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What changed in CVRx, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of CVRx, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+298 added−277 removedSource: 10-K (2026-02-13) vs 10-K (2025-02-18)

Top changes in CVRx, Inc.'s 2025 10-K

298 paragraphs added · 277 removed · 246 edited across 8 sections

Item 1. Business

Business — how the company describes what it does

104 edited+12 added−17 removed244 unchanged
Biggest changeThese payments generally cover the hospital’s costs for the device and the implantation procedure. ​ The surgeon implanting Barostim is paid an additional physician payment under the Medicare Physician Fee Schedule, and the physician that manages the device performs multiple device interrogations and is paid using the payment code APC 5721, which has a national average of $156 per visit in 2025. ​ Reimbursement rates from commercial payers vary depending on a variety of factors, including the commercial payor and contract terms. ​ Government program and commercial payer coverage in the United States Since approximately 67% of our target treatment population includes Medicare-eligible patients, we have prioritized CMS coverage while simultaneously developing processes to engage commercial payers.
Biggest changeReimbursement rates from commercial payers for procedures performed in the inpatient setting vary depending on a variety of factors. ​ Government program and commercial payer coverage in the United States Since approximately 67% of our target treatment population includes Medicare-eligible patients, we have prioritized CMS coverage while simultaneously developing processes to engage commercial payers.
These results led to FDA Premarket Approval (“PMA”) approval of Barostim in August 2019 on an accelerated basis of only four months from the submission of the clinical trial report. ​ The BeAT-HF pivotal trial continued enrolling patients in the post-market stage of the trial in order to gather and evaluate additional, long-term data.
These results led to FDA Premarket Approval (“PMA”) of Barostim in August 2019 on an accelerated basis of only four months from the submission of the clinical trial report. ​ The BeAT-HF pivotal trial continued enrolling patients in the post-market stage of the trial in order to gather and evaluate additional, long-term data.
HF worsens over time due to maladaptive responses from the body’s control systems, mediated by the ANS, that lead to excessive neural and hormonal activation.
HF worsens over time due to maladaptive responses from the body’s control systems, mediated by the ANS, that lead to excessive neural and hormonal activation.
Patients receiving Barostim Therapy for two years reported persistent improvement in their ability to work around the house, sleep, their sense of control, and their mobility, while feeling like less of a burden to their family or friends.
Patients receiving Barostim Therapy for two years reported persistent improvement in their ability to work around the house, sleep, their sense of control, and their mobility, while feeling like less of a burden to their family or friends.
The benefits of treatment with Barostim were shown to be similarly robust and reproducible across all three of our HF clinical studies, including BAT-in-HF (Phase I), HOPE4HF (Phase II), and BeAT-HF (Phase III pivotal trial), evaluating 624 patients in aggregate across the U.S., Germany, Italy, France, Canada and the United Kingdom.
The benefits of treatment with Barostim were shown to be similarly robust and reproducible across all three of our HF clinical studies, including BAT-in-HF (Phase I), HOPE4HF (Phase II), and BeAT-HF (Phase III pivotal trial), evaluating 624 patients in aggregate across the U.S., Germany, Italy, France, Canada and the United Kingdom.
Barostim Therapy’s trial results have been published in more than 65 peer-reviewed publications, approximately 25 of which relate to the treatment of HF, including, among others, the Journal of the American College of Cardiology and the European Journal of Heart Failure. • Minimally invasive implant procedure.
Barostim Therapy’s trial results have been published in more than 65 peer-reviewed publications, approximately 25 of which relate to the treatment of HF, including, among others, the Journal of the American College of Cardiology and the European Journal of Heart Failure. • Minimally invasive implant procedure.
A Company-sponsored and co-authored cost-impact analysis, which was published in BMC Cardiovascular Disorders , a peer-reviewed manuscript, predicted BAT plus GDMT would become the lower-cost alternative treatment within three years from implantation, as compared to GDMT alone, resulting in significant cost savings to healthcare systems. • Inherent patient compliance and durability.
A Company-sponsored and co-authored cost-impact analysis, which was published in BMC Cardiovascular Disorders , a peer-reviewed manuscript, predicted BAT plus GDMT would become the lower-cost alternative treatment within three years from implantation, as compared to GDMT alone, resulting in significant cost savings to healthcare systems. • Inherent patient compliance and durability.
Barostim ensures patient compliance, unlike most commercially available drug treatments, as it requires no device interaction by the patient. Our device has a battery that does not require recharging, has an average service life of five to six years and is replaced through a short outpatient procedure.
Barostim ensures patient compliance, unlike most commercially available drug treatments, as it requires no device interaction by the patient. Our device has a battery that does not require recharging, has an average service life of five to six years and is replaced through a short outpatient procedure.
Our customers bill various third-party payers, such as government agencies, administrative contractors, commercial payers and integrated managed care organizations, for the cost required to treat each patient. ​ Third-party payers generally require physicians and hospitals to identify the service for which they are seeking reimbursement for by using CPT codes, which are created and maintained by the American Medical Association.
Our customers bill various third-party payers, such as government agencies, administrative contractors, commercial payers and integrated managed care organizations, for the cost required to treat each patient. ​ Third-party payers generally require physicians and hospitals to identify the service for which they are seeking reimbursement by using CPT codes. CPT codes are created and maintained by the American Medical Association.
Intent to deceive is not required to establish liability under the civil federal civil False Claims Act. ​ In addition, private parties may initiate “qui tam” whistleblower lawsuits against any person or entity under the federal civil False Claims Act in the name of the government and share in the proceeds of the lawsuit.
Intent to deceive is not required to establish liability under the federal civil False Claims Act. ​ In addition, private parties may initiate “qui tam” whistleblower lawsuits against any person or entity under the federal civil False Claims Act in the name of the government and share in the proceeds of the lawsuit.
Unlike directives, which must be implemented into the national laws of the EEA, the regulations are directly applicable in all EEA 32 Table of Contents member states and are intended to eliminate differences in the regulation of medical devices among EEA member states. ​ The new regulations: ​ • Require demonstration of clinically meaningful outcomes for the performance of the medical device; • Require stricter control of Class IIb and Class III medical devices during the clinical investigational phase; • Require rigorous post-market oversight by the manufacturer and increased post-market surveillance authority by the Notified Body, including unannounced audits and product sample checks and testing; • 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; • Provide greater transparency by establishing a central database (EUDAMED) 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, which may have to undergo an additional check by an independent expert panel before they are placed on the market.
Unlike directives, which must be implemented into the national laws of the EEA, the regulations are directly applicable in all EEA member states and are intended to eliminate differences in the regulation of medical devices among EEA member states. ​ The new regulations: ​ • Require demonstration of clinically meaningful outcomes for the performance of the medical device; • Require stricter control of Class IIb and Class III medical devices during the clinical investigational phase; • Require rigorous post-market oversight by the manufacturer and increased post-market surveillance authority by the Notified Body, including unannounced audits and product sample checks and testing; • 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; 33 Table of Contents • Provide greater transparency by establishing a central database (EUDAMED) 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, which may have to undergo an additional check by an independent expert panel before they are placed on the market.
The government may assert that a claim includes items or services resulting from a violation of the federal Anti-Kickback Statute and thus constitutes a false or fraudulent claim for purposes of the false claims statute; • clearance or approval of product modifications to 510(k)-cleared devices that could significantly affect safety or effectiveness or that would constitute a major change in intended use of one of our cleared devices, or approval of a supplement for certain modifications to PMA and HDE devices; • medical device reporting regulations, which require that a manufacturer report to the FDA if a device it markets may have caused or contributed to a death or serious injury, or has malfunctioned and the device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur; • correction, removal, and recall reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; • the federal law and regulations requiring Unique Device Identifiers (“UDI”) on devices and also requiring the submission of certain information about each device to the FDA’s Global Unique Device Identification Database (“GUDID”); • the FDA’s recall authority, whereby the agency can order device manufacturers to recall from the market a product that is in violation of governing laws and regulations; and • post-market surveillance activities and regulations, which apply when deemed by the FDA to be necessary to protect the public health or to provide additional safety and effectiveness data for the device.
The government may assert that a claim includes items or services resulting from a violation of the federal Anti-Kickback Statute and thus constitutes a false or fraudulent claim for purposes of the false claims statute; 31 Table of Contents • clearance or approval of product modifications to 510(k)-cleared devices that could significantly affect safety or effectiveness or that would constitute a major change in intended use of one of our cleared devices, or approval of a supplement for certain modifications to PMA and HDE devices; • medical device reporting regulations, which require that a manufacturer report to the FDA if a device it markets may have caused or contributed to a death or serious injury, or has malfunctioned and the device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur; • correction, removal, and recall reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; • the federal law and regulations requiring Unique Device Identifiers (“UDI”) on devices and also requiring the submission of certain information about each device to the FDA’s Global Unique Device Identification Database (“GUDID”); • the FDA’s recall authority, whereby the agency can order device manufacturers to recall from the market a product that is in violation of governing laws and regulations; and • post-market surveillance activities and regulations, which apply when deemed by the FDA to be necessary to protect the public health or to provide additional safety and effectiveness data for the device.
Under the 510(k) process, the manufacturer must submit to the FDA a premarket notification demonstrating that the device is “substantially equivalent” to either a device that was legally marketed prior to May 28, 1976, the date upon which the Medical Device Amendments of 1976 were enacted, or another commercially available device that was cleared through the 510(k) process. ​ Devices deemed by the FDA to pose the greatest risks are placed in Class III, requiring approval of an HDE or PMA. ​ 28 Table of Contents Our currently U.S.-marketed Barostim devices are Class III devices which have received both a PMA and an HDE approval. ​ PMA & HDE approval pathway Class III devices require PMA or HDE approval before they can be marketed, although some pre-amendment Class III devices for which the FDA has not yet required a PMA are cleared through the 510(k) process.
Under the 510(k) process, the manufacturer must submit to the FDA a premarket notification demonstrating that the device is “substantially equivalent” to either a device that was legally marketed prior to May 28, 1976, the date upon which the Medical Device Amendments of 1976 were enacted, or another commercially available device that was cleared through the 510(k) process. ​ Devices deemed by the FDA to pose the greatest risks are placed in Class III, requiring approval of an HDE or PMA. ​ Our currently U.S.-marketed Barostim devices are Class III devices which have received both a PMA and an HDE approval. ​ PMA & HDE approval pathway Class III devices require PMA or HDE approval before they can be marketed, although some pre-amendment Class III devices for which the FDA has not yet required a PMA are cleared through the 510(k) process.
These include: ​ • establishment registration and device listing with the FDA; • QSR requirements, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation, and other quality assurance procedures during all aspects of the design and manufacturing process; • labeling and marketing regulations, which require that promotion is truthful, not misleading, fairly balanced and provides adequate directions for use and that all claims are substantiated and also prohibit the promotion of products for unapproved or “off-label” uses and impose other restrictions on labeling; FDA guidance on off-label dissemination of information and responding to unsolicited requests for information; and Federal Trade Commission guidance on endorsements and testimonials; 30 Table of Contents • the federal Physician Payments Sunshine Act and various state and foreign laws on reporting remunerative relationships with health care customers; • the federal Anti-Kickback Statute (and similar state laws) prohibiting, among other things, soliciting, receiving, offering, or providing remuneration intended to induce the purchase or recommendation of an item or service reimbursable under a federal healthcare program, such as Medicare or Medicaid.
These include: ​ • establishment registration and device listing with the FDA; • QSR requirements, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation, and other quality assurance procedures during all aspects of the design and manufacturing process; • labeling and marketing regulations, which require that promotion is truthful, not misleading, fairly balanced and provides adequate directions for use and that all claims are substantiated and also prohibit the promotion of products for unapproved or “off-label” uses and impose other restrictions on labeling; FDA guidance on off-label dissemination of information and responding to unsolicited requests for information; and Federal Trade Commission guidance on endorsements and testimonials; • the federal Physician Payments Sunshine Act and various state and foreign laws on reporting remunerative relationships with health care customers; • the federal Anti-Kickback Statute (and similar state laws) prohibiting, among other things, soliciting, receiving, offering, or providing remuneration intended to induce the purchase or recommendation of an item or service reimbursable under a federal healthcare program, such as Medicare or Medicaid.
Barostim also is eligible for reimbursement in certain other European countries, where annual healthcare budgets for the hospital generally determine the number of patients to be treated and the prices to be paid for the related devices that may be purchased. ​ Research and development Our research and development team has significant experience bringing innovative medical devices to market, including minimally invasive neuromodulation systems. ​ We are committed to ongoing research and development efforts of Barostim with an emphasis on improving clinical outcomes, optimizing patient adoption and comfort, increasing access for a greater number of patients and enabling more physicians to perform the procedure. ​ The primary focus of our research and development efforts in the near-term will be the continued technological advancement of Barostim. 25 Table of Contents ​ While we are currently focused on the treatment of patients with HFrEF, we believe our platform technology can provide meaningful benefits to a broader set of patients suffering from cardiovascular diseases with significant unmet needs.
Barostim also is eligible for reimbursement in certain other European countries, where annual healthcare budgets for the hospital generally determine the number of patients to be treated and the prices to be paid for the related devices that may be purchased. ​ Research and development Our research and development team has significant experience bringing innovative medical devices to market, including minimally invasive neuromodulation systems. ​ We are committed to ongoing research and development efforts of Barostim with an emphasis on improving clinical outcomes, optimizing patient adoption and comfort, increasing access for a greater number of patients and enabling more physicians to perform the procedure. ​ The primary focus of our research and development efforts in the near-term will be the continued technological advancement of Barostim. ​ While we are currently focused on the treatment of patients with HFrEF, we believe our platform technology can provide meaningful benefits to a broader set of patients suffering from cardiovascular diseases with significant unmet needs.
