What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2025-02-18 compared with 2024-02-09 · 151 added, 150 removed, 723 unchanged (29% of the section changed)

CVRx is a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases.

CVRx is a commercial-stage medical device company focused on developing, manufacturing, and commercializing innovative and minimally invasive neuromodulation solutions for patients with cardiovascular disease.

Barostim is the first medical technology approved by the U.S.

Food and Drug Administration (the “FDA”) that uses neuromodulation to improve the symptoms of patients with heart failure (“HF”).

Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery.

Barostim provides Baroreflex Activation Therapy (“BAT,” or “Barostim Therapy”), which in turn triggers an autonomic response to the heart.

The therapy is designed to restore balance to the Autonomic Nervous System (“ANS”) and thereby reduce the symptoms of HF.

Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery to counteract decreased baroreceptor signaling, which creates an imbalance in the brain’s Autonomic Nervous System (“ANS”) resulting in excess neurohormones that drive HF progression.

Barostim provides Baroreflex Activation Therapy (“BAT,” or “Barostim Therapy”), which links the cardiovascular system to the ANS.

This therapy complements the pharmaceutical neurohormonal blockade, or Guideline Directed Medical Therapy (“GDMT”), by increasing the signaling of the baroreceptors, thereby, reducing symptoms of HF.

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

2 unchanged sentences

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

We estimate that there are approximately 26 million people globally suffering from HF, including approximately 6.2 million people in the U.S.

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.

Every year, 1.3 million and 1.4 million new patients are diagnosed with HF in the U.S.

and the European Five, respectively.

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.

This impacts a patient’s ability to function and leads to a variety of symptoms such as shortness of breath, extreme fatigue, exercise intolerance, swelling, and fluid retention that affects the patient’s quality of life, both physically and emotionally.

HF usually develops from an imbalance of the ANS, which is also the primary cause of multiple other cardiovascular diseases, such as hypertension, angina pectoris and arrhythmia.

The ANS plays a vital role in the function of the heart and is strongly influenced by baroreceptors located in certain arterial walls.

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.

Autonomic activation is also a significant mechanism involved with multiple other cardiovascular diseases, such as hypertension, angina pectoris, and cardiac arrhythmia, as well as other diseases, such as chronic kidney disease.

We are currently focused on the treatment of patients with HF with reduced Ejection Fraction (“HFrEF”), which represent approximately 31% of the patients with HF.

4 unchanged sentences

We believe there is a significant need and market opportunity for a safe, effective, and minimally invasive device-based treatment option for HFrEF.

We believe Barostim offers meaningful benefits for patients, physicians and payors that will continue to drive adoption of our therapy.

We believe Barostim offers meaningful benefits for patients, physicians and payers that will continue to drive adoption of our therapy.

The primary benefits include:

9 unchanged sentences

A 25-meter improvement in walking distance is considered clinically meaningful.

• Quality of life (measured by Minnesota Living with Heart Failure (“MLWHF”)):

Our therapy demonstrated a 14-point, 8-point and 10-point improvement in quality of life for patients in the Barostim group relative to patients in the Control group at 6 months, 1 year and 2 years following implant, again demonstrating sustained improvement.

A 5-point improvement is considered clinically meaningful.

• Quality of life (measured by Minnesota Living with Heart Failure (“MLWHF”) questionnaire):

Our therapy improved quality of life by 14-points at six months, 8-points at one year and 10-points after two years of therapy compared to patients receiving GDMT alone.

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.

A 5-point improvement in the MLWHF questionnaire is considered clinically meaningful.

• Functional status (determined by New York Heart Association (“NYHA”) classification):

Our therapy demonstrated the following improvements in NYHA functional status versus the control group at the specific points in time, meaning Barostim demonstrated greater and sustained improvement:

at 6 months, 67% in the BAT+ group and 37% in the Control group, favoring the BAT+ group by 30 percentage points;

at 1 year, 73% in the BAT+ group and 41% in the Control group, favoring the BAT+ group by 32 percentage points;

and, at 2 years, 68% in the BAT+ group and 41% in the Control group, favoring the BAT+ group by 27 percentage points.

at six months, 67% in the Barostim group and 37% in the control group, favoring the Barostim group by 30 percentage points;

at one year, 73% in the Barostim group and 41% in the control group, favoring the Barostim group by 32 percentage points;

and, at two years, 68% in the Barostim group and 41% in the control group, favoring the Barostim group by 27 percentage points.

• Freedom from All-Cause Death, LVAD, or Transplant.

