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Item 1. Business

2025-02-14 compared with 2024-02-16 · 118 added, 108 removed, 347 unchanged (39% of the section changed)

We are a leading innovator in treatments for atrial fibrillation (Afib), left atrial appendage (LAA) management and post-operative pain management.

Afib is an irregular heartbeat, or arrhythmia, which affects over 37 million people worldwide, including more than eight million people in the United States, and is a growing epidemic.

Afib is an irregular heartbeat, or arrhythmia, which affects over 59 million people worldwide and is a growing epidemic.

It is the most common cardiac arrhythmia encountered in clinical practice and results in high utilization of healthcare services and significant cost burden.

Patients often progress from being in Afib intermittently (paroxysmal) to being in Afib continuously.

Patients often progress from being in Afib intermittently (paroxysmal) to being in Afib continuously (non-paroxysmal).

The continuous Afib patient population includes early persistent Afib, which lasts seven days to 6 months, persistent Afib, which lasts 6 months to one year, and long-standing persistent Afib, which lasts longer than one year.

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Our cardiac ablation and left atrial appendage management (LAAM) products are used by physicians during open-heart and minimally invasive surgical procedures.

In open-heart procedures, the physician is performing heart surgery for other conditions, such as a mitral valve repair or a coronary artery bypass, and our products are used in conjunction with (“concomitant” to) such a procedure.

Minimally invasive procedures are performed on a standalone basis, and often include multi-disciplinary or “hybrid” approaches, combining surgical procedures using AtriCure ablation and AtriCure LAAM products with catheter ablation performed by an electrophysiologist.

In open-heart procedures, the patient is undergoing heart surgery for other conditions, such as a mitral or aortic valve repair or a coronary artery bypass, and our products are used by physicians in conjunction with (“concomitant” to) such a procedure.

Minimally invasive procedures are performed on a standalone basis, and often include multi-disciplinary or “hybrid” approaches, combining surgical procedures using our ablation and LAAM products with catheter ablation performed by an electrophysiologist.

Our pain management solutions are used by physicians to freeze nerves during cardiothoracic or thoracic surgical procedures.

Recovery from cardiothoracic and thoracic surgery can be complicated and painful.

Many surgeons use multi-modal pain management strategies that include oral delivery of opioid and non-opioid pain medications.

Our cryoICE cryoSPHERE ® probe for pain management (Cryo Nerve Block) provides temporary relief of post-operative pain, allowing the patient's body to heal after surgery while the nerves regenerate and sensation is regained.

Many surgeons use multiple pain management strategies that include oral delivery of opioid and non-opioid pain medications.

Our cryoICE cryoSPHERE ® probes for pain management (known as Cryo Nerve Block) provides temporary relief of post-operative pain, allowing the patient's body to heal after surgery while the nerves regenerate and sensation is regained.

We sell our products to medical centers through our direct sales force in the United States, Germany, France, the United Kingdom, the Benelux region, Canada and Australia.

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Afib is the most commonly diagnosed sustained cardiac arrhythmia, with over one million diagnoses annually in the United States alone.

Afib is an under-diagnosed condition due in large part to the fact that patients with Afib often have mild or no symptoms, and their Afib is diagnosed when they seek treatment for an associated condition, such as a structural heart disease or stroke.

Afib is also an under-diagnosed condition due in large part to the fact that patients with Afib often have mild or no symptoms, and their Afib is diagnosed when they seek treatment for an associated condition, such as a structural heart disease or stroke.

Symptoms of Afib may include heart palpitations, dizziness, fatigue and shortness of breath, and these symptoms may be debilitating and life threatening in some cases.

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This difficulty is exacerbated with more serious forms of Afib, or persistent and long-standing persistent Afib.

Over the past two decades, technology advancements have made surgical ablation more effective, repeatable and available to cardiac surgeons and electrophysiologists around the world.

Societal guideline changes from the Society of Thoracic Surgeons (STS), Heart Rhythm Society (HRS) and American Association of Thoracic Surgery (AATS) now have Class I recommendations for concomitant surgical ablation, meaning that it is a “recommended” treatment for patients who have structural heart disease and Afib.

Over the past two decades, technological advancements have made surgical ablation more effective, repeatable and available to cardiac surgeons and electrophysiologists around the world.

Societal guidelines from the Society of Thoracic Surgeons (STS), Heart Rhythm Society (HRS) and American Association of Thoracic Surgery (AATS) have Class I recommendations for concomitant surgical ablation, meaning that it is a “recommended” treatment for patients who have structural heart disease and Afib.

Guidelines for the treatment of more serious forms of Afib for patients without structural heart disease have also been introduced in the past several years.

In 2023, the American College of Cardiology (ACC), American Heart Association (AHA), American College of Clinical Pharmacy (ACCP), and HRS released Guidelines for Diagnosis and Management of Atrial Fibrillation, and upgraded Left Atrial Appendage

Management to the highest recommendation of Class 1 and now include Hybrid AF™ Therapy as a Class 2 recommendation.

In 2024, the European Society of Cardiology (ESC) released Guidelines for Management of Atrial Fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS), in which they upgraded LAAM to the highest Class 1 recommendation.

2023, the American College of Cardiology (ACC), American Heart Association (AHA), American College of Clinical Pharmacy (ACCP) and HRS released Guidelines for Diagnosis and Management of Atrial Fibrillation, and upgraded LAAM to the highest recommendation of Class 1 and now include Hybrid AF™ Therapy as a Class 2 recommendation.

