What changed in this filing

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Item 1A. Risk Factors

2026-02-13 compared with 2025-02-18 · 98 added, 67 removed, 706 unchanged (19% of the section changed)

47 unchanged sentences

In addition, physicians typically need to perform several procedures to become comfortable using Barostim.

If a physician experiences difficulties during an initial procedure or otherwise, that physician may be less likely to continue to use our product or to recommend it to other physicians.

If a physician experiences difficulties during an initial procedure or otherwise, that physician may be less likely

to continue to use our product or to recommend it to other physicians.

It is critical to the success of our commercialization efforts to educate physicians on the proper use of Barostim, and to provide them with adequate product support during clinical procedures.

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• greater experience in and resources for conducting research and development, clinical studies, manufacturing, preparing regulatory submissions, obtaining regulatory clearance or approval for products and marketing approved products.

Our competitors may develop and patent processes or products earlier than us, obtain patents that may apply to us at any time, obtain regulatory clearance or approvals for competing products more rapidly than us or develop more effective or less expensive products or technologies that render our technology or products obsolete or less competitive.

develop more effective or less expensive products or technologies that render our technology or products obsolete or less competitive.

We also face fierce competition, particularly in this tight labor market, in recruiting and retaining qualified sales, scientific and management personnel, establishing clinical trial sites and enrolling patients in clinical studies.

If our competitors are more successful than us in these matters, our business may be harmed.

In addition, we face a particular challenge overcoming the long-standing practices by some physicians of using the products of our larger, more established potential competitors.

In addition, we face a particular challenge overcoming the long-standing practices by some physicians of using the products of our larger, more established competitors.

Physicians who have completed many successful implants using the products made by these competitors may be reluctant to try new products from a source with which they are less familiar.

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• we may not be able to obtain an adequate supply of components in a timely manner or on commercially reasonable terms;

• our suppliers, especially new suppliers, may make errors in manufacturing that could negatively affect the effectiveness or safety of Barostim or cause delays in shipment;

• our suppliers, especially new suppliers, may make errors in manufacturing that could negatively affect

the effectiveness or safety of Barostim or cause delays in shipment;

• we may have difficulty locating and qualifying alternative suppliers;

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If we fail to increase our production capacity efficiently, our sales may not increase in line with our forecasts and our operating margins could fluctuate or decline.

In addition, although we expect some of our product candidates in development to share product features and components with Barostim, manufacturing of these product candidates may require the modification of our production lines, the hiring of specialized employees, the identification of new suppliers for specific components, or the development of new manufacturing technologies.

identification of new suppliers for specific components, or the development of new manufacturing technologies.

It may not be possible for us to manufacture these product candidates at a cost or in quantities sufficient to make these product candidates commercially viable.

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Our principal offices and our only manufacturing facility are located in Minneapolis, Minnesota.

Substantially all of our operations are conducted at this location, including our manufacturing processes, research,

development and engineering activities, customer and technical support and management and administrative functions.

Substantially all of our operations are conducted at this location, including our manufacturing processes, research, development and engineering activities, customer and technical support and management and administrative functions.

In addition, substantially all of our inventory of component supplies and finished goods is held at the manufacturing facility.

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or elsewhere, we will be unable to commercialize our products for these indications.

We will likely need to conduct additional clinical studies in the future to support approval for new indications.

We are conducting and may need to conduct additional clinical studies in the future to support approval for new indications.

Clinical testing takes many years, is expensive and carries uncertain outcomes.

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Clinical trials can fail at any stage.

Our clinical studies may produce negative or inconclusive results and we may decide, or regulators may require us, to conduct additional clinical or non-clinical studies in addition to those we have planned.

In addition, if the FDA determines for any reason, including safety or their risk-benefit analysis, that the results of a trial are negative, the FDA may decide to modify or revoke our existing approval or such data may impact the adoption of Barostim.

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We experienced some disruption within the sales organization at the time of the Chief Executive Officer transition, which led to decreased productivity and higher salesforce turnover, as well as the termination of employment of our Senior Vice President of U.S.

Since the beginning of the second quarter of fiscal 2024, we have hired new leaders for sales, medical affairs, clinical, reimbursement and human resources, completing the expansion of the executive team.

Since the beginning of the second quarter of fiscal 2024, we have hired new leaders for sales, medical affairs, clinical, reimbursement and human resources.

