iRhythm Technologies  

650 Townsend St
Suite 500
San Francisco,  CA  94103

United States
888-693-2401
https://www.irhythmtech.com

• Booth: 1413

Profile

iRhythm Technologies is a digital health company redefining the way cardiac arrhythmias are diagnosed and managed. Zio by iRhythm is a unique cardiac monitoring service that facilitates high patient compliance and continuous ECG recording up to 14 days through simple and elegant design — enabling doctors to diagnose with certainty after a single test. Backed by over 25 clinical studies, the Zio service helps doctors confidently rule in and rule out arrhythmias, enabling more informed decision making and more precise clinical management. Zio by iRhythm reveals a clear path forward to what clinicians and patients need most — answers. For more information, please visit irhythmtech.com.

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 Press Releases

• Research Published in Nature Medicine Demonstrates the Promise of Algorithm-Based Ambulatory Cardiac Monitoring (Feb 25, 2019)
  Collaboration produces advanced artificial intelligence capable of expert-level arrhythmia detection

  SAN FRANCISCO, Jan. 07, 2019 (GLOBE NEWSWIRE) -- iRhythm Technologies, Inc. (NASDAQ: IRTC), a leading digital health company focused on the advancement of cardiac care, announced the publication of a new study in the January 2019 edition of Nature Medicine showing expert-level detection of cardiac arrhythmias using a new deep learning, or artificial intelligence, approach for electrocardiogram (ECG) analysis across a variety of diagnostic classes. The findings come from a collaboration with the Stanford Machine Learning Group that has resulted in the development of a cutting-edge deep learning model capable of arrhythmia detection at a level comparable to a panel of expert cardiologists for a total of 12 output classes. The study is titled, Cardiologist-Level Arrhythmia Detection in Ambulatory Electrocardiograms with Deep Neural Networks.

  The collaboration leveraged the iRhythm data science and clinical teams’ expertise in ECG analysis and the company’s proprietary and diversely labeled ECG data set to produce an arrhythmia detection algorithm delivering expert-level classification performance. To date, this is the only model published and shown to reliably detect and label 10 cardiac arrhythmias, as well as distinguish sinus rhythm and noise from artifact, for a total of 12 output classes, potentially giving clinicians a more comprehensive understanding of their patients’ heart rhythms. By applying these sophisticated algorithms to the vast amounts of data captured by continuous ECG monitors, this approach has the potential to increase the accuracy of physician diagnosis and improve the efficiency of expert-human ECG interpretation, so physicans can spend their limited time and resources focused on getting patients the right care.

  "As powerful, deep learning algorithms become available for cardiac care, it’s important for the medical community to become more discerning about the overall quality of the algorithms that power the analytical tools we use", said Dr. Martin Maron, Director of the Hypertrophic Cardiomyopathy Center at Tufts Medical Center. "Not all algorithms perform equally and we need to educate ourselves on the sophistication and accuracy of those we rely on to drive our clinical decision-making. The results of iRhythm’s collaboration with Stanford is the first time an artificial intelligence model has been able to successfully detect and label these many arrhythmias, showing great promise for the future of arrhythmia diagnosis and care. An ongoing commitment to advancements in data analysis is critical to improving patient care."

  The study results represent the significant effort to evaluate algorithm performance compared to a set of board-certified practicing cardiologists and referenced against a consensus committee of cardiology experts. The publication expands and validates the researchers’ previous findings around the performance of the algorithm, a 34-layer Deep Neural Network, which learned from 91,232 ECG records collected from 53,549 unique patients using the Zio by iRhythm ambulatory continuous cardiac monitoring device. This is the first time a model was developed across this number of arrhythmia classes with a data set of this size.  

  "Since our company’s inception we have been committed to advancing scientific discovery and methods that improve arrhythmia detection and analysis for better patient care.  We are delighted that the Nature Medicine findings expand further our leadership in ECG analysis", said Kevin King, Chief Executive Officer of iRhythm Technologies, Inc. "We believe iRhythm’s state-of-the-art deep learning techniques, coupled with quality assurance by our human experts, will augment physicians’ ability to reach a confident diagnosis quickly and will be an important part of the future of health care delivery."

  You can learn more about the study at www.irhythmtech.com/ai.  

  About iRhythm Technologies, Inc. 
  iRhythm is a leading digital health care company redefining the way cardiac arrhythmias are clinically diagnosed. The company combines wearable biosensor devices worn for up to 14 days and cloud-based data analytics with powerful proprietary algorithms that distill data from millions of heartbeats into clinically actionable information. The company believes improvements in arrhythmia detection and characterization have the potential to change clinical management of patients.