These results demonstrated that BAT is safe in patients with HFrEF, showed a directional reduction in the primary endpoint of CV mortality and HF morbidity (although not reaching statistical significance), and favored patient-centered symptomatic improvements at 6 and 12 months in 6MHW and at 6,12 and 24 months in the MLWHF quality of life questionnaire and NYHA Class. ​ 18 Table of Contents • Exercise capacity (measured by the standardized 6MHW distance test): The Barostim group showed an improvement at both 6 and 12 months compared to the control group.
These results demonstrated that BAT is safe in patients with HFrEF, showed a directional reduction in the primary endpoint of CV mortality and HF morbidity (although not reaching statistical significance), and favored patient-centered symptomatic improvements at 6 and 12 months in 6MHW and at 6,12 and 24 months in the MLWHF quality of life questionnaire and NYHA Class. ​ 19 Table of Contents • Exercise capacity (measured by the standardized 6MHW distance test): The Barostim group showed an improvement at both 6 and 12 months compared to the control group.
A total of 146 patients (72 in the U.S. and 74 in Germany, Italy, France, and Canada) at 45 centers were randomized 1:1 with 76 patients in the Barostim group and 70 patients in the control group. ​ 21 Table of Contents Patients were eligible for the study based on symptoms, historical treatment plan and anatomical criteria, including if they were NYHA Class III, received GDMT for their HF, had a LVEF ≤ 35% and were considered a suitable surgical candidate, among others.
A total of 146 patients (72 in the U.S. and 74 in Germany, Italy, France, and Canada) at 45 centers were randomized 1:1 with 76 patients in the Barostim group and 70 patients in the control group. ​ 22 Table of Contents Patients were eligible for the study based on symptoms, historical treatment plan and anatomical criteria, including if they were NYHA Class III, received GDMT for their HF, had a LVEF ≤ 35% and were considered a suitable surgical candidate, among others.
The differences between the groups at 6, 12 and 24 months are -14, -8 and -10, respectively, which is not only statistically significant, but is greater than a clinically meaningful difference of 5 points. ​ 19 Table of Contents • Functional status (determined by NYHA classification): Approximately two-thirds of the Barostim group improved at least one NYHA class across the follow-up visits.
The differences between the groups at 6, 12 and 24 months are -14, -8 and -10, respectively, which is not only statistically significant, but is greater than a clinically meaningful difference of 5 points. ​ 20 Table of Contents • Functional status (determined by NYHA classification): Approximately two-thirds of the Barostim group improved at least one NYHA class across the follow-up visits.
The FDA regulates the development, design, non-clinical and clinical research, manufacturing, safety, effectiveness, labeling, packaging, storage, installation, servicing, recordkeeping, premarket clearance or approval, device tracking, adverse event reporting, recalls, safety alerts, injunctions, seizures, bans, advertising, promotion, marketing and distribution and import and export of medical devices to ensure that medical devices distributed domestically are safe and effective for their intended uses and otherwise meet the requirements of the FDCA. ​ In addition to U.S. regulations, we are subject to a variety of regulations in the EEA governing clinical trials and the commercial sales and distribution of our products.
The FDA regulates the development, design, non-clinical and clinical research, manufacturing, safety, effectiveness, labeling, packaging, storage, installation, servicing, recordkeeping, premarket clearance or approval, device tracking, adverse event reporting, recalls, safety alerts, injunctions, 28 Table of Contents seizures, bans, advertising, promotion, marketing and distribution and import and export of medical devices to ensure that medical devices distributed domestically are safe and effective for their intended uses and otherwise meet the requirements of the FDCA. ​ In addition to U.S. regulations, we are subject to a variety of regulations in the EEA governing clinical trials and the commercial sales and distribution of our products.
Our Field Clinical Specialists work to ensure that every procedure is done correctly by educating the implanting physicians, including vascular surgeons and EPs, about the technical aspects of Barostim and the implantation procedure. ​ Similar to our direct sales team, our marketing team has a significant amount of relevant expertise and a strong track record of success in the medical device industry.
Our Field Clinical Specialists work to ensure that every procedure is done correctly by educating the implanting physicians, including vascular surgeons and cardiothoracic surgeons, about the technical aspects of Barostim and the implantation procedure. ​ Similar to our direct sales team, our marketing team has a significant amount of relevant expertise and a strong track record of success in the medical device industry.
This led to the FDA approval of expanded labeling with these results and a simplification and clarification of the following indications for use. ​ Barostim is indicated for patients who are NYHA Class III or Class II (with a recent history of Class III) despite treatment with guideline-directed medical therapies (medications and devices), have a LVEF ≤ 35% and a NT-proBNP ​ The safety and effectiveness of Barostim Therapy have been published in more than 65 peer-reviewed publications, approximately 25 of which relate to the treatment of HF, including, among others, the publications on the pivotal trial results in the Journal of the American College of Cardiology and the European Journal of Heart Failure. ​ We have established a U.S. patient registry to evaluate and assess real world patient outcomes from patients who have been implanted with Barostim.
This led to the FDA approval of expanded labeling with these results and a simplification and clarification of the following indications for use. ​ Barostim is indicated for patients who are NYHA Class III or Class II (with a recent history of Class III) despite treatment with guideline-directed medical therapies (medications and devices), have a LVEF ≤ 35% and a NT-proBNP ​ The safety and effectiveness of Barostim Therapy have been published in more than 65 peer-reviewed publications, approximately 25 of which relate to the treatment of HF, including, among others, the publications on the pivotal trial results in the Journal of the American College of Cardiology and the European Journal of Heart Failure. ​ We established a U.S. patient registry and are collecting RWE to evaluate and assess real world patient outcomes from patients who have been implanted with Barostim in commercial settings.
We support all aspects of the patient journey, which includes initial diagnosis, surgical support, and patient follow-up. Our Account Managers are focused on prioritizing high volume cardiology centers that are strategically located and on educating and training physicians who have strong connectivity to the HFrEF patient population that may be eligible for our therapy.
We support all aspects of the patient journey, which includes initial diagnosis, surgical support, and patient follow-up. Our Territory Managers are focused on prioritizing high volume cardiology centers that are strategically located and on educating and training physicians who have strong connectivity to the HFrEF patient population that may be eligible for our therapy.
We are registered with the FDA as a medical device manufacturer and licensed by the State of Minnesota to manufacture our device. 27 Table of Contents ​ Seasonality We have seen seasonally lower rates of implants in our first fiscal quarter in recent years, which we believe is primarily due to U.S. patients shifting medical treatments to the later months of the year when they have better information about spending against the annual deductibility limits under their health insurance coverage, and we expect this trend to continue.
We are registered with the FDA as a medical device manufacturer and licensed by the State of Minnesota to manufacture our device. ​ Seasonality We have seen seasonally lower rates of implants in our first fiscal quarter in recent years, which we believe is primarily due to U.S. patients shifting medical treatments to the later months of the year when they have better information about spending against the annual deductibility limits under their health insurance coverage, and we expect this trend to continue.
This resulted in a Win Ratio of 1.26, reflecting beneficial trend in the heart transplant/LVAD over the course of the study and MLWHF at 12 months. ​ 20 Table of Contents • Freedom from All-Cause Mortality: In addition to the results above, freedom from all-cause mortality (all-cause death, LVAD and heart transplant) demonstrated a 34% reduction between the groups.
This resulted in a Win Ratio of 1.26, reflecting beneficial trend in the heart transplant/LVAD over the course of the study and MLWHF at 12 months. ​ 21 Table of Contents • Freedom from All-Cause Mortality: In addition to the results above, freedom from all-cause mortality (all-cause death, LVAD and heart transplant) demonstrated a 34% reduction between the groups.
We are currently selling Barostim in Germany, where the German Institute of Medical Documentation and Information supports various codes for reimbursement coverage. OPS code 5-059.c6 covers the implantation or replacement of a device stimulating the peripheral nervous system by activating the baroreceptors.
We are currently selling Barostim in Germany, where the German Institute of Medical Documentation and Information supports various codes for reimbursement coverage. OPS code 5-059.c6 covers the implantation and OPS code 5-059.d6 covers the replacement of a device stimulating the peripheral nervous system by activating the baroreceptors.
However, because Barostim is designed to be used in conjunction with pharmaceutical therapies to alleviate the symptoms of HFrEF, we do not consider existing pharmaceutical therapies to be direct competition. 26 Table of Contents ​ We also compete with other medical technology companies to recruit and retain qualified sales, training, and other personnel. ​ Intellectual property We rely on a combination of patent, copyright, trademark and trade secret laws and confidentiality and invention assignment agreements to protect our intellectual property rights.
However, because Barostim is designed to be used in conjunction with pharmaceutical therapies to alleviate the symptoms of HFrEF, we do not consider existing pharmaceutical therapies to be direct competition. ​ We also compete with other medical technology companies to recruit and retain qualified sales, training, and other personnel. ​ Intellectual property We rely on a combination of patent, copyright, trademark and trade secret laws and confidentiality and invention assignment agreements to protect our intellectual property rights.
This OPS code is combined with G-DRG ICD I50.13 to cover reimbursement of Barostim for the treatment of HFrEF. It can also be combined with G-DRG ICD I10.10 to cover reimbursement of Barostim for the treatment of hypertension. These DRG codes for both indications are combined with ZE code ZE2021-86 to cover the cost of the device.
This OPS code is combined with G-DRG ICD I50.13 to cover reimbursement of Barostim for the treatment of HFrEF. It can also be combined with G-DRG ICD I10.10 to cover reimbursement of Barostim for the treatment of hypertension. These DRG codes for both indications are combined with ZE code ZE2025-86 to cover the cost of the device.
Failure to comply with the HIPAA privacy and security standards can result in civil monetary penalties up to $63,973 per violation, not to exceed $1.92 million per calendar year for non-compliance of an identical provision and, in certain circumstances, criminal penalties with fines up to $250,000 per violation and/or imprisonment. ​ 37 Table of Contents HIPAA authorizes state attorneys general to file suit on behalf of their residents for violations.
Failure to comply with the HIPAA privacy and security standards can result in civil monetary penalties up to $63,973 per violation, not to exceed $1.92 million per calendar year for non-compliance of an identical provision and, in certain circumstances, criminal penalties with fines up to $250,000 per violation and/or imprisonment. ​ HIPAA authorizes state attorneys general to file suit on behalf of their residents for violations.
The discovery of previously unknown problems with any of our products, including unanticipated adverse events or adverse events of increasing severity or frequency, whether resulting from the use of the device within the scope of its clearance or off-label by a physician in the practice of medicine, could result in restrictions on the device, including the removal of the product from the market or voluntary or mandatory device recalls. ​ 31 Table of Contents The FDA has broad regulatory compliance and enforcement powers.
The discovery of previously unknown problems with any of our products, including unanticipated adverse events or adverse events of increasing severity or frequency, whether resulting from the use of the device within the scope of its clearance or off-label by a physician in the practice of medicine, could result in restrictions on the device, including the removal of the product from the market or voluntary or mandatory device recalls. ​ The FDA has broad regulatory compliance and enforcement powers.
The totality of the 6, 12 and 24-month data demonstrated symptomatic improvements 17 Table of Contents for HF patients who are NYHA Class III or Class II (who had a recent history of Class III) despite treatment with guideline-directed therapies and who have a LVEF ≤ 35% and a NT-proBNP ​ Pre-market phase results ​ The safety and effectiveness data in the BeAT-HF pivotal trial support the HFrEF clinical benefits of Barostim.
The totality of the 6, 12 and 24-month data demonstrated symptomatic improvements for HF patients who are NYHA Class III or Class II (who had a recent history of Class III) despite treatment with guideline-directed therapies and who have a LVEF ≤ 35% and a NT-proBNP ​ Pre-market phase results ​ The safety and effectiveness data in the BeAT-HF pivotal trial support the HFrEF clinical benefits of Barostim.
The Data Protection Act of 2018, which came into effect on May 25, 2018 and was amended on January 1, 2021, works alongside and supplements the UK GDPR. ​ We are subject to the supervision of local data protection authorities in those jurisdictions where we are established or otherwise subject to applicable law. ​ 38 Table of Contents We depend on third parties in relation to our provision of our services, a number of which process personal data on our behalf.
The Data Protection Act of 2018, which came into effect on May 25, 2018 and was amended on January 1, 2021, works alongside and supplements the UK GDPR. ​ We are subject to the supervision of local data protection authorities in those jurisdictions where we are established or otherwise subject to applicable law. ​ We depend on third parties in relation to our provision of our services, a number of which process personal data on our behalf.
Also, many U.S. states have 36 Table of Contents similar fraud and abuse statutes or regulations that may be broader in scope and may apply regardless of payer, in addition to items and services reimbursed under Medicaid and other state programs. ​ Additionally, there has been a recent trend of increased foreign, federal, and state regulation of payments and transfers of value provided to healthcare professionals or entities.
Also, many U.S. states have similar fraud and abuse statutes or regulations that may be broader in scope and may apply regardless of payer, in addition to items and services reimbursed under Medicaid and other state programs. ​ Additionally, there has been a recent trend of increased foreign, federal, and state regulation of payments and transfers of value provided to healthcare professionals or entities.
Available Information We make our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act, available free of charge at our website as soon as reasonably practicable after they have been filed with, or 40 Table of Contents furnished to, the U.S.
Available Information We make our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act, available free of charge at our website as soon as reasonably practicable after they have been filed with, or furnished to, the U.S.
If the FDA determines that there are deficiencies or other concerns with an IDE for which it requires modification, the FDA may permit a clinical trial to proceed under a conditional approval. ​ In addition, the study must be approved by, and conducted under the oversight of, an institutional review board (“IRB”), for each clinical site.
If the FDA determines that there are deficiencies or other concerns with an IDE for which it requires modification, the FDA may permit a clinical trial to proceed under a conditional approval. ​ 30 Table of Contents In addition, the study must be approved by, and conducted under the oversight of, an institutional review board (“IRB”), for each clinical site.
