SEATTLE, Sept. 26, 2018 /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, including the Carnation Ambulatory Monitor (“CAM™”), the world’s first P-wave centric™ ambulatory cardiac monitor and arrhythmia detection device, announced it was selected as one of six winners of the “Make Your Medical Device Pitch for Kids!” Competition hosted by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System.

Eleven finalists from a field of 45 worldwide submissions were selected to present their products this past weekend at the Sixth Annual Pediatric Device Innovation Symposium. A distinguished judging panel of industry experts awarded BardyDx a $25,000 prize based on the CAM patch’s pediatric-friendly design, innovative P-wave centric technology, and potential to address significant unmet needs in pediatric healthcare.

“BardyDx is excited to receive this award and this honor reinforces our commitment to the advancement of pediatric cardiology care,” said Ken Nelson, BardyDx Chief Commercial Officer. “The CAM patch is one of only a few FDA-approved products that is commercially available for patients weighing 10 kg (22 lbs) or more. This award prize will be used towards development efforts to expand our labeling to cover all of pediatrics and make the CAM patch the gold-standard for pediatric ambulatory cardiac monitoring.”

The competition is one of the highlights of this year’s symposium, themed “Using Real-World Evidence to Drive Pediatric Innovation,” organized by Children’s National to bring together medical device innovators, investors, researchers, clinicians and policy makers to advance pediatric healthcare and address the unmet surgical and medical device needs of children. Along with the theme, BardyDx’s body of clinical evidence recently expanded, highlighting the significance of the CAM patch’s P-wave focused clinical value in this month’s issue of the American Heart Journal.

The published results of the head-to-head comparison study with the iRhythm Zio® XT patch, “Comparison of two ambulatory patch ECG monitors: The benefit of the P-wave and signal clarity,” (Am Heart J 2018; 203:109-117) revealed that the CAM patch identified 40% more arrhythmias and resulted in better, more informed clinical decision-making in 41% of patients over the Zio XT patch primarily due to the enhanced design of the CAM patch to provide unparalleled clarity of tracings. These promising results have spurred interest in additional CAM patch studies to drive innovation in the pediatric population, especially in the younger sub-groups, where off-label use of devices is common.

“We are honored to recognize these outstanding innovations and we already envision the ways they can advance care for children,” said Kolaleh Eskandanian, PhD, Vice President and Chief Innovation Officer at Children’s National and Principal Investigator of the National Capital Consortium for Pediatric Device Innovation (NCC-PDI).

About Children’s National Health System:

Children’s National Health System, based in Washington, D.C., has served the nation’s children since 1870. Children’s National is one of the nation’s Top 5 pediatric hospitals and, for a second straight year, is ranked No. 1 in newborn care, as well as ranked in all specialties evaluated by U.S. News & World Report. It has been designated two times as a Magnet® hospital, a designation given to hospitals that demonstrate the highest standards of nursing and patient care delivery. This pediatric academic health system offers expert care through a convenient, community-based primary care network and specialty outpatient centers in the D.C. Metropolitan area, including the Maryland suburbs and Northern Virginia. Home to the Children’s Research Institute and the Sheikh Zayed Institute for Pediatric Surgical Innovation, Children’s National is the seventh-highest NIH-funded pediatric institution in the nation. Children’s National is recognized for its expertise and innovation in pediatric care and as a strong voice for children through advocacy at the local, regional and national levels.

About Bardy Diagnostics:

Bardy Diagnostics, Inc. is an innovator in digital health and remote patient monitoring, with a focus on providing diagnostically-accurate and patient-friendly cardiac patch and other 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 men, women, and children through its lifestyle-enabling patch 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 innovative and broadly-patented 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. Additional information can be found at the recently launched redesign of the BardyDx corporate website at www.bardydx.com.

MEDIA CONTACT:
Jonathan Wu
Director, Marketing
Bardy Diagnostics, Inc.
1-844-422-7393
jwu@bardydx.com

SOURCE Bardy Diagnostics, Inc.

