BELLEVUE, WA — July 29, 2021– A recent clinical study from Overlake Medical Center utilizing the Bardy Diagnostics Carnation Ambulatory Monitor (CAM) patch was presented at the 2021 Heart Rhythm Society (HRS) Conference. The abstract, “Accelerating Proper Evaluation of Emergency Department Patients for Arrhythmia Concerns with Discharge Use of ECG Patch Monitors,” authored by Marie Yabut, Sarahi Gomes-Duarte, MA., and Eric Shipley, MD, MBA., explores the role of the CAM ECG monitor as a solution for outpatient evaluation after presenting symptoms of cardiac arrhythmias with an inconclusive diagnosis in the emergency department. The decision to either admit or discharge patients for outpatient evaluation is typically arbitrary and there are few alternatives. The abstract concludes that emergency department adoption of ECG monitoring provided an alternative to hospital admission while providing a diagnosis 3 times sooner than average and dramatically reducing return visits to the emergency department.

By utilizing the CAM patch on 412 patients over the 2-year period, the average time of emergency department discharge to diagnosis was 7 days compared to the previous average of 21 days. In addition, emergency department readmissions within 30 days of the initial visit decreased to 7% of study patients compared to readmission of 40% of patients who had the same type of cardiac complaints in the year prior to CAM patch availability.

According to Yabut, using the CAM patch in the emergency department was crucial in providing care for patients with cardiac arrhythmia symptoms occurring outside of normal clinic operating hours. “In the process of this study, we discovered that most patients discharged with the patch occurred outside clinic hours. The availability of the patch in the emergency department benefitted patients who would have otherwise been discharged without a cardiac monitor.” Without application of the CAM patch in the emergency department, patients may experience a substantial waiting period until receiving diagnostic results and proper care.

The study also revealed that using the CAM patch as a point of care solution in the emergency department resulted in new patient referrals to the cardiology/EP department. Between 2018 and 2020, 369 patients were discharged with the CAM patch from the emergency department, and 57 of those patients were then established as cardiac patients. Additionally, 209 patients in the study had no prior cardiology care and were new referrals to Overlake Medical Center’s cardiology/EP department. Due to the diagnostic capabilities of the CAM patch, 178 patients either received further diagnostic testing or a cardiac procedure.

Bardy Diagnostics will be showcasing their CAM patch technology at the 2021 Heart Rhythm Society (HRS) conference in Boston and participating in the conference both virtually and in-person with an exhibitor booth offering visitors an opportunity to explore clinical case studies, experience a new interactive arrhythmia challenge, view a product demo, and discuss clinical issues and trends with the founder of Bardy Diagnostics, Gust H. Bardy, MD. Visit booth #760 at HRS or go to www.bardydx.com/hrs2021.

 

 

Source:

Yabut, M., Gomez-Duarte, S. & Shipley, E. (2021, February 11). Accelerating Proper Evaluation Of Emergency Department Patients For Arrhythmia Concerns With Discharge Use Of ECG Patch Monitors. Overlake Medical Center, Bellevue, WA; cOASIS, The Online Abstract Submission and Invitation System.

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.

 

About Overlake Medical Center & Clinics

Overlake Medical Center & Clinics is a nonprofit regional healthcare system based in Bellevue serving the Eastside community since 1960. The health system includes a 349-bed hospital and a growing network of primary, urgent and specialty care clinics located throughout the region. Overlake is recognized locally and nationally for quality and safety, including recurring Leapfrog A ratings and Healthgrades’ Patient Safety Excellence Award in 2019 and 2020. Overlake offers comprehensive advanced services including a dedicated Cancer Center, Level lll Trauma Center, Childbirth Center and Level lll NICU, cardiac, neurosciences, orthopedic and mental health services. As part of Overlake’s commitment to deliver high-quality care and exceptional patient experience for the Eastside community, Overlake collaborates with EvergreenHealth in cardiac services, neurosciences and quality, and with Seattle Cancer Alliance for cancer services. Overlake employs more than 3,000 and is dedicated to its mission of compassionate care for every life it touches. Overlake provided nearly $48 million in charity care over the last three years and is committed to providing exceptional patient care and services. For more information, visit overlakehospital.org.

