What changed in this filing

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Item 1. Business

2026-02-13 compared with 2025-02-18 · 137 added, 124 removed, 750 unchanged (26% of the section changed)

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Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in HF patients in the U.S.

We estimate that our annual market opportunity for HFrEF is $2.2 billion in the U.S.

and $2.8 billion in select European Markets (Germany, France, Italy, Spain, and the United Kingdom, or “European Five”).

We estimate our total market opportunity using both prevalence and incidence epidemiologic models in which prevalence reflects the total number of individuals indicated for therapy at a given time, while incidence captures the annual occurrence of new cases meeting the indication.

Based on these distinct models, we estimate that our prevalence-based market opportunity for HFrEF is $10.5 billion in the U.S.

Using an incidence-based model, we estimate an annual market opportunity of $2.4 billion in the U.S.

HF is one of the most prevalent and devastating cardiovascular diseases.

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.

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Approximately 75% of HFrEF patients die within five years of being admitted to the hospital for HFrEF.

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.

These other implantable devices mostly target different HFrEF patient populations, may require an invasive procedure that places hardware directly inside the heart, and are not designed to address the imbalance of the ANS that causes the disease.

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Our BeAT-HF pivotal trial, which was a multi-center, prospective, randomized, controlled trial, met the primary safety and effectiveness endpoints and demonstrated meaningful improvement in the quality of life, both physically and emotionally, for patients suffering from HFrEF.

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.

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.

In December 2023, the FDA approved expanded labeling for Barostim based on the BeAT-HF trial data, resulting in simplification and clarification of the indications for use, as well as inclusion of the primary endpoint results, the 6, 12 and 24 month symptomatic data, the Win Ratio and the all-cause mortality data in the “Clinical Summary” discussion included in Barostim’s indications for use.

We currently believe our annual market opportunity in the U.S.

is an estimated $2.2 billion, or 76,000 patients, based on this new long-term safety and effectiveness data as well as our commercial experience and, as discussed below, the new reimbursement assignment for Barostim in 2025.

We currently believe, using a prevalence-based epidemiologic model, our market opportunity in the U.S.

is an estimated $10.5 billion, or 339,000 patients.

We continue to develop and expand upon our significant body of published clinical evidence that supports the meaningful benefits of Barostim Therapy.

We are continuing to collect data through the U.S.

patient registry

that we have established in order to evaluate and assess real world outcomes from HFrEF patients who have been implanted with Barostim.

We are investigating the benefits of Barostim in an expanded population of patients with HF with mildly Reduced Ejection Fraction (“HFmrEF”) and HFrEF with NT-proBNP < 5,000 pg/mL in a large, multi-center, randomized controlled trial.

If successful, we believe that our market

opportunity in the U.S.

could increase to an estimated $30.5 billion or 983,000 patients using a prevalence-based epidemiologic model.

We are also analyzing data from U.S.

and European Union (“EU”) patient registries and other real world evidence (“RWE”) datasets, in order to evaluate and assess a comprehensive view of outcomes from HFrEF patients who have been implanted with Barostim.

We are continuing to invest in investigator-sponsored studies, driven by the strong interest of independent clinicians seeking to further validate the mechanisms underlying the device’s benefits.

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.

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.

and Germany and through distributors in Austria, Spain, and other European countries.

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.

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

Our primary activities include continuing to increase education and awareness among physicians, advanced practice providers and patients, develop a more robust portfolio of clinical evidence, and improve patient access to Barostim Therapy.

We generated revenue of $56.7 million, a gross margin of 85% and a net loss of $53.3 million for the year ended December 31, 2025, compared to revenue of $51.3 million, a gross margin of 84% and a net loss of $60.0 million for the year ended December 31, 2024.

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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.

HF is associated with a five-fold increase in sudden cardiac death.

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These two systems are strongly influenced by baroreceptors that are located in carotid artery walls.

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).

Baroreceptors provide beat-by-beat regulation of the body’s circulatory system by sending electrical signals to the brain.

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Despite currently available pharmaceutical and device-based treatments, HF remains underpenetrated and imposes significant direct and indirect costs on the healthcare system through patient care, morbidity, unpaid care costs, premature mortality and lost productivity.

