What the changes say
- Cash burn of $2.9M continues, driving going concern doubts with only $1.1M in cash remaining.
- Tariffs on components sourced from China and reliance on the CompuFlo Epidural System shape core risks.
- NYSE American listing compliance and cybersecurity threats to connected medical devices are highlighted.
What changed since the prior 10-K
New
- NewRisks Related to Our Financial Position and Need for Additional Capital
Financial institution instability could adversely affect our operations and financial condition
Uninsured cash deposits at banks exceed FDIC limits, exposing the company to potential loss or delayed access if a financial institution fails.
- NewRisks Related to Our Financial Position and Need for Additional Capital
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
Substantial doubt exists regarding the company's ability to continue as a going concern without securing additional capital.
- NewRisks Related to Sales and Distribution of Our Products
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
Technologies may fail to perform as expected, gain market acceptance, or keep pace with rapid obsolescence in target markets.
- NewRisks Related to Sales and Distribution of Our Products
Healthcare reform laws and regulations significantly affect the U.S. healthcare services industry
Healthcare reform proposals and Medicare/Medicaid budget cuts could restrict marketing approvals or reduce product profitability.
- NewRisks Related to Regulatory Compliance and Other Legal Matters
Regulatory uncertainty may increase following recent federal developments
The Supreme Court's Loper Bright decision overturned the Chevron Doctrine, creating regulatory uncertainty by reducing judicial deference to federal agencies like the FDA.
- NewRisks Related to Regulatory Compliance and Other Legal Matters
Federal actions related to tariffs and research funding may disrupt our business
U.S. tariffs on components sourced from China have increased costs and constrained access to imported equipment.
- NewRisks Related to Regulatory Compliance and Other Legal Matters
Geopolitical instability, labor unrest, and economic disruptions in certain foreign jurisdictions may indirectly affect our operations
Labor unrest and political instability in Venezuela could indirectly disrupt international trade, energy markets, or logistics.
- NewRisks Related to Regulatory Compliance and Other Legal Matters
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
The company faces potential de-listing from the NYSE American if it fails to regain compliance with strict listing requirements.
- NewRisks Related to Regulatory Compliance and Other Legal Matters
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
Common stock trading between $0.23 and $1.39 in 2025 creates extreme stock price volatility for investors.
- NewGeneral 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
Cybersecurity incidents could compromise products, data, and operations.
- NewGeneral Business Risks
We rely extensively on information technology (“IT”) systems, cloud-based platforms, software, and connected technologies to conduct our operations, develop and manufacture our medical devices, maintain clinical and regulatory data, and support customers and patients who use our connected products
Cyberattacks on connected medical devices could interrupt performance or pose risks to patient safety.
Dropped
- DroppedRisks Related to Our Financial Position and Need for Additional Capital
Changes in financial institutions could adversely affect our current and projected business operations, financial condition and results of operations
- DroppedRisks Related to Sales and Distribution of Milestone Scientific Products
effectiveness of marketing and distribution efforts by us and our licensees and distributors
- DroppedRisk Related to Our Dependence on Third Parties
Contract manufacturers may not perform as agreed or may not remain in the contract manufacturing business for the time required to successfully produce, store, and distribute our products
- DroppedRisk Related to Our Dependence on Third Parties
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 may be required to pay fees or other costs for access to such improvements
- DroppedRisks Related to Milestone Scientific Common Stock
change in securities analysts’ estimates of our performance, or our failure to meet analysts’ expectations
Bank deposits exceeding the $250,000 FDIC insurance limit.
- DroppedGeneral Business Risks
Our business and operations would suffer in the event of cybersecurity or other system failures
Reworded
- 99% rewrittenRisks Related to Sales and Distribution of Our Products
We are exposed to the risks inherent in international sales
Updated international sales figures for 2025, noting export sales made up 45% of total sales across 37 countries.
- 98% rewrittenRisks Related to Regulatory Compliance and Other Legal Matters
Changes to U.S. trade policy, including tariffs and import/export regulations, may adversely affect our operations, cash flows, and financial condition
Added specific mention of Chinese retaliatory trade measures increasing supply-chain costs and reducing product availability.
