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Item 1A. Risk Factors

2026-03-02 compared with 2025-03-03 · 270 added, 159 removed, 929 unchanged (32% of the section changed)

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This summary is not complete, and the risks summarized below are not the only risks we face.

summarized below as well as a discussion of other risks related to our business and an investment in our common stock, as well as our other public filings with the Securities and Exchange Commission, or SEC.

You should review and consider carefully the risks and uncertainties described in the “Risk Factors” section of this Annual Report on Form 10-K, which includes a more complete discussion of the risks summarized below as well as a discussion of other risks related to our business and an investment in our common stock, as well as our other public filings with the Securities and Exchange Commission, or SEC.

Any of the following risks could have a material adverse effect on our business, financial condition, results of operations and prospects and cause the trading price of our common stock to decline:

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Our results of operations may fluctuate significantly from quarter to quarter or year to year.

● We expect that a substantial majority of our future revenue will result from our Commercialization Agreement with Ascensia.

If Ascensia fails to perform satisfactorily under this agreement, including among other things if they are delayed or unsuccessful in growing the adoption of our product, our commercialization efforts and financial results would be directly and adversely affected.

● If we are unable to successfully transition commercial responsibility for Eversense back from Ascensia and successfully expand our commercialization of Eversense in the United States and Europe, including among other things if we are delayed or unsuccessful in growing the adoption of our product, our commercialization efforts and financial results would be directly and adversely affected.

● The markets in which we participate are highly competitive, and our primary competitors, as well as a number of other companies, medical researchers and existing medical device companies, are pursuing new delivery devices, delivery technologies, sensing technologies, procedures, drugs and other therapies for the monitoring, treatment and prevention of diabetes.

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● Failure to secure or retain coverage or adequate reimbursement for Eversense or future versions of Eversense systems, including the related insertion and removal procedures, by third-party payors could adversely affect our business, financial condition and operating results.

● We have partnerships with companies such as NPG and directly contract with healthcare professionals to establish broad inserter networks and as the number of insertions increase so does our reliance on these partners.

If NPG or other partners fail to perform satisfactorily under these agreements our commercialization efforts and financial results would be directly and adversely affected.

● If we are unable to establish a broad inserter network through Eon Care, our commercialization efforts and financial results will be directly and adversely affected.

● Our stock price has been highly volatile and may continue to be highly volatile.

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federal, state and local laws and regulations, including those promulgated by the FDA and equivalent foreign regulatory authorities, among others.

Failure to comply

with applicable laws and regulations should harm our business and we may incur significant expenditures related to compliance efforts.

Failure to comply with applicable laws and regulations could harm our business and we may incur significant expenditures related to compliance efforts.

● Failure or perceived failure to comply with existing or future laws, regulations, contracts, self-regulatory schemes, standards, and other obligations related to data privacy and security (including security incidents) could harm our business.

Compliance or the actual or perceived failure to comply with such obligations could increase the costs to our products, limit their use or adoption, and otherwise negatively affect our operating results and business .

Compliance or the actual or perceived failure to comply with such obligations could increase the costs of our products, limit their use or adoption, and otherwise negatively affect our operating results and business.

● Holders of debt instruments may exert substantial influence over us and may exercise their control in a manner adverse to the interests of our common stockholders.

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We incurred total net loss of $(69.1) million and $(78.6) million for the years ended December 31, 2025, and 2024, respectively.

As of December 31, 2024, we had an accumulated deficit of $947.9 million.

As of December 31, 2025, we had an accumulated deficit of $1.0 billion.

To date, we have financed our operations primarily through sales of our equity securities and debt financings.

We have devoted substantially all of our resources to the research and development of our products, including conducting clinical trials, and the commercial launch of Eversense in the United States, select markets in Europe, the Middle East, and Africa (EMEA).

To implement our business strategy we need to, among other things, gain regulatory approval or certification in other regions where we intend to sell our products, expand our commercial launch in the United States and Europe, and develop future generations of Eversense.

To implement our business strategy we need to, among other things, successful transition commercial responsibility for Eversense back to the Company from Ascensia, gain regulatory approval or certification in other regions where we intend to sell our products, expand our commercial launch in the United States and Europe, and develop future generations of Eversense.

We have never been profitable from operations and do not expect to be profitable for at least the next several years.

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Our failure to become and remain profitable would depress the value of our company and could impair our ability to raise capital, expand our business, maintain our development efforts, obtain regulatory approvals or certificates, diversify our product offerings or continue our operations.

Our Commercialization Agreement with Ascensia to market Eversense may not be successful.

We have a Commercialization Agreement with Ascensia, pursuant to which we have granted Ascensia the exclusive right to distribute Eversense worldwide, subject to certain exceptions.

Pursuant to this agreement, our future success will be dependent on Ascensia effectively marketing and selling Eversense.

We expect that the substantial majority of our future revenue will come pursuant to this agreement.

Prior to our Commercialization Agreement with Ascensia, Ascensia had limited experience with marketing durable medical equipment and no experience marketing CGM systems.

In order to strengthen commercial execution, Ascensia has recently established an independent dedicated business unit responsible for commercializing Eversense, which reports directly to Ascensia’s parent company, PHC Holdings Corporation (“PHC”), and Ascensia has engaged a new president of CGM to lead that business unit.

However, there can be no assurance that these efforts will be successful.

The Commercialization Agreement is terminable by Ascensia under a number of circumstances, including if we undergo a change of control.

The agreement is terminable by either party if the other party materially breaches its obligations under the agreement;

provided, however, that if Ascensia is unable to achieve the specified minimum spending or revenue targets described above, then we will only have the right to convert Ascensia’s exclusive rights to

nonexclusive rights, which may make it difficult for us to successfully engage with another commercial partner.

The agreement is also terminable by either party if the other party undergoes bankruptcy, dissolution or winding up.

We cannot guarantee this agreement with Ascensia will be successful, that it will continue, or that we will be able to achieve or maintain any particular volume of sales under the agreement or increase the volume of sales at a satisfactory pace or at all from this relationship in the future.

Our Commercialization Agreement with Ascensia and the terms of our debt may discourage a change of control of our company.

The terms of our agreements with Ascensia and PHC may discourage a third party from acquiring, or attempting to acquire, control of our company, even if a change of control was considered favorable by some or all of our stockholders.

For example, because of the exclusivity of the distribution arrangements with Ascensia and the minimum five-year term of that exclusivity (which may be extended under certain circumstances), prospective strategic acquirors may be unwilling to undertake an acquisition of our company.

The transition of commercial responsibility for Eversense to Senseonics in European markets is subject to the finalization and execution of definitive agreements with Ascensia and an uncertain government approval process.

We executed the Master Asset Purchase Agreement and the A&R Commercialization Agreement with Ascensia related to the termination of our Existing Commercialization Agreement and the transfer of commercial responsibility for Eversense from Ascensia back to the Company.

Pursuant to these agreements, we resumed responsibility for U.S.

commercial activities as of January 1, 2026 and are entitled to 100% of revenue from European Territories, subject to certain transitional arrangements.

While the Master Asset Purchase Agreement and A&R Commercialization Agreement establish the primary terms of the transition, the timing and scope of certain transition activities, costs, and obligations remain subject to ongoing coordination with Ascensia.

Additionally, the formal transition of commercial responsibility in the European countries is subject to the finalization and execution of definitive local purchase agreements for those jurisdictions, the negotiation of which is ongoing.

Accordingly, we cannot predict with certainty the total costs that we will incur, or liabilities that we may assume, in connection with the commercial transition.

If the transition requires greater resources than anticipated or the final outcomes differ from our expectations, it could have a material adverse effect on our ability to fully implement the commercial transition or on our future results of operations.

The commercialization of Eversense in certain European countries is also subject to government tender systems within the various countries.

The ability of the Company to participate in the various tenders will require the satisfaction of the requirements of these countries’ regulatory bodies, and in some cases approval, which vary country by country and are further governed by specific regional level requirements within the countries.

Although we are working with Ascensia and our advisors to understand these processes and the necessary requirements for each country, this process is inherently uncertain, as is the timing for receipt of any required approvals.

As a result, the timeline for our eventual assumption of full commercial responsibilities in these countries is difficult to predict.

Additionally, if one or more countries were to condition the transfer of a tender to the Company on terms that are less favorable than we expect, it could adversely affect the success of our European commercialization efforts.

Our resumption of commercial responsibility for Eversense will require us to develop a number of internal functions and may not be successful.

Prior to our resumption of commercial responsibility for Eversense in the United States on January 1, 2026, it had been more than five years since we had direct commercial responsibility for Eversense.

In order to effectively resume commercial responsibility for the product, we will need to develop internal sales, marketing and distribution capabilities.

This will require us to integrate, and in some cases, recruit, hire and train additional sales and dedicated marketing personnel, as well as other supportive functions.

As a result, we expect our operating expenses to significantly increase as we resume commercial responsibility for Eversense.

Although we expect to capture a larger portion of the revenue from Eversense sales following the transition, these revenue increases may not be sufficient to cover our increased operating expenses.

We have hired many of the Ascensia personnel previously responsible for Eversense commercialization in the United States and plan to offer employment to additional European personnel after finalization of the definitive agreements with Ascensia and appropriate local labor law processes.

However, we cannot guarantee you that we will be successful in transitioning all needed personnel to our Company or that we will not experience operational challenges and inefficiencies as we resume commercial responsibility for the product.

Additionally, although we are working to transition the commercial responsibility of Eversense in a smooth manner, with minimal disruption to the supply of Eversense to patients, it is possible that health care providers, patients or tender authorities may have questions or concerns regarding the transition that could adversely affect demand for the product.

If we encounter any of the issues described above in the transition of commercial responsibility for Eversense back to the Company, it could have a material adverse effect on our business, prospects and results of operations.

We have limited operating history as a commercial-stage company and may face difficulties encountered by companies early in their commercialization in competitive and rapidly evolving markets.

