CVRX 10-K & 10-Q changes, risk factors and insider trading

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. 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. 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. If these physicians do not try and subsequently adopt our product, then our revenue growth will slow or decline.

We willare likelyconducting 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. The initiation and completion of studies may be prevented, delayed, or halted for numerous reasons, including, but not limited to, the following: the FDA, IRBs, ethics committees, EU competent authorities, or other regulatory authorities do not approve a clinical study protocol, force us to modify a previously approved protocol, or place a clinical study on hold;

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 in progress or 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. Moreover, a negative perception of clinical results for one indication for use could impact the use of Barostim for other FDA approved and clinically supported indications for use.

Transitions in executive leadership can adversely affect relationships with our customers, suppliers, and employees, make it difficult to attract and retain talent, and disrupt execution of our strategy, sales growth, and our efforts to enhance our operations. Additionally, such transitions can require significant payments to recruit and attract qualified employees to join our company and may involve severance payments to certain departing employees. Changes in key management positions may temporarily affect our financial performance and results of operations as the new management becomes familiar with our business and establishes their team dynamic. For example, in February 2024, we appointed a new Chief Executive Officer who replaced our prior Chief Executive Officer, who had been in the role for 17 years. 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. Sales. 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.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.

Although non-compete agreements are becoming more disfavored and, in some cases, banned, manyMany 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. Such litigation, whether or not meritorious, may impede our ability to attract or use executive officers and other key employees who have been employed by our competitors and may result in claims against us.

We rely on information technology and telephone networks and systems, including the Internet, to process and transmit sensitive electronic information and to manage or support a variety of business processes and activities, including sales, billing, marketing, procurement, and supply chain, manufacturing, and distribution. 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, 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. IfFor 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.

Our business strategy was developed based on a number of important assumptions about the HF market in general, any one or more of which may prove to be inaccurate. For example, we believe that the benefits of Barostim as compared to other common HF devices will continue to drive growth in the market for Barostim. 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 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 addressablemarket marketopportunity 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 addressablemarket marketopportunity 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 annual total addressablemarket marketopportunity for our product is smaller than we have estimated, it may impair our sales growth and have an adverse impact on our business.

Medicare reimbursement levels are important to increasing adoption of Barostim and establishing Barostim as the standard of care because nearly two-thirds of the target patient population for Barostim is over the age of 65. On January 1, 2024, Barostim was reassigned to New Technology APC 1580, which carries an average payment amount of $45,000. The APC payment of approximately $45,000 will continue in 2025,2026, as published in the 20252026 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,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 in 2025,$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,therapy expectedthat to taketook 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.

Our operations have consumed substantial amounts of cash since inception, and we anticipate our expenses will increase as we continue to build our commercial sales force in the U.S., investigate the potential use of Barostim for the treatment of other HF conditions, continue to grow our business and operate as a public company. 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 threetwo 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. As a result, we may need to seek additional funds in the future. If we are unable to raise funds on favorable terms, or at all, we may not be able to support our commercialization efforts or increase our research and development activities and the growth of our business may be negatively impacted. As a result, we may be unable to compete effectively. For the fiscal years ended December 31, 20242025 and 2023,2024, net cash used in operating activities was $39.1$40.2 million and $39.0$39.1 million, respectively. Our cash requirements in the future may be significantly different from our current estimates and depend on many factors, including, among others:

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. 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. In that respect, many jurisdictions have detailed transfer pricing rules, which require that all transactions with related parties be priced using arm’s length pricing principles within the meaning of such rules. The application of such transfer pricing rules, as well as of withholding taxes, goods and services taxes, sales taxes and other taxes is not always clear, and we may be subject to tax audits relating to such rules or taxes.

