What changed in this filing

/stocks — the workspaceLOADING

Item 1A. Risk Factors

2026-03-06 compared with 2025-03-06 · 93 added, 82 removed, 391 unchanged (31% of the section changed)

We operate in a rapidly changing environment that involves many risks that could materially affect our business, financial condition or future results, and some of which are beyond our control.

The occurrence of any of these risks could harm our business, financial condition, results of operations and/or growth prospects or cause our actual results to differ materially from those contained in forward-looking statements we have made in this report and those we may make from time to time.

In evaluating the Company and its business, you should carefully consider the information included under Part I, Item 1A “Risk Factors” in this Annual Report.

Investing in our common stock involves a high degree of risk.

Before you decide to invest in our common stock, you should carefully consider the risks described below, together with all other information included in this Annual Report, including our consolidated financial statements and related notes appearing elsewhere in this Annual Report.

We believe the risks described below are the risks that are material to us as of the date of this Annual Report.

If any of the following risks actually materialize, our business, financial condition or results of operations could be materially and adversely affected.

In that case, you could experience a partial or complete loss of your investment.

Further, to the extent that any of the information in this Annual Report constitutes forward-looking statements, the risk factors below also are cautionary statements identifying important factors that could cause actual results to differ materially from those expressed in any forward-looking statements made by us or on our behalf.

See “Cautionary Note Regarding Forward-Looking Statements.

Risk Factors Summary

14 unchanged sentences

● Inability to scale our operations or adequately manage generational upgrades to our own products.

● Our engagement in related party transactions.

● Difficulties associated with accurately forecasting our business performance.

2 unchanged sentences

● Changes in effective tax rates or results from examination of income or other tax returns.

● The development and increased use of Artificial Intelligence presents operational risks and challenges that could damage our reputation or materially harm our business.

● The development and increased use of AI presents operational risks and challenges that could damage our reputation or materially harm our business;

similarly, AI presents opportunities that we may fail to seize and employ which could materially harm our business.

● Our financial condition, results of operations and cash flow may be adversely affected by changing economic conditions, including interest rates and inflation, and other factors beyond our control.

Risks Related to Our Industry

● Changes in government regulations or U.S.

● Changes in government regulations such as tariffs, sanctions, export controls and other trade restrictions, or U.S.

healthcare policy could force us to make modifications to how we develop, manufacture, market, and price our products which may have a material adverse effect on our financial condition and results of operations.

6 unchanged sentences

Foreign Corrupt Practices Act and similar worldwide anti-bribery laws.

● We and our suppliers and customers are required to obtain regulatory approvals and maintain compliance with regulations applicable to medical devices and infusion pumps.

● We and our suppliers and customers are required to obtain regulatory approvals and maintain compliance with regulations applicable to medical devices (infusion pumps and patient monitors).

Risks Relating to our Intellectual Property

4 unchanged sentences

● Significant fluctuations and volatility of our common stock

● Use of capital to repurchase shares of our common stock, need or choice to raise additional capital in the future, payment of dividends, or reduction or cessation of expected dividends.

● Use of capital for the payment of dividends (or the reduction or suspension of expected dividends), repurchases of our common stock, and the potential need or decision to raise additional capital in the future

● The requirements of being a public company may strain our resources, divert management’s attention and affect our ability to attract and retain executive management and qualified Board members.

5 unchanged sentences

Our financial performance is significantly dependent on a limited number of products, and disruptions in our ability to sell these products may have a material adverse effect on our business.

Our current revenue and profitability are significantly dependent on the sale of the MRidium 3860+ MRI compatible IV infusion pump system, the 3880 MRI compatible patient vital signs monitoring system (both Class II medical devices) and the ongoing sale of related disposables and services.

Our current revenue and profitability are significantly dependent on the sale of the MRidium MRI compatible IV infusion pump systems, the 3880 MRI compatible patient vital signs monitoring system (both Class II medical devices) and the ongoing sale of related disposables and services.

There can be no guarantee that in the future, the FDA will not impact our ability to commercially distribute.