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http://www.bardydx.com

SEATTLE, Oct. 11, 2018 /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced today it was awarded an Innovative Technology contract with Vizient, Inc. for the Carnation Ambulatory Monitor (“CAM™”), the world’s first P-wave centric™ ambulatory cardiac patch monitor and arrhythmia detection device. The contract resulted from the recommendation of hospital experts serving on one of Vizient’s member-led councils. Vizient, the largest member-driven health care performance improvement company in the US, awards Innovative Technology contracts to companies with technologies that demonstrate an ability to enhance clinical care or patient safety, and those that improve an organization’s care delivery and business model.

Debbie Archer, procurement director and leader of Vizient’s Innovative Technology program for suppliers said, “Due to the number of products and services being released and marketed as ‘innovative,’ our member hospitals value the thorough review process in place at Vizient to help them identify products worth further evaluation at their own facilities. After a full review of the Carnation Ambulatory Monitor, Vizient’s member council agreed this solution offers unique and incremental benefit over other available products on the market today and recommended it for an Innovative Technology contract. We are pleased to award this new contract to Bardy Diagnostics.”

Unlike other cardiac patch monitors on the market, the CAM is the first ambulatory ECG monitor with high fidelity, novel detection technology that reliably records the P-wave, the small amplitude ECG signal that is essential to accurate arrhythmia diagnosis and the determination of appropriate medical treatments or procedural interventions. CAM reporting is enabled by BDxCONNECT, a cloud-based ECG analysis and patient management portal that can be tailored to support different clinical workflows and the care delivery needs and business model of a specific provider or health system.

“We are delighted that Vizient’s member-led council selected the CAM for an Innovative Technology contract. We look forward to working with Vizient’s diverse membership to develop strong relationships that will improve patient outcomes with the use of our CAM patch and monitoring services,” said Ken Nelson, Chief Commercial Officer of Bardy Diagnostics.

Commenting on the novel attributes of the CAM, BDx Founder and Chief Executive Officer, Gust H. Bardy, MD, remarked, “Our P-wave centric CAM recordings are distilled into clinically-actionable data represented in a proprietary report format incorporating beat-to-beat R-R interval plots – a feature not available with any other product or service. We appreciate the recognition and distribution opportunity offered by Vizient and its members.”

Vizient, Inc. represents the combined strengths of the organizations formerly known as VHA Inc., University HealthSystem Consortium, Novation, and MedAssets’ Spend and Clinical Resource Management. Since 2003, nearly 2200 new and innovative products and technologies have been submitted through the Vizient Innovative Technology program. Vizient works with member-led councils and task forces to identify and review potentially innovative products. If it is determined that a product is innovative, a contract may be awarded outside of Vizient’s competitive bid cycle.

About Bardy Diagnostics:

Bardy Diagnostics, Inc. is an innovator in digital health and remote patient monitoring, with a focus on providing diagnostically-accurate and patient-friendly cardiac patch and other 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. Additional information can be found at the recently launched redesign of the BardyDx corporate website at www.bardydx.com.

MEDIA CONTACT:
Jonathan Wu
Director, Marketing
Bardy Diagnostics, Inc.
1-844-422-7393
jwu@bardydx.com

SOURCE Bardy Diagnostics, Inc.

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SEATTLE, July 16, 2018 /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, including the Carnation Ambulatory Monitor (“CAM™”), the world’s first P-wave centric™ ambulatory cardiac monitor and arrhythmia detection device, announced today it has raised additional growth capital from its existing equity investors, including SV Health Investors (“SVHI”), Health Enterprise Partners, and Ascension Ventures. The growth capital will be used to expand BardyDx’s sales force and monitoring services, advance research and development programs, and accelerate development of artificial intelligence diagnostic capabilities.

“We are excited and fortunate to be backed by a strong syndicate of investors that believe in and continue to support our vision to deliver industry-leading and disruptive cardiac monitoring technologies,” said Gust H. Bardy, MD, Founder and Chief Executive Officer of BardyDx. “The capital will enable us to properly scale to match the rapidly growing demand for the CAM patch and develop a portfolio of P-wave focused product solutions to address the varying and evolving cardiac monitoring needs of healthcare professionals and their patients.”  