We estimate there are approximately 1.2 million HF hospitalizations every year in the U.S., representing approximately $39.5 billion in annual spending.

National U.S.

statistics indicate there are approximately 1.1 million HF hospital discharges every year, and annual costs are expected to reach $70 billion by 2030.

Barostim’s market opportunity

In late 2023, we revised our U.S.

annual market opportunity – based on the long-term safety and effectiveness data of BeAT-HF, our commercial experience and to account for the new reimbursement assignment for Barostim – to $2.2 billion, or 76,000 new patients per year.

We have since also revised our estimate of the European Five annual HFrEF market opportunity to $2.8 billion, or 98,000 patients per year.

This yields a total combined market of $5.0 billion, or 174,000 patients per year.

In late 2025, we revised our market opportunity and now estimate that our prevalence-based market opportunity for HFrEF is $10.5 billion, or 339,000 patients, in the U.S.

We developed our Barostim platform technology to transform the treatment of HFrEF and other cardiovascular diseases and become the standard of care for this vulnerable and underpenetrated patient population.

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The IPG provides control and delivery of electrical pulses to baroreceptors located in the wall of the carotid artery through the stimulation lead.

Nominal dimensions for the current IPG are listed in the figure below:

Nominal dimensions for the current IPG are 68 millimeters in height, 50 millimeters in width, and 14 millimeters in depth.

Stimulation lead

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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.

There are two lengths of the stimulation lead available to allow for anatomical variations to be used at the physician’s discretion.

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, implant tool and implant adaptor, all of which were designed to facilitate the implantation of Barostim.

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.

Once implanted, Barostim is managed wirelessly by a programmer that communicates with the IPG.

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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.

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.

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.

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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.

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.

Investment in clinical evidence continues to be one of our core strategies, and we intend to continue to develop and expand upon a significant body of published clinical evidence that supports the safety and effectiveness of Barostim Therapy.

Clinicians using Barostim often identify key insights and propose single- or multi-center studies to explore its physiological mechanisms in indicated patients.

We actively invest in scientifically rigorous protocols to advance these initiatives, aligning with our strategy to build a comprehensive evidence base.

Pivotal phase III study:

In November 2025, the Food and Drug Administration granted an investigational device exemption (“IDE”) study designed as a prospective, multi-center, randomized controlled trial to evaluate the Barostim device’s impact on all-cause mortality and heart failure decompensation events in an expanded population of HF patients.

In January 2026, we initiated the trial, supported by CMS Category B IDE coverage.

We expect to begin enrolling the trial across approximately 150 centers in the first half of 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.

We expect net trial costs of $20 million to $30 million spread over the period of the trial.

A successful outcome could expand Barostim’s total addressable prevalence-based U.S.

market from approximately 339,000 patients to approximately 983,000 patients, representing a sales market opportunity from $10.5 billion to $30.5 billion.

Design summary

• Prospective, randomized, controlled trial at up to 200 centers in the U.S.

and Germany, randomizing 2,500 patients with two-year follow-up.

• 2:1 randomization to Barostim implantation or control group receiving only guideline-directed medical and device therapies.

• Eligibility:

NYHA Class II or III symptoms, LVEF <50%, and NT-proBNP levels of 400 to <5,000 pg/mL, despite optimal medical and device therapies.

• Primary efficacy endpoint:

Composite of all-cause death, LVAD implantation, heart transplant, and HF events requiring emergency department visits or hospitalization.

• Secondary endpoints:

Improvements in MLWHF, 6-MHW test, days alive and out of hospital through 24 months, NT-proBNP changes at 12 months, and all-cause mortality through 24 months.

• Supplemental endpoint:

LVEF changes at 6, 12, and 24 months.

• Safety assessment:

MANCE within 180 days post-implantation.

Pivotal phase III study:

BeAT-HF was a multi-center, prospective, randomized, controlled trial that began in April 2016 to develop scientific evidence for the safety and effectiveness of BAT with Barostim.

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Additional post-market phase effectiveness analyses (Win Ratio and freedom from all-cause mortality) suggested a favorable effect of Barostim Therapy.

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 < 1600 pg/ml.

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 < 1,600 pg/mL.

Pre-market phase results

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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 < 0.001;

MLWHF is a self-administered disease-specific questionnaire for HF, which is comprised of 21 questions rated on six-point Likert scales, representing different degrees of impact of HF on a patient’s quality of life, and is approved by the FDA as a Medical Device Development Tool.