These societal guidelines are reflective of the scientific evidence suggesting that surgical and hybrid ablation is safe and effective for patients who have Afib.

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Today, we estimate that less than 20% of those candidates are being treated with surgical ablation.

Therefore, we believe that the market for our ablation products represents a significant growth opportunity.

In addition, Afib is thought to be responsible for approximately 15% to 20% of the estimated 800,000 strokes that occur annually in the United States.

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Studies have also suggested that 90% of clots that cause strokes in patients who have Afib originate from within the LAA.

Recently, a large independent international randomized trial, Left Atrial Appendage Occlusion Study (LAAOS) III, demonstrated a significant reduction in strokes when the LAA was managed during cardiac surgery.

In 2021, a large independent international randomized trial, Left Atrial Appendage Occlusion Study (LAAOS) III, demonstrated a significant reduction in strokes when the LAA was managed during cardiac surgery.

Afib accounts for billions of dollars in hospitalization-related and office visit costs in the United States each year.

Indirect costs, such as the management of Afib-related strokes, are also believed to be significant.

Because of the risk of stroke and the significant cost burden on the healthcare system, more and more surgeons are routinely addressing the LAA, both in patients who have Afib and in those who do not have Afib but may be at increased risk of developing the disease in the future.

Due to the risk of stroke and the significant cost burden on the healthcare system, more and more surgeons are routinely addressing the LAA, both in patients who have Afib and in those who do not have Afib but may be at increased risk of developing the disease in the future.

We believe that our AtriClip system is safer, more effective and easier to use than other products and techniques for excluding the LAA during cardiac surgery.

Therefore, we believe that the market for our ablation products and the AtriClip system represent significant growth opportunities.

Therefore, we believe that the market for our AtriClip system represents a significant growth opportunity.

Many Afib patients without other underlying structural heart disease, especially those with more advanced forms of Afib, are symptomatic and experience conditions such as palpitations, breathlessness and drowsiness.

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In addition to catheter ablation, there are other treatment options for patients with Afib, including pharmacological therapy (anti-arrhythmic drugs) and implantable pacemakers.

It is estimated that approximately 350,000 to 450,000 Afib patients are treated by catheter ablation every year in the U.S., a number that is expected to grow 10 to 15% annually.

It is estimated that approximately 500,000 Afib patients are treated by catheter ablation every year in the United States, a number that is expected to grow well over 10% annually.

While the majority of paroxysmal Afib patients treated by catheter ablation tend to experience freedom from Afib, less than a third of long-standing persistent patients treated by catheter ablation are cured of their Afib at one year, and it declines even more thereafter.

Randomized, prospective, multi-center data from the CONVERGE™ IDE clinical trial, along with a number of other recent real-world studies performed by physician investigators, show that these long-standing persistent Afib patients can experience more than double the success rate by adding an ablation on the outside surface of the heart using AtriCure’s EPi-Sense ablation system.

Thus, we believe the EPi-Sense ablation system used as a minimally invasive or Hybrid AF TM therapy also represents a significant growth opportunity for the Company.

Thus, we believe the EPi-Sense ablation system used as a minimally invasive or Hybrid AF therapy also represents a significant growth opportunity for the Company.

Thoracic surgery involving an incision through the ribcage, typically referred to as thoracotomy access, and cardiothoracic surgery can often result in significant post-operative pain and longer hospital recovery times as patients refrain from mobilizing their chest near the incision site.

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Most surgeons will employ a multi-modal pain management protocol that includes various pain management techniques, including techniques such as epidural delivery of medication directly around the spinal cord, intravenous or oral delivery of opioid and non-opioid pain medications, or other strategies.

More focused, local techniques include syringe injections between vertebrates and Cryo Nerve Block which uses cryothermic energy to ablate peripheral nerves, temporarily stopping the transmission of pain signals coming from the chest wall during surgery.

More focused, local techniques include syringe injections between vertebrates and Cryo Nerve Block which uses cryogenic energy to ablate peripheral nerves, temporarily stopping the transmission of pain signals coming from the chest wall during surgery.

The nerve “scaffolds” remain intact, allowing axons to regenerate and restore nerve function over time.

Cryo Nerve Block can be delivered using our cryoICE cryoSPHERE ® probe, which is specifically designed for Cryo Nerve Block therapy.

Cryo Nerve Block can be delivered using our cryoICE cryoSPHERE probes, which are specifically designed for Cryo Nerve Block therapy.

Depending on the degree of invasiveness, physicians and their nursing staff will take advantage of multiple ways of managing pain for their patients.

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It is also estimated that one in seven thoracic surgery patients develops an unhealthy post-procedural addiction to prescription narcotics, making alternative, non-opioid pain management modalities, such as Cryo Nerve Block, an increasingly important part of how physicians manage post-operative pain.

We believe the market for our pain management ablation product represents a significant growth opportunity.

We believe the market for our pain management ablation products represents a significant growth opportunity.

Further, applications for Cryo Nerve Block outside of thoracic surgery use are being studied by physician investigators and represent future possible growth opportunities.

AtriCure Solutions and Products

We believe that we are currently the market leader in the surgical treatment of Afib and left atrial appendage management, and pioneers of the application of Cryo Nerve Block in thoracic procedures.

We believe that we are currently the market leader in the surgical treatment of Afib and LAAM, and pioneers of the application of Cryo Nerve Block in cardiothoracic surgical procedures.

We anticipate that substantially all our revenue for the foreseeable future will relate to products we currently sell or are in the process of developing.