2 unchanged sentences

Based on a hierarchical composite outcomes analysis (including cardiovascular (“CV”) mortality, LVAD/transplant, HF hospitalization and quality of life), the Win Ratio (defined below) was 1.26 in favor of the Barostim group.

• Implant safety.

T he major adverse neurological or cardiovascular system or procedure-related event (“MANCE”) free rate exceeded the performance criteria of 85%, with 121 out of 125 implanted patients being event free, resulting in an event-free rate of 97% (p < 0.001;

95% 1-sided CI:

93% to 100%).

In summary, the primary safety endpoint in the pre-market phase was previously met and subsequently confirmed in the post-market phase.

In the pre-market phase, all effectiveness endpoints were previously met, demonstrating 6-month improvements in 6MHW, quality of life, NYHA Class and NT-proBNP (described below).

In the pre-market phase, all effectiveness endpoints were previously met, demonstrating 6-month improvements in 6MHW, quality of life, NYHA Class and NT-proBNP (defined below).

The post-market phase effectiveness primary endpoint of CV mortality and HF hospitalization was not met.

Additional post-market phase effectiveness analyses (Win Ratio, 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 left ventricular ejection fraction ≤ 35% and a NT-proBNP<1600 pg/ml.

• Widely accepted mechanism of action.

Our platform technology is based on a widely accepted mechanism of action and is designed to address the imbalance of the ANS, which causes HFrEF and other cardiovascular diseases.

Our platform technology is based on a widely accepted mechanism of action and is designed to complement GDMT to further address the imbalance of the ANS and the consequent excess of neurohormones that cause HFrEF and other cardiovascular diseases to worsen over time.

• Strong global clinical evidence.

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 60 peer-reviewed publications, approximately 20 of which relate to the treatment of HF, including, among others, the Journal of the American College of Cardiology.

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.

9 unchanged sentences

The IPG contains the electronics and battery in a hermetic enclosure and controls and delivers the imperceptible and persistent electrical pulses to the carotid baroreceptors through the stimulation lead attached to the exterior wall of the carotid artery.

Barostim has no intravascular components.

These electrical pulses delivered to the baroreceptors increase signals to the brain to modulate the cardiovascular function, thereby improving symptoms of HFrEF.

9 unchanged sentences

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.

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 primarily sell Barostim to hospitals through a direct sales organization in the U.S.

3 unchanged sentences

We support all aspects of the patient journey, which includes initial diagnosis, surgical support, and patient follow-up.

We also highlight our compelling clinical benefits and value

proposition to build awareness and adoption among physicians through targeted key opinion leader (“KOL”) development, referral network education and direct-to-consumer marketing.

We also highlight our compelling clinical benefits and value proposition to build awareness and adoption among physicians through targeted key opinion leader (“KOL”) development, referral network education and direct-to-consumer marketing.

We utilize direct communication channels to inform and educate patients about Barostim Therapy and utilize a qualification process to aid in the identification of the appropriate patients for our therapy.

2 unchanged sentences

We plan to continue actively expanding our direct sales force and commercial organization in the U.S., which is where we expect to focus most of our sales and marketing efforts in the near-term.

The primary focus of our research and development efforts in the near-term will be the continued technological advancement of Barostim, including tools to simplify the implant procedure for physicians.

In 2022, we launched an enhanced IPG that is approximately 10% smaller in size and improves battery life by approximately 20% to an average of six years.

We are also enrolling a clinical trial for a new implant toolkit called BATwire, which enables an ultrasound-guided implant procedure to implant Barostim and the use of local anesthetics, potentially expanding our annual market opportunity in the U.S.

The primary focus of our research and development efforts in the near-term will be the continued technological advancement of Barostim.

In the future, we plan to explore Barostim’s potential to expand its indications for use to other cardiovascular diseases, including different forms of HF, hypertension, and arrhythmias.

2 unchanged sentences

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 $51.3 million, a gross margin of 84% and a net loss of $60.0 million for the year ended December 31, 2024, compared to revenue of $39.3 million, a gross margin of 84% and a net loss of $41.2 million for the year ended December 31, 2023.

4 unchanged sentences

and approximately 10.5 million people in the European Five.

Every year, 1.3 million and 1.4 million new patients are diagnosed with HF in the U.S.

and the European Five, respectively.

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

2 unchanged sentences

Without proper blood circulation, insufficient levels of oxygen and nourishment are delivered to various body parts, impacting a person’s ability to function and leading to a variety of symptoms that affect quality of life, both physically and emotionally, such as shortness of breath, extreme fatigue, exercise intolerance, swelling and fluid retention.

HF usually develops as a result of an imbalance of the ANS, which is also the primary cause of multiple other cardiovascular diseases, such as hypertension, angina pectoris and arrhythmia.