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● manage expanding operations;

● manage and secure effective sales of our product through our new collaboration with Ascensia, including its establishment of required commercial infrastructure in the U.S.

and elsewhere, and its adapting to a new product category in which it has limited experience;

● manage and secure effective sales of our product, including the establishment of required commercial infrastructure in the U.S.

and elsewhere;

● expand the capabilities and capacities of our third-party manufacturers, including increasing production of current products efficiently and having our vendors adapt their manufacturing facilities to the production of new products;

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Due to our limited operating history as a commercial-stage company, we may not have the institutional knowledge or experience to be able to effectively address these and other risks that may face our business.

In addition, we may not be able to develop insights into trends that could emerge and negatively affect our business and may fail to respond effectively to those trends.

As a result of these or other risks, we may not be able to execute key components of our business strategy, and our business, financial condition and operating results may suffer.

If we are unable to successfully expand our commercialization of Eversense in the United States and Europe through our Commercialization Agreement with Ascensia, our business will be harmed.

In addition, we may not be able to develop insights into trends that could emerge and negatively affect our business and may fail to respond effectively to those trends As a result of these or other risks, we may not be able to execute key components of our business strategy, and our business, financial condition and operating results may suffer.

If we are unable to successfully expand our commercialization of Eversense in the United States and Europe our business will be harmed.

We have limited commercialization experience in both the United States and Europe.

We have invested substantially all of our efforts and financial resources to the development and commercialization of Eversense.

Our ability to generate revenue from our products will depend heavily on successful commercialization of products in the

United States and Europe, which is entirely dependent on our collaboration with Ascensia, and on continuing development of future generations of our Eversense system.

Our ability to generate revenue from our products will depend heavily on successful commercialization of products in the United States and Europe and on continuing development of future generations of our Eversense system.

The success of any products that we develop will depend on several factors, including:

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If the number of people with diabetes we target is not as significant as we estimate or the treatment population is narrowed by competition, physician choice or treatment guidelines, we may not generate significant revenue from sales of such products.

Our revenue is dependent on the success of Ascensia in commercializing our product and its future versions.

Our product is a new product for Ascensia globally and they must continue to establish certain functions of their U.S.

commercial organization to successfully market and sell our CGM system.

Ascensia’s continued organizational development of its sales and marketing capabilities will be critical to successful commercialization of our Eversense systems.

If Ascensia is unable to maintain effective sales, marketing and other functions that are required to support the product, it will have a materially negative impact on our net revenues from Eversense.

Approval in the United States by the FDA or approval, or certification by a regulatory agency or notified body in another country does not guarantee approval, or certification by the regulatory authorities or notified bodies in other countries or jurisdictions or ensure approval, or certification for the same conditions of use.

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and EU regulations.

We will also be subject to periodic inspections by the FDA, the Notified Bodies in the EEA and comparable foreign authorities to determine compliance with regulatory requirements, such as the QSR, of the FDA, medical device reporting regulations, vigilance in reporting of adverse events and regulations regarding notification, corrections, and recalls.

We will also be subject to periodic inspections by the FDA, the notified bodies in the EEA and comparable foreign authorities to determine compliance with regulatory requirements, such as the QMSR of the FDA, medical device reporting regulations, vigilance in reporting of adverse events and regulations regarding notification, corrections, and recalls.

These inspections can result in observations or reports, warning letters or other similar notices or forms of enforcement action.

If the FDA, or any comparable foreign regulatory authority concludes that we are not in compliance with applicable laws or regulations, or that any of our products are ineffective or pose an unreasonable health risk, such authority could ban these products, suspend, vary or cancel our marketing authorizations or CE Certificates of Conformity, impose “stop-sale” and “stop-import” orders, refuse to issue export certificates, detain or seize adulterated or misbranded products, order a recall, repair, replacement, correction or refund of such products, or require us to notify health providers and others that the products present unreasonable risks of substantial harm to the public health.

Discovery of previously unknown problems with our product's design or manufacture may result in restrictions on the use of Eversense, restrictions placed on us or our suppliers, or withdrawal or variation of an existing regulatory clearance

or CE Certificate of Conformity for Eversense.

Discovery of previously unknown problems with our product’s design or manufacture may result in restrictions on the use of Eversense, restrictions placed on us or our suppliers, or withdrawal or variation of an existing regulatory clearance or CE Certificate of Conformity for Eversense.

The FDA, competent authorities of EEA countries and comparable foreign regulatory authorities may also impose operating restrictions, enjoin and restrain certain violations of applicable law pertaining to medical devices, assess civil or criminal penalties against our officers, employees or us, or recommend criminal prosecution of our company.

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Any domestic or foreign governmental law or regulation imposed in the future may have a material adverse effect on our business, financial condition and operating results.

Our collaboration agreement with Sequel Med Tech may not lead to the benefits that we anticipate.

In April 2025, we entered into a collaboration agreement with Sequel Med Tech (the “Sequel Collaboration”), for the purpose of integrating the companies’ technologies to jointly create the first ever automated insulin delivery system with a once-yearly CGM.

The development program seeks to integrate Eversense 365 and Sequel’s twiist™ AID system to enable improved outcomes for people living with diabetes In January 2026, the first commercial patients began using the integrated twiist AID system paired with Eversense 365, marking the first time the world’s only one-year CGM has been utilized within an AID system, and we are continuing to work with Sequel toward broader commercialization of the integrated solution.

The Sequel Collaboration subjects us to additional risks in our business operations, including but not limited to:

● costs and expenses associated with the Sequel Collaboration, including the possibility that the costs associated with the integration of the companies’ technologies materially exceed our current expectations;

● potential distraction from other development priorities that may provide more value to the Company;

● the possibility that either party to the Sequel Collaboration may not devote sufficient financial or other resources to the collaboration, including as a result of changes to corporate priorities;

● potential technological challenges that may be experienced in the course of the collaboration, which could disrupt integration or impede adoption;

● potential claims for infringement, misappropriation or violation of intellectual property rights of others, which could expose us to potential litigation or other legal proceedings;

● the potential for disputes to arise between the Company and Sequel Med Tech regarding the integration of the companies’ technologies or other aspects of the Sequel Collaboration;

● compliance with regulatory and legal requirements.

In addition, there is no guarantee that the Sequel Collaboration will result in the financial and economic benefits we anticipate.

Any of the risks listed above and other risks may cause disruption to the technology integration under the Sequel Collaboration or even prevent us from further development efforts related to the project altogether.

If the Sequel Collaboration is not successful or if we are unable to generate sufficient revenue as a result of the Sequel Collaboration, it could adversely affect our business and results of operations, and may damage our reputation.

We are dependent on one product, Eversense.

Our success depends on our ability to continue to develop, commercialize and gain market acceptance for our products.

Our current business strategy is highly dependent on the successful commercialization of Eversense by Ascensia and achieving and maintaining market acceptance.

In order to sell Eversense to people with diabetes, we and Ascensia must educate them, their caregivers and healthcare providers that Eversense is an attractive alternative to competitive products for the monitoring of glucose levels, including SMBG, as well as other competitive CGM systems and alternatives to CGM methodologies.

Our current business strategy is highly dependent on the successful commercialization of Eversense and achieving and maintaining market acceptance.

In order to sell Eversense to people with diabetes, we must educate them, their caregivers and healthcare providers that Eversense is an attractive alternative to competitive products for the monitoring of glucose levels, including SMBG, as well as other competitive CGM systems and alternatives to CGM methodologies.

Market acceptance and adoption of Eversense depends on educating people with diabetes, as well as their caregivers and healthcare providers, as to the distinct features, ease-of-use, positive lifestyle impact, and other perceived benefits of Eversense as compared to competitive products.

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● loss of regulatory approval or CE Certificates of Conformity for Eversense, adverse publicity or other adverse events including any product liability lawsuits;

● any limitations in the ability of Ascensia to effectively communicate and promote product benefits.

● any limitations in our ability to effectively communicate and promote product benefits.

In addition, Eversense may be perceived by people with diabetes, their caregivers or healthcare providers to be more complicated or less effective than traditional monitoring methodologies, including SMBG or CGM systems which may require less calibration, and people may be unwilling to change their current regimens.

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Accordingly, healthcare providers may not recommend Eversense unless and until there is sufficient evidence to convince them to alter the treatment methods they typically recommend, such as receiving recommendations from prominent healthcare providers or other key opinion leaders in the diabetes treatment community.

potential, strategic objectives and profitability could be negatively impacted, which would adversely affect our business, financial condition and operating results.

If we are not successful in educating people with diabetes of the benefits of Eversense, or if we are unable to achieve the support of caregivers and healthcare providers or widespread market acceptance for Eversense, then our sales potential, strategic objectives and profitability could be negatively impacted, which would adversely affect our business, financial condition and operating results.

We contract with third parties for the manufacture of Eversense.

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We currently rely, and expect to continue to rely, on third parties for the manufacture of Eversense for commercial sale and development of future CGM products.

Our business strategy depends on our third-party manufacturers' ability to manufacture Eversense in sufficient quantities and on a timely basis so as to meet consumer demand, while adhering to product quality standards, complying with regulatory requirements and managing manufacturing costs.

with regulatory requirements and managing manufacturing costs.

We are subject to numerous risks relating to our reliance on the manufacturing capabilities of our third-party manufacturers, including:

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As a result, our ability to purchase adequate quantities of components or our products may be limited, and we may not be able to convince suppliers to make components and products available to us.

Additionally, our suppliers may encounter problems that limit their ability to supply components or manufacture products for us,

including financial difficulties, damage to their manufacturing equipment or facilities, or product discontinuations.

Additionally, our suppliers may encounter problems that limit their ability to supply components or manufacture products for us, including financial difficulties, damage to their manufacturing equipment or facilities, or product discontinuations.

As a result, there is a risk that certain components could be discontinued and no longer available to us.

