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iRhythm Technologies, Inc. (NASDAQ: IRTC) is a commercial-stage digital healthcare company redefining the diagnosis of cardiac arrhythmias through its innovative technologies. By combining wearable biosensing technology with cloud-based data analytics and advanced machine learning capabilities, iRhythm aims to be the leading provider of first-line ambulatory electrocardiogram (ECG) monitoring, particularly for patients at risk of arrhythmias.
The company's flagship product, the Zio service, represents a comprehensive solution that includes an easy-to-wear biosensor capable of monitoring a patient's heart rhythm continuously for up to 14 days. This device, paired with the company's proprietary algorithms, transforms millions of heartbeats into clinically actionable data, significantly enhancing the diagnostic yield compared to traditional Holter monitors and other event monitoring systems. This approach not only expedites diagnosis but also reduces the need for repeat testing, thereby allowing timely medical intervention and potentially preventing severe outcomes like stroke.
Recent accomplishments highlight iRhythm's commitment to advancing cardiac care. The Zio monitor system has received the CE mark, underscoring its recognition as a leading innovation in ambulatory cardiac monitoring. The Zio monitor is designed to be thinner, lighter, and more discreet than its predecessor, the Zio XT, while improving patient compliance and monitoring accuracy. Furthermore, the company has integrated the ZEUS (Zio ECG Utilization Software) System, an advanced AI algorithm, to enhance data analysis and capture.
iRhythm's clinical research, such as the Cardiac Ambulatory Monitor EvaLuation of Outcomes and Time to Events (CAMELOT) study, has demonstrated the superior diagnostic accuracy and lower retest rates of the Zio service. These findings, published in the American Heart Journal, indicate significant advantages in clinical utility and cost-effectiveness over other monitoring systems.
On the financial front, iRhythm has shown robust performance, with significant increases in gross profit driven by higher demand for Zio services. The company's strategic initiatives include expanding its market presence in Europe, strengthening customer engagement through digital tools, and launching new products. The recent closure of a substantial non-dilutive senior secured term loan facility ensures continued financial flexibility and supports iRhythm's growth ambitions.
With nearly 8 million reports posted since its inception, iRhythm remains focused on delivering better data, better insights, and better health outcomes. The company's relentless focus on patient care and strategic partnerships positions it well for sustained growth and innovation in the digital healthcare landscape.
iRhythm Technologies (NASDAQ: IRTC) reported updated reimbursement rates for CPT codes 93243 and 93247 by Novitas Solutions, set at $103 and $115, respectively, retroactive to January 1, 2021. Despite this increase, iRhythm expressed disappointment, stating that the rates do not reflect the value of its Zio® XT service, leading to the potential discontinuation of the service for Medicare. The updated rates could have negatively impacted 2020 revenue by $41.3 million, reducing total revenue from $265.2 million to $223.8 million. Preliminary Q1 results indicate a 9% volume growth but a projected $13 million revenue decline due to the new rates.
iRhythm Technologies (NASDAQ: IRTC) announced a conference call to discuss Novitas Solutions' updated reimbursement rates for CPT codes 93243 and 93247, published on April 10, 2021. The new rates are retroactive to January 1, 2021, at $103 and $115, replacing earlier rates from January 29, 2021. iRhythm is evaluating the impact of these changes and will provide insights during the call on April 12, 2021. This announcement highlights the company's focus on enhancing cardiac care through innovative digital health solutions.
iRhythm Technologies (NASDAQ: IRTC) reported strong financial results for Q4 and full year 2020. Q4 revenue surged 33.3% to $78.8 million, driven by Zio XT volume expansion. However, gross margin slipped to 74%, reflecting rising costs. Full year revenue reached $265.2 million, a 23.6% increase, with net losses narrowed to $43.8 million. The firm's Zio XT obtained a NICE recommendation, indicating a promising future. While the company expects 5% volume growth in Q1 2021, guidance on revenue and operating expenses remains uncertain due to reimbursement challenges.
iRhythm Technologies has announced significant findings from the SCREEN-AF study published in JAMA Cardiology, demonstrating a tenfold increase in atrial fibrillation (AF) detection using its Zio wearable ECG monitoring solution compared to standard care. The study involved 856 participants aged 75 and older with hypertension. Results indicate that 75% of newly diagnosed patients were prescribed blood thinners to prevent strokes. This highlights Zio's efficacy in identifying undiagnosed AF and its potential role in improving stroke prevention strategies.
iRhythm Technologies (NASDAQ: IRTC) will announce its Q4 and full year 2020 financial results on February 25, 2021, after market close. A conference call will follow at 1:30 p.m. PT/4:30 p.m. ET, providing insights into the company's performance. iRhythm is recognized for its innovative digital healthcare solutions, particularly in cardiac care, utilizing wearable technology and advanced data analytics to enhance arrhythmia detection. This approach aims to improve clinical management and patient outcomes.
iRhythm Technologies, Inc. (NASDAQ: IRTC) has commented on Novitas Solutions' publication of rates for CPT codes 93241, 93243, 93245, and 93247. Following the CMS Calendar Year 2021 Medicare Physician Fee Schedule Final Rule, iRhythm is working with industry participants to establish appropriate pricing. A meeting with Novitas has been requested but not scheduled. The Company believes the new rates are derived from existing codes for electrocardiographic recording. Further updates will be provided as more information is obtained from Novitas.
iRhythm Technologies (NASDAQ: IRTC), a leader in digital healthcare for cardiac care, will present at the 39th Annual J.P. Morgan Healthcare Conference on January 12, 2021, at 2:50 p.m. Eastern Time. The event will be accessible via a live and archived webcast on their website. iRhythm specializes in diagnosing cardiac arrhythmias using advanced wearable biosensor devices and sophisticated data analytics to enhance patient management.
iRhythm Technologies (NASDAQ: IRTC) announced a leadership transition with Kevin King retiring as President and CEO effective January 12, 2021, and Mike Coyle stepping in. Under King's leadership, iRhythm's annual revenue grew from $5 million in 2011 to an estimated $263 million in 2020, with market capitalization increasing from $80 million to over $5.5 billion. King will remain on the board and serve as an advisor. Coyle brings extensive experience from Medtronic, positioned to leverage iRhythm's innovative Zio platform in cardiac care as the company seeks continued growth.
iRhythm Technologies (NASDAQ: IRTC) commented on the CMS 2021 MPFS Final Rule, which was released on December 1, 2020. This rule introduces new Category I CPT codes (93241-93248) for long-term ECG monitoring, replacing previous temporary codes. These codes are expected to increase reimbursement efficiency starting January 1, 2021. iRhythm anticipates widespread adoption of these codes by U.S. payors. However, the CMS did not finalize national pricing for certain ECG-related services, which may impact reimbursement negotiations with contractors.
iRhythm Technologies (NASDAQ: IRTC) has received a positive recommendation for its Zio XT remote cardiac monitoring service from the National Institute for Health and Care Excellence (NICE). This recommendation follows NICE's evaluation of digital health technologies, recognizing Zio XT as a valuable tool for patients with suspected cardiac arrhythmias who require ECG monitoring for more than 24 hours. The guidance highlights Zio XT's convenience, patient compliance, and potential cost savings compared to traditional 24-hour Holter monitoring.
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