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.

Autonomic activation is also a significant mechanism involved with multiple other cardiovascular diseases, such as hypertension, angina pectoris and cardiac arrhythmia, as well as other diseases, such as chronic kidney disease.

The role of the imbalance of ANS in HF

3 unchanged sentences

the sympathetic system and the parasympathetic system.

The sympathetic system of the ANS is responsible for preparing the body for action through the “fight or flight” response.

When the body perceives a threat in the environment, the sympathetic system reacts by increasing

the heart rate, widening the airways to allow for easier breathing, releasing stored energy, increasing strength in the muscles and slowing digestion and other bodily processes that are not as critical for taking action.

The sympathetic system of the ANS is responsible for preparing the body for action through the “fight or flight” response, which consists of the release of specific neurohormones that act across the cardiovascular system.

When the body perceives a threat in the environment, the sympathetic system stimulates the release of these neurohormones, which increase the heart rate, widen the airways to allow for easier breathing, release stored energy, increase strength in the muscles, and slow digestion and other bodily processes that are not as critical for taking action.

These changes prepare the body to respond appropriately to a threat in its environment.

1 unchanged sentence

This is done by decreasing the heart rate, conserving energy, constricting the airways, relaxing the muscles, and increasing digestion.

These two systems are strongly influenced by baroreceptors that are located in certain arterial walls.

The baroreceptors regulate the baroreflex, which is one of the body’s homeostatic mechanisms that help to maintain blood pressure at nearly constant levels.

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).

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

Healthy individuals have balanced sympathetic and parasympathetic activities, promoting the effective function of the heart.

However, there are many factors, including a person’s diet, lifestyle and underlying conditions such as diabetes and obesity that can cause an imbalance of the ANS.

Healthy individuals have balanced sympathetic and parasympathetic activities due to normal baroreceptor signaling, promoting the effective function of the heart.

However, there are many factors, including a person’s diet, lifestyle, and underlying conditions such as diabetes and obesity that can contribute to an imbalance of the ANS and an excess of neurohormones.

This imbalance, or the elevated levels of sympathetic activity and reduced levels of parasympathetic activity, may result in additional stress on the heart, leading to HF and potentially death.

24 unchanged sentences

It measures the percentage of blood that is ejected from the left ventricle with each beat.

A LVEF < 50% is considered dysfunctional and indicative of HFrEF.

An LVEF < 50% is considered dysfunctional and indicative of HFrEF.

• Co-morbidities / clinical fit:

30 unchanged sentences

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 800,000 HF hospitalizations every year in the U.S., representing approximately $39.5 billion in annual spending.

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

Barostim’s market opportunity

In 2021, we estimated that our annual market opportunity for HFrEF was $2.9 billion, including a $1.4 billion initial market opportunity (55,000 HFrEF patients) in the U.S., and a $1.5 billion initial market opportunity (61,000 HFrEF patients) in the European Five.

In late 2023, we revised our U.S.

annual market opportunity – based on the new 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.

Thus, we believe our global annual market opportunity for HFrEF is $3.7 billion.

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.

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.

We believe Barostim offers meaningful benefits for patients, physicians and payors that will continue to drive adoption of our therapy.

We believe Barostim offers meaningful benefits for patients, physicians and payers that will continue to drive adoption of our therapy.

Overview of Barostim Therapy

Our integrated platform technology, Barostim, leverages the power of the brain and nervous system to address the primary cause of HFrEF and other cardiovascular diseases.

Our integrated platform technology, Barostim, leverages the power of the brain and its ANS to address the primary cause of HFrEF and other cardiovascular diseases.

Our product, Barostim, is the first and only commercially available neuromodulation device indicated to improve symptoms for patients with HFrEF.

Barostim Therapy utilizes a widely accepted mechanism of action and works by sending imperceptible and persistent electrical pulses to baroreceptors located in the wall of the carotid artery to signal the brain to decrease sympathetic activity and increase parasympathetic activity.

This integrated response to rebalancing the ANS is well understood to normalize blood pressure, improve remodeling of the heart, increase vasodilation (widening of blood vessels) and improve kidney function.

Barostim Therapy utilizes a widely accepted mechanism of action and works by sending imperceptible and persistent electrical pulses to baroreceptors located in the wall of the carotid artery to counteract decreased baroreceptor signaling, which results in an excess of neurohormones that drives HF progression.

Barostim provides BAT, which complements the neurohormonal blockade, or GDMT, by increasing the signaling of the baroreceptors.

This increased signaling is well understood to normalize blood pressure, improve remodeling of the heart, increase vasodilation (widening of blood vessels), and improve kidney function.