Our products enable cardiothoracic surgeons to perform surgical ablation procedures with faster, less invasive and less technically challenging approaches.

We have completed, and continue to invest in, clinical studies for the use of our ablation and LAAM products to treat Afib and reduce stroke.

Our products enable cardiothoracic surgeons to perform surgical ablation procedures with faster, less invasive and less technically challenging approaches and clinically proven results.

We have completed, and continue to invest in, clinical studies for the use of our ablation and LAAM products to treat Afib, reduce post-operative Afib, and prevent strokes.

Leading cardiothoracic surgeons and electrophysiologists, including those who serve or who have served as consultants to us, have published results of preclinical and clinical studies utilizing our devices.

The results of these studies have assessed efficacy, ease of use and safety endpoints.

Products for cardiac tissue ablation include those that create scar tissue using radio frequency (RF) energy or cryothermic modalities.

Our ablation products are part of platforms each consisting of disposable hand pieces which connect to either a RF generator or a cryothermic generator.

Products for cardiac tissue ablation include those that create scar tissue using radio frequency (RF) energy or cryogenic (cryo) modalities.

Our ablation products are part of platforms, each consisting of disposable hand pieces which connect to either a RF generator or a cryo generator.

We generally place this capital equipment with our direct customers and sell to our distributors.

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Our Isolator Synergy Ablation System clamps are single-use disposable RF products with jaws that close in a parallel fashion.

The system consists of the clamp and an RF generator.

We sell multiple configurations of our Isolator Synergy clamps.

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Our Isolator Synergy Ablation System includes multiple configurations approved by the United States Food and Drug Administration (FDA) for the treatment of persistent and long-standing persistent Afib concomitant to other open-heart surgical procedures.

Certain products of our Isolator Synergy clamps bear the CE mark and may be commercially distributed throughout the member states of the European Union and other countries that comply with or mirror the Medical Device Directive.

Certain products within our Isolator Synergy clamp line are in compliance with the European Union Medical Device Regulations (EU MDR) and bear the CE mark for commercial distribution throughout the member states of the European Union (EU) and other countries that comply with or mirror EU MDR.

These products are available for sale in a number of other countries globally.

In April 2022, we launched our most recent configuration, the ENCOMPASS ® clamp, following 510(k) clearance in July 2021.

The ENCOMPASS clamp is indicated for cardiac soft tissue ablation.

The configuration is designed to make concomitant surgical ablations more efficient and is expected to drive deeper penetration of cardiac surgery procedures.

In 2022, we launched the EnCompass ® clamp in the United States, following 510(k) clearance in 2021.

The EnCompass clamp is indicated for cardiac soft tissue ablation and is designed to make concomitant surgical ablations more efficient and is expected to drive deeper penetration of cardiac surgery procedures.

In 2024, we received 510(k) clearance for our most recent configuration of the Isolator Synergy platform, the EnCapture™ clamp, which has enhanced geometry and features to facilitate engagement with the intended cardiac tissue.

• Multifunctional Pens and Linear Ablation Devices .

These devices are single-use disposable RF products that come in multiple configurations.

The MAX Pen devices enable surgeons to evaluate cardiac arrhythmias, perform temporary cardiac pacing, sensing and stimulation and ablate cardiac tissue with the same device.

Surgeons can readily toggle back and forth between these functions.

The device comes in multiple configurations that have unique tissue contacting and shaft lengths.

The Coolrail ® device enables the user to make longer linear lines of ablation.

Surgeons generally use one or more of our pen and linear devices in combination with Isolator Synergy clamps.

All our pen and linear ablation devices are cleared for sale in the United States under FDA 510(k) clearances, with indications for the ablation of cardiac tissue and/or the treatment of cardiac arrhythmias.

Our Isolator Synergy pens bear the CE mark, and most configurations may be commercially distributed throughout the member states of the European Union and other countries that comply with or mirror the Medical Device Directive.

These products are available for sale in a number of other countries globally.

Our pen and linear ablation devices are cleared for sale in the United States under FDA 510(k) clearances, with indications for the ablation of cardiac tissue and/or the treatment of cardiac arrhythmias.

Certain configurations of our pen and linear ablation devices are also cleared or approved for sale outside of the United States.

Products for open ablation:

• cryoICE Cryoablation System .

The cryoICE cryoablation system is used in both open ablation procedures and cryoanalgesia.

The cryoICE ® cryoablation system is used in both open ablation procedures and cryoanalgesia for post-operative pain management.

The system consists of the cryoICE BOX generator along with a variety of single-use disposable probes.

The primary differences between these cryoablation probes is the form of the tissue-contacting distal end.

The cryoICE devices enable the user to make linear ablations of varied lengths.

The various configurations of cryoICE devices enable the user to make linear ablations of varied length, providing the surgeon with options to address the specific procedural objectives.

Surgeons may utilize the cryoICE devices in combination with Isolator Synergy clamps or independently.

Our cryoablation devices are cleared for sale in the United States under FDA 510(k) clearances, bear the CE mark for commercial distribution throughout the member states of the European Union and other countries that comply with or mirror the Medical Device Directive.

Our cryoablation devices are cleared for sale in the United States under FDA 510(k) clearances, and are in compliance with EU MDR and bear the CE mark for commercial distribution throughout the member states of the EU and other countries that comply with or mirror EU MDR.

These products are available for sale in a number of other countries globally.

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• EPi-Sense Systems .