1 unchanged sentence

The FDA may also issue warning letters or untitled letters, refuse future requests for 510(k) submission or premarket approval, revoke existing 510(k) clearances or premarket approvals previously granted, impose operating restrictions, enjoin and restrain certain violations of applicable law pertaining to medical devices and assess civil or criminal penalties against our officers, employees, or us.

As inflationary measures have affected the greater market in the last several years, we have considered the effects of inflation on our business operations and financial results.

We have assessed that inflation has not had a material impact on our revenues, expenses, assets, liabilities, or cash flows for the current reporting period.

We have also evaluated our exposure to future inflationary risk and concluded that it is not significant based on our current business model and market conditions.

We have mitigated the impact of inflation on our cost of goods sold by continued operational efficiency.

Our products could be rendered obsolete or economically impractical by numerous factors, many of which are beyond our control, including but not limited to:

14 unchanged sentences

In the near term, we do not anticipate finding alternative sources for our primary suppliers.

Therefore, if our primary suppliers become unable or unwilling to manufacture or deliver materials, or manufacture or deliver such materials later than anticipated, we could experience protracted delays or interruptions in the supply of materials which would ultimately delay our manufacture of products for commercial sale, which could materially and adversely affect our development programs, commercial activities, operating results, and financial condition.

Any such delay could materially and adversely affect our development programs, commercial activities, operating results, and financial condition.

Certain raw materials and components are proprietary products of those unaffiliated third-party suppliers and are specifically cited in our applications with regulatory agencies so that they must be obtained from that specific sole source or sources and could not be obtained from another supplier unless and until an appropriate application amendment is approved by the regulatory agency.

3 unchanged sentences

● a supplier’s inability or unwillingness to continue supplying raw materials and/or components;

● regulatory requirements or action by regulatory agencies or others, including changes in international trade treaties and/or tariffs;

● regulatory requirements or action by regulatory agencies or others, including changes in international trade treaties and/or tariff rates, the countries, components and materials to which such tariffs apply ;

● adverse financial or other strategic developments at or affecting the supplier, including bankruptcy;

6 unchanged sentences

We may experience these or other shortages in the future resulting in delayed shipments, supply constraints, contract disputes and/or stock-outs of our products.

A cyber security incident or failure to protect our information technology infrastructure could be disruptive to our business, compromise confidential data, cause reputation harm, adversely affect our business and operating results, subject us to litigation and federal and state governmental inquiries.

A cybersecurity incident or failure to protect our information technology infrastructure could be disruptive to our business, compromise confidential data, cause reputation harm, adversely affect our business and operating results, subject us to litigation and federal and state governmental inquiries.

We collect and store sensitive business and other information, including intellectual property and trade secrets, on our networks.

10 unchanged sentences

While we maintain insurance that covers certain security incidents, we may not carry appropriate insurance or maintain sufficient coverage to compensate for damage from all events and related potential liability.

We are subject to diverse laws and regulations relating to data privacy and security, such as federal and state data protection regulations, including the California Consumer Privacy Act, as amended by the California Privacy Rights Act, the Virginia Consumer Data Protection Act, the Colorado Privacy Act, the Connecticut Data Privacy Act, and other state privacy laws that have been enacted or may be enacted in the future, and European data privacy laws, including the General Data Protection Regulation.

Complying with these numerous and complex regulations is expensive and difficult, and failure to comply with these regulations could result in regulatory scrutiny, civil liability and related fines, or damage to our reputation.

In addition, any security breach or attempt thereof could result in liability for stolen assets or information, additional costs associated with repairing any system damage, incentives offered to clients or other business partners to maintain business relationships after a breach, and implementation of measures to prevent future breaches, including organizational changes, deployment of additional personnel and protection technologies, increased employee training, and engagement of third-party experts and consultants.

In addition, any security breach or attempt thereof could result in liability for stolen assets or information, additional costs associated with repairing any system damage, incentives offered to customers or other business partners to maintain business relationships after a breach, and implementation of measures to prevent future breaches, including organizational changes, deployment of additional personnel and protection technologies, increased employee training, and engagement of third-party experts and consultants.

The costs incurred to remediate any security incident could be substantial.

We are also subject to recent and increasing cybersecurity regulatory requirements from the FDA.

