Press Release :

Bardy Diagnostics® Announces CE Mark Certification for 14-Day Carnation® Ambulatory Monitor (CAM™) Patch in Europe and Expansion of Home Enrollment Program Amidst COVID-19 Crisis

SEATTLE, May 26, 2020 /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced today it received CE mark certification for the 14-Day version of the Carnation Ambulatory Monitor (“CAM”) patch, the industry’s only P-wave centric ambulatory cardiac patch monitor and arrhythmia detection device. The 14-Day CAM patch provides clinicians greater flexibility to monitor their patients over a longer period and expands the portfolio of existing 2-Day and 7-Day CAM patches currently offered by BardyDx. The 14-Day CAM patch received 510(k) clearance from the U.S. Food and Drug Administration in September 2019 and Health Canada clearance in February 2020.

“CE marking of the 14-Day CAM patch is a significant corporate milestone and a testament to the quality of the CAM patch and BardyDx’s compliance with all applicable European health, safety, performance and environmental requirements,” said Ed Vertatschitsch, Chief Operating Officer.  Ken Nelson, Chief Commercial Officer added, “Along with our Health Canada Medical Device License, the ability to distribute a CE-marked 14-CAM patch outside of the United States is one more step towards our P-wave centric detection and analysis technology becoming the global standard of care in long-term cardiac monitoring.”  The CAM patch is distributed by Dot Medical in the United Kingdomand by JNC Medical in Canada.

The 14-Day CAM patch enables up to double the duration of the current 7-Day CAM patch, providing clinicians a greater opportunity to detect less-frequently occurring arrhythmias and to better inform decisions and prioritize care. The clinical value of the BardyDx P-wave centric detection technology was reported in a study published in the American Heart Journal describing the results of a head-to-head comparison with the iRhythm Zio® XT patch. The study, “Comparison of two ambulatory patch ECG monitors: The benefit of the P-wave and signal clarity,” (Am Heart J 2018; 203:109-117) concluded that the BardyDx CAM Patch identified 40% more arrhythmias and resulted in better, more informed clinical decision-making in 41% of patients as compared to the iRhythm Zio XT patch.

BardyDx also announced the expansion of its Home Enrollment Program. Typically, the CAM patch is applied to a patient in a clinic setting, but the rapidly evolving COVID-19 public health emergency has increased the use of telehealth and direct to patient delivery of remote monitoring devices, particularly in the cardiac monitoring space, to reduce resource burdens on healthcare facilities and risk of exposure of patients and their caregivers to emerging or other infectious diseases.

“We are all fighting the COVID-19 Pandemic together. To help address the evolving needs of physicians and patients in this public health emergency, facilitate the rapid transition to telehealth for clinics around the country and to ensure uninterrupted access to our CAM patch, our team has worked around the clock to increase our manufacturing capacity and expand our internal business operations to enable patients to receive and apply our disposable, single-use CAM patch at home,” said Ken Nelson. Mr. Nelson continued, “The home application program eliminates the need for in-person patient and healthcare provider contact, reduces the potential for exposure to COVID-19, streamlines care, and allows healthcare personnel who are already resource-constrained to focus on other areas of critical need.” The CAM patch is currently used in hospital protocols to help physicians better identify and understand arrhythmias that may be related to COVID-19, including in a number of clinical trials of COVID-19 patients at academic centers across the U.S. who are being treated with Hydroxychloroquine, Azithromycin, or both in order to monitor for QT interval prolongation, which may lead to potentially life threatening cardiac arrhythmias.

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.