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We have in the past experienced, and we may in the future experience, delays in various phases of product development, approval, certification and commercial launch, including during research and development, regulatory submission and approval or certification, manufacturing, limited release testing, marketing and customer education efforts.

Any delays in our anticipated product launches may significantly impede our ability to successfully compete in our markets.

Any delays in our anticipated product launches may significantly impede our ability to successfully

compete in our markets.

In particular, such delays could cause customers to delay or forego purchases of our products, or to purchase our competitors' products.

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Failure to secure or retain coverage or adequate reimbursement for Eversense or future versions of Eversense systems, including the related insertion and removal procedures, by third-party payors, and an inability of patients to be able to access the product, could adversely affect our business, financial condition and operating results.

We plan to derive nearly all of our revenue from sales of Eversense in the United States and Europe and expect to do so for the next several years.

We derive nearly all of our revenue from sales of Eversense in the United States and Europe and expect to do so for the next several years.

Patients who receive treatment for their medical conditions and their healthcare providers generally rely on third party payors to reimburse all or part of the costs associated with their medical treatment, including healthcare providers' services.

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Many of these coverage policies reimburse for CGM systems under durable medical equipment benefits, which are restrictive in nature and require the healthcare provider or supplier to comply with extensive documentation and other requirements.

those third-party payors that cover CGM products may and have included limitations as to the patient conditions and characteristics eligible for coverage and may adopt different coverage and reimbursement policies for our products, which could also diminish payments for Eversense.

In addition, those third-party payors that cover CGM products may and have included limitations as to the patient conditions and characteristics eligible for coverage and may adopt different coverage and reimbursement policies for our products, which could also diminish payments for Eversense.

It is possible that some third-party payors will not offer any coverage for our products.

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Without a Category 1 code to define the payment process, there will be some heterogeneity in this process.

Given this heterogeneity, we will have to work closely with certified clinics to keep abreast of which process to follow and what to expect.

Given this heterogeneity, we will have to work closely with certified clinics to keep abreast of which process to follow

and what to expect.

This will be disruptive to some clinics and could delay product uptake until the process of payment becomes more homogenous and well defined for clinics to follow.

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However, our market research is based on interviews, focus groups and online surveys involving people with diabetes on insulin, their caregivers and healthcare providers that represent only a small percentage of the overall diabetes market.

As a result, the attributes we incorporated into the Eversense system may not be reflective of what is desired by the various constituents in the diabetes market.

As a result, the attributes we incorporated into the Eversense system may not be reflective of what is desired by the various constituents

in the diabetes market.

Consequently, our estimates of our future market share and penetration may not be accurate and our sales may be less than estimated.

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Competitive products or other technological innovations for the monitoring, treatment or prevention of diabetes may render our products less competitive or obsolete.

Our ability to achieve our strategic objectives will depend, among other things, on our ability to develop and commercialize products for the monitoring and management of diabetes that offer distinct features, have a longer duration than available alternatives, are easy-to-use, receive adequate coverage and reimbursement from third-party payors, include essential safety features and are more appealing than available alternatives.

duration than available alternatives, are easy-to-use, receive adequate coverage and reimbursement from third-party payors, include essential safety features and are more appealing than available alternatives.

Our primary competitors, as well as a number of other companies, medical researchers and existing medical device companies are pursuing new delivery devices, delivery technologies, sensing technologies, procedures, drugs and other therapies for the monitoring, treatment and prevention of diabetes.

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A key to maintaining and growing our revenue will be establishing a customer base and retaining a high percentage of our customers due to the potentially significant revenue generated from ongoing purchases of disposable sensors.

Ascensia intends to continue developing customer loyalty programs to help with retention aimed at patients, their caregivers and healthcare providers, which include patient ambassadors, training specific to Eversense, ongoing support by sales and clinical employees and 24/7 technical support and customer service.

We intend to continue developing customer loyalty programs to help with retention aimed at patients, their caregivers and healthcare providers, which include patient ambassadors, training specific to Eversense, ongoing support by sales and clinical employees and 24/7 technical support and customer service.

If demand for our products fluctuates as a result of the introduction of competitive products, changes in reimbursement policies, manufacturing problems, perceived safety issues with our or our competitors' products, the failure to secure regulatory clearance or approvals, certifications or for other reasons, our ability to attract and retain customers could be harmed.

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If that occurs, we may incur significant costs, the attention of our key personnel could be diverted, or other significant customer relations problems may arise.

also be subject to increased warranty and liability claims for damages related to errors or defects in Eversense or future versions of Eversense.

We may also be subject to increased warranty and liability claims for damages related to errors or defects in Eversense or future versions of Eversense.

A material liability claim or other occurrence that harms our reputation or decreases market acceptance of Eversense could harm our business and operating results.

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Product liability claims may be brought against us by people with diabetes, healthcare providers or others selling or otherwise coming into contact with our products, among others.

If we cannot successfully defend ourselves against product liability claims, we will incur substantial liabilities and reputational harm.

cannot successfully defend ourselves against product liability claims, we will incur substantial liabilities and reputational harm.

In addition, regardless of merit or eventual outcome, product liability claims may result in:

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It is possible that conflicts may arise with our collaborators, such as conflicts concerning the achievement of performance milestones, or the interpretation of significant terms under any agreement, such as those related to financial obligations or the ownership or control of intellectual property developed during the collaboration.

If any conflicts arise with any future collaborators, they may act in their self-interest, which may be adverse to our best interest, and they may

breach their obligations to us.

If any conflicts arise with any future collaborators, they may act in their self-interest, which may be adverse to our best interest, and they may breach their obligations to us.

For example, one of our vendors who provides a component to the Eversense sensor has communicated to us its belief that one of its employees should be named as a co-inventor on a related patent application.

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Future licensors could retain the right to prosecute and defend the intellectual property rights licensed to us, in which case we would depend on the ability of our licensors to obtain, maintain and enforce intellectual property protection for the licensed intellectual property.

These licensors may determine not to pursue litigation against other companies or may pursue such litigation less aggressively than we would.

These licensors may

determine not to pursue litigation against other companies or may pursue such litigation less aggressively than we would.

Further, entering into such license agreements could impose various diligence, commercialization, royalty or other obligations on us.

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Increased inflation rates can adversely affect us by increasing our costs, including labor and employee benefit costs.

International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects.

We operate in a global economy, and our business depends on a global supply chain for the development, manufacturing, and distribution of our products, and for the advancement of the development programs for our future generation products.

There is inherent risk, based on the complex relationships among the U.S.

and the countries in which we conduct our business, that political, diplomatic, and national security factors can lead to global trade restrictions and changes in trade policies and export regulations that may adversely affect our business and operations.

The current international trade and regulatory environment is subject to significant ongoing uncertainty.

We do not own or operate any manufacturing facilities.

We currently rely, and expect to continue to rely, on third parties for the manufacture of our products as well as the future generations of our products under development.

Currently, several of our suppliers are located outside of the United States.

Tariff policies, particularly those affecting countries where our suppliers are located and medical devices generally, could materially increase our costs and reduce our profitability, including as a result of our inability to adjust pricing for our products.

Although these tariff policies have not, to date, had a material effect on our production costs, recent and potential future changes in international trade policies, and medical device-specific tariffs, could present material risks to our operations and financial performance.

Recent policy discussions have included potential targeted tariffs or other trade measures specifically aimed at medical technologies as part of broader healthcare cost control or national security initiatives.

Unlike consumer goods, medical devices are subject to unique regulatory constraints that make rapid supply chain adjustments particularly difficult and costly.

Should additional tariffs be imposed specifically targeting medical device components, our production costs could rise significantly, and it may be difficult and costly to qualify alternative sources within another country with a lower tariff rate or within the United States, as developing and qualifying alternative sources typically requires at least several months and substantial investment and regulatory approvals.

Moreover, the dynamic and unpredictable tariff and trade landscape creates substantial uncertainty and significant planning challenges for our operations.

Changes in tariff classifications, country-of origin requirements, or customs procedures can occur with limited notice.

This uncertainty complicates our long-term investment decisions regarding manufacturing facilities, supply chain optimization, and research and development activities.

Unlike many industries, our ability to pass increased costs to customers is limited by the nature of medical device pricing and reimbursement systems.

Many of our products are distributed pursuant to pricing established through annual or multi-year contracts with commercial, third-party payors, and reimbursement methodologies established by government programs, such as Medicare.

These arrangements typically include fixed pricing terms that were negotiated prior to the implementation of the recently announced tariffs.

As a result, and depending on the timing and scope of the implementation of these tariffs, cost increases due to tariffs may be difficult or impossible to pass through to customers until the next negotiation cycle.

Current or future tariffs will also result in increased research and development expenses, including with respect to increased costs associated with raw materials, laboratory equipment and research materials and components.

Trade restrictions affecting the import of materials necessary for the clinical trials of our future generation products could result in delays to our development timelines.

Increased development costs and extended development timelines could place us at a competitive disadvantage compared to companies operating in regions with more favorable trade relationships and could reduce investor confidence and negatively impact our business, results of operations, financial condition and growth prospects.

The complexity of announced or future tariffs may also increase the risk that we or our customers or suppliers may be subject to civil or criminal enforcement actions in the United States or foreign jurisdictions related to compliance with trade regulations.

Foreign governments may also adopt non-tariff measures, such as procurement preferences or informal disincentives to engage with, purchase from or invest in U.S.

entities, which may limit our ability to compete internationally and attract non-U.S.

investment, employees, customers and suppliers.

Foreign governments may also take other retaliatory actions against U.S.

entities, such as decreased intellectual property protection, increased enforcement actions, or delays in regulatory approvals, which may result in heightened international legal and operational risks.

In addition, the United States and other governments have imposed and may continue to impose additional sanctions, such

as trade restrictions or trade barriers, which could restrict us from doing business directly or indirectly in or with certain countries or parties and may impose additional costs and complexity to our business.