The EPi-Sense Guided Coagulation System with VisiTrax technology and the new EPi-Sense ST ® Guided Coagulation System utilize monopolar RF energy for the coagulation of tissue.

The EPi-Sense Guided Coagulation System and the EPi-Sense ST ® Guided Coagulation System utilize monopolar RF energy for the coagulation of tissue.

The system consists of the device and an RF generator.

Our EPi-Sense devices are single-use disposable ablation devices capable of intraoperative cardiac signal sensing and recording when connected to an external recording device.

Our EPi-Sense ® System was studied through the CONVERGE clinical trial and was subsequently approved in 2021 by FDA for the treatment of patients with systemic, drug refractory, long-standing persistent Afib when augmented with an endocardial ablation catheter.

Our EPi-Sense System was studied through the CONVERGE clinical trial and approved in 2021 by FDA for the treatment of patients with systemic, drug refractory, long-standing persistent Afib when augmented with an endocardial ablation catheter.

Our EPi-Sense ST Guided Coagulation System was approved via PMA supplement in late 2022.

Hybrid AF ™ Therapy is the only FDA-approved minimally invasive procedure to treat patients with long-standing persistent Afib and represents a proven option for patients with advanced disease.

The EPi-Sense System bears the CE mark and is commercially distributed throughout the member states of the European Union and other countries that comply with or mirror the Medical Device Directive.

Hybrid AF Therapy is the only FDA-approved minimally invasive procedure to treat patients with long-standing persistent Afib and represents a proven option for patients with this advanced disease.

The EPi-Sense System is in compliance with EU MDR and bear the CE mark for commercial distribution throughout the member states of the EU and other countries that comply with or mirror EU MDR.

This system is available for sale in a number of other countries globally.

In 2024, FDA granted 510(k) clearance for EPi-Ease ™ , our Hybrid access device to facilitate guide-wire delivery, vacuum application and endoscope insertion.

Products for pain management:

• cryoSPHERE probe .

The cryoSPHERE probe is used to apply cryothermic energy to targeted intercostal peripheral nerves in the ribcage in order to provide temporary pain relief.

• cryoSPHERE probes .

The cryoSPHERE probe is used to apply cryogenic energy to targeted intercostal peripheral nerves in the ribcage in order to provide temporary pain relief.

This technique, called Cryo Nerve Block, is applied intraoperatively by cardiothoracic or thoracic surgeons and results in temporary pain relief for up to 90 days after the procedure.

Sensation typically returns to the affected region of the chest after this period.

Scientific data that has been published on the effects of Cryo Nerve Block has generally shown a significant reduction in prescription of opioids, significantly reduced length of stay for patients in the hospital and other benefits.

The cryoSPHERE probe is 510(k) cleared for managing pain by temporarily ablating peripheral nerves and bears the CE mark for commercial distribution throughout the member states of the European Union and other countries that comply with or mirror the Medical Device Directive.

Scientific data that has been published on the effects of Cryo Nerve Block therapy has generally shown a significant reduction in prescription of opioids, significantly reduced length of stay for patients in the hospital and reduced healthcare utilization costs.

The cryoSPHERE probe is 510(k) cleared for managing pain by temporarily ablating peripheral nerves and is in compliance with EU MDR and bears the CE mark for commercial distribution throughout the member states of the EU and other countries that comply with or mirror EU MDR.

During 2024, we launched two new cryoSPHERE probes for pain management in the United States.

The cryoSPHERE ® + cryoablation probe leverages new technology that minimizes thermal loss by focusing energy at the ball tip, allowing for a reduction in freeze time by 25%.

The cryoSPHERE MAX ™ probe features a larger ball tip, designed to optimize Cryo Nerve Block therapy.

The cryoSPHERE MAX probe reduces freeze times by 50% when compared to the first generation cryoSPHERE cryoablation probe, and over 30% when compared to the cryoSPHERE+ probe.

Products for appendage management:

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The AtriClip device is designed to exclude the left atrial appendage by mechanically clamping the appendage from the outside of the heart.

The left atrial appendage has been shown to be a source of arrhythmias.

In addition to the risk of blood clots originating in the left atrial appendage, the left atrial appendage has also been shown to be a source of arrhythmias.

The exclusion of the LAA eliminates blood flow between the left atrial appendage and the atrium while avoiding contact with circulating blood and provides electrical isolation benefits after placement.

We believe that the AtriClip system is potentially safer, more effective and easier to use than other techniques for permanently excluding the left atrial appendage.

The device comes in two geometries (a rectangular configuration which encircles the targeted tissue and “V” shape which allows for an alternative lateral access) and a variety of lengths, which are matched to each patient's anatomy.

We believe that the AtriClip system is safer, more effective and easier to use than other techniques for permanently excluding the left atrial appendage.

The device comes in two geometries:

a rectangular configuration which encircles the targeted tissue and a “V” shape which allows for an alternative lateral access, and a variety of lengths which are matched to each patient's anatomy.

The appliers come in multiple forms tailored to specific procedural needs depending on the type of surgery and how the surgeon is accessing the heart.

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Direct visualization, in this context, requires that the surgeon can see the heart directly, with or without assistance from a camera, endoscope or other appropriate viewing technologies.

Certain products of our AtriClip LAA Exclusion System bear the CE mark for commercial distribution throughout the member states of the European Union and other countries that comply with or mirror the Medical Device Directive.

Certain products of our AtriClip LAA Exclusion System are in compliance with EU MDR and bear the CE mark for commercial distribution throughout the member states of the EU and other countries that comply with or mirror EU MDR.