MLWHF is a self-administered disease-specific questionnaire for HF, which is comprised of 21 questions

rated on six-point Likert scales, representing different degrees of impact of HF on a patient’s quality of life, and is approved by the FDA as a Medical Device Development Tool.

According to the medical community, a 5-point improvement is considered to be clinically meaningful.

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It also demonstrated that the reduction is accompanied by the improvement of a major modulator of sympathetic activity, the arterial baroreflex and baroreflex activation is accompanied by favorable therapeutic impact on cardiac function and clinical profile, as shown in the improved quality of life, increased exercise tolerance and improved NYHA functional status.

Other clinical trials

BATwire implant toolkit

In the second half of 2020, the FDA approved a two-stage pivotal trial design to assess the safety and effectiveness of the BATwire implant toolkit.

This trial was expected to enroll up to 400 subjects and follow up to 100 implanted subjects for one year.

In April 2024, we suspended enrollment in the BATwire clinical trial

because of slow recruitment, due in part to trial candidates choosing the commercially approved procedure.

All enrolled patients will be followed per the protocol until the trial is completed.

We have completed two clinical trials in Europe and North America for the treatment of drug-resistant hypertension using our first-generation Barostim Therapy device called Rheos, and determined this study was successful in achieving three of the required five safety and effectiveness endpoints (“ Baroreflex Activation Therapy Lowers Blood Pressure in Patients with Resistant Hypertension:

Other clinical trial

Therapy Lowers Blood Pressure in Patients with Resistant Hypertension:

Results from the Double-Blind, Randomized, Placebo-Controlled Rheos Pivotal Trial ,” by John D.

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In December 2019, after review of the clinical data and the competitive landscape, FDA granted a Breakthrough Device designation for Barostim for the treatment of resistant hypertension.

In March 2020, after review of early clinical data and the competitive landscape, the FDA granted a Breakthrough Device designation for Barostim for the treatment of HFpEF.

In 2023, the FDA admitted us into the Total Life Cycle Advisory Program (“TAP”) for Barostim’s treatment of HFpEF.

TAP is an initial pilot program limited only to Breakthrough Device designated indications for new products.

Sales and marketing

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Barostim has FDA approval to improve symptoms of HFrEF in the U.S.

and an Active Implantable Medical Device Directive (“AIMDD”) CE Mark for the treatment of HFrEF and resistant hypertension in Europe.

and Medical Device Regulation (“MDR”) approval for the treatment of HFrEF and resistant hypertension in Europe.

Additionally, the EU approved an amendment to the MDR (as defined below) which allows qualifying AIMDD CE certificates to be accepted through December of 2027.

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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.

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.

and Germany, and through distributors in Austria, Spain, and other European countries.

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 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 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.

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.

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.

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 also employ Field Clinical Specialists who generally have experience in medical device clinical support.

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.

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.

Our marketing organization is focused on building physician awareness through targeted KOL development, referral network education and direct-to-consumer marketing.

Our marketing organization is focused on

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.

Our primary method of patient outreach is through digital social networks.

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.

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.

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

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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.

Implantation of Barostim is described by CPT code 0266T, a Category III code approved in July 2011 and effective as of January 2012.

Hospitals are able to use this code to submit for a system implant payment.

CPT code 0268T is used to submit for an IPG replacement procedure payment, and CPT codes 0272T and 0273T are used for interrogation and programming of the IPG, respectively.

We believe these Category III codes will be transitioned to Category I codes on January 1, 2026.

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.

Prior to 2026, the implantation of Barostim was described by CPT code 0266T, a Category III code.

Hospitals were able to use this code to submit for a system implant.

CPT code 0268T was used to submit for an IPG replacement procedure, and CPT codes 0272T and 0273T were used for interrogation and programming of the IPG, respectively.

Effective January 2026, implantation of Barostim is described by CPT code 64654, a Category I code.

CPT code 64655 is used to submit for an IPG replacement procedure, and CPT codes 93145 and 93146 are used for interrogation and programming of the IPG, respectively.