InRegulations orderin the EU were updated to continuerequire compliance to sellRegulation Barostim(EU) in2017/745 Europe,on weMedical mustDevices comply(“MDR”). Additional amendments to the regulation have delayed required implementation dates to December 31, 2027. Compliance with the MDRnew regulation required extensive updates to the quality system and itsdevice evolvingtechnical transitionfile documentation to new requirements. WeUpdates were made and annual Notified Body inspections assessing compliance of the quality system to the MDR have submittedbeen ourongoing since 2020. An application was made for Barostim to comply with the general safety and performance requirements of the EU MDRMDR. (whichFinal approval and certificates of compliance for both the technical file and quality system were issued on April 9, 2025. We are similarrequired to continue to submit updates for any substantial changes to the Essentialdesign, Requirementsmanufacturing ofor thequality AIMDD),system andfor itassessment is currently under review. Additionally, the EU approved an amendment toagainst the MDR thatrequirements. allowsAnnual qualifyingaudits AIMDDby CEthe certificatesNotified 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 acceptedsold under the Active Implantable Medical Device Directive approval 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, suspensionsuspension, or withdrawal of our CE Certificates of Conformity by our Notified Body (the National Standards Authority of Ireland, or NSAIIreland), which could impair our ability to market products in the EEA in the future.

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. We train our marketing and sales force against promoting our products for uses outside of the approved indications for use, known as “off-label uses.” We cannot, however, prevent a physician from using our product off-label when, in the physician’s independent professional medical judgment, he or she deems appropriate. There may be increased risk of injury to patients if physicians attempt to use our product off-label. Furthermore, the use of our product for indications other than those approved by the applicable regulatory body may not effectively treat such conditions, which could harm our reputation in the marketplace among physicians and patients.

Further, the advertising and promotion of our products is subject to EEA member state laws implementing the MDD,MDR, Directivespecifically 2006/114/ECArticle 7, concerning misleading and comparative advertising andas well as Directive 2005/29/EC on unfair commercial practices,practices. asAdditionally, well as otherindividual EEA member state legislation governinggoverns the advertising and promotion of medical devices.devices EEA member state legislationand may also restrict or impose limitations on our ability to advertise our products directly to the general public. In addition, voluntaryVoluntary EU and national codes of conduct (such as MedTech Europe) provide guidelines on the advertising and promotion of our products to the general public and may impose limitations on our promotional activities and interactions with healthcare professionals.

Under the FDA medical device reporting regulations, medical device manufacturers are required to submit information to the FDA when they receive a report or become aware that a device has or may have caused or contributed to a death or serious injury or has or may have a malfunction that would likely cause or contribute to death or serious injury if the malfunction were to recur. 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,MDR, an incident is defined as any malfunction or deterioration in the characteristics and/or performance of a device, asincluding welluse-errors or inadequacies in labeling or instructions for use. A serious incident is further defined as any inadequacyincident in the labeling or the instructions for use which,that, directly or indirectly, might lead toled or might have led to the death of a patient, or useruser, or of other persons orperson, to a serious deterioration in their state of health.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. We may fail to report adverse events of which we become aware within the prescribed timeframe. We may also fail to recognize that we have become aware of a reportable adverse event, especially if it is not reported to us as an adverse event or if it is an adverse event that is unexpected or removed in time from the use of the product. If we fail to comply with our reporting obligations, the FDA or European regulators could take action, including warning letters, untitled letters, administrative actions, criminal prosecution, imposition of civil monetary penalties, revocation of our device approval, seizure of our products or delay in clearance or approval of future products.

The expansionChanges 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.

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 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.

We are an “emerging growth company,” as defined in the JOBS Act, and we intend to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies, including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. We cannot predict if investors will find our common stock less attractive because we rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may decline or be more volatile. We may take advantage of these reporting exemptions until we are no longer an emerging growth company. 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.

Our current controls and any new controls that we develop may become inadequate and weaknesses in our internal control over financial reporting may be discovered in the future. If we fail to develop and maintain effective internal control over financial reporting, we may not detect errors on a timely basis and our financial statements may be materially misstated. 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,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 sales and marketing efforts are directed at EPs, HF specialists, interventional and general cardiologists, and vascular surgeons because they are the primary users of our technology. However, we consider hospitals, where the procedures are performed primarily in an outpatient setting, to be our customers, as they are the purchasing entities of Barostim in the U.S. We intend to continue making significant investments building our U.S. commercial infrastructure by expanding and training our U.S. sales force. We have dedicated significant resources to educate physicians and APPs who treat HFrEF about the advantages of Barostim and train them on the implant procedure.