The FDA has issued guidance on premarket and post-market cybersecurity for medical devices, which include requirements implementing a Software Bill of Materials (SBOM), conducting vulnerability assessments, and maintaining cybersecurity risk management processes.

The FDA may also require cybersecurity labeling and documentation of our ability to provide timely security updates for our devices.

Failure to comply with the FDA’s cybersecurity requirements could result in warning letters, refusal of 510(k) clearances, recalls, or other enforcement actions.

In addition, we cannot assure you that any of our third-party service providers with access to our sensitive or confidential information, or to that of our customers and/or employees, will not experience security breaches or attempts thereof, which could have a corresponding effect on our business.

4 unchanged sentences

If problems arise during production, the affected products may have to be discarded.

Manufacturing problems or delays could also lead to increased costs, lost sales, damage to customer relations, failure to supply penalties, time and expense spent investigating the cause and, depending on the cause, similar losses with respect to other batches of products.

If problems are not discovered before the product is released to the market, voluntary recalls, corrective actions, or product liability related

costs may also be incurred.

Manufacturing problems or delays could also lead to increased costs, lost sales, damage to customer relations, time and expense spent investigating the cause and, depending on the cause, similar losses with respect to other batches of products.

If problems are not discovered before the product is released to the market, voluntary recalls, corrective actions, or product liability related costs may also be incurred.

Should we encounter difficulties in the manufacture of our products or be subject to a product recall, our business could suffer materially.

7 unchanged sentences

We manufacture and store our products at a single facility in Florida.

We manufacture and store our products at a single facility in Winter Springs, Florida, which is also the location of our principal executive offices.

We manufacture and store our products at a single facility in Orlando, Florida, which is also the location of our principal executive offices.

If by reason of fire, hurricane, or other natural disaster, or for any other reason, the facility is destroyed or seriously damaged or our access to it is limited, our ability to provide products to our customers would be seriously interrupted or impaired completely and our operating results and financial condition would be materially and negatively affected.

1 unchanged sentence

In addition, regardless of the level of insurance coverage, damage to our facility may harm our business, financial condition, and operating results.

Our manufacturing facility in Winter Springs, Florida, is our only manufacturing facility, and if it is damaged or

Our manufacturing facility in Orlando, Florida is our only manufacturing facility, and if it is damaged or

rendered inoperable or inaccessible due to political, social or economic upheaval or due to natural or other disasters, it

would be difficult or impossible for us to manufacture our product for a period of time, which may lead to a loss of customers and significant impairment of our financial condition and operating results.

would be difficult or impossible for us to manufacture our product for some period of time, which may lead to a loss of customers and significant impairment of our financial condition and operating results.

If we fail to maintain relationships with IDNs and GPOs, sales of our products could decline.

6 unchanged sentences

Should a GPO negotiate a sole source or bundling contract covering a future or current competitor’s products, we may be precluded from making sales of our competing products to members of that GPO for the duration of the contractual arrangement.

For example, even if we have an existing contract with a GPO for sales of our MRidium 3860+ MRI compatible IV infusion pump, we may encounter difficulties in selling, or be unable to sell, our 3880 MRI compatible patient vital signs monitoring system to that GPO’s affiliated hospitals and other members, which may result in a longer sales cycle or an inability to sell.

For example, even if we have an existing contract with a GPO for sales of

our MRidium MRI compatible IV infusion pumps, we may encounter difficulties in selling, or be unable to sell, our 3880 MRI compatible patient vital signs monitoring system to that GPO’s affiliated hospitals and other members, which may result in a longer sales cycle or an inability to sell.

Our failure to renew contracts with GPOs may cause us to lose market share and could have a material adverse effect on our sales, financial condition, and results of operations.

2 unchanged sentences

The decision-making process of customers is often complex and time-consuming.

Based on our experience, we believe the period between initial discussions with customers regarding our products and a customer’s purchase of our

products have varied widely and have historically ranged between three and six months in duration.

Sales cycles can also be delayed because of capital budgeting procedures.

Based on our experience, we believe the period between initial discussions with customers regarding our products and a customer’s purchase of our products have varied widely and have historically ranged between three and six months in duration.

Sales cycles can also be delayed because of capital budgeting procedures in hospitals.

