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Item 1. Business

2026-02-19 compared with 2025-02-14 · 107 added, 70 removed, 395 unchanged (31% 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.

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

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

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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.

It is estimated that over 4 million people in the United States currently suffer from long-standing persistent Afib.

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

It is estimated that over four million people in the United States currently suffer from long-standing persistent Afib.

Afib often occurs in conjunction with other cardiovascular diseases, including hypertension, congestive heart failure, left ventricular dysfunction, coronary artery disease and valvular disease.

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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.

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

Recovery from these surgeries can be complicated and painful.

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.

Our cryoICE cryoSPHERE ® and cryoXT™ probes for pain management (known as Cryo Nerve Block) provide 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, Australia and Canada.

We also sell our products through distributors who in turn sell our products to medical centers in other international markets.

Our business is primarily transacted in U.S.

direct sales transactions outside the United States are transacted in Euros, British Pounds, Canadian Dollars or Australian Dollars.

direct sales transactions outside the United States are primarily transacted in Euros, British Pounds, Australian Dollars or Canadian Dollars.

Market Overview

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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 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.

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.

During 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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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.

Additionally, our Le ft A trial A ppendage Exclusion for P rophylactic S troke Reduction (LeAAPS) IDE clinical trial is evaluating the safety and effectiveness of our AtriClip system in reducing stroke in cardiac surgery patients without a pre-existing Afib diagnosis.

Our Box Lesion and Left Atrial Appendage E X clusion Procedure for the Prevention of N ew O nset of A trial F ibrillation (BoxX-NoAF) IDE trial evaluates the impact of concomitant ablation using the EnCompass clamp and the AtriClip system in non-AF patients for the reduction of post-operative Afib (POAF) and clinical AF.

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

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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 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.

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 see significant continued growth.

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 our EPi-Sense® ablation system.

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.

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

Beyond the Afib treatment opportunity, it is estimated that up to 50% of patients who undergo cardiac surgery who do not have diagnosed pre-operative Afib eventually develop POAF.

Patients with POAF tend to have worse acute and long-term clinical outcomes, including the risk of developing long-term clinical Afib.

Additionally, various studies have associated POAF with higher healthcare cost related burdens.

Currently, there are no FDA approved therapies to prevent the onset of POAF in cardiac surgery patients.

In October, we enrolled the first patient in the BoxX-NoAF IDE trial, which is intended to demonstrate that ablation and left atrial appendage exclusion during cardiac surgery is safe and effective for reducing POAF and long-term clinical Afib in patients without a documented pre-operative history of Afib.

If the trial is successful, we believe this significantly expands our addressable market for concomitant ablation and LAAM to be inclusive of non-Afib patients undergoing cardiac surgery.

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.

It is estimated that each year approximately 150,0000 thoracic procedures and approximately 250,000 cardiothoracic procedures are performed in the United States.

Hospital recovery times can vary from two to fifteen days depending on the procedure, operative complications associated with the procedure, pain management protocol and other factors.

Hospital recovery times can vary from two to fifteen days depending on the procedure, operative complications associated with the

procedure, pain management protocol and other factors.

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.

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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.

In September 2025, we announced the launch of the cryoXT™ device, an innovative cryoablation technology used to help manage post-operative pain following amputation procedures.

Each year, over 180,000 amputations occur in the U.S., with approximately 60% of patients experiencing residual limb pain and up to 85% reporting phantom limb pain.

With the introduction of the cryoXT device, physicians now have access to a next-generation tool that brings this long-lasting approach to post-amputation pain management.

Applications for Cryo Nerve Block outside of cardiac, thoracic, and amputation surgery are being studied 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 LAAM, and pioneers of the application of Cryo Nerve Block in cardiothoracic surgical 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 cardiac, thoracic and amputation 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 and clinically proven results.

Our products enable surgeons to perform ablation and LAAM 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.

Leading 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.

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The parallel closure evenly compresses tissue and evacuates the blood and fluids from the energy pathway to make the ablation more effective.

The Isolator Synergy Ablation System has been studied in multiple FDA approved clinical trials, including the previously completed ABLATE clinical trial which supported a pre-market approval (PMA) in 2011, as well as the ongoing DEEP AF IDE and HEAL-IST clinical trials.

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 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.

All 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.

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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.

The EnCompass clamp 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.

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.

The BoxX-NoAF clinical trial is evaluating if prophylactic box lesion ablation with the EnCompass clamp and exclusion of the Left Atrial Appendage using our AtriClip devices at the time of other routine cardiac surgery can reduce the incidence of post operative AF and clinical AF during long term follow up in patients who have not yet developed AF but are at risk.

• Multifunctional Pens and Linear Ablation Devices .

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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.

All products 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.

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

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

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

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

The findings from this study were published in 2025.

Products for minimally invasive ablation:

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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.

These cryoSPHERE probes 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.

AtriCure’s cryoSPHERE devices have been used in over 100,000 procedures since FDA clearance in November 2018.