Accordingly, our future financial performance will depend on our ability to attract, motivate, integrate, and retain our senior management and employees, and effectively manage this period of transition under our new leadership.

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Our employees may be more likely to leave us if the shares they own or the shares underlying their vested options have significantly appreciated in value relative to the original purchase prices of the shares or the exercise prices of the options, or if the exercise prices of the options that they hold are significantly below the market price of our common stock.

Although non-compete agreements are becoming more disfavored and, in some cases, banned, many executive officers and employees in the medical device industry are still subject to strict non-compete or confidentiality agreements with their employers.

In addition, some of our existing and future employees are subject to confidentiality agreements with previous employers.

Many executive officers and employees in the medical device industry are still subject to strict non-compete or confidentiality agreements with their employers.

In addition, some of our existing and future employees are

subject to confidentiality agreements with previous employers.

Our competitors may allege breaches of and seek to enforce such non-compete agreements or initiate litigation based on such confidentiality agreements.

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We use enterprise information technology systems to record, process and summarize financial information and results of operations for internal reporting purposes and to comply with regulatory, financial reporting, legal and tax requirements.

Our information technology systems, some of which are managed by third parties, may be susceptible to damage, disruptions or shutdowns due to computer viruses, attacks by computer hackers, failures during the process of upgrading or replacing software, databases, or components thereof, power outages, hardware failures, telecommunication failures, user errors or catastrophic events.

If our systems suffer severe damage, disruption or shutdown and we are unable to effectively resolve the issues in a timely manner, our business and operating results may suffer.

Our information technology systems, some of which are managed by third parties, have been and may in the future be susceptible to damage, disruptions or shutdowns due to computer viruses, attacks by computer hackers, failures during the process of upgrading or replacing software, databases, or components thereof, power outages, hardware failures, telecommunication failures, user errors or catastrophic events.

For example, we and third parties who manage our systems have been threatened by, among others, phishing, social engineering attacks (such as direct voice contact and any technology or communication mechanism to contact a person), account takeovers, introductions of malware, attempts at electronic break-ins, and the submission of fraudulent payment requests.

The number of threats and events has increased substantially every year, which is expected to continue.

As a result of these types of attempts, both we and our vendors have experienced information security, cybersecurity, and data privacy incidents from time to time, none of which have had a material impact on our business.

We maintain cybersecurity liability insurance;

however, this insurance may not be sufficient to cover the financial, legal, business or reputational losses that may result from an interruption or breach of our information systems.

Accordingly, if our systems suffer severe damage, disruption or shutdown and we are unable to effectively resolve the issues in a timely manner, our business and operating results may suffer.

In addition, we may also be involved in lawsuits in connection with the past or future interruptions or breaches of our information systems.

Even if such lawsuits are without merit, defending against these claims can result in substantial costs and divert management time and resources.

An adverse judgment could result in monetary damages which could have a negative impact on our business and operating results.

If important assumptions about the potential market for our product are inaccurate, or if we have failed to understand what people with HF are seeking in a treatment, we may not be able to increase our revenue or achieve profitability.

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Despite our review of studies reporting on the trends of HF incidence in the U.S., the actual incidence of HF and the actual demand for our product or competitive products could differ materially from our expectations.

In addition, our strategy of focusing exclusively on patients with HFrEF who are looking for an improvement in the symptoms associated with HFrEF may limit our ability to increase sales or achieve profitability, especially if there are any significant clinical breakthroughs or product or drug introductions that significantly delay or reduce the need for heart disease therapy.

In addition, our current strategy of focusing exclusively on patients with HFrEF who are looking for an improvement in the symptoms associated with HFrEF may limit our ability to increase sales or achieve profitability, especially if there are any significant clinical breakthroughs or product or drug introductions that significantly delay or reduce the need for heart disease therapy.

Moreover, a percentage of our indicated patients may be ineligible to undergo a Barostim procedure if they have certain co-morbidities or other disqualifying factors as determined by their physicians.

Our estimates of the annual total addressable market for Barostim are based on a number of internal and third-party estimates, including, without limitation, the number of patients with HFrEF and the assumed prices at which we can sell our device.

While we believe our assumptions and the data underlying our estimates are reasonable, these assumptions and estimates may not be correct and the conditions supporting our assumptions or estimates may change at any time, thereby reducing the predictive accuracy of these underlying factors.

As a result, our estimates of the annual total addressable market for Barostim may prove to be incorrect.