Moreover, even if one or two units are sold to a hospital, we believe that it will take additional time and experience with our products before other medical professionals routinely use them for other procedures and in other departments of the hospital.

3 unchanged sentences

We rely on distributors for all our sales outside the U.S.

and hence do not have direct control over foreign sales activities.

These distributors also assist us with regulatory approvals and the education of physicians and government agencies.

and do not have direct control over foreign sales activities.

These distributors also assist us with regulatory approvals and the education of physicians and government agencies outside of the U.S.

Our revenues outside the U.S.

11 unchanged sentences

We believe that Mr.

Susi will continue to play a significant role in the development of new products.

Susi will continue to play a leading and significant role in the development of new products and be an extremely valuable source of institutional knowledge about our markets, industry, customers and competitors due to his 40 year tenure in our field.

Our current and future operations could be adversely impacted if we were to lose his services.

Accordingly, our success will be dependent on appropriately managing the risks related to maintaining his continued services, including having a succession plan.

Accordingly, our success will be dependent on appropriately managing risks related to maintaining his continued services, including having a succession plan.

We may be unable to scale our operations successfully.

4 unchanged sentences

If we are unable to respond to and manage changing business conditions, or the scale of our products, services, and operations, then the quality of our services, our ability to retain key personnel and our business could be harmed.

In February 2023, we purchased 26 acres of land in Orlando, Florida and continue construction on an expanded facility to increase capacity.

Any failure to successfully complete construction and operate such a facility expansion might limit our ability to grow as we expect.

We do not plan to retain the current Winter Springs, Florida leased facility once the larger facility is fully operational.

We engage in related party transactions, which result in a conflict of interest involving our management.

We have engaged in the past, and continue to engage, in related party transactions, particularly between our Company and Roger Susi and his affiliates.

The only significant ongoing related party transaction is the lease agreement between our Company and Susi, LLC, an affiliate of Roger Susi, with respect to our current sole production and headquarters facility in Winter Springs, Florida.

Related party transactions that present difficult conflicts of interest, could result in disadvantages to our Company, and may impair investor confidence, which could materially and adversely affect us.

Related party transactions could also cause us to become materially dependent on related parties in the ongoing conduct of our business, and related parties may be motivated by personal interests to pursue courses of action that are not necessarily in the best interests of our Company and our stockholders.

The newly constructed, larger facility, expected to be occupied in mid-2025, will reduce our related party transaction exposure by the eventual termination of the current lease with Susi, LLC.

The environment in which we operate makes it difficult to accurately forecast our business performance.

Significant changes and volatility in most aspects of the current business environment, including financial markets, customer behavior, speed of technological, regulatory, and competitive changes, and the recent health pandemic, make it increasingly difficult for us to predict our revenues and earnings into the future.

Significant changes and volatility in most aspects of the current business environment, including financial markets, customer behavior, speed of technological, regulatory, and competitive changes make it increasingly difficult for us to predict our revenues and earnings into the future.

Our quarterly sales and profits depend substantially on the volume and timing of orders fulfilled during the quarter, and such orders are difficult to forecast.

13 unchanged sentences

These changes introduce risk to our financial reporting processes due to implementation and internal control implications.

We base the aforementioned estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, as discussed in greater detail in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” Our actual operating results may differ and fall below our assumptions and the financial forecasts of securities analysts and investors, resulting in a significant decline in our stock price.

Our actual operating results may differ and fall below our assumptions and the financial forecasts of securities analysts and investors, resulting in a significant decline in our stock price.

Changes in effective tax rates or adverse outcomes resulting from examination of our income or other tax returns could adversely affect our results.

In July 2024, the Company received notice of examination from the U.S.

Internal Revenue Service (the “IRS”) for the tax year ended December 31, 2021.

We are currently complying with the taxing authority and believe our tax position for the year under review was appropriate and have not accounted for any proposed adjustments at this time.

We are subject to the continuous examination of our income tax returns by the IRS and other tax authorities.

On July 29, 2025, the Company received notice that the IRS completed its review of our tax return for the tax year ended December 31, 2021, with no changes to our reported tax return, and closed out its examination.

The Company remains subject to income tax examinations for our U.S.

federal and certain U.S.

state income taxes for 2022 and subsequent years .

