iRhythm has expanded internationally in 2024. Could you share your experience with entering new markets?
We initially launched Zio monitor, our next generation long-term continuous monitoring (LTCM) service, in the US, and it has now been used by over a million patients, with expectations to reach nearly two million by 2025. We are thrilled with the uptake, and this momentum has set the stage for our international expansion. Recently, we launched in the Netherlands, Switzerland, Spain, and Austria, where the Zio brand is already well-recognized. In these markets, the traditional method for cardiac monitoring, the Holter monitor, is outdated. It only records for 24 to 48 hours, whereas our Zio monitor tracks continuously for up to 14 days, significantly increasing the chances of detecting arrhythmias that might be missed otherwise.
In Europe, our early reception has been strong, with awareness high among healthcare providers. Moving into the Asian market, particularly Japan, we are positioned for major growth. Japan has already granted us regulatory approval, labeling the Zio monitor as a "high medical needs" device, a designation specific to our product. This has accelerated our plans to secure reimbursement approvals, and we anticipate a commercial launch in Japan by the first half of 2025, bringing our Zio technology to a very high-demand market.
Could you elaborate on the difference between your different Zio devices?
Our mainstay product, the Zio monitor, is the next generation of the Zio XT (LTCM), which records all heartbeats over a 14-day period. Patients wear it continuously, and at the end of the period, it provides a comprehensive end-of-wear report, allowing physicians to diagnose cardiac arrhythmias like atrial fibrillation. LTCM is currently about 90% of our business.
On the other hand, the Zio AT device, our mobile cardiac telemetry (MCT) monitoring service, provides the physician with an actionable wear-time report to both the patient and physician, alerting them during those 14 days if an arrhythmia is detected. This is particularly valuable for patients under close monitoring. We are also working on a new product, Zio MCT, which will succeed the Zio AT and aims to serve that segment even more effectively.
What feedback have you received from US practitioners and patients regarding their experience with the Zio Monitor?
The response has been outstanding, with our Zio monitor maintaining a net promoter score (NPS) above 90, which is exceptional in healthcare. Patients find it comfortable and often forget they are even wearing it, leading to better compliance and duration of wear. This longer monitoring period increases the likelihood of detecting arrhythmias, which are often elusive in shorter monitoring windows. As a result, we are seeing a higher diagnostic yield with the Zio monitor, directly benefiting patients by improving the accuracy and effectiveness of diagnoses.
What is the potential of your devices to identify arrhythmias correlated with other disease, such as diabetes?
We are particularly excited about this, as our data shows a strong correlation between arrhythmias and other diseases, such as diabetes, chronic obstructive pulmonary disease (COPD), obstructive sleep apnea (OSA), and chronic kidney disease. Many patients with these conditions are asymptomatic for arrhythmias until a serious event, like a stroke, occurs. We are moving into primary care to enable earlier detection, with over 20% of our prescriptions now coming from primary care physicians. By proactively monitoring at-risk patients, we are capturing arrhythmias sooner and helping prevent severe outcomes, opening up a much larger market for proactive cardiac care.
Could you talk more about your partnership with BioIntelliSense on proactively identifying arrhythmias?
Our partnership with BioIntelliSense is key, as it adds new sensor capabilities to our monitors. Besides EKG data, the BioIntelliSense technology allows us to monitor pulse oximetry and respiratory rate directly from the chest. This partnership enables us to detect more vital signs, such as oxygen saturation and breathing patterns, which can provide critical insights even when no arrhythmias are present.
Additionally, we are forming partnerships with innovative primary care networks that analyze patient data, such as medical claims, to identify asymptomatic patients with a high likelihood of arrhythmias. Through this proactive approach, we are identifying arrhythmias in as many as 60–70% of these patients, enabling early intervention and better outcomes.
Do you anticipate growth-related challenges, given iRhythm’s rapid expansion?
Absolutely, and you raise a critical point. As we push forward in this new category of cardiac monitoring, the FDA’s involvement has become more intensive, especially since this field has grown exponentially in the past few years. For example, we received a warning letter for our Zio AT product a little over a year ago, and we have also had a few 483 observations. We are working closely with the FDA to define regulatory standards for this new category, especially since the technology is replacing traditional Holter monitors, which are outdated and limited.
The FDA recently created a new category, MCT, specifically for mobile cardiac telemetry, and our Zio AT product was promptly placed within this category. This collaboration is significant because we have both a physical product and an Independent Diagnostic Testing Facility (IDTF), staffed by trained and qualified cardiac technicians who review the data. Traditionally, the FDA only regulated the physical device, but now they recognize the need to regulate both the hardware and the diagnostic service. While we did not anticipate these challenges initially, we are committed to meeting FDA requirements fully as we continue to shape this high-growth market.
What are your primary goals for 2025?
Our key objective for 2025 is to work collaboratively with the FDA to address their concerns and establish clear standards for this emerging industry. Beyond regulatory efforts, we are focused on expanding into primary care settings, where the potential for early detection and treatment is significant. Today, around 5.5 million ambulatory cardiac monitoring tests are prescribed annually, mostly by cardiologists and electrophysiologists. However, nearly 25 million patients annually are potential candidates for arrhythmia detection in primary care – today around 15 million that visit primary care present with symptoms that might indicate an arrhythmia, like lightheadedness or hypertension, while another 10–12 million, though asymptomatic, would likely seek care through primary care as their frontline healthcare provider
Our aim is to broaden access to our technology within primary care. By enabling primary care physicians to prescribe these patches directly, we can expedite diagnoses, reducing the wait time for patients who might otherwise wait months to see a specialist. This shift could transform the market, potentially increasing the number of annual tests to 25 million. We expect primary care adoption to be a major driver for us, both in the U.S. and internationally, as we work toward proactive and early intervention for arrhythmias, improving patient outcomes globally.