These products are available for sale in a number of other countries globally.

During 2024, we launched the newest generation AtriClip, the AtriClip ® FLEX-Mini™ device, in the United States.

The AtriClip FLEX-Mini sets a new standard as the smallest profile for a surgical LAA device on the market and builds upon the proven technology and clinical benefits of our AtriClip platform, with ease of use and design simplicity that offers enhanced access and increased visibility for physicians.

The AtriClip LAA Exclusion System is currently being evaluated under the Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction (LeAAPS™) IDE clinical trial.

We sell additional products and enabling technologies that hold 510(k) approvals and/or bear the CE mark.

We sell additional products and enabling technologies that hold 510(k) approvals, and certain products are in compliance with EU MDR and bear the CE mark for commercial distribution.

The LARIAT ® System is a solution for soft-tissue closure that includes a suture loop coupled to a single-use disposable applier.

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We are passionately focused on healing the lives of patients affected by Afib and pain after surgery.

Our strategy is to expand the treatment options for patients who suffer from Afib, have a high risk of stroke, or who suffer from post-operative pain, through the continued development of our technologies and expansion of our product offerings, clinical science investments and global commercial expansion.

Our strategy is to expand the treatment options for patients who suffer from Afib, have a high risk of stroke, may develop post-operative Afib, or who suffer from post-operative pain, through the continued development of our technologies and expansion of our product offerings, clinical science investments and global commercial expansion.

The key elements of our strategy include:

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We are partnering with leading surgical and cardiology societies to increase the awareness of Afib treatment options.

In the past five years, the Society for Thoracic Surgeons (STS), Heart Rhythm Society (HRS), American College of Cardiology (ACC), American Heart Association (AHA) and American College of Clinical Pharmacy (ACCP) have released new guidelines on the surgical treatment of Afib in both open-heart and minimally-invasive settings.

In the past seven years, the Society for Thoracic Surgeons (STS), Heart Rhythm Society (HRS), American College of Cardiology (ACC), American Heart Association (AHA), American College of Clinical Pharmacy (ACCP), European Society of Cardiology (ESC) and European Association of Cardio-Thoracic Surgery (EACTS) have released new guidelines on the surgical treatment of Afib in both open-heart and minimally-invasive settings, as well as the management of the left atrial appendage in surgical procedures.

Provide Training and Education.

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With the approval of the EPi-Sense System, we began programs to train physicians on the use of the EPi-Sense system in a hybrid approach to treating patients with long-standing persistent Afib.

More recently, we have implemented multidisciplinary training programs focused on the heart team approach for creating and growing an arrhythmia treatment program and managing post-operative pain.

More recently, we have implemented multidisciplinary training programs focused on

the heart team approach for creating and growing an arrhythmia treatment program and managing post-operative pain.

We believe these training and education programs have increased awareness about the surgical treatment of Afib, and we will continue to make investments to serve our physician customers.

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Our ongoing research and development activities support our business strategy to expand treatment options and increase awareness in our current markets, as well as enabling expansion into adjacent markets.

We are engaged in developing and researching new and existing products or concepts, preclinical studies, clinical trials and other regulatory

We are engaged in developing and researching new and existing products or concepts, preclinical studies, clinical trials and other regulatory activities.

We make significant investments in both product development and clinical science activities to drive the advancement and adoption of new therapies in the marketplace.

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The trial provides for enrollment of up to 6,500 subjects at up to 250 sites worldwide.

In January 2023, we enrolled our first patient;

site initiation and enrollment is ongoing.

We enrolled our first patient in January 2023;

site initiation and enrollment is ongoing and we expect to complete enrollment in 2025.

In February 2022, FDA approved the protocol for the Hybrid Epicardial and Endocardial Sinus Node Sparing Ablation Therapy for Inappropriate Sinus Tachycardia (IST) clinical trial (HEAL-IST).

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The CONVERGE IDE clinical trial proved the safety and efficacy of the EPi-Sense System to treat symptomatic persistent and long-standing persistent Afib patients who are refractory or intolerant to at least one Class I and/or III anti-arrhythmic drug.

In April 2021, we announced the PMA approval of the EPi-Sense System for treatment of symptomatic, drug-refractory, long-standing persistent atrial fibrillation, when augmented with an endocardial ablation catheter.

We believe the Convergent procedure, or Hybrid AF therapy, provides the only compelling treatment option for a large and vastly underpenetrated population of Afib patients.

In April 2021, FDA granted PMA approval of the EPi-Sense System for treatment of symptomatic, drug-refractory, long-standing persistent atrial fibrillation, when augmented with an endocardial ablation catheter.

We believe the Convergent procedure, or Hybrid AF therapy, provides the only compelling treatment option for a large and vastly underpenetrated population of long-standing persistent Afib patients.

The CONVERGE trial demonstrated superiority in the hybrid therapy arm compared to endocardial catheter ablation alone.

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This study allows for 325 patients to be enrolled at up to 50 sites.

The first patient enrollment in the trial occurred in June 2022;

site initiation and enrollment is ongoing.

We have invested in other clinical trials to validate the long-term results of procedures using our products and to support applications to regulatory agencies for expanded indications.

Site initiation and enrollment in the CONVERGE PAS is ongoing.

We have and will continue to invest in other clinical trials to validate the long-term results of procedures using our products and to support applications to regulatory agencies for expanded indications.