Trade disputes, tariffs, restrictions and other political tensions between the United States and other countries may also exacerbate unfavorable macroeconomic conditions including inflationary pressures, foreign exchange volatility, financial market instability, and economic recessions or downturns.

The ultimate impact of current or future tariffs and trade restrictions remains uncertain and could materially and adversely affect our business, financial condition, and prospects.

While we actively monitor these risks, any prolonged economic downturn, escalation in trade tensions, or deterioration in international perception of U.S.-based companies could materially and adversely affect our business, ability to access the capital markets or other financing sources, results of operations, financial condition and prospects.

In addition, tariffs and other trade developments have and may continue to heighten the risks related to the other risk factors described elsewhere in this Annual Report.

Risks Related to our Financial Results and Need for Financing

We will need to generate significant sales to achieve profitable operations.

We intend to continue to increase our operating expenses in connection with the commercialization of Eversense with our collaboration partner Ascensia, our ongoing research and development activities including the development of next generation products and the clinical trials for those products, and the commensurate development of our management and administrative functions.

We intend to continue to increase our operating expenses in connection with the commercialization of Eversense, our ongoing research and development activities including the development of next generation products and the clinical trials for those products, and the commensurate development of our management and administrative functions.

We will need to generate significant sales to achieve profitability, and we might not be able to do so.

Even if we do generate significant sales, we might not be able to achieve, sustain or increase profitability on a quarterly or annual basis in the future.

If our sales grow more slowly than we expect, or if our operating expenses exceed our expectations, our financial performance and operating results will be adversely affected.

If our sales grow more slowly than we expect or if our operating expenses otherwise exceed our expectations, our financial performance and operating results will be adversely affected.

We cannot predict the ultimate effect on our common stock share price of the one-for-twenty Reverse Stock Split of our common stock that was effected on October 17, 2025.

The Reverse Stock Split may decrease the liquidity of our common stock and magnify any decrease in our overall market capitalization.

The ultimate effect of the Reverse Stock Split on the market price of our common stock cannot be predicted with any certainty, and we cannot assure you that the Reverse Stock Split will result in any or all of the benefits we expect.

While we expect that the reduction in the number of outstanding shares of common stock will proportionally increase the market price of our common stock, we cannot assure you that the Reverse Stock Split will increase the market price of our common stock by a multiple of the Reverse Stock Split ratio or result in any permanent or sustained increase in the market price of our common stock.

The market price of our common stock depends on multiple factors, many of which are unrelated to the number of shares outstanding, including our business and financial performance, general market conditions and prospects for future success, any of which could have a counteracting effect to the Reverse Stock Split on the per share price.

In addition, the Reverse Stock Split also reduced the total number of outstanding shares of common stock, which may lead to reduced trading for our common stock.

As a result of a lower number of shares outstanding, the market for our common stock may also become more volatile.

The Reverse Stock Split also increased the number of stockholders who own “odd lots” of less than 100 shares of common stock.

A purchase or sale of less than 100 shares of common stock (an “odd lot” transaction) may result in incrementally higher trading costs through certain brokers, particularly “full service” brokers.

Therefore, those stockholders who own fewer than 100 shares of common stock following the Reverse Stock Split may be required to pay higher transaction costs if they sell their common stock.

Our operating results may fluctuate from quarter to quarter or year to year.

We have limited operating history as a commercial-stage company and we anticipate that there will be meaningful variability in our operating results among years and quarters, as well as within each year and quarter.

We anticipate that there will be meaningful variability in our operating results among years and quarters, as well as within each year and quarter.

Our operating results, and the variability of these operating results, will be affected by numerous factors, including:

● regulatory clearance, certification or approvals affecting our products or those of our competitors;

● Ascensia’s ability to increase sales of Eversense and to commercialize and sell our future products, and the number of our products sold in each quarter;

● Ascensia’s ability to establish and grow an effective sales and marketing infrastructure and third-party distribution network;

● the ability to increase sales of Eversense and to commercialize and sell our future products, and the number of our products sold in each quarter;

● the ability to establish and grow an effective sales and marketing infrastructure and third-party distribution network;

● acceptance of our products by people with diabetes, their caregivers, healthcare providers and third-party payors;

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● the ability of our suppliers to timely provide us with an adequate supply of components and CGM systems that meet our requirements;

● changes in the fair value of embedded derivative instruments in the terms of some of our financings, which are subject to potentially wide fluctuations from period to period as a result of changes in our stock price;

● the timing of revenue recognition associated with our product sales pursuant to applicable accounting standards.

As a result of our lack of operating history as a commercial-stage company and Ascensia’s lack of experience selling CGM systems, and Eversense in particular, and due to the complexities of the industry and regulatory framework in which we operate, it will be difficult for us to forecast demand for our future products and to forecast our sales with any degree of certainty.

As a result of our lack of operating history as a commercial-stage company and lack of experience selling CGM systems, and Eversense in particular, and due to the complexities of the industry and regulatory framework in which we operate, it will be difficult for us to forecast demand for our future products and to forecast our sales with any degree of certainty.

For example, many of the products we will seek to develop and introduce in the future will require regulatory approval, certification or clearance and import licenses before we can sell such products and given that the timing of such approvals, certification, clearances or licenses may be uncertain, it will be difficult for us to predict sales projections for these products with any degree of certainty before such approvals, certifications, clearances or licenses are obtained.

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We believe this arises primarily due to the annual reset of health insurance plan deductibles that occur at the beginning of the insurance plan year and the utilization of patient assistance programs to offset those costs and our distributors reductions of inventory of our products in the first quarter.

The seasonal variance is has also been impacted by the timing of Ascensia’s purchases in accordance with minimum purchase requirements under our distribution agreement.

As a result, our distributors typically end the calendar year with higher levels of inventory than at the end of the first quarter of the following year.

The seasonal variance has also historically been impacted by the timing of Ascensia’s purchases in accordance with minimum purchase requirements under our distribution agreement.

As a result, our net sales are typically lower in the first quarter of the year than would otherwise have been the case as a result of the reduction of product inventory at our distributors.

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(“Hercules”), as administrative agent.

The Loan and Security Agreement contains customary terms and covenants, including financial covenants, such as operating within an approved budget and achieving minimum revenue and liquidity targets, and negative covenants, such as limitations on indebtedness, liens, mergers, asset transfers, certain investing activities and other matters customarily restricted in such agreements.

On September 3, 2025, the Company amended the Loan and Security Agreement (the “Amended Loan and Security Agreement”).

The Amended Loan and Security Agreement contains customary terms and covenants, including financial covenants, such as operating within an approved budget and achieving minimum revenue and liquidity targets, and negative covenants, such as limitations on indebtedness, liens, mergers, asset transfers, certain investing activities and other matters customarily restricted in such agreements.

Most of these restrictions are subject to certain minimum thresholds and exceptions.

The Loan and Security Agreement also contains customary events of default, after which borrowings under the Loan and Security Agreement will be due and payable immediately, including defaults related to payment compliance, material inaccuracy of representations and warranties, covenant compliance, material adverse changes, bankruptcy and insolvency proceedings, cross defaults to certain other agreements, judgments against the Company, change of control or delisting events, termination of any guaranty, governmental approvals, and lien priority.

The Amended Loan and Security Agreement also contains customary events of default, after which borrowings under the term loan will be due and payable immediately, including defaults related to payment compliance, material inaccuracy of representations and warranties, covenant compliance, material adverse changes, bankruptcy and insolvency proceedings, cross defaults to certain other agreements, judgments against the Company, change of control or delisting events, termination of any guaranty, governmental approvals, and lien priority.

As a result, we are limited in the manner in which we conduct our business and we may be unable to engage in favorable business activities, repurchase shares of our common stock or finance future operations or capital needs.

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Despite our current debt levels, subject to certain conditions and limitations, we may still incur substantially more debt or take other actions which would intensify the risks discussed above.

Despite our current consolidated debt levels, subject to certain conditions and limitations in the indentures related to the 2025 Notes and the Loan and Security Agreement, we may be able to incur substantial additional debt in the future, some of which may be secured debt.

Despite our current consolidated debt levels, we may be able to incur substantial additional debt in the future, some of which may be secured debt.

We may not be subject to any restrictions on incurrence of additional indebtedness under the terms of any future indebtedness.

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There is uncertainty regarding our ability to maintain liquidity sufficient to operate our business effectively, which raises substantial doubt about our ability to continue as a going concern.

The accompanying financial statements have been prepared assuming the Company will continue as a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.

Our management concluded that our recurring losses from operations, existing unrestricted cash, cash equivalents and marketable securities, anticipated debt repayments, and minimum cash and satisfaction of performance milestones to comply with debt covenants under its Loan and Security Agreement raise substantial doubt about our ability to continue as a going concern for the next twelve months after issuance of our financial statements.

The financial statements in this Annual Report have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.

Our management has concluded that the capital considerations required to assume Eversense commercialization and distribution responsibilities, our existing unrestricted cash and cash equivalents, and the minimum cash requirements and satisfaction of performance milestones to comply with debt covenants under our Amended Loan and Security Agreement raise substantial doubts regarding our ability to continue as a going concern for the next twelve months after issuance of our financial statements in this Annual Report.

As of December 31, 2025 the Company had unrestricted cash, cash equivalents and marketable securities of $94.0 million consisting of cash and investments in highly liquid U.S.

money market funds.

On October 28, 2024, we raised additional proceeds of approximately $14.8 million before expenses incurred by the Company in a registered direct offering of the Company’s common stock and concurrent private placement of warrants to purchase shares of the Company’s common stock.

We do not expect our existing cash and cash equivalents will be sufficient to fund our operations through the next twelve months and we will need to seek additional capital to fund our operations, working capital needs, capital expenditures and other strategic initiatives beyond that time.

