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

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

+270 added−247 removedSource: 10-K (2026-02-19) vs 10-K (2025-02-14)

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

270 paragraphs added · 247 removed · 211 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

83 edited+28 added−7 removed133 unchanged
Biggest changeMore recently, we have implemented multidisciplinary training programs focused on 6 Table of Contents 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.
Biggest changeWe 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. As a result of the educational process, we believe that awareness of our technologies is growing and will result in the increased use of our products. Evaluate Acquisition Opportunities.
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. 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.
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.
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.
Today, we estimate that less than 15% 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.
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.
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 DEEP AF IDE clinical trial and ongoing HEAL-IST clinical trial.
We are 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.
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.
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.
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 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.
Dollars; direct sales transactions outside the United States are transacted in Euros, British Pounds, Canadian Dollars or Australian Dollars. Market Overview Afib is the most commonly diagnosed sustained cardiac arrhythmia, with over one million diagnoses annually in the United States alone.
Dollars; direct sales transactions outside the United States are primarily transacted in Euros, British Pounds, Australian Dollars or Canadian Dollars. Market Overview Afib is the most commonly diagnosed sustained cardiac arrhythmia, with over one million diagnoses annually in the United States alone.
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.
These societal guidelines are reflective of the scientific evidence suggesting that surgical and hybrid ablation is safe and effective for patients who have Afib. Of the patients undergoing open-heart surgery globally on an annual basis, we estimate that over 300,000 are potential candidates for surgical ablation using our products, as they have pre-operative Afib.
These societal guidelines are reflective of the scientific evidence suggesting that surgical and hybrid ablation is safe and effective for patients who have Afib. Of the patients undergoing open-heart surgery globally on an annual basis, we estimate that over 500,000 are potential candidates for surgical ablation using our products, as they have pre-operative Afib.
Our international sales team includes approximately 70 employees focused on our direct markets, such as Germany, France, the United Kingdom, the Benelux region, Canada and Australia. We also maintain a network of distributors who market and sell our products in Asia and South America, as well as certain countries in Europe.
Our international sales team includes approximately 75 employees focused on our direct markets, such as Germany, France, the United Kingdom, the Benelux region, Canada and Australia. We also maintain a network of distributors who market and sell our products in Asia and South America, as well as certain countries in Europe.
We also make clinical research grants 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. Build Physician and Societal Relationships.
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. Build Physician and Societal Relationships.
During 2 Table of Contents 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.
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.
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.
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, 12 Table of Contents 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.
We only promote our products for uses described in their labeling as cleared or approved by relevant regulatory agencies, and train our sales force on the use of our products to the extent the products are cleared or approved. Our sales team in the United States has approximately 310 employees.
We only promote our products for uses described in their labeling as cleared or approved by relevant regulatory agencies, and train our sales force on the use of our products to the extent the products are cleared or approved. Our sales team in the United States has approximately 330 employees.
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. 5 Table of Contents In the United States, our AtriClip LAA Exclusion System products are 510(k)-cleared with an indication for the exclusion of the LAA, performed under direct visualization and in conjunction with other cardiac surgical procedures.
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. In the United States, our AtriClip LAA Exclusion System products are 510(k)-cleared with an indication for the exclusion of the LAA, performed under direct visualization and in conjunction with other cardiac surgical procedures.
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.
Many surgeons use multiple pain management strategies that include oral delivery of opioid and non-opioid pain medications. 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.
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 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.
On occasion, promotional activities for FDA-regulated products can be the subject of enforcement action brought under healthcare reimbursement laws and consumer protection statutes. In addition, under the Federal Lanham Act and similar state laws, competitors and others can initiate litigation relating to advertising claims. Fraud, Abuse and False Claims .
On occasion, promotional activities for FDA-regulated products can be the subject of enforcement action brought under healthcare reimbursement laws and consumer protection statutes. In addition, under the Federal Lanham Act and similar state laws, competitors and others can initiate litigation relating to advertising claims. 11 Table of Contents Fraud, Abuse and False Claims .
Adoption of the AdvaMed Code of Ethics for Interactions with Healthcare Professionals (AdvaMed Code) 10 Table of Contents 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.
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.
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 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.
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.
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 surgeons to perform ablation and LAAM procedures with faster, less invasive and less technically challenging approaches and clinically proven results.
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 FLEX-Mini sets a new standard as the smallest profile for a surgical LAA 6 Table of Contents 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.
ITEM 1. BUSINESS Overview 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 59 million people worldwide and is a growing epidemic.
ITEM 1. BUSINESS Overview 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.
Our manufacturing facilities and processes are also subject to FDA inspections to ensure compliance with Quality System Regulations (QSR). 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.
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.
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 11 Table of Contents 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.
FDA regulates the total product lifecycle from early design, development and testing, to manufacturing and commercialization activities, as well as post-market surveillance and reporting, including corrective actions, removals and recalls. Unless an exemption applies, most medical devices distributed in the United States require either 510(k) clearance or PMA from FDA. 9 Table of Contents 510(k) Clearance Pathway .
FDA regulates the total product lifecycle from early design, development and testing, to manufacturing and commercialization activities, as well as post-market surveillance and reporting, including corrective actions, removals and recalls. Unless an exemption applies, most medical devices distributed in the United States require either 510(k) clearance or PMA from FDA. 510(k) Clearance Pathway .
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.
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.
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 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.
In 2024, FDA granted 510(k) clearance for EPi-Ease ™ , our Hybrid access device to facilitate guide-wire delivery, vacuum application and endoscope insertion. 5 Table of Contents Products for pain management: • 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.
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.
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 3 Table of Contents procedure, pain management protocol and other factors.
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.
In 2024, the European Society of Cardiology (ESC) released Guidelines for Management of Atrial Fibrillation developed in collaboration with the European Association 2 Table of Contents of Cardio-Thoracic Surgery (EACTS), in which they upgraded LAAM to the highest Class 1 recommendation.
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.
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.
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.
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.
In 2024, the Company earned recognition by Fast Company, Inc. as the company that offers the best opportunities for women 14 Table of Contents innovators. This honor reflects our commitment to fostering an environment where women can thrive, innovate and lead in advancing solutions.
We regularly audit our suppliers for compliance with our quality system requirements, the QSR 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 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 13 Table of Contents international standards.
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.
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 cardiac, thoracic or amputation surgical procedures. Recovery from these surgeries can be complicated and painful.
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. • Foster a culture of inclusion and belonging where all employees are valued and empowered. • Enhance DE&I understanding and behaviors through education and development. • Increase awareness and advocate for diversity in medical research and clinical trials through healthcare partnerships. • Collaborate with our partners to engage communities to promote heart health awareness. 13 Table of Contents Our DE&I efforts and programs advance our commitment by fostering employee understanding, intentionality and measurable processes.
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. • Foster a culture of inclusion and belonging where all employees are valued and empowered. • Enhance DE&I understanding and behaviors through education and development. • Increase awareness and advocate for diversity in medical research and clinical trials through healthcare partnerships. • Collaborate with our partners to engage communities to promote heart health awareness.
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. 8 Table of Contents Third-Party Reimbursement Reimbursement for health care services in the United States is generally made by third-party payors.
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 Reimbursement for health care services in the United States is generally made by third-party payors.
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.
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 used by electrophysiologists as first-line therapy for Afib patients.
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: • AtriClip System .
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.
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.
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.
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 AtriClip system represents a significant growth opportunity.
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.
Further, applications for Cryo Nerve Block outside of thoracic surgery use are being studied by physician investigators and represent future possible growth opportunities. 3 Table of Contents 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.
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 cardiac, thoracic and amputation surgical procedures.
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 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 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.
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.
Surgeons generally use one or more of our pen and linear devices in combination with Isolator Synergy clamps. 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 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.
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. 14 Table of Contents
In the event that we grant a waiver under our Code of Conduct to any of our 15 Table of Contents officers or directors or make any material amendments to the Code of Conduct, we will publish it on our website within four business days.
The CONVERGE trial demonstrated superiority in the hybrid therapy arm compared to endocardial catheter ablation alone. In patients diagnosed with long-standing persistent Afib, the therapy arm showed a 29% absolute difference in efficacy at 12 months (78% relative improvement) and an absolute difference of 35% at 18 months (110% relative improvement).
In patients diagnosed with long-standing persistent Afib, the therapy arm showed a 29% absolute difference in efficacy at 12 months (78% relative improvement) and an absolute difference of 35% at 18 months (110% relative improvement).
Performance expectations are communicated to employees at the time of hiring, as well as upon internal transfer or promotion, and documented through our annual performance management process.
Annual pay increases and other forms of incentive compensation are based on performance and market evaluation. Performance expectations are communicated to employees at the time of hiring, as well as upon internal transfer or promotion, and documented through our annual performance management process.
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.
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.
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.
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.
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.
Surgeons may utilize the cryoICE devices in combination with Isolator Synergy clamps or independently. 4 Table of Contents 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.
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.
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.
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 (EU MDR), effective May 26, 2021.
As a result of the educational process, we believe that awareness of our technologies is growing and will result in the increased use of our products. Evaluate Acquisition Opportunities. We expect to continue to be opportunistic with respect to acquisitions. We evaluate acquisition opportunities on a variety of factors, including product innovation, clinical differentiation and other strategic and financial criteria.
We expect to continue to be opportunistic with respect to acquisitions. We evaluate acquisition opportunities on a variety of factors, including product innovation, clinical differentiation and other strategic and financial criteria.
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. Products for minimally invasive ablation: • EPi-Sense Systems .
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: • EPi-Sense Systems .
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. These patients tend to be motivated to seek treatment to alleviate their symptoms. Patients who are symptomatic are often treated by an electrophysiologist using catheter ablation.
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. These patients tend to be motivated to seek treatment to alleviate their symptoms.
We enrolled our first patient in January 2023; site initiation and enrollment is ongoing and we expect to complete enrollment in 2025. HEAL-IST. 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).
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).
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.
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.
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.
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.
Human Capital Management Successful execution of our strategy is dependent on attracting, developing and retaining key employees and members of our management team. As of December 31, 2024, we had approximately 1,300 employees.
Human Capital Management Successful execution of our strategy is dependent on attracting, developing and retaining key employees and members of our management team. As of December 31, 2025, we had approximately 1,350 employees. 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.
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. Compensation and Benefits Competitive compensation and benefits are an integral part of our efforts to attract and retain world-class talent.
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.
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.
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. 9 Table of Contents 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 believe that the AtriClip system is safer, more effective and easier to use than other techniques for permanently excluding the left atrial appendage.
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 safer, more effective and easier to use than other techniques for permanently excluding the left atrial appendage.
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.
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. The CONVERGE trial demonstrated superiority in the hybrid therapy arm compared to endocardial catheter ablation alone.
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.
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.
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.
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. HEAL-IST.
We are actively working to pursue market access in certain geographies, which includes applying for new reimbursement for therapies in which our devices are being used or pursuing specific reimbursement for utilization of our devices.
We are actively working to pursue market access in certain geographies, which includes applying for new reimbursement for therapies in which our devices are being used or pursuing specific reimbursement for utilization of our devices. 10 Table of Contents Government Regulation 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.
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). Educational Grants .
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.
The Company continues to perform long-term patient follow-up in multiple studies and plans to present results at 2025 meetings. 7 Table of Contents • In May 2024, the Company finished twelve-month patient follow-up required by the ICE-AFIB study protocol.
The Company continues to perform long-term patient follow-up in multiple studies and plans to present results at 2026 meetings.
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.
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.
Catheter ablation is considered a percutaneous procedure that does not require the opening of the chest; rather, catheters are inserted through a small puncture in the groin. In addition to catheter ablation, there are other treatment options for patients with Afib, including pharmacological therapy (anti-arrhythmic drugs) and implantable pacemakers.
Patients who are symptomatic are often treated by an electrophysiologist using catheter ablation. Catheter ablation is considered a percutaneous procedure that does not require the opening of the chest; rather, catheters are inserted through a small puncture in the groin.