We are subject to the regular examination of our income tax returns by the U.S.

Internal Revenue Service (the “IRS”) and other tax authorities.

It is possible that tax authorities may disagree with certain positions we have taken, and any adverse outcome of such a review or audit could have a negative effect on our financial position and operating results.

1 unchanged sentence

Although we believe that our estimates are reasonable, the ultimate tax outcome may differ from the amounts recorded in our financial statements and may materially affect our financial results in the period or periods for which such determination is made.

There can be no assurance that the outcomes from continuous examinations will not have an adverse effect on our business, financial condition, and results of operations.

The constant growth and development of technology, including the increased use of Artificial Intelligence, presents

There can be no assurance that the outcomes from regular examinations will not have an adverse effect on our business, financial condition, and results of operations.

The constant growth and development of technology, including the increased use of AI, presents

risks and challenges to our operations that could give rise to legal or regulatory action, damage our reputation or otherwise materially harm of our business.

1 unchanged sentence

If we fail to comply with these laws, we may be subject to penalties, fines or criminal or civil liability.

The development and use of Artificial Intelligence (“AI”) presents new risks and challenges that can impact our operations if we incorporate AI into our operations, or if used by our third-party vendors.

While we aim to develop and use AI responsibly and attempt to mitigate ethical and legal issues presented by its use, we may ultimately be unsuccessful in identifying or resolving issues before they arise.

The development and use of AI presents new risks and challenges that can impact our operations if we incorporate AI into our operations, or if used by our third-party vendors.

While we aim to continue to develop and use AI responsibly and attempt to mitigate ethical and legal issues presented by its use, we may ultimately be unsuccessful in identifying or resolving issues before they arise.

AI technologies are complex and rapidly evolving and the technologies that we develop or use may ultimately be flawed.

1 unchanged sentence

Moreover, AI technology is subject to rapidly evolving domestic and international laws and regulations, which could impose significant costs and obligations on the Company.

For example, in 2023 the Biden Administration issued a new, executive order on safe, secure and trustworthy AI, including transparency requirements for AI and other predictive algorithms that are part of certified health information technology.

Some states have adopted or are considering additional measures regarding the use of AI within the health care industry.

Emerging regulations may pertain to data privacy, data protection, and the ethical use of AI, as well as clarifying intellectual property considerations.

For example, the EU’s Artificial Intelligence Act classifies certain AI systems used in healthcare or medical devices as 'high-risk' systems, which are subject to strict requirements including conformity assessments, risk management systems, data governance, transparency, human oversight, and post-market monitoring.

If we develop or use AI in systems or products that we sell in the EU, or any other jurisdiction that adopts similar regulatory frameworks, we could be subject to such requirements, which could lead to increased development and manufacturing timing and costs.

In the United States, some states have adopted or are considering additional measures regarding the use of AI within the health care industry.

Various state requirements related to data privacy, data protection, and the ethical use of AI create additional complexity and could require us to modify our use of AI on a state-by-state basis.

The FDA has also recently modified its approach to AI-enabled medical devices, including allowing certain AI algorithm modifications to medical devices without requiring new premarket submissions.

However, the FDA’s approach is evolving and there is uncertainty regarding the scope and application of its new policies.

Our use of AI could give rise to legal or regulatory action, increased scrutiny or liability, damage our reputation or otherwise materially harm our business.

Additionally, if we fail to keep pace with various AI technological developments, our competitive position and business results may be

negatively impacted.

Additionally, if we fail to keep pace with various AI technological developments, our competitive position and business results may be negatively impacted.

Our financial condition, results of operations and cash flow may be adversely affected by changing economic

conditions, including interest rates and inflation, and other factors beyond our control.

In recent years, the U.S.

market has experienced cyclical or episodic downturns, and worldwide economic conditions remain uncertain and volatile, as a result of current geopolitical conditions including conflicts in the Middle East, the ongoing Russia-Ukraine War and geopolitical tensions between China and Taiwan, instability in the U.S.

and global banking systems, a high inflation environment, the imposition of tariffs or other trade barriers and the risk of retaliatory actions or prolonged trade conflict, the downgrading of the U.S.’s credit rating and the possibility of an economic slowdown.