Based on the results of our BeAT-HF pivotal trial, Barostim has demonstrated its ability to meaningfully improve the quality of daily life, both physically and emotionally, for patients suffering from HFrEF.

18 unchanged sentences

Barostim is indicated for patients who are NYHA Class III or II (who had a recent history of Class III) despite treatment with guideline-directed medical therapies (medications and devices), have a LVEF ≤ 35% and a NT-proBNP < 1600 pg/ml.

Barostim delivers Baroreflex Activation Therapy to improve patients’ NYHA functional status, 6MHW and quality of life.

Barostim delivers BAT to improve patients’ NYHA functional status, 6MHW and quality of life.

Once a patient is diagnosed with HFrEF and recommended for an ICD and/or CRT, interventional or general cardiologists will often refer them to EPs, who often conduct a series of diagnostic tests, including an electrocardiogram, ultrasound, and various blood tests, from which they will determine the patient’s eligibility for our therapy.

17 unchanged sentences

After the titration period, it is recommended that the patient attend a clinical visit two times each year to check impedance, battery longevity and adequacy of programming.

Key benefits for patients, physicians and payors

Key benefits for patients, physicians and payers

Barostim is designed to advance patient care and provide a safe, effective, and economically attractive treatment option to an underserved patient population suffering from HFrEF.

We believe the following factors offer meaningful benefits for patients, physicians and payors that will continue to drive broad adoption of our therapy:

We believe the following factors offer meaningful benefits for patients, physicians and payers that will continue to drive broad adoption of our therapy:

• Addresses significant unmet medical need.

8 unchanged sentences

A 25-meter improvement in walking distance is considered clinically meaningful.

• Quality of life (measured by MLWHF):

A 5-point improvement is considered clinically meaningful.

• Quality of life (measured by MLWHF questionnaire):

Our therapy improved quality of life by 14-points at six months, 8-points at one year and 10-points after two years of therapy compared to patients receiving GDMT alone.

A 5-point improvement in the MLWHF questionnaire is considered clinically meaningful.

• Functional status (determined by NYHA classification):

Our therapy demonstrated the following improvements in NYHA functional status versus the control group at the specific points in time, meaning Barostim demonstrated greater and sustained improvement:

at 6 months, 67% in the BAT+ group and 37% in the Control group, favoring the BAT+ group by 30 percentage points;

at 1 year, 73% in the BAT+ group and 41% in the Control group, favoring the BAT+ group by 32 percentage points;

and, at 2 years, 68% in the BAT+ group and 41% in the Control group, favoring the BAT+ group by 27 percentage points.

at six months, 67% in the Barostim group and 37% in the control group, favoring the Barostim group by 30 percentage points;

at one year, 73% in the Barostim group and 41% in the control group, favoring the Barostim group by 32 percentage points;

and, at two years, 68% in the Barostim group and 41% in the control group, favoring the Barostim group by 27 percentage points.

• Freedom from All-Cause Death, LVAD, or Transplant.

2 unchanged sentences

Based on a hierarchical composite outcomes analysis (including CV mortality, LVAD/transplant, HF hospitalization and quality of life), the Win Ratio was 1.26 in favor of the Barostim group.

• Implant safety.

T he MANCE-free rate exceeded the performance criteria of 85%, with 121 out of 125 implanted patients being event free, resulting in an event-free rate of 97% (p < 0.001;

95% 1-sided CI:

93% to 100%).

The significant benefits of our therapy were observed despite a four-fold uptake of ARNI medication in the control arm, as compared to the device arm.

• Widely accepted mechanism of action.

Our platform technology is based on a widely accepted mechanism of action and is designed to address the imbalance of the ANS, which causes HFrEF and other cardiovascular diseases.

• Strong global clinical evidence.

1 unchanged sentence

The BeAT-HF pivotal trial, which was a multi-center, prospective, randomized, controlled trial, met its primary endpoints and the positive safety and effectiveness data exceeded the pre-specified performance criteria across multiple dimensions, measuring the improvement in the quality of patients’ daily lives.

• Minimally invasive implant procedure.

2 unchanged sentences

Patients typically recover quickly and are discharged from the hospital within 24 hours of the procedure.

In addition, we are currently enrolling a clinical trial for a new implant toolkit called BATwire, which enables an ultrasound-guided procedure to implant Barostim and the use of local anesthetics.

As a result of this simplified implantation process, we believe more physicians, including EPs, would be confident and comfortable implanting Barostim, thereby expanding our addressable patient population to include those who are deemed clinically unfit for the current procedure.