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.
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 see significant continued growth.
We are committed to regularly analyzing and evaluating the effectiveness of our compensation and benefit programs and benchmarking our programs against the market and our industry peers. Annual pay increases and other forms of incentive compensation are based on performance and market evaluation.
Compensation and Benefits Competitive compensation and benefits are an integral part of our efforts to attract and retain world-class talent. We are committed to regularly analyzing and evaluating the effectiveness of our compensation and benefit programs and benchmarking our programs against the market and our industry peers.
In addition, we also conduct various studies to gather clinical data regarding our products. Key trials and studies are: LeAAPS. In April 2022, FDA approved the protocol for the Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction (LeAAPS) IDE clinical trial.
In addition, we also conduct various studies to gather clinical data regarding our products. Key trials and studies are: BoxX-NoAF.
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.
At AtriCure, our employees are crucial to the ongoing success of the company. The skills, experience and industry knowledge of our employees significantly benefit our operations and performance. 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.
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.
During 2024, we launched the newest generation AtriClip, the AtriClip ® FLEX-Mini™ device, in the United States.
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 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 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.
Products for open ablation: • cryoICE Cryoablation System . 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.
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 for post-operative pain management.
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.
Sales, Marketing and Medical Education Our global sales and marketing efforts focus on educating physicians about our unique technologies and their clinical benefits.
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 Our global sales and marketing efforts focus on educating physicians about our unique technologies and their clinical benefits.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeIn addition, the number of medical device reports we make, or the magnitude of the problems reported, could cause us or FDA to terminate or modify our clinical trials or recall or cease the sale of our products, and could hurt commercial acceptance of our products and harm our reputation with customers.
Biggest changeIn addition, the number of medical device reports we make, or the magnitude of the problems reported, could cause us or FDA to terminate or modify our clinical trials or recall or cease the sale of our products, and could hurt commercial acceptance of our products and harm our reputation with customers. 25 Table of Contents Unless and until we obtain additional FDA approval for our products, we will not be able to promote them for the treatment of Afib, prevention of stroke, or reduction of post-operative Afib, and our ability to maintain and grow our business could be harmed.
Industry Condition Risks • A prolonged downturn in macroeconomic conditions may materially adversely affect our business. • Government and private payors may contain or reduce healthcare spending, including reimbursement for procedures that utilize our products. • Adverse changes in governmental and third-party payors’ policies toward coverage and reimbursement for surgical procedures would harm our ability to promote and sell our products.
Industry Condition Risks • A prolonged downturn in macroeconomic conditions may materially and adversely affect our business. • Government and private payors may contain or reduce healthcare spending, including reimbursement for procedures that utilize our products. • Adverse changes in governmental and third-party payors’ policies toward coverage and reimbursement for surgical procedures would harm our ability to promote and sell our products.
Specifically, impacts to procedure volumes and hospital staffing may result in reductions of our revenue and materially and adversely affect our results of operations and cash flows. Geopolitical issues around the world have impacted the global supply chain and could materially adversely affect global economic growth, disrupt discretionary spending habits and generally decrease demand for our products and services.
Specifically, impacts to procedure volumes and hospital staffing may result in reductions of our revenue and materially and adversely affect our results of operations and cash flows. Geopolitical issues around the world have impacted the global supply chain and could materially and adversely affect global economic growth, disrupt discretionary spending habits and generally decrease demand for our products and services.
Physicians may use our products in circumstances where they deem it medically appropriate, such as for the treatment Afib, prevention of stroke, or reduction of post-operative Afib, even though FDA may not have approved or cleared our products to be marketed specifically for those indications.
Physicians may use our products in circumstances where they deem it medically appropriate, such as for the treatment of Afib, prevention of stroke, or reduction of post-operative Afib, even though FDA may not have approved or cleared our products to be marketed specifically for those indications.
Financial Risks • Our quarterly financial results are likely to fluctuate significantly. • We have a history of net losses, and we may never become profitable. • Governmental authorities may challenge our intercompany transfer pricing policies or change their laws in a manner that could increase our effective tax rate. • Our goodwill may become impaired which could adversely affect our financial performance. • We may take inventory-related charges as a result of inaccurate forecasting or estimates of product life cycles which would negatively affect our gross margins and results of operations. • We are subject to credit risk from our accounts receivable related to our sales. • We may be unable to comply with the covenants of our Loan Agreement.
Financial Risks • Our quarterly financial results are likely to fluctuate significantly. • We have a history of net losses, and we may never become profitable. • Governmental authorities may challenge our intercompany transfer pricing policies or change their laws in a manner that could increase our effective tax rate. • Our goodwill may become impaired which could adversely affect our financial performance. • We may take inventory-related charges as a result of inaccurate forecasting or estimates of product life cycles which would negatively affect our gross margins and results of operations. • We are subject to credit risk from our accounts receivable related to our sales. • We may be unable to comply with the covenants of our Credit Agreement.
Legal & Compliance Risks • We could face substantial penalties if we do not fully comply with federal, state and foreign regulations. • We may be subject to fines, injunctions and penalties if we fail to comply with extensive FDA regulations. • Unless and until we obtain additional FDA approval for our products, we will not be able to promote them for treatment of Afib, prevention of stroke, or reduction of post-operative Afib, and our inability to maintain or grow our business could be harmed.
Legal & Compliance Risks • We could face substantial penalties if we do not fully comply with federal, state and foreign regulations. • We may be subject to fines, injunctions and penalties if we fail to comply with FDA regulations. • Unless and until we obtain additional FDA approval for our products, we will not be able to promote them for treatment of Afib, prevention of stroke, or reduction of post-operative Afib, and our inability to maintain or grow our business could be harmed.
Common Stock Risks • We may fail to achieve our publicly announced guidance about our business which could cause a decline in our stock price. • Securities analysts may discontinue coverage for our common stock or issue reports which could have a negative impact on the market price of our common stock. • Our common stock may experience extreme fluctuations in the price and trading volume causing our stockholders to lose some or all of their investment. • The sale of material amounts of common stock could encourage short sales by third parties and depress the price of our common stock causing our stockholders to lose part or all of their investment. • Stockholder ownership of our common stock may be diluted if we sell common stock in a capital raising transaction or issue shares in a future acquisition. • Anti-takeover provisions in our amended and restated certificate of incorporation and amended and restated bylaws and under Delaware law could inhibit a change in control or a change in management that stockholders consider favorable. • Our stockholders must rely on stock appreciation for any return on investment as we do not expect to pay dividends in the foreseeable future. 16 Table of Contents Commercial Execution and Product Performance Risks If our products do not achieve widespread market acceptance in the United States, our operating results will be harmed, and we may not achieve or sustain profitability.
Common Stock Risks • We may fail to achieve our publicly announced guidance about our business which could cause a decline in our stock price. • Securities analysts may discontinue coverage for our common stock or issue reports which could have a negative impact on the market price of our common stock. • Our common stock may experience extreme fluctuations in the price and trading volume causing our stockholders to lose some or all of their investment. • The sale of material amounts of common stock could encourage short sales by third parties and depress the price of our common stock, causing our stockholders to lose some or all of their investment. • Stockholder ownership of our common stock may be diluted if we sell common stock in a capital raising transaction or issue shares in a future acquisition. • Anti-takeover provisions in our amended and restated certificate of incorporation and amended and restated bylaws and under Delaware law could inhibit a change in control or a change in management that stockholders consider favorable. • Our stockholders must rely on stock appreciation for any return on investment as we do not expect to pay dividends in the foreseeable future. 18 Table of Contents Commercial Execution and Product Performance Risks If our products do not achieve widespread market acceptance in the United States, our operating results will be harmed, and we may not achieve or sustain profitability.
If our insurance is not adequate or available to pay liabilities associated with our operations, or if we are unable to purchase adequate insurance at reasonable rates in the future, our business, financial condition, results of operations or cash flows may be materially adversely impacted.
If our insurance is not adequate or available to pay liabilities associated with our operations, or if we are unable to purchase adequate insurance at reasonable rates in the future, our business, financial condition, results of operations or cash flows may be materially and adversely impacted.
The introduction of new products, procedures or clinical solutions, or our competitors obtaining FDA approvals or clearances, may result in price reductions, reduced margins, loss of market share, or may render our products obsolete, which could adversely affect our revenue and future profitability.
The introduction of new products, procedures or clinical solutions, or our competitors obtaining FDA approvals or clearances, may result in price reductions, reduced margins, loss of market share, or may render our products obsolete, which could adversely affect our revenue and profitability.
The Credit Agreement contains mandatory prepayment provisions which require prepayment of amounts outstanding (i) upon the receipt of proceeds from the issuance of any non-permitted indebtedness and (ii) when there is an Availability shortfall, as defined.
The Credit Agreement contains mandatory prepayment provisions which require prepayment of amounts outstanding (i) upon the receipt of proceeds from the issuance of any non-permitted indebtedness and (ii) when there is an Availability shortfall, as defined in the Credit Agreement.
In addition, the U.S. or other governments may seek to hold us liable for successor liability FCPA violations or violations of other anti-corruption laws committed by companies in which we invest or that we acquired or will acquire. 27 Table of Contents The use of artificial intelligence ("AI") technology by our employees or business partners could result in misuse or loss of proprietary information, violation of laws and regulations, or damage to our reputation and credibility.
In addition, the U.S. or other governments may seek to hold us liable for successor liability FCPA violations or violations of other anti-corruption laws committed by companies in which we invest or that we acquired or will acquire. 29 Table of Contents The use of artificial intelligence ("AI") technology by our employees or business partners could result in misuse or loss of proprietary information, violation of laws and regulations, or damage to our reputation and credibility.
We believe that such publicity would potentially have a negative impact on our business, results of operations and financial condition and our clinical studies, or cause other adverse effects, including a decline in the price of our stock. 19 Table of Contents We rely upon single and limited source third-party suppliers and third-party service providers, making us vulnerable to supply problems and price fluctuations which could harm our business.
We believe that such publicity would potentially have a negative impact on our business, results of operations and financial condition and our clinical studies, or cause other adverse effects, including a decline in the price of our stock. 21 Table of Contents We rely upon single and limited source third-party suppliers and third-party service providers, making us vulnerable to supply problems and price fluctuations which could harm our business.
Patient enrollment in clinical trials and completion of patient participation and follow-up depends on many factors, including the size of the patient population; the nature of the trial protocol; the attractiveness of, or the discomforts and risks associated with, the treatments received by enrolled subjects; the availability of appropriate clinical trial investigators, support staff, and proximity of patients to clinical sites; and the ability to comply with the eligibility and exclusion criteria for participation in the clinical trial and patient compliance.
Patient enrollment in clinical trials and completion of patient participation and follow-up depend on many factors, including the size of the patient population; the nature of the trial protocol; the attractiveness of, or the discomforts and risks associated with, the treatments received by enrolled subjects; the availability of appropriate clinical trial investigators, support staff, and proximity of patients to clinical sites; and the ability to comply with the eligibility and exclusion criteria for participation in the clinical trial and patient compliance.
Furthermore, if we make downward revisions of our previously announced guidance, or if our publicly announced guidance of future operating results fails to meet expectations of securities analysts, investors, or other interested parties, the market price of our common stock could decline. 29 Table of Contents Securities analysts may not continue, or additional securities analysts may not initiate, coverage for our common stock or may issue negative reports.
Furthermore, if we make downward revisions of our previously announced guidance, or if our publicly announced guidance of future operating results fails to meet expectations of securities analysts, investors, or other interested parties, the market price of our common stock could decline. 31 Table of Contents Securities analysts may not continue, or additional securities analysts may not initiate, coverage for our common stock or may issue negative reports.
A negative reaction by investors and securities analysts to any sale of our equity securities could result in a decline in the trading price of our common stock. 30 Table of Contents Anti-takeover provisions in our amended and restated certificate of incorporation and amended and restated bylaws and under Delaware law could inhibit a change in control or a change in management that stockholders consider favorable.