The Company continues to perform long-term patient follow-up in multiple studies and plans to present results at 2025 meetings.

• In May 2024, the Company finished twelve-month patient follow-up required by the ICE-AFIB study protocol.

The Company has completed the analyses of the primary effectiveness and safety endpoints and is pursuing publication opportunities with reputable cardiac surgery journals.

The ICE-AFIB clinical trial is designed to study the safety and efficacy of the cryoICE system for persistent and long-standing persistent Afib treatment during concomitant on-pump cardiac surgery.

The trial provides for enrollment of up to 150 patients at up to 20 sites in the United States, which was completed in May 2023.

Patient follow-up for twelve months post ablation required by the study protocol remains ongoing.

During the second quarter of 2023, results from our CEASE-AF trial were presented at the European Heart Rhythm Association meeting and subsequently published in July 2023.

• The CEASE-AF three-year outcomes abstract was submitted and accepted for presentation at the 2025 European Heart Rhythm Association (EHRA) meeting.

CEASE-AF is a prospective, multi-center randomized control trial that demonstrated superior freedom from atrial arrhythmias for staged hybrid ablation compared to endocardial catheter ablation.

• During the fourth quarter of 2023, the 12-month follow-up results of enrolled patients from the DEEP AF Pivotal study were presented at the American Heart Association meeting.

The two-year DEEP outcomes poster has been accepted for presentation at the 2025 AF Symposium.

The DEEP AF IDE pivotal trial evaluated the safety and efficacy of the AtriCure Bipolar System when used in a staged approach where a minimally invasive surgical ablation procedure is first performed.

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The results from this single arm study demonstrated superior freedom from atrial arrhythmias for staged hybrid ablation compared to a pre-specified performance goal.

The Company is in the process of analyzing additional trial data for publication, future development activities, or possible evaluation of label expansions.

The Company is conducting analyses of additional trial data for publication, future development activities, or possible evaluation of label expansions.

Sales, Marketing and Medical Education

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Our primary competitor in the cardiac surgery market is Medtronic, plc, who provides surgical ablation products and LAAM devices used by physicians for the treatment of Afib and related conditions.

For standalone treatment of Afib, several companies offer intracardiac catheter devices that are commonly used by electrophysiologists.

These catheter devices are FDA-approved to treat the paroxysmal and persistent forms of Afib, but they are not FDA indicated to treat long-standing persistent Afib.

Our Hybrid AF Therapy involves both epicardial and endocardial techniques, therefore, these catheters are complementary to our business and not competitive.

We believe that our products improve treatment outcomes for patients with non-paroxysmal forms of Afib when combined with intracardiac catheter devices.

For standalone treatment of Afib, several companies offer endocardial catheter devices that are commonly used by electrophysiologists.

These catheter devices are FDA-approved to treat the paroxysmal and persistent forms of Afib, but they are not FDA indicated and have not been studied for the treatment of long-standing persistent Afib.

Since our Hybrid AF Therapy involves both epicardial and endocardial techniques, we believe these catheters are complementary to our business because our products improve treatment outcomes for patients with non-paroxysmal forms of Afib when combined with intracardiac catheter devices.

AtriCure is monitoring other companies who are conducting clinical trials that may support FDA approval of their devices to treat persistent and long-standing persistent Afib, although we are not aware of any ongoing FDA trials by other companies to study ablation of long-standing persistent Afib patients.

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In addition to the cardiac surgery market, we also consider competition within the post-operative pain market.

Currently, we are not aware of other companies in the United States who are pursuing cryothermic nerve block therapies for thoracic surgery.

Currently, we are not aware of other companies in the United States who are pursuing cryo nerve block therapies for thoracic surgery.

There are other companies outside of the United States who market their devices for a similar therapy.

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We believe hospital reimbursement rates for sole therapy and concomitant therapy cardiac surgical ablation or surgical LAAM are adequate to cover the cost of our products even when multiple procedures are performed.

Similar to surgical ablation for Afib or surgical LAAM, cryoablation performed for post-operative pain

management is reimbursed as part of the primary procedure, open thoracic or cardiac surgery, MS-DRG.

Similar to surgical ablation for Afib or surgical LAAM, cryoablation performed for post-operative pain management is reimbursed as part of the primary procedure, open thoracic or cardiac surgery, MS-DRG.

We believe hospital reimbursement rates are typically adequate in these situations.

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Our products are medical devices and are subject to regulation in the United States by FDA and other federal agencies, and by comparable authorities in the European Union (EU) and other countries worldwide.

US Regulation:

United States Regulation:

FDA regulations govern nearly all of the activities that we perform, or which are performed on our behalf, to ensure that medical products distributed domestically or exported internationally are safe and effective for their intended uses.

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Our clinical trials must be conducted under the oversight of an Institutional Review Board (IRB) for the relevant clinical trial sites and must comply with FDA regulations, including, but not limited to, those relating to current good clinical practices.

We are also required to obtain the written informed consent of patients in form and substance that complies with both FDA requirements and other human

subject protection regulations established by FDA.

We are also required to obtain the written informed consent of patients in form and substance that complies with both FDA requirements and other human subject protection regulations established by FDA.

We must conduct our clinical studies in compliance with state and federal privacy laws, including the Health Insurance Portability and Accountability Act (HIPAA).

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This association has established guidelines and protocols for medical device manufacturers in their relationships with healthcare professionals on matters including research and development, product training and education, grants and charitable contributions, support of third-party educational conferences and consulting arrangements.