• Potential reduction in total healthcare costs for HFrEF patients.

7 unchanged sentences

We designed our BeAT-HF (Phase III) pivotal trial in collaboration with the FDA under the Breakthrough Devices Program, which was implemented to accelerate the approval of novel therapies targeting unmet needs for debilitating or life-threatening conditions.

The pre-market phase of our BeAT-HF pivotal 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.

The pre-market phase of our BeAT-HF pivotal 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 the FDA approval of Barostim in August 2019 on an accelerated basis of only four months from the submission of the final clinical trial report.

2 unchanged sentences

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 < 1,600 pg/ml.

Barostim delivers Baroreflex Activation Therapy to improve patients’ NYHA functional status, 6MHW and quality of life.

The safety and effectiveness of Barostim Therapy have been published in more than 60 peer-reviewed publications, approximately 20 of which relate to the treatment of HF, including, among others, the publication of the pivotal trial results in the Journal of the American College of Cardiology.

Barostim delivers BAT to improve patients’ NYHA functional status, 6MHW and quality of life.

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.

2 unchanged sentences

Pivotal Phase III Study:

BeAT-HF is 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.

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.

Between May 2016 and July 2020, 467 adult patients were randomized at 72 sites within the U.S.

1 unchanged sentence

The BeAT-HF study was designed to encompass two stages in an integrated and seamless approach:

(1) A pre-market stage that examined three primary effectiveness endpoints (quality of life, 6MHW and NT-proBNP), as well as one safety endpoint that included the major adverse neurological or cardiovascular system or procedure-related event rate (“MANCE”).

(2) A post-market stage that examined the effects of BAT on rates of HF hospitalization and cardiovascular mortality, as well as sustained safety and symptomatic improvements, which expanded the labeling for Barostim.

(1) A pre-market stage that examined three primary effectiveness endpoints (quality of life, 6MHW and NT-proBNP), as well as one safety endpoint that included the MANCE-free rate.

(2) A post-market stage that examined the effects of BAT on rates of HF hospitalization and CV mortality, as well as sustained safety and symptomatic improvements, which expanded the labeling for Barostim.

Patients were eligible for the trial if they were NYHA Class III or Class II (with a recent history of Class III);

14 unchanged sentences

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):

BAT resulted in a 14-point reduction (improvement) in quality of life for patients in the BAT+ group relative to patients in the Control group (p < 0.001;

• 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 < 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.

According to the medical community, a five-point reduction (improvement) is considered to be clinically meaningful.

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 BAT+ 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 < 0.001;

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 < 0.001;

40 to 80 meters).

2 unchanged sentences

• Functional status (determined by NYHA classification):

BAT demonstrated that 65% of patients in the BAT+ group improved at least one NYHA class (p < 0.001;

22% to 46%) as compared to only 31% in the Control group and 13% of patients in the BAT+ group improved two NYHA classes as compared to only 2% in the Control group.

BAT demonstrated that 65% of patients in the Barostim group improved at least one NYHA class (p < 0.001;

22% to 46%) as compared to only 31% in the control group and 13% of patients in the Barostim group improved two NYHA classes as compared to only 2% in the control group.

• 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 BAT+ group relative to that of patients in the Control group (p=0.004;

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 independent research that took place in a large multicenter pharmaceutical clinical trial, a 10% change in NT-proBNP is associated with a change in the subsequent risk of cardiovascular mortality and HF hospitalization.

The MANCE-free rate exceeded the performance criteria of 85%, with 121 out of 125 implanted patients being event free, resulting in an event-free rate of 97% (p < 0.001;

2 unchanged sentences

In addition to the results noted above, we observed a reduction in the rate of cardiovascular serious adverse events (non-HF related events) by 51% (events per patient-year;

0.101 BAT+ vs 0.206 Control;

0.101 Barostim group vs 0.206 control group;

nominal p= 0.023;

5 unchanged sentences

The safety and effectiveness data in the BeAT-HF pivotal trial support the HFrEF clinical benefits of Barostim.

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 and NYHA Class.

• Exercise capacity (measured by the standardized 6MHW distance test):

The BAT+ group showed an improvement at both 6 and 12 months compared to the Control group.

The Barostim group showed an improvement at both 6 and 12 months compared to the control group.

The difference between the arms at 6 months was 56 meters and at 12 months the difference was sustained with 44 meters.

These improvements between the groups are not only statistically significant, but they are approximately twice the clinically significant value of 25 meters.

• Quality of life (measured by MLWHF):

The BAT+ group showed a decrease (improvement) in quality of life points ranging from 17 to 20 points from baseline across the follow-up visits.