We do not expect our existing cash and cash equivalents will be sufficient to fund our operations, including the expanded operations that will be required to resume commercialization of Eversense, through the next twelve months and we will need to seek additional capital to fund our operations, working capital needs, capital expenditures and other strategic initiatives beyond that time.

There can be no assurance that we will be successful in raising additional capital or that any needed financing will be available in the future at terms acceptable to us.

As such, we cannot conclude that such plans will be effectively implemented within one year after the date that the financial statements are issued and there is uncertainty regarding our ability to maintain liquidity sufficient to operate our business effectively, and substantial doubt exists about our ability to continue as a going concern.

If we are unable to generate to secure additional capital on acceptable terms or at all, we may be required to significantly reduce or cease our operations, which could result in the loss to investors of their investment in our securities.

If we are unable to secure additional capital on acceptable terms or at all, we may be required to significantly reduce or cease our operations, pursue strategic alternatives, or consider other actions which could result in a loss to investors of their investment in our securities.

Risks Related to Development of our Products

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Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.

We are highly dependent on the management, research and development, clinical, financial and business development expertise of Tim Goodnow, our Chief Executive Officer, Rick Sullivan, our Chief Financial Officer, Mukul Jain, our Chief Operating Officer, and Ken Horton, our General Counsel and Corporate Development Advisor, as well as the other members of our scientific and clinical teams.

We are highly dependent on the management, research and development, commercial, financial and business development expertise of Tim Goodnow, our Chief Executive Officer, Rick Sullivan, our Chief Financial Officer, Mukul Jain, our Chief Operating Officer, Brian Hansen, Chief Commercial Officer and Ken Horton, our General Counsel and Corporate Development Advisor, as well as the other members of our scientific and clinical teams.

Although we have employment agreements with our executive officers, each of them may terminate their employment with us at any time and will continue to be able to do so.

We do not maintain “key person” insurance for any of our executives or employees.

Recruiting and retaining qualified scientific and clinical personnel and, as we progress the development of our product pipeline toward scaling up for commercialization, manufacturing and sales and marketing personnel, will also be critical to our success.

The loss of the services of our executive officers or other key employees could impede the achievement of our research, development and commercialization objectives and seriously harm our ability to successfully implement our business strategy.

Recruiting and retaining qualified scientific, clinical and marketing personnel are critical to our success.

In addition, as we have begun to transition responsibility for the commercialization of our products, we will also be required to recruit and retain a qualified sales force and supporting functions.

The loss of the services of our executive officers or other key employees, or the inability to add required staff, could impede the achievement of our research, development and commercialization objectives or the expansion of activities to support Eversense, and seriously harm our ability to successfully implement our business strategy.

Furthermore, replacing executive officers and key employees may be difficult and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to successfully develop, gain regulatory approval of and commercialize our products.

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This liquidity may represent material wealth to such individuals and impact retention and focus of existing key members of management.

We may need to expand our development and regulatory capabilities and our marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.

We will need to expand our sales and marketing and potentially other capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.

As of December 31, 2025, we had 137 full-time employees.

As our commercialization progresses, we may experience significant growth in the number of our employees and the scope of our operations, particularly in the areas of research, product development, clinical sciences, regulatory affairs, supply chain, and marketing.

As we resume responsibility for the commercialization of our products, we expect to experience significant growth in the number of our employees and the scope of our operations, particularly in the areas of sales and marketing and commercial operations.

In connection with that effort, effective January 2, 2026, we expanded our workforce by hiring more than 150 employees, primarily within commercial sales, marketing, and related support functions.

We also may experience growth in the number of employees in the areas of research, product development, clinical sciences, regulatory affairs, supply chain, logistics, clinical/insertion services, or additional commercial activities.

To manage our future growth, we must continue to implement and improve our managerial, operational and financial systems, expand our facilities and continue to recruit and train additional qualified personnel.

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Misconduct by these parties could also involve the improper use of individually identifiable information, including, without limitation, information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation.

Our exposure to these risks will increase as we significantly increase our work force and resume responsibility for the commercialization of our products.

We have adopted a code of business conduct and ethics, but it is not always possible to identify and deter misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations.

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Our patents expire between 2026 and 2049, subject to any patent extensions that may be available for such patents.

If patents are issued on our pending patent applications, the resulting patents are projected to

expire on dates ranging from 2033 to 2044, subject to any patent term extensions or adjustments that may be available for such patents.

If patents are issued on our pending patent applications, the resulting patents are projected to expire on dates ranging from 2037 to 2043, subject to any patent term extensions or adjustments that may be available for such patents.

We are also seeking patent protection for our proprietary technology in Europe, Japan, China, Canada, India, Australia and other countries and regions throughout the world.

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For example, we have one pending foreign application for the "Eversense Now" trademark relating to our mobile application.

We cannot assure you that our trademark applications will be approved in a timely manner or at all.

We cannot assure you that our

trademark applications will be approved in a timely manner or at all.

Third parties also may oppose our trademark applications, or otherwise challenge our use of the trademarks.

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Significant litigation regarding patent rights exists in our industry.

Our competitors in both the United States and abroad, many of which have substantially greater resources and have made substantial investments in competing technologies, may have applied for or obtained or may in the future apply for and obtain, patents that will prevent, limit or otherwise interfere with our ability to make and sell our products.

Our competitors in both the United States and

abroad, many of which have substantially greater resources and have made substantial investments in competing technologies, may have applied for or obtained or may in the future apply for and obtain, patents that will prevent, limit or otherwise interfere with our ability to make and sell our products.

The large number of patents, the rapid rate of new patent issuances, and the complexities of the technology involved increase the risk of patent litigation.

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For example, as noted in Item 3:

Legal Proceedings, in May 2024, we were served with a complaint by Cellspin Soft, Inc., a non-practicing entity, filed against us in the United States District Court for the Eastern District of Texas, alleging that we infringe on certain patents owned by it and seeking unspecified damages.

We note that the validity of all three patents-in-suit is currently being challenged in Inter Partes Review proceedings at the U.S.

Patent and Trademark Office, where the Patent Trial and Appeal Board instituted a review which the Company has joined.

On February 5, 2025, the court issued an order staying the complaint pending resolution of the Inter Partes Review.

Legal Proceedings, in May 2024, the Company received notice and accepted service of a civil complaint that had been filed in the Eastern District of Texas and styled Cellspin Soft, Inc.

Senseonics Holdings, Inc., and Ascensia Diabetes Care Holdings AG Case No.

The case was filed by a non-practicing entity alleging patent infringement of three patents.

The validity of all three of these patents currently is being challenged in Inter Partes Review proceedings at the U.S.

Patent and Trademark Office by another party, TikTok Inc., (the “TikTok IPR”) and on September 30, 2024, the Patent Trial and Appeal Board instituted a review with respect to each of the asserted claims in these three patents.

Together with LifeScan, Inc.

and Ascensia, on October 30, 2024, we filed a joint motion to join the TikTok IPR as well as our own independent, similar Inter Partes Review petitions challenging these patents.

On February 5, 2025, the court issued an order staying the proceedings in the Eastern District of Texas pending resolution of the Inter Partes Reviews.

On June 5, 2025, prior to the imminent TikTok IPR final hearings, the Acting Director of the U.S.

Patent and Trademark Office ordered a sua sponte review by the Acting Director of whether the TikTok IPR could proceed based on certain novel issues relating to TikTok’s Chinese ownership status.

On January 23, 2026, the Director of the U.S.

Patent and Trademark Office issued and order stating that, in view of a recent order by the Patent Trial and Appeal Board and TikTok Inc.’s announced joint venture (and the referenced ownership attributes thereof), the parties were authorized to file an additional brief addressing whether the evidence Cellspin Soft, Inc.

submitted is sufficient to put TikTok Inc.’s real party in interest identification into dispute, and what effect, if any, the announced joint venture has on the TikTok IPR proceedings.

and Cellspin Soft, Inc.

filed additional briefs on February 2, 2026.

To date, no decision has been rendered on by the Director whether the TikTok IPR can proceed.

The Inter Partes Review proceedings are all stayed pending the outcome of the sua sponte Director’s review.

The timing of this review remains uncertain.

Were the TikTok IPR terminated, it is our belief that our independent Inter Partes Review should continue because the issues raised in the challenge to the TikTok IPR are not relevant to our filings.

Should any asserted claim in the three patents survive the invalidity challenge in the Inter Partes Review proceedings, the Company intends to vigorously defend the lawsuit.

We are further reviewing the allegations, and intend to vigorously defend this matter, however, the outcome of any litigation, such as this, is inherently unpredictable.

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In addition, because patent applications can take many years to issue, there may be patent applications that are currently pending and unknown to us, which may later result in issued patents that third parties could assert against us and harm our business.

In preparation for commercializing our Eversense products, we are performing an analysis, the purpose of which is to review and assess publicly available information to determine whether third parties hold any valid patent rights that a well-informed court would more likely than not find that we would infringe by commercializing our products, understanding that there are risks and uncertainties associated with any litigation and no predictions or

assurances can be made regarding the outcome of any such litigation.

Although our review and analysis are not complete and subject to the express limitations in the preceding sentence, we are not aware of any such valid patent rights.

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If we or our third-party suppliers fail to comply with the FDA's or other foreign regulatory authorities’ good manufacturing practice regulations, this could impair our ability to market our products in a cost-effective and timely manner.

We and our third-party suppliers are required to comply with the FDA's QSR, which covers the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage and shipping of our products.

The FDA audits compliance with the QSR through periodic announced and unannounced inspections of manufacturing and other facilities.

We and our third-party suppliers are required to comply with the FDA's QMSR, which covers the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage and shipping of our products.

The FDA audits compliance with the QMSR through periodic announced and unannounced inspections of manufacturing and other facilities.

The FDA may impose inspections or audits at any time.

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Our current and future global operations will expose us to trade and economic sanctions and other restrictions imposed by the United States, the European Union and other governments and organizations.