A negative reaction by investors and securities analysts to any sale of our equity securities could result in a decline in the trading price of our common stock. 32 Table of Contents Anti-takeover provisions in our amended and restated certificate of incorporation and amended and restated bylaws and under Delaware law could inhibit a change in control or a change in management that stockholders consider favorable.
Conversely, inadequate inventory levels may make it difficult for us to meet customer product demand, resulting in decreased revenue. An inability to forecast future revenue or estimated life cycles of products may result in inventory-related charges that would negatively affect our gross margins and results of operations and increase our accumulated deficit.
Conversely, inadequate inventory levels may make it difficult for us to meet customer product demand, resulting in decreased revenue. An inability to forecast future revenue or estimate life cycles of products may result in inventory-related charges that would negatively affect our gross margins and results of operations and increase our accumulated deficit.
Negative data could affect the use of our products and harm our business and prospects. 17 Table of Contents Conversely, positive results from clinical trial experience should not be relied upon as evidence that any of our products will gain market acceptance or that they will satisfy regulatory requirements for product approval.
Negative data could affect the use of our products and harm our business and prospects. 19 Table of Contents Conversely, positive results from clinical trial experience should not be relied upon as evidence that any of our products will gain market acceptance or that they will satisfy regulatory requirements for product approval.
We may also encounter interruption or delays in 18 Table of Contents the operations of FDA or other regulatory authorities, which may impact review and approval timelines. We are unable to predict the extent to which current or future worldwide economic conditions may impact our business. Healthcare costs have risen significantly over the past decade.
We may also encounter interruption or delays in the operations 20 Table of Contents of FDA or other regulatory authorities, which may impact review and approval timelines. We are unable to predict the extent to which current or future worldwide economic conditions may impact our business. Healthcare costs have risen significantly over the past decade.
Our manufacturing facilities and the manufacturing facilities of any of our third-party component manufacturers, critical suppliers or third-party sterilization facilities are required to comply with FDA’s QSR, which sets forth minimum standards for the procedures, execution and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage and shipping of the products we sell.
Our manufacturing facilities and the manufacturing facilities of any of our third-party component manufacturers, critical suppliers or third-party sterilization facilities are required to comply with FDA’s QMSR, which sets forth minimum standards for the procedures, execution and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage and shipping of the products we sell.
If in conducting an inspection of our manufacturing facilities or the manufacturing facilities of any of our third-party component manufacturers, critical suppliers or third-party sterilization facilities, an FDA investigator observes conditions or practices believed to violate the QSR, the investigator may document their observations on a Form FDA-483 that is issued at the conclusion of the inspection.
If in conducting an inspection of our manufacturing facilities or the manufacturing facilities of any of our third-party component manufacturers, critical suppliers or third-party sterilization facilities, an FDA investigator observes conditions or practices believed to violate the QMSR, the investigator may document their observations on a Form FDA-483 that is issued at the conclusion of the inspection.
Market acceptance and adoption of our products for the treatment of Afib also depends on the level of health insurer (including Medicare) reimbursement to physicians and hospitals for procedures using our products. Negative publicity resulting from incidents involving our products, or similar products could have a significant adverse effect on the overall acceptance of our products.
Market acceptance and adoption of our products for the treatment of Afib also depend on the level of health insurer (including Medicare) reimbursement to physicians and hospitals for procedures using our products. Negative publicity resulting from incidents involving our products, or similar products could have a significant adverse effect on the overall acceptance of our products.
Any finding that the value of our goodwill has been impaired would require us to record an impairment charge which could 28 Table of Contents materially reduce the value of our assets and reduce our net income or increase our net loss for the year in which the impairment charge occurs and increase our accumulated deficit.
Any finding that the value of our goodwill has been impaired would require us to record an impairment charge which could 30 Table of Contents materially reduce the value of our assets and reduce our net income or increase our net loss for the year in which the impairment charge occurs and increase our accumulated deficit.
Any clinical data that is generated regarding our products may not be positive, and our current and planned clinical trials may not satisfy the requirements of the FDA or other regulatory authorities. Our clinical trials are expensive to conduct, typically taking many years to complete and have uncertain outcomes.
Any clinical data that is generated regarding our products may not be positive, and our current and planned clinical trials may not satisfy the requirements of the FDA or other regulatory authorities. Our clinical trials are expensive to conduct, typically take many years to complete and have uncertain outcomes.
A manufacturer that receives an FDA-483 may respond in writing and explain any corrective actions taken in response to the inspection observations. FDA will typically review the facility’s written response and may re-inspect to determine the facility’s compliance with the QSR and other applicable regulatory requirements.
A manufacturer that receives an FDA-483 may respond in writing and explain any corrective actions taken in response to the inspection observations. FDA will typically review the facility’s written response and may re-inspect to determine the facility’s compliance with the QMSR and other applicable regulatory requirements.
Although our historical write-offs of accounts receivable have not been significant, we monitor the financial performance and credit worthiness of our customers so that we can properly assess and respond to changes in their credit profile.
Although our historical write-offs of accounts receivable have not been significant, we monitor the financial performance and creditworthiness of our customers so that we can properly assess and respond to changes in their credit profile.
Our failure, or the failure of our distributors, to comply with current or future 26 Table of Contents foreign regulatory requirements, or the assertion by foreign authorities that we or our distributors have failed to comply, could result in adverse consequences, including enforcement actions, fines and penalties, recalls, cessation of sales, civil and criminal prosecution, and the consequences could be disproportionate to the relative contribution of our international operations to our results of operations.
Our failure, or the failure of our distributors, to comply with current or future foreign regulatory requirements, or the assertion by foreign authorities that we or our distributors have failed to comply, could result in adverse consequences, including enforcement actions, fines and penalties, recalls, cessation of sales, civil and criminal prosecution, and the consequences could be disproportionate to the relative contribution of our international operations to our results of operations.
The following information should be carefully considered in addition to the other information set forth in this report, including the Management’s Discussion and Analysis of Financial Conditions and Results of Operations section and Consolidated Financial Statements and accompanying notes.
The following information should be carefully considered in addition to the other information set forth in this report, including the Management’s Discussion and Analysis of Financial Condition and Results of Operations section and Consolidated Financial Statements and accompanying notes.
Moreover, if political or economic conditions deteriorate in these countries, or if any of these countries are affected by a natural disaster or other catastrophe, our ability to conduct our international operations or collect on international accounts receivable could be limited and our costs could be increased, which could negatively affect our operating results.
Moreover, if political or economic conditions deteriorate in these countries, or if any of these countries are affected by a natural disaster or other catastrophe, our ability to conduct our international operations or collect on international accounts receivable could be limited and our costs could be increased, which could negatively 28 Table of Contents affect our operating results.
In developing this guidance, our management makes certain assumptions and judgments about our future operating performance, including rate of adoption of our products, projected hiring to support our growth, continued increase of our market share, potential impact from competitive devices and therapies, and stability of the macro-economic environment in our key markets.
In developing this guidance, our management makes certain assumptions and judgments about our future operating performance, including rate of adoption of our products, projected hiring to support our growth, continued increase of our market share, potential impact from competitive devices and therapies, and stability of the macroeconomic environment in our key markets.
Our expansion efforts may prove to be more expensive than we currently anticipate, and we may not succeed in increasing our revenue sufficiently to offset these higher expenses. Our losses have had, and are expected to continue to have, an adverse impact on our working capital, total assets and accumulated deficit.
Our expansion efforts may prove to be more expensive than we currently anticipate, and we may not succeed in increasing our revenue sufficiently to offset these higher expenses. Our losses have had, and may have, an adverse impact on our working capital, total assets and accumulated deficit.
FDA may evaluate our compliance with the QSR, among other ways, through periodic announced or unannounced inspections which could disrupt our operations and interrupt our manufacturing.
FDA may evaluate our compliance with the QMSR, among other ways, through periodic announced or unannounced inspections which could disrupt our operations and interrupt our manufacturing.
The laws that affect our ability to operate our business in addition to the FDCA and FDA regulations include, but are not limited to, the following: • the Federal Anti-Kickback Statute, which prohibits persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce either the referral of an individual, or furnishing or arranging for a good or service, for which payment may be made under federal healthcare programs such as the Medicare and Medicaid Programs; • the Federal False Claims Act, which prohibits submitting a false claim or causing the submission of a false claim to the government; • Medicare laws and regulations that prescribe the requirements for coverage and payment, including the amount of such payment, and laws prohibiting false claims for reimbursement under Medicare and Medicaid; • state consumer protection, fraud and business practice laws, including the California Consumer Privacy Act (“CCPA”), which among other things, requires disclosures to California consumers and provides consumers new abilities to opt out of certain sales of personal information; • state laws that prohibit the practice of medicine by non-doctors and by doctors not licensed in a particular state, and fee-splitting arrangements between doctors and non-doctors, as well as state law equivalents to the Anti-Kickback Statute and the Stark Law, which may not be limited to government-reimbursed items; • federal and state healthcare fraud and abuse laws or laws protecting the privacy of patient medical information, including the Health Insurance Portability and Accountability Act (HIPAA) which protects medical records and other personal health information by limiting their use and disclosure, giving individuals the right to access, amend and seek accounting reasonably necessary to accomplish the intended purpose; • laws and regulations, such as the General Data Protection Regulation in the European Union, that govern collection, use, disclosure, transfer and storage of personal data that we may collect from our employees, consultants or in conjunction with clinical trials; • the Federal Trade Commission Act and similar laws regulating advertising and consumer protection; and • similar and other regulations outside the United States. 22 Table of Contents Healthcare fraud and abuse regulations are complex, and even minor, inadvertent irregularities can potentially give rise to claims that a law has been violated.
The laws that affect our ability to operate our business in addition to the FDCA and FDA regulations include, but are not limited to, the following: • the Federal Anti-Kickback Statute, which prohibits persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce either the referral of an individual, or furnishing or arranging for a good or service, for which payment may be made under federal healthcare programs such as the Medicare and Medicaid Programs; • the Federal False Claims Act, which prohibits submitting a false claim or causing the submission of a false claim to the government; • Medicare laws and regulations that prescribe the requirements for coverage and payment, including the amount of such payment, and laws prohibiting false claims for reimbursement under Medicare and Medicaid; • state consumer protection, fraud and business practice laws, including the California Consumer Privacy Act (“CCPA”), which among other things, requires disclosures to California consumers and provides consumers new abilities to opt out of certain sales of personal information; • state laws that prohibit the practice of medicine by non-doctors and by doctors not licensed in a particular state, and fee-splitting arrangements between doctors and non-doctors, as well as state law equivalents to the Anti-Kickback Statute and the Stark Law, which may not be limited to government-reimbursed items; • federal and state healthcare fraud and abuse laws or laws protecting the privacy of patient medical information, including the Health Insurance Portability and Accountability Act (HIPAA) which protects medical records and other personal health information by limiting their use and disclosure, giving individuals the right to access, amend and seek accounting reasonably necessary to accomplish the intended purpose; • laws and regulations, such as the General Data Protection Regulation in the European Union, that govern collection, use, disclosure, transfer and storage of personal data that we may collect from our employees, consultants or in conjunction with clinical trials; • the Federal Trade Commission Act and similar laws regulating advertising and consumer protection; and • similar and other regulations outside the United States.
Our manufacturing operations and research and development activities involve the use of biological materials and hazardous substances and are subject to a variety of federal, state and local environmental laws and regulations relating to the storage, use, discharge, disposal, remediation of and human exposure to hazardous substances.
Our manufacturing operations and research and development activities involve the use of biological materials and hazardous substances and are subject to a variety of federal, state and local environmental laws and regulations relating to 24 Table of Contents the storage, use, discharge, disposal, remediation of and human exposure to hazardous substances.
FDA may not agree with our decisions regarding whether submissions were required. If FDA were to disagree with us and require us to submit a 510(k), PMA or a PMA supplement for then-existing modifications, we could be required to cease promoting or to recall the modified product until we obtain clearance or 24 Table of Contents approval.