About Dot Medical:
Dot Medical is an independent medical device distributor based in the UK serving the fields of Cardiology, Respiration and Airway Management and Cardiac Surgery. The company offers over 300 products with leading edge technology in its total portfolio and provides product training, education and support both in the National Healthcare System (NHS) and private hospitals. Dot’s staff is composed of both sales and clinical training specialists passionate about providing solutions for patient care. The company’s mission is to constantly look for new products which will make procedures easier to perform, locating new technologies which will enhance patient’s lives and bringing solutions to highly technical problems. For more information, please visit http://www.dot-medical.com/

About JNC Medical:
JNC Medical is an independent distributor of medical devices based in Ottawa, Ontario. JNC Medical was established in 2016 with a vision to bring the world’s most innovative device technologies to Canadian physicians and patients. For more information, please visit https://jncmedical.ca/

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Press Release :

Bardy Diagnostics™ Announces Use of The Carnation Ambulatory Monitor Patch to Measure QT Segments in COVID-19 Patients Using Hydroxychloroquine

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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Press Release :

Bardy Diagnostics™ Announces Commercial Launch of the 14-Day Carnation Ambulatory Monitor (CAM) Patch

SEATTLE, Jan. 23, 2020 /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced today the commercial launch of the 14-Day version of the Carnation Ambulatory Monitor (“CAM™”), the industry’s only P-wave centric™ ambulatory cardiac patch monitor and arrhythmia detection device, following recent clearance by the FDA

BardyDx Carnation Ambulatory Monitor (CAM™) - P-wave centric™ ambulatory cardiac patch monitoring and arrhythmia detection (PRNewsfoto/Bardy Diagnostics, Inc.)
BardyDx Carnation Ambulatory Monitor (CAM™) – P-wave centric™ ambulatory cardiac patch monitoring and arrhythmia detection (PRNewsfoto/Bardy Diagnostics, Inc.)

“The 14-Day CAM is the culmination of years of development focused on uncovering the full complexity and meaning of a patient’s cardiac rhythm,” said Gust H. Bardy, MD, Founder and Chief Executive Officer of BardyDx. “We are proud to develop and introduce the most advanced and accurate cardiac monitoring technologies that enable new opportunities to reimagine and redefine patient care.”

The significance of the CAM Patch’s P-wave centric clinical value was highlighted in the American Heart Journal that published the results of a head-to-head comparison with the iRhythm Zio® XT patch, concluding that the BardyDx CAM Patch identified 40% more arrhythmias and resulted in better, more informed clinical decision-making in 41% of patients over the iRhythm Zio XT patch. In addition, a preceding study also published in the American Heart Journal comparing the CAM Patch and a traditional Holter monitor, showed a four times increase in arrhythmia detection using the CAM Patch, including arrhythmias missed or incorrectly identified using the Holter monitor, concluding that the CAM Patch offered significantly improved rhythm diagnostics.

Strong market uptake of BardyDx’s P-wave centric solutions has spurred recent expansion of the company’s infrastructure to maintain its rapid pace. A second ECG monitoring center located in New Jersey was established last quarter, which received Medicare enrollment approval by the Centers for Medicare & Medicaid Services effective December 2, 2019. In addition, BardyDx recently announced the addition of medical device industry veteran, Ed Vertatschitsch, as Chief Operating Office, along with several new vice president appointments to strengthen the Leadership Team.  

“We are extremely proud of the continued momentum of the CAM Patch becoming the cardiac monitor of choice and trusted solution of cardiologists and electrophysiologists across the U.S., U.K., and Canada,” said Ken Nelson, Chief Commercial Officer. “It is increasingly clear that customers are realizing the true clinical and market-differentiating value of our P-wave focused detection technology in enabling optimal patient care.”

The growing market 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 to 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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Bardy Diagnostics™ Names Ed Vertatschitsch as Chief Operating Officer and Announces Additions to the Leadership Team

SEATTLE, Jan. 13, 2020 /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, including the Carnation Ambulatory Monitor (“CAM™”), the only P-wave centric™ ambulatory cardiac patch monitor and arrhythmia detection device, announced today the appointment of Ed Vertatschitsch as Chief Operating Officer effective January 2, 2020. With over 17 years in the medical device industry, Vertatschitsch will be responsible for leading all operations, research & development, and regulatory and quality affairs functions.