Medicare provides reimbursement to hospitals using Barostim under the hospital outpatient prospective system (“OPPS”), which provides bundled amounts generally intended to reimburse a hospital for all facility costs related to procedures performed in its outpatient setting.

On January 1, 2024, the Barostim implant procedure was reassigned to New Technology APC 1580, which carries an average payment amount of approximately $45,000.

The APC payment of approximately $45,000 will continue in 2025, as published in the 2025 OPPS ﬁnal rule.

The IPG replacement will continue to be assigned to Level 5 Neurostimulator payment APC 5465, which has a national average of approximately $30,500.

In August 2024, CMS reassigned the Barostim implant procedure for the inpatient setting as part of the Medicare Hospital Inpatient Prospective Payment System (“IPPS”) final rule for CMS’ Fiscal Year 2025, which

took effect on October 1, 2024.

On that date, Barostim was reassigned to MS-DRG 276, which carries a national average payment of approximately $44,000 in 2025.

These 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.

On January 1, 2024, the Barostim implant procedure was reassigned to New Technology APC 1580, which currently has an average payment amount of approximately $45,000.

The IPG replacement will continue to be assigned to Level 5 Neurostimulator payment APC 5465, which currently has an average payment amount of approximately $31,500.

Reimbursement rates from commercial payers for procedures performed in the outpatient setting vary depending on a variety of factors.

Medicare provides reimbursement to hospitals using Barostim under the hospital inpatient prospective system (“IPPS”), which provides bundled amounts generally intended to reimburse a hospital for all facility costs related to procedures performed in its inpatient setting.

On October 1, 2024, the Barostim implant procedure was reassigned to MS-DRG 276, which currently has an average payment amount of approximately $44,000.

Reimbursement 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.

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.

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.

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We believe our market access team is highly effective in obtaining prior authorizations, including navigating the appeals process.

We believe that we will continue to benefit from this efficient prior authorization process in the near-and-long-term by expanding on our positive coverage policies with commercial payers.

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.

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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.

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.

This OPS code is combined with G-DRG ICD I50.13 to cover reimbursement of Barostim for the treatment of HFrEF.

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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.

For both the years ended December 31, 2025 and 2024, we incurred research and development expenses of $11.1 million.

Our industry is subject to rapid change from the introduction of new products and technologies and other activities of industry participants.

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As of December 31, 2025, we owned 41 issued U.S.

patents and had six pending U.S.

patents and had 18 pending U.S.

patent applications.

Outside of the U.S., we owned nine patents in multiple countries and had 10 pending 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.

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Our products are subject to regulation as medical devices under the Federal Food, Drug, and Cosmetic Act (the “FDCA”), as implemented and enforced by the FDA.

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.

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.

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requires either FDA clearance of a 510(k) premarket notification, HDE, or PMA approval.

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.

Class I includes devices with the lowest risk to the patient and are those for which safety and effectiveness can be assured by adherence to the FDA’s General Controls for medical devices, which include compliance with the applicable portions of the Quality System Regulation (“QSR”), facility registration and product listing, reporting of adverse medical events and truthful and non-misleading labeling, advertising and promotional materials.

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If the FDA accepts the application for review, it has 180 days under the FDCA to complete its review of a PMA, although in practice, the FDA’s review often takes significantly longer, and at times can take up to several years.

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

approvability of the device.

In addition, the FDA will generally conduct a preapproval inspection of the applicant or its third-party manufacturers’ or suppliers’ manufacturing facilities to ensure compliance with the QSR.

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Clinical trials are usually required to support a PMA and are sometimes required to support an HDE, 510(k) or De Novo submission.

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.

If the device presents a “significant risk” to human health, as defined by the FDA, the FDA requires the device sponsor to submit an IDE application to the FDA, which must be approved prior to commencing human clinical trials.

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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:

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”).

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 MDR repealed and replaced the EU Medical Devices Directive (Council Directive 93/42/EEC — “MDD” or Council Directive 90/385/EEC).

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The regulations impose strict demands on medical device manufacturers and the Notified Bodies whom they must involve in the conformity assessment procedure.

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.

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:

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To avoid market disruption and allow a smooth transition from the MDD/AIMDD to the MDR, several transitional provisions are in place, which include allowing devices lawfully placed on the market prior to expiration of their MDD/AIMDD CE Marks to remain available on the market and be put into service, both under certain prerequisites and until a certain time.