If the actual number of patients who would benefit from our product, the price at which we can sell our product, or the annual total addressable market for our product is smaller than we have estimated, it may impair our sales growth and have an adverse impact on our business.

Our estimates of the total market opportunity for Barostim are based on a number of internal and third-party estimates, including, without limitation, the number of patients with HFrEF and the assumed prices at which we can sell our device.

While we believe our assumptions and the data underlying our estimates are reasonable, these assumptions and estimates may not be correct and the conditions supporting our

assumptions or estimates may change at any time, thereby reducing the predictive accuracy of these underlying factors.

As a result, our estimates of total market opportunity for Barostim on both a prevalence and annual incidence basis may prove to be incorrect.

If the actual number of patients who would benefit from our product, the price at which we can sell our product, or the total market opportunity for our product is smaller than we have estimated, it may impair our sales growth and have an adverse impact on our business.

Unfavorable economic conditions could adversely affect our business, financial condition, or results of operations.

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An economic downturn could result in a variety of risks to our business, including weakened demand for Barostim and our ability to raise additional capital when needed on acceptable terms, if at all.

A weak or declining economy could also strain our manufacturers or suppliers, resulting in supply disruption, or causing our customers to delay making

payments for our services.

A weak or declining economy could also strain our manufacturers or suppliers, resulting in supply disruption, or causing our customers to delay making payments for our services.

Certain of the foregoing have harmed and could in the future harm our business, and we cannot anticipate all of the ways in which the economic climate and financial market conditions may further affect our business.

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The APC payment of approximately $45,000 will continue in 2026, as published in the 2026 OPPS ﬁnal rule.

In August 2024, CMS reassigned the Barostim implant procedure for the inpatient setting as part of the IPPS final rule for CMS’ Fiscal Year 2025, which took effect on October 1, 2024.

On that date, Barostim was reassigned to MS-DRG 276, which carries a national average payment of approximately $44,000 in 2025, a significant increase from the previous payment range of $17,000-$23,000.

Additionally, the American Medical Association's CPT Editorial Panel approved new Category I codes for Barostim therapy, expected to take effect January 1, 2026.

In August 2024, CMS reassigned the Barostim implant procedure for the inpatient setting as part of the IPPS final rule, which took effect on October 1, 2024.

On that date, Barostim was reassigned to MS-DRG 276, which carries a national average payment of approximately $44,000, a significant increase from the previous payment range of $17,000-$23,000.

Additionally, the American Medical Association's CPT Editorial Panel approved new Category I codes for Barostim therapy that took effect January 1, 2026.

Any future decline in the amount Medicare is willing to reimburse our customers for procedures using Barostim could make it difficult for new customers to adopt Barostim and could create additional pricing pressure for us, which could adversely affect our ability to invest in and grow our business, or establish Barostim as the standard of care.

Additionally, any declines in physician payments could make it difficult to promote the adoption of Barostim.

From time to time, physicians and hospitals have in the past experienced, and others may experience, denials in Medicare and commercial reimbursement, which have delayed or may delay their willingness to schedule additional Barostim procedures.

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Numerous state and local jurisdictions have historically imposed, and others in the future may impose, “shelter-in-place” orders, quarantines, executive orders and similar government orders and restrictions for their residents to control the spread of infectious disease.

Such orders or restrictions previously resulted, and may in the future result, in reduced operations at our headquarters, slowdowns and delays, travel restrictions and cancellation of events and restrictions on the ability of our front-line sales representatives to attend procedures in which our products are used, among other effects, thereby negatively impacting our operations.

our products are used, among other effects, thereby negatively impacting our operations.

Other disruptions or potential disruptions include restrictions on the ability of our sales representatives and other personnel to travel and access customers for training and case support;

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To the extent a pandemic adversely affects our business and financial results, it may also have the effect of heightening many of the other risks described in this “Risk Factors” section.

The constant growth and development of technology, including the increased use of Artificial Intelligence (“AI”), present risks and challenges to our operations and the use of our products that could give rise to legal or regulatory action, damage our reputation or otherwise materially harm of our business.

Emerging technology is a consistent subject of new laws or regulations and evolving interpretations and applications of laws and regulations.

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

The development and use of AI, including generative AI and machine learning, present new risks and challenges that, if incorporated into our business, can impact our operations or the use of our products, including if used by our third-party business associates.