Adoption of the AdvaMed Code of Ethics for Interactions with Healthcare Professionals (the “AdvaMed Code”) by a medical device manufacturer is voluntary, and while the Office of the Inspector General and other federal and state healthcare regulatory agencies encourage its adoption and may look to the AdvaMed Code, they do not view adoption of the AdvaMed Code as proof of compliance with applicable laws.

We have adopted the AdvaMed Code and incorporated its principles in our standard operating procedures, employee training programs and relationships with medical professionals.

Adoption of the AdvaMed Code of Ethics for Interactions with Healthcare Professionals (AdvaMed Code)

by a medical device manufacturer is voluntary, and while the Office of the Inspector General and other federal and state healthcare regulatory agencies encourage its adoption and may look to the AdvaMed Code, they do not view adoption of the AdvaMed Code as proof of compliance with applicable laws.

We have adopted the AdvaMed Code by incorporating its fundamental principles into our Global Health Care Compliance Manual and incorporated its principles in our compliance policies, employee training programs and relationships with medical professionals.

Regulation Outside of the United States:

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In addition, regulatory agencies and authorities can halt distribution within the country or otherwise take action in accordance with local laws.

AtriCure is a member of MedTech Europe, a voluntary trade association for the medical technology industry including diagnostics, medical devices and digital health.

MedTech Europe and its members are committed to a high level of ethical business practices and have put in place strict guidelines to advise medical technology manufacturers on how to collaborate ethically with healthcare professionals (HCPs).

These guidelines are set out in the MedTech Europe Code of Ethical Business Practice (MedTech Code), which regulates all aspects of the industry's relationships with HCPs and healthcare organizations (HCOs).

It covers medical education and research and development.

It also introduces an independent enforcement mechanism and transparency obligations.

The Code sets clear and transparent rules for the industry's relationships with HCPs and HCOs, including company events, third-party organized events, arrangements with consultants, gifts, research and financial support to medical education.

We have adopted the MedTech Code and incorporated its principles into our Global Health Care Compliance Manual, employee training programs and relationships with medical professionals.

This manual also takes into account other global compliance principles as set forth in other international codes of ethics, such as the APAC Med Code of Ethical Conduct and AdvaMed China Code.

Global anti-bribery laws such as the US Foreign Corrupt Practices Act, the UK Anti-Bribery Act, and other similar laws apply in markets around the world.

We have incorporated these principles into our compliance policies and Global Health Care Compliance Manual, training programs, and business practices.

Conformity Assessment Pathway .

In the European Union, various directives regulate the design, manufacture and labeling of medical devices, and more stringent conformity assessment requirements have been put in place with the 2017 Medical Device Regulation, effective May 26, 2021.

The method for assessing conformity varies depending on the type and class of the product, but typically involves a combination of quality system assessment and product conformity

assessment by a third-party notified body, an independent and neutral institution appointed by a country to conduct the conformity assessment.

The method for assessing conformity varies depending on the type and class of the product, but typically involves a combination of quality system assessment and product conformity assessment by a third-party notified body, an independent and neutral institution appointed by a country to conduct the conformity assessment.

This third-party assessment includes a review of documentation related to the device that may be as extensive as the documentation requirements that the United States FDA requires for higher risk products.

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labeling, advertising and promotion, reporting of device modifications, monitoring the safety of the product and performing corrections and removals when necessary, maintaining “state of the art” requirements for the devices through compliance with standards, and obtaining recertification of the quality system and individual device certificates on a periodic basis.

AtriCure is a member of MedTech Europe, a voluntary trade association for the medical technology industry including diagnostics, medical devices and digital health.

It covers medical education and research and development.

It also introduces an independent enforcement mechanism and transparency obligations.

We have adopted the MedTech Code and incorporated its principles in our standard operating procedures, employee training programs and relationships with medical professionals.

Consulting Relationships

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As such, they provide for payment of a fair market value fee only for legitimate services rendered to us.

We do not expect or require the consultant to utilize or promote our products, and consultants are required to disclose their relationship with us as appropriate, such as when publishing an article in which one of our products is discussed.

We do not expect or require the consultant to utilize or promote our products, and consultants are required to disclose their relationship with us as

appropriate, such as when publishing an article in which one of our products is discussed.

Amounts paid to physicians in the United States are disclosed by us in annual reports submitted to CMS under the federal “Open Payments” law.

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As of December 31, 2024, we had approximately 1,300 employees.

Our Board of Directors, along with the Compensation Committee, provides oversight of the human capital management including demographics, diversity and inclusion efforts, and aspects of employee compensation.

Our Board of Directors, along with the Compensation Committee, provides oversight of human capital management including demographics, diversity and inclusion efforts, and aspects of employee compensation.

At AtriCure, our employees are crucial to the ongoing success of the company.

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We continuously evaluate, modify and enhance our internal processes to increase employee engagement, productivity and efficiency, as well as to recruit new employees to support our growth.

Recognizing the significance of our employees to our success, in 2022 we introduced a “people objective” to our annual incentive plan focused on attraction, development and retention of talent, in addition to strategic Diversity, Equity and Inclusion (DE&I) initiatives.

Recognizing the significance of our employees to our success, we include a “people objective” in our annual incentive plan to ensure focus and accountability.

Talent Attraction and Retention

We attract top talent to AtriCure and provide mechanisms for them to take ownership of their career paths to support their career aspirations so they can build a long-term future with our company.

Over the last five years, voluntary turnover rate among our employees has remained consistently below 10%, outperforming the industry average.