Was: Changes to trade policy, including tariff and import/export regulations, may have a material adverse effect on our results of operations, cash flows and financial condition
- 95% rewrittenRisks Related to Sales and Distribution of Our Products
If physicians neither accept nor use our CompuFlo Epidural System, our ability to generate revenue from sales will be materially impaired
Consolidated marketing acceptance factors and explicitly linked CompuFlo Epidural System failure to potential financing difficulties.
- 90% rewrittenRisks Related to Our Financial Position and Need for Additional Capital
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
Updated 2025 operating cash use to $2.9 million and added a cross-reference to NYSE American de-listing risks.
- 85% rewrittenRisks Related to Our Financial Position and Need for Additional Capital
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
Refined language regarding debt covenants and licensing restrictions on product candidates.
- 77% rewrittenRisks 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
Updated operating loss figures to $5.7 million for 2025 compared to $6.8 million for 2024.
- 66% rewrittenRisks Related to Regulatory Compliance and Other Legal Matters
Changes to United States federal and state regulatory agencies may cause disruptions and delays in the approval processes and regulations relating to our products
Removed specific references to the Trump administration and DOGE, replacing them with broader FDA review-time and funding factors.
Was: 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
- 59% rewrittenRisks Related to Regulatory Compliance and Other Legal Matters
All of which could make it more difficult for a third party to acquire, or discourage a third party from seeking to acquire, control of our company
Retained Delaware General Corporation Law Section 203 anti-takeover provisions with minor stylistic tightening.
- 54% rewrittenRisks Related to Employee Matters
We may not be able to attract and retain qualified employees
- 50% rewrittenRisks 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. Failure by us to comply with these standards could have an adverse effect on our business, financial condition, or results of operations
- 49% rewrittenRisks Related to Regulatory Compliance and Other Legal Matters
Failure to implement effective internal controls required by the Sarbanes-Oxley Act of 2002 could result in material misstatements in our financial statements, cause investors to lose confidence in the Company ’ s reported financial information and have a negative effect on the trading price of our common stock
- 45% rewrittenRisks Related to Regulatory Compliance and Other Legal Matters
Your percentage of ownership in the Company may be diluted in the future
Was: Your percentage of ownership in Milestone Scientific may be diluted in the future
- 44% rewrittenRisk Related to Our Dependence on Third Parties
We have limited internal experience in manufacturing operations and have not historically established our own manufacturing facilities. We currently lack the internal resources to manufacture any of our products, including our CompuFlo® Epidural Computer Controlled Anesthesia System
- 42% rewrittenRisks Related to Regulatory Compliance and Other Legal Matters
The Company is effectively controlled by a limited number of stockholders
Was: Milestone Scientific is effectively controlled by a limited number of stockholders
- 40% rewrittenRisks Related to Our Financial Position and Need for Additional Capital
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
Was: 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
- 39% rewrittenRisks Related to Sales and Distribution of Our Products
Our sales and marketing efforts in the United States rely upon its E-Commerce platform
Was: Milestone Scientific’s sales and marketing efforts in the United Stated rely upon its E-Commerce platform
- 33% rewrittenRisks Related to Regulatory Compliance and Other Legal Matters
The Company may be subject to enforcement actions if it engages in improper marketing or promotion of its products
Was: Milestone Scientific may be subject to enforcement actions if it engages in improper marketing or promotion of its products
- 33% rewrittenRisks Related to Regulatory Compliance and Other Legal Matters
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
- 30% rewrittenRisks Related to Regulatory Compliance and Other Legal Matters
We have never paid and do not intend to pay cash dividends in the foreseeable future. As a result, capital appreciation, if any, will be your sole source of gain
- 24% rewrittenRisks Related to Regulatory Compliance and Other Legal Matters
Changes in laws and regulations over which we have no control can significantly affect our business and results of operations
- 23% rewrittenRisk Related to Our Dependence on Third Parties
The use of third parties to manufacture our products may increase the risk that we will not have enough of our products or such quantities at acceptable levels of cost and quality, which could impair our commercialization efforts
All 42 risk factors
Headings as the filing states them, in filing order.