• cryoXT probes .

In April 2025, FDA granted 510(k) clearance for the cryoICE cryoXT probe, a cryoablation device designed specifically for Cryo Nerve Block therapy to alleviate pain in amputation patients.

The device temporarily blocks pain by freezing target peripheral nerves, blocking the conduction pathway at the site of amputation.

As part of the cryoICE® platform, the cryoXT device builds on the proven safety and efficacy of our cryoSPHERE platform.

The device features a newly designed tip with multi-surface freezing technology to precisely target large diameter exposed peripheral nerves.

In September 2025, the cryoXT probe was launched in the United States.

We also launched the VANISH Registry to capture real-world safety and performance data on cryoablation devices used when freezing nerves during an extremity amputation procedure.

Products for appendage management:

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

Our AtriClip devices are the most widely sold LAA management devices worldwide, with more than 750,000 patients treated.

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 certain products are in compliance with EU MDR and bear the CE mark for commercial distribution.

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.

During the first quarter of 2025, FDA granted 510(k) clearance for the AtriClip® PRO-Mini™ LAA Exclusion System.

This device is built on the existing AtriClip platform, preloaded with the smallest surgical LAA management implant available in the market.

The size reduction provides surgeons with enhanced visualization for precise, secure exclusion of the LAA during minimally invasive procedures.

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

We sell additional products and enabling technologies that hold 510(k) approvals and 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 continue to invest in landmark clinical trials to validate the long-term results of procedures using our products and to support applications to regulatory agencies for expanded indications.

We also make clinical research grants to support our product development efforts and expand the body of clinical evidence.

We also make clinical research grants and fund clinical registries to support our product development efforts and expand the body of clinical evidence.

We believe publication of additional scientific evidence, in addition to robust ongoing research activities, will ultimately create an increased demand for our products.

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

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.

In the past eight 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.

We have recruited and trained sales and physician education professionals to effectively communicate to our customers the unique features and benefits of our technologies as they relate to their indications for use.

Our highly trained professionals meet with physicians at institutions around the world to provide education and technical training on the features, benefits and safe-and-effective use of our products.

Our highly trained professional education team conducts a variety of in-person and virtual training programs with physicians at institutions around the world to provide education and technical training on the features, benefits and safe-and-effective use of our products.

With the approval of our Isolator Synergy System, we instituted a program to train providers on the use of the Isolator Synergy System to treat persistent and long-standing persistent Afib in patients undergoing open-heart surgery.

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.

During 2025, we launched new and innovative training methods for physicians that include virtual proctoring and observerships as well as the ability to review case-in-a-box on a peer-to-peer basis.

We have also extended our courses for Advanced Practice Providers, incorporating

new content and workshops.

We also recently launched our first electronic manual created by physicians for physicians that provides an outline for best practices in developing and growing a Hybrid Ablation Program.

These new training events along with our traditional on-demand, local and national training courses allow for collaborative, hands-on engagement with our physician partners and other healthcare professionals.

Additionally, our professional education courses continue to be enhanced by the use of simulation models or synthetic cadavers, known as CADets.

These reusable CADets provide a sustainable alternative to the use of cadaver specimens, in addition to increasing the efficiencies of education and more cost effective training alternatives.

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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Key trials and studies are:

In April 2022, FDA approved the protocol for the Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction (LeAAPS) IDE clinical trial.

The trial is designed to evaluate the effectiveness of prophylactic LAA exclusion using the AtriClip LAA Exclusion System for the prevention of ischemic stroke or systemic arterial embolism in cardiac surgery patients without pre-operative AF diagnosis who are at risk for these events.

This prospective, multicenter, randomized trial evaluates safety at 30 days post-procedure to demonstrate no increased risk with LAA exclusion during cardiac surgery and effectiveness with a minimum follow-up of five years post procedure for all subjects.

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

We enrolled our first patient in January 2023;

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

The Box Lesion and Left Atrial Appendage E X clusion Procedure for the Prevention of N ew O nset of A trial F ibrillation (BoxX-NoAF) IDE trial evaluates the impact of concomitant ablation using the EnCompass clamp and LAA exclusion with the AtriClip system in non-AF patients for the reduction of post-operative AF (POAF) and clinical AF.

This prospective, multicenter, multi-national randomized trial evaluates safety at 30 days post-procedure for POAF and secondary effectiveness for clinical AF through three years.

The trial provides for enrollment of up to 960 subjects at up to 75 sites globally.

FDA approved the trial protocol during the fourth quarter of 2024 and during October 2025 we completed the first patient enrollment.

Site initiation and enrollment is ongoing.

The Le ft A trial A ppendage Exclusion for P rophylactic S troke Reduction (LeAAPS) IDE clinical trial is designed to evaluate the effectiveness of prophylactic LAA exclusion using the AtriClip LAA Exclusion System for the prevention of ischemic stroke or systemic arterial embolism in cardiac surgery patients without pre-operative AF diagnosis who are at risk for these events.