FDA may not agree with our decisions regarding whether submissions were required. If FDA were to disagree with us and require us to submit a 510(k), PMA or a PMA supplement for then-existing modifications, we could be required to cease promoting or to recall the modified product until we obtain clearance or approval.
We may be subject to fines, injunctions and penalties if we are found to be promoting our products for unapproved or off-label uses. • Modifications to our products may require new clearances or approvals by FDA; failure to obtain such clearances or approvals where required could result in a recall of the modified products and limitation on future sales until cleared or approved. 15 Table of Contents • If we or our third-party vendors fail to comply with extensive FDA regulations relating to the manufacturing of our products, we may be subject to fines, injunctions and penalties. • The use of products we sell may result in injuries or other adverse events that lead to product liability claims. • Our ability to compete in the marketplace could be affected if our intellectual property rights fail to provide meaningful commercial protection for our products. • Litigation and administrative proceedings over patent and other intellectual property rights are common in our industry, and any litigation or claim against us may cause us to incur substantial costs. • We are subject to various regulatory and other risks related to selling our products internationally which could harm our revenue. • Any allegation or determination of wrongdoing under the Foreign Corrupt Practices Act or other anti-corruption laws could have a material adverse effect on our business. • The use of artificial intelligence technology by our employees or business partners could result in misuse or loss of proprietary information, violation of laws and regulations, or damage to our reputation and credibility.
We may be subject to fines, injunctions and penalties if we are found to be promoting our products for unapproved or off-label uses. • Modifications to our products may require new clearances or approvals by FDA; failure to obtain such clearances or approvals where required could result in a recall of the modified products and limitation on future sales until cleared or approved. • If we or our third-party vendors fail to comply with FDA regulations relating to the manufacturing of our products, we may be subject to fines, injunctions and penalties. • The use of products we sell may result in injuries or other adverse events that lead to product liability claims. • Our ability to compete in the marketplace could be affected if our intellectual property rights fail to provide meaningful commercial protection for our products. • Litigation and administrative proceedings over patent and other intellectual property rights are common in our industry, and any litigation or claim against us may cause us to incur substantial costs. 17 Table of Contents • We are subject to various regulatory and other risks related to selling our products internationally which could harm our revenue. • Changes in United States and international trade policies may adversely impact our business and operating results. • Any allegation or determination of wrongdoing under the Foreign Corrupt Practices Act or other anti-corruption laws could have a material adverse effect on our business. • The use of artificial intelligence technology by our employees or business partners could result in misuse or loss of proprietary information, violation of laws and regulations, or damage to our reputation and credibility.
In addition, other products may be sold at lower prices. Due to the size of our markets, we anticipate that new or existing competitors may develop competing products, procedures and/or clinical solutions. There are few barriers to prevent new entrants or existing competitors from developing products to compete directly with ours.
In addition, other products may be sold at lower prices. Due to the size of our markets, we anticipate that new or existing competitors may introduce competing products, procedures and/or clinical solutions. There are few barriers to prevent new entrants or existing competitors from introducing products to compete directly with ours.
In the future, we may experience difficulties in increasing production, including problems with production yields and quality control, component supply and shortages of qualified personnel. These problems could result in delays in product 20 Table of Contents availability and increases in expenses.
In the future, we may experience difficulties in increasing production, including problems with production yields and quality control, component supply and shortages of qualified personnel. These problems could result in delays in product availability and increases in expenses.
It would be a time consuming and lengthy process to secure these products from an alternative supplier. Additionally, our devices are sterilized prior to use using ethylene oxide at third-party sterilizers.
It would be a time-consuming and lengthy process to secure these products from alternative suppliers. Additionally, our devices are sterilized prior to use using ethylene oxide at third-party sterilizers.
We may need to raise capital in the future to fund our operations or new initiatives or reduce or pay in full our indebtedness. If we raise funds by issuing equity securities, our stock price may decline and our existing stockholders may experience significant dilution.
We may need to raise capital in the future to fund our operations or new initiatives or reduce or pay in full our borrowings and financing obligations. If we raise funds by issuing equity securities, our stock price may decline and our existing stockholders may experience significant dilution.
We expect to continue to incur substantial expenditures and to potentially incur additional operating losses in the future as we further develop and commercialize our products. If sales of our products do not continue to grow as we anticipate, we may not be able to achieve profitability.
We expect to continue to incur substantial expenditures in the future as we further develop and commercialize our products. If sales of our products do not continue to grow as we anticipate, we may not be able to achieve profitability.
Any product liability claim, even a meritless or unsuccessful one, would be time-consuming and expensive to defend and could result in the diversion of our management’s attention from our business and result in adverse publicity, withdrawal of clinical trial participants, injury to our reputation and loss of revenue.
Any product liability claim, even a meritless or unsuccessful one, would be time-consuming and expensive to defend and could result in the diversion of our management’s attention from our business and result in adverse publicity, withdrawal of clinical trial participants, injury to our reputation and loss of revenue. Any of these events could negatively affect our financial condition.
If we encounter difficulties growing the market for our products in the United States, we may not be able to increase our revenue enough to achieve or sustain profitability, and our business and operating results will be seriously harmed.
If we encounter difficulties growing market adoption of our products in the United States, we may not be able to increase our revenue enough to achieve or sustain profitability, and our business and operating results could be seriously harmed.
These fluctuations may also affect our annual operating results and may cause those results to fluctuate unexpectedly from year to year. We have a history of net losses, and we may never become profitable. We have a history of net losses, including $44,698 in 2024, $30,438 in 2023, and $46,466 in 2022.
These fluctuations may also affect our annual operating results and may cause those results to fluctuate unexpectedly from year to year. We have a history of net losses, and we may never become profitable. We have a history of net losses, including $11,448 in 2025, $44,698 in 2024, and $30,438 in 2023.
As of December 31, 2024, we had an accumulated deficit of $401,755. Our net losses have resulted principally from costs and expenses relating to sales, training and promotional efforts, research and development, clinical trials, seeking regulatory clearances and approvals and general operating expenses.
As of December 31, 2025, we had an accumulated deficit of $413,203. Our net losses have resulted principally from costs and expenses relating to sales, training and promotional efforts, research and development, clinical trials, seeking regulatory clearances and approvals and general operating expenses.
Competition from existing and new products and procedures may decrease our market share and may cause our revenue to decline, and could adversely affect our operating results. The medical device industry, including the market for the treatment of Afib, is highly competitive, is subject to rapid technological change and can be significantly affected by new product introductions and promotional activities.
Competition from existing and new products and procedures may decrease our market share and may cause our revenue to decline, and could adversely affect our operating results. The medical device industry, including the markets in which we operate, is highly competitive, is subject to rapid technological change and can be significantly affected by new product introductions and promotional activities.
Industry Conditions Risks A prolonged downturn in macroeconomic conditions in which we operate may materially adversely affect our business. A prolonged economic downturn as a result of the collateral effects of inflationary pressures, increases in interest rates, slower economic activity, a future outbreak of COVID-19 or a similar infectious disease, among other factors, may adversely impact our business.
Industry Conditions Risks A prolonged downturn in macroeconomic conditions may materially and adversely affect our business. A prolonged economic downturn as a result of the collateral effects of inflationary pressures, increases in interest rates, slower economic activity, a future outbreak of an infectious disease, among other factors, may adversely impact our business.
Any such delay or increased expense could adversely affect our ability to generate revenues and adversely impact our operating results. Future growth will also impose significant added responsibilities on management, including the need to identify, recruit, train and integrate additional employees. In addition, rapid and significant growth will place a strain on our administrative and operational infrastructure.
Any such delay or increased expense could adversely affect our ability to generate revenues and adversely impact our operating results. 22 Table of Contents Future growth will also impose significant added responsibilities on management, including the need to identify, recruit, train and integrate additional employees.
Our exposure to each of these risks may increase our costs and require significant management attention. We cannot assure you that one or more of these factors will not harm our business.
Our exposure to each of these risks may increase our costs and require significant management attention. We cannot assure you that one or more of these factors will not harm our business. Changes in United States and international trade policies may adversely impact our business and operating results.
We could sustain damage to our reputation and customer and employee relationships, suffer disruptions to our business and incur increased operating costs including costs to mitigate any damage caused and protect against future damage, and be exposed to additional regulatory scrutiny or penalties and to civil litigation and possible financial liability, any of which could have a material adverse effect on our business, operating margins, revenues and competitive position. 21 Table of Contents We also rely in part on information technology to store information, interface with customers, maintain financial accuracy, secure our data and accurately produce our financial statements.
We could sustain damage to our reputation and customer and employee relationships, suffer disruptions to our business and incur increased operating costs including costs to mitigate any damage caused and protect against future damage, and be exposed to additional regulatory scrutiny or penalties and to civil litigation and possible financial liability, any of which could have a material adverse effect on our business, operating margins, revenues and competitive position.
If any of these events were to occur, we could lose customers and our production, product sales, business, results of operations and financial condition would be harmed. 23 Table of Contents We are also subject to medical device reporting regulations that require us to file reports with FDA if our products may have caused or contributed to a death or serious injury or, in the event of product malfunction, that if such malfunction were to recur, would likely cause or contribute to a death or serious injury.
We are also subject to medical device reporting regulations that require us to file reports with FDA if our products may have caused or contributed to a death or serious injury or, in the event of product malfunction, that if such malfunction were to recur, would likely cause or contribute to a death or serious injury.
The Credit Agreement entered into on January 5, 2024, contains specific financial covenants and a minimum liquidity requirement, along with other terms restricting indebtedness, liens, investments and acquisitions, asset dispositions, certain payments and other customary representations and warranties.
Our Credit Agreement contains specific financial covenants, along with other terms restricting indebtedness, liens, investments and acquisitions, asset dispositions, certain payments and other customary representations and warranties.
If our goodwill becomes impaired, it could materially reduce the value of our assets and reduce our net income or increase our net loss for the year in which the impairment occurs. As of December 31, 2024, we had $234,781 in goodwill, which represents purchase price we paid in excess of the fair value of the net assets we acquired.
If our goodwill becomes impaired, it could materially reduce the value of our assets and reduce our net income or increase our net loss for the year in which the impairment occurs.
Our issued patents and those that may be issued in the future may be challenged, invalidated or circumvented, which could limit our ability to stop competitors from marketing related products.
Our patent applications may not issue as patents at all or in a form that will be advantageous to us. Our issued 27 Table of Contents patents and those that may be issued in the future may be challenged, invalidated or circumvented, which could limit our ability to stop competitors from marketing related products.
If we or our third-party vendors fail to comply with extensive FDA regulations relating to the manufacturing of our products or component parts, we may be subject to fines, injunctions and penalties, and our ability to commercially distribute and sell our products may be hurt.
Delays in receipt or failure to receive clearances or approvals, the loss of previously received clearances or approvals or the failure to comply with existing or future regulatory requirements could reduce our sales, profitability and future growth prospects. 26 Table of Contents If we or our third-party vendors fail to comply with extensive FDA regulations relating to the manufacturing of our products or component parts, we may be subject to fines, injunctions and penalties, and our ability to commercially distribute and sell our products may be hurt.
Any of these events could negatively affect our financial condition. 25 Table of Contents Our intellectual property rights may not provide meaningful commercial protection for our products, which could enable third parties to use our technology or methods, or very similar technology or methods, and could reduce our ability to compete.
Our intellectual property rights may not provide meaningful commercial protection for our products, which could enable third parties to use our technology or methods, or very similar technology or methods, and could reduce our ability to compete. Our success depends significantly on our ability to protect our proprietary rights to the technologies used in our products.
Any violations of these laws could result in a material adverse effect on our business, financial condition and results of operations.
These actions are unpredictable and could have a material adverse impact on our business, financial condition and results of operations.
The Financial Accounting Standards Board’s (FASB) Accounting Standards Codification (ASC) 350, “Goodwill and Other Intangible Assets” requires that goodwill be tested for impairment at least annually (absent any impairment indicators). We may have future impairment adjustments to our recorded goodwill.