• Quality of life (measured by MLWHF questionnaire):

The Barostim group showed an improvement in quality of life points ranging from 17 to 20 points from baseline 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.

• Functional status (determined by NYHA classification):

Approximately two-thirds of the BAT+ group improved at least one NYHA class across the follow-up visits.

Additionally, the percentage of subjects improving between the arms at 6, 12 and 24 months was higher in the BAT+ group compared to the Control group.

Approximately two-thirds of the Barostim group improved at least one NYHA class across the follow-up visits.

Additionally, the percentage of subjects improving between the arms at 6, 12, and 24 months was higher in the Barostim group compared to the control group.

• Hierarchical Win Ratio:

3 unchanged sentences

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.

In the BAT+ group, the crude event rate was 7.0 per 100 years with 38 events during 544 patient-years at risk.

In the Barostim group, the crude event rate was 7.0 per 100 years with 38 events during 544 patient-years at risk.

In the control group, the crude event rate was 10.4 per 100 years with 51 events during 492 patient-years at risk.

As shown below, the hazard ratio for all-cause mortality = 0.662 (95% CI 0.435, 1.007), representing a relative risk reduction of 34% in the BAT+ group compared with the Control group.

The hazard ratio for all-cause mortality using a per protocol analysis = 0.589 (95% CI 0.380, 0.923), representing a relative risk reduction of 41% in the BAT+ group compared with the Control group.

As shown below, the hazard ratio for all-cause mortality = 0.662 (95% CI 0.435, 1.007), representing a relative risk reduction of 34% in the Barostim group compared with the control group.

The hazard ratio for all-cause mortality using a per protocol analysis = 0.589 (95% CI 0.380, 0.923), representing a relative risk reduction of 41% in the Barostim group compared with the control group.

The system or procedure related MANCE endpoint includes all events that occurred across the duration of follow-up.

The analysis includes subjects in BAT+ group who had an implant attempted (n=159), representing 6,664 total months of implant follow-up.

The analysis includes subjects in Barostim group who had an implant attempted (n=159), representing 6,664 total months of implant follow-up.

All implant attempts were successful.

3 unchanged sentences

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 BAT+ group and 70 patients in the Control group.

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.

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.

1 unchanged sentence

The overall MANCE-free rate was 97% (lower 95% CI bound 91%).

Patients assigned to BAT+ group, compared with Control group patients, experienced improvements in MLWHF quality of life score (–17 ± 2.8 points BAT+ vs.

2.1 ± 3.1 points Control;

p < 0.001), 6MHW distance (60 ± 14 meters BAT+ vs.

1.5 ± 13 meters Control;

p=0.004) and NT-pro BNP (-69 pg/ml BAT+ vs.

130 pg/ml Control;

BAT+ patients also experienced at least a one-class improvement in NYHA class when compared to the Control group (55% BAT+ vs 24% Control;

Patients assigned to Barostim group, compared with control group patients, experienced improvements in MLWHF quality of life score (–17 ± 2.8 points Barostim group vs.

2.1 ± 3.1 points control group;

p < 0.001), 6MHW distance (60 ± 14 meters Barostim group vs.

1.5 ± 13 meters control group;

p=0.004) and NT-pro BNP (-69 pg/ml Barostim group vs.

130 pg/ml control group;

Barostim group patients also experienced at least a one-class improvement in NYHA class when compared to the control group (55% Barostim group vs 24% control group;

p=0.002) and showed a trend toward fewer days hospitalized for HF (p=0.08) as compared to the control group.

16 unchanged sentences

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 is expected to enroll up to 400 subjects and follow up to 100 implanted subjects for one year.

If the trial data meets the safety and effectiveness endpoints, we will submit an application for a PMA-supplement approval by FDA.

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:

41 unchanged sentences

In the U.S., we sell Barostim primarily to hospitals, where the device is implanted in outpatient and inpatient settings.

Our customers bill various third-party payors, such as government agencies, administrative contractors, commercial payors and integrated managed care organizations, for the cost required to treat each patient.

Third-party payors 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 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.

1 unchanged sentence

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.

Physician reimbursement under Medicare is generally based on a defined fee schedule, the Physician Fee Schedule, through which payment amounts are determined by the relative values of the professional services rendered.

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

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.

Under the OPPS in 2023, the national Medicare payment to a hospital for a new patient implant or an IPG replacement is paid using the Level 5 Neurostimulator payment code APC 5465, which has a national average of $29,358.

Under the 2024 OPPS final rule, Barostim was reassigned to New Technology APC 1580, which carries an average payment amount of $45,000, and took effect January 1, 2024.

