ATRC

MKT CAP $2.9BP/E 274.6DIV YIELD —FCF YIELD 1.81%REV TTM $569.6M +13.9%NET INCOME $10.6MNET CASH $106.8M52W 25.86 – 60.77SEC XBRL · TTM TO Invalid Date

How ATRC rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025

Text kept

75%

of sentences unchanged

Added

134

new sentences

Dropped

sentences removed

Length

+1,159

words, now 24,533

New in FY2025

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.
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.
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 cryoICE cryoSPHERE ® and cryoXT™ probes for pain management (known as Cryo Nerve Block) provide temporary relief of post-operative pain, allowing the patient's body to heal after surgery while the nerves regenerate and sensation is regained.
We sell our products to medical centers through our direct sales force in the United States, Germany, France, the United Kingdom, the Benelux region, Australia and Canada.
Dollars; direct sales transactions outside the United States are primarily transacted in Euros, British Pounds, Australian Dollars or Canadian Dollars.
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.
Today, we estimate that less than 15% of those candidates are being treated with surgical ablation.
Additionally, our Le ft A trial A ppendage Exclusion for P rophylactic S troke Reduction (LeAAPS) IDE clinical trial is evaluating the safety and effectiveness of our AtriClip system in reducing stroke in cardiac surgery patients without a pre-existing Afib diagnosis.
Our Box Lesion and Left Atrial Appendage E X clusion Procedure for the Prevention of N ew O nset of A trial F ibrillation (BoxX-NoAF) IDE trial evaluates the impact of concomitant ablation using the EnCompass clamp and the AtriClip system in non-AF patients for the reduction of post-operative Afib (POAF) and clinical AF.
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.
Thus, we believe the EPi-Sense ablation system used as a minimally invasive or Hybrid AF therapy also represents a growth opportunity for the Company.
Beyond the Afib treatment opportunity, it is estimated that up to 50% of patients who undergo cardiac surgery who do not have diagnosed pre-operative Afib eventually develop POAF.
Patients with POAF tend to have worse acute and long-term clinical outcomes, including the risk of developing long-term clinical Afib.
Additionally, various studies have associated POAF with higher healthcare cost related burdens.
Currently, there are no FDA approved therapies to prevent the onset of POAF in cardiac surgery patients.
In October, we enrolled the first patient in the BoxX-NoAF IDE trial, which is intended to demonstrate that ablation and left atrial appendage exclusion during cardiac surgery is safe and effective for reducing POAF and long-term clinical Afib in patients without a documented pre-operative history of Afib.
If the trial is successful, we believe this significantly expands our addressable market for concomitant ablation and LAAM to be inclusive of non-Afib patients undergoing cardiac surgery.
In September 2025, we announced the launch of the cryoXT™ device, an innovative cryoablation technology used to help manage post-operative pain following amputation procedures.
Each year, over 180,000 amputations occur in the U.S., with approximately 60% of patients experiencing residual limb pain and up to 85% reporting phantom limb pain.
With the introduction of the cryoXT device, physicians now have access to a next-generation tool that brings this long-lasting approach to post-amputation pain management.
Applications for Cryo Nerve Block outside of cardiac, thoracic, and amputation surgery are being studied and represent future possible growth opportunities AtriCure Solutions and Products We believe that we are currently the market leader in the surgical treatment of Afib and LAAM, and pioneers of the application of Cryo Nerve Block in cardiac, thoracic and amputation surgical procedures.
Our products enable surgeons to perform ablation and LAAM procedures with faster, less invasive and less technically challenging approaches and clinically proven results.
Leading surgeons and electrophysiologists, including those who serve or who have served as consultants to us, have published results of preclinical and clinical studies utilizing our devices.
The 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.
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.
The EnCompass clamp is in compliance with EU MDR and bears the CE mark for commercial distribution throughout the member states of the EU and other countries that comply with or mirror EU MDR.
In 2024, we received 510(k) clearance for our most recent configuration of the Isolator Synergy platform, the EnCapture™ clamp, which has enhanced geometry and features to facilitate engagement with the intended cardiac tissue.
The BoxX-NoAF clinical trial is evaluating if prophylactic box lesion ablation with the EnCompass clamp and exclusion of the Left Atrial Appendage using our AtriClip devices at the time of other routine cardiac surgery can reduce the incidence of post operative AF and clinical AF during long term follow up in patients who have not yet developed AF but are at risk. • Multifunctional Pens and Linear Ablation Devices .
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.
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.
These cryoSPHERE probes are in compliance with EU MDR and bear the CE mark for commercial distribution throughout the member states of the EU and other countries that comply with or mirror EU MDR.
AtriCure’s cryoSPHERE devices have been used in over 100,000 procedures since FDA clearance in November 2018. • cryoXT probes .
In April 2025, FDA granted 510(k) clearance for the cryoICE cryoXT probe, a cryoablation device designed specifically for Cryo Nerve Block therapy to alleviate pain in amputation patients.
The device temporarily blocks pain by freezing target peripheral nerves, blocking the conduction pathway at the site of amputation.
As part of the cryoICE® platform, the cryoXT device builds on the proven safety and efficacy of our cryoSPHERE platform.
The device features a newly designed tip with multi-surface freezing technology to precisely target large diameter exposed peripheral nerves.

and 94 more.