Unlike the Directive (which needed to be transposed at national level), the GDPR text is directly applicable in each EU member state, resulting in a more uniform application of data privacy laws across the EU. The GDPR imposes onerous accountability obligations, requiring data controllers and processors to maintain a record of their data processing and policies.
Unlike the Directive (which needed to be transposed at national level), the GDPR text is directly applicable in each EU member state, resulting in a more uniform application of data privacy laws across the EU. The GDPR 38 Table of Contents imposes onerous accountability obligations, requiring data controllers and processors to maintain a record of their data processing and policies.
Further, manufacturers, medical practitioners and medical institutions are obliged to report any incident involving a medical device, including any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which 34 Table of Contents might lead to or might have led to the death of a patient or to a serious deterioration in his or her state of health.
Further, manufacturers, medical practitioners and medical institutions are obliged to report any incident involving a medical device, including any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or to a serious deterioration in his or her state of health.
An additional limitation for HDE devices is they must be prescribed for a patient population that has a medical condition or disease that afflicts less than 8,000 people per year in the United States and have been designated as a Humanitarian Use Device by the FDA. ​ 29 Table of Contents Clinical trials Clinical trials are usually required to support a PMA and are sometimes required to support an HDE, 510(k) or De Novo submission.
An additional limitation for HDE devices is they must be prescribed for a patient population that has a medical condition or disease that afflicts less than 8,000 people per year in the United States and have been designated as a Humanitarian Use Device by the FDA. ​ Clinical trials Clinical trials are usually required to support a PMA and are sometimes required to support an HDE, 510(k) or De Novo submission.
We consider our primary competition to be other device-based therapies designed to treat patients with HFrEF and a narrow QRS complex. ​ There is only one other commercially available device-based option, CCM, that targets a limited subset of the same HFrEF patient population indicated for Barostim.
We consider our primary competition to be other device-based therapies designed to treat patients with HFrEF and a narrow QRS complex. 26 Table of Contents ​ There is only one other commercially available device-based option, CCM, that targets a limited subset of the same HFrEF patient population indicated for Barostim.
We market our therapy in the U.S. to hospitals and clinics where EPs, HF specialists, interventional and general cardiologists and vascular surgeons treat patients with HFrEF. We primarily sell Barostim to hospitals through a direct sales organization in the U.S. and Germany, and through distributors in Austria, Spain, Italy, the Nordic region, and other European countries.
We market our therapy in the U.S. to hospitals and clinics where EPs, HF specialists, interventional and general cardiologists and vascular surgeons treat patients with HFrEF. We primarily sell Barostim to hospitals through a direct sales organization in the U.S. and Germany, and through distributors in Austria, Spain, and other European countries.
The Notified Body also reviews the Technical File that includes the Biological Evaluation, Clinical Evaluation and Risk Management reports and Post Market Clinical Follow-Up (“PMCF”), among other items, submitted for approval of the CE 33 Table of Contents Mark. If the quality management system audit and the technical file review are successful, the Notified Body issues certificates of conformity.
The Notified Body also reviews the Technical File that includes the Biological Evaluation, Clinical Evaluation and Risk Management reports and Post Market Clinical Follow-Up (“PMCF”), among other items, submitted for approval of the CE Mark. If the quality management system audit and the technical file review are successful, the Notified Body issues certificates of conformity.
As of July 2020, all Medicare Administrative Contractors (“MACs”) have retired automatic coverage denial policies, thereby allowing implants to be adjudicated on a case-by-case basis. CMS has committed to considering additional process improvements to increase access to innovative devices.
As of July 2020, all Medicare Administrative Contractors (“MACs”) have retired automatic coverage denial policies, 25 Table of Contents thereby allowing implants to be adjudicated on a case-by-case basis. CMS has committed to considering additional process improvements to increase access to innovative devices.
See “Risk Factors—Risks Related to Intellectual Property” for additional information regarding these and other risks related to our intellectual property portfolio and their potential effect on us. ​ Manufacturing and supply We manage all aspects of manufacturing operations and product supply of Barostim, which include final assembly, testing and packaging of our IPG and stimulation lead, at our 31,505 square foot headquarters in Minneapolis, Minnesota.
See “Risk Factors—Risks Related to Intellectual Property” for additional information regarding these and other risks related to our intellectual property portfolio and their potential effect on us. ​ Manufacturing and supply We manage all aspects of manufacturing operations and product supply of Barostim, which include final assembly, testing and packaging of our IPG and stimulation lead, at our 35,183 square foot headquarters in Minneapolis, Minnesota.
There is no active patent litigation involving any of our patents, and we have not received any notices of patent infringement. ​ We also rely, in part, upon unpatented trade secrets, know-how and continuing technological innovation to develop and maintain our competitive position.
There is no active patent litigation involving any of our patents, and we have not received any notices of patent infringement. 27 Table of Contents ​ We also rely, in part, upon unpatented trade secrets, know-how and continuing technological innovation to develop and maintain our competitive position.
All clinical investigations of investigational devices to determine safety and effectiveness must be conducted in accordance with the FDA’s investigational device exemption (“IDE”), regulations which govern investigational device labeling, prohibit promotion of the investigational device, and specify an array of recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators.
All clinical investigations of investigational devices to determine safety and effectiveness must be conducted in accordance with the FDA’s IDE, regulations which govern investigational device labeling, prohibit promotion of the investigational device, and specify an array of recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators.
They also set forth certain rights that an individual has with respect to his or her PHI maintained by a covered entity, including the right to access or amend certain records containing PHI, or to request restrictions on the use or disclosure of PHI.
They also set forth certain rights that an individual has with respect to his or 37 Table of Contents her PHI maintained by a covered entity, including the right to access or amend certain records containing PHI, or to request restrictions on the use or disclosure of PHI.
If clinical studies for additional indications do not produce results necessary to support regulatory clearance or approval in the U.S. or elsewhere, we will be unable to commercialize our products for these indications. ​ For the years ended December 31, 2024 and 2023, we incurred research and development expenses of $11.1 million and $11.6 million, respectively. ​ Competition Our industry is subject to rapid change from the introduction of new products and technologies and other activities of industry participants.
If clinical studies for additional indications do not produce results necessary to support regulatory clearance or approval in the U.S. or elsewhere, we will be unable to commercialize our products for these indications. ​ For both the years ended December 31, 2025 and 2024, we incurred research and development expenses of $11.1 million. ​ Competition Our industry is subject to rapid change from the introduction of new products and technologies and other activities of industry participants.
The baroreceptors regulate the baroreflex, which is one of the mechanisms of the ANS that help to maintain blood pressure at nearly constant levels (i.e., homeostasis).
The baroreceptors regulate the baroreflex, which is one of the mechanisms of the ANS that helps to maintain blood pressure at nearly constant levels (i.e., homeostasis).
Many of our indicated patients may have already been pre-indicated for an ICD, whether or not they chose to undergo the ICD implantation procedure. ​ Implantation ​ Barostim is implanted during a short, minimally invasive procedure that is typically performed on an outpatient basis by a vascular surgeon and possibly an EP. The procedure has two steps.
Many of our indicated patients may have already been pre-indicated for an ICD, whether or not they chose to undergo the ICD implantation procedure. ​ Implantation ​ Barostim is implanted during a short, minimally invasive procedure that is typically performed on an outpatient basis by a vascular surgeon or a cardiothoracic surgeon. The procedure has two steps.
Our global sales and marketing team engages in sales efforts and promotional activities focused on EPs, HF specialists, interventional and general cardiologists, and vascular surgeons.
Our global sales and marketing team engages in sales efforts and promotional activities focused on HF specialists, interventional and general cardiologists, APPs, EPs, vascular surgeons, and cardiothoracic surgeons.
We also are subject to similar anticorruption legislation implemented 39 Table of Contents in Europe under the Organization for Economic Co-operation and Development’s Convention on Combating Bribery of Foreign Public Officials in International Business Transactions.
We also are subject to similar anticorruption legislation implemented in Europe under the Organization for Economic Co-operation and Development’s Convention on Combating Bribery of Foreign Public Officials in International Business Transactions.
We estimate that there are approximately 64 million people worldwide suffering from HF, including approximately 6.7 million people in the U.S. and 10.5 million people in the European Five. HF is characterized by the heart’s inability to effectively circulate blood throughout the body resulting in insufficient levels of oxygen and nourishment to various body parts.
We estimate that there are approximately 64 million people worldwide suffering from HF, including approximately 6.7 million people in the U.S. HF is characterized by the heart’s inability to effectively circulate blood throughout the body resulting in insufficient levels of oxygen and nourishment to various body parts.
The objective of this outreach is to inform potential patients about our education webinars and website, where they can find a wealth of information on HFrEF and the purpose and benefits of Barostim Therapy, based on our approved labeling. ​ In addition to driving broad awareness and increasing physician and patient education, our marketing team has developed the in-house resources necessary to obtain prior authorization approval for Barostim procedures and expand reimbursement coverage. ​ Third-party coverage and reimbursement Coding and payment in the United States In the U.S., we sell Barostim primarily to hospitals, where the device is implanted in outpatient and inpatient settings.
The objective of this outreach is to inform potential patients about our education webinars and website, where they can find a wealth of information on HFrEF and the purpose, benefits, and risks of Barostim Therapy, based on our approved labeling. ​ In addition to driving broad awareness and increasing physician and patient education, our team has developed the in-house resources necessary to support physicians and patients in obtaining prior authorization approval for Barostim procedures. ​ Third-party coverage and reimbursement Coding and payment in the United States In the U.S., we sell Barostim primarily to hospitals, where the device is implanted in outpatient and inpatient settings.
When an entity is determined to have violated the federal civil False Claims Act, the government may impose civil fines and penalties ranging from $12,537 to $25,076 for each false claim, plus treble damages, and exclude the entity from participation in Medicare, Medicaid, and other federal healthcare programs. ​ The Civil Monetary Penalty Act of 1981 imposes penalties against any person or entity that, among other things, is determined to have presented or caused to be presented a claim to a federal healthcare program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent, or 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 Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) also created additional federal criminal statutes that prohibit, among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payers, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.
When an entity is determined to have violated the federal civil False Claims Act, the government may impose civil fines and penalties ranging from $14,308 to $28,629 (as adjusted for inflation) for each false claim, plus treble damages, and exclude the entity from participation in Medicare, Medicaid, and other federal healthcare programs. ​ The Civil Monetary Penalty Act of 1981 imposes penalties against any person or entity that, among other things, is determined to have presented or caused to be presented a claim to a federal healthcare program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent, or offering or transferring remuneration to a federal healthcare beneficiary that a person knows or 36 Table of Contents 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 Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) also created additional federal criminal statutes that prohibit, among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payers, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.
A CE Mark was first issued for Barostim for the treatment of resistant hypertension in 2011 and for the treatment of HFrEF in 2014. ​ European Union (“EU”) Legislation: medical devices regulation The regulatory framework governing medical devices in the EEA underwent a major change on April 5, 2017, when the European Parliament passed the Medical Devices Regulation (Regulation (EU) 2017/745 — “MDR”).
A CE Mark was first issued for Barostim for the treatment of resistant hypertension in 2011 and for the treatment of HFrEF in 2014. ​ EU Legislation: medical devices regulation The regulatory framework governing medical devices in the EEA underwent a major change on April 5, 2017, when the European Parliament passed the MDR (Regulation (EU) 2017/745).
The principal purposes of our equity incentive plans are to attract, retain and motivate selected employees, consultants, and directors through the granting of stock-based compensation awards. ​ As of December 31, 2024, we had 206 employees worldwide, all of which were employed on a full-time basis.
The principal purposes of our equity incentive plans are to attract, retain and motivate selected employees, consultants, and directors through the granting of stock-based compensation awards. ​ As of December 31, 2025, we had 223 employees worldwide, all of which were employed on a full-time basis.
An Advisory Committee or panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as to the approvability of the device.
An Advisory Committee or panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as to the 29 Table of Contents approvability of the device.
For example, the Budget Control Act of 2011, among other things, included reductions to Medicare payments to providers of 2% per fiscal year, which went into effect on April 1, 2013 and will remain in effect through 2027 unless additional Congressional action is taken.
For example, the Budget Control Act of 2011, among other things, included reductions to Medicare payments to providers of 2% per fiscal year, which went into effect on April 1, 2013 and will remain in effect through 2032 unless 39 Table of Contents additional Congressional action is taken.
We are continuing to actively expand our direct sales force and commercial organization in the U.S. 23 Table of Contents ​ Our direct sales representatives, which we refer to as Account Managers, generally have substantial and applicable medical device experience, specifically in the cardiovascular space, and market our products directly to the approximately 2,500 EPs, 800 HF specialists and 20,000 general cardiologists in the U.S.
We are continuing to actively expand our direct sales force and commercial organization in the U.S. ​ Our direct sales representatives, which we refer to as Territory Managers, generally have substantial and applicable medical device experience, specifically in the cardiovascular space, and market our products directly to the approximately 800 HF specialists, 20,000 general cardiologists and 2,500 EPs in the U.S.
Patients with HFrEF are typically placed on a treatment progression plan during which they are initially given Guideline Directed Medical Therapy (“GDMT”) to help manage symptoms, and then progress to more invasive and costly treatment options involving other implantable devices with the most severe patients often requiring Left Ventricular Assist Devices (“LVADs”) or heart transplants.
Patients with HFrEF are typically placed on a treatment progression plan during which they are initially given GDMT to help manage symptoms, and then progress to more invasive and costly treatment options involving other implantable devices with the most severe patients often requiring Left Ventricular Assist Devices (“LVADs”) or heart transplants.
Our global sales and marketing team engages in sales efforts and promotional activities focused on electrophysiologists (“EPs”), HF specialists, interventional cardiologists, general cardiologists, and vascular surgeons. We are prioritizing our sales and marketing efforts on high volume cardiology centers that are strategically located and on educating and training physicians.