Departments of Justice, Commerce, State and Treasury and other federal agencies and authorities have a broad range of civil and

criminal penalties they may seek to impose against corporations and individuals for violations of economic sanctions laws, export control laws, the Foreign Corrupt Practices Act (“FCPA”) and other federal statutes and regulations, including those established by the Office of Foreign Assets Control (“OFAC”).

Departments of Justice, Commerce, State and Treasury and other federal agencies and authorities have a broad range of civil and criminal penalties they may seek to impose against corporations and individuals for violations of economic sanctions laws, export control laws, the Foreign Corrupt Practices Act (“FCPA”) and other federal statutes and regulations, including those established by the Office of Foreign Assets Control (“OFAC”).

In addition, the U.K.

Bribery Act of 2010 (“Bribery Act”) prohibits both domestic and international bribery, as well as bribery across both private and public sectors.

Bribery Act of 2010 (“Bribery Act”) prohibits both domestic and international bribery, as well as bribery across both private and public

An organization that "fails to prevent bribery" by anyone associated with the organization can be charged under the Bribery Act unless the organization can establish the defense of having implemented "adequate procedures" to prevent bribery.

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● HIPAA, and its implementing regulations, which created federal criminal and civil statutes that prohibit, among other things, executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;

information for or on behalf of a covered entity and their subcontractors, regarding the privacy, security and transmission of such individually identifiable health information;

● federal "sunshine" requirements imposed by the PPACA, on device manufacturers regarding the annual reporting to CMS, of any "transfer of value" made or distributed to physicians (defined to include doctors, dentists, optometrists, podiatrists, and chiropractors), other healthcare professionals (such as physician assistants and nurse practitioners, and teaching hospitals, and ownership and investment interests held by physicians and their immediate family members.

● HIPAA, as amended by HITECH, and their implementing regulations, which also imposes obligations on “covered entities,” including certain healthcare providers, health plans, and healthcare clearinghouses, as well as their respective “business associates” that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity and their subcontractors, regarding the privacy, security and transmission of such individually identifiable health information;

● federal "sunshine" requirements, under the Physician Payments Sunshine Act, imposed by the PPACA, on device manufacturers regarding the annual reporting to CMS, of any "transfer of value" made or distributed to physicians (defined to include doctors, dentists, optometrists, podiatrists, and chiropractors), other healthcare

professionals (such as physician assistants and nurse practitioners), and teaching hospitals, and ownership and investment interests held by physicians and their immediate family members.

Failure to timely submit required information may result in significant civil monetary penalties;

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Any of these challenges could impact our reputation, business, financial condition and operating results.

Our activities, including our research, sales and marketing, and patient reimbursement support activities, and relationships with Eon Care PCs, may be subject to scrutiny under these laws.

If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the future, we may be subject to penalties, including significant civil, criminal, and administrative penalties, damages, fines, disgorgement of profits, imprisonment, exclusion from governmental health care programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our financial results.

Our activities, including our research, sales and marketing, training programs, and patient reimbursement support activities, and relationships with Eon Care PCs, may be subject to scrutiny under these laws.

If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the future, we may be subject to penalties, including significant civil, criminal, and administrative penalties, damages, fines, disgorgement of profits, imprisonment, exclusion from governmental health care programs, such as Medicare and Medicaid, payment denials, and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our financial results.

Any federal, state or foreign regulatory review to which we may become subject, regardless of the outcome, would be costly and time-consuming.

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For example, to enforce compliance with the federal laws, the U.S.

Department of Justice has recently increased its scrutiny of interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry.

Department of Justice has increased its scrutiny of interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry.

Dealing with investigations can be time and resource consuming and can divert management's attention from our core business.

Additionally, if we settle an investigation with law enforcement or other regulatory agencies, we may be forced to agree to additional onerous

compliance and reporting requirements as part of a consent decree or corporate integrity agreement.

Additionally, if we settle an investigation with law enforcement or other regulatory agencies, we may be forced to agree to additional onerous compliance and reporting requirements as part of a consent decree or corporate integrity agreement.

Any such investigation or settlement could increase our costs or otherwise have an adverse effect on our business.

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In the United States, federal, state, and local governments have enacted numerous data privacy and security laws, including data breach notification laws, personal data privacy laws, consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act), and other similar laws (e.g., wiretapping laws).

For example, the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), imposes specific requirements relating to the privacy, security, and transmission of individually identifiable protected health information.

Numerous U.S.

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These state laws allow for statutory fines for noncompliance.

The California Consumer Privacy Act of 2018 (“CCPA”) and other comprehensive U.S.

state privacy laws exempt some data processed in the context of clinical trials, but these developments may further complicate compliance efforts, and increase legal risk and compliance costs for us and the third parties with whom we work.

Similar laws are being considered in several other states, as well as at the federal and local levels, and we expect more states to pass similar laws in the future.

The collection and use of personal health data in the EEA and the UK is governed by the EU and UK GDPR (collectively, GDPR).

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In particular, the EEA and the UK have significantly restricted the transfer of personal data to the United States and other countries whose privacy laws it generally believes are inadequate.

Although there are currently various mechanisms that may be used to transfer personal data from the EEA and UK or other jurisdictions to the United States in compliance with law, such as the EEA standard contractual clauses, the UK’s International Data Transfer Agreement / Addendum, and the EU-U.S.

Data Privacy Framework and the UK extension thereto (which allows for transfers to relevant U.S.-based organizations who self-certify compliance and participate in the Framework, these mechanisms are subject to legal challenges, and there is no assurance that we can satisfy or rely on these measures to lawfully transfer

personal data to the United States.

Although there are currently various

mechanisms that may be used to transfer personal data from the EEA and UK or other jurisdictions to the United States in compliance with law, such as the EEA standard contractual clauses, the UK’s International Data Transfer Agreement / Addendum, and the EU-U.S.

Data Privacy Framework and the UK extension thereto (which allows for transfers to relevant U.S.-based organizations who self-certify compliance and participate in the Framework).

These mechanisms are subject to legal challenges, and there is no assurance that we can satisfy or rely on these measures to lawfully transfer personal data to the United States.

If there is no lawful manner for us to transfer personal data from the EEA or UK or other jurisdictions to the United States, or if the requirements for a legally-compliant transfer are too onerous, we could face significant adverse consequences, including the interruption or degradation of our operations, the need to relocate part of or all of our business or data processing activities to other jurisdictions at significant expense, increased exposure to regulatory actions, substantial fines and penalties, the inability to transfer data and work with partners, vendors and other third parties, and injunctions against our processing or transferring of personal data necessary to operate our business.

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Other jurisdictions have adopted and may adopt stringent data localization and cross-border data transfer laws.

Additionally, the U.S.

Department of Justice issued a rule entitled the Preventing Access to U.S.

Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons, which places additional restriction on certain data transactions involving countries of concern (e.g., China, Russia, Iran) and covered persons (i.e., individuals and entities who are designated as such by the U.S.

Attorney General or considered “foreign persons” and are majority owned by, organized under the laws of, a primary resident in, or a contractor of, a covered person or country of concern, as applicable) that may impact certain business activities such as vendor engagements, sale or sharing of data, employment of certain individuals, and investor agreements.

Violations of the rule could lead to significant civil and criminal fines and penalties.

The rule applies regardless of whether data is anonymized, key-coded, pseudonymized, de-identified or encrypted, which presents particular challenges for companies like ours and may impact our ability to engage in transactions or agreements with certain third parties in the future.

In addition to data privacy and security laws, we are contractually subject to certain industry standards adopted by industry groups and, we are, and may become subject in the future, to additional such obligations.

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Our contracts may not contain limitations of liability, and even where they do, there can be no assurance that limitations of liability in our contracts are sufficient to protect us from liabilities, damages, or claims related to our data privacy and security obligations.

We publish privacy policies, whitepapers and other statements concerning data privacy and security.

We publish privacy policies, and other statements concerning data privacy and security.

Regulations in the United States are increasingly scrutinizing these statements, and if these policies or statements are found to be deficient, lacking in transparency, deceptive, unfair, misleading, or misrepresentative of our practices, we may be subject to investigation, enforcement actions by regulators or other adverse consequences.

Our employees and personnel use generative artificial intelligence (“AI”) technologies to perform their work, and the disclosure and use of personal data in generative AI technologies is subject to various privacy laws and other privacy obligations.

Governments have passed and are likely to pass additional laws regulating generative AI.

Governments have passed and are likely to pass additional laws and regulations regulating generative AI.

Our use of this technology could result in additional compliance costs, regulatory investigations and actions, and lawsuits.

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Additionally, under various privacy laws and other obligations, we may be required to obtain certain consents to process personal data.

For example, some of our data processing practices may be challenged under wiretapping laws, if we obtain consumer information from third parties through various methods, including chatbot providers.

For example, some of our data processing practices may be challenged under wiretapping laws, if we obtain consumer information from third parties through various methods, including chatbot and session replay providers, cookies, or via third-party marketing pixels.

These practices are subject to increased challenges by class action plaintiffs.

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Obligations related to data privacy and security (and consumers’ expectations) are quickly changing, becoming increasingly stringent, and creating uncertainty.

Additionally, these obligations may be subject to differing applications and interpretations, which may be inconsistent or conflict among jurisdictions.

Additionally, these obligations may be subject to differing applications

and interpretations, which may be inconsistent or conflict among jurisdictions.

Preparing for and complying with these obligations requires us to devote significant resources, which has in the past and may in the future necessitate changes to our services, information technologies, systems, and practices and to those of any third parties that process personal data on our behalf.

If we or our parties on which we rely fail to comply or are alleged to have failed to comply with applicable data privacy obligations, we could face significant consequences, including but not limited to:

If we or the parties on which we rely fail to comply or are alleged to have failed to comply with applicable data privacy obligations, we could face significant consequences, including but not limited to:

government enforcement actions (e.g., investigations, fines, penalties, audits, inspections, and similar);

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Some of these claims allow for the recovery of statutory damages on a per violation basis, and, if viable, carry the potential for monumental statutory damages, depending on the volume of data and the number of violations.

