CVRX

New in FY2025

• We incurred net losses of $53.3 million and $60.0 million for the years ended December 31, 2025 and 2024, respectively.
• As of December 31, 2025 and 2024, our accumulated deficit was $590.7 million and $537.3 million, respectively.
• 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.
• We are conducting and may need to conduct additional clinical studies in the future to support approval for new indications.
• 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.
• Since the beginning of the second quarter of fiscal 2024, we have hired new leaders for sales, medical affairs, clinical, reimbursement and human resources.
• 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. ​ Many executive officers and employees in the medical device industry are still subject to strict non-compete or confidentiality agreements with their employers.
• 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.
• 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 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.
• 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.
• 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, 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.
• 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 We may in the future become involved in lawsuits to protect or enforce our intellectual property or defend ourselves against intellectual property disputes, which could be expensive, time consuming and ultimately unsuccessful, and could result in the diversion of significant resources, thereby hindering our ability to effectively commercialize our existing or future products.
• 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.
• For the fiscal years ended December 31, 2025 and 2024, net cash used in operating activities was $40.2 million and $39.1 million, respectively.
• As of December 31, 2025, we had federal and state NOL carryforwards of approximately $483.7 million and $9.7 million, respectively.
• As of December 31, 2025, we had federal and state tax credit carryforwards of approximately $10.3 million and $1.9 million, respectively.

and 24 more.

Gone since FY2024

• We incurred net losses of $60.0 million and $41.2 million for the years ended December 31, 2024 and 2023, respectively.
• As of December 31, 2024 and 2023, our accumulated deficit was $537.3 million and $477.4 million, respectively.
• 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.
• We will likely need to conduct additional clinical studies in the future to support approval for new indications.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• The APC payment of approximately $45,000 will continue in 2025, as published in the 2025 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. ​ 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.
• 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. ​ Risks related to intellectual property We may in the future become involved in lawsuits to protect or enforce our intellectual property or defend ourselves against intellectual property disputes, which could be expensive, time consuming and ultimately unsuccessful, and could result in the diversion of significant resources, thereby hindering our ability to effectively commercialize our existing or future products.
• 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.
• For the fiscal years ended December 31, 2024 and 2023, net cash used in operating activities was $39.1 million and $39.0 million, respectively.
• As of December 31, 2024, we had federal and state NOL carryforwards of approximately $429.7 million and $8.1 million, respectively.
• As of December 31, 2024, we had federal and state tax credit carryforwards of approximately $10.2 million and $1.7 million, respectively.
• 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.
• 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.
• Barostim has been indicated for the improvement of symptoms of HFrEF by the FDA and the treatment of HFrEF in the EEA.
• 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.
• 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.
• The expansion 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. ​ We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services. ​ Additionally, on April 5, 2017, the European Parliament passed the MDR, which repeals and replaces the MDD and the AIMDD.
• 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: ​ • strengthen the rules on placing devices on the market and reinforce surveillance once they are available; • establish explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices placed on the market; • improve the traceability of medical devices throughout the supply chain to the end-user or patient through a unique identification number; • set up a central database to provide patients, healthcare professionals and the public with comprehensive information on products available in the EU; and • strengthen rules for the assessment of certain high-risk devices, such as implants, which may have to undergo an additional check by experts before they are placed on the market.
• 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. ​ Risks related to our common stock We expect that the price of our common stock will fluctuate substantially, and you may not be able to resell shares of our common stock at or above the price you paid.
• 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.
• As of December 31, 2024, our executive officers, directors, holders of 5% or more of our capital stock and their respective affiliates beneficially owned approximately 43% of our outstanding voting stock.