BardyDx Carnation Ambulatory Monitor (CAM™) - P-wave centric™ ambulatory cardiac patch monitoring and arrhythmia detection (PRNewsfoto/Bardy Diagnostics, Inc.)

BardyDx Carnation Ambulatory Monitor (CAM™) – P-wave centric™ ambulatory cardiac patch monitoring and arrhythmia detection (PRNewsfoto/Bardy Diagnostics, Inc.)

“We are pleased to have Ed Vertatschitsch join BardyDx’s executive team,” said Gust Bardy, MD, Bardy Diagnostics’ Founder and Chief Executive Officer. “Vertatschitsch brings a wealth of operational and development experience across the spectrum from early-stage to large-sized companies. We are thrilled to have him join our team as we continue to expand our product line and rapidly broaden our customer base.”

Prior to joining BardyDx, Vertatschitsch served as VP of Global Portfolio Solutions, VP of Treatment and Imaging Solutions – Delivery Systems, and General Manager at Varian Medical Systems. Vertatschitsch joined Varian Medial Systems following the acquisition of Calypso Medical, where he was President and CEO. Previously, he also served as EVP Operations and R&D and VP of Engineering at Calypso Medical. Vertatschitsch possesses strong cross-industry development experience, including leadership roles at Palm and Boeing. 

“BardyDx is experiencing accelerating growth with the success of the CAM patch and the development of novel ECG analysis technologies,” said Vertatschitsch. “It is an honor to join Dr. Bardy and the innovative team at BardyDx, and I am excited and eager to help further the company’s success.”

BardyDx also announced today the following additions to its Leadership Team: 

  • Cristina Gutierrez – Gutierrez has been appointed VP of Market Development & Training. She brings cardiac monitoring experience having formerly served as Director of Marketing at iRhythm Technologies. Gutierrez possesses over 19 years of experience and has held senior marketing and sales positions at MedBridge, Athios Health, Velano Vascular, FoxHollow Technologies (acquired by ev3 and Covidien), and Cordis. 
  • Liz Mynhier – Mynhier has been promoted from Sr. Director to VP of Clinical Services & Customer Experience. With over 17 years of experience in cardiology and electrophysiology, Mynhier has managed and grown BardyDx’s ECG monitoring center located in Houston, Texas. Prior to BardyDx, she served in the Cardiac Rhythm Management division at Medtronic and Biotronik. 
  • Brit Baird – Baird has been promoted from Sr. Director to VP of Regulatory Affairs & Quality Assurance. He possesses over 23 years of experience with senior regulatory, quality, and manufacturing roles at EKOS Corporation (a BTG International group company), Pathway Medical Technologies (acquired by Bayer Healthcare), and Boston Scientific.

“I’m thrilled to welcome the newest additions to our Leadership Team,” said Mark Handfelt, Chief Administrative Officer. “I have had the pleasure of working with Vertatschitsch in the past and look forward to working with him again. Our ability to recruit talented people from the outside, while providing opportunities for promotions and career progression within our organization, is a testament to the strength of our products, our management team, and our investors.”

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 patch monitors to 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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Bardy Diagnostics™ Wins the Remote Monitoring in Arrhythmias Digital Health Pitch Session at European Society of Cardiology Congress 2019 and Presents at UK Heart Rhythm Congress 2019

SEATTLE, Oct. 24, 2019 /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced that it was selected as winner of the “Remote Monitoring in Arrhythmias” Technology and Innovation Pitch Session held as part of the Digital Health program at the European Society of Cardiology (ESC) Congress 2019. BardyDx earned this distinction for its Carnation Ambulatory Monitor (CAM™), the only P-wave centric™ ambulatory cardiac patch monitoring and arrhythmia detection device.