Our global sales and marketing team engages in sales efforts and promotional activities focused on HF specialists, interventional cardiologists, general cardiologists, advanced practice providers (“APPs”), electrophysiologists (“EPs”), vascular surgeons, and cardiothoracic surgeons. We are prioritizing our sales and marketing efforts on high volume cardiology centers that are strategically located and on educating and training physicians.
Under the MDR, performance must be linked to expected clinical metrics and outcomes. From a practical standpoint, “performance” is analogous to the term “effectiveness” when applied to our medical devices.
Under the MDR, performance must be linked to expected clinical metrics and outcomes. From a 34 Table of Contents practical standpoint, “performance” is analogous to the term “effectiveness” when applied to our medical devices.
Manufacturers must prepare a periodic safety update report for each device summarizing the results and conclusions of the analyses of the post-market surveillance data gathered. ​ Non-compliance If we fail to comply with applicable EU, UK and Swiss regulatory requirements, we may be subject to, among other things, fines, product recalls, seizure of products, operating restrictions, and criminal prosecution.
Manufacturers must prepare a periodic safety update report for each device summarizing the results and conclusions of the analyses of the post-market surveillance data gathered. ​ Non-compliance If we fail to comply with applicable EU, UK and Swiss regulatory requirements, we may be subject to, among other things, fines, product recalls, seizure of products, operating restrictions, enforcement actions by competent authorities or Notified Bodies, and criminal prosecution.
Practices that involve remuneration that may be alleged to be intended to induce prescribing, purchases or recommendations may be subject to scrutiny if they do not qualify for an exception or safe harbor.
Practices that involve remuneration that may be 35 Table of Contents alleged to be intended to induce prescribing, purchases or recommendations may be subject to scrutiny if they do not qualify for an exception or safe harbor.
Moreover, a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act (described below). ​ Violations of the federal Anti-Kickback Statute may result in civil monetary penalties up to $100,000 for each violation, plus up to three times the remuneration involved.
Moreover, a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act (described below). ​ Violations of the federal Anti-Kickback Statute may result in civil monetary penalties up to $100,000 for each violation, or the maximum amount as adjusted for inflation under federal law, plus up to three times the remuneration involved.
Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. ​ Many foreign countries have similar laws relating to healthcare fraud and abuse. Foreign laws and regulations may vary greatly from country to country.
Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. ​ Many foreign countries have similar laws relating to healthcare fraud and abuse.
HF is associated with a five-fold increase in sudden cardiac death. There is no known prevention for HF other than the treatment of the common risk factors associated with the disease, such as hypertension, diabetes, and obesity. ​ HF is a debilitating, progressive and potentially life-threatening condition where the heart does not pump enough blood throughout the body.
There is no known prevention for HF other than the treatment of the common risk factors associated with the disease, such as hypertension, diabetes, and obesity. ​ HF is a debilitating, progressive and potentially life-threatening condition where the heart does not pump enough blood throughout the body.
If the FDA determines that we failed to comply with applicable regulatory requirements, it can take a variety of compliance or enforcement actions, which may result in any of the following sanctions: ​ • warning letters, untitled letters, fines, injunctions, consent decrees and civil penalties; • recalls, withdrawals, injunctions, or administrative detention or seizure of our products; • operating restrictions or partial suspension or total shutdown of production; • refusing or delaying requests for 510(k) marketing clearance or PMA approvals of new products or modified products; • withdrawing 510(k) clearances or PMA approvals that have already been granted; refusal to grant export or import approvals for our products; or • criminal prosecution.
If the FDA determines that we failed to comply with applicable regulatory requirements, it can take a variety of compliance or enforcement actions, which may result in any of the following sanctions: ​ • warning letters, untitled letters, fines, injunctions, consent decrees and civil penalties; • recalls, withdrawals, injunctions, or administrative detention or seizure of our products; • operating restrictions or partial suspension or total shutdown of production; • refusing or delaying requests for 510(k) marketing clearance or PMA approvals of new products or modified products; • withdrawing 510(k) clearances or PMA approvals that have already been granted; refusal to grant export or import approvals for our products; or • criminal prosecution. 32 Table of Contents Regulation of medical devices in the EEA To be placed on the market in the EEA, medical devices require a CE Mark and a corresponding declaration of conformity.
Our marketing organization is focused on building physician awareness through targeted KOL development, referral network education and direct-to-consumer marketing. ​ In terms of patient education, we utilize direct communication channels to inform patients about Barostim Therapy and to enable them to connect with sites that offer Barostim. Our primary method of patient outreach is through digital social networks.
Our marketing organization is focused on 24 Table of Contents building physician and APP awareness through targeted KOL development, referral network education and direct-to-consumer marketing. ​ In terms of patient education, we utilize direct communication channels to inform patients about Barostim Therapy and to enable them to connect with sites that offer Barostim.
In our discussions with commercial payers, we highlight our compelling and robust clinical data, including the long-term post-market BeAT-HF data, the potential economic cost-savings associated with our highly compliant treatment, increased patient demand and support from leading medical societies and KOLs.
We believe our market access team is highly effective in obtaining prior authorizations, including navigating the appeals process. In our discussions with commercial payers, we highlight our compelling and robust clinical data, including the long-term post-market BeAT-HF data, the potential economic cost-savings associated with our highly compliant treatment, increased patient demand and support from leading medical societies and KOLs.
This allows the stimulation lead to carry the electrical pulses from the IPG to the baroreceptors located in the wall of the carotid artery. The stimulation lead terminates with a two-millimeter electrode.
This allows the stimulation lead to carry the electrical pulses from the IPG to the baroreceptors located in the wall of the carotid artery.
A manufacturer’s failure to submit timely, accurately, and completely the required information for all payments, transfers of value or ownership or investment interests may result in civil monetary penalties of up to $12,646 per failure up to an aggregate of $189,692 per year (or up to an aggregate of $1.265 million per year for “knowing failures”).
A manufacturer’s failure to submit timely, accurately, and completely the required information for all payments, transfers of value or ownership or investment interests may result in civil monetary penalties of up to $14,067 per failure up to an aggregate of $211,008 per year (or up to an aggregate of $1.406 million per year for “knowing failures”), as adjusted for inflation.
As of December 31, 2024, we owned 49 issued U.S. patents and had six pending U.S. patent applications. Outside of the U.S., we owned nine patents in multiple countries and had 10 pending applications. Our trademark portfolio focuses on nine trademarks in the U.S. and multiple other countries.
As of December 31, 2025, we owned 41 issued U.S. patents and had 18 pending U.S. patent applications. Outside of the U.S., we owned 45 issued foreign patents in multiple countries and had seven pending applications. Our trademark portfolio focuses on nine trademarks in the U.S. and multiple other countries.
Under the FDCA, medical devices are classified as Class I, Class II, Class III, or De Novo, depending on the degree of risk associated with each medical device and the extent of manufacturer and regulatory control needed to ensure its safety and effectiveness.
Under the FDCA, medical devices are classified as Class I, Class II, Class III, depending on the degree of risk associated with each medical device and the extent of manufacturer and regulatory control needed to ensure its safety and effectiveness. In addition, a novel device with no predicate may be classified through the FDA’s De Novo classification process.
Additionally, the Affordable Care Act has expanded eligibility criteria for Medicaid programs and created a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in and conduct comparative clinical effectiveness research, along with funding for such research.
Additionally, the Affordable Care Act has expanded eligibility criteria for Medicaid programs and created a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in and conduct comparative clinical effectiveness research, along with funding for such research. There have been judicial and Congressional challenges to certain aspects of the Affordable Care Act, and we expect additional amendments in the future.
Nominal dimensions for the current IPG are listed in the figure below: ​ ​ Stimulation lead ​ The stimulation lead is attached via six suture points to the exterior wall of the carotid artery and is connected to the current IPG.
Nominal dimensions for the current IPG are 68 millimeters in height, 50 millimeters in width, and 14 millimeters in depth. ​ ​ Stimulation lead ​ The stimulation lead is attached via six suture points to the exterior wall of the carotid artery and is connected to the current IPG.
There are two lengths of the stimulation lead available to allow for anatomical variations to be used at the physician’s discretion. ​ ​ Ancillary surgical accessories ​ In addition to the IPG and stimulation lead, we provide physicians with single-use surgical tools, including the port plug, torque wrench, implant tool and implant adaptor, all of which were designed to facilitate the implantation of Barostim. ​ 13 Table of Contents Programmer ​ Once implanted, Barostim is managed wirelessly by a programmer that communicates with the IPG.
The stimulation lead is 40 centimeter long and terminates with a two-millimeter electrode. ​ Ancillary surgical accessories ​ In addition to the IPG and stimulation lead, we provide physicians with single-use surgical tools, including the port plug, torque wrench, and implant tool, all of which were designed to facilitate the implantation of Barostim. 13 Table of Contents Programmer ​ Once implanted, Barostim is managed wirelessly by a programmer that communicates with the IPG.
Our accumulated deficit as of December 31, 2024 and 2023, was $537.3 million and $477.4 million, respectively. ​ Our market and industry Overview of HF It is estimated that HF currently affects approximately 64 million people globally, including approximately 6.7 million people in the U.S. and approximately 10.5 million people in the European Five.
Our accumulated deficit as of December 31, 2025 and 2024, was $590.7 million and $537.3 million, respectively. ​ Our market and industry Overview of HF It is estimated that HF currently affects approximately 64 million people globally, including approximately 6.7 million people in the U.S. HF is associated with a five-fold increase in sudden cardiac death.
These results demonstrated that BAT is safe in patients with HFrEF and significantly improves the patient-centered symptomatic endpoints of the quality-of-life score, 6MHW and NYHA functional status, as well as the confirmatory nature of the evidence provided by a reduction of NT-proBNP. ​ • Quality of life (measured by MLWHF questionnaire): BAT resulted in a 14-point improvement in quality of life for patients in the Barostim group relative to patients in the control group (p • Exercise capacity (measured by the standardized 6MHW distance test): BAT resulted in a 60-meter increase in the distance patients in the Barostim group were able to walk on a flat, hard surface in a six-minute period relative to that of patients in the control group (p • Functional status (determined by NYHA classification): BAT demonstrated that 65% of patients in the Barostim group improved at least one NYHA class (p • NT-proBNP (serum biomarker used as indicator of severity of HF): BAT resulted in a 25% greater reduction (improvement) in NT-proBNP for patients in the Barostim group relative to that of patients in the control group (p=0.004; 95% CI = -38% to -9%).
According to the medical community, a 5-point improvement is considered to be clinically meaningful. • Exercise capacity (measured by the standardized 6MHW distance test): BAT resulted in a 60-meter increase in the distance patients in the Barostim group were able to walk on a flat, hard surface in a six-minute period relative to that of patients in the control group (p • Functional status (determined by NYHA classification): BAT demonstrated that 65% of patients in the Barostim group improved at least one NYHA class (p • NT-proBNP (serum biomarker used as indicator of severity of HF): BAT resulted in a 25% greater reduction (improvement) in NT-proBNP for patients in the Barostim group relative to that of patients in the control group (p=0.004; 95% CI = -38% to -9%).
We use a qualification process to aid in the identification of the appropriate patients for our therapy.
Our primary method of patient outreach is through digital marketing. We use a qualification process to aid in the identification of the appropriate patients for our therapy.
For example, the advertising and promotion of our products is subject to EU Directives concerning misleading and comparative advertising and unfair commercial practices, as well as other EEA member state legislation governing the advertising and promotion of medical devices.
Foreign laws and regulations may vary greatly from country to country and may carry civil, criminal, or administrative penalties for non-compliance. For example, the advertising and promotion of our products is subject to EU Directives concerning misleading and comparative advertising and unfair commercial practices, as well as other EEA member state legislation governing the advertising and promotion of medical devices.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeEEA 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.
Biggest changeAdditionally, 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.
Our reliance on these third-party suppliers also subjects us to other risks that could harm our business, including, among others: ​ • we are not a major customer of many of our suppliers, and these suppliers may therefore give other customers’ needs higher priority than ours; • third parties may threaten or enforce their intellectual property rights against our suppliers, which may cause disruptions or delays in shipment, or may force our suppliers to cease conducting business with us; • 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; • we may have difficulty locating and qualifying alternative suppliers; • switching components or suppliers may require product redesign and possibly submission to the FDA, EEA, or other foreign regulatory bodies, which could significantly impede or delay our commercial activities; • one or more of our limited source suppliers may be unwilling or unable to supply components of Barostim; 44 Table of Contents • other customers may use fair or unfair negotiation tactics and/or pressures to impede our use of the supplier; • we do not conduct rigorous, formal environmental, social or governance due diligence on our supply chain and thus may not be aware if our suppliers pose such risks; • the occurrence of a fire, natural disaster or other catastrophe impacting one or more of our suppliers may affect their ability to deliver products to us in a timely manner; and • our suppliers may encounter financial, geopolitical, or other business hardships unrelated to our demand, which could inhibit their ability to fulfill our orders and meet our requirements.
Our reliance on these third-party suppliers also subjects us to other risks that could harm our business, including, among others: ​ • we are not a major customer of many of our suppliers, and these suppliers may therefore give other customers’ needs higher priority than ours; • third parties may threaten or enforce their intellectual property rights against our suppliers, which may cause disruptions or delays in shipment, or may force our suppliers to cease conducting business with us; • 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 44 Table of Contents the effectiveness or safety of Barostim or cause delays in shipment; • we may have difficulty locating and qualifying alternative suppliers; • switching components or suppliers may require product redesign and possibly submission to the FDA, EEA, or other foreign regulatory bodies, which could significantly impede or delay our commercial activities; • one or more of our limited source suppliers may be unwilling or unable to supply components of Barostim; • other customers may use fair or unfair negotiation tactics and/or pressures to impede our use of the supplier; • we do not conduct rigorous, formal environmental, social or governance due diligence on our supply chain and thus may not be aware if our suppliers pose such risks; • the occurrence of a fire, natural disaster or other catastrophe impacting one or more of our suppliers may affect their ability to deliver products to us in a timely manner; and • our suppliers may encounter financial, geopolitical, or other business hardships unrelated to our demand, which could inhibit their ability to fulfill our orders and meet our requirements.