On October 31, 2022, we entered into the Loan Agreement underallowing which we may borrow,borrowing subject to our achievement of certain milestones, up to a total of $50.0 million in a series of Term Loans described in Note 4 to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K. On January 9, 2026, we entered into an amendment (the “Amendment”) to our existing Loan Agreement. Pursuant to the Amendment, the terms loans available were increased by $50.0 million, to an aggregate principal amount of up to $100.0 million, subject to our achievement of certain milestones. We had $50.0 million in outstanding principal amount of Term Loans under the Loan Agreement at December 31, 2024.2025 and, on the closing date of the Amendment, we borrowed an additional $10.0 million. As a result of thesethe planned investments and to fund our commercialization efforts, we expect to continue to incur net losses for the next several years, which may require additional funding and could include future equity and debt financing.

We calculate gross margin as revenue less cost of goods sold divided by revenue. Our gross margin has been and will continue to be affected by a variety of factors, but is primarily driven by the average sale priceASP of our product, the percentage of products sold that include a full system (i.e., an IPG and a stimulation lead), as compared to individual IPG sales, and the allocated manufacturing overhead. Although we sell the majority of our devices directly to hospitals, the impact of the average selling price on gross margin is driven by the percentage of products we sold to distributors as compared to those sold directly to hospitals, as our average selling price is typically higher on products we sell directly. The full system sales typically have a lower gross margin as they include the cost of an IPG and a stimulation lead whereas individual IPG sales only include the cost of an IPG. The manufacturing overhead costs of Barostim are directly aligned to our production volume and therefore the cost per product is reduced if production levels increase. While we expect our gross margin to be positively affected over time to the extent we are successful in selling more product through our direct sales force and by increasing our production volumes, it will likely fluctuate from period to period as we continue to introduce new or modified products and adopt new manufacturing processes and technologies.

Research and development (“R&D”) expenses consist primarily of personnel costs, including salaries, bonuses, employee benefits and stock-based compensation expenses for our R&D employees. R&D expenses also include costs associated with product design efforts, development prototypes, testing, clinical trial programs and regulatory activities, contractors, and consultants, equipment, and software to support our development, facilities, and information technology. We expense R&D costs as they are incurred. We expect R&D expenses to increase in absolute dollars as we continue to develop enhancements to Barostim. Our R&D expenses may fluctuate from period to period due to the timing and extent of our product development and clinical trial expenses.

ProvisionBenefit (provision) for income taxes consists primarily of income taxes in foreign jurisdictions in which we conduct business. We maintain a full valuation allowance for deferred tax assets including NOL carryforwards, R&D credits, and other tax credits.

Revenue generated in the U.S. was $47.2$51.9 million for the year ended December 31, 2024,2025, an increase of $12.1$4.7 million, or 34%,10%, over the year ended December 31, 2023.2024. HF revenueRevenue units in the U.S. totaled 1,5061,648 and 1,1231,522 for the years ended December 31, 20242025 and 2023, respectively. HF revenue in the U.S. totaled $46.8 million and $34.6 million for the years ended December 31, 2024 and 2023,2024, respectively. The increase was primarily driven by continued growth as a result of the expansion into new sales territories and new accounts, as well as increased physician and patient awareness of Barostim.

Revenue generated in Europe was $4.1$4.8 million for the year ended December 31, 2024,2025, aan decreaseincrease of $0.1$0.6 million, or 1%,16%, over the year ended December 31, 2023.2024. Total revenue units in Europe decreasedincreased to 204219 for the year ended December 31, 2024,2025, from 207204 for the prior year. As of December 31, 2025 and December 31, 2024, we had five sales territories in Europe as compared to six sales territories as of December 31, 2023.Europe.

Cost of goods sold increaseddecreased $2.1 million, or 33%,$23,000 to $8.3 million for the year ended December 31, 2024,2025, compared to the year ended December 31, 2023.2024. This increasedecrease was driven by a lower cost per unit, primarily due to higheran salesincrease ofin Barostim.manufacturing efficiencies.

Gross profit was $43.0$48.3 million for the year ended December 31, 2024,2025, an increase of $9.9$5.4 million, or 30%,13%, over the year ended December 31, 2023.2024. Gross margin wasincreased 84%to 85% for both the yearsyear ended December 31, 20242025 compared to 84% for the year ended December 31, 2024. Gross margin for the year ended December 31, 2025 was higher due to an increase in the average selling price and 2023.a decrease in the cost per unit, primarily due to an increase in manufacturing efficiencies.