  Investor Relations Contact
  Lynn Pieper Lewis or Leigh Salvo
  (415) 937-5404
  investors@irhythmtech.com
  
  Media Contact
  Cherise Adkins  
  (415) 486-3235
  media@irhythmtech.com

• Study Results Show Zio by iRhythm Improves Detection of Asymptomatic Atrial Fibrillation in At-Risk Population (Feb 25, 2019)
  Results of first of its kind clinical study published in JAMA

  SAN FRANCISCO, July 10, 2018 (GLOBE NEWSWIRE) -- iRhythm Technologies, Inc.(NASDAQ:IRTC), a leading digital health care solutions company focused on the advancement of cardiac care, today announced that results of the mHealth Screening to Prevent Strokes (mSToPS) study, which showed increased detection of asymptomatic atrial fibrillation (AF) in high-risk individuals using Zio by iRhythm, have been published in the Journal of the American Medical Association (JAMA).

  Utilizing an innovative home-based study design, electrocardiogram (ECG) recording and analysis were carried out using the FDA-cleared Zio by iRhythm ambulatory continuous monitoring patch to evaluate detection of asymptomatic AF, also known as silent AF. At one-year, primary results showed that AF was newly diagnosed in 6.7 percent of patients who were actively monitored by the Zio service versus 2.6 percent in the observational control group receiving routine care. In addition, 4.0 percent of patients in the Zio monitored group were found to have potentially actionable arrhythmias other than AF including ventricular tachycardia, pause, AV block, and symptomatic supraventricular tachycardia.

  Researchers at the Scripps Translational Science Institute (STSI) conducted the study in partnership with collaborators, Aetna and Janssen Pharmaceuticals.

  Our study shows an almost threefold improvement in the rate of diagnosis of AF in those actively monitored compared to usual care, said Steven Steinhubl, MD, director of digital medicine at STSI and an associate professor at The Scripps Research Institute (TSRI). Diagnosing AF more effectively can enable the initiation of effective therapies and help reduce strokes and death.

  Monitoring with Zio led to significant change in clinical treatment of the actively monitored group including initiation of anticoagulation therapies (5.7 percent), antiarrhythmic medications (0.8 percent), and pacemaker placement (0.8 percent). Patients receiving anticoagulation for AF appeared to fulfill current clinical guidelines for appropriateness and need. Mean wear time for the Zio patch was 12 days with 98 percent analyzable ECG data.

  Studies like mSToPS play a significant role in defining at-risk patient populations that can benefit from extended continuous cardiac monitoring, ultimately resulting in more accurate and efficient AF diagnoses, said Judy Lenane, RN, MHA, executive vice president of operations and chief clinical officer of iRhythm. Publication of the mSToPS study in JAMA further reinforces the important role Zio by iRhythm plays in the advancement of cardiovascular research, while having a practical, real-world impact on patient outcomes.

  The study involved 5214 eligible Aetna members who were identified through claims data to have risk factors for AF but had not been previously diagnosed. One-third of individuals were enrolled via a web-based platform to undergo either immediate or delayed active ECG monitoring at home for up to 4 weeks with a Zio XT patch monitor (two-week monitoring periods spaced four months apart). Each monitored participant was matched with two non-monitored participants with a similar CHA2DS2-VASc, a standardized stroke-risk assessment score, to act as controls. The study looked at time to first diagnosis of AF and its clinical consequences for the active monitoring cohort as well as the cohort undergoing usual care.

  Utilizing the digital Zio monitoring service by iRhythm enabled the team to approach a large, geographically diverse population of at-risk individuals and include people who otherwise may have no access to participation in clinical trials because they do not live close to a research center.

  This study demonstrates the utility of a digital approach not only to diagnosing asymptomatic AF, but to the clinical research field as a whole, said Steinhubl. We hope that it will set a precedent for future real-world, participant-centric clinical trials that leverage the power of digital medicine technologies.

  STSI’s founder and director Eric Topol, MD, also a TSRI professor, added that, For clinical research to change practice it needs to be more participant focused and reflect the real world of those participants, by taking advantage of digital tools and infrastructure that is possible as never before, says Topol.

  About Atrial Fibrillation

  Atrial fibrillation (AF or AFib) is a quivering or irregular heartbeat, also known as an arrhythmia, which can lead to blood clots, stroke, heart failure and other heart-related complications.

  Normally, your heart contracts and relaxes to a regular beat. In AF, the upper chambers of the heart (the atria) beat irregularly instead of beating effectively to move blood into the ventricles.
  
  AF is associated with a five-fold increase in the risk of stroke, with these strokes tending to be more severe and associated with higher mortality.¹ However, approximately one-third of those who have AF are not aware that they have it.² Asymptomatic AF is referred to as being silent and there are certain risk factors like high blood pressure, diabetes and sleep apnea that increase an individual’s likelihood for developing it.

  You can learn more about the study and silent AF at www.SilentAF.com.

  About iRhythm Technologies, Inc. 
  iRhythm is a leading digital health care company redefining the way cardiac arrhythmias are clinically diagnosed. The company combines wearable biosensor devices worn for up to 14 days and cloud-based data analytics with powerful proprietary algorithms that distill data from millions of heartbeats into clinically actionable information. The company believes improvements in arrhythmia detection and characterization have the potential to change clinical management of patients.