 

About Heart Rhythm 2021

The Heart Rhythm Society’s annual meeting attracts more than 6,000 of the world’s finest clinicians, scientists, researchers, and innovators in the field of cardiac pacing and electrophysiology. Heart Rhythm 2021 attendees were able to determine how to participate – virtually or in-person. More than 600 international experts in the field will serve as faculty for programing that includes Daily Plenary Sessions, Late-Breaking Clinical Trials, Recorded Cases, Debates, Rhythm Theater Presentations and more, while over 100 exhibitors will showcase innovative products and services.

 

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(Seattle, WA – November 17, 2020) – Chief Medical Officer of Bardy Diagnostics and Clinical Professor of Medicine University of Washington Professor Gust H. Bardy sat down with Trudie Lobban, MBE, Founder and CEO of Arrhythmia Alliance, a non-profit organization dedicated to improving the diagnosis, treatment, and quality of life for all those affected by arrhythmias, to discuss the intricacies of heart arrhythmias (irregular heart rhythm disorders) and the importance of early detection in a patient-facing educational video series.  The videos, spanning topics including information about arrhythmias, the importance of regular heart monitoring, various devices in the market, and the treatment differences between using a pacemaker, an ICD, or an S-ICD, bring awareness of these often overlooked but potentially deadly heart conditions.

“We are delighted that Professor Bardy has partnered with us in this important educational video series, which will help increase awareness about arrhythmias, detection, and information about available treatments for people with arrhythmias,” said Lobban.

“I’ve treated arrhythmia patients since 1982.  Sometimes arrhythmias are minor. Sometimes they are life-threatening. People over 50 are more likely to have serious arrhythmias, but it can happen in very young people too. It is wise to always pay attention to our hearts as heart problems are a major and common cause of disability and premature death.  We commonly get annual blood tests to check for cholesterol levels or diabetes, but we also should have annual tests of our heart rhythms as well, especially in our older years,” said Professor Bardy.

Arrhythmias affect millions of Americans every year, and the most dangerous arrhythmia, ventricular tachycardia, can cause sudden cardiac death, affecting approximately a half million people annually in the United States[1]. Equally serious is the fact that over 2 million people have known atrial fibrillation[2] and many more have episodic asymptomatic atrial fibrillation.  Atrial fibrillation carries a significant risk of stroke whether the patient has symptoms or not.

Consequently, screening for atrial fibrillation with ambulatory monitors is critical to help avoid stroke and to reduce the associated stroke-related costs that burden the healthcare system.  “That said, there are many disorders that appear to be Atrial Fibrillation but are, in fact, not atrial fibrillation even though they superficially appear to be.  Medical grade monitors with a high specificity for differentiating these various atrial fibrillation-like disorders from true atrial fibrillation is critical.  One should not rely upon commercial monitors in this case.  Moreover, several other serious arrhythmias can coexist with atrial fibrillation.  Discerning the difference between these various atrial arrhythmias requires a medical grade ECG monitor.  Commercial devices often focus on an irregular rhythm and casually presume the diagnosis of atrial fibrillation, unaware of the myriad arrhythmias that can masquerade as atrial fibrillation,” said Professor Bardy.

The problem of cardiac arrhythmias does not merely affect those in middle age or advanced age.  There are an estimated 2 million people living with congenital structural heart disease (CHD) in the United States[3], many of whom are in their 20’s and 30’s. People with CHD often develop arrhythmias as young adults.  Per Professor Bardy, such individuals, as well as those with known underlying heart disease should consider cardiac monitoring.  Those over the age of 60 regardless of health status would probably benefit from a heart rhythm evaluation just as they do other periodic checks of their health, like blood pressure, cholesterol, mammography, glucose, etc.  Lobban and Professor Bardy are working hard to bring public awareness and early detection to save lives and improve quality of lives due to irregular heart rhythm disorders.  To learn more, visit https://www.bardydx.com/about-arrhythmias/ and https://www.heartrhythmalliance.org/aa/us/videos

 

About Gust H. Bardy, M.D.