In 2022, we successfully completed the Stage 1 and 2 MDR Quality Management System (“QMS”) audits, and our Notified Body officially issued an approval document stating that the QMS has been assessed to the MDR and approved.

We have since received confirmation that all sections of the submission have been reviewed and all queries have been responded to and the responses accepted.

The file remains under review.

Notably, the European Commission extended qualifying AIMDD CE certificates, including ours, through December 31, 2027.

We received MDR approval for Barostim on April 9, 2025, which included the 9020 Programmer.

Additionally, the European Commission extended qualifying AIMDD CE certificates, including ours, through December 31, 2027.

This extension was driven by delays in notified body reviews and approvals across the medical device industry as well as the fact that a substantial number of CE Mark certificates were continuing to expire during this unpredictable and extended transition period to MDR.

We will continue to supply applicable AIMDD legacy devices until December 2027.

Regulation of medical devices under MDR

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The Notified Body typically audits the quality management system of the manufacturer, which must comply with the current version of ISO 13485 requiring that manufacturers follow defined and approved design and development procedures, testing, control, documentation and other quality assurance procedures throughout the entire design and manufacturing process.

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

If the quality management system audit and the technical file review are successful, the Notified Body issues certificates of conformity.

These certificates entitle the manufacturer to draw up the EU declaration of conformity and affix the CE Mark to the labeling of its medical devices and place the medical device on the EEA market.

CE marking in UK and UK Conformity Assessed marking

Since January 1, 2021, the UK (excluding Northern Ireland) has recognized medical devices with an EEA-issued CE Mark, and has since indicated it will continue to do so until December 31, 2027.

Additionally, certificates issued by EU-recognized Notified Bodies will continue to be valid for the UK market until December 31, 2027.

Since January 1, 2021, all medical devices placed on the UK market must be registered with the Medicines and Healthcare products Regulatory Agency (the “MHRA”).

There are different grace periods depending on the type of medical device to allow time for compliance with the new registration process.

Where a medical device is not already registered with the MHRA, a conformity assessment must be conducted by an “authorised” body (a so-called UK Approved Body, approved by the MHRA) and a separate dossier application for the UKCA marking must be submitted.

However, the data to support an EEA-issued CE Mark is expected to be sufficient for a UKCA mark.

Manufacturers based outside the UK who wish to place a device on the UK market need to appoint a single UK Responsible Person who will take responsibility for the product in the UK.

We have registered with MHRA, have a UK Responsible Person, and are prepared to conduct a conformity assessment when necessary.

CE Marking in Switzerland

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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.

practical standpoint, “performance” is analogous to the term “effectiveness” when applied to our medical devices.

Clinical investigations must be conducted in accord with Good Clinical Practices (ISO 14155) and are subject to audits by the Notified Bodies.

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Manufacturers must guarantee that their medical device continues to provide the promised benefit to patients as well as the lack of any unacceptable risks, through a constant and systematic approach to post-market surveillance.

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.

The reporting also includes any device recalls.

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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.

Failure to comply with EU, UK or Swiss regulatory requirements could prevent us from developing, manufacturing and later selling the products in the respective region.

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Our arrangements with physicians, hospitals and other persons or entities who are in a position to refer may not fully meet the stringent criteria specified in the various safe harbors.

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

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.

Failure to meet all of the requirements of a particular applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under the federal Anti-Kickback Statute.

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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.

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.

Civil penalties for such conduct can further be assessed under the federal civil False Claims Act.

Violations can also result in criminal penalties, including criminal fines of up to $100,000 and imprisonment of up to 10 years.

Violations can also result in criminal penalties, including criminal fines of up to $100,000, or such higher amounts as may be provided by law, and imprisonment of up to 10 years.

Similarly, violations can result in exclusion from participation in government healthcare programs, including Medicare and Medicaid.

Liability under the federal Anti-Kickback Statute may also arise because of the intentions or actions of the parties with

whom we do business.

Liability under the federal Anti-Kickback Statute may also arise because of the intentions or actions of the parties with whom we do business.

While we are not aware of any such intentions or actions, we have only limited knowledge regarding the intentions or actions underlying those arrangements.