Mark Handfelt, BardyDx’s Chief Operating Officer, continued, “Growing awareness among healthcare professionals about the importance of the P-wave visualization technologies pioneered by the CAM patch has resulted in strong sales growth. To match increasing monitoring volumes, a portion of the funding will be deployed to expand our monitoring services center and to aid in development of automated arrhythmia detection technologies, a key component of the ongoing R&D efforts at BardyDx to redefine and elevate the standard of care in cardiac monitoring.”

BardyDx recently presented a poster at the Heart Rhythm Society’s 39^th Annual Scientific Session that described an electrophysiologist-vetted, artificial intelligence-enabled (AI) screening technology to detect atrial fibrillation (AF) events that distinguishes pseudo-AF events from genuine AF, marking an important milestone in BardyDx’s pipeline of future AI-driven diagnostic products intended to be used for widespread public screening of arrhythmias.

“We have strong confidence in the ability of Bardy Diagnostics to transform the cardiac monitoring industry by delivering market-changing diagnostic technologies that drastically improve clinical management and outcomes for patients,” said Paul LaViolette, Managing Partner at SVHI. “We are very pleased with BardyDx’s clinical and commercial success and look forward to helping the company become the global standard of care in the diagnosis of arrhythmias.”

About Bardy Diagnostics:

Bardy Diagnostics, Inc. is an innovator in digital health and remote patient monitoring, with a focus on providing diagnostically-accurate and patient-friendly cardiac patch and other 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 men, women, and children through its lifestyle-enabling patch design. Designed to be worn comfortably and discreetly by both men and women, 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 innovative and broadly-patented 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 SV Health Investors

SV Health Investors (formerly SV Life Sciences) is a healthcare and life sciences venture capital and growth equity firm. SV targets early-stage opportunities in biotechnology; early-stage and revenue-stage opportunities in medical devices; and growth equity investments for later-stage businesses in healthcare services and digital health. Over the past 20 years, SV Health Investors has invested in more than 175 companies. The firm currently has over $2.5 billion of capital commitments under management. SV Health Investors has offices in Boston, San Francisco, and London. For more information, please visit www.svhealthinvestors.com.

About Health Enterprise Partners

Health Enterprise Partners (HEP) invests primarily in privately held, middle market companies in health care services and health care information technology. Central to HEP’s strategy is its unique and extensive hospital system and health plan network, 26 members of which are investors in HEP’s funds. HEP seeks to invest in companies that improve the quality of the patient experience, expand access, and reduce the cost of health care. For more information, please visit www.hepfund.com.

About Ascension Ventures

Ascension Ventures is a strategic healthcare venture firm with more than $800 million in capital under management. The firm is a wholly owned subsidiary of Ascension, the nation’s largest Catholic and non-profit health system. Ascension Ventures’ role is to construct and manage a strategic portfolio of investments that deliver venture-level investment returns, have the potential to transform the healthcare industry, and significantly enhance the experience for patients, their families and their caregivers. Its health system limited partners operate 474 hospitals, have 578,000 employees and generate $88 billion in annual revenue. For more information, please visit www.ascensionventures.org.

MEDIA CONTACT:
Jonathan Wu
Director, Marketing
Bardy Diagnostics, Inc.
1-844-422-7393
jwu@bardydx.com

SOURCE Bardy Diagnostics, Inc.

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http://www.bardydx.com

SEATTLE, May 9, 2018 /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, including the Carnation Ambulatory Monitor (“CAM™”), the world’s only P-wave centric™ ambulatory cardiac patch monitor and arrhythmia detection device, presented a poster today titled “Artificial Intelligence for the Automatic Detection of Atrial Fibrillation” at the Heart Rhythm Society 39^th Annual Scientific Sessions that described a validated artificial intelligence-enabled (AI) screening technology to detect atrial fibrillation (AF) events.