R&D expenses decreased $0.5 million, or 4%, towere $11.1 million for the years ended December 31, 2025 and December 31, 2024, respectively. R&D expense for the year ended December 31, 2024,2025 comparedincluded toa the$0.4 yearmillion endedincrease Decemberin 31,compensation 2023.expenses, Thismainly changeas wasa primarilyresult drivenof increased headcount, offset by a $0.5 million decrease in consulting expenses, a $0.3 million decrease in compensation expenses, and a $0.2 million decrease in travel expenses, partially offset by a $0.5 million increase in clinical study expenses.

SG&A expenses increaseddecreased $26.8$2.8 million, or 42%,3%, to $91.3$88.5 million for the year ended December 31, 2024,2025, compared to the year ended December 31, 2023.2024. This change was driven by a $12.7$7.9 million increasedecrease in non-cash stock-based compensation expense, ana $11.0$0.2 million decrease in insurance expenses, and a $0.2 million decrease in bad debt expense, partially offset by a $4.0 million increase in compensation expenses, mainly as a result of increased headcount,headcount and a $1.3$1.5 million increase in travel expenses, a $0.6 million increase in bad debt expenses, and a $0.5 million increase in consulting expenses. Approximately $8.4 million of the increasedecrease in non-cash stock-based compensation expense is related to the modification of stock options held by our former Chief Executive Officer in connection with his retirement in the first quarter of 2024 described in Note 7 to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K.

Interest expense increased $2.6$1.4 million to $4.4$5.8 million for the year ended December 31, 2024,2025, compared to the year ended December 31, 2023.2024. This increase was driven by the interest expense on higher levels of borrowings under the Term Loan Agreement enteredwith intoInnovatus onCapital October 31, 2022.Partners.

Other income, net was $3.8 million for the year ended December 31, 2025, compared to $4.0 million for the year ended December 31, 2024, compared to $3.9 million for the year ended December 31, 2023.2024. This increasedecrease was primarily driven by greaterless interest income on our interest-bearing accounts.

On October 31, 2022, we entered into the Loan Agreement under which we may borrow, subject to our achievement of certain milestones, up to a total of $50.0 million in a series of Term Loans described in Note 4 to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K. On January 9, 2026, we entered into an Amendment to our existing Loan Agreement. Pursuant to the Amendment, the terms loans available were increased by $50.0 million, to an aggregate principal amount of up to $100.0 million, subject to our achievement of certain milestones. On the closing date, we borrowed an additional $10.0 million under the Loan Agreement. We had $50.0 million in outstanding Term Loans under the Loan Agreement at December 31, 2024.2025.

On November 4, 2022, we entered into an Equity Distribution Agreement with Piper Sandler & Co., as agent, under which we may offer and sell, from time to time at our sole discretion, shares of our common stock having an aggregate offering price of up to $50.0 million in an “at-the-market” (“ATM”) offering, to or through the agent. In January 2024, we commenced this ATM offering and issued 3,251,198 shares of common stock for gross proceeds of $33.8 million under the ATM offering during the year ended December 31, 2024.  We haveissued remaining capacity to issue and sell up to $16.2 million of additional543,462 shares of common stock underfor thisgross proceeds of $9.5 million during the year ended December 31, 2025. On November 4, 2025, we and the agent mutually agreed to terminate the Equity Distribution Agreement for the ATM, effective on November 6, 2025. On January 12, 2026, we entered into a Sale Agreement with Jefferies LLC, as agent. Pursuant to the terms of the Sale Agreement, we may offer and sell, from time to time at our sole discretion, shares of common stock having an aggregate offering price up to $50.0 million in an ATM offering.offering, to or through the agent.

We believe that our existing cash resources together with cash from operations will be sufficient to meet our forecasted requirements for operating liquidity, capital expenditures and debt services for at least the next threetwo years. If these sources are insufficient to satisfy our liquidity requirements, or provide funding to execute or accelerate our growth strategies, however, we may seek to sell additional equity or enter into an additional loan agreement. If we raise additional funds by issuing equity securities, our stockholders would experience dilution. Additional debt financing, if available, may involve covenants further restricting our operations or our ability to incur additional debt. Any such debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders.