Any associated claims, inquiries, or investigations or other government actions could lead to unfavorable outcomes that have a material impact on our business including through significant penalties or fines, monetary judgments or settlements including criminal and civil liability for us and our officers and directors, increased compliance

costs, delays or impediments in the development of new products, inability to process personal data or to operate in certain jurisdictions;

negative publicity, increased operating costs, diversion of management time and attention, or other remedies that harm our business, including orders that we modify or cease existing business practices.

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Extortion payments may alleviate the negative impact of a ransomware attack, but we may be unwilling or unable to make such payments due to, for example, applicable laws or regulations prohibiting such payments.

Because of our hybrid work policies, sensitive information that is normally protected may be less secure as more of our employees utilize network connections, computers and devices outside our premises or network, including working at home, while in transit and in public locations.

It may be difficult and/or costly to detect, investigate, mitigate, contain, and remediate a security incident.

Our efforts to do so may not be successful.

Actions taken by us or the third parties with whom we work to detect, investigate,

mitigate, contain, and remediate a security incident could result in outages, data losses, and disruptions of our business.

Threat actors may also gain access to other networks and systems after a compromise of our networks and systems.

For example, threat actors may use an initial compromise of one part of our environment to gain access to other parts of our environment, or leverage a compromise of our networks or systems to gain access to the networks or systems of third parties with whom we work, such as through phishing or supply chain attacks.

Because of our hybrid work policies, sensitive information may be less secure as more of our employees utilize network connections, computers and devices outside our premises or network, including working at home, while in transit and in public locations.

Future or past business transactions (such as acquisitions or integrations) could expose us to additional cybersecurity risks and vulnerabilities, as our systems could be negatively affected by vulnerabilities present in acquired or integrated entities’ systems and technologies.

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A security incident or other interruption could disrupt our ability (and that of third parties with whom we work) to provide our products and services.

We may expend significant resources or modify our business activities to try to protect against security incidents, and have in the past.

We may expend significant resources or modify our business activities, including our clinical trial activities, to try to protect against security incidents, and have in the past.

Certain data privacy and security obligations have required us to implement and maintain specific security measures to protect our information technology systems and sensitive information.

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and other similar harms.

Security incidents and attendant consequences may prevent or cause customers to stop using our products, deter new customers from using our products, and negatively impact our ability to grow and operate our business.

Security incidents and attendant consequences

may prevent or cause customers to stop using our products, deter new customers from using our products, and negatively impact our ability to grow and operate our business.

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It is also possible that other federal, state or competent authorities of the EEA countries, or foreign enforcement authorities might take action if they consider our promotional or training materials to constitute promotion of an unapproved use, which could result in significant fines or penalties.

Although we intend to train our marketing and direct sales force to not promote our

products for uses outside of their cleared uses and our policy will be to refrain from statements that could be considered off-label promotion of our products, the FDA competent authorities of the EEA countries, or another regulatory agency could disagree and conclude that we have engaged in off-label promotion.

Although we intend to train our marketing and direct sales force to not promote our products for uses outside of their cleared uses and our policy will be to refrain from statements that could be considered off-label promotion of our products, the FDA competent authorities of the EEA countries, or another regulatory agency could disagree and conclude that we have engaged in off-label promotion.

In addition, the off-label use of our products may increase the risk of product liability claims.

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If a patient fails to do so and has an adverse reaction to self-medication, the patient might make a claim against us.

While we do not believe that, as a general matter, such a claim would have merit, the possibility of an adverse result to the manufacturer cannot be dismissed, and in any event, we could incur significant defense costs.

defense costs.

Also, if there should be widespread off-label use of our system by patients, and resulting adverse medical events, the FDA, competent authorities of the EEA countries or other foreign regulatory bodies might require us to implement additional measures to reduce off-label use, which could be costly or reduce adoption of Eversense.

Legislative or regulatory healthcare reforms may make it more difficult and costly for us to obtain regulatory clearance, certification or approval of our products.

Legislative or regulatory healthcare reforms may make it more difficult and costly for us to obtain regulatory clearance, certification or approval of our products or otherwise impact our profitability.

Recent political, economic and regulatory influences are subjecting the healthcare industry to fundamental changes.

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We affixed the CE Mark to the original 90-day Eversense CGM system in June 2016, which marked the first certification for the product to be sold within the European Economic Area (“EEA”).

Subsequently, we affixed the CE mark to the extended life Eversense XL CGM system in September 2017 which was sold in select markets in Europe and the Middle East.

indicate risk levels, requirements for third party testing by Notified Bodies, tightened and streamlined quality management system assessment procedures and additional requirements for the quality management system, additional requirements for traceability of products and transparency as well as a refined responsibility of economic operators.

Subsequently, we affixed the CE Mark to the extended life Eversense XL CGM system in September 2017 which was sold in select markets in Europe and the Middle East and in January 2026 obtained CE Mark approval for Eversense 365 which is expected to launch in the European Territories by the second half of 2026.

The changes to the regulatory system implemented in the EU by the Medical Device Regulation include stricter requirements for clinical evidence and pre-market assessment of safety and performance, new classifications to indicate risk levels, requirements for third party testing by Notified Bodies, tightened and streamlined quality management system assessment procedures and additional requirements for the quality management system, additional requirements for traceability of products and transparency as well as a refined responsibility of economic operators.

We are also required to provide clinical data in the form of a clinical evaluation report.

Fulfilment of the obligations imposed by the Medical Device Regulation may cause us to incur substantial costs.

We may be unable to fulfil these obligations, or our Notified Body may consider that we have not adequately demonstrated compliance with our related obligations to merit a CE Certificate of Conformity on the basis of the Medical Device Regulation.

In addition, the exit of the UK from the EU, commonly referred to as “Brexit” could lead to regulatory divergence between the EU and the UK.

On May 26, 2021, the MDR entered into application in the EU.

We may be unable to fulfill these obligations, or our Notified Body may consider that we have not adequately demonstrated compliance with our related obligations to merit a CE Certificate of Conformity on the basis of the Medical Device Regulation.

On May 26, 2021, the Medical Device Regulation entered into application in the EU.

However, the MDR is not applicable in Great Britain (i.e.

England, Wales and Scotland) but does apply in Northern Ireland.

In Great Britain, medical devices are governed by the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) which, for the time being, retains a regulatory framework similar to the framework set out by the MDD.

The UK’s regulator, the Medicines & Healthcare products Regulatory Agency plans on introducing new legislation governing medical devices with an aim to bring the new regulations into force during 2025 (“MHRA”) has published a road-map to new regulations for medical devices.

The first of the regulations, which strengthen post-market surveillance requirements, is scheduled to come into force on June 17, 2025.

Further updated regulations are scheduled to follow in 2025 and 2026.

In Great Britain, medical devices are governed by the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) which, currently retains a regulatory framework similar to the framework set out by the MDD.

The UK’s regulator, the Medicines & Healthcare products Regulatory Agency (“MHRA”) introduced new regulations for medical devices.

The first of the regulations, which strengthen post-market surveillance requirements came into force on June 16, 2025.

Further updated regulations are scheduled to follow in and the course of 2026.

Should the UK or Great Britain further diverge from the EU from a regulatory perspective, tariffs could be put into place in the future.

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impose extensive compliance and monitoring obligations on our business.

These agencies review our design and manufacturing practices, labeling, record keeping, manufacturers’ required reports of adverse experiences and other information to identify potential problems with marketed medical devices.

These agencies review

our design and manufacturing practices, labeling, record keeping, manufacturers’ required reports of adverse experiences and other information to identify potential problems with marketed medical devices.

We are subject to unannounced device inspections by Notified Bodies, as well as other regulatory authorities overseeing the implementation and adherence of applicable regulations.

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Non-compliance may also result in Notified Bodies revoking, suspending or varying any CE Certificate of Conformity that they have issued for a device or the manufacturer’s quality system.

In addition, FDA regulations and guidance are often revised or reinterpreted by the FDA in ways that may significantly affect our business and our products.

In addition, FDA and foreign regulations and guidance are often revised or reinterpreted by the FDA and comparable foreign regulatory authorities in ways that may significantly affect our business and our products.

For example, in July 2024, Regulation (EU) 2024/1860 entered into application in the EU.

The Regulation imposes new manufacturer obligations, including mandatory pre-notification of supply interruptions starting January 10, 2025.

In addition, the Regulation introduces the gradual rollout of EUDAMED, the EU’s central database for medical devices and diagnostics.

Starting from May 28, 2026, the use of the first four modules will become mandatory - actor registration, UDI/Devices registration, notified bodies and certificates, and Market Surveillance.

The evolving nature of the EU regulatory environment creates uncertainty, and additional amendments or guidance could further increase compliance burden or disrupt market access for certain products.

Any new regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of our products.

Government shutdowns, reductions in force among FDA personnel, and funding shortages have and may result in significant delays.

Delays in receipt of or failure to receive regulatory clearances or approvals for our products would harm our business, financial condition and operating results.

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For example, the PPACA was enacted in March 2010.

The PPACA substantially changes the way healthcare is financed by both governmental and private insurers, encourages improvements in the quality of healthcare items and services and significantly impacts the medical device industries.

The PPACA substantially changed the way healthcare is financed by both governmental and private insurers, encourages improvements in the quality of healthcare items and services and significantly impacts the medical device industries.

There have been executive, judicial and Congressional challenges and amendments to certain aspects of the PPACA.

For example, on August 16, 2022, President Biden signed the IRA into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in PPACA 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 maximum out-of-pocket cost and creating a new manufacturer discount program.

It is possible that the

PPACA will be subject to judicial or Congressional challenges in the future.

It is unclear how such challenges and the healthcare reform measures of the second Trump administration will impact the PPACA and our business.