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

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

If AI technologies fail to operate as anticipated or not perform as specified, including any biases or errors in the outputs of AI, patient care may be affected, legal claims may be asserted against us and our reputation may be harmed.

Rapidly evolving international and domestic AI regulations, including the EU Artificial Intelligence Act and emerging U.S.

state laws, may impose additional compliance obligations, limit our ability to deploy certain AI models, and expose us to enforcement actions or litigation if we fail to comply.

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

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

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

Risks related to intellectual property

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Our success depends in part on obtaining, maintaining, and enforcing patents and other intellectual property rights and not infringing the patents or violating the other proprietary rights of others.

Intellectual property disputes can be costly to defend and may cause our business, operating results, and financial condition to

Intellectual property disputes can be costly to defend and may cause our business, operating results, and financial condition to suffer.

Significant litigation regarding patent rights occurs in the medical device industry.

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Our competitors in both the U.S.

and abroad, many of which have substantially greater resources and have made substantial investments in patent portfolios and 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, use, sell, or export our products.

and abroad, many of which

have substantially greater resources and have made substantial investments in patent portfolios and 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, use, sell, or export our products.

These competitors may have one or more patents for which they can threaten or initiate patent infringement actions against us or any of our third-party suppliers.

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If a court determines that we failed to secure necessary patents, competitors may be able to market competing products and make, use or sell products that are substantially the same as ours without incurring the sizeable development costs that we have incurred, which would adversely affect our ability to compete.

Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and could distract our technical and management personnel from their

normal responsibilities.

In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments, and if securities analysts or investors perceive these results to be negative, it could have a material adverse effect on the price of our common stock.

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We could in the future be subject to claims that we or our employees have inadvertently or otherwise used or disclosed alleged trade secrets or other proprietary information about former employers or competitors.

in the future be subject to claims that we caused an employee to breach the terms of his or her non-disclosure or confidentiality agreement, or that we or these individuals have, inadvertently or otherwise, used or disclosed the alleged trade secrets or other proprietary information of a former employer or competitor, resulting in litigation.

Even if we are successful in defending against these claims, the litigation could be costly and a distraction to management.

Although we have procedures in place that seek to prevent our employees and consultants from using the intellectual property, proprietary information, know-how or trade secrets of others in their work for us, we may in the future be subject to claims that we caused an employee to breach the terms of his or her non-disclosure or confidentiality agreement, or that we or these individuals have, inadvertently or otherwise, used or disclosed the alleged trade secrets or other proprietary information of a former employer or competitor, resulting in litigation.

Even if we are successful in defending against these claims, the litigation could be costly

and a distraction to management.

If we are unsuccessful in defending against these claims, in addition to paying monetary damages, a court could prohibit us from using technologies or features that are essential to our products, if such technologies or features are found to incorporate or be derived from the trade secrets or other proprietary information of the former employers.

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As a result, disputes may arise regarding the ownership of the proprietary rights to such technology or know-how and any such dispute may not be resolved in our favor.

If any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent them, or those with whom they share it, from using that technology or information to compete with us and our competitive position could

be adversely affected.

If our intellectual property is not adequately protected to protect our market against competitors’ products and methods, our competitive position and business could be adversely affected.

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We believe that our growth will depend, in part, on our ability to fund our commercialization and research and development efforts.

We believe that our existing cash, cash equivalents, short-term investments and revenue will be sufficient to meet our capital requirements and fund our operations for at least the next three years.

We believe that our existing cash, cash equivalents, short-term investments and revenue will be sufficient to meet our capital requirements and fund our operations for at least the next two years.

However, we have based these estimates on assumptions that may prove to be incorrect, and we could spend our available financial resources much faster than we currently expect.

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We are subject to complex tax rules, and any audits, investigations or tax proceedings could have a material adverse effect on our business, results of operations, and financial condition.

We are subject to income and/or non-income taxes in the U.S., Switzerland, Italy, Germany, France, and the Netherlands, as well as the tax laws and regulations related to such matters.

We are subject to income and/or non-income taxes in the U.S., Switzerland, Germany, France, and the Netherlands, as well as the tax laws and regulations related to such matters.

Tax accounting and compliance often involves complex issues, and judgment and interpretation is required in determining our provision for income taxes and other tax liabilities as well as the application of tax laws and regulations.

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This process can be expensive and time-consuming.

In order to continue to sell Barostim in Europe, we must comply with the MDR and its evolving transition requirements.