Net cash provided by financing activities for the year ended December 31, 20242025 was $55.9$10.5 million and consisted of $32.5$9.0 million related to proceeds from the issuance of common stock through the ATM offering, $20.0 million related to proceeds under the Loan Agreement, $2.7$0.8 million related to proceeds from the exercise of common stock options, and $0.8 million related to proceeds from the Employee Stock Purchase Plan (“ESPP”), partially offset by $0.2 million related to debt financing costs..

Net cash provided by financing activities for the year ended December 31, 20232024 was $24.0$55.9 million and consisted of $22.5 million related to proceeds from debt financing, $0.9$32.5 million related to proceeds from the ESPPissuance andof $0.7common stock through the ATM offering, $20.0 million related to proceeds under the Loan Agreement, $2.7 million related to proceeds from the exercise of common stock options, and $0.8 million related to proceeds from the ESPP, partially offset by $0.2 million related to debt financing costs of $0.2 million.costs.

For a discussion of our potential risks and uncertainties, see the information in Part I, Item IA.1A. “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025. There have been no material changes to the risk factors disclosed in our Annual Report on Form 10-K.

On October 31, 2022, we entered into the Loan Agreement allowing borrowing, subject to our achievement of certain milestones, up to a total of $50.0 million in a series of Term Loans described in Note 4 to our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q. On January 9, 2026, we entered into an Amendment to our existing Loan Agreement. Pursuant to the Amendment, the termsterm loans available were increased by $50.0 million, to an aggregate principal amount of up to $100.0 million, subject to our achievement of certain milestones, and the maturity date was extended to 2031. In connection with the Amendment, we borrowed an additional $10.0 million under the Loan Agreement. We had $60.0 million in outstanding Term Loans under the Loan Agreement as of MarchJune 31,30, 2026.

Consolidated results of operations for the three months ended MarchJune 31,30, 2026, compared to the three months ended MarchJune 31,30, 2025

Revenue was $14.8$15.7 million for the three months ended MarchJune 31,30, 2026, an increase of $2.4$2.1 million, or 20%,16%, over the three months ended MarchJune 31,30, 2025.

Revenue generated in the U.S. was $13.7$14.8 million for the three months ended MarchJune 31,30, 2026, an increase of $2.4$2.5 million, or 22%,21%, overcompared to the three months ended MarchJune 31,30, 2025. Revenue units in the U.S. totaled 429466 and 359391 for the three months ended MarchJune 31,30, 2026 and 2025, respectively. The increases were primarily driven by continued growth in the U.S. HF business as a result of the expansion into new sales territories, new accounts, and increased physician and patient awareness of Barostim.

As of MarchJune 31,30, 2026, we had a total of 257258 active implanting centers in the U.S., as compared to 227240 as of MarchJune 31,30, 2025. Active implanting centers are customers that have completed at least one commercial HF implant in the last 12 months. As of MarchJune 31,30, 2026, we had a total of 56 sales territories in the U.S. as compared to 4547 sales territories as of MarchJune 31,30, 2025.

Revenue generated in Europe was $1.1$0.9 million for the three months ended MarchJune 31,30, 2026, a $27,000$0.4 million decrease, or 2%,31%, compared to the three months ended MarchJune 31,30, 2025. Total revenue units in Europe decreased to 5640 for the three months ended MarchJune 31,30, 2026, as compared to 5961 in the prior year period. We had five sales territories in Europe as of MarchJune 31,30, 2026 and MarchJune 31,30, 2025.

Cost of goods sold decreased $0.1$0.2 million, or 7%, to $1.9$2.0 million for the three months ended MarchJune 31,30, 2026, compared to the three months ended MarchJune 31,30, 2025. This decrease was driven by a lower cost per unit, primarily due to an increase in manufacturing efficiencies.

Gross profit was $12.9$13.7 million for the three months ended MarchJune 31,30, 2026, an increase of $2.6$2.3 million, or 25%,20%, over the three months ended MarchJune 31,30, 2025. Gross margin increased to 87% for the three months ended MarchJune 31,30, 2026, compared to 84% for the three months ended MarchJune 31,30, 2025. Gross margin for the three months ended MarchJune 31,30, 2026 was higher due to an increase in the average selling price and a decrease in the cost per unit, primarily due to an increase in manufacturing efficiencies.

