AtriCure(ATRC) - 2025 Q4 - Annual Report

Company Overview - AtriCure is a leading innovator in surgical treatments for atrial fibrillation (Afib), with over 59 million people affected globally[18]. - AtriCure is recognized as a market leader in surgical Afib treatment and LAAM, with ongoing investments in clinical studies to validate the efficacy and safety of its products[29]. - AtriCure is the only company with FDA-approved devices for treating long-standing persistent Afib, including the Isolator Synergy Ablation and the EPi-Sense System[58]. Market Opportunity - The market for AtriCure's ablation products represents a significant growth opportunity, with less than 15% of potential candidates for surgical ablation currently being treated[23]. - Approximately 500,000 Afib patients are treated by catheter ablation annually in the U.S., a number expected to grow significantly[25]. - The annual diagnoses of Afib exceed one million in the United States, with a significant percentage of cases being under-diagnosed[21]. - Up to 50% of cardiac surgery patients without pre-operative Afib may develop post-operative Afib (POAF), indicating a large addressable market for preventative therapies[26]. Clinical Trials and Research - The Left Atrial Appendage Occlusion Study (LAAOS) III trial demonstrated a significant reduction in strokes when the LAA was managed during cardiac surgery[24]. - The BoxX-NoAF IDE trial aims to evaluate the safety and effectiveness of ablation and LAA exclusion in reducing post-operative Afib (POAF) in non-Afib patients[26]. - The ICE-AFIB clinical trial showed a 70% freedom from atrial fibrillation/atrial flutter/atrial tachycardia from 6 to 12 months, with a 30-day major adverse event rate of 9.3%[59]. - The LeAAPS IDE clinical trial completed enrollment of 6,573 patients across 139 centers globally in July 2025, focusing on prophylactic LAA exclusion for stroke reduction[53]. - The EPi-Sense System received FDA PMA approval for treating symptomatic, drug-refractory, long-standing persistent atrial fibrillation, demonstrating a 29% absolute difference in efficacy at 12 months compared to endocardial catheter ablation alone[59]. Product Innovations - AtriCure's EPi-Sense ablation system can double the success rate for long-standing persistent Afib patients when used in conjunction with catheter ablation[25]. - The cryoXT™ device was launched in September 2025 to manage post-operative pain following amputations, addressing the needs of over 180,000 amputations annually in the U.S.[28]. - The cryoSPHERE MAX probe reduces freeze times by 50% compared to the first-generation cryoSPHERE probe, showcasing advancements in pain management technology[37]. - The AtriClip LAA Exclusion System has treated more than 750,000 patients globally, making it the most widely sold LAA management device[38]. - The AtriClip FLEX-Mini device, launched in 2024, sets a new standard as the smallest surgical LAA management device on the market[39]. Regulatory and Compliance - AtriCure's products are subject to regulation by the FDA and comparable authorities in the EU and other countries[66]. - The company is an FDA-registered medical device manufacturer and certified to ISO 13485:2016, ensuring compliance with quality system requirements[89]. - The European Union's Medical Device Regulation (EU MDR) effective May 26, 2021, imposes stringent conformity assessment requirements for medical devices[79]. - The company has successfully participated in the Medical Device Single Audit Program (MDSAP), recognized in Australia, Brazil, Canada, Japan, and the United States[90]. Employee and Workplace Culture - AtriCure had approximately 1,350 employees as of December 31, 2025, with a voluntary turnover rate consistently at or below 10% over the last five years[92]. - The company has been recognized as a Top Workplace ten times in the past eleven years and has been voted a Great Place to Work for four consecutive years[94]. - AtriCure is committed to advancing Diversity, Equity, and Inclusion (DE&I) initiatives, earning recognition for providing opportunities for women[98]. - The company regularly analyzes and benchmarks its compensation and benefits programs to attract and retain top talent[99]. Sales and Market Access - AtriCure's sales team in the United States consists of approximately 330 employees, with an additional 75 employees in international markets[57]. - The company is actively pursuing market access in various geographies, focusing on obtaining reimbursement for therapies involving its devices[65]. - Medicare's reimbursement policies are significant for AtriCure, as a large percentage of its product users are Medicare beneficiaries[61]. - Hospital reimbursement rates for cardiac surgical ablation procedures are believed to be adequate to cover the cost of AtriCure's products[62]. Supply Chain and Manufacturing - AtriCure's manufacturing facilities are located in Ohio, where the majority of products are assembled, inspected, tested, and packaged[87]. - The company maintains inventory levels of components and raw materials to minimize supply chain risks and has not experienced significant product availability issues[88]. - The company conducts regular audits of suppliers for compliance with quality system requirements[89].