As of December 31, 2025, we had $234,781 in goodwill, which represents the purchase price we paid in excess of the fair value of the net assets we acquired. The Financial Accounting Standards Board’s (FASB) Accounting Standards Codification (ASC) 350, “Goodwill and Other Intangible Assets” requires that goodwill be tested for impairment at least annually (absent any impairment indicators).
Our success depends significantly on our ability to protect our proprietary rights to the technologies used in our products. We rely on patent protection, as well as a combination of copyright, trade secret and trademark laws and nondisclosure, confidentiality and other contractual restrictions to protect our proprietary technology.
We rely on patent protection, as well as a combination of copyright, trade secret and trademark laws and nondisclosure, confidentiality and other contractual restrictions to protect our proprietary technology. However, these legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep any competitive advantage.
In addition, some of our software systems are cloud-based data management applications, hosted by third-party service providers whose security and information technology systems are subject to similar risks. The failure to protect either our or our service providers’ information technology infrastructure could disrupt our operations.
We also rely in part on information technology to store information, interface with customers, maintain financial accuracy, secure our data and accurately produce our financial statements. In addition, some of our software systems are 23 Table of Contents cloud-based data management applications, hosted by third-party service providers whose security and information technology systems are subject to similar risks.
In order to manage our operations and growth, we will need to continue to improve our operational and management controls, reporting and information technology systems and financial internal control procedures. If we are unable to manage our growth effectively, it may be difficult for us to execute our business strategy and our operating results and business could suffer.
In addition, rapid and significant growth will place a strain on our administrative and operational infrastructure. In order to manage our operations and growth, we will need to continue to improve our operational and management controls, reporting and information technology systems and financial internal control procedures.
Removed
Unless and until we obtain additional FDA approval for our products, we will not be able to promote them for the treatment of Afib, prevention of stroke, or reduction of post-operative Afib, and our ability to maintain and grow our business could be harmed.
Added
For example, we may require further investments and enhancements to our enterprise resource planning software system that may impact our financial processes and operations. If we are unable to manage our growth effectively, it may be difficult for us to execute our business strategy and our operating results and business could suffer.
Removed
Delays in receipt or failure to receive clearances or approvals, the loss of previously received clearances or approvals or the failure to comply with existing or future regulatory requirements could reduce our sales, profitability and future growth prospects.
Added
The failure to protect either our or our service providers’ information technology infrastructure could disrupt our operations.
Removed
However, these legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep any competitive advantage. Our patent applications may not issue as patents at all or in a form that will be advantageous to us.
Added
Healthcare fraud and abuse regulations are complex, and even minor, inadvertent irregularities can potentially give rise to claims that a law has been violated. Any violations of these laws could result in a material adverse effect on our business, financial condition and results of operations.
Added
If any of these events were to occur, we could lose customers and our production, product sales, business, results of operations and financial condition would be harmed.
Added
The United States government has made statements and taken certain actions that may lead to potential changes to United States and international trade policies, including imposing tariffs or taxes. Our products are manufactured in the United States, and a significant portion of our revenues are domestic.
Added
Because some of revenues and direct and downstream suppliers of components for our products are located in foreign countries, we are exposed to potential supply chain disruptions or delays and increasing costs in the event of changes in policies, laws, rules and regulations of the United States or foreign governments.
Added
Due to the global nature of our business, international results could be impacted. Implementation of tariffs or other restrictive trade measures by the United States government and reciprocal measures potentially enacted by other countries subject to such tariffs remain highly uncertain and may cause material short-term or long-term fluctuations in our results.
Added
We may have future impairment adjustments to our recorded goodwill.

Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeWe evaluate our physical, electronic and administrative safeguards on a continuous basis to ensure they are effectively deployed across the business. We also work with trusted and recognized third parties to help us assess, strengthen and monitor the operations of our information security program.
Biggest changeWe evaluate our physical, electronic and administrative safeguards on a continuous basis to ensure they are effectively deployed across the business. We collaborate with reputable third parties to assess, enhance and monitor our information security program. Independent audits and advisory services conducted by experienced providers evaluate our security controls in alignment with evolving industry best practices.
In conducting the assessment, the team considers 31 Table of Contents factors including, but not limited to: the probability of an adverse outcome; the potential significance of loss; the nature and extent of harm to individuals, customers, and vendors; the nature and extent of harm to our competitive position or reputation; and the possibility of litigation or regulatory investigations.
In conducting the assessment, the team considers factors including, but not limited to: the probability of an adverse outcome; the potential significance of loss; the nature and 33 Table of Contents extent of harm to individuals, customers, and vendors; the nature and extent of harm to our competitive position or reputation; and the possibility of litigation or regulatory investigations.
The Vice President of Information Technology, assisted by our broader IT team, is responsible for setting the strategic direction and priorities for information security, coordination of enterprise-wide compliance with information security policies and procedures, as well as day-to-day information security management.
The Vice President of Information Technology and Director of Information Security, assisted by our broader IT team, are responsible for setting the strategic direction and priorities for information security, coordination of enterprise-wide compliance with information security policies and procedures, as well as day-to-day information security management.
Our Vice President of IT has served in various roles in information technology and information security for over 20 years. Our information security team has an aggregate of more than 60 years of experience in information technology roles across several industries. 32 Table of Contents
Our Vice President of IT has served in various roles in information technology and information security for over 20 years. Our information security team has an aggregate of more than 60 years of experience in information technology roles across several industries.
We have continued to expand investments in information security, including additional end-user training, using layered defenses, identifying and protecting critical assets, strengthening monitoring and alerting mechanisms, and engaging experts. Information security awareness trainings are a compliance requirement for employees.
We have continued to expand investments in information security and resiliency, including additional end-user training, using layered defenses, identifying and protecting critical assets, enhanced monitoring and alerting, recovery capabilities and engaging experts. Information security awareness trainings are a compliance requirement for employees.
Removed
We engage third-party services to conduct evaluations of our security controls, whether through penetration testing, independent audits or consulting on best practices to address new challenges. These evaluations include testing both the design and operational effectiveness of security controls. We also share and receive threat intelligence with information sharing and analysis centers and cybersecurity associations.
Added
These evaluations encompass both testing the design and operational effectiveness of security controls. We maintain ongoing vulnerability and exposure assessments and actively participate in information sharing and analysis centers and cybersecurity associations.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeThe office is approximately 32,000 square feet. • Pleasanton, California – This location is used for product development activities and is approximately 6,000 square feet. • Amsterdam, Netherlands – This location houses administrative functions for our international operations.
Biggest changeThe Mason Manufacturing Building is used for manufacturing, quality and engineering activities and is currently under construction to expand the 38,500 square feet facility to approximately 103,500 square feet for additional manufacturing and office space. • Minnetonka, Minnesota – This location includes administrative, clinical, regulatory and product development space and is approximately 32,000 square feet. • Pleasanton, California – This location is used for product development activities and is approximately 6,000 square feet. • Amsterdam, Netherlands – This location houses administrative functions for our international operations and is approximately 9,000 square feet. • Hertogenbosch, Netherlands – This location is used for European service activities and is approximately 19,000 square feet.
ITEM 2. PROPERTIES The Company operates in the following principal locations: • AtriCure Corporate Headquarters Campus; Mason, Ohio – This campus encompasses three locations in Mason, Ohio, including our global headquarters facility that contains the Company's administrative, clinical, regulatory, engineering, product development, quality and manufacturing functions. The headquarters facility is approximately 106,000 square feet.
ITEM 2. PROPERTIES The Company operates in the following principal locations: • AtriCure Corporate Headquarters Campus; Mason, Ohio – The campus encompasses three buildings in Mason, Ohio, including our global headquarters facility that contains the Company's administrative, clinical, regulatory, engineering, 34 Table of Contents product development, quality and manufacturing functions. The headquarters facility is approximately 106,000 square feet.
See Note 11 – Commitments and Contingencies to our Consolidated Financial Statements. ITEM 4. MINE SAFETY DISCLOSURES Not applicable. 33 Table of Contents PART II
LEGAL PROCEEDINGS We may from time to time become a party to additional legal proceedings that arise in the ordinary course of business. See Note 10 – Commitments and Contingencies to our Consolidated Financial Statements. ITEM 4. MINE SAFETY DISCLOSURES Not applicable. 35 Table of Contents PART II
We intend to add new facilities as we grow, and we believe that suitable additional space will be available in the future on commercially reasonable terms as needed. ITEM 3. LEGAL PROCEEDINGS We may from time to time become a party to additional legal proceedings that arise in the ordinary course of business.
The Company believes that its existing facilities, including current expansion activities. are adequate to meet its immediate needs. We intend to add new facilities as we grow, and we believe that suitable additional space will be available in the future on commercially reasonable terms as needed. ITEM 3.
The Mason Distribution Warehouse is primarily used for warehousing and distribution activities and is approximately 52,000 square feet. The Mason Manufacturing Building is approximately 37,000 square feet and is used for manufacturing, quality and engineering activities. • Minnetonka, Minnesota – This location includes administrative, clinical, regulatory and product development space.
The Mason Distribution Warehouse is primarily used for warehousing and distribution activities and is approximately 52,000 square feet.
Removed
The space is approximately 9,000 square feet. • Hertogenbosch, Netherlands – This location is used for European service activities and is approximately 19,000 square feet. The Company believes that its existing facilities are adequate to meet its immediate needs.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeStock performance shown in the above chart for our common stock is historical and should not be considered indicative of future price performance. 12/31/2019 12/31/2020 12/31/2021 12/31/2022 12/31/2023 12/31/2024 AtriCure, Inc. $ 100.00 $ 171.24 $ 213.87 $ 136.51 $ 109.78 $ 94.00 NASDAQ Composite $ 100.00 $ 144.92 $ 177.06 $ 119.45 $ 172.77 $ 223.87 NASDAQ Health Care $ 100.00 $ 127.18 $ 114.41 $ 86.04 $ 86.74 $ 84.53 ITEM 6. [RESERVED] 34 Table of Contents
Biggest changeStock performance shown in the above chart for our common stock is historical and should not be considered indicative of future price performance. 12/31/2020 12/31/2021 12/31/2022 12/31/2023 12/31/2024 12/31/2025 AtriCure, Inc. $ 100.00 $ 124.90 $ 79.72 $ 64.11 $ 54.89 $ 71.06 NASDAQ Composite $ 100.00 $ 122.18 $ 82.43 $ 119.22 $ 154.48 $ 187.14 NASDAQ Health Care $ 100.00 $ 89.96 $ 67.65 $ 68.20 $ 66.46 $ 81.27 ITEM 6. [RESERVED] 36 Table of Contents
This graph assumes that $100.00 was invested on December 31, 2019, in our common stock, the NASDAQ Composite Index and the NASDAQ Health Care Index, and that all dividends are reinvested. No dividends have been declared or paid on our common stock.
This graph assumes that $100.00 was invested on December 31, 2020, in our common stock, the NASDAQ Composite Index and the NASDAQ Health Care Index, and that all dividends are reinvested. No dividends have been declared or paid on our common stock.
COMPARISON OF 5 YEAR CUMULATIVE TOTAL RETURN* Among AtriCure, Inc., the NASDAQ Composite Index and the NASDAQ Health Care Index *$100 invested on 12/31/19 in stock or index, including reinvestment of dividends. Fiscal year ending December 31.
COMPARISON OF 5 YEAR CUMULATIVE TOTAL RETURN* Among AtriCure, Inc., the NASDAQ Composite Index and the NASDAQ Health Care Index *$100 invested on 12/31/20 in stock or index, including reinvestment of dividends. Fiscal year ending December 31.
Performance Graph The following graph compares the cumulative total stockholder return on our common stock with the cumulative total return of the NASDAQ Composite Index (“NASDAQ Composite”) and the NASDAQ Health Care Index (“NASDAQ Health Care”) for the period beginning on December 31, 2019, and ending on December 31, 2024.