  ¹Circulation. 2017;135:00–00. DOI: 10.1161/CIR.0000000000000485. Heart Disease and Stroke Statistics—2017 Update.
  ²Friberg L, Rosenqvist M, Lindgren A, Terént A, Norrving B, Asplund K. High prevalence of atrial fibrillation among patients with ischemic stroke. Stroke 2014;45:2599-605.

  Investor Relations Contact
  Lynn Pieper Lewis or Leigh Salvo
  (415) 937-5404
  investors@irhythmtech.com
  
  Media Contact
  Cherise Adkins  
  (415) 486-3235
  media@irhythmtech.com

• JAMA Cardiology publishes RHYTHM Study Revealing Link Between Total AF Burden and Stroke Risk (Feb 25, 2019)
  Zio by iRhythm’s extended continuous cardiac monitoring capabilities enabled measurement of True AF Burden™

  SAN FRANCISCO, May 16, 2018 (GLOBE NEWSWIRE) -- iRhythm Technologies, Inc.(NASDAQ:IRTC), a leading digital health care solutions company focused on the advancement of cardiac care, today announced results of a study which utilized Zio by iRhythm, an extended continuous cardiac monitoring system, to provide a comprehensive picture of the burden of atrial fibrillation (AF) in patients. Utilizing this data in combination with electronic health record data, the researchers concluded that an increase in the burden of atrial fibrillation (AF) is independently associated with a higher risk of ischemic stroke and arterial thromboembolism in patients who are not taking anticoagulant medication. The findings have been published in JAMA Cardiology.

  The study, the Kaiser Permanente Real-World Heart Monitoring Strategy Evaluation Treatment Patterns and Health Metrics in Atrial Fibrillation (KP-RHYTHM) study, derived its findings from a retrospective cohort of 1,965 patients at two large integrated health care delivery systems who underwent up to 14 days of continuous ambulatory electrocardiogram (ECG) monitoring using Zio by iRhythm and were found to have paroxysmal (intermittent) AF. By using Zio by iRhythm to measure heart rhythm, the researchers were able to overcome limitations of previous studies which only looked at patients undergoing cardiac monitoring via invasive and expensive devices.  

  True AF burden™, as detected and measured by the Zio Service, gives physicians a comprehensive understanding of the amount of time a patient’s heart spends in AF over the extended monitoring period given Zio’s longer wear time and ability to bridge AF episodes that may be separated by noise or artifact. The results of the study show that the total burden of AF was the key indicating factor for stroke risk, as opposed to longer individual AF episodes with smaller overall burden. The results show that an AF burden lasting more than 11% of the total time their heart rhythm was monitored was found to be associated with a 3-fold increase in stroke risk, independent of other known risk factors in those patients.

  There is an emerging recognition of the importance of AF burden as a potentially better measure of stroke risk, which is underscored by the recent AHA Scientific Statement ‘Atrial Fibrillation Burden: Moving Beyond Atrial Fibrillation as a Binary Entity’, said Dr. Elsayed Z. Soliman Professor and Director, Epidemiological Cardiology Research Center, Wake Forest University School of Medicine, Winston Salem, NC. Studies like the KP-RHYTHM study demonstrate how advances in cardiac monitoring technology enhance our understanding of AF burden, which could help improve the current standards of care and improve patient outcomes.

  Strokes associated with AF tend to be more severe and are associated with higher mortality. By providing a deeper understanding of the link between burden of AF with risk of stroke, this study can have a direct impact on clinical decision making to prevent stroke, as it provides another stroke risk indicator that physicians can evaluate and share with their patients while discussing stroke prevention.

  We are proud that Zio by iRhythm’s extended continuous cardiac monitoring capability coupled with our algorithm’s ability to bridge AF episodes allowed the researchers to develop new insights, as it gave the researchers a more comprehensive picture of AF burden than has been available previously, said Judy Lenane, RN, MHA, Executive Vice President of Operations and Chief Clinical Officer of iRhythm and one of the authors of the study. This study adds to the growing body of research showing Zio by iRhythm has practical implications for clinical care. It is an important tool that helps physicians achieve certainty in a single test and accelerates care for their patients.

  The research was led by Dr. Alan Go, Chief, Cardiovascular and Metabolic Conditions Research at Kaiser Permanente. JAMA Cardiology is a peer-reviewed journal dedicated to publishing exceptional original research, state-of-the-art reviews, and informative opinion that will advance the science and practice of cardiology, enhance cardiovascular health, and inform health care policy.

  You can learn more about the study and AF burden at www.AFBurden.com.  

  About iRhythm Technologies, Inc. 
  iRhythm is a leading digital health care company redefining the way cardiac arrhythmias are clinically diagnosed. The company combines wearable biosensor devices worn for up to 14 days and cloud-based data analytics with powerful proprietary algorithms that distill data from millions of heartbeats into clinically actionable information. The company believes improvements in arrhythmia detection and characterization have the potential to change clinical management of patients.

  Investor Relations Contact
  Lynn Pieper Lewis or Leigh Salvo
  (415) 937-5404
  investors@irhythmtech.com
  
  Media Contact
  Cherise Adkins  
  (415) 486-3235
  media@irhythmtech.com

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