Payment codes such as APC 1580 are indexed to adjust for cost of living and thus vary by location.

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.

CMS had also granted a TPT payment for the implantation of Barostim in an outpatient setting, which took effect in January 2021 and expired at the end of 2023.

The TPT payment was an incremental payment for new and innovative technologies that meet certain qualifications.

It allowed hospitals to bill for a pass-through of the device cost, which included up to $35,000, and could be added to the procedure costs.

We anticipate inpatient procedures to continue to represent a small percentage of our sales.

For these inpatient procedures, ICD-10-PCS codes 0JH60MZ + 03HL3M are commonly mapped into Diagnosis Related Group (“DRG”) 252, which has an established national average Medicare payment of $23,482 in 2024.

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 payors vary depending on a variety of factors, including the commercial payor and contract terms.

Government program and commercial payor 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 payors.

As of July 2020, all Medicare Administrative Contractors (“MACs”) have retired automatic coverage denial policies, thereby allowing hospitals to be paid for our procedure.

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.

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.

We will continue to monitor developments in this space, including decisions made by private payors, if any.

We will continue to monitor developments in this space, including decisions made by private payers, if any.

We will continue to leverage our in-house market access team to obtain appropriate prior authorization approvals in advance of treatment on a case-by-case basis where positive coverage policies currently do not exist.

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 payors.

In our discussions with commercial payors, 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 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.

As our operations continue to grow, we intend to continue to further expand our market access team accordingly.

10 unchanged sentences

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.

In 2022, we launched an enhanced IPG that is approximately 10% smaller in size and improves the battery life by approximately 20% to an average of six years.

We are also enrolling a clinical trial for a new implant toolkit called BATwire, which enables an ultrasound-guided procedure to implant Barostim and the use of local anesthetics.

This simplified procedure would also allow EPs to complete the procedure in an outpatient catheter lab center.

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.

8 unchanged sentences

CCM is offered by a privately-held medical technology company and has the potential to improve a patient’s quality of life and reduce symptoms of HFrEF.

However, CCM is associated with a number of drawbacks, including not being designed to address the imbalance of the ANS;

However, CCM is associated with a number of drawbacks, including not being designed to address excess of neurohormones;

less favorable clinical effectiveness results in patients with LVEF 25–35% as compared to patients with LVEF 35–45% related to exercise capacity, quality of life and NYHA functional status;

18 unchanged sentences

As of December 31, 2024, we owned 49 issued U.S.

patents and had 12 pending U.S.

patents and had six pending U.S.

patent applications.

Outside of the U.S., we owned seven patents in multiple countries and had 14 pending 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.

21 unchanged sentences

We are registered with the FDA as a medical device manufacturer and licensed by the State of Minnesota to manufacture our device.

We expect that revenue could fluctuate from quarter to quarter as a result of timing and seasonality.

We anticipate mild seasonality based on national holiday patterns specific to certain nations.

These seasonal variations are difficult to predict accurately and may vary among different markets.

In addition to the above factors, in the U.S.

it is possible that we may experience seasonality based on patients’ annual deductibility limits under their health insurance coverage.

In Europe, we may be required to engage in a contract bidding process in order to sell Barostim, which processes are only open at certain periods of time, and we may not be successful in such bidding processes.

In addition, it is possible that we may experience variations in demand for our product in the first fiscal quarter of each year in Europe, following publication of new coverage status and changes in hospital budgets pertaining to allocation of funds to purchase products such as Barostim.

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.

Otherwise, mild seasonal variations are difficult to predict accurately and may vary among different markets.

Government regulation

13 unchanged sentences

Class II devices are subject to the FDA’s General Controls, and special controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device.

These special controls

can include performance standards, post-market surveillance, patient registries and FDA guidance documents.

These special controls can include performance standards, post-market surveillance, patient registries, and FDA guidance documents.

While most Class I devices are exempt from the 510(k) premarket notification requirement, manufacturers of most Class II devices must submit to the FDA a premarket notification under Section 510(k) of the FDCA requesting permission to commercially distribute the device.

20 unchanged sentences

PMA supplements often require submission of the same type of information as a PMA, except that the supplement is limited to information needed to support any changes from the device covered by the original PMA and typically does not require as extensive clinical data or the convening of an advisory panel.

Certain other changes to an approved device require the submission of a new PMA, such as when the design change causes a different intended use,

mode of operation, and technical basis of operation, or when the design change is so significant that a new generation of the device will be developed, and the data that were submitted with the original PMA are not applicable for the change in demonstrating a reasonable assurance of safety and effectiveness.