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The federal civil False Claims Act also applies to false submissions that cause the government to be paid less than the amount to which it is entitled, such as a rebate.

Intent to deceive is not required to establish liability under the civil federal civil False Claims Act.

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.

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The federal criminal False Claims Act prohibits the making or presenting of a claim to the government knowing such claim to be false, fictitious, or fraudulent and, unlike the federal civil False Claims Act, requires proof of intent to submit a false claim.

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.

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.

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.

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Many foreign countries have similar laws relating to healthcare fraud and abuse.

Foreign laws and regulations may vary greatly from country to country.

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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Also, many U.S.

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.

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.

The federal Physician Payments Sunshine Act imposes annual reporting requirements on certain drug, biologics, medical supplies and device manufacturers for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program for payments and other transfers of value provided by them, directly or indirectly, to physicians (including physician family members), certain other healthcare providers and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.

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.

Manufacturers must submit reports by the 90th day of each calendar year.

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The HIPAA privacy regulations cover the use and disclosure of PHI by covered entities as well as business associates, which are defined to include subcontractors that create, receive, maintain, or transmit PHI on behalf of a business associate.

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

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.

The security regulations establish requirements for safeguarding the confidentiality, integrity and availability of PHI that is electronically transmitted or electronically stored.

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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.

imposes onerous accountability obligations, requiring data controllers and processors to maintain a record of their data processing and policies.

It requires data controllers to be transparent and disclose to data subjects (in a concise, intelligible and easily accessible form) how their personal information is to be used, imposes limitations on retention of information, increases requirements pertaining to pseudonymized (i.e., key-coded) data, introduces mandatory data breach notification requirements and sets higher standards for data controllers to demonstrate that they have obtained valid consent for certain data processing activities.

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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 challenges and amendments in the future.

There have been judicial and Congressional challenges to certain aspects of the Affordable Care Act, and we expect additional amendments in the future.

Moreover, the Trump Administration and the U.S.

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In addition, other legislative changes have been adopted since the Affordable Care Act.

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.

additional Congressional action is taken.

Additionally, the American Taxpayer Relief Act of 2012, among other things, reduced Medicare payments to several providers, including hospitals, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

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corporations and their foreign affiliates, which are intended to prevent the diversion of corporate funds to the payment of bribes and other improper payments, and to prevent the establishment of “off books” slush funds from which such improper payments can be made.

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 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.

Environmental laws

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We consider our relationship with our employees to be good.

Our mission is to advance health for people everywhere, giving each patient a fuller life.

Our mission is to team with clinicians to advance innovative device therapies that modulate the ANS to meaningfully improve the lives of people with chronic disease.

We envision Barostim becoming a standard of care for the treatment of HF, accessible to all who would benefit.

In seeking to accomplish our mission, we rely on our values, which are central to our human capital management policies and practices.

These values are:

• Commitments are Sacred — Honor relationships by doing what we say, when we say we’ll do it.

• Bold Mindset, Driven Spirit — Always push the boundaries, energetically seeking out impactful opportunities and inspiring others.

• Pioneer with Purpose…and a Smile!

— As individuals, team leaders and industry innovators, it’s how we pave the way forward that defines us.

• Collaborate with Enjoyment — Achieve goals and celebrate as a team.

• Determination Overcomes Targets — Determine the pathway, overcome obstacles, accelerate, and successfully implement.

• Embrace the Challenge of Change — Have an eye for identifying when change is needed, and the flexibility to chart a new course.

• Patient Focused — We put patients at the center of every decision:

We are guided by our commitment to improving patient outcomes by delivering uncompromising quality in all we do.

• Integrity — We do what’s right, not what’s easy:

We lead with honesty, transparency, and ethical actions that build trust.

• Collaboration — Together, we achieve more:

We build meaningful partnerships with clinicians, patients, and each other by sharing knowledge, supporting one another, and recognizing our diverse strengths.

• Accountability — We take ownership of results:

We align our actions with our shared vision and deliver on our commitments.

• Innovation — We pioneer impactful solutions:

We continuously innovate technologies and solutions to improve patient outcomes and expand access to our therapies.

• Resilience — We rise to every challenge:

We persevere through obstacles and turn challenges into opportunities as we advance our mission.

Health and safety

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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.

Securities and Exchange Commission (the “SEC”).

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business