A decline in economic conditions, such as a recession, an economic downturn, and/or inflationary conditions in the U.S., can adversely and negatively impact our patients in a manner that could adversely affect our financial condition, results of operations and cash flow.

Risks Related to Our Industry

We are subject to substantial government regulation that is subject to change and could force us to make modifications to how we develop, manufacture, market, and price our products.

We are subject to substantial government regulation and trade policies that are subject to change and could force us to make modifications to how we develop, manufacture, market, and price our products.

The medical device industry is regulated extensively by governmental authorities, principally the FDA in the U.S.

7 unchanged sentences

Regulatory changes could result in restrictions on our ability to carry on or expand our operations, higher than anticipated costs or lower than anticipated revenue.

The actual impacts of tariffs and other trade restrictions on our business, financial condition and results of operations continue to be subject to a number of factors that are not yet known or are subject to change, including the effect such tariffs and restrictions may have on consumer demand and global automotive production volumes, the duration of such tariffs and restrictions, future changes in the amounts and scope of tariffs, the potential withdrawal of such tariffs and restrictions in whole or in part, the scope and effective date of any exemptions to such tariffs or restrictions, any modification to existing exemptions to such tariffs or restrictions, countermeasures that target countries may take in response to such tariffs and restrictions, the impact such tariffs and restrictions may have on our customers and our supply chain, and whether and to what extent such tariffs are materially impacted by judicial review.

If we fail to obtain, or experience significant delays in obtaining, FDA clearances or other necessary approvals to commercially distribute new products, our ability to maintain profitability or grow will suffer.

9 unchanged sentences

sales will contribute to future growth.

A majority of our international sales originate from Europe and Japan, and we also make sales in Canada, Hong Kong, Australia, Mexico and certain parts of the Middle East.

A majority of our international sales originate from Europe

and Japan, and we also make sales in Canada, Hong Kong, Australia, Mexico and certain parts of the Middle East.

The risks associated with operations outside the U.S.

12 unchanged sentences

federal tax laws and tariff practices;

● political instability and actual or anticipated military or political conflicts, including instability related to war and terrorist attacks, such as Russia’s invasion of Ukraine, and conflict in the Middle East;

● political instability and actual or anticipated military or political conflicts, including Russia’s continuing war to subjugate Ukraine, Israel and the Islamic Republic of Iran , various protracted conflicts and deteriorating security conditions in the Middle East and Africa, U.S.-China trade tensions, Taiwan Strait regional instability, and other geopolitical disruptions that could affect our supply chains or international markets;

● longer payment cycles;

6 unchanged sentences

We carry third-party product liability insurance coverage to protect against such risks, but there can be no assurance that our policy is adequate.

In the ordinary course of business, we may become the subject of product liability claims and lawsuits alleging that our products have resulted or could result in an unsafe condition or injury to patients.

ordinary course of business, we may become the subject of product liability claims and lawsuits alleging that our products have resulted or could result in an unsafe condition or injury to patients.

Any product liability claim brought against us, with or without merit, could be costly to defend and could result in settlement payments and adjustments not covered by or in excess of our product liability insurance.

17 unchanged sentences

Any new regulations or statutory provisions could result in delays or increased costs during the periods of product development, clinical trials and regulatory review and approval, as well as increased costs to assure compliance.

Furthermore, certain state governments have enacted

legislation to limit and/or increase transparency of interactions with healthcare providers, pursuant to which we are required by law to disclose payments and other transfers of value to healthcare providers licensed by certain states.

In addition, with the current political climate, funding adjustments that change or impact Medicare or Medicaid as well as general uncertainties regarding these programs may impact a hospitals ability to honor payment obligations.

Furthermore, certain state governments have enacted legislation to limit and/or increase transparency of interactions with healthcare providers, pursuant to which we are required by law to disclose payments and other transfers of value to healthcare providers licensed by certain states.

We are subject to healthcare fraud and abuse regulations that could result in significant liability, require us to change our business practices and restrict our operations in the future.

4 unchanged sentences

In addition, violations of these laws, or allegations of such violations, could disrupt our business and result in a material adverse effect on our sales, profitability, and financial condition.

