Financial Performance & Guidance - Second quarter 2025 revenue reached $186.7 million, a 26.1% increase compared to the second quarter of 2024[8] - The company updated its 2025 annual net revenue guidance to $720 - $730 million[45] - The adjusted EBITDA margin is expected to be 8.0% - 8.5% of revenue for 2025[45] Market Opportunity & Penetration - The potential market includes over 27 million patients in the United States who could benefit from ambulatory cardiac monitoring[11] - The company has achieved over 30% penetration in the core U S ambulatory cardiac monitoring market as of December 31, 2024[13] - The international market represents a $1+ billion total addressable market (TAM) with 5+ million tests in prioritized countries across EMEA and Asia Pacific[36] Expansion & Growth Strategies - The company is targeting over 5 million ambulatory cardiac monitoring (ACM) tests in prioritized countries across EMEA and Asia Pacific[17] - There are over 27 million potential patients presenting in primary care who may be symptomatic or at-risk for arrhythmias[17,24] - The company is addressing population health management through targeted monitoring for undiagnosed arrhythmias, leveraging AI[25,26] Technology & Innovation - The company has curated over 2.5 billion hours of ECG data since its inception through 2024[15] - The company's AI capabilities are used for prediction of atrial fibrillation and heart failure[39,40]

Financial Performance & Guidance - iRhythm Technologies reported first quarter 2025 revenue of $158.7 million, a 20.3% increase compared to the first quarter of 2024[8] - The company's gross profit margin for the first quarter of 2025 was 68.8%[42] - Adjusted operating expenses for the first quarter of 2025 were $140.4 million[42] - The adjusted EBITDA margin for the first quarter of 2025 was -1.7%[42] - The company updated its 2025 annual revenue guidance to $690 - $700 million and adjusted EBITDA margin to 7.5% - 8.5% of revenue[46] Market Opportunity & Expansion - The company estimates a potential market of over 27 million patients in the United States who could benefit from ambulatory cardiac monitoring[10] - There is a target market opportunity of over 5 million tests across prioritized EU and APAC countries[10] - The company estimates over 30% penetration in the core U S ambulatory cardiac monitoring market as of March 31, 2025[13] - The international market represents a $1+ billion total addressable market (TAM) with 5+ million tests in prioritized countries across EMEA and Asia Pacific[36] Technology & Clinical Data - The company has accumulated over 2.5 billion hours of curated ECG data since its inception through 2024[15]

Core Viewpoint - iRhythm Technologies has launched its Zio long-term continuous ECG monitoring system in Japan, offering up to 14 days of uninterrupted ECG monitoring, which is a significant improvement over existing options in the market [1][4]. Company Overview - iRhythm Technologies, Inc. is a leading digital health care company focused on creating solutions that detect, predict, and prevent disease through wearable biosensors and cloud-based data analytics [14]. - The company has a strong commitment to improving patient outcomes, supported by over 125 original research manuscripts and insights from more than 2 billion hours of curated heartbeat data [7]. Product Details - The Zio ECG Recording and Analysis System includes a patch-based ECG monitoring device that can be worn for up to 14 days and utilizes a deep-learned AI algorithm approved by Japan's Pharmaceuticals and Medical Devices Agency (PMDA) [3][5]. - The system demonstrates 99% patient compliance with prescribed wear time and 99% analyzable data, providing high-quality, actionable insights [5]. - The Zio service is associated with the highest diagnostic yield and lowest likelihood of retesting compared to other monitoring services, including Holter monitoring [5]. Market Opportunity - Japan is the second largest ambulatory cardiac monitoring market globally, with an estimated 1.6 million tests prescribed annually, a number expected to rise due to the aging population and increasing prevalence of cardiac arrhythmias [10][11]. - The launch of the Zio system is timely, addressing the growing demand for early and accurate detection of arrhythmias in Japan [4]. Clinical Validation - The clinical value of the Zio LTCM service has been validated through studies, including the CAMELOT study, which found it to be associated with the highest yield of specified arrhythmia diagnosis and the lowest likelihood of repeat testing [6][8]. - The Zio service combines advanced AI with expert clinical review to support accurate and timely diagnoses, enhancing patient care [8]. Distribution and Availability - The Zio ECG Recording and Analysis System will be available to healthcare customers in Japan starting May 2025, with nationwide availability expected by July 2025, through Senko Medical Instrument, the exclusive distribution partner [12].