This prospective, multicenter, randomized trial evaluates safety at 30 days post-procedure to demonstrate no increased risk with LAA exclusion during cardiac surgery, and efficacy over a minimum follow-up period of five years post procedure.

In July 2025, we completed trial enrollment of 6,573 patients across 139 centers globally and patient follow-up remains ongoing.

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 trial provides for enrollment of up to 142 patients at up to 40 sites in the United States, United Kingdom and European Union.

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

site initiation and enrollment is ongoing.

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.

The first patient enrollment in the trial occurred in June 2022 and enrollment 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 2026 meetings.

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

• 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.

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.

Site initiation and enrollment in the CONVERGE PAS is ongoing.

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

The trial is ongoing with long-term patient follow-up;

however, no further participants are being enrolled.

• 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 primary effectiveness and safety results were published in 2025 in The Journal of Thoracic and Cardiovascular Surgery , showing 70% freedom from atrial fibrillation/atrial flutter/atrial tachycardia from 6 through 12 months and a 30-day major adverse event (defined as stroke, myocardial infarction, major bleeding and death) rate of 9.3%, all events unrelated to surgical ablation/device.

Quality of life data will be presented at American Association of Thoracic Surgery in May 2026.

• 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.

The patient undergoes the endocardial catheter procedure approximately 91-120 days later.

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

Durable Effects of Hybrid Ablation Versus Catheter Ablation:

Final Results of the CEASE-AF Trial were presented at European Association of Cardio-Thoracic Surgery during 2025 and demonstrated that physical and mental quality of life scores significantly improved from baseline to three years after ablation.

Compared to catheter ablation, hybrid ablation had statistically similar safety rates and required fewer interventions through three years.

Analyses from study data continue and may lead to additional publications.

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 endocardial catheter devices that are commonly used by electrophysiologists.

For standalone treatment of Afib, several companies offer endocardial catheter devices that are used by electrophysiologists as first-line therapy for Afib patients.

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.

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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.

We are aware of other companies developing technology for cardiac tissue ablation and appendage management.

We are also aware of other companies developing technology for cardiac tissue ablation and appendage management.

New product introductions, technological advances and regulatory clearances from competitors may impact the use of our products in cardiac procedures.

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 cryo nerve block therapies for thoracic surgery.

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

Currently, we are not aware of other companies in the United States who are pursuing cryo nerve block therapies, however, there are other companies outside of the United States who market their devices for a similar therapy.

Third-Party Reimbursement

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There are category one CPT codes for both concomitant and standalone surgical Afib treatment, as well as surgical LAAM.

However, some providers utilize unlisted CPT codes to obtain reimbursement when no appropriate CPT code exists, such as Cryo Nerve Block ablation when used for post operative pain control.

However, some providers utilize unlisted CPT or G codes to obtain reimbursement when no appropriate Category I CPT code exists, such as Cryo Nerve Block ablation when used for post operative pain control.

In addition to the Medicare program, many private payors look to CMS policies as a guideline in setting their coverage policies and payment amounts.

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Clinical trials are subject to extensive recordkeeping and reporting requirements.

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

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 and EU regulations and international standards, 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 all regulatory requirements and other human subject protection regulations established by FDA or other international agencies.

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

Educational Grants .

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and reporting certain device corrections and removals.

Our manufacturing facilities and processes are also subject to FDA inspections to ensure compliance with Quality System Regulations (QSR).

Our manufacturing facilities and processes are also subject to FDA inspections to ensure compliance with Quality Management System Regulations (QMSR).

In addition to FDA regulation, the advertising and promotion of certain medical devices are also regulated by the Federal Trade Commission and by state regulatory and enforcement authorities.

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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 (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.

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.

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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.

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There are numerous regulatory requirements that apply after a product has been approved by the notified body for CE marking, including, but not limited to:

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.

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.

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.

23 unchanged sentences

To date, we have not experienced significant product availability or delay issues directly related to obtaining any of our components.

We regularly audit our suppliers for compliance with our quality system requirements, the QSR and/or applicable International Organization of Standardization (ISO) standards.

We regularly audit our suppliers for compliance with our quality system requirements, the QMSR and/or applicable International Organization of Standardization (ISO) standards.

We are an FDA-registered medical device manufacturer and certified to ISO 13485:2016.

We routinely conduct internal audits of our quality systems in accordance with various international standards.

We routinely conduct internal audits of our quality systems in accordance with various

international standards.

In addition, we have successfully participated in the Medical Device Single Audit Program (MDSAP) and have been certified accordingly.

8 unchanged sentences

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, 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, 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.

Over the last five years, the voluntary turnover rate among our employees has remained consistently at or below 10%, 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 nine times in the past ten years, and internationally, our employees have voted us a Great Place to Work for three consecutive years.

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

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

17 unchanged sentences

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

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

as the company that offers the best opportunities for women

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

40 unchanged sentences

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.

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.

Information on our website is not deemed to be a part of this Form 10-K.

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