iRhythm Unveils Data Demonstrating Superior Real-World Performance of Next-Generation Zio® Monitor at HRX 2024 Meeting

Rhea-AI Summary

iRhythm Technologies (NASDAQ:IRTC) presented data at HRX 2024 showcasing the superior performance of its next-generation Zio® monitor compared to the previous Zio® XT device. The study revealed that the new Zio monitor demonstrated fewer early wear terminations (1.1% vs 2.8%), longer wear duration (12.6 vs. 11.9 days), and longer analyzable time (12.2 vs 11.5 days). These improvements may lead to enhanced diagnostic yield, building upon Zio XT's already superior performance among ambulatory cardiac monitoring services. The new Zio monitor also showed higher detection rates for paroxysmal AF (8.7% vs 6.8%) and overall arrhythmia (80.9% vs 76.4%). Since its launch in late 2023, the Zio monitor has been worn by over 1 million patients, demonstrating its rapid adoption in the market.

Positive

• Next-generation Zio monitor showed longer wear duration (12.6 vs 11.9 days) and analyzable time (12.2 vs 11.5 days) compared to Zio XT
• Fewer early wear terminations with new Zio monitor (1.1% vs 2.8%)
• Higher detection rates for paroxysmal AF (8.7% vs 6.8%) and overall arrhythmia (80.9% vs 76.4%) with Zio monitor
• Over 1 million patients have worn the Zio monitor since its launch in late 2023

Negative

• None.

Insights

Medical Device Expert

The unveiling of iRhythm's next-generation Zio® monitor data at HRX 2024 represents a significant advancement in ambulatory cardiac monitoring. The improved wear duration (12.6 vs. 11.9 days) and analyzable time (12.2 vs 11.5 days) are crucial metrics that directly impact diagnostic yield.

The reduction in early wear terminations (1.1% vs 2.8%) is particularly noteworthy, as it suggests enhanced patient compliance. This improvement likely stems from the device's redesign, including its smaller size, lighter weight and waterproof housing. These features address common patient concerns and may contribute to the observed increase in wear time.

The higher detection rates for paroxysmal AF (8.7% vs 6.8%) and overall arrhythmias (80.9% vs 76.4%) are clinically significant. These improvements could lead to earlier interventions and potentially better patient outcomes. However, it's important to note that these are unadjusted analyses and further studies may be needed to confirm these findings across different patient populations.

Market Research Analyst

iRhythm's new Zio® monitor data presents a strong market position for the company. With over 1 million patients using the device since its late 2023 launch, iRhythm has demonstrated rapid market penetration. This adoption rate, coupled with improved performance metrics, could translate into increased market share and potential revenue growth.

The superior performance of the Zio® monitor compared to its predecessor may provide iRhythm with a competitive edge in the ambulatory cardiac monitoring market. The company's focus on continuous improvement aligns with healthcare trends towards more efficient and patient-friendly diagnostic tools.

Investors should note the potential for increased reimbursement rates due to improved diagnostic yield. However, it's important to monitor how these advancements impact production costs and pricing strategies. The medical device market is highly competitive and maintaining a balance between innovation and profitability will be key to iRhythm's long-term success.

• iRhythm’s next-generation Zio^® monitor demonstrated longer wear duration and analyzable time compared to the prior generation Zio^® XT device.
• Longer wear duration and analyzable time may further improve diagnostic yield, building upon Zio XT service’s superior yield among ambulatory cardiac monitoring services as demonstrated by the prior CAMELOT study findings.¹
• The Zio monitor ECG device has been worn by over 1 million patients since launching in late 2023.²
  

SAN FRANCISCO, Sept. 09, 2024 (GLOBE NEWSWIRE) --  iRhythm Technologies, Inc. (NASDAQ:IRTC) today announced initial research findings on post-market, real-world performance of Zio^® monitor, its next-generation Zio^® long-term continuous monitoring (LTCM) patch ECG device, presented at the Heart Rhythm Society’s HRX 2024 meeting.

Building on the high performance of its previous generation Zio^® XT device, the Zio LTCM monitor was designed to be smaller and lighter,³ with a waterproof housing and a new breathable adhesive. ^4,5 For the study, titled “Performance of a Novel Next-Generation Ambulatory ECG Long-Term Patch Monitor: A Multicenter Post-Market Evaluation,” the investigators sought to determine whether these design enhancements translated into improved, post-market real-world device performance compared to its predecessor.

The investigators compared U.S. post-market real-world data of iRhythm’s next-generation Zio monitor to its prior generation Zio XT device. The new Zio monitor demonstrated fewer early wear terminations (i.e., wear time ≤48 hours; 1.1% vs 2.8%, p<0.0001), longer wear duration (average 12.6 vs. 11.9 days, p<0.0001), and longer analyzable time (average 12.2 vs 11.5 days, p<0.0001) compared to the prior generation Zio XT device. In unadjusted analyses, there was greater yield of paroxysmal AF (8.7% vs 6.8%, p<0.0001) and overall arrhythmia detection (80.9% vs 76.4%, p<0.0001) with Zio monitor.