We have submitted our application for Barostim to comply with the general safety and performance requirements of the EU MDR (which are similar to the Essential Requirements of the AIMDD), and it is currently under review.

Additionally, the EU approved an amendment to the MDR that allows qualifying AIMDD CE certificates to be accepted through December of 2027.

We have already met the qualifications identified within this amendment to allow continued distribution of Barostim through this time.

Failing to continue to comply with applicable foreign regulatory requirements, including those administered by authorities of the EEA countries, could result in enforcement actions against us, including refusal, suspension or withdrawal of our CE Certificates of Conformity by our Notified Body (the National Standards Authority of Ireland, or NSAI), which could impair our ability to market products in the EEA in the future.

Regulations in the EU were updated to require compliance to Regulation (EU) 2017/745 on Medical Devices (“MDR”).

Additional amendments to the regulation have delayed required implementation dates to December 31, 2027.

Compliance with the new regulation required extensive updates to the quality system and device technical file documentation to new requirements.

Updates were made and annual Notified Body inspections assessing compliance of the quality system to the MDR have been ongoing since 2020.

An application was made for Barostim to comply with the general safety and performance requirements of the EU MDR.

Final approval and certificates of compliance for both the technical file and quality system were issued on April 9, 2025.

We are required to continue to submit updates for any substantial changes to the design, manufacturing or quality system for assessment against the MDR requirements.

Annual audits by the Notified Body are required to verify that we continue to meet the MDR requirements.

The current integrated platform technology, Barostim, is approved under the MDR.

Barostim Legacy is not approved under MDR, but can still be sold under the Active Implantable Medical Device Directive approval through 2027.

our CE Certificates of Conformity by our Notified Body (the National Standards Authority of Ireland), which could impair our ability to market products in the EEA in the future.

Our business is subject to extensive governmental regulation that could make it more expensive and time consuming for us to market Barostim in the U.S.

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and similar agencies in foreign jurisdictions.

These requirements involve lengthy and detailed laboratory and clinical testing

procedures, sampling activities, extensive agency review processes and other costly and time-consuming procedures.

These requirements involve lengthy and detailed laboratory and clinical testing procedures, sampling activities, extensive agency review processes and other costly and time-consuming procedures.

It often takes several years to satisfy these requirements, depending on the complexity and novelty of the product.

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The misuse or off-label use of our product may harm our image in the marketplace, result in injuries that lead to product liability suits, which could be costly to our business, or result in costly investigations and sanctions from the FDA and other regulatory bodies if we are deemed to have engaged in inappropriate promotion.

Barostim has been indicated for the improvement of symptoms of HFrEF by the FDA and the treatment of HFrEF in the EEA.

Barostim has been indicated for the improvement of symptoms of HFrEF by the FDA and the treatment of HFrEF and hypertension in the EEA.

We may only promote or market Barostim for its specifically approved indications as described on the approved label.

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In addition, if the FDA determines that our promotional materials or training constitute promotion of an off-label use, it could request that we modify our training or promotional materials or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, a warning letter, injunction, seizure, civil fine or criminal penalties.

penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs and the curtailment of our operations.

It is also possible that other federal, state or foreign enforcement authorities might take action if they consider our business activities to constitute inappropriate promotion, including promotion of an off-label use, which could result in significant penalties, including, but not limited to, criminal, civil and/or administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs and the curtailment of our operations.

Any of these events could significantly harm our business and results of operations and cause our stock price to decline.

Further, the advertising and promotion of our products is subject to EEA member state laws implementing the MDD, Directive 2006/114/EC concerning misleading and comparative advertising and Directive 2005/29/EC on unfair commercial practices, as well as other EEA member state legislation governing the advertising and promotion of medical devices.

EEA member state legislation may also restrict or impose limitations on our ability to advertise our products directly to the general public.

In addition, voluntary EU and national codes of conduct provide guidelines on the advertising and promotion of our products to the general public and may impose limitations on our promotional activities with healthcare professionals.

Further, the advertising and promotion of our products is subject to the MDR, specifically Article 7, concerning misleading and comparative advertising as well as Directive 2005/29/EC on unfair commercial practices.

Additionally, individual EEA member state legislation governs the advertising and promotion of medical devices and may restrict or impose limitations on our ability to advertise our products directly to the general public.

Voluntary EU and national codes of conduct (such as MedTech Europe) provide guidelines on advertising to the public and impose limitations on promotional activities and interactions with healthcare professionals.