BardyDx Carnation Ambulatory Monitor (CAM™) - P-wave centric™ ambulatory cardiac patch monitoring and arrhythmia detection (PRNewsfoto/Bardy Diagnostics, Inc.)
BardyDx Carnation Ambulatory Monitor (CAM™) – P-wave centric™ ambulatory cardiac patch monitoring and arrhythmia detection (PRNewsfoto/Bardy Diagnostics, Inc.)

The pitch event was held on the Digital Health Stage as part of ESC’s focus on highlighting innovative technological applications in the field of e-cardiology and how they are impacting research and clinical practice, including wearable devices, mobile apps, electronic health records, and big data. Over a dozen pitch session events provided selected applicants the opportunity to present on their digital health technology, including categories in artificial intelligence, m-health, wearables, and remote monitoring.

“It is an honor for the CAM patch to be chosen and recognized as one of the best remote cardiac monitoring solutions from among those presenting by an audience of pioneering cardiac physicians and industry thought leaders,” said Ken Nelson, BardyDx Chief Commercial Officer and pitch session presenter. “We are committed to providing optimal P-wave focused digital health solutions that inform the modern-day cardiology practice.” 

In addition, BardyDx Founder and Chief Executive Officer, Gust H. Bardy, MD was invited to speak at Heart Rhythm Congress (HRC) 2019 held at The International Convention Centre in Birmingham, UK. As part of the AF Association Symposia’s “Management of Atrial Fibrillation” Session, Dr. Bardy’s presentation, “The importance of P-Wave centric ECG monitoring analysis,” highlighted the significance of high-fidelity ECG tracings in accurate arrhythmia diagnosis and treatment decisions.

The CAM patch has experienced strong commercial demand due to its proprietary and innovative P-wave centric digital health platform, which provides clinicians diagnostically-accurate data recognized as superior to other patch and Holter monitoring technologies. Also, the CAM patch recently received 510(k) clearance by the U.S. Federal Drug and Administration to extend monitoring duration up to 14 days. The growing market recognition of the innovative P-wave centric CAM patch includes recently being named finalists for the UCSF Digital Health Awards for Best Cardiovascular Digital Diagnostic and the Medtech Insight Awards for Best Technological Diagnostic Innovation & Best Proof-of-Value of an Innovation. Earlier this year, 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 Heart Rhythm Congress

The Heart Rhythm Congress (HRC) 2019 was held in Birmingham, UK during October 6-9th. Organized by Arrhythmia Alliance, HRC provides unrivalled opportunity for health care professionals interested in the management of arrhythmias to share effective practice, showcase innovation, learn about latest developments and network with UK & international delegates. For more information, please visit http://www.heartrhythmcongress.org.

About European Society of Cardiology Congress

The European Society of Cardiology (ESC) Congress 2019 was held in Paris during August 31st to September 4th. This year’s special edition of ESC Congress was held in conjunction with the World Congress of Cardiology with a spotlight on Global Cardiovascular Health, highlighting differences in prevalence, clinical manifestations, prevention strategies, diagnostic modalities and management of cardiovascular diseases around the world. The congress focuses on the best and latest science with renowned leaders in cardiovascular medicine. The five-day conference showcased over 500 sessions with an estimated 30,000 delegates – the largest such gathering in the world. For more information, please visit https://www.escardio.org/Congresses-&-Events/ESC-Congress.

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 patch monitors to 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 design. Designed to be worn comfortably and discreetly, 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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Bardy Diagnostics™ Receives FDA 510(k) Clearance for 14-Day Carnation Ambulatory Monitor (CAM) Patch

SEATTLE, Sept. 6, 2019 /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced today it received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for the 14-Day version of the Carnation Ambulatory Monitor (“CAM™”), the industry’s only P-wave centric™ ambulatory cardiac patch monitor and arrhythmia detection device. Developed to provide clinicians greater flexibility in cardiac monitoring over a longer period, the award-winning CAM patch will now be offered in a 14-day extended wear version that utilizes the same innovative P-wave focused technology that powers the existing 2-Day and 7-Day CAM product lines.