Dr. Bardy has been a cardiac electrophysiologist since 1983 with research interests in cardiac defibrillator technology, cardiac arrest, ablation, heart failure and atrial fibrillation from both a public health and a technological perspective. He has been a researcher and clinician in the field of sudden death and disabling cardiac rhythm disorders for 38 years with over 400 peer-reviewed publications. Dr. Bardy has also developed technological solutions to patient rhythm related problems with over 280 U.S. patents issued, all of which have been incorporated in cardiac rhythm management technologies in use by many medical device companies. Dr. Bardy’s previous company, Cameron Health, was successfully acquired by Boston Scientific in 2012 for its revolutionary Subcutaneous Implantable Defibrillator (S-ICD) product. In addition to serving Bardy Diagnostics, Dr. Bardy holds a faculty position as Clinical Professor of Medicine, Cardiology at the University of Washington.

 

About Arrhythmia Alliance

ARRHYTHMIA ALLIANCE – Working together to improve the diagnosis, treatment, and quality of life for all those affected by arrhythmias. Arrhythmia Alliance is a coalition of patients, caregivers, patient groups, healthcare professionals and organizations and allied professionals working together to improve the detection, diagnosis, and treatment for all those affected by cardiac arrhythmias. By raising awareness and campaigning for the improved detection and care of heart rhythm disorders, Arrhythmia Alliance aims to extend and improve the lives of the millions around the world that these conditions affect. For more information go to www.heartrhythmalliance.org

 

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.

 

[1] https://www.heart.org/en/health-topics/heart-attack/about-heart-attacks/heart-attack-or-sudden-cardiac-arrest-how-are-they-different

[2] https://www.heart.org/en/health-topics/atrial-fibrillation/what-is-atrial-fibrillation-afib-or-af

[3] https://www.cdc.gov/ncbddd/heartdefects/data.html

Seattle, WA – September 8, 2020 – Bardy Diagnostics, Inc., (“BardyDx”), a leading developer and provider of remote ambulatory cardiac monitoring and digital health solutions, announced today the appointment of Kevin Hykes as President and Chief Executive Officer, effective August 31, 2020. Hykes will also become a member of BardyDx’s Board of Directors. With over 28 years of experience in the medical device industry, Hykes will be responsible for leading the development and execution of short- and long-term business and financial strategies and managing the overall operations of BardyDx.

Gust H. Bardy, M.D., founder and Chairman of BardyDx, commenting on the appointment said “I’m very excited and pleased to have Kevin join our executive team as President and CEO. I’ve had the privilege of working with Kevin when he was CEO of the last company I founded, Cameron Health, where he led the global commercialization of the subcutaneous implantable cardioverter defibrillator and ultimately our successful sale to Boston Scientific.  I am looking forward to transitioning into my new role as Chief Medical Officer and Chief Innovation Officer and turning day-to-day management of the company over to Kevin as we continue to experience tremendous growth in the adoption of our CAM^® P-wave centric patch as the new standard of care in ambulatory cardiac monitoring devices.”

Prior to joining BardyDx, Hykes held operational roles in numerous venture-backed medical device companies including serving as the President and CEO of Relievant Medical Systems, Metavention, Inc. and Cameron Health.  Hykes has also been an Operating Partner at both Revival Healthcare Capital and Versant Ventures and currently serves as an independent director at Veran Medical Systems and Metavention, Inc. Earlier in his career, Hykes spent sixteen years at Medtronic where he held leadership positions in the CRM, Neurostimulation and Cardiac Surgery business in the United States and Europe.

“It’s an honor to join the outstanding team at Bardy Diagnostics and to build upon the significant momentum that the company has established in the marketplace with its best in class ambulatory ECG monitoring and analysis technology,” said Hykes.  “The demonstrated clinical superiority of Bardy Diagnostics’ P-wave centric technology uniquely positions the company to capitalize on the growing interest in remote patient monitoring for patients with chronic health conditions.”

Warren Watson, a Bardy Diagnostics’ board member, continued “I’ve worked with Kevin at multiple points over the last 20 years and I’m pleased to welcome him to Bardy Diagnostics.  Kevin’s extensive experience leading venture-backed medical device companies and his successful track record commercializing breakthrough technologies on a global basis will be instrumental in taking the company to the next level in its growth trajectory.”

 

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.

 

MEDIA CONTACT:

Mark Handfelt

Chief Administrative Officer

Bardy Diagnostics, Inc.

1-844-422-7393

mhandfelt@bardydx.com

 

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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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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. 

“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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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.)

“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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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.

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 6-9^th. 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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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.

“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, 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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