Gone since FY2024

BUSINESS Overview We are a leading innovator in treatments for atrial fibrillation (Afib), left atrial appendage (LAA) management and post-operative pain management.
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.
Our pain management solutions are used by physicians to freeze nerves during cardiothoracic or thoracic surgical procedures.
Recovery from cardiothoracic and thoracic surgery can be complicated and painful.
Our cryoICE cryoSPHERE ® probes for pain management (known as Cryo Nerve Block) provides temporary relief of post-operative pain, allowing the patient's body to heal after surgery while the nerves regenerate and sensation is regained.
We sell our products to medical centers through our direct sales force in the United States, Germany, France, the United Kingdom, the Benelux region, Canada and Australia.
Dollars; direct sales transactions outside the United States are transacted in Euros, British Pounds, Canadian Dollars or Australian Dollars.
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.
Today, we estimate that less than 20% of those candidates are being treated with surgical ablation.
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.
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.
Further, applications for Cryo Nerve Block outside of thoracic surgery use are being studied by physician investigators and represent future possible growth opportunities.
AtriCure Solutions and Products We believe that we are currently the market leader in the surgical treatment of Afib and LAAM, and pioneers of the application of Cryo Nerve Block in cardiothoracic surgical procedures.
Our products enable cardiothoracic surgeons to perform surgical ablation procedures with faster, less invasive and less technically challenging approaches and clinically proven results.
Leading cardiothoracic surgeons and electrophysiologists, including those who serve or who have served as consultants to us, have published results of preclinical and clinical studies utilizing our devices.
The 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.
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.
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 .
The ICE-AFIB clinical trial is studying the safety and efficacy of the cryoICE system for persistent and long-standing persistent Afib treatment during concomitant on-pump cardiac surgery.
The 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.
We also make clinical research grants to support our product development efforts and expand the body of clinical evidence.
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.
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.
In April 2022, FDA approved the protocol for the Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction (LeAAPS) IDE clinical trial.
The trial is designed to evaluate the effectiveness of prophylactic LAA exclusion using the AtriClip LAA Exclusion System for the prevention of ischemic stroke or systemic arterial embolism in cardiac surgery patients without pre-operative AF diagnosis who are at risk for these events.
This prospective, multicenter, randomized trial evaluates safety at 30 days post-procedure to demonstrate no increased risk with LAA exclusion during cardiac surgery and effectiveness with a minimum follow-up of five years post procedure for all subjects.
The trial provides for enrollment of up to 6,500 subjects at up to 250 sites worldwide.
We enrolled our first patient in January 2023; site initiation and enrollment is ongoing and we expect to complete enrollment in 2025.
The first patient enrollment in the trial occurred in June 2022; site initiation and enrollment is ongoing.
The CONVERGE IDE clinical trial proved the safety and efficacy of the EPi-Sense System to treat symptomatic persistent and long-standing persistent Afib patients who are refractory or intolerant to at least one Class I and/or III anti-arrhythmic drug.
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.
Site initiation and enrollment in the CONVERGE PAS is ongoing.
The Company continues to perform long-term patient follow-up in multiple studies and plans to present results at 2025 meetings. • In May 2024, the Company finished twelve-month patient follow-up required by the ICE-AFIB study protocol.
The Company has completed the analyses of the primary effectiveness and safety endpoints and is pursuing publication opportunities with reputable cardiac surgery journals.
The ICE-AFIB clinical trial is designed to study the safety and efficacy of the cryoICE system for persistent and long-standing persistent Afib treatment during concomitant on-pump cardiac surgery. • The CEASE-AF three-year outcomes abstract was submitted and accepted for presentation at the 2025 European Heart Rhythm Association (EHRA) meeting.
CEASE-AF is a prospective, multi-center randomized control trial that demonstrated superior freedom from atrial arrhythmias for staged hybrid ablation compared to endocardial catheter ablation. • During the fourth quarter of 2023, the 12-month follow-up results of enrolled patients from the DEEP AF Pivotal study were presented at the American Heart Association meeting.
The two-year DEEP outcomes poster has been accepted for presentation at the 2025 AF Symposium.
The DEEP AF IDE pivotal trial evaluated the safety and efficacy of the AtriCure Bipolar System when used in a staged approach where a minimally invasive surgical ablation procedure is first performed.

and 55 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

Watch ATRC. Know when insiders buy.

One email the day a filing lands. Free.