“Not all ambulatory cardiac monitoring services are the same. We first learned that in the CAMELOT study,¹ where Zio XT provided greater diagnostic yield and less retesting than other monitors,” said Rod S. Passman, MD, MSCE, cardiac electrophysiologist, Professor of Medicine at Northwestern University, and presenting author. “Now, we are seeing the impact of design enhancements on device performance, with even better wear time and analyzable time with the new device. Taken together, these advancements could contribute to better patient compliance and higher arrhythmia detection rates.”

Figure 1 - Zio monitor LTCM patch ECG device by iRhythm Technologies

About the “Performance of a Novel Next-Generation Ambulatory ECG Long-Term Patch Monitor: A Multicenter Post-Market Evaluation” study
Authors: Bradley P. Knight, Vladimir Fokin, Jeffrey Ellis, Oussama M.Wazni, Rod S. Passman, Mintu P. Turakhia, Suneet Mittal

Researchers retrospectively compared U.S. real-world data from patients using two long term continuous monitors monitoring (LTCM) services, iRhythm’s prior generation Zio XT service and its next-generation Zio monitor service, both available for commercial use. The analysis period corresponded to the initial launch of Zio monitor and included 14-day prescriptions between May 2022 and September 2023, comprising 7,433 Zio monitors and 1,336,391 Zio XT devices. The new Zio LTCM service demonstrated fewer early wear terminations (i.e., wear time ≤48 hours ; 1.1% vs 2.8%, p<0.0001), longer average wear duration (12.6 ± 2.7 vs. 11.9 ± 3.4 days, p<0.0001), longer average analyzable time (12.2 ± 2.8 vs 11.5 ± 3.5 days, p<0.0001), and fewer reports of skin irritation (0.47% vs 1.35%, p<0.0001) compared to the prior generation Zio XT. In unadjusted analyses, there was greater yield of paroxysmal AF (8.7% vs 6.8%, p<0.0001) and overall arrhythmia detection (80.9% vs 76.4%, p<0.0001) with the new LTCM service.

“Prior studies have already demonstrated high wear time, high analyzable time,⁶ high diagnostic yield and less retesting of Zio XT,¹” said Mintu Turakhia MD, iRhythm’s Chief Medical and Scientific Officer and EVP, Product Innovation. “This new data goes one step further and show how our newest long-term continuous Zio monitor patch performs even better in the real-world.”

In addition to the new research presented, Mintu Turakhia, MD, MAS, iRhythm Chief Medical and Scientific Officer and EVP, Product Innovation, and HRX Founding Co-Chair in 2021, also participated in the following HRX events:

• What is New About Our Old Tools in Electrophysiology? – HRX Concurrent Sessions, September 6
• Standards Development for Wearables – Beginning the Discussion – HRX Roundtables, September 7
• HRX Pitch Competition – Panel Judge, September 5 and 7
  

The research findings and thought leadership participation at HRX underscore iRhythm’s commitment to innovation, patient-centered design, and rigorous clinical evidence. To learn more about iRhythm, please visit https://www.irhythmtech.com/.

Since launching the next-generation Zio LTCM monitor and enhanced Zio service in the U.S. in September 2023, the Zio monitor ECG device has been worn by over 1 million patients, representing nearly 70% of iRhythm’s LTCM registrations in the U.S.² Additionally, iRhythm recently announced the commercial launch of Zio^® monitor and Zio^® LTCM service in Austria, the Netherlands, Spain, and Switzerland.

iRhythm Technologies sponsored the Performance of a Novel Next-Generation Ambulatory ECG Long-Term Patch Monitor: A Multicenter Post-Market Evaluation study.

About iRhythm Technologies
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.

Investor 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
² Data on file. iRhythm Technologies, 2024.
³ Data on file. iRhythm Technologies, 2023.
⁴ Data on file. iRhythm Technologies, 2017, 2023.
⁵ 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.
⁶ Steinhubl SR, et al. Effect of a Home-Based Wearable Continuous ECG Monitoring Patch on Detection of Undiagnosed Atrial Fibrillation: The mSToPS Randomized Clinical Trial. JAMA. 2018 Jul 10;320(2):146-155.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/1f309e78-4eed-4e7b-8423-28efb5cffe7f

FAQ

What are the key performance improvements of iRhythm's next-generation Zio monitor compared to Zio XT (IRTC)?

The new Zio monitor showed longer wear duration (12.6 vs 11.9 days), longer analyzable time (12.2 vs 11.5 days), fewer early wear terminations (1.1% vs 2.8%), and higher detection rates for paroxysmal AF (8.7% vs 6.8%) and overall arrhythmia (80.9% vs 76.4%) compared to Zio XT.

How many patients have used iRhythm's new Zio monitor since its launch in 2023 (IRTC)?

Over 1 million patients have worn the new Zio monitor since its launch in late 2023.

What study presented at HRX 2024 demonstrated the performance of iRhythm's next-generation Zio monitor (IRTC)?

The study titled 'Performance of a Novel Next-Generation Ambulatory ECG Long-Term Patch Monitor: A Multicenter Post-Market Evaluation' was presented at HRX 2024, comparing real-world data of the new Zio monitor to the prior generation Zio XT device.

How does the new Zio monitor's design differ from the previous Zio XT device (IRTC)?

The new Zio monitor was designed to be smaller and lighter, with a waterproof housing and a new breathable adhesive, aiming to improve patient comfort and compliance.