R&D expenses increased $0.6$0.7 million, or 23%,27%, to $3.1 million for the three months ended MarchJune 31,30, 2026, compared to the three months ended MarchJune 31,30, 2025. This change was driven by a $0.4$0.6 million increase in consultingheadcount expenses, a $0.3 million increase in compensation expenses,expenses and a $0.1 million increase in non-cash stock-based compensation expenses, partially offset by a $0.2 million decrease in clinical trial expenses.

SG&A expenses increased $0.7$0.3 million, or 3%,1%, to $22.0$23.6 million for the three months ended MarchJune 31,30, 2026, compared to the three months ended MarchJune 31,30, 2025. This change was primarily driven by a $1.0 million increase in compensation expenses and a $0.3$0.7 million increase in non-cash stock-based compensation expenses and a $0.5 million increase in legal expenses, partially offset by a $0.3$0.6 million decrease in consultingadvertising expenses and a $0.3 million decrease in advertisingtravel expenses.

Interest expense increased $0.1 million for the three months ended MarchJune 31,30, 2026, compared to the three months ended MarchJune 31,30, 2025. This increase was driven by the interest expense on higher levels of borrowings under the Loan Agreement.

Other income, net wasdecreased $0.6 and $1.1 million for the three months ended MarchJune 31,30, 2026 andcompared 2025,to respectively.the Thesethree balancesmonths consistedended ofJune 30, 2025. This decrease was driven by the interest income on lower balances of our interest-bearing accounts. The decrease was primarily driven by the lower cash balance.

Benefit (provision) for income taxes was nominal for each of the three months ended March 31, 2026 and 2025.

We have incurred significant operating losses and negative cash flows from operations since our inception, and we anticipate that we will incur significant losses for at least the next several years. As of MarchJune 31,30, 2026 and December 31, 2025, we had cash and cash equivalents of $72.3$64.6 million and $75.7 million, respectively. For the three months ended MarchJune 31,30, 2026 and 2025, our net losses were $13.1$14.0 million and $13.8$14.7 million, respectively. For the six months ended June 30, 2026 and 2025, our net losses were $27.2 million and $28.5 million, respectively. Our net cash used in operating activities for the threesix months ended MarchJune 31,30, 2026 and 2025 was $12.2$21.0 million and $12.8$20.7 million, respectively.

On October 31, 2022, we entered into the Loan Agreement under which we were allowed to borrow, subject to our achievement of certain milestones, up to a total of $50.0 million in a series of Term Loans described in Note 4 to our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q. On January 9, 2026, we entered into an Amendment to our existing Loan Agreement. Pursuant to the Amendment, the termsterm loans available were increased by $50.0 million, to an aggregate principal amount of up to $100.0 million, subject to our achievement of certain milestones. OnIn connection with the closing date,Amendment, we borrowed an additional $10.0 million under the Loan Agreement. We had $60.0 million in outstanding Term Loans under the Loan Agreement as of MarchJune 31,30, 2026.

On November 4, 2022, we entered into an Equity Distribution Agreement with Piper Sandler & Co., as agent, under which we may offer and sell, from time to time at our sole discretion, shares of our common stock having an aggregate offering price of up to $50.0 million in an ATM offering, to or through the agent. We issued 543,462 shares of common stock for gross proceeds of $9.5 million during the year ended December 31, 2025. On November 4, 2025, we and the agent mutually agreed to terminate the Equity Distribution Agreement for the ATM, effective on November 6, 2025. On January 12, 2026, we entered into a Sale Agreement with Jefferies LLC, as agent. Pursuant to the terms of the Sale Agreement, we may offer and sell, from time to time at our sole discretion, shares of common stock having an aggregate offering price up to $50.0 million in an ATM offering, to or through the agent. We issued 102,154 shares of common stock for gross proceeds of $0.8 million during the six months ended June 30, 2026. We have remaining capacity to issue and sell up to approximately $49.2 million of additional shares of common stock under this ATM offering.