The novel AF detection technology was developed using a machine learning technique that employs a convolutional, feed-forward neural network trained using P-wave centric CAM recordings consisting of 12 million ECG samples of persistent AF, paroxysmal AF, and no findings of AF. Additionally, specific “no findings of AF” training counter-examples incorporated beat-to-beat varying rhythms that are commonly mistaken for AF by many of the commercially-available, R-wave focused automated AF detectors, including dense atrial or ventricular ectopy, atrial flutter, and atrial tachycardia with variable conduction.

Commenting on this advancement, Bardy Diagnostics Founder and Chief Executive Officer, Gust H Bardy, MD, said, “Automated arrhythmia detection is a key component of our ongoing research and development efforts at BardyDx to advance and redefine the standard of care in cardiac monitoring.” Dr. Bardy continued, “The CAM patch’s distinctive P-wave centric design and low-amplitude signal detection presents the unique opportunity to leverage its high clarity ECG signal in developing a reliable detector that surpasses less accurate methods of algorithmic approaches using RR interval variability or AI methods weighted on R-wave analysis.”

For an AF event spanning 10 minutes or longer, the detection technology’s expert-validated sensitivity was 95% (p<0.01) and the specificity was 91% (p<0.02). Dr. Bardy said, “Diagnostic accuracy is of utmost importance in these types of automated approaches. False positive AF diagnoses can be particularly concerning given the profound harmful consequences of administering unnecessary anticoagulants, antiarrhythmic drugs, or procedural interventions.”

The successful validation of this technology marks an important milestone in BardyDx’s R&D pipeline of future AI-enabled diagnostic products with the potential for widespread public screening of atrial fibrillation and other arrhythmias. Dr. Bardy said, “This automatic AF detector is the first step into the development of AI-driven heart rhythm diagnostics that can accurately screen a broad list of arrhythmias; the CAM patch’s powerful ability to bring detailed quality and character to the atrial ECG makes this all possible.”

About Bardy Diagnostics:

Bardy Diagnostics, Inc. is an innovator in digital health and remote patient monitoring, with a focus on providing diagnostically-accurate and patient-friendly cardiac and vital signs 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 men, women, and children through its lifestyle-enabling patch design. Designed to be worn comfortably and discreetly by both men and women, 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 innovative and broadly-patented technology of the CAM patch provides optimal detection and clear recording of the often difficult-to-detect P-wave, the part of the ECG waveform that is essential for accurate arrhythmia diagnosis.

For more information please visit www.bardydx.com

MEDIA CONTACT:
Jonathan Wu
Director, Marketing
Bardy Diagnostics, Inc.
1-844-422-7393
jwu@bardydx.com

SOURCE Bardy Diagnostics, Inc.

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http://www.bardydx.com

SEATTLE, May 7, 2018 /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, including the Carnation Ambulatory Monitor (“CAM™”), the world’s only P-wave centric™ ambulatory cardiac monitor and arrhythmia detection device, announced today that the American Heart Journal has published the results of a head-to-head comparison of two patch-based arrhythmia monitoring systems. The study, “Comparison of two ambulatory patch ECG monitors: The benefit of the P-wave and signal clarity” concluded that the BardyDx CAM single-channel patch ambulatory ECG monitor (AEM), designed specifically to enhance P-wave detection, identified significantly more arrhythmias and resulted in better, more informed clinical decision-making over the iRhythm Zio® XT patch.

In the prospective time-paired comparative study led by electrophysiologist Robert Rho, MD, FHRS, FACC, 30 patients simultaneously wore a pectorally-placed arrhythmia monitoring patch (iRhythm Technologies, Zio XT patch) and a P-wave centric arrhythmia monitoring patch (Bardy Diagnostics, CAM patch) placed over the sternum with the intent of recording for 7 days. At the end of the monitoring period, the patches were removed at the same visit. The outcome measures were to compare diagnostic yield, ECG signal clarity, ease of use and comfort, and, importantly, an assessment of differences in clinical decision-making based upon each device’s rhythm diagnosis.