Risks Related to Our Financial Position and Need for Additional Capital
- 01We 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 profitability77% rewritten
- 02We 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 operations90% rewritten
- 03Sales 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 stock40% rewritten
- 04Raising 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 rights85% rewritten
- 05Financial institution instability could adversely affect our operations and financial conditionNew
- 06Our 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 capitalNew
Risks Related to Sales and Distribution of Our Products
- 07Our sales and marketing efforts in the United States rely upon its E-Commerce platform39% rewritten
- 08We are exposed to the risks inherent in international sales99% rewritten
- 09If physicians neither accept nor use our CompuFlo Epidural System, our ability to generate revenue from sales will be materially impaired95% rewritten
- 10If 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 affectedNew
- 11Developments by competitors may render our products or technologies obsolete or non-competitive
- 12Our 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
- 13Healthcare reform laws and regulations significantly affect the U.S. healthcare services industryNew
- 14We could lose our market advantage earlier than expected
Risks Related to Employee Matters
- 15We may not be able to attract and retain qualified employees54% rewritten
Risk Related to Our Dependence on Third Parties
- 16We have limited internal experience in manufacturing operations and have not historically established our own manufacturing facilities. We currently lack the internal resources to manufacture any of our products, including our CompuFlo® Epidural Computer Controlled Anesthesia System44% rewritten
- 17Our 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
- 18Issues 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
- 19The use of third parties to manufacture our products may increase the risk that we will not have enough of our products or such quantities at acceptable levels of cost and quality, which could impair our commercialization efforts23% rewritten
Risks Related to Regulatory Compliance and Other Legal Matters
- 20We are subject to substantial domestic and international government regulation, including regulatory quality standards applicable to our manufacturing and quality processes. Failure by us to comply with these standards could have an adverse effect on our business, financial condition, or results of operations50% rewritten
- 21Once 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 device33% rewritten
- 22Changes to United States federal and state regulatory agencies may cause disruptions and delays in the approval processes and regulations relating to our products66% rewritten
- 23The Company may be subject to enforcement actions if it engages in improper marketing or promotion of its products33% rewritten
- 24Changes in laws and regulations over which we have no control can significantly affect our business and results of operations24% rewritten
- 25Changes to U.S. trade policy, including tariffs and import/export regulations, may adversely affect our operations, cash flows, and financial condition98% rewritten
- 26Regulatory uncertainty may increase following recent federal developmentsNew
- 27Federal actions related to tariffs and research funding may disrupt our businessNew
- 28International conflict has affected commerce worldwide and may have a material adverse effect on our results of operations, cash flows, and financial condition
- 29Geopolitical instability, labor unrest, and economic disruptions in certain foreign jurisdictions may indirectly affect our operationsNew
- 30The Company is effectively controlled by a limited number of stockholders42% rewritten
- 31We 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 allNew
- 32Failure to implement effective internal controls required by the Sarbanes-Oxley Act of 2002 could result in material misstatements in our financial statements, cause investors to lose confidence in the Company ’ s reported financial information and have a negative effect on the trading price of our common stock49% rewritten
- 33The 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 CompanyNew
- 34We have never paid and do not intend to pay cash dividends in the foreseeable future. As a result, capital appreciation, if any, will be your sole source of gain30% rewritten
- 35Provisions 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
- 36All of which could make it more difficult for a third party to acquire, or discourage a third party from seeking to acquire, control of our company59% rewritten
- 37Your percentage of ownership in the Company may be diluted in the future45% rewritten
Risks Related to Our Intellectual Property
- 38If 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
- 39Third parties may claim that one or more aspects of our technologies or products may infringe on their intellectual property rights
General Business Risks
- 40Cybersecurity 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 operationsNew
- 41We rely extensively on information technology (“IT”) systems, cloud-based platforms, software, and connected technologies to conduct our operations, develop and manufacture our medical devices, maintain clinical and regulatory data, and support customers and patients who use our connected productsNew
- 42Insurance coverage may be inadequate or unavailable to cover any product liability losses we incur
Other Milestone Scientific 10-Ks
- FY2024 10-K risk factors37 risks
Milestone Scientific faces significant operating losses and ongoing cash burn, requiring additional funding and equity dilution risks. The company relies heavily on single suppliers in China and the US, alongside international sales. Regulatory oversight, patent protection, and market adoption of the CompuFlo system are critical vulnerabilities.
Filed Apr 15, 2025
About this page
The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.