeable future. Currently, sales of the STA Single Tooth Anesthesia Systems® (STA) and handpieces in the United States are reliant on E-Commerce sales. We have exposure to risks of operating in an E-commerce platform:
Current wording
We believe that a significant portion of our sales will continue to be from its E-Commerce platform launched in January 2023, for the foreseeable future. Currently, sales of the STA Single Tooth Anesthesia Systems® (STA) and handpieces in the United States are reliant on E-Commerce sales. We have exposure to risks of operating in an E-commerce platform:
Previous wording
If Milestone Scientific is unable to maintain or expand its E-Commerce platform its sales will be negatively affected.
Current wording
If we are unable to maintain or expand our E-Commerce platform, our sales will be negatively affected.
Previous wording
Because we expect sales of theCompuFlo Epidural Computer Controlled Anesthesia System to generate substantially all our medical product revenues in the near-term, the failure of this product to find market acceptance would harm our business and could require us to seek additional financing or make such financing difficult to obtain on favorable terms, if at all.
Current wording
Because we expect sales of theCompuFlo Epidural Computer Controlled Anesthesia System to generate substantially all our medical product revenues in the near-term, the failure of this product to find market acceptance would harm our medical business. It could require us to seek additional financing or make such financing difficult to obtain on favorable terms, if at all. Since the Company generates a significant portion of its net sales from a single product category, a decline in demand for that product could significantly impact our net sales and gross margins.
Previous wording
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.
Current wording
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.
Previous wording
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. Healthcare payers, including Medicare, are challenging the prices charged for medical products and services. Government and other healthcare payers increasingly attempt to contain healthcare costs by limiting both coverage and the level of reimbursement for products. Insurance coverage may not be available, or reimbursement levels may be inadequate to cover the charges for the use of such a product. If the government and other healthcare payers do not provide adequate coverage and reimbursement for any of our products, market acceptance of such products could be reduced.
Current wording
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. Healthcare payers, including Medicare, are challenging the prices charged for medical products and services. Government and other healthcare payers increasingly attempt to contain healthcare costs by limiting both coverage and the level of reimbursement for products. Insurance coverage may not be available, or reimbursement levels may be inadequate to cover the charges for the use of such a product. If the government and other healthcare payers do not provide adequate coverage and reimbursement for any of our products, market acceptance of such products could be reduced.
Previous wording
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. 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. 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.
Current wording
Our future success depends upon the services of our executive officers. The Company has recently appointed Eric Hines as President and Chief Executive Officer, and as a director of the Company, replacing Arjan Haverhals, who retired at the end of 2024, and appointed Jason Papes as Senior Vice President, Global Head of Sales and Marketing. 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. 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.
Previous wording
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.
Current wording
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.
Previous wording
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. At present, we have an informal arrangement with the manufacturers of our products. Our current arrangement with our manufacturers is on a purchase order-by-purchase order basis. As a result, we do not have price protection or a supply commitment for our devices or handpieces. If either manufacturer insists on a material change in terms or determines to discontinue manufacture of our products, it could have an adverse effect on our financial condition and results of operation.
Current wording
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. At present, we have an informal arrangement with the manufacturers of our products. Our current arrangement with our manufacturers is on a purchase order-by-purchase order basis. As a result, we do not have price protection or a supply commitment for our devices or handpieces. If either manufacturer insists on a material change in terms or determines to discontinue manufacture of our products, it could have an adverse effect on our financial condition and results of operation.
Previous wording
Each of these risks could delay the commercialization of ourCompuFlo 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. 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.
Current wording
Each of these risks could delay the commercialization of ourCompuFlo 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. 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.
Previous wording
Because the sole manufacturer of our dental handpieces is in China, our business is disproportionately exposed to the economic, environmental, and political conditions of the region. 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. 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.
Current wording
Because the sole manufacturer of our dental handpieces is in China, our business is disproportionately exposed to the economic, environmental, and political conditions of the region. 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. 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.
Previous wording
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. In addition, as the Chinese legal system develops, there can be no assurance that changes in laws and regulations and their interpretation or their enforcement will not have a material adverse effect on our business relationship with the sole manufacturer of our dental handpieces. Any adverse change in the economic, environmental, and political conditions in China could have a material adverse effect on economic growth and the level of investments and availability of capital in China, which in turn could lead to a reduction in the supply of our dental handpieces and consequently have a material adverse effect on our businesses.
Current wording
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 addition, as the Chinese legal system develops, there can be no assurance that changes in laws and regulations and their interpretation or their enforcement will not have a material adverse effect on our business relationship with the sole manufacturer of our dental handpieces. Any adverse change in the economic, environmental, and political conditions in China could have a material adverse effect on economic growth and the level of investments and availability of capital in China, which in turn could lead to a reduction in the supply of our dental handpieces and consequently have a material adverse effect on our businesses.
Previous wording
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. 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.
Current wording
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. 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.
Previous wording
While Milestone Scientific works with suppliers to ensure continuity of supply, no assurance can be given that these efforts will be successful. 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. The termination, reduction or interruption in supply of these raw materials and components could adversely impact Milestone Scientific Scientific’s ability to manufacture and sell certain of its products.
Current wording
While we work with suppliers to ensure continuity of supply, no assurance can be given that these efforts will be successful. 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 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.
Previous wording
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. 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.
Current wording
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. Any such failure to perform or a reduction or interruption in supply could have a material adverse effect on our business and operations.
Previous wording
We may be subject, directly, or indirectly, to U.S. federal and state health care fraud and abuse and false claims laws and regulations. Prosecutions under such laws have increased in recent years and we may become subject to such litigation. If we are unable to comply or have not fully complied with such laws, we could face substantial penalties.