Certain other changes to an approved device require the submission of a new PMA, such as when the design change causes a different intended use, mode of operation, and technical basis of operation, or when the design change is so significant that a new generation of the device will be developed, and the data that were submitted with the original PMA are not applicable for the change in demonstrating a reasonable assurance of safety and effectiveness.

The FDA will approve the new device for commercial distribution if it determines that the data and information in the HDE constitute valid scientific evidence and that there is reasonable assurance that the device is safe and has probable benefit for its intended use(s) according to the instructions for use or labeling.

The HDE approved devices are subject to the same requirement elements and changes as the above PMA devices.

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 FDA.

Clinical trials

19 unchanged sentences

• 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 provide 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;

• 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;

46 unchanged sentences

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:

8 unchanged sentences

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 also received and responded to queries from all MDR sections, with the exception of Clinical Research, in 2022.

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

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.

5 unchanged sentences

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 Mark.

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.

28 unchanged sentences

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.

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.

10 unchanged sentences

Department of Health, and Human Services (“HHS”) issued regulations in July 1991, which HHS has referred to as “safe harbors.” These safe harbor regulations set forth certain provisions which, if met in form and substance, will assure medical device manufacturers, healthcare providers and other parties that they will not be prosecuted under the federal Anti-Kickback Statute.

Additional safe harbor provisions providing similar protections have been published intermittently

Additional safe harbor provisions providing similar protections have been published intermittently since 1991.

Although there are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, the exceptions and safe harbors are drawn narrowly.

7 unchanged sentences

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.

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

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.

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.

Conduct and business arrangements that do not fully satisfy one of these safe harbor provisions may result in increased scrutiny by government enforcement authorities.

The majority of states also have anti-kickback laws that establish similar prohibitions and, in some cases, may apply more broadly to items or services covered by any third-party payor, including commercial insurers and self-pay patients.

The majority of states also have anti-kickback laws that establish similar prohibitions and, in some cases, may apply more broadly to items or services covered by any third-party payer, including commercial insurers and self-pay patients.

The federal civil False Claims Act prohibits, among other things, any person or entity from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment or approval to the federal government or knowingly making, using, or causing to be made or used a false record or statement material to a false or fraudulent claim to the federal government.

3 unchanged sentences

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.

Penalties for federal civil False Claim Act violations include fines for each false claim, plus up to three times the amount of damages sustained by the federal government and, most critically, may provide the basis for exclusion from the federally funded healthcare program.

Penalties for federal civil False Claims Act violations include fines for each false claim, plus up to three times the amount of damages sustained by the federal government and, most critically, may provide the basis for exclusion from the federally funded healthcare program.

On May 20, 2009, the Fraud Enforcement Recovery Act of 2009 (“FERA”), was enacted, which modifies and clarifies certain provisions of the federal civil False Claims Act.

1 unchanged sentence

The government may further prosecute conduct constituting a false claim under the federal criminal False Claims Act.

The 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.

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.

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 payors, 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.

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.

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.

4 unchanged sentences

Also, many U.S.

states have similar fraud and abuse statutes or regulations that may be broader in scope and may apply regardless of payor, in addition to items and services reimbursed under Medicaid and other state programs.

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.

49 unchanged sentences

and some foreign jurisdictions are considering or have enacted a number of legislative and regulatory proposals to change the healthcare system in ways that could affect our ability to sell our products profitably.

Among policy makers and payors in the U.S.

Among policy makers and payers in the U.S.

and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality, or expanding access.

Current and future legislative proposals to further reform healthcare or reduce healthcare costs may limit coverage of or lower reimbursement for the procedures associated with the use of our products.

The cost containment measures that payors and providers are instituting and the effect of any healthcare reform initiative implemented in the future could impact our revenue from the sale of our products.

The cost containment measures that payers and providers are instituting and the effect of any healthcare reform initiative implemented in the future could impact our revenue from the sale of our products.

The implementation of the Affordable Care Act in the U.S., for example, has changed healthcare financing and delivery by both governmental and private insurers substantially, and affected medical device manufacturers significantly.

2 unchanged sentences

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.

Moreover, the Biden Administration and the U.S.

Moreover, the Trump Administration and the U.S.

Congress may take further action regarding the Affordable Care Act.

10 unchanged sentences

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

4 unchanged sentences

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, 2023, we had approximately 200 employees worldwide, all of which were employed on a full-time basis.

As of December 31, 2024, we had 206 employees worldwide, all of which were employed on a full-time basis.

None of our employees is subject to a collective bargaining agreement or represented by a trade or labor union.

15 unchanged sentences

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.

furnished to, the U.S.

Securities and Exchange Commission (the “SEC”).

3 unchanged sentences

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