0A7L Irhythm Technologies Inc

iRhythm Technologies Expands Global Reach with the Launch of Zio® Cardiac Arrhythmia Monitoring Service in Austria, the Netherlands, Switzerland, and Spain

• Zio long-term continuous monitoring (LTCM) service consists of a prescription only patch ECG monitoring device (Zio monitor) worn for up to 14 days, the ZEUS (Zio ECG Utilization Software) System (iRhythm’s advanced AI algorithm), and a comprehensive end-of-wear report reviewed and curated by certified cardiographic technicians.
  
• The next-generation Zio monitor LTCM provides up to 14 days of continuous, uninterrupted, patch-based ECG monitoring, marking a significant advancement in these countries, compared to older, commonly used 24- to 48-hour (Holter) monitoring technology¹.
• Zio LTCM is associated with a greater diagnostic yield of specified arrhythmias, the lowest likelihood of retesting and the lowest incremental acute care utilization, as compared to Holter monitoring services^1,2,3,4.
• Zio products and services are backed by over 100 peer-reviewed clinical research and scientific papers⁵.

SAN FRANCISCO, Aug. 29, 2024 (GLOBE NEWSWIRE) --  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 times^6,7 and 99% analyzable time^6,
• 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 services^1-4.
  
  

Additionally, Zio monitor demonstrates:

• Improved form-factor over the previous generation for a better patient wear experience and is 23% thinner^8,9, 62% lighter¹⁰, 72% smaller¹⁰and weighs 10 grams
• Patient-centric design that is breathable, waterproof housing^10,11, 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 study^1-4.

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 Prevalence
A 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 Europe^1-4. 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, 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 Contact
Stephanie Zhadkevich
investors@irhythmtech.com

Media Contact
Kassandra Perry
irhythm@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.2023.12.002
²A 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-articles
⁶ Based on the US data
⁷ Zio service provides continuous, uninterrupted recording and a comprehensive end-of-wear report
⁸ 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.122.060274
¹⁸Mensah, 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.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/57909a3f-08ca-4a8a-859d-e0bfe63b59d9