These risks include, among others: ​ • difficulties in enforcing our intellectual property rights and in defending against third-party threats and intellectual property enforcement actions against us, our distributors, or any of our third-party suppliers; • reduced or varied protection for intellectual property rights in some countries; • potential pricing pressure; • a shortage of high-quality sales representatives and distributors; • competitive disadvantage to competition with established business and customer relationships; • foreign currency exchange rate fluctuations; • the imposition of additional U.S. and foreign governmental controls or regulations; • economic instability; • changes in duties and tariffs, license obligations and other non-tariff barriers to trade; • the imposition of restrictions on the activities of foreign agents, representatives, and distributors; • scrutiny of U.S. and foreign tax authorities, which could result in significant fines, penalties and additional taxes being imposed on us; • laws and business practices favoring local companies; • longer payment cycles; • difficulties in maintaining consistency with our internal guidelines; • difficulties in enforcing agreements and collecting receivables through certain foreign legal systems; 46 Table of Contents • the imposition of costly and lengthy new export licensing requirements; • the imposition of U.S. or international sanctions against a country, company, person, or entity; and • the imposition of new trade restrictions.
These risks include, among others: ​ • difficulties in enforcing our intellectual property rights and in defending against third-party threats and intellectual property enforcement actions against us, our distributors, or any of our third-party suppliers; • reduced or varied protection for intellectual property rights in some countries; • potential pricing pressure; • a shortage of high-quality sales representatives and distributors; • competitive disadvantage to competition with established business and customer relationships; • foreign currency exchange rate fluctuations; • the imposition of additional U.S. and foreign governmental controls or regulations; • economic instability; • changes in duties and tariffs, license obligations and other non-tariff barriers to trade; 46 Table of Contents • the imposition of restrictions on the activities of foreign agents, representatives, and distributors; • scrutiny of U.S. and foreign tax authorities, which could result in significant fines, penalties and additional taxes being imposed on us; • laws and business practices favoring local companies; • longer payment cycles; • difficulties in maintaining consistency with our internal guidelines; • difficulties in enforcing agreements and collecting receivables through certain foreign legal systems; • the imposition of costly and lengthy new export licensing requirements; • the imposition of U.S. or international sanctions against a country, company, person, or entity; and • the imposition of new trade restrictions.
These include the following provisions that: ​ • permit our Board of Directors to issue shares of preferred stock, with any rights, preferences, and privileges as they may designate, without stockholder approval, which could be used to dilute the ownership of a hostile bidder significantly; • 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 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 70 Table of Contents 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; and • provide that special meetings of our stockholders may be called only by the Chairman of the board, the Chief Executive Officer, or a majority of the Board of Directors then in office, which may delay the ability of our stockholders to force consideration by our company of a take-over proposal or to take certain corporate actions, including the removal of directors.
These include the following provisions that: ​ • permit our Board of Directors to issue shares of preferred stock, with any rights, preferences, and privileges as they may designate, without stockholder approval, which could be used to dilute the ownership of a hostile bidder significantly; • 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 71 Table of Contents 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; and • provide that special meetings of our stockholders may be called only by the Chairman of the board, the Chief Executive Officer, or a majority of the Board of Directors then in office, which may delay the ability of our stockholders to force consideration by our company of a take-over proposal or to take certain corporate actions, including the removal of directors.
The initiation and completion of studies may be prevented, delayed, or halted for numerous reasons, including, but not limited to, the following: 47 Table of Contents • 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; • patients do not enroll in, or enroll at a lower rate than we expect, or do not complete a clinical study; • patients or investigators do not comply with study protocols; • patients do not return for post-treatment follow-up at the expected rate; • patients experience serious or unexpected adverse side effects for a variety of reasons that may or may not be related to our products, such as the advanced stage of co-morbidities that may exist at the time of treatment, causing a clinical study to be put on hold; • sites participating in an ongoing clinical study withdraw, requiring us to engage new sites; • difficulties or delays associated with establishing additional clinical sites; • third-party clinical investigators decline to participate in our clinical studies, do not perform the clinical studies on the anticipated schedule, or perform in a manner inconsistent with the investigator agreement, clinical study protocol, good clinical practices, other FDA, IRB or ethics committee requirements, and EEA member state or other foreign regulations governing clinical trials; • third-party organizations do not perform data collection and analysis in a timely or accurate manner; • regulatory inspections of our clinical studies or manufacturing facilities require us to undertake corrective action or suspend or terminate our clinical studies; • changes in federal, state, or foreign governmental statutes, regulations, or policies; • interim results are inconclusive or unfavorable as to immediate and long-term safety or effectiveness; • regional or worldwide conditions, like an infectious disease or pandemic, precluding or interfering with execution; • the study design is inadequate to demonstrate safety and effectiveness; or • the statistical endpoints are not met.
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; • patients do not enroll in, or enroll at a lower rate than we expect, or do not complete a clinical study; • patients or investigators do not comply with study protocols; • patients do not return for post-treatment follow-up at the expected rate; • patients experience serious or unexpected adverse side effects for a variety of reasons that may or may not be related to our products, such as the advanced stage of co-morbidities that may exist at the time of treatment, causing a clinical study to be put on hold; • sites participating in an ongoing clinical study withdraw, requiring us to engage new sites; • difficulties or delays associated with establishing additional clinical sites; • third-party clinical investigators decline to participate in our clinical studies, do not perform the clinical studies on the anticipated schedule, or perform in a manner inconsistent with the investigator agreement, clinical study protocol, good clinical practices, other FDA, IRB or ethics committee requirements, and EEA member state or other foreign regulations governing clinical trials; • third-party organizations do not perform data collection and analysis in a timely or accurate manner; • regulatory inspections of our clinical studies or manufacturing facilities require us to undertake corrective action or suspend or terminate our clinical studies; • changes in federal, state, or foreign governmental statutes, regulations, or policies; • interim results are inconclusive or unfavorable as to immediate and long-term safety or effectiveness; • regional or worldwide conditions, like an infectious disease or pandemic, precluding or interfering with execution; • the study design is inadequate to demonstrate safety and effectiveness; or • the statistical endpoints are not met.
A person or entity does not need to have actual knowledge of this statute or specific intent to violate it; • 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 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 64 Table of Contents 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.
A person or entity does not need to have actual knowledge of this statute or specific intent to violate it; 65 Table of Contents • 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 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.
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.
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.
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.
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 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, Germany, France, and the Netherlands, as well as the tax laws and regulations related to such matters.
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.
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.
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. ​ 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.
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.
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.
Barostim has been indicated for the improvement of symptoms of HFrEF by the FDA and the treatment of HFrEF in the EEA. We may only promote or market Barostim for its specifically approved indications as described on the approved label.
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.
The Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business and financial condition. 54 Table of Contents ​ In addition, patent reform legislation may pass in the future that could lead to additional uncertainties and increased costs surrounding the prosecution, enforcement and defense of our patents and applications. ​ Furthermore, the U.S. and foreign courts are continually interpreting various aspects of patent law.
The Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business and financial condition. ​ In addition, patent reform legislation may pass in the future that could lead to additional uncertainties and increased costs surrounding the prosecution, enforcement and defense of our patents and applications. ​ 55 Table of Contents Furthermore, the U.S. and foreign courts are continually interpreting various aspects of patent law.
We have developed and expect to continue to refine our disclosure controls and other procedures that are designed to ensure that 68 Table of Contents 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 69 Table of Contents 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.
In the most extreme cases, criminal sanctions or closure of our 60 Table of Contents manufacturing facilities are possible. If any of these risks materialize, our business would be adversely affected. Barostim is also subject to extensive governmental regulation in foreign jurisdictions, such as Europe, and our failure to comply with applicable requirements could cause our business to suffer.
In the most extreme cases, criminal sanctions or closure of our 61 Table of Contents manufacturing facilities are possible. If any of these risks materialize, our business would be adversely affected. Barostim is also subject to extensive governmental regulation in foreign jurisdictions, such as Europe, and our failure to comply with applicable requirements could cause our business to suffer.
If the Internal Revenue Service or any other tax authorities were successful in challenging our positions, we may be liable for additional tax and penalties and interest related 59 Table of Contents thereto or other taxes, as applicable, in excess of any reserves established therefor, which may have a significant impact on our results, operations and future cash flow.
If the Internal Revenue Service or any other tax authorities were successful in challenging our positions, we may be liable for additional tax and penalties and interest related 60 Table of Contents thereto or other taxes, as applicable, in excess of any reserves established therefor, which may have a significant impact on our results, operations and future cash flow.
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. ​ Finally, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise the funds necessary to continue our operations. ​ If any of the foregoing occurs, we may have to withdraw existing products from the market or may be unable to commercialize one or more of our products, all of which could have a material adverse effect on our business, results of operations and financial condition.
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. ​ 54 Table of Contents Finally, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise the funds necessary to continue our operations. ​ If any of the foregoing occurs, we may have to withdraw existing products from the market or may be unable to commercialize one or more of our products, all of which could have a material adverse effect on our business, results of operations and financial condition.
If we do not obtain additional resources, our ability to capitalize on business opportunities will be limited, we may be unable to compete effectively and the growth of our business may be adversely affected. 57 Table of Contents Our operating results may vary significantly annually or from quarter to quarter, which may negatively impact our stock price in the future.
If we do not obtain additional resources, our ability to capitalize on business opportunities will be limited, we may be unable to compete effectively and the growth of our business may be adversely affected. 58 Table of Contents Our operating results may vary significantly annually or from quarter to quarter, which may negatively impact our stock price in the future.
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 55 Table of Contents 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.
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.
As a result, changes in the exchange rates between such foreign currencies, particularly the Euro and the U.S. dollar, could materially impact our reported results of operations and distort period to period 58 Table of Contents comparisons. Fluctuations in foreign currency exchange rates also impact the reporting of our receivables and payables in non-U.S. currencies.
As a result, changes in the exchange rates between such foreign currencies, particularly the Euro and the U.S. dollar, could materially impact our reported results of operations and distort period to period 59 Table of Contents comparisons. Fluctuations in foreign currency exchange rates also impact the reporting of our receivables and payables in non-U.S. currencies.
Any adverse determination in litigation could also subject us to significant liabilities. 67 Table of Contents Securities analysts may not publish favorable research or reports about our business or may publish no information at all, which could cause our stock price and trading volume to decline.
Any adverse determination in litigation could also subject us to significant liabilities. 68 Table of Contents Securities analysts may not publish favorable research or reports about our business or may publish no information at all, which could cause our stock price and trading volume to decline.
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 62 Table of Contents 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.
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 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 two years.
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.
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.
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 69 Table of Contents against us that is governed by the internal affairs doctrine.
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.
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.
Our competitors in both the U.S. and abroad, many of which 53 Table of Contents 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.
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.
Moreover, if we do not adequately address problems associated with our devices, we may 64 Table of Contents 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.
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. ​ Physicians may also misuse our product or use improper techniques, potentially leading to injury and an increased risk of product liability.
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. ​ 63 Table of Contents Physicians may also misuse our product or use improper techniques, potentially leading to injury and an increased risk of product liability.
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.
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.
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 56 Table of Contents be adversely affected.
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.
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.
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.
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.
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 52 Table of Contents our products are used, among other effects, thereby negatively impacting our operations.
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.
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.
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.
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 45 Table of Contents identification of new suppliers for specific components, or the development of new manufacturing technologies.
These requirements involve lengthy and detailed laboratory and clinical testing 61 Table of Contents 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.
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.
If these physicians do not try and subsequently adopt our product, then our revenue growth will slow or decline. 43 Table of Contents If we fail to receive access to hospitals, our sales may decrease. In the U.S., in order for physicians to use Barostim, hospitals where these physicians treat patients typically require us to enter into purchasing contracts.
If these physicians do not try and subsequently adopt our product, then our revenue growth will slow or decline. If we fail to receive access to hospitals, our sales may decrease. In the U.S., in order for physicians to use Barostim, hospitals where these physicians treat patients typically require us to enter into purchasing contracts.
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. ​ Risks related to our financial and operating results We may be required to obtain additional funds in the future, and these funds may not be available on acceptable terms or at all.
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. ​ 57 Table of Contents Risks related to our financial and operating results We may be required to obtain additional funds in the future, and these funds may not be available on acceptable terms or at all.
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.
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 62 Table of Contents 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.
Any corrective action, whether voluntary or involuntary, as well as defending 63 Table of Contents 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.
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.
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 66 Table of Contents management’s attention from the business.
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.
In addition, some of our existing and future employees are 49 Table of Contents 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.
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.
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 50 Table of Contents assumptions or estimates may change at any time, thereby reducing the predictive accuracy of these underlying factors.
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 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 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.
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 43 Table of Contents develop more effective or less expensive products or technologies that render our technology or products obsolete or less competitive.
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.
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.
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 53 Table of Contents normal responsibilities.
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.
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. One of our non-employee directors is also affiliated with one of our principal stockholders.
As of December 31, 2025, our executive officers, directors, holders of 5% or more of our capital stock and their respective affiliates beneficially owned approximately 37% of our outstanding voting stock. One of our non-employee directors is also affiliated with one of our principal stockholders.
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. ​ 66 Table of Contents 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.
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 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.
In such circumstances, our results of operations would be materially adversely affected. ​ Patients may not choose or be able to receive Barostim if, among other potential reasons, they are reluctant to receive an implantable device as opposed to an alternative, non-implantable treatment, they are worried about potential adverse effects of Barostim, or they are unable to obtain adequate third-party coverage or reimbursement. 42 Table of Contents Our industry is highly competitive.