Performance Graph The following graph compares the cumulative total stockholder return on our common stock with the cumulative total return of the NASDAQ Composite Index (“NASDAQ Composite”) and the NASDAQ Health Care Index (“NASDAQ Health Care”) for the period beginning on December 31, 2020, and ending on December 31, 2025.
MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Common Stock Market Price Our common stock is traded on the NASDAQ Global Market under the symbol “ATRC.” As of February 11, 2025, the closing price of our common stock on the NASDAQ Global Market was $41.51 per share, and the number of stockholders of record was 59.
MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Common Stock Market Price Our common stock is traded on the NASDAQ Global Market under the symbol “ATRC.” As of February 12, 2026, the closing price of our common stock on the NASDAQ Global Market was $31.80 per share, and the number of stockholders of record was 55.

Item 7. Management's Discussion & Analysis

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

44 edited+21 added−24 removed30 unchanged
Biggest changeThese societal guidelines are reflective of the scientific evidence suggesting that surgical and hybrid ablation is safe and effective for patients who have Afib. 36 Table of Contents Results of Operations Year Ended December 31, 2024 compared to December 31, 2023 The following table sets forth, for the periods indicated, our results of operations expressed as dollar amounts and as percentages of total revenue: Year Ended December 31, 2024 2023 % of % of Amount Revenue Amount Revenue Revenue $ 465,307 100.0 % 399,245 100.0 % Cost of revenue 117,783 25.3 98,875 24.8 Gross profit 347,524 74.7 300,370 75.2 Operating expense: Research and development expenses 96,178 20.7 73,915 18.5 Selling, general and administrative expenses 291,359 62.6 253,138 63.4 Total operating expenses 387,537 83.3 327,053 81.9 Loss from operations (40,013) (8.6) (26,683) (6.7) Other expense, net (3,661) (0.8) (3,164) (0.8) Loss before income tax expense (43,674) (9.4) (29,847) (7.5) Income tax expense 1,024 0.2 591 0.1 Net loss $ (44,698) (9.6) % $ (30,438) (7.6) % Revenue.
Biggest changeThese 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. 38 Table of Contents Results of Operations Year Ended December 31, 2025 compared to December 31, 2024 The following table sets forth, for the periods indicated, our results of operations expressed as dollar amounts and as percentages of total revenue: Year Ended December 31, 2025 2024 % of % of Amount Revenue Amount Revenue Revenue $ 534,528 100.0 % 465,307 100.0 % Cost of revenue 133,749 25.0 117,783 25.3 Gross profit 400,779 75.0 347,524 74.7 Operating expense: Research and development expenses 99,209 18.6 96,178 20.7 Selling, general and administrative expenses 311,017 58.2 291,359 62.6 Total operating expenses 410,226 76.8 387,537 83.3 Loss from operations (9,447) (1.8) (40,013) (8.6) Other expense, net (716) (0.1) (3,661) (0.8) Loss before income tax expense (10,163) (1.9) (43,674) (9.4) Income tax expense 1,285 0.2 1,024 0.2 Net loss $ (11,448) (2.1) % $ (44,698) (9.6) % Revenue.
Amounts available to be drawn from time to time under the ABL Facility are determined by calculating the applicable borrowing base, which is based upon applicable percentages of the values of eligible accounts receivable, eligible inventory, eligible liquid assets, less reserves as determined by the Administrative Agent, all as specified in the Credit Agreement.
Amounts available to be drawn from time to time under the amended ABL Facility are determined by calculating the applicable borrowing base, which is based upon applicable percentages of the values of eligible accounts receivable, eligible inventory, eligible liquid assets, less reserves as determined by the Administrative Agent, all as specified in the Credit Agreement.
The borrowings bear interest at a rate per annum equal to, at the Company's election: (i) an alternate base rate (ABR) plus an applicable margin or (ii) an adjusted term secured overnight financing rate (SOFR) plus an applicable margin.
The borrowings bear interest at a rate per annum equal to, at the Company's election: (i) an alternate base rate (ABR) plus an applicable margin or (ii) a term secured overnight financing rate (SOFR) plus an applicable margin.
We have described our significant accounting policies in Note 1 – Description of Business and Summary of Significant Accounting Policies to our Consolidated Financial Statements included in this Form 10-K. 40 Table of Contents We believe the following critical accounting policies involve a significant level of estimation uncertainty and judgments that are reasonably likely to have a material impact on our Consolidated Financial Statements.
We have described our significant accounting policies in Note 1 – Description of Business and Summary of Significant Accounting Policies to our Consolidated Financial Statements included in this Form 10-K. 42 Table of Contents We believe the following critical accounting policies involve a significant level of estimation uncertainty and judgments that are reasonably likely to have a material impact on our Consolidated Financial Statements.
With respect to these performance share awards, the number of shares that vest and are issued to the recipient is based upon revenue performance over the performance period. We may adjust the expense over the performance period based on changes to estimates of performance target achievement.
With respect to these performance share awards, the number of shares that vest and are issued to the recipient is based upon revenue and Adjusted EBITDA performance over the performance period. We may adjust the expense over the performance period based on changes to estimates of performance target achievement.
Inflation Inflationary pressures may have an adverse impact on our results of operations or financial condition in the foreseeable future. Inflation has impacted our operating costs throughout 2024 and 2023.
Inflation Inflationary pressures may have an adverse impact on our results of operations or financial condition in the foreseeable future. Inflation has impacted our operating costs throughout 2025 and 2024.
This section of this Form 10-K generally discusses 2024 and 2023 items and year-to-year comparisons between 2024 and 2023. This discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions.
This section of this Form 10-K generally discusses 2025 and 2024 items and year-to-year comparisons between 2025 and 2024. This discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions.
As of December 31, 2024, we believe the likelihood of payment is remote, and the estimated fair value of the contingent consideration is $0. See Note 2 – Fair Value. Sources of liquidity.
As of December 31, 2025, we believe the likelihood of payment is remote, and the estimated fair value of the contingent consideration is $0. See Note 2 – Fair Value. Sources of liquidity.
Year Ended December 31, 2023 compared to December 31, 2022 For a comparison of our results of operations for the years ended December 31, 2023 and December 31, 2022, see “Part II, Item 7.
Year Ended December 31, 2024 compared to December 31, 2023 For a comparison of our results of operations for the years ended December 31, 2024 and December 31, 2023, see “Part II, Item 7.
Management’s Discussion and Analysis of Financial Condition and Results of Operations” of our annual report on Form 10-K for the year ended December 31, 2023, filed with the SEC on February 16, 2024. Overview We are a leading innovator in treatments for atrial fibrillation, left atrial appendage management and post-operative pain management.
Management’s Discussion and Analysis of Financial Condition and Results of Operations” of our annual report on Form 10-K for the year ended December 31, 2024, filed with the SEC on February 14, 2025. Overview We are a leading innovator in treatments for atrial fibrillation, left atrial appendage management and post-operative pain management.
Recent Accounting Pronouncements See Note 1 – Description of Business and Summary of Significant Accounting Policies to the Consolidated Financial Statements in Item 8 of Part II for more information regarding recent accounting pronouncements.
Recent Accounting Pronouncements See Note 1 – Description of Business and Summary of Significant Accounting Policies to the Consolidated Financial Statements in Item 8 of Part II for more information regarding recent accounting pronouncements. 43 Table of Contents
Our ablation and left atrial appendage management products are used by physicians during both open-heart and minimally invasive procedures. In open-heart procedures, the physician is performing heart surgery for other conditions, and our products are used in conjunction with (or “concomitant” to) such a procedure.
Our ablation and left atrial appendage management products are used by physicians during both open-heart and minimally invasive surgical procedures. In open-heart procedures, the physician performs heart surgery for other conditions, and our products are used in conjunction with (or “concomitant” to) such a procedure.
Because changes in foreign currency exchange rates have a non-operating impact on revenue, we believe that evaluating growth in revenue on a constant currency basis provides an additional and meaningful assessment of revenue to both management and investors. 37 Table of Contents Cost of revenue and gross margin. Cost of revenue increased $18,908 primarily reflecting higher sales volumes.
Because changes in foreign currency exchange rates have a non-operating impact on revenue, we believe that evaluating growth in revenue on a constant currency basis provides an additional and meaningful assessment of revenue to both management and investors. 39 Table of Contents Cost of revenue and gross margin. Cost of revenue increased $15,966 primarily reflecting higher sales volumes.
The EnCompass clamp and the AtriClip in 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 will evaluate the impact of concomitant ablation and LAA exclusion in non-AF patients for the reduction of post-operative AF (POAF) and Clinical AF.
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.
Historically there have been limited competitors in our key markets, but new entrants are marketing and developing competing products, procedures, and/or clinical solutions that may cause variability in our results. Highlights of the strategic and operational advancements in 2024 include: PRODUCT INNOVATION.
There are limited competitors in our key markets; however, new entrants are developing and marketing competing products, procedures, and/or clinical solutions that may cause variability in our results. Highlights of the strategic and operational advancements in 2025 include: PRODUCT INNOVATION.
On January 5, 2024, we entered into an asset-based credit agreement with JPMorgan Chase Bank, N.A. as Administrative Agent, JPMorgan Chase Bank, N.A. and Silicon Valley Bank, a division of First-Citizen Bank and Trust Company, as Joint Lead Arrangers and Joint Bookrunners (Credit Agreement) that provides for a $125,000 asset-based revolving credit facility (ABL Facility), with an option to increase the revolving commitment by an additional $40,000.
As of December 31, 2025, we had an asset-based credit agreement with JPMorgan Chase Bank, N.A. as Administrative Agent, JPMorgan Chase Bank, N.A. and Silicon Valley Bank, a division of First-Citizen Bank and Trust Company, as Joint Lead Arrangers and Joint Bookrunners (Credit Agreement) that provides for a $125,000 ABL Facility, with an option to increase the revolving commitment by an additional $40,000.
If we are unable to maintain these financing arrangements, we may be required to reduce the scope of our planned research and development, clinical activities and selling, training, education and marketing efforts. 39 Table of Contents Historical Cash Flow Activity.
If we 41 Table of Contents are unable to maintain these financing arrangements, we may be required to reduce the scope of our planned research and development, clinical activities and selling, training, education and marketing efforts. Historical Cash Flow Activity. The following table summarizes our consolidated cash flow activities: Cash flows provided by operating activities.
The Left Atrial Appendage Exclusion for Prophylactic Stroke 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.
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.
Minimally invasive procedures are performed on a standalone basis, and often include multi-disciplinary or “hybrid” approaches, combining surgical procedures using AtriCure ablation and LAAM products with catheter ablation procedures performed by electrophysiologists. Our pain management devices are used by physicians to freeze nerves during cardiothoracic or thoracic surgical procedures.
Minimally invasive procedures are performed on a standalone basis, and often include multi-disciplinary or “hybrid” approaches, combining surgical procedures using AtriCure ablation and LAAM products with catheter ablation procedures performed by electrophysiologists. Our pain management devices are used by physicians to ablate peripheral nerves, providing pain relief in cardiac, thoracic and amputation procedures.
In 2024, we realized significant global revenue growth and continued our strategic initiatives of product innovation, clinical science and physician education and training to expand awareness and adoption.
In 2025, we realized global revenue growth resulting from our strategic initiatives of product innovation, clinical science and physician education and training to expand awareness and adoption.
A minor portion of our cash is held in foreign banks to support our international operations. We had net working capital of $194,402 and an accumulated deficit of $401,755 as of December 31, 2024. Uses of liquidity and capital resources.
A minor portion of our cash is held in foreign banks to support our international operations. We had net working capital of $240,997 and an accumulated deficit of $413,203 as of December 31, 2025. Uses of liquidity and capital resources.
This prospective, multi-center, 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. During the fourth quarter of 2024, FDA approved the trial protocol. We expect site initiation to begin by the end of 2025. TRAINING.
This prospective, multi-center, 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 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.
For additional information, see Note 10 – Leases. We have a contractual obligation for a contingent consideration payment under the SentreHEART merger agreement that would be paid in AtriCure common stock and cash, up to a specified maximum number of shares.
