▸ 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.· · · · ● 1 ▸ 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.· · · · ● 1 ▸ International conflict has affected commerce worldwide, and may have a material adverse effect on our results of operations, cash flows and financial condition.· · · · ● 1 ▸ We anticipatethat 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.· · · · ● 1 ▸ If Milestone Scientific is unable to maintain or expand its E-Commerce platform its sales will be negatively affected.· · · ● ● 2 rw ▸ Milestone Scientific’s sales and marketing efforts in the United Stated relyupon its E-Commerce platform.· · · ● ● 2 rw ▸ 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.· · ● ● ● 3 ▸ Any of these events could seriously harm our business, operating results, and financial condition.· · ● ● ● 3 ▸ 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.· · ● ● ● 3 ▸ Changes in financial institutions could adversely affect our current and projected business operations, financial condition and results of operations.· · ● ● ● 3 rw ▸ Insurance coverage may be inadequate or unavailable to cover any product liability losses we incur.· · ● ● ● 3 ▸ Milestone Scientific may be subject to enforcement actions if it engages in improper marketing or promotion of its products.· · ● ● ● 3 ▸ 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.· · ● ● ● 3 ▸ Our business and operations would suffer in the event of cybersecurity or other system failures.· · ● ● ● 3 ▸ group Risk Related to Our Dependence on Third Parties· · ● ● ● 3 ▸ group Risks Related to Employee Matters· · ● ● ● 3 ▸ group Risks Related to Milestone Scientific Common Stock· · ● ● ● 3 ▸ Risks Related to Our Financial Position and Need for Additional Capital· · ● ● ● 3 ▸ group Risks Related to Our Intellectual Property· · ● ● ● 3 ▸ group Risks Related to Regulatory Compliance and Other Legal Matters· · ● ● ● 3 ▸ Risks Related to Sales and Distribution of Milestone Scientific Products· · ● ● ● 3 ▸ 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.· · ● ● ● 3 rw ▸ Your percentage of ownership in Milestone Scientificmay be diluted in the future.· · ● ● ● 3 rw ▸ Changes in our distribution arrangements exposes us to risks of interruption of marketing efforts and building new marketing channels.· · ● · · 1 ▸ Milestone Scientific’s International Operations Subject it to Certain Business Risks.· · ● · · 1 ▸ group Risks Related to the Covid-19 Pandemic· · ● · · 1 ▸ We are experiencing supply delays and shortages due to the disruptions the ongoing COVID-19 pandemic is having on the global supply chain, especially with respect to goods from China.· ● ● · · 2 ▸ Business interruptions, including any interruptions resulting from COVID-19, could significantly disrupt our operations and could have a material adverse impact on our business.● · · · · 1 ▸ Continued instability in the credit and financial markets may negatively impact our ability to commercialize our products.● ● ● · · 3 ▸ Returns under our Distribution and Supply Agreement with Henry Schein, Inc. could have a material adverse effect on our business, financial condition, and results of operations.● ● ● · · 3 rw ▸ group Risks related to Human Capital Management● · · · · 1 ▸ The ability of the Company’s employees to work may be significantly impacted by the COVID-19 pandemic● ● · · · 2 rw ▸ The full effects of the COVID-19 pandemic are highly uncertain and cannot be predicted.● ● · · · 2 ▸ We have a history of operating losses that 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.● ● · · · 2 ▸ We may be subject to product liability claims that are not fully covered by insurance and that could put Milestone Scientific under financial strain.● ● · · · 2 ▸ We may require additional funding and may be unable to raise capital when needed, which may force us to delay, curtail or eliminate commercialization efforts of our CompuFlo Epidural Computer Controlled Anesthesia System.● ● ● · · 3 rw ▸ We rely on the continuing services of our Director of Clinical Affairs and Chief Executive Officer.● ● · · · 2 rw ▸ Changes in laws and regulations over which we have no control can significantly affect our business and results of operations.● ● ● ● ● 5 ▸ Developments by competitors may render our products or technologies obsolete or non-competitive.● ● ● ● ● 5 ▸ If physicians neither accept nor use our CompuFlo Epidural System, our ability to generate revenue from sales will be materially impaired.● ● ● ● ● 5 rw ▸ Issues with product quality could have a material adverse effect upon our business, subject us to regulatory actions and cause a loss of customer confidence in us or our products.● ● ● ● ● 5 ▸ Milestone Scientific is effectively controlled by a limited number of stockholders.● ● ● ● ● 5 ▸ Our business is exposed to risks associated with the economic, environmental, and political conditions in China because the sole manufacturer of our handpieces is in China.● ● ● ● ● 5 rw ▸ Provisions in our certificate of incorporation, our by-laws and Delaware law might discourage, delay, or prevent a change in control of our company or changes in our management and, therefore, depress the trading price of our common stock.● ● ● ● ● 5 ▸ 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.● ● ● ● ● 5 ▸ 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.● ● ● ● ● 5 rw ▸ Third parties could obtain patents that may require us to negotiate licenses to commercialize our technologies, and we cannot assure you that the required licenses would be available on reasonable terms or at all.● ● ● ● ● 5 ▸ Third parties may claim that one or more aspects of our technologies or products may infringe on their intellectual property rights.● ● ● ● ● 5 ▸ We are exposed to the risks inherent in international sales.● ● ● ● ● 5 rw ▸ We could lose our market advantage earlier than expected.● ● ● ● ● 5 ▸ We may not be able to attract and retain qualified employees.● ● ● ● ● 5