In such circumstances, our results of operations would be materially adversely affected. ​ Patients may not choose or be able to receive Barostim if, among other potential reasons, they are reluctant to receive an implantable device as opposed to an alternative, non-implantable treatment, they are worried about potential adverse effects of Barostim, or they are unable to obtain adequate third-party coverage or reimbursement.
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.
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.
If we do not achieve and sustain profitability, our financial condition could suffer. We have experienced significant net losses since our inception and we expect to continue to incur losses for the foreseeable future. We incurred net losses of $60.0 million and $41.2 million for the years ended December 31, 2024 and 2023, respectively.
If we do not achieve and sustain profitability, our financial condition could suffer. We have experienced significant net losses since our inception and we expect to continue to incur losses for the foreseeable future. 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, 2024, we had federal and state tax credit carryforwards of approximately $10.2 million and $1.7 million, respectively. The federal and state tax credit carryforwards began expiring in 2021 and begin expiring in 2028, respectively. These NOL and tax credit carryforwards could expire unused and be unavailable to offset future income tax liabilities.
As of December 31, 2025, we had federal and state tax credit carryforwards of approximately $10.3 million and $1.9 million, respectively. The federal and state tax credit carryforwards began expiring in 2021 and begin expiring in 2028, respectively. These NOL and tax credit carryforwards could expire unused and be unavailable to offset future income tax liabilities.
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.
Even if we are successful in defending against these claims, the litigation could be costly and a distraction to management.
Even if we are successful in defending against these claims, the litigation could be costly 56 Table of Contents and a distraction to management.
We have generated and expect to continue to generate significant federal and state net operating loss (“NOLs”) and tax credit carryforwards. As of December 31, 2024, we had federal and state NOL carryforwards of approximately $429.7 million and $8.1 million, respectively. The federal NOLs began expiring in 2021 and state NOLs began expiring in 2020.
We have generated and expect to continue to generate significant federal and state net operating loss (“NOLs”) and tax credit carryforwards. As of December 31, 2025, we had federal and state NOL carryforwards of approximately $483.7 million and $9.7 million, respectively. The federal NOLs began expiring in 2021 and state NOLs began expiring in 2020.
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.
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 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. 67 Table of Contents This regulation has not yet had a material effect on the way we conduct our business in the EEA.
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.
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.
If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the future, we may be subject to penalties, including civil and criminal penalties, damages, fines, disgorgement, exclusion from governmental health care programs and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our financial results. 65 Table of Contents Healthcare legislative reform measures may have a material adverse effect on us.
If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the future, we may be subject to penalties, including civil and criminal penalties, damages, fines, disgorgement, exclusion from governmental health care programs and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our financial results.
Significant litigation regarding patent rights occurs in the medical device industry. Whether merited or not, it is possible that third parties controlling U.S. and foreign patents allege such patents cover our products, or we may decide to initiate infringement claims or litigation to protect our patents or other intellectual property rights.
Whether merited or not, it is possible that third parties controlling U.S. and foreign patents allege such patents cover our products, or we may decide to initiate infringement claims or litigation to protect our patents or other intellectual property rights.
Because we do not yet have other products currently in development, if we are unsuccessful in commercializing Barostim or are unable to market Barostim as a result of a quality problem, failure to maintain regulatory approvals, unexpected or serious complications or other unforeseen negative effects related to Barostim or the other factors discussed in these risk factors, we would lose our main source of revenue, and our business, reputation, liquidity and results of operations will be materially and adversely affected. 41 Table of Contents We have limited commercial sales experience marketing and selling Barostim, and if we are unable to continue to maintain and grow sales and marketing capabilities, we will be unable to generate sustained and increasing product revenue.
Because we do not yet have other products currently in development, if we are unsuccessful in commercializing Barostim or are unable to market Barostim as a result of a quality problem, failure to maintain regulatory approvals, unexpected or serious complications or other unforeseen negative effects related to Barostim or the other factors discussed in these risk factors, we would lose our main source of revenue, and our business, reputation, liquidity and results of operations will be materially and adversely affected.
Pandemics, epidemics, or outbreaks of an infectious disease may adversely affect our business. 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.
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.
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 52 Table of Contents suffer.
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 suffer. Significant litigation regarding patent rights occurs in the medical device industry.
Although increasing as our commercial sales grow, Barostim still has limited product and brand recognition. In addition, demand for Barostim may decline or may not continue to increase as quickly as we expect. If we are unable to achieve significant market acceptance in the U.S. for Barostim, our results of operations will be adversely affected.
In addition, demand for Barostim may decline or may not continue to increase as quickly as we expect. If we are unable to achieve significant market acceptance in the U.S. for Barostim, our results of operations will be adversely affected.
In the U.S., there have been and continue to be a number of legislative initiatives to contain healthcare costs. In March 2010, the Affordable Care Act was enacted in the U.S., which made a number of substantial changes in the way healthcare is financed by both governmental and private insurers.
In March 2010, the Affordable Care Act was enacted in the U.S., which made a number of substantial changes in the way healthcare is financed by both governmental and private insurers.
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.
As a result, this concentration of ownership may not be in the best interests of our other stockholders. 70 Table of Contents 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.
These may include the requirement of prior authorization by the competent authorities of the country in which the study takes place and the requirement to obtain a positive opinion from a competent Ethics Committee. This process can be expensive and time-consuming.
These may include the requirement of prior authorization by the competent authorities of the country in which the study takes place and the requirement to obtain a positive opinion from a competent Ethics Committee. This process can be expensive and time-consuming. Regulations in the EU were updated to require compliance to Regulation (EU) 2017/745 on Medical Devices (“MDR”).
Any of these occurrences may harm our business, financial condition, and prospects significantly. 48 Table of Contents We may face product liability claims that could be costly, divert management’s attention and harm our reputation. Manufacturing and marketing of Barostim and clinical testing of Barostim Therapy may expose us to product liability claims.
We may face product liability claims that could be costly, divert management’s attention and harm our reputation. Manufacturing and marketing of Barostim and clinical testing of Barostim Therapy may expose us to product liability claims.
Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than, those in the U.S. or the EEA, including additional preclinical studies or clinical trials.
Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than, those in the U.S. or the EEA, including additional preclinical studies or clinical trials. Any of these occurrences may harm our business, financial condition, and prospects significantly.
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.
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.
As of December 31, 2024 and 2023, our accumulated deficit was $537.3 million and $477.4 million, respectively.
As of December 31, 2025 and 2024, our accumulated deficit was $590.7 million and $537.3 million, respectively.
In addition, any amortization or charges resulting from the costs of acquisitions could increase our expenses . 51 Table of Contents If third-party payers do not provide adequate coverage and reimbursement for the use of Barostim, our revenue will be negatively impacted.
Our inability to integrate any acquired products or technologies effectively could impair our ability to execute our business strategies. In addition, any amortization or charges resulting from the costs of acquisitions could increase our expenses . If third-party payers do not provide adequate coverage and reimbursement for the use of Barostim, our revenue will be negatively impacted.
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.
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 the MDR, specifically Article 7, concerning misleading and comparative advertising as well as Directive 2005/29/EC on unfair commercial practices.
If these relationships and any related compensation to or ownership interest by the clinical investigator carrying out the study result in perceived or actual conflicts of interest, or if the FDA concludes that the financial relationship may have affected interpretation of the study, the integrity of the data generated at the applicable clinical trial site may be questioned and the utility of the clinical trial itself may be jeopardized.
If these relationships and any related compensation to or ownership interest by the clinical investigator carrying out the study result in perceived or actual conflicts of interest, or if the FDA concludes that the financial relationship may have affected interpretation of the study, the integrity of the data generated at the applicable clinical trial site may be questioned and the utility of the clinical trial itself may be jeopardized. 48 Table of Contents Even if our products are approved in the U.S. and the EEA, comparable regulatory authorities of additional foreign countries must also approve the manufacturing and marketing of our products in those countries.
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.
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.
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.
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.
We have a limited history operating as a commercial company and are highly dependent on a single product, Barostim. The failure to increase market acceptance in the U.S. for Barostim would negatively impact our business, liquidity, and results of operations.
The failure to increase market acceptance in the U.S. for Barostim would negatively impact our business, liquidity, and results of operations. We first commercialized Barostim in the EEA in 2012 and in the U.S. in 2020 and therefore do not have a long history operating as a commercial company.
As a result, our estimates of the annual total addressable market for Barostim may prove to be incorrect.
As a result, our estimates of total market opportunity for Barostim on both a prevalence and annual incidence basis may prove to be incorrect.
Further, these transactions and arrangements are contractual in nature and may be terminated or dissolved under the terms of the applicable agreements and, in such event, we may not continue to have rights to the products relating to such transaction or arrangement or may need to purchase such rights at a premium.
Further, these transactions and arrangements are contractual in nature and may be terminated or dissolved under the terms of the applicable agreements and, in such event, we may not continue to have rights to the products relating to such transaction or arrangement or may need to purchase such rights at a premium. 51 Table of Contents We may seek to grow our business through acquisitions of complementary products or technologies, and the failure to manage acquisitions, or the failure to integrate them with our existing business, could impair our ability to execute our business strategies.
If we do not provide support to physicians or do not adequately educate physicians on the benefits and proper use of Barostim, physicians may not use or advocate for Barostim.
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. If we do not provide support to physicians or do not adequately educate physicians on the benefits and proper use of Barostim, physicians may not use or advocate for Barostim.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeWe also retain third parties to assist with the monitoring and detection of cybersecurity threats and responding to any cybersecurity threats or incidents. ​ 71 Table of Contents With respect to third parties that manage or use our information technology or data, we obtain reports to assess the security of their systems and processes.
Biggest changeWe also retain third parties to assist with the monitoring and detection of cybersecurity threats and responding to any cybersecurity threats or incidents. ​ With respect to third parties that manage or use our information technology or data, we obtain reports to assess the security of their systems and processes.
We seek to further mitigate cybersecurity risks through a combination of monitoring and detection activities, use of anti-malware applications, employee training, quality audits and communication and reporting structures, among other processes.
We seek to further mitigate cybersecurity risks through a combination of monitoring and detection activities, use of anti-malware applications, employee training, quality audits and communication and reporting 72 Table of Contents structures, among other processes.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeItem 2. Properties We lease 31,505 square feet of office space in Minneapolis, Minnesota, which houses our principal executive offices and our manufacturing facility. We lease this space under an operating lease agreement that commenced December 1, 2008 and expires August 31, 2028 .
Biggest changeItem 2. Properties We lease 35,183 square feet of office space in Minneapolis, Minnesota, which houses our principal executive offices and our manufacturing facility. We lease this space under an operating lease agreement that commenced December 1, 2008 and expires August 31, 2028 .

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeItem 5. Market for Registrant’s Common Equity , Related Stockholder Matters and Issuer Purchases of Equity Securities ​ Market Information ​ Our common stock trades on the Nasdaq Global Select Market under the symbol “CVRX.” ​ Holders ​ As of February 11, 2025, there were approximately 62 holders of record of our common stock.
Biggest changeItem 5. Market for Registrant’s Common Equity , Related Stockholder Matters and Issuer Purchases of Equity Securities ​ Market Information ​ Our common stock trades on the Nasdaq Global Select Market under the symbol “CVRX.” ​ Holders ​ As of February 6, 2026, there were approximately 53 holders of record of our common stock.

Item 6. [Reserved]

Selected Financial Data — reserved (removed by SEC in 2021)

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Biggest changeItem 6. ​ [Reserved] ​ 73 ​ ​ ​ ​ ​ ​ ​ Item 7. ​ Management’s Discussion and Analysis of Financial Condition and Results of Operations ​ 73 ​ ​ ​ ​ ​ ​ ​ Item 7A. ​ Quantitative and Qualitative Disclosures About Market Risk ​ 82 ​ ​ ​ ​ ​ ​ ​ Item 8. ​ Financial Statements and Supplementary Data ​ 83 ​ ​ ​ ​ ​ ​ ​ Item 9. ​ Changes in and Disagreements with Accountants on Accounting and Financial Disclosure ​ 100 ​ ​ ​ ​ ​ ​ ​ Item 9A. ​ Controls and Procedures ​ 100 ​ ​ ​ ​ ​ ​ ​ Item 9B. ​ Other Information ​ 101 ​ ​ ​ ​ ​ ​ ​
Biggest changeItem 6. ​ [Reserved] ​ 74 ​ ​ ​ ​ ​ ​ ​ Item 7. ​ Management’s Discussion and Analysis of Financial Condition and Results of Operations ​ 74 ​ ​ ​ ​ ​ ​ ​ Item 7A. ​ Quantitative and Qualitative Disclosures About Market Risk ​ 84 ​ ​ ​ ​ ​ ​ ​ Item 8. ​ Financial Statements and Supplementary Data ​ 85 ​ ​ ​ ​ ​ ​ ​ Item 9. ​ Changes in and Disagreements with Accountants on Accounting and Financial Disclosure ​ 103 ​ ​ ​ ​ ​ ​ ​ Item 9A. ​ Controls and Procedures ​ 103 ​ ​ ​ ​ ​ ​ ​ Item 9B. ​ Other Information ​ 104 ​ ​ ​ ​ ​ ​ ​

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeResults of operations Consolidated results of operations for the year ended December 31, 2024, compared to the year ended December 31, 2023 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year ended ​ ​ ​ ​ ​ ​ December 31, ​ Change ​ (in thousands) ​ 2024 2023 ​ $ % Revenue ​ $ 51,292 ​ $ 39,295 ​ $ 11,997 31 % Cost of goods sold ​ 8,334 ​ 6,256 ​ 2,078 33 % Gross profit ​ 42,958 ​ 33,039 ​ 9,919 30 % Gross margin ​ 84 % 84 % ​ Operating Expenses: ​ ​ ​ ​ Research and development ​ 11,131 ​ 11,633 ​ (502) (4) % Selling, general and administrative ​ 91,317 ​ 64,509 ​ 26,808 42 % Total operating expenses ​ 102,448 ​ 76,142 ​ 26,306 35 % Loss from operations ​ (59,490) ​ (43,103) ​ (16,387) 38 % Interest expense ​ (4,397) ​ (1,799) ​ (2,598) 144 % Other income, net ​ 3,977 ​ 3,850 ​ 127 3 % Loss before income taxes ​ (59,910) ​ (41,052) ​ (18,858) 46 % Provision for income taxes ​ (55) ​ (147) ​ 92 (63) % Net loss ​ $ (59,965) ​ $ (41,199) ​ $ (18,766) 46 % 76 Table of Contents ​ Revenue ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Revenue by Geography ​ ​ Year ended ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ Change ​ (in thousands) ​ 2024 2023 ​ $ % United States ​ $ 47,167 ​ $ 35,111 ​ $ 12,056 34 % Europe ​ 4,125 ​ 4,184 ​ (59) (1) % Total Revenue ​ $ 51,292 ​ $ 39,295 ​ $ 11,997 31 % ​ Revenue was $51.3 million for the year ended December 31, 2024, an increase of $12.0 million, or 31%, over the year ended December 31, 2023.