The financing obligation includes a current obligation of $81 and long-term obligation of $6,154. For additional information, see Note 8 – Borrowings and Financing Obligation. We have a contractual obligation for a contingent consideration payment under the SentreHEART merger agreement that would be paid in cash and AtriCure common stock, up to a specified maximum number of shares.
Our professional education and marketing teams conduct a variety of virtual and in-person training programs for physicians and other healthcare professionals. These training methods ensure access to continuing education and awareness of our products and related procedures.
Site initiation and enrollment is ongoing. TRAINING. Our professional education team conducts a variety of in-person and virtual training programs for physicians and other healthcare professionals. These training methods ensure access to continuing education and awareness of our products and related procedures.
International revenue increased 25.6% as reported and on a constant currency basis, across all franchises and major geographic regions, while key products contributing to the increase in revenue in the United States were: • EnCompass clamp in open ablation, • cryoSPHERE probes for post-operative pain management and • AtriClip ® Flex⋅V ® for appendage management.
Key products contributing to the increase in revenue in the United States were EnCompass clamp in open ablation, cryoSPHERE MAX probe for post-operative pain management and AtriClip FLEX-Mini device for appendage management in open chest procedures. International revenue increased 20.2% as reported (17.5% on a constant currency basis), across all franchises and major geographic regions.
Share-Based Employee Compensation— We estimate the fair value of performance share awards with a performance condition initially based on the closing stock price on the date of grant assuming the performance goal will be achieved. Such performance share awards have specified performance targets based on the compound annual growth rate (CAGR) of our revenue over a three-year performance period.
Share-Based Employee Compensation— We estimate the fair value of performance share awards with a performance condition initially based on the closing stock price on the date of grant assuming the performance goal will be achieved.
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 of five years post procedure. The trial provides for enrollment of up to 6,500 subjects at up to 250 sites worldwide.
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 of five years post procedure. In July 2025, we completed trial enrollment of 6,573 patients across 139 centers globally. Patient follow-up remains ongoing. BoxX-NoAF .
Our finance leases consist primarily of principal and interest payments related to our Mason, Ohio headquarters building. As of December 31, 2024, current finance lease obligations are $1,186 and long-term obligations are $7,281. Our operating leases for office and warehouse space includes current obligations of $1,619 and long-term obligations of $4,579 as of December 31, 2024.
We have operating and finance leases primarily for our offices, manufacturing and warehouse facilities and automobiles. Our finance leases consist primarily of principal and interest payments related to our Mason, Ohio headquarters building. As of December 31, 2025, current finance lease obligations are $1,306 and long-term obligations are $5,975.
The following table sets forth, for the periods indicated, our revenue by product type and geography expressed as dollar amounts and the corresponding change in such revenues between periods, in both dollars and percentages: Year Ended December 31, Change 2024 2023 Amount % Open ablation $ 123,647 $ 105,287 $ 18,360 17.4 % Minimally invasive ablation 45,737 44,577 1,160 2.6 % Pain management 61,844 49,199 12,645 25.7 % Appendage management 151,588 134,481 17,107 12.7 % Total United States $ 382,816 $ 333,544 $ 49,272 14.8 % Total International 82,491 65,701 16,790 25.6 % Total Revenue $ 465,307 $ 399,245 $ 66,062 16.5 % Worldwide revenue increased 16.5% as reported and on a constant currency basis.
The following table sets forth, for the periods indicated, our revenue by product type and geography expressed as dollar amounts and the corresponding change in such revenues between periods, in both dollars and percentages: Year Ended December 31, Change 2025 2024 Amount % Open ablation $ 143,847 $ 123,647 $ 20,200 16.3 % Minimally invasive ablation 31,475 45,737 (14,262) (31.2) % Pain management 81,923 61,844 20,079 32.5 % Appendage management 178,127 151,588 26,539 17.5 % Total United States 435,372 382,816 52,556 13.7 % Total International 99,156 82,491 16,665 20.2 % Total Revenue $ 534,528 $ 465,307 $ 69,221 14.9 % Worldwide revenue increased 14.9% as reported (14.4% on a constant currency basis).
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.
Additionally, our professional education courses continue to be enhanced by the use of simulation models or synthetic cadavers, known as CADets.
Our future obligations include both current and long-term obligations. In 2022, the Company entered into a clinical trial management agreement for the LeAAPS clinical trial. The terms of the agreement require payments upon achievement of various enrollment and project milestones over the estimated ten-year term, yet the agreement may be terminated early for any reason.
The terms of the agreement require payments upon achievement of various enrollment and project milestones over the estimated ten-year term, yet the agreement may be terminated early for any reason. Furthermore, we incur additional variable costs, including pass through costs from clinical trial sites.
We incur capital expenditures on an ongoing basis to continue investment in our growth and our ability to better serve our customers. In recent years, we have expanded the manufacturing and engineering facilities in our Mason, Ohio campus and expect to continue to invest in facilities to support our growth. Other Contractual Obligations.
In recent years, we have expanded the manufacturing and engineering facilities in our Mason, Ohio campus and expect to continue to invest in facilities to support our growth. Other Contractual Obligations. In 2022, the Company entered into a clinical trial management agreement for the LeAAPS clinical trial.
We continue to invest in research and development of new products and pursue regulatory approvals to market and sell globally across all franchises. • Open .
We continue to invest in research and development of new products and pursue regulatory approvals to market and sell globally across all franchises. Appendage management. During the first quarter of 2025, FDA granted 510(k) clearance for the AtriClip ® PRO-Mini ™ LAA Exclusion System.
Liquidity and Capital Resources As of December 31, 2024, we had cash and cash equivalents of $122,721 and unused borrowing capacity of approximately $61,885 under our existing credit agreement. All cash equivalents and most of our operating cash are held in United States financial institutions.
Liquidity and Capital Resources As of December 31, 2025, we had cash and cash equivalents of $167,428 and unused borrowing capacity of approximately $61,885 under our asset-backed credit agreement with JPMorgan Chase Bank, N.A.
We expect to disburse between $6,000 and $10,000 based on estimated achievement of milestone payments within the next twelve months. For additional information, see Note 3 – Asset Acquisition. We have operating and finance leases primarily for our offices, manufacturing and warehouse facilities and automobiles.
The agreement requires that we pay additional contingent consideration in cash upon achievement of specified developmental and regulatory approval milestones within defined periods over the ten-year term. We expect to disburse between $6,000 and $8,000 based on estimated achievement of milestone payments within the next twelve months. For additional information, see Note 3 – Asset Acquisition.
Net cash used in financing activities increased by $3,571 in 2024 compared to 2023, driven by $1,686 payment for extinguishment of debt and financing fees, net of borrowings, and a $1,491 decrease in proceeds from stock option exercises and the employee stock purchase plan.
Net cash provided by financing activities increased by $4,779 in 2025 compared to 2024, driven by $6,250 in proceeds from the August 2025 sale-and-leaseback arrangement and a $1,204 increase in proceeds from stock option exercises and the employee stock purchase plan. These inflows were offset by a $4,212 increase in shares repurchased for payment of taxes on stock awards.
See Note 3 - Asset Acquisition for additional information. CLINICAL SCIENCE. We invest in studies to expand labeling claims, support various indications for our products and publish clinical data for therapies and procedures involving our products. During 2024, we supported the publication of 19 articles and 17 congress abstracts featuring clinical studies with our product. LeAAPS.
We expect to initiate a clinical trial in the coming year, marking a key milestone in our product development pipeline. CLINICAL SCIENCE. We invest in studies to expand labeling claims, support various indications for our products and publish clinical data for therapies and procedures involving our products.
Net cash provided by investing activities increased by $8,417 in 2024 compared to 2023. This increase is attributable to a $18,000 decrease in cash paid for acquisitions year over year, offset by a $10,147 decrease in maturities of available-for-sale securities. Cash flows used in financing activities.
This increase in cash used is attributable to a $53,668 decrease in sales and maturities of available-for-sale securities, while acquired IPR&D milestone payments declined $6,000 in 2025. Cash flows provided by financing activities.
We experienced growth in all key product lines as a result of deepening market penetration, continuing physician adoption and new product launches.
We experienced significant growth in our open ablation, appendage management and pain management product lines as a result of deepening market penetration, continuing physician adoption and several new product launches. Minimally invasive ablation sales declined from continued reduction in Hybrid procedures as physicians adopt PFA catheters to treat patients.
Gross margin decreased by 55 basis points driven by less favorable geographic and product mix, as well as an increase in product costs. Research and development expenses. Research and development expenses increased $22,263, or 30.1%.
Gross margin increased by 29 basis points driven by more favorable product mix, offsetting increasing product costs as well as less favorable geographic mix. Research and development expenses. Research and development expenses increased $3,031, or 3.2%. Personnel costs increased $5,948 as a result of headcount growth and higher variable and share-based compensation.
Furthermore, we incur additional variable costs, including pass through costs from clinical trial sites. We expect to disburse between $14,000 and $17,000 of fixed and variable costs based on estimated achievement of milestone payments, site initiation and trial enrollment within the next twelve months.
We expect to disburse between $10,000 and $12,000 of fixed and variable costs based on estimated achievement of milestone payments within the next twelve months. In 2024, we entered into an exclusive licensing agreement to co-develop and commercialize equipment incorporating PFA technology.
The proceeds of the ABL Facility were used to terminate the Company’s indebtedness under the prior loan agreement with Silicon Valley Bank. As of December 31, 2024, our outstanding debt was $61,865 and we had unused borrowing availability of approximately $61,885.
A portion of the ABL facility, limited to $5,000, is available for the issuance of letters of credit. As of December 31, 2025, our outstanding debt was $61,865 and we had unused borrowing availability of approximately $61,885. As of January 9, 2026, we entered into the First Amendment to Credit Agreement and Security Agreement.
During 2023, we launched new training courses for Advanced Practice Providers, pain management in pectus procedures, as well as a best practice course for developing arrhythmia programs, with a primary focus on Hybrid therapies. These trainings allow for collaborative, hands-on engagement with our physician partners and other healthcare professionals.
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.
Our corporate headquarters lease requires a $1,250 letter of credit which renews annually and remains outstanding as of December 31, 2024. 38 Table of Contents For additional information on the terms and conditions, as well as applicable interest and fee payments, see Note 9 – Indebtedness. Capital Expenditures.
Borrowings outstanding under the existing Credit Agreement have been classified as long-term in the Consolidated Balance Sheet as of December 31, 2025. Our corporate headquarters lease requires a $1,250 letter of credit which renews annually and remains outstanding as of December 31, 2025.
Removed
Our worldwide revenues for the year ended December 31, 2024 of $465,307 was an increase of 16.5% over the prior year driven by growing adoption across key product lines as well as new product launches.
Added
Our worldwide revenues for the year ended December 31, 2025 of $534,528 increased by 14.9% over the prior year, driven by expanding adoption of our pain management, open ablation and appendage management product lines. Our recent product launches, including our cryoSPHERE MAX probe, AtriClip FLEX-Mini device and EnCompass clamp meaningfully contributed to our growth in 2025.
Removed
Upon receiving regulatory approval during the third quarter of 2024, we began selling the EnCompass clamp in CE-marked countries in the European Union, representing a significant expansion of our open ablation franchise products in Europe. • Minimally invasive .
Added
The 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 PRO-Mini device was launched in the United States during the second half of 2025. Pain management.
Removed
In the first half of 2024, FDA granted 510(k) clearance for EPi-Ease, our Hybrid access device to facilitate guide-wire delivery, vacuum application and endoscope insertion.
Added
During the second quarter of 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. This device temporarily stops pain by freezing target peripheral nerves, blocking the conduction pathway at the site of amputation.
Removed
During the third quarter, FDA granted 510(k) clearance for our EnCapture clamp, the newest in our line of Isolator Synergy Ablation System clamps, with enhanced geometry and features to facilitate engagement with intended cardiac tissue. • Pain management . During the second quarter of 2024, we launched the cryoSPHERE+ cryoablation probe for pain management in the United States.