We attract top talent to AtriCure, provide mechanisms for them to take ownership of their career paths and support their career aspirations to build a long-term future with our company.

Over the last five years, the voluntary turnover rate among our employees has remained consistently below 12%, outperforming the industry average for medical device companies.

We conduct engagement surveys of our employees at least annually with our last Organizational Health Survey resulting in above average results when compared to similar size companies.

In addition, our employees have voted us as a Top Workplace eight times in the past nine years, and internationally, our employees have voted us a Great Place to Work for two consecutive years.

In addition, our employees have voted us as a Top Workplace nine times in the past ten years, and internationally, our employees have voted us a Great Place to Work for three consecutive years.

We also promote employee retention and development by supporting internal movement to create accretive experiences for our employees.

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Under this philosophy, we believe our leaders will better help attract, develop and retain talent.

We are committed to identifying and developing the talents of our next-generation leaders, and conduct a

comprehensive Talent and Organization Planning to position AtriCure with appropriate organization and leadership capability to meet current and future business needs.

In that process, we review existing leaders and prospective leaders throughout the organization and determine next best steps for their future development.

We are committed to identifying and developing the talents of our next-generation leaders, and conduct a comprehensive Talent and Organization Planning to position AtriCure with appropriate organization and leadership capability to meet current and future business needs.

In that process, we review existing leaders and prospective leaders throughout the organization and determine the next best steps for their future development.

Employee development is an important part of the way we drive retention and foster a strong culture of learning.

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Programs and offerings for development include AMPLIFY, our leadership development program for mid-level leaders across the company;

and AtriCure YOUniversity, a series of competency-based courses for global employees.

Manager Foundations Certification Program to provide all people-managers with tools and resources to be effective managers, and AtriCure YOUniversity, a series of competency-based courses for global employees.

In addition to development programs for all employees, we have several functional development programs, such as the Engineering Development Program that offers four six-month rotations through different departments as part of our differentiated early pipeline talent development and the Sales Training Associates program focused on rotating talent within functions to support future commercial roles.

Lastly, we provide tuition reimbursement for employees pursuing undergraduate and graduate degrees.

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We have an ongoing commitment to advancing DE&I throughout our workplace and the communities in which we operate.

Our leaders lead from the front by creating an environment that fosters a sense of belonging and ignites passion within their team.

Our leaders create an environment that fosters a sense of belonging and ignites passion within their team.

This leader-led approach to building an equitable and inclusive workforce has a longstanding commitment to fostering a workplace that rejects discrimination, celebrates differences, and promotes equality.

Our DEI framework guides our long-term vision and is grounded in the following objectives:

• Attract and develop employees resembling the diversity of the communities, partners and patients we serve

In 2024, the Company earned recognition by Fast Company, Inc.

as the company that offers the best opportunities for women innovators.

This honor reflects our commitment to fostering an environment where women can thrive, innovate and lead in advancing solutions.

Our DE&I framework guides our long-term vision and is grounded in the following objectives:

• Attract and develop employees resembling the diversity of the communities and patients we serve.

• Create a diverse talent pipeline by fostering awareness of STEM and healthcare careers for women and ethnically diverse groups.

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• Increase awareness and advocate for diversity in medical research and clinical trials through healthcare partnerships.

• Explore opportunities to invest in local economic growth by supporting women and ethnically diverse groups, while collaborating with our partners to engage communities to promote heart health awareness

Our DE&I efforts are overseen internally by our Chief Human Resources Officer who works with our leadership to further advance our commitment and programs by fostering employee understanding, intentionality and measurable processes.

• Collaborate with our partners to engage communities to promote heart health awareness.

Our DE&I efforts and programs advance our commitment by fostering employee understanding, intentionality and measurable processes.

This commitment is also reflected in the current makeup of our Board of Directors, which helps to set the “tone at the top” for our DE&I initiatives.

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We have implemented multiple safety programs and regularly perform safety hazard evaluations within our facilities.

Programs include our Emergency Site Action Plan for emergencies such as fire response, severe weather threats and shelter in place

incidents, as well as our Certified First Responders safety program that include Red Cross training of employees in CPR, AED Usage and First Aid practices.

Programs include our Emergency Site Action Plan for emergencies such as fire response, severe weather threats and shelter in place incidents, as well as our Certified First Responders safety program that include Red Cross training of employees in CPR, AED Usage and First Aid practices.

We recognize that the use of tobacco is linked to many adverse health effects, including those that impact the heart, and we offer our employees tobacco cessation programs.

Since 2021, our Ohio office locations are entirely tobacco- and nicotine-free, and to the extent permitted in the states of our other offices, those locations are also entirely tobacco- and nicotine-free.

Since 2021, our Ohio office locations are entirely tobacco- and nicotine-free, and to the extent permitted in the local jurisdictions of our other offices, those locations are also tobacco- and nicotine-free.

Available Information

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Such filings are placed on our website as soon as reasonably practicable after they are filed or furnished, as the case may be, with the SEC.

Our charters for our Audit, Compensation, Nominating and Corporate Governance, Strategy, and Compliance, Quality and Risk Committees and our Code of Conduct are available on our website.

Charters for our Audit, Compensation, Nominating and Corporate Governance, Strategy, and Compliance, Quality and Risk Committees and our Code of Conduct are available on our website.

In the event that we grant a waiver under our Code of Conduct to any of our officers or directors or make any material amendments to the Code of Conduct, we will publish it on our website within four business days.

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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