BardyDx Carnation Ambulatory Monitor (CAM™) - P-wave centric™ ambulatory cardiac patch monitoring and arrhythmia detection (PRNewsfoto/Bardy Diagnostics, Inc.)
BardyDx Carnation Ambulatory Monitor (CAM™) – P-wave centric™ ambulatory cardiac patch monitoring and arrhythmia detection (PRNewsfoto/Bardy Diagnostics, Inc.)

“Comfortable dermal ECG recordings that focus on the P-wave for up to 14 days carry the potential to minimize use of costly additional rhythm diagnostic tools,” said Gust H. Bardy, MD, Founder and Chief Executive Officer of BardyDx. “We are excited to receive clearance from the FDA to enable clinicians the option to monitor longer and anticipate incremental detection of accurate, medically actionable data to improve patient management.”

The CAM patch’s breakthrough technology reliably detects and records the P-wave, a small amplitude signal of the ECG originating in the atrium that is essential to accurate arrhythmia diagnosis and patient management. Unlike other commercially available patches that include licensed, acquired, or off-the-shelf technologies, the CAM was specially engineered by BardyDx engineers for optimal detection and recording of the P-wave in relation to the rest of the ECG signal to deliver industry leading diagnostic accuracy. The critically acclaimed disruptive technology has been well-received by clinicians, particularly for its ease of use and workflow-friendly design, which allows patients to mail the device back for analysis or the physician office to upload data from a patient’s monitor within several minutes upon completion of a study.

The new 14-Day CAM patch enables up to double the duration of P-wave optimized detection and monitoring over the current 7-Day CAM patch, potentially discovering additional, less-frequent arrhythmias. The clinical value of P-wave focused detection was highlighted in the American Heart Journal that published the results of a head-to-head comparison with the iRhythm Zio® XT patch. The study, “Comparison of two ambulatory patch ECG monitors: The benefit of the P-wave and signal clarity,” (Am Heart J 2018; 203:109-117) 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.

In addition, a preceding study comparing the BardyDx CAM patch and a traditional Holter monitor, entitled “Comparison of diagnostic value using a small, single channel, P-wave centric sternal ECG monitoring patch with a standard 3-lead Holter system over 24 hours,” (Am Heart J 2017; 185:65-73) 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 diagnosis and avoided inaccurate diagnoses made using a Holter monitor.

“Combining the excellence of our proven P-wave technology with the capability of longer duration monitoring produces an unmatched cardiac monitoring solution,” said Ken Nelson, BardyDx Chief Commercial Officer. “We are excited to offer a 14-Day CAM patch that truly provides value for clinicians and patients alike.”

The innovative P-wave centric CAM patch continues to distinguish itself in an increasingly crowded market of cardiac monitoring patch entrants. Recently, BardyDx was 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. Also, BardyDx has been recently named the winner of the Impact Pediatric Health Competition hosted by the nation’s leading pediatric healthcare institutions at SXSW 2019 for the CAM’s unique pediatric-friendly design and potential to address significant unmet needs in pediatric healthcare. In addition, BardyDx was also selected as the winner of the 2018 Fierce Innovation Life Sciences Award for Medical Device Innovation from the leading industry publisher of FierceBiotech & FiercePharma.

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 patch monitors to 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 design. Designed to be worn comfortably and discreetly, 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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Bardy Diagnostics™ Selected As Finalist For Two MedTech Insight Awards To Be Announced At AdvaMed’s Annual MedTech Conference

Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced that Informa Pharma Intelligence, a leading international healthcare intelligence consultancy, has recognized BardyDx as a finalist in two categories for the 2nd Annual Medtech Insight Awards for “Best Technical Innovation: Diagnostics” and “Best Proof-of-Value of an Innovation”. BardyDx earned these distinctions for its Carnation Ambulatory Monitor (CAM™), the only P-wave centric™ ambulatory cardiac patch monitoring and arrhythmia detection device.

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