For example, on July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was signed into law, which narrowed access to PPACA marketplace exchange enrollment and declined to extend the PPACA enhanced advanced premium tax credits that expired at the end of 2025, which, among other provisions in the law, are anticipated to reduce the number of Americans with health insurance.

The OBBBA also 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.

Congress is considering proposed legislation intended to further reduce healthcare costs with alternatives to replace the expired PPACA subsidies.

It is possible that the PPACA will be subject to judicial or Congressional challenges in the future.

It is unclear how such challenges and the healthcare reform measures of the current administration will impact the PPACA and our business.

In addition, other legislative changes have been proposed and adopted since the PPACA was enacted.

On August 2, 2011, the Budget Control Act of 2011 was signed into law, which, among other things, includes reductions to Medicare payments to providers of 2% per fiscal year, which went into effect on April 1, 2013 and, due to subsequent legislative amendments to the statute, will remain in effect through 2032 unless additional Congressional action is taken.

On January 2, 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, reduced Medicare payments to several providers, including hospitals, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

The current administration is pursuing policies to reduce regulations and expenditures across government agencies including at the Department of Health and Human Services, the FDA, CMS and related agencies.

Such actions and policies may, among other things, significantly reduce U.S.

medical device prices, potentially impacting manufacturers’ global pricing strategies and profitability, while increasing their operational costs and compliance risks.

At this time, we cannot predict which, if any, additional healthcare reform proposals will be adopted, when they may be adopted or what impact they, or the PPACA, may have on our business and operations, and any of these impacts may be adverse on our operating results and financial condition.

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● analyst coverage, recommendations or changes in their estimates of our financial performance;

● our degree of success in transitioning commercial responsibility for Eversense back from Ascensia;

● future announcements about us or our competitors, including the results of technological innovations or new commercial products;

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Our certificate of incorporation authorizes us to issue up to 70,000,000 shares of common stock and up to 5,000,000 shares of preferred stock with such rights and preferences as may be determined by our board of directors.

Subject to compliance with applicable rules and regulations, we may issue our shares of common stock, including securities convertible into common stock, in connection with a financing, acquisition, investment, our equity incentive plans or otherwise.

plans or otherwise.

This includes the issuance, from time to time, of non-statutory stock options exercisable for shares of our common stock and/or restricted stock units that may be settled in shares of our common stock pursuant to the Senseonics Holdings, Inc.

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PHC may have the ability exert substantial influence over us in a manner adverse to your interests.

Subject to maintaining specified ownership thresholds, PHC continues to hold the right to designate up to two individuals to serve on our board of directors as outlined in their Investor Rights Agreement.

As of the date of this filing, PHC beneficially owns approximately 9.6% of our common stock.

Additionally, although PHC’s designee to the Company’s board of directors resigned from our board in connection with the execution of the Master Asset Purchase Agreement on December 31, 2025, PHC continues to have the right to designate one individual to serve on our board of directors as outlined in their Investor Rights Agreement and that right will continue as long as PHC beneficially owns in excess of 5% of our outstanding common stock.

As a result, PHC may be able to significantly influence our decisions, including the election and removal of directors, any merger, consolidation, sale of all or substantially all of our assets, or other significant corporate transactions.

PHC may have interests different from the interests of the other holders of our common stock.

The rights that we have granted to Abbott in connection with a recent private placement may affect the likelihood of a change of control of Senseonics.

In connection with an investment in Senseonics made by Abbott Laboratories in May 2025, we granted Abbott certain information rights regarding the clinical and regulatory development status and progress of our Gemini and Freedom development programs.

We also granted Abbott preferential negotiation rights with respect to certain future strategic transactions, including a merger, acquisition or other transaction involving a change in control of Senseonics, the sale or disposition of a material portion of our consolidated assets, the sale, exclusive license or exclusive distribution arrangement involving any of our material intellectual property (including the Gemini product and/or the Freedom product), excluding certain distribution agreements with respect to any product in one or more jurisdictions outside of the United States.

Although these rights are subject to certain conditions and limitations, the existence of these rights may, prior to their expiration, impact the likelihood that Abbott or other third parties may seek to explore an acquisition of us or pursue a distribution agreement with us with respect to future products.

As a result, the existence of these rights could have an adverse effect on our stock price until the rights terminate.

If our estimates relating to our critical accounting policies are based on assumptions or judgments that change or prove to be incorrect, our operating results could fall below expectations of financial analysts and investors, resulting in a decline in our stock price.

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Our operating results may be adversely affected if our assumptions change or if actual circumstances differ from those in our assumptions, which could cause our operating results to fall below the expectations of financial analysts and investors, resulting in a decline in our stock price.

Significant assumptions and estimates used in preparing our consolidated financial statements include those related to revenue recognition and variable consideration, reserves for inventory obsolescence and warranties, stock-based compensation, embedded features of our senior convertible notes and income taxes.

We do not intend to pay cash dividends in the foreseeable future.

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In addition, pursuant to our debt agreements, we are precluded from paying any cash dividends.

Accordingly, you may have to sell some or all of your shares of our common stock in order to generate cash flow from your investment.

Accordingly, you may have to sell some or all of your shares of our common stock in order to generate

cash flow from your investment.

You may not receive a gain on your investment when you sell shares and you may lose the entire amount of the investment.

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We note that investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder.

These exclusive forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees, which may discourage lawsuits against us and our directors, officers and other employees.

us and our directors, officers and other employees.

Any person or entity purchasing or otherwise acquiring any interest in any of our securities shall be deemed to have notice of and consented to these provisions.

There is uncertainty as to whether a court would enforce such provisions, and the enforceability of similar choice of forum provisions in other

companies’ charter documents has been challenged in legal proceedings.

There is uncertainty as to whether a court would enforce such provisions, and the enforceability of similar choice of forum provisions in other companies’ charter documents has been challenged in legal proceedings.

While the Delaware courts have determined that such choice of forum provisions are facially valid, a stockholder may nevertheless seek to bring a claim in a venue other than those designated in the exclusive forum provisions, and there can be no assurance that such provisions will be enforced by a court in those other jurisdictions.

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If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired .

We are subject to the reporting requirements of the Securities Exchange Act of 1934, as amended, the Sarbanes-Oxley Act of 2002, the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010 and the rules and regulations of the NYSE American.

The Sarbanes-Oxley Act requires, among other things, that we maintain effective disclosure controls and procedures and internal control over financial reporting and perform system and process evaluation and testing of our internal control over financial reporting to allow management to report on the effectiveness of our internal control over financial reporting.

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Any failure to maintain effective internal control over financial reporting could severely inhibit our ability to accurately report our financial condition or results of operations.

If we are unable to conclude that our internal control over financial reporting is effective, or if our independent registered public accounting firm determines we have a material weakness or significant deficiency in our internal control over financial reporting, we could lose investor confidence in the accuracy and completeness of our financial reports, the market price of our common stock could decline, and we could be subject to sanctions or investigations by the NYSE American, the SEC or other regulatory authorities.

Failure to remedy any material weakness in our internal control over financial reporting, or to implement or maintain other effective control systems required of public companies, could also restrict our future access to the capital markets.

Our effective tax rate may fluctuate, and we may incur obligations in tax jurisdictions in excess of accrued amounts.

We are subject to taxation for U.S.

Federal and numerous U.S.

We are subject to taxation at the U.S.

federal level and in numerous U.S.

As a result, our effective tax rate is derived from a combination of applicable tax rates in the various places that we operate.

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At December 31, 2025, we had gross federal and state net operating loss (“NOL”) carryforwards of $791.3 million and $134.9 million, respectively and research and experimental credit carryforwards of $18.1 million.

Federal NOL carryforwards in the amount of $193.3 million will expire in varying amounts between 2025 and 2037 and tax credits of $17.1 million will expire in varying amounts between 2025 and 2044.

Federal NOL carryforwards in the amount of $190.1 million will expire in varying amounts through 2037 and tax credits of $18.1 million will expire in varying amounts through 2045.

These net operating loss carryforwards and credits could expire unused and be unavailable to offset future income tax liabilities.

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Any such enactment, interpretation, change, repeal, or modification could adversely affect us, possibly with retroactive effect.

For instance, the Inflation Reduction Act (“IRA”) imposes, among other rules, a 15% minimum tax on the book income of certain large corporations and a 1% excise tax on certain corporate stock repurchases.

The Tax Cuts and Jobs Act of 2017 (“TCJA”), as modified by the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act significantly reformed existing tax laws.

The IRA, TCJA, or any future tax reform legislation could have a material impact on the value of our deferred tax assets, result in significant one-time charges, and increase our future tax expenses.

Legislation commonly referred to as the One Big Beautiful Bill Act enacted in 2025 (the “OBBBA”), the Inflation Reduction Act enacted in 2022, the Coronavirus Aid, Relief, and Economic Security Act enacted in 2020, and the Tax Cuts and Jobs Act enacted in 2017 made many significant changes to the U.S.

Internal Revenue Code of 1986, as amended.

Future guidance from the Internal Revenue Service and other tax authorities with respect to any legislation may affect us, and certain aspects of such legislation could be repealed or modified in future legislation or sunset in future years.

Changes in or interpretations under the OBBBA, the Tax Cuts and Jobs Act, the IRA, or other tax legislation, or the enactment of new tax legislation, could increase our future tax liability, which could in turn adversely impact our business and future profitability.

We are unable to predict what changes to the tax laws of the U.S.

and other jurisdictions may be proposed or enacted in the future or what effect such changes would have on our business.

Any of these or similar developments or changes to tax laws or rulings (which changes may have retroactive application) could have a material impact on the value of our deferred tax assets, result in significant one-time charges, and increase our future tax expenses.

Our bank deposits in excess of the Federal Deposit Insurance Corporation (“FDIC”) insurance limits could be impacted if the underlying financial institutions fail.

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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