The discovery of serious safety issues with Barostim, or a recall of Barostim either voluntarily or at the direction of the FDA or another governmental authority, could harm our reputation, business, and financial results.

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Seeking such approvals may delay our ability to replace the recalled devices in a timely manner.

Moreover, if we do not adequately address problems associated with our devices, we may face additional regulatory enforcement actions, including FDA warning letters, product seizure, injunctions, administrative penalties or civil or criminal fines.

Moreover, if we do not adequately address problems associated with our devices, we may

face additional regulatory enforcement actions, including FDA warning letters, product seizure, injunctions, administrative penalties or civil or criminal fines.

Companies are required to maintain certain records of recalls and corrections, even if they are not reportable to the FDA.

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A future recall announcement could harm our reputation with customers, potentially lead to product liability claims against us and negatively affect our sales.

Any corrective action, whether voluntary or involuntary, as well as defending

ourselves in a lawsuit, will require the dedication of our time and capital, distract management from operating our business and may harm our reputation and financial results.

Any corrective action, whether voluntary or involuntary, as well as defending ourselves in a lawsuit, will require the dedication of our time and capital, distract management from operating our business and may harm our reputation and financial results.

Our products may cause or contribute to adverse medical events or be subject to failures or malfunctions that we are required to report to the FDA and European regulators, and if we fail to do so, we would be subject to sanctions that could harm our reputation, business, financial condition, and results of operations.

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All manufacturers placing medical devices on the market in the EEA are legally bound to report incidents involving devices they produce or sell to the regulatory agency, or competent authority, in whose jurisdiction the incident occurred.

Under the MDD, an incident is defined as any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient, or user or of other persons or to a serious deterioration in their state of health.

Under the MDR, an incident is defined as any malfunction or deterioration in the characteristics and/or performance of a device, including use-errors or inadequacies in labeling or instructions for use.

A serious incident is further defined as any incident that, directly or indirectly, led or might have led to the death of a patient, user, or other person, to a serious deterioration in their state of health, or to a serious public health threat.

The timing of our obligation to report is triggered by the date we become aware of the adverse event as well as the nature of the event.

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• federal civil and criminal false claims laws and civil monetary penalty laws, including civil whistleblower or qui tam actions, that prohibit, among other things, knowingly presenting, or causing to be presented, claims for payment or approval to the federal government that are false or fraudulent, knowingly making a false statement material to an obligation to pay or transmit money or property to the federal government or knowingly concealing or knowingly and improperly avoiding or decreasing an obligation to pay or transmit money or property to the federal government;

the beneficiary’s decision to order or receive items or services reimbursable by the government from a particular provider or supplier;

• the federal Civil Monetary Penalties Law, which prohibits, among other things, offering or transferring remuneration to a federal healthcare beneficiary that a person knows or should know is likely to influence the beneficiary’s decision to order or receive items or services reimbursable by the government from a particular provider or supplier;

• the federal HIPAA, which created federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters.

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All of this has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry, including for medical device companies.

Responding to investigations can be time and resource consuming and can divert management’s attention from the business.

Responding to investigations can be time and resource consuming and can divert

management’s attention from the business.

Additionally, as a result of these investigations, healthcare providers and entities may have to agree to additional onerous compliance and reporting requirements as part of a consent decree or corporate integrity agreement.

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• expanded the eligibility criteria for Medicaid programs.

The expansion in the government’s role in the U.S.

Changes in the government’s role in the U.S.

healthcare industry may result in decreased profits to us, lower reimbursement by payers for Barostim and any future products and/or reduced medical procedure volumes, all of which may have a material adverse effect on our business, financial condition, and results of operations.

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The MDR, among other things, is intended to establish a uniform, transparent, predictable, and sustainable regulatory framework across the EEA for medical devices and ensure a high level of safety and health while supporting innovation.

The MDR is set to become effective in January 2028 and, among other things is designed to:

The MDR is designed to:

• strengthen the rules on placing devices on the market and reinforce surveillance once they are available;

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This regulation has not yet had a material effect on the way we conduct our business in the EEA.

However, it is possible the regulation will change in the future, and we cannot be certain that future changes will not have an adverse effect on our business operations.

However, it is possible the regulation and guidance for compliance will change in the future, and we cannot be certain that future changes will not have an adverse effect on our business operations.