Current wording
We may be subject, directly or indirectly, to U.S. federal and state healthcare fraud and abuse and false claims laws and regulations. Prosecutions under such laws have increased in recent years and we may become subject to such litigation. If we are unable to comply or have not fully complied with such laws, we could face substantial penalties.
Previous wording
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. These laws may impact, among other things, our proposed sales, and marketing and education programs. 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. 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. 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 health care 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 health care programs. An alleged violation of the Anti-Kickback Statute may be used as a predicate offense to establish liability pursuant to other federal laws and regulations such as the federal False Claims Act. 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.
Current wording
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. These laws may impact, among other things, our proposed sales, and marketing and education programs. 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. 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. 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. An alleged violation of the Anti-Kickback Statute may be used as a predicate offense to establish liability pursuant to other federal laws and regulations, such as the federal False Claims Act. 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.
Previous wording
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. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of the government and such individuals, commonly known as “relators” or “whistleblowers,” may share in any amounts paid by the entity to the government in fines or settlement. 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. When an entity is determined to have violated the federal False Claims Act, it may be required to pay up to three times the actual damages sustained by the government, plus civil penalties for each separate false claim. The Deficit Reduction Act of 2005 encouraged states to enact or modify their state false claims act to be at least as effective as the federal False Claims Act by granting states a portion of any federal Medicaid funds recovered through Medicaid-related actions. Most states have enacted state false claims laws, and many of those states included laws with qui tam provisions.
Current wording
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. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of the government, and such individuals, commonly known as “relators” or “whistleblowers,” may share in any amounts paid by the entity to the government in fines or settlement. 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. When an entity is determined to have violated the federal False Claims Act, it may be required to pay up to three times the actual damages sustained by the government, plus civil penalties for each separate false claim. The Deficit Reduction Act of 2005 encouraged states to enact or modify their state False Claims Act to be at least as effective as the federal False Claims Act by granting states a portion of any federal Medicaid funds recovered through Medicaid-related actions. Most states have enacted state false claims laws, and many of those states include laws with qui tam provisions.
Previous wording
Manufacturers must also disclose investment interests held by physicians and their family members. Failure to submit the required information may result in civil monetary penalties of up to $1 million per year for knowing violations and may result in liability under other federal laws or regulations. 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. These laws could affect our promotional activities by limiting the kinds of interactions we could have with hospitals, physicians or other potential purchasers or users of our products. Both the disclosure laws and gift bans will impose administrative, cost and compliance burdens on us. 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.
Current wording
Manufacturers must also disclose investment interests held by physicians and their family members. Failure to submit the required information may result in civil monetary penalties of up to $1 million per year for knowing violations and may result in liability under other federal laws or regulations. 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. These laws could affect our promotional activities by limiting the kinds of interactions we could have with hospitals, physicians or other potential purchasers or users of our products. Both the disclosure laws and gift bans will impose administrative, cost and compliance burdens on us. 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.
Previous wording
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.
Current wording
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.
Previous wording
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. The FDA may not agree with Milestone Scientific’s decisions regarding whether new clearances are necessary. 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. Milestone Scientific may make similar modifications or add additional features in the future that it believes do not require a new 510(k) clearance. 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.
Current wording
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. 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. The Company may make similar modifications or add additional features in the future that it believes do not require a new 510(k) clearance. 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.
Previous wording
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.
Current wording
Changes to United States federal and state regulatory agencies may cause disruptions and delays in the approval processes and regulations relating to our products.
Previous wording
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. 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. 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.
Current wording
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. 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. 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.
Previous wording
Milestone Scientific may be subject to enforcement actions if it engages in improper marketing or promotion of its products.
Current wording
The Company may be subject to enforcement actions if it engages in improper marketing or promotion of its products.
Previous wording
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”). 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.
Current wording
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”). 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.
Previous wording
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.
Current wording
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.
Previous wording
The Ukraine/Russia conflict and various Middle East conflicts have received significant media coverage. Geopolitical instability can lead to significant disruption in supply chain efficiency, adding cost and delays. 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. 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.
Current wording
The Ukraine/Russia conflict and various Middle East conflicts have received significant media coverage. Geopolitical instability can lead to significant disruption in supply chain efficiency, adding cost and delays. 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 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.
Previous wording
Milestone Scientific is effectively controlled by a limited number of stockholders.
Current wording
The Company is effectively controlled by a limited number of stockholders.
Previous wording
Milestone Scientific Scientific’s principal stockholders, Leonard Osser and BP4, Srl, control approximately 20% of the issued and outstanding shares of common stock. As a result, they can exercise substantial control over our affairs and corporate actions requiring stockholder approval, including electing directors, selling all or substantially all our assets, merging with another entity, or amending our certificate of incorporation. 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. 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.
Current wording
Our principal stockholder, BP4, Srl, an Italian investment vehicle that is currently in liquidation (“BP4”), controls approximately 11.05% of the Company’s issued and outstanding shares of common stock. 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. 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. 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.
Previous wording
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.
Current wording
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.
Previous wording
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. 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. 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.
Current wording
To maintain its listing, the Company submitted a plan of compliance outlining the actions it has taken or will take to regain compliance. The Company will be able to continue its listing but will be subject to periodic reviews by the NYSE American. If the Company fails to comply with the continued listing standards by April 8, 2027, or if the Company does not make progress consistent with the plan, the NYSE American will initiate delisting procedures as appropriate. 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. 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. 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.
Previous wording
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
Current wording
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 the Company.
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Previous report — wording carried elsewhere
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.