Biggest changeWe maintain a full valuation allowance for deferred tax assets including NOL carryforwards, R&D credits, and other tax credits. 77 Table of Contents Results of operations Consolidated results of operations for the year ended December 31, 2025, compared to the year ended December 31, 2024 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year ended ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ Change ​ (in thousands) ​ 2025 ​ ​ ​ 2024 ​ $ ​ ​ ​ % Revenue ​ $ 56,651 ​ $ 51,292 ​ $ 5,359 10 % Cost of goods sold ​ 8,311 ​ 8,334 ​ (23) (0) % Gross profit ​ 48,340 ​ 42,958 ​ 5,382 13 % Gross margin ​ 85 % 84 % ​ ​ ​ Operating Expenses: ​ ​ ​ ​ ​ ​ ​ ​ Research and development ​ 11,132 ​ 11,131 ​ 1 0 % Selling, general and administrative ​ 88,473 ​ 91,317 ​ (2,844) (3) % Total operating expenses ​ 99,605 ​ 102,448 ​ (2,843) (3) % Loss from operations ​ (51,265) ​ (59,490) ​ 8,225 (14) % Interest expense ​ (5,827) ​ (4,397) ​ (1,430) 33 % Other income, net ​ 3,768 ​ 3,977 ​ (209) (5) % Loss before income taxes ​ (53,324) ​ (59,910) ​ 6,586 (11) % Benefit (provision) for income taxes ​ 18 ​ (55) ​ 73 (133) % Net loss ​ $ (53,306) ​ $ (59,965) ​ $ 6,659 (11) % ​ Revenue ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Revenue by Geography ​ ​ Year ended ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ Change ​ (in thousands) ​ 2025 ​ ​ ​ 2024 ​ $ ​ ​ ​ % United States ​ $ 51,883 ​ $ 47,167 ​ $ 4,716 10 % Europe ​ 4,768 ​ 4,125 ​ 643 16 % Total Revenue ​ $ 56,651 ​ $ 51,292 ​ $ 5,359 10 % ​ Revenue was $56.7 million for the year ended December 31, 2025, an increase of $5.4 million, or 10%, over the year ended December 31, 2024.
Research and development expenses 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.
Research and development expenses 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, consultants, equipment, and software to support our development, facilities, and information technology.
We have dedicated significant resources to educate physicians who treat HFrEF about the advantages of Barostim and train them on the implant procedure. The costs for the device and implantation procedure are reimbursed through various third-party payers, such as government agencies and commercial payers.
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. The costs for the device and implantation procedure are reimbursed through various third-party payers, such as government agencies and commercial payers.
Other income, net Other income, net consists primarily of interest income on our interest-bearing accounts, partially offset by the effect of exchange rates on our foreign currency-denominated asset and liability balances. Provision for income taxes Provision for income taxes consists primarily of income taxes in foreign jurisdictions in which we conduct business.
Other income, net Other income, net consists primarily of interest income on our interest-bearing accounts, partially offset by the effect of exchange rates on our foreign currency-denominated asset and liability balances. Benefit (provision) for income taxes Benefit (provision) for income taxes consists primarily of income taxes in foreign jurisdictions in which we conduct business.
We expect to derive future revenue by continuing to both expand our own dedicated salesforce and increase awareness of Barostim among payers, physicians, and patients. 73 Table of Contents 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.
We expect to derive future revenue by continuing to both expand our own dedicated salesforce and increase awareness of Barostim among payers, physicians, and patients. 74 Table of Contents 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.
These factors include: ● Growing and supporting our U.S. commercial organization; ● Promoting awareness among physicians, hospitals, and patients to accelerate adoption of Barostim; ● Continuing to develop and disseminate clinical evidence supporting the benefits of Barostim; 74 Table of Contents ● Raising awareness among payers to build upon reimbursement for Barostim; ● Investing in research and development to foster innovation; and ● Leveraging our manufacturing capacity to further improve our gross margins.
These factors include: ● Growing and supporting our U.S. commercial organization; ● Promoting awareness among physicians, hospitals, and patients to accelerate adoption of Barostim; ● Continuing to develop and disseminate clinical evidence supporting the benefits of Barostim; ● Raising awareness among payers to build upon reimbursement for Barostim; ● Investing in research and development to foster innovation; and ● Leveraging our manufacturing capacity to further improve our gross margins.
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 three years.
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 two years.
We expect cost of goods sold to increase in absolute dollars primarily as, and to the extent, our revenue grows. Gross margin may also vary based on regional differences in rebates and incentives negotiated with certain customers. We calculate gross margin as revenue less cost of goods sold divided by revenue.
We expect cost of goods sold to increase in absolute dollars primarily as, and to the extent, our revenue grows. Gross margin may also vary based on regional differences in rebates and incentives negotiated with certain customers. 76 Table of Contents We calculate gross margin as revenue less cost of goods sold divided by revenue.
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 75 Table of Contents R&D expenses may fluctuate from period to period due to the timing and extent of our product development and clinical trial expenses.
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.
Stock-based compensation We maintain an equity incentive plan that was adopted in 2001 to provide long-term incentives for employees, consultants, and members of the Board of Directors. The plan allows for the issuance of non-statutory and 80 Table of Contents incentive stock options to employees and non-statutory stock options to consultants and non-employee directors.
Stock-based compensation We maintain an equity incentive plan that was adopted in 2001 to provide long-term incentives for employees, consultants, and members of the Board of Directors. The plan allows for the issuance of non-statutory and incentive stock options to employees and non-statutory stock options to consultants and non-employee directors.
Our gross margin has been and will continue to be affected by a variety of factors, but is primarily driven by the average sale price 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.
Our gross margin has been and will continue to be affected by a variety of factors, but is primarily driven by the ASP 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.
Approximately $8.4 million of the increase in non-cash stock-based compensation expense is related to the modification of stock options held by our 77 Table of Contents 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.
Approximately $8.4 million of the decrease 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.
Cash provided by financing activities: Net cash provided by financing activities for the year ended December 31, 2024 was $55.9 million and consisted of $32.5 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 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, 2024 was $55.9 million and consisted of $32.5 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 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.
We had $50.0 million in outstanding Term Loans under the Loan Agreement at December 31, 2024. ​ 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.
We had $50.0 million in outstanding Term Loans under the Loan Agreement at December 31, 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 ATM offering, to or through the agent.
Indebtedness On October 31, 2022, we entered into the Loan Agreement with Innovatus, as the collateral agent and a lender, 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.
Indebtedness On October 31, 2022, we entered into the Loan Agreement with Innovatus, as the collateral agent and a lender, allowing us to borrow, subject to our achievement of certain milestones, up to a total of $50.0 million in a series of term loans.
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 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 consolidated financial statements included elsewhere in this Annual Report on Form 10-K.
Liquidity, capital resources and plan of operations 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 December 31, 2024 and 2023, we had cash and cash equivalents of $105.9 million and $90.6 million, respectively.
Liquidity, capital resources and plan of operations 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 December 31, 2025 and 2024, we had cash and cash equivalents of $75.7 million and $105.9 million, respectively.
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.
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 issued 543,462 shares of common stock for gross proceeds of $9.5 million during the year ended December 31, 2025.
Other income, net Other income, net was $4.0 million for the year ended December 31, 2024, compared to $3.9 million for the year ended December 31, 2023. This increase was primarily driven by greater interest income on our interest-bearing accounts. Provision for income taxes Provision for income taxes was nominal for the years ended December 31, 2024 and 2023.
Other income, net 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. This decrease was primarily driven by less interest income on our interest-bearing accounts . Provision for income taxes Provision for income taxes was nominal for the years ended December 31, 2025 and 2024.
Net cash used in operating activities for the year ended December 31, 2023 was $39.0 million and consisted primarily of a net loss of $41.2 million and a decrease in net operating assets of $4.8 million, partially offset by $6.3 million from non-cash stock-based compensation expense, $0.5 million from the depreciation of property and equipment and $0.2 million from amortization of deferred financing costs and loan discount.
Net cash used in operating activities for the year ended December 31, 2024 was $39.1 million and consisted primarily of a net loss of $60.0 million, partially offset by $19.1 million from non-cash stock-based compensation expense, an increase in net operating assets of $0.9 million, $0.6 million from the depreciation of property and equipment, and $0.2 million from amortization of deferred financing costs and loan discount.
As of December 31, 2024, we had a total of 223 active implanting centers in the U.S., as compared to 178 as of December 31, 2023. Active implanting centers are customers that have completed at least one commercial HF implant in the last 12 months.
Active implanting centers are customers that have completed at least one commercial HF implant in the last 12 months. As of December 31, 2025, we had 53 sales territories in the U.S. as compared to 48 sales territories as of December 31, 2024.
We have remaining capacity to issue and sell up to $16.2 million of additional shares of common stock under this ATM offering. ​ Our future liquidity and capital funding requirements will depend on numerous factors, including: ● our investment in our U.S. commercial infrastructure and sales forces; ● the degree and rate of market acceptance of Barostim and the ability for our customers to obtain appropriate levels of reimbursement; ● the costs of commercialization activities, including product sales, marketing, manufacturing, and distribution; ● our R&D activities for product enhancements and to expand our indications; 78 Table of Contents ● the costs of filing, prosecuting, defending, and enforcing any patent claims and other intellectual property rights; ● our need to implement additional infrastructure and internal systems; ● our ability to hire additional personnel to support our operations as a public company; and ● the emergence of competing technologies or other adverse market developments.
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. ​ Our future liquidity and capital funding requirements will depend on numerous factors, including: ● our investment in our U.S. commercial infrastructure and sales forces; ● the degree and rate of market acceptance of Barostim and the ability for our customers to obtain appropriate levels of reimbursement; ● the costs of commercialization activities, including product sales, marketing, manufacturing, and distribution; ● our R&D activities for product enhancements and to expand our indications; ● the costs of filing, prosecuting, defending, and enforcing any patent claims and other intellectual property rights; ● our need to implement additional infrastructure and internal systems; ● our ability to hire additional personnel to support our operations as a public company; and ● the emergence of competing technologies or other adverse market developments.
This change was driven by a $12.7 million increase in non-cash stock-based compensation expense, an $11.0 million increase in compensation expenses, mainly as a result of increased headcount, a $1.3 million increase in travel expenses, a $0.6 million increase in bad debt expenses, and a $0.5 million increase in consulting expenses.
This change was driven by a $7.9 million decrease in non-cash stock-based compensation expense, a $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 and a $1.5 million increase in travel expenses.
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.
Our net cash used in operating activities for the years ended December 31, 2025 and 2024 was $40.2 million and $39.1 million, respectively. 79 Table of Contents 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.
Selling, general and administrative expenses SG&A expenses increased $26.8 million, or 42%, to $91.3 million for the year ended December 31, 2024, compared to the year ended December 31, 2023.
Selling, general and administrative expenses SG&A expenses decreased $2.8 million, or 3%, to $88.5 million for the year ended December 31, 2025, compared to the year ended December 31, 2024.
As a result, our financial statements may not be comparable to the financial statements of issuers who are required to comply with the effective dates for new or revised accounting standards that are applicable to public companies, which may make comparison of our financials to those of other public companies more difficult. 81 Table of Contents Recent accounting pronouncements A discussion of recent accounting pronouncements is included in Note 2 to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K.
As a result, our financial statements may not be comparable to the financial statements of issuers who are required to comply with the effective dates for new or revised accounting standards that are applicable to public companies, which may make comparison of our financials to those of other public companies more difficult.
As of December 31, 2024, we had five sales territories in Europe as compared to six sales territories as of December 31, 2023. ​ Cost of goods sold and gross margin Cost of goods sold increased $2.1 million, or 33%, to $8.3 million for the year ended December 31, 2024, compared to the year ended December 31, 2023.
As of December 31, 2025 and December 31, 2024, we had five sales territories in Europe. ​ 78 Table of Contents Cost of goods sold and gross margin Cost of goods sold decreased $23,000 to $8.3 million for the year ended December 31, 2025, compared to the year ended December 31, 2024.
The APC payment of approximately $45,000 will continue in 2025, as published in the 2025 OPPS final rule. Factors affecting our performance We believe there are several important factors that have impacted and that we expect will continue to impact our business and results of operations.
Factors affecting our performance We believe there are several important factors that have impacted and that we expect will continue to impact our business and results of operations.
In connection with the IPO, we adopted the 2021 Equity Incentive Plan under which we may grant equity incentive awards to eligible employees (including our named executive officers), non-employee directors and consultants in order to enable us to obtain and retain services of these individuals, which we deem as essential to our long-term success.