Furthermore, since many of our customers rely on reimbursement from Medicare, Medicaid, and other governmental programs to cover a substantial portion of their expenditures, if we or our customers are excluded from such programs as a result of a violation of these laws, it could have an adverse effect on our results of operations and financial condition.

Furthermore, since many of our customers rely on reimbursement from Medicare, Medicaid, and other governmental

programs to cover a substantial portion of their expenditures, if we or our customers are excluded from such programs as a result of a violation of these laws, it could have an adverse effect on our results of operations and financial condition.

We have developed and implemented business practices and processes to train our personnel to perform their duties in compliance with healthcare fraud and abuse laws and conduct informal oversight to detect and prevent these types of fraud and abuse.

8 unchanged sentences

Violations of these laws, or allegations of such violations, could have a material adverse effect on our business, financial position and results of operations and could cause the market value of our common stock to decline.

We and our suppliers and customers are required to obtain regulatory approvals and maintain compliance with regulations applicable to medical devices, including infusion pumps, and these approvals could result in delays or increased costs in developing new products, subject us to sanctions and could adversely affect our business.

We and our suppliers and customers are required to obtain regulatory approvals and maintain compliance with regulations applicable to medical devices, including infusion pumps and patient monitors, and these approvals could result in delays or increased costs in developing new products, subject us to sanctions and could adversely affect our business.

In December 2014, the FDA issued guidance entitled “Infusion Pumps Total Product Life Cycle.” This guidance established substantial additional pre-market requirements for new and modified infusion pumps.

1 unchanged sentence

The process for obtaining regulatory approvals to market infusion pumps and related accessories have become more costly and time consuming.

The impact of this guidance is likely to result in a more time consuming and costly process to obtain regulatory clearance to market infusion pumps.

In addition, new requirements could result in longer delays for the clearance of new products, modification of existing infusion pump products or remediation of existing products in the market.

29 unchanged sentences

These parties may breach or terminate these agreements, and we may not have adequate remedies for such breaches.

Furthermore, these agreements may not provide meaningful protection for our trade secrets or other confidential or proprietary information or result in the effective assignment to us of intellectual property and may not provide an adequate remedy in the event of unauthorized use or disclosure of confidential information or other

breaches of the agreements.

Despite our efforts to protect our trade secrets and our other confidential and proprietary information, we or our collaboration partners, Board members, employees, consultants, contractors, or scientific and other advisors may unintentionally or willfully disclose our proprietary information to competitors.

26 unchanged sentences

In the event that a competitor infringes upon our patent or other intellectual property rights, enforcing those rights may be costly, difficult, and time-consuming.

Even if successful, litigation to enforce our intellectual property rights or to defend our patents against challenge could be expensive and time-consuming and could divert our management’s attention.

Even if successful, litigation to enforce our intellectual property rights or to defend our patents against challenge could be expensive and time-consuming and could divert our

management’s attention.

We may not have sufficient resources to enforce our intellectual property rights or to defend our patent or other intellectual property rights against a challenge.

If we are unsuccessful in enforcing and protecting our intellectual property rights and protecting our products, it could materially harm our business.

If we are unsuccessful in enforcing and protecting our intellectual property rights and protecting our products, our business could be materially affected.

There may also be situations where we use our business judgment and decide to market and sell products, notwithstanding the fact that allegations of patent infringement(s) have not been finally resolved by the courts (i.e., an “at-risk launch”).

34 unchanged sentences

Stock repurchases now are burdened with a federal excise tax which diminishes their attraction to deliver returns to stockholders.

In February 2025, our Board of Directors declared a regular quarterly cash dividend of $0.17 per share.

Even though our Board of Directors has approved the payment of a regular quarterly cash dividend on the Company’s common stock, there can be no assurance as to whether or when we may pay dividends on our common stock in the future.

In February 2026, our Board of Directors declared an increased regular quarterly cash dividend of $0.20 per share of common stock.

Even though our Board of Directors has approved the payment of a regular quarterly cash dividend on the Company’s common stock since 2024, there can be no assurance as to whether or when we may pay dividends on our common stock in the future.

Future dividends, if any, will be declared and paid at the discretion of the Board of Directors and will depend on a number of factors.