Risks related to our common stock

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We will remain an emerging growth company until the earliest of (1) the last day of the fiscal year (a) following the fifth anniversary of the completion of the IPO, (b) in which we have total annual gross revenue of at least $1.235 billion, or (c) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by non-affiliates exceeds $700 million as of the prior June 30th, and (2) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.

Accordingly, we expect to lose our status as an emerging growth company on December 31, 2026.

Because we have opted to take advantage of the JOBS Act provision which allows us to delay implementing new accounting standards, our financial statements may not be directly comparable to other public companies.

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The Sarbanes-Oxley Act requires that we maintain effective disclosure controls and procedures and internal control over financial reporting.

We have developed and expect to continue to refine our disclosure controls and other procedures that are designed to ensure that

information required to be disclosed by us in the reports that we file with the SEC is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms, and that information required to be disclosed in reports under the Exchange Act is accumulated and communicated to our principal executive and financial officers.

We have developed and

expect to continue to refine our disclosure controls and other procedures that are designed to ensure that information required to be disclosed by us in the reports that we file with the SEC is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms, and that information required to be disclosed in reports under the Exchange Act is accumulated and communicated to our principal executive and financial officers.

Section 404 of the Sarbanes-Oxley Act requires that we evaluate and determine the effectiveness of our internal control over financial reporting and provide a management report on internal control over financial reporting.

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We have designed and implemented and expect to continue to refine the internal control over financial reporting required to comply with this obligation, which process will be time-consuming, costly, and complicated.

If we identify material weaknesses in our internal control over financial reporting, if we are unable to comply with the requirements of Section 404 of the Sarbanes-Oxley Act in a timely manner, if we are unable to assert that our internal control over financial reporting is effective, or, when required in the future, if our independent registered public accounting firm is unable to express an opinion as to the effectiveness of our internal control over financial reporting, or if our internal control over financial reporting is perceived as inadequate or we are unable to produce timely or accurate financial statements, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our common stock could decline and we could become subject to investigations or removal by the stock exchange on which our securities are listed, the SEC, or other regulatory authorities, which could require additional financial and management resources.

If we identify material weaknesses in our internal control over financial reporting, if we are unable to comply with the requirements of Section 404 of the Sarbanes-Oxley Act, if we are unable to assert that our internal control over financial reporting is effective, or, when required in the future, if our independent registered public accounting firm is unable to express an opinion as to the effectiveness of our internal control over financial reporting, or if our internal control over financial reporting is perceived as inadequate or we are unable to produce timely or accurate financial statements, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our common stock could decline and we could become subject to investigations or removal by the stock exchange on which our securities are listed, the SEC, or other regulatory authorities, which could require additional financial and management resources.

Our principal stockholders, management, and directors (one of whom is affiliated with one of our principal stockholders) own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.

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Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders' ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees.

Our amended and restated certificate of incorporation provides that, to the fullest extent permitted by law, the Court of Chancery of the State of Delaware is the exclusive forum for any derivative action or proceeding brought on our behalf, any action asserting a breach of fiduciary duty, any action asserting a claim against us arising pursuant to the Delaware General Corporation Law (the “DGCL”) or any action asserting a claim

against us that is governed by the internal affairs doctrine.

The exclusive forum provision does not apply to suits brought to enforce any liability or duty created by the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction.

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• provide that the authorized number of directors may be changed only by resolution of our Board of Directors and that a director may only be removed with cause by the affirmative vote of the holders of at least a majority of our outstanding voting stock, voting together as a single class;

• provide that all vacancies, including newly created directorships, may, except as otherwise required by law, be filled by the affirmative vote of a majority of directors then in office, even if less than a quorum;

• provide that all vacancies, including newly created directorships, may, except as otherwise required by

law, be filled by the affirmative vote of a majority of directors then in office, even if less than a quorum;

• provide that our amended and restated bylaws may only be altered, amended, or repealed by our stockholders upon the affirmative vote of a two-thirds majority of the voting power of all of our outstanding voting stock, voting together as a single class;

• provide that stockholders seeking to present proposals before a meeting of stockholders or to nominate candidates for election as directors at a meeting of stockholders must provide notice in writing in a timely manner and also specify requirements as to the form and content of a stockholder’s notice, which may discourage or deter a potential acquiror from conducting a solicitation of proxies to elect the

acquiror’s own slate of directors or otherwise attempting to obtain control of our company;

• prohibit cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director candidates;

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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