In connection with the IPO, we adopted the 2021 Equity Incentive Plan under which we may grant equity incentive awards to eligible employees (including our named executive officers), non-employee directors and consultants in order to enable us to obtain and retain services of these individuals, which we deem as essential to our long-term success. 82 Table of Contents We recognize equity-based compensation expense for awards of equity instruments to employees and non-employees based on the grant date fair value of those awards in accordance with Financial Accounting Standards Board Accounting Standards Codification Topic 718, Compensation—Stock Compensation (“ASC 718”).
Cash flows The following table sets forth the primary sources and uses of cash for each of the periods presented below: ​ ​ ​ ​ ​ ​ ​ ​ Year ended ​ ​ December 31 (in thousands) ​ 2024 2023 Net cash (used in) provided by: ​ ​ Operating activities ​ $ (39,144) $ (39,021) Investing activities ​ (1,361) (591) Financing activities ​ 55,870 23,984 Effect of currency exchange on cash and cash equivalents ​ (1) 3 Net change in cash and cash equivalents ​ $ 15,364 $ (15,625) ​ Cash used in operating activities Net cash used in operating activities for the year ended December 31, 2024 was $39.1 million and consisted primarily of a net loss of $60.0 million, partially offset by $19.1 million from non-cash stock-based compensation expense, an increase in net operating assets of $0.9 million, $0.6 million from the depreciation of property and equipment, and $0.2 million from amortization of deferred financing costs and loan discount.
If we are unable to obtain additional financing when needed to satisfy our liquidity requirements, we may be required to delay the commercialization and marketing of Barostim. 80 Table of Contents Cash flows The following table sets forth the primary sources and uses of cash for each of the periods presented below: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year ended ​ ​ December 31 (in thousands) ​ 2025 ​ ​ ​ 2024 Net cash (used in) provided by: ​ ​ ​ ​ Operating activities ​ $ (40,170) $ (39,144) Investing activities ​ (580) (1,361) Financing activities ​ 10,520 55,870 Effect of currency exchange on cash and cash equivalents ​ 5 (1) Net change in cash and cash equivalents ​ $ (30,225) $ 15,364 ​ Cash used in operating activities Net cash used in operating activities for the year ended December 31, 2025 was $40.2 million and consisted primarily of a net loss of $53.3 million, partially offset by $11.1 million from non-cash stock-based compensation expense, an increase in net operating assets of $1.0 million, $0.8 million from the depreciation of property and equipment, $0.2 million from amortization of deferred financing costs and loan discount, and $0.1 million from the disposal of equipment.
Revenue generated in the U.S. was $47.2 million for the year ended December 31, 2024, an increase of $12.1 million, or 34%, over the year ended December 31, 2023. HF revenue units in the U.S. totaled 1,506 and 1,123 for the years ended December 31, 2024 and 2023, respectively.
Revenue generated in the U.S. was $51.9 million for the year ended December 31, 2025, an increase of $4.7 million, or 10%, over the year ended December 31, 2024. Revenue units in the U.S. totaled 1,648 and 1,522 for the years ended December 31, 2025 and 2024, respectively.
As a result of these investments and 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. ​ Recent developments On November 4, 2024, we announced that CMS assigned the Barostim procedure to New Technology APC 1580.
As a result of the 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. ​ Recent developments In October 2025, the CMS released the final 2026 Medicare Physician Fee Schedule.
Net cash provided by financing activities for the year ended December 31, 2023 was $24.0 million and consisted of $22.5 million related to proceeds from debt financing, $0.9 million related to proceeds from the ESPP and $0.7 million related to proceeds from the exercise of common stock options, partially offset by debt financing costs of $0.2 million.
Cash provided by financing activities: Net cash provided by financing activities for the year ended December 31, 2025 was $10.5 million and consisted of $9.0 million related to proceeds from the issuance of common stock through the ATM offering, $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”).
HF revenue in the U.S. totaled $46.8 million and $34.6 million for the years ended December 31, 2024 and 2023, 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.
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. As of December 31, 2025, we had a total of 252 active implanting centers in the U.S., as compared to 223 as of December 31, 2024.
Interest expense Interest expense increased $2.6 million to $4.4 million for the year ended December 31, 2024, compared to the year ended December 31, 2023. This increase was driven by the interest expense on higher levels of borrowings under the Loan Agreement entered into on October 31, 2022.
Interest expense Interest expense increased $1.4 million to $5.8 million for the year ended December 31, 2025, compared to the year ended December 31, 2024. This increase was driven by the interest expense on borrowings under the Term Loan Agreement with Innovatus Capital Partners.
On September 30, 2024, we borrowed the remaining $20.0 million under the third and final tranche of the Loan Agreement. The term loans advanced pursuant to the Loan Agreement (collectively, the “Term Loans”) bear interest at a floating rate per annum equal to the sum of (a) the greater of (i) the prime rate and (ii) 5.50% plus (b) 2.65%.
Initially, the term loans advanced pursuant to the Loan Agreement (collectively, the “Term Loans”) bore interest at a floating rate per annum equal to the sum of (a) the greater of (i) the prime 81 Table of Contents rate and (ii) 5.50%; plus (b) 2.65%. On January 9, 2026, we entered into an Amendment to our existing Loan Agreement.
We had $50.0 million in outstanding Term Loans under the Loan Agreement at December 31, 2024.
We had $50.0 million in outstanding Term Loans under the Loan Agreement as of December 31, 2025. On the closing date of the Amendment, we borrowed an additional $10.0 million under the Loan Agreement.
For the years ended December 31, 2024 and 2023, our net losses were $60.0 million and $41.2 million, respectively. Our net cash used in operating activities for the years ended December 31, 2024 and 2023 was $39.1 million and $39.0 million, respectively.
For the years ended December 31, 2025 and 2024, our net losses were $53.3 million and $60.0 million, respectively.
Additional financing may not be available at all or may only be available in amounts or on terms that we do not deem to be favorable. If we are unable to obtain additional financing when needed to satisfy our liquidity requirements, we may be required to delay the commercialization and marketing of Barostim.
Additional financing may not be available at all or may only be available in amounts or on terms that we do not deem to be favorable.
Net operating assets consisted primarily of inventory, accounts receivable, prepaid expenses and other current assets, accrued expenses to support the growth of our operations and accounts payable. 79 Table of Contents Cash used in investing activities: Cash used in investing activities was $1.4 million and $0.6 million for the years ended December 31, 2024 and 2023, respectively, and consisted of purchases of property and equipment.
Cash used in investing activities: Cash used in investing activities was $0.6 million and $1.4 million for the years ended December 31, 2025 and 2024, respectively, and consisted of purchases of property and equipment.
Total revenue units in Europe decreased to 204 for the year ended December 31, 2024, from 207 for the prior year.
Revenue generated in Europe was $4.8 million for the year ended December 31, 2025, an increase of $0.6 million, or 16%, over the year ended December 31, 2024. Total revenue units in Europe increased to 219 for the year ended December 31, 2025, from 204 for the prior year.
Research and development expenses R&D expenses decreased $0.5 million, or 4%, to $11.1 million for the year ended December 31, 2024, compared to the year ended December 31, 2023.
Research and development expenses R&D expenses were $11.1 million for the years ended December 31, 2025 and December 31, 2024, respectively. R&D expense for the year ended December 31, 2025 included a $0.4 million increase in compensation expenses, mainly as a result of increased headcount, offset by a $0.5 million decrease in clinical study expenses.
A performance covenant took effect upon the third tranche funding, requiring that we achieve 50% of the trailing twelve months revenue target set in the Board-approved revenue plan in effect for such period. ​ Critical accounting policies and estimates The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires our management to make estimates and judgments that affect the amounts reported in our consolidated financial statements and accompanying notes included elsewhere in this Annual Report on Form 10-K.
The Loan Agreement requires the payment of certain penalties if the Term Loans are paid off prior to maturity for any reason, including pursuant to an acceleration clause, and includes various restrictive covenants, including a restriction on the payment of dividends or making other distributions or payments on our capital stock, subject to limited exceptions. ​ Critical accounting policies and estimates The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires our management to make estimates and judgments that affect the amounts reported in our consolidated financial statements and accompanying notes included elsewhere in this Annual Report on Form 10-K.
This increase was primarily due to higher sales of Barostim. Gross profit was $43.0 million for the year ended December 31, 2024, an increase of $9.9 million, or 30%, over the year ended December 31, 2023. Gross margin was 84% for both the years ended December 31, 2024 and 2023.
This decrease was driven by a lower cost per unit, primarily due to an increase in manufacturing efficiencies. Gross profit was $48.3 million for the year ended December 31, 2025, an increase of $5.4 million, or 13%, over the year ended December 31, 2024.
On the closing date, we borrowed the minimum amount of $7.5 million under the Loan Agreement. On March 10, 2023, we borrowed the $7.5 million remaining under the first tranche of the Loan Agreement. On December 15, 2023, we borrowed $15.0 million under the second tranche of the Loan Agreement.
We had $50.0 million in outstanding principal amount of Term Loans under the Loan Agreement at December 31, 2025 and, on the closing date of the Amendment, we borrowed an additional $10.0 million.
Removed
We maintain a full valuation allowance for deferred tax assets including NOL carryforwards, R&D credits, and other tax credits.
Added
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.
Removed
As of December 31, 2024, we had 48 sales territories in the U.S. as compared to 38 sales territories as of December 31, 2023. Revenue generated in Europe was $4.1 million for the year ended December 31, 2024, a decrease of $0.1 million, or 1%, over the year ended December 31, 2023.
Added
This final rule includes the new Category I CPT codes for the Barostim implant and follow-up services. The rule establishes national pricing for the code series used to report procedures associated with Barostim, supporting continued access for Medicare beneficiaries.
Removed
This change was primarily driven 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.
Added
We expect the transition to Category I will eliminate the automatic denials regularly seen with Category III codes and improve prior authorization predictability to fairly pay physicians for the procedure. The final rule took effect January 1, 2026.
Removed
The Term Loans mature on January 31, 2028 and require interest-only payments until November 1, 2027. The Term Loans are secured by substantially all of our personal property.
Added
In November 2025, the FDA granted an IDE study designed as a prospective, multi-center, randomized controlled trial to evaluate the Barostim device’s impact on all-cause mortality and HF decompensation events in an expanded population of HF patients. In January 2026, we initiated the trial, supported by CMS Category B IDE coverage.
Removed
We recognize equity-based compensation expense for awards of equity instruments to employees and non-employees based on the grant date fair value of those awards in accordance with Financial Accounting Standards Board Accounting Standards Codification Topic 718, Compensation—Stock Compensation (“ASC 718”).
Added
We expect to begin enrolling the trial across approximately 150 centers in the first half of 75 Table of Contents 2026 and complete enrollment within five years. The trial provides for a two-year follow-up period, resulting in the expected conclusion of the trial in five to seven years.
Added
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, and the maturity date was extended to 2031.
Added
On the closing date, we borrowed an additional $10.0 million under the Loan Agreement. On January 12, 2026, we entered into an Open Market Sale Agreement SM (the “Sale Agreement”) with Jefferies LLC, as agent.
Added
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 “at-the-market” (“ATM”) offering, to or through the agent.
Added
Gross margin increased to 85% for the year ended December 31, 2025 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 a decrease in the cost per unit, primarily due to an increase in manufacturing efficiencies.
Added
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.
Added
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.
Added
Net operating assets consisted primarily of accrued expenses, accounts receivable, accounts payable, prepaid expenses and other current assets, and inventory to support the growth of our operations .
Added
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, and now bear interest at a floating rate per annum equal to the sum of (a) the greater of (i) the prime rate and (ii) 6.75% plus (b) 2.65%, which margin will decrease to 2.00% after we achieve a positive adjusted EBITDA for two consecutive quarters.
Added
We have the option to draw an additional (i) $15 million between June 1, 2027 and December 31, 2027 upon achieving trailing 6-month revenue of $37.5 million and market capitalization greater than $190 million, and (ii) $25 million between March 1, 2028 and September 30, 2028 upon achieving trailing 6-month revenue of $47.5 million and market capitalization greater than $300 million. ​ The Loan Agreement initially required interest only payments through November 2027, followed by three monthly principal and interest payments, of which a principal payment of $16.7 million was due in December 2027 and two principal payments of $16.7 million each were due in January 2028.
Added
Subsequent to the Amendment, the Loan Agreement requires interest only payments through January 2030, subject to a further one-year extension upon our achievement of certain milestones, followed by 16 monthly principal and interest payments, of which a principal payment of $3.8 million is due in each of these months.
Added
A final payment of $2.7 million, equal to 4.5% of the borrowed principal, is due in May 2031. The Term Loans are secured by substantially all of our personal property.
Added
A performance covenant took effect upon the third tranche funding, requiring that we achieve 50% of the trailing twelve months revenue target set in the Board-approved revenue plan in effect for such period, which will be suspended when trailing 12-month revenue exceeds $100 million.
Added
Recent accounting pronouncements A discussion of recent accounting pronouncements is included in Note 2 to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K. 83 Table of Contents

Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

1 edited+0 added−0 removed5 unchanged
Biggest changeCredit risk As of December 31, 2024 and 2023, our cash and cash equivalents were maintained with financial institutions which we believe have sufficient assets and liquidity to conduct their operations in the ordinary course of business with little or no credit risk to us; however, our cash balances were in excess of insured limits. ​ 82 Table of Contents
Biggest changeCredit risk As of December 31, 2025 and 2024, our cash and cash equivalents were maintained with financial institutions which we believe have sufficient assets and liquidity to conduct their operations in the ordinary course of business with little or no credit risk to us; however, our cash balances were in excess of insured limits. ​ 84 Table of Contents

Other CVRX 10-K year-over-year comparisons