Added
During the third quarter of 2025, this device was launched in the United States. Dual energy platform . During the fourth quarter of 2025, we executed successful first-in-human treatments using our novel dual energy platform that integrates Pulsed Field Ablation (PFA) with Advanced Radiofrequency Ablation (Advanced RFA).
Removed
The cryoSPHERE+ device leverages new technology that minimizes thermal loss by focusing energy at the ball tip, allowing for a reduction in freeze time by 25%. Further, the cryoSPHERE MAX probe was launched during the fourth quarter of 2024 and features a larger ball tip designed 35 Table of Contents to optimize Cryo Nerve Block therapy.
Added
The new platform delivers the benefits of both technologies, combining the proven safety and 37 Table of Contents effectiveness of radiofrequency (RF) ablation with the efficiency of PFA. The Advanced RFA and PFA technologies are not yet approved for use in any market.
Removed
This new probe reduces freeze times by 50% when compared to the first generation cryoSPHERE cryoablation probe, and over 30% when compared to the cryoSPHERE+ probe. • Appendage management . We launched the AtriClip FLEX-Mini device in the United States during the third quarter of 2024.
Added
During 2025, we supported the publication of 13 articles and 15 congress abstracts featuring clinical studies with our products. LeAAPS.
Removed
The AtriClip FLEX-Mini sets a new standard as the smallest profile for surgical LAA device on the market and builds upon the proven technology of our AtriClip platform, with ease of use and design simplicity that offers enhanced access and increased visibility for physicians. We also obtained additional international regulatory approvals for our AtriClip platform during the third quarter.
Added
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.
Removed
In China, we received approval to market and sell several models of our AtriClip Left Atrial Appendage Exclusion System from the National Medical Products Administration (NMPA) of China. In CE-marked countries in Europe, we received expanded indication for the AtriClip for use in patients at high risk of thromboembolism for whom left atrial appendage exclusion is warranted.
Added
Clinical trial expenses increased $3,498, primarily due to enrollment and follow-up activities for our LeAAPS trial and site initiation and patient enrollment expenses for the BoxX-NoAF trial. These increases were partially offset by a $6,000 decrease in pulsed-field ablation (PFA) co-development agreement payments. See Note 3 – Asset Acquisition for further information. Selling, general and administrative expenses.
Removed
Throughout 2024, we received several additional CE Mark certifications under the European Union Medical Device Regulation (EU MDR). As of December 31, 2024, substantially all of our products were cleared under EU MDR. During the fourth quarter of 2024, we entered into an exclusive licensing agreement with a third-party to co-develop and commercialize equipment incorporating pulsed field ablation.
Added
Selling, general and administrative expenses increased $19,658, or 6.7%. Personnel costs, including travel and share-based compensation, increased $18,331 as a result of headcount growth and higher variable and share-based compensation. Operational growth resulted in an additional $1,629 in IT and corporate expenses. Other income and expense.
Removed
In January 2023, the first patient was enrolled in the trial, and we ended 2024 with over 4,200 patients enrolled. Site initiation and enrollment is ongoing. BoxX-NoAF .
Added
Other expense declined by $2,945, primarily due to the $1,362 loss on debt extinguishment in the first quarter of 2024. Net foreign currency transaction gain increased $975 and net interest expense decreased $574 from lower borrowing costs.
Removed
In 2024, we continue to innovate physician training to improve accessibility and efficiency for our physician partners. We are currently piloting the use of live streaming to enable remote proctoring and case observation. SOCIETY GUIDELINES.
Added
In connection with the amended credit agreement entered into on January 9, 2026, the Company paid down $865 of borrowings and had $62,750 available borrowing capacity under the amended asset-based revolving credit facility (ABL Facility). All cash equivalents and most of our operating cash are held in United States financial institutions.
Removed
In 2024, the European Society of Cardiology (ESC) released Guidelines for Management of Atrial Fibrillation developed in collaboration with European Association of Cardio-Thoracic Surgery (EACTS), in which they upgraded LAAM to the highest Class 1 recommendation.
Added
The First Amendment provides a three-year extension of the Credit Agreement, expiring on January 9, 2029, reduces the overall interest rate on the loans under the ABL Facility and removes the minimum utilization financial covenant in addition to certain other loan administration updates.
Removed
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 included Hybrid AF Therapy as a Class 2 recommendation.
Added
The applicable margin on borrowings will adjust ranging from 1.25% to 1.50% per annum for ABR borrowings and from 2.25% to 2.50% per annum for SOFR term borrowings determined by the 40 Table of Contents average historical excess availability. The First Amendment was treated as a debt modification.
Removed
All major cardiac societal guidelines now include a Class 1 recommendation for surgical management of the left atrial appendage.
Added
For additional information on the terms and conditions, as well as applicable interest and fee payments, see Note 8 – Borrowings and Financing Obligation. Capital Expenditures. We incur capital expenditures on an ongoing basis to continue investment in our growth and our ability to better serve our customers.
Removed
During 2024, we entered into an exclusive licensing agreement requiring upfront cash payment of $12,000 for the acquired in-process research and development (IPR&D), which was included in research and development expenses in 2024. See Note 3 – Asset Acquisition for further information.
Added
Our operating leases for office and warehouse space include current obligations of $1,734 and long-term obligations of $5,541 as of December 31, 2025. For additional information, see Note 9 – Leases. In 2025, the Company transferred legal ownership of a building and certain real property on its corporate headquarters campus in Mason, Ohio for cash consideration of $6,250.
Removed
Expansion of product development, regulatory and clinical teams resulted in additional headcount-related costs (including travel and share-based compensation) of $6,773. Clinical trial expenses increased $4,801 due to increased trial activity driven by our LeAAPS clinical trial.
Added
Simultaneously, the Company entered into a contract to lease back the existing building and real property, as well as the planned building expansion space from the buyer-lessor. The buyer-lessor is financing the development and construction of the expansion of additional manufacturing and office space.
Removed
These increases were partially offset by a $1,606 decrease in product development project spend and regulatory approval costs as several new products were brought to market in 2024, including cryoSPHERE+ and AtriClip FLEX-Mini. Selling, general and administrative expenses. Selling, general and administrative expenses increased $38,221, or 15.1%.
Added
During construction of the expansion, the Company will maintain occupancy and pay rent for the existing building. The lease of the existing building and certain real property sold is a failed sale-and-leaseback as a result of finance lease classification. The Company recorded a financing obligation equal to the $6,250 cash proceeds received.
Removed
Personnel costs, including travel and share-based compensation, increased $27,384 as a result of growth in headcount and variable compensation. Operational growth drove $2,156 additional professional services, IT and corporate costs along with $2,079 additional marketing and meeting activities. Finally, the increase reflects a $4,412 non-recurring net gain in 2023 related to legal settlements.
Added
Net cash provided by operating activities increased $45,130 in 2025 as compared to 2024, primarily reflecting the improvement in operating results of $33,250. This improvement includes $6,000 reduction in the acquired IPR&D milestone payments in 2025 in comparison to 2024, and cash used for working capital and other assets and liabilities decreased $14,072 due to moderating investments in inventory.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeQUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK (Amounts referenced in this Item 7A are in thousands, except per share amounts.) The Company is exposed to various market risks, which include potential losses arising from adverse changes in market rates and prices, such as foreign exchange fluctuations and changes in interest rates. 41 Table of Contents Credit and Interest Rate Risk The Company invests its cash primarily in money market accounts, U.S. government and agency obligations, corporate bonds, and asset-backed securities.
Biggest changeITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK (Amounts referenced in this Item 7A are in thousands, except per share amounts.) The Company is exposed to various market risks, which include potential losses arising from adverse changes in market rates and prices, such as foreign exchange fluctuations and changes in interest rates.
Dollars; direct international sales transactions are transacted in Euros, British Pounds, Australian Dollars or Canadian Dollars. Sales to international distributors outside of Europe are under agreements primarily denominated in U.S. Dollars. If products are priced in U.S. Dollars and competitors price their products in the local currency, an increase in the relative strength of the U.S.
Dollars; direct international sales are transacted in Euros, British Pounds, Australian Dollars or Canadian Dollars. Sales to international distributors outside of Europe are under agreements primarily denominated in U.S. Dollars. If products are priced in U.S. Dollars and competitors price their products in the local currency, an increase in the relative strength of the U.S.
Outstanding amounts under the Credit Agreement bear interest at a rate per annum equal to, at the Company's election: (i) an alternate base rate (ABR) plus an applicable margin or (ii) an adjusted term secured overnight financing rate (SOFR) plus an applicable margin.
Outstanding amounts under the Credit Agreement bear interest at a rate per annum equal to, at the Company's election: (i) an alternate base rate (ABR) plus an applicable margin or (ii) a term secured overnight financing rate (SOFR) plus an applicable margin.
Interest rate risk is highly sensitive due to many factors, including United States monetary and tax policies and United states and international economic factors beyond our control. A hypothetical 100 basis-point (one percentage point) increase or decrease in interest rates compared to actual rates at December 31, 2024, would not have had a significant effect on our results.
Interest rate risk is highly sensitive due to many factors, including United States monetary and tax policies and United states and international economic factors beyond our control. A hypothetical 100 basis-point (one percentage point) increase or decrease in interest rates compared to actual rates at December 31, 2025, would not have had a significant effect on our results.
Dollar to the Canadian Dollar and local currencies of international trial sites may impact the cash outlay required for future milestone payments and variable pass-through costs under the clinical trial management agreement. 42 Table of Contents
Dollar to the Canadian Dollar and local currencies of international trial sites may impact the cash outlay required for future milestone payments and variable pass-through costs under the clinical trial management agreement. 45 Table of Contents
Alternate base rate is equal to the greatest of Prime, the NYFRB Rate plus 0.50% and Adjusted Term SOFR Rate plus 1.00%. The applicable margin spread is 1.50% to 2.75%, as determined by the average excess availability of the aggregate revolving commitment.
Alternate base rate is equal to the greatest of Prime, the NYFRB Rate plus 0.50% and Term SOFR Rate plus 1.00%. The applicable margin spread is 1.25% to 2.50%, as determined by the average excess availability of the aggregate revolving commitment.
Dollar could result in the Company’s price not being competitive in a market where business is not transacted in U.S. Dollars. Products sold by AtriCure Europe, B.V. and its subsidiaries are primarily denominated in Euros or British Pounds. European product sales accounted for 10.4% and 9.4% of the Company’s total revenue for 2024 and 2023.
Dollar could result in the Company’s price not being competitive in a market where business is not transacted in U.S. Dollars. Products sold by AtriCure Europe, B.V. and its subsidiaries are denominated in Euros or British Pounds. European product sales accounted for 11.2% and 10.4% of the Company’s total revenue for 2025 and 2024.
Fixed milestone payments are denominated in Canadian Dollars, while variable pass-through fees incurred at clinical trial sites outside the United States may be billed in U.S. Dollars or other local currencies. Fluctuations in the conversation rates of the U.S.
Fixed milestone payments are denominated in Canadian Dollars, while variable pass-through fees 44 Table of Contents incurred at clinical trial sites outside the United States may be billed in U.S. Dollars or other local currencies. Fluctuations in the conversion rates of the U.S.
For 2024 and 2023, foreign currency transaction losses of $272 and $101 were recorded primarily in connection with settlements of the intercompany balances and invoices transacted in Euros, British Pounds, Australian Dollars or Canadian Dollars. For revenue denominated in Euros, if there is an increase in the rate at which Euros are exchanged for U.S.
For 2025 and 2024, foreign currency transaction gain of $598 and loss of $272 were recorded primarily in connection with settlements of the intercompany balances and invoices transacted in Euros, British Pounds, Australian Dollars or Canadian Dollars. For revenue denominated in Euros, if there is an increase in the rate at which Euros are exchanged for U.S.
Added
Credit and Interest Rate Risk The Company invests its cash primarily in money market accounts, U.S. government and agency obligations, corporate bonds, and asset-backed securities.

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