11 unchanged sentences

As a public company, we are subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act of 2002, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of Nasdaq and other applicable securities rules and regulations.

Compliance with these rules and regulations will increase our legal and financial compliance costs, make some activities more difficult, time consuming or costly and increase demand on our systems and resources.

Compliance with these rules and regulations will cause us to incur legal and financial compliance costs, makes some activities more difficult, time-consuming or costly and results in demand on our systems and resources.

The Exchange Act requires, among other things, that we file annual, quarterly, and current reports with respect to our business and operating results.

As a result, management’s attention may be diverted from other business concerns, which could adversely affect our business and operating results.

We may need to hire more employees in the future or engage outside consultants to monitor and advise us regarding compliance, which will increase our costs and expenses.

We may need to hire more employees in the future or engage outside consultants to monitor and advise us regarding compliance, which would increase our costs and expenses.

In addition, changing laws, regulations and standards relating to corporate governance and public disclosure are creating uncertainty for public companies, increasing legal and financial compliance costs, and making some activities more time consuming.

These laws, regulations and standards are subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies.

This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.

This results in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.

We may need to invest in additional resources to comply with evolving laws, regulations and standards, and this investment may result in increased general and administrative expenses and a diversion of management’s time and attention from revenue-generating activities to compliance activities.

5 unchanged sentences

Susi may be able to significantly influence matters requiring approval by our stockholders, including the election of directors and the approval of mergers, acquisitions, or other extraordinary transactions.

He may also have

interests that differ from yours and may vote in a way with which you disagree, and which may be adverse to your interests.

He may also have interests that differ from yours and may vote in a way with which you disagree, and which may be adverse to your interests.

This concentration of ownership may have the effect of promoting, delaying or deterring a change of control of our Company.

10 unchanged sentences

Such payment could have a material impact on how investors view our Company and result in a decline in our stock price.

If securities or industry analysts fail to initiate research coverage of our stock, downgrade our stock, or discontinue coverage, our trading volume might be reduced, and our stock price could decline.

The trading market for our common stock depends, in part, on the research reports that securities or industry analysts publish about our business.

If securities or industry analysts do not commence or continue coverage of our Company, the trading market for our stock may not be robust and the price of our stock could likely be negatively impacted.

In the event securities or industry analysts initiate coverage, and later downgrade our stock or discontinue such coverage, our stock price could decline.

If securities or industry analysts do not publish research or reports about our business, or if they publish unfavorable research or downgrade our stock, our stock price and trading volume could decline.

The trading market for our common stock depends, in part, on the research and reports that securities or industry analysts publish about us, our business, our industry and our competitors.

We do not control these analysts or the content, opinions, or timing of their reports.

If one or more analysts who currently cover us cease coverage, fail to publish regular reports, or downgrade our stock, our stock price and trading volume could decline.

In addition, if securities or industry analysts do not initiate or maintain coverage of our Company, the trading market for our common stock may be less active, and the liquidity of our shares may be negatively affected.

The absence of research coverage may also make it more difficult for investors to evaluate our business and prospects, which could adversely affect investor demand for our stock.

If analysts publish unfavorable or inaccurate research regarding our business model, financial performance, capital structure, competitive position, or future prospects, or if our operating results fail to meet analyst expectations, our stock price could decline, potentially materially.

Furthermore, any reduction in the number of analysts covering us could lead to greater volatility in our stock price.

Our charter documents and Delaware law have provisions that may discourage an acquisition of us by others and may prevent attempts by our stockholders to replace or remove our current management.

5 unchanged sentences

We are subject to Section 203 of the DGCL, which generally prohibits a Delaware corporation from engaging in any of a broad range of business combinations with an interested stockholder for a period of three years following the date on which the stockholder became an interested stockholder, unless such transactions are approved by our Board of Directors.

provision could have the effect of delaying or preventing a change of control, whether or not it is desired by or beneficial to our stockholders, which could also affect the price that some investors are willing to pay for our common stock.

This provision could have the effect of delaying or preventing a change of control, whether or not it is desired by or beneficial to our stockholders, which could also affect the price that some investors are willing to pay for our common stock.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors