IRTC iRhythm Technologies Inc

iRhythm Technologies, Inc. (NASDAQ:IRTC), a leading digital health care company focused on creating trusted solutions that detect, predict, and prevent disease, today announced the commercial launch of its Zio® monitor and Zio® long-term continuous (LTCM) ambulatory ECG monitoring service in Austria, the Netherlands, Spain, and Switzerland. The Zio monitor and ZEUS (Zio ECG Utilization Software) system received the European Union’s CE Marking Under Medical Device Regulation (EU MDR) in December 2023. The Zio LTCM service provides up to 14 days of continuous, uninterrupted ECG monitoring, marking a significant advancement in these countries, compared to older, commonly used 24- to 48-hour Holter monitoring services1.

“Expanding access to our innovative Zio cardiac arrhythmia monitoring system and services for millions more people in Europe is an important milestone for iRhythm’s patient-first mission to positively impact people across the globe,” said Quentin Blackford, iRhythm President and CEO. “Our commitment extends to broadening our highly innovative digital healthcare solutions, while ensuring they are cost-effective and accessible worldwide.”

Advancing Cardiac Care in Europe Zio LTCM service offers a range of distinct advantages that set it apart as a leading solution for cardiac monitoring in Europe:

• Up to 14 days of continuous, uninterrupted ECG monitoring
• 99% patient compliance with prescribed wear times6,7 and 99% analyzable time6,
• Highest diagnostic yield of specified arrhythmias, lowest likelihood of retesting, and lowest incremental acute care utilization compared to traditionally used 24- or 48-hour Holter monitoring services1-4.

Additionally, Zio monitor demonstrates:

• Improved form-factor over the previous generation for a better patient wear experience and is 23% thinner8,9, 62% lighter10, 72% smaller10and weighs 10 grams
• Patient-centric design that is breathable, waterproof housing10,11, increased adhesive area, a symptom button for easy patient interaction, and no maintenance or battery changes are required12

Zio® monitor by iRhythm Technologies

Clinically Proven Performance The value of the Zio service has been demonstrated in over 100 original scientific research manuscripts5, including the recent real-world Cardiac Ambulatory Monitor EvaLuation of Outcomes and Time to Events (CAMELOT) study, published in the American Heart Journal. The CAMELOT study, a US retrospective data analysis of 287,789 Medicare patients, found that the Zio LTCM service, is associated with the highest diagnostic yield of specified arrhythmias, lowest likelihood of retesting, and the lowest incremental of acute care utilization compared to all other monitoring services, including other long-term continuous monitoring services, in the study1-4.

iRhythm’s advanced CE-marked and FDA-cleared AI has a deep-learned algorithm clinically proven to be as accurate as expert cardiologists,13,14 The deep learning approach can classify a broad range of distinct arrhythmias with high diagnostic performance similar to that of cardiologists13.

“The global burden of arrhythmias continues to rise, with atrial fibrillation (AF) alone affecting 1.5-2% of Europeans and with a lifetime risk of 1 in 4,” said Mintu Turakhia, iRhythm Chief Medical and Scientific Officer and EVP, Product Innovation. “At the same time, we are also seeing a greater need for post-treatment monitoring, with catheter ablation strongly on the rise in Europe and worldwide. Zio monitor is an evidence-based solution that provides 2 weeks of uninterrupted monitoring from a single patch in places where only 1-2 days of monitoring is available, often from bulkier technologies that don’t leverage AI like we do. We believe the introduction of the Zio service in these countries will positively disrupt the monitoring paradigm to align clinical practice with evidence and improve outcomes.”

Cardiac Arrhythmias and PrevalenceA cardiac arrhythmia is a condition in which the heart beats too quickly, too slowly or irregularly due to abnormal electrical impulses15. If undetected and untreated, some arrhythmias can damage the heart, brain, or other organs, and lead to an increased risk of stroke and death16. Early detection and treatment of arrhythmias can prevent adverse outcomes and improve quality of life17.

As the prevalence of arrhythmias continues to rise across Europe18, atrial fibrillation—the most common cardiac arrhythmia—now affects 1.5-2% of European adults, with projections indicating a surge to 9.5% in individuals over 65 by 206019. The recent CAMELOT study has demonstrated that Zio LTCM service offers the highest diagnostic yield for specified arrythmias, the lowest likelihood of retesting, and the most significant reduction in acute care utilization as compared to Holter monitoring services which are traditionally utilized in Europe1-4. This positions Zio LTCM service as a significant advancement in cardiac arrhythmia monitoring for the region.

"The introduction of the Zio monitor to European countries can help physicians better identify, diagnose, and manage cardiac arrhythmias faster, as speed to diagnosis is especially critical for cardiac care," said José L. Merino, MD, PhD, FEHRA, and Chief of the Arrhythmia and Robotic EP Unit, Hospital Universitario La Paz in Madrid, who took part in a Zio market evaluation in Spain. "The Zio service enhances clinical workflows and boosts productivity, enabling more precise and timely diagnoses, which ultimately alleviates pressure on healthcare services. And Zio monitor is really convenient for the patient.”

“The availability of a long-term cardiac arrhythmia monitoring solution that is friendly to wear closes an important clinical gap for patients in Europe," said Patrick Badertscher, Professor and Senior Physician, Cardiac Electrophysiology, and Michael Kühne, Professor of Cardiology at the University Hospital Basel both who took part in a Zio market evaluation in Switzerland. “We will be able to streamline clinical processes with highly accurate diagnoses allowing for more effective treatment decisions. And when it comes to the monitoring device, many patients express a preference for Zio."

Availability Zio monitor will begin shipping in Austria, the Netherlands, Switzerland, and Spain in September, with widespread availability in these countries anticipated in 2025. Zio monitor, Zio XT and Zio AT (mobile cardiac telemetry) services are currently available in the U.S., and Zio XT service is available in the UK. To learn more about Zio monitor in Austria, the Netherlands, Switzerland, and Spain, go to info.irhythmtech.com.

About iRhythm Technologies, Inc.iRhythm is a leading digital health care company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm’s vision is to deliver better data, better insights, and better health for all. To learn more about iRhythm, go to iRhythmtech.com.

Investor Relations ContactStephanie Zhadkevichinvestors@irhythmtech.com

Media ContactKassandra Perryirhythm@highwirepr.com

1 Reynolds et al. Comparative effectiveness and healthcare utilization for ambulatory cardiac monitoring strategies in Medicare beneficiaries. Am Heart J. 2024;269:25–34. Accessed January 2, 2024. https://doi.org/10.1016/j.ahj.2023.12.0022A specified arrhythmia refers to an arrhythmia encounter diagnosis as per Hierarchical Condition Categories (HCC) 96.3Based on previous generation Zio XT device data. Zio monitor utilizes the same operating principles and ECG algorithm. Additional data on file.4Zio LTCM service refers to Zio XT and Zio monitor service.5 Data on file. iRhythm Technologies, 2023: https://www.irhythmtech.com/providers/evidence/list-of-clinical-articles6 Based on the US data7 Zio service provides continuous, uninterrupted recording and a comprehensive end-of-wear report8 Data on file. iRhythm Technologies, 2023.9 Compared to previous generation.10 Data on file. iRhythm Technologies, 2017, 2023.11 The Zio monitor patch should not be submerged in water. During a bath, keep the device above water. Please refer to the Zio monitor labeling instructions or Patient Guide for the full set of details.12 Zio monitor Instructions for Use. iRhythm Technologies, 2023.14 Zio has the only FDA-cleared, deep learned algorithm that’s as accurate as human, expert-level interpretation: https://www.irhythmtech.com/providers/zio-service/ai 15 American Heart Association (2024) What is an arrhythmia? https://www.heart.org/en/health-topics/arrhythmia/about-arrhythmia (Accessed 8-2-24)16 National Heart Lung and Blood Institute, 2022. What is an arrhythmia? https://www.nhlbi.nih.gov/health/arrhythmias (Accessed 8-2-24)17 Rillig et al. Early Rhythm Control in Patients With Atrial Fibrillation and High Comorbidity Burden. Circulation. 2022;146(11):836-847. doi:https://doi.org/10.1161/circulationaha.122.06027418Mensah, AH. et al. Global Burden of Cardiovascular Diseases and Risks, 1990-2022. Journal of the American College of Cardiology, 2023.19Linz, D. et. Al. Atrial fibrillation: epidemiology, screening and digital health. The Lancet Regional Health, 2024.

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