Seattle, WA — March 25, 2020 — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced today that its Carnation Ambulatory Monitor (“CAM™”) Patch has been chosen for use in protocols to measure QT Segments in COVID-19 patients who have been prescribed Hydroxychloroquine (HCQ).
BardyDx’s CAM Patch will be utilized in newly established protocols at hospitals across the Seattle, Washington area to monitor cardiac rhythms for COVID-19 patients on HCQ after hospital discharge, as well as for outpatients. HCQ has been demonstrated, in certain populations, to prolong the QT interval, resulting in a potentially lethal arrhythmia called Torsades de Pointes. The unique ability of the BardyDx CAM Patch to detect and record low frequency, low amplitude cardiac rhythms is especially valuable in measuring QT intervals and diagnosing Torsades de Pointes.
“The world is currently at war against the COVID-19 virus and we are proud that the CAM Patch is being used in that fight to help physicians better identify and understand any arrhythmias, or other cardiac irregularities, that may be related to use of HCQ in COVID-19 patients, as well as how any potential COVID-19 vaccines might impact cardiac function,” said electrophysiologist Gust Bardy, M.D., the founder, CEO, and Chief Medical Officer of BardyDx.
A head-to-head peer-reviewed clinical study published in the American Heart Journal comparing the CAM Patch and a traditional Holter monitor, demonstrated that QT, PR and QRS intervals measured by the CAM Patch correlated with measurements taken by a traditional 3-channel (6-lead) Holter monitor, resulting in correlation coefficients of 0.94, 0.93, and 0.86, respectively. In addition, the study showed a four-times increase in arrhythmia detection using the CAM Patch, including arrhythmias missed or incorrectly identified using the Holter monitor. The study concluded that the CAM Patch offered significantly improved rhythm diagnostics as compared to a traditional Holter.
The clinical value of the CAM Patch’s P-wave centric engineering was also demonstrated in a head-to-head peer-reviewed clinical study comparing the CAM Patch to iRhythm’s Zio® XT patch. That study, also published in the American Heart Journal, concluded that the BardyDx CAM Patch identified 40% more arrhythmias and resulted in better, more informed clinical decision-making in 41% of patients compared to the iRhythm Zio XT patch.
“The CAM Patch is quickly becoming the new standard of care in cardiac monitoring and the trusted cardiac monitor of choice by electrophysiologists, cardiologists, and other physicians across the U.S., U.K., and Canada,” said Ken Nelson, Chief Commercial Officer. “It is increasingly clear that physicians and patients are realizing the true clinical- and market-differentiating value of our P-wave focused detection technology in optimizing patient care and clinic workflow.”
The growing recognition of the innovative P-wave centric CAM Patch includes recently being selected as winner of the Remote Monitoring in Arrhythmias Digital Health Pitch Session at European Society of Cardiology Congress 2019 and finalist of the UCSF Digital Health Award for Best Cardiovascular Digital Diagnostic. In addition, BardyDx was also named the winner of the 2019 MedTech Breakthrough Award for Best New Diagnostic Technology and the winner of the 2019 Frost & Sullivan Award for Technology Innovation in Remote Cardiac Monitoring.
About Bardy Diagnostics:
Bardy Diagnostics, Inc. is an innovator in digital health and remote patient monitoring, with a focus on providing the most diagnostically-accurate and patient-friendly cardiac monitors in the industry. The company’s CAM Patch is a non-invasive, P-wave centric™ ambulatory cardiac monitor and arrhythmia detection device that is designed to improve patient compliance for adults and children through its lifestyle-enabling form factor. Designed to be worn comfortably and discreetly for up to 14 days, the female-friendly, hourglass-shaped CAM Patch is placed on the center of the chest, directly over the heart for optimum ECG signal collection. The proprietary technology of the CAM Patch provides optimal detection and clear recording of the often difficult-to-detect P-wave, the signal of the ECG waveform that is essential for accurate arrhythmia diagnosis. For more information, please visit www.bardydx.com.
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