The study evaluated the differences in specific rhythm diagnosis and ECG clarity between the two commercially available patch AEMs. The CAM patch identified more arrhythmias (particularly atrial tachycardia, atrial flutter, and non-sustained VT) than the Zio XT patch in contrast to atrial fibrillation, where both monitors performed adequately. ECG clarity was ranked as “high” in all CAM reports compared to the Zio XT reports (100% versus 16%, p<0.001). Both devices were considered user-friendly; however, the CAM patch was observed to be slightly easier to attach and remove, more stable, and associated with less skin reaction. Importantly, it was found that the superior signal clarity provided by the CAM patch may result in more informed clinical decisions in over a third of the patients.

Dr. Rho commented “Most innovations in AEMs have focused on increased monitoring duration. Although duration of recording improves arrhythmia diagnosis, a very important factor is the clarity of the ECG recording. AEM diagnostics and ECG clarity vary with electrode location, signal noise, signal processing technology, and electronic design.  The clarity of an ECG signal is important in providing the ability to see P-waves during a recorded arrhythmia. The ability to accurately detect P-waves during an arrhythmia event allows physicians to make a more specific and confident rhythm diagnosis. This study demonstrates that significant differences in diagnostic yield exist between these two seemingly similar patch ambulatory ECG monitors applied during the same 7-day monitoring period and that these differences can impact clinical decision making.”  

Dr. Rho et al.’s patch-to-patch comparison study builds on a study conducted by Warren Smith, MBChB, et al., comparing the BardyDx CAM patch and a traditional Holter monitor also in a simultaneous, paired assessment. That study, 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) demonstrated that the BardyDx CAM “resulted in a significantly improved rhythm diagnosis and avoided inaccurate diagnoses made by the standard 3-channel Holter monitor” on a time-controlled basis.

Commenting on the positive results of both studies, BardyDx Founder and Chief Executive Officer, Gust H Bardy, MD explained, “After a personal loss, I set out to build a P-wave focused, low-noise, easy-to-use ambulatory cardiac monitor with contextual beat-to-beat R-R interval data to complement the P-wave centric design. Our goal was to create a tool with the ability to definitively diagnose the broad array of arrhythmias that afflict patients. We are confident that our monitoring technology enables physicians to better manage profound medical decisions involving anticoagulation, antiarrhythmic drugs, ablation, or device therapies. It is very rewarding to see the clinical results of the CAM compared to other monitors. We are proud to provide actionable medical data to physicians for their patients with this new technology and look forward to its continued widespread adoption.”

About Bardy Diagnostics:

Bardy Diagnostics, Inc. is an innovator in digital health and remote patient monitoring, with a focus on providing diagnostically-accurate and patient-friendly cardiac and vital signs 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 men, women, and children through its lifestyle-enabling patch design. Designed to be worn comfortably and discreetly by both men and women, 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 innovative and broadly-patented technology of the CAM patch provides optimal detection and clear recording of the often difficult-to-detect P-wave, the part of the ECG waveform that is essential for accurate arrhythmia diagnosis.

For more information please visit www.bardydx.com

MEDIA CONTACT:
Jonathan Wu
Director, Marketing
Bardy Diagnostics, Inc.
1-844-422-7393
jwu@bardydx.com

SOURCE Bardy Diagnostics, Inc.

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http://www.bardydx.com

EATTLE, April 24, 2018 /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, including the Carnation Ambulatory Monitor (“CAM™”), the world’s only P-wave centric™ ambulatory cardiac monitor and arrhythmia detection device, announced today the appointment of Alan J. Levy, PhD to its Board of Directors. He will serve as Executive Director, expanding Bardy Diagnostics’ Board of Directors to seven members. Dr. Levy brings more than 40 years of senior operational leadership and entrepreneurial experience in the medical device industry.

“We are extraordinarily fortunate and honored to welcome Alan Levy as our newest board member,” said Gust Bardy, MD, Bardy Diagnostics Founder and Chief Executive Officer. “Dr. Levy combines the strengths of being an astute business executive, investor, and scientist as demonstrated by his impressive track record of leading early-stage med tech companies to successful exits and IPOs. We are excited to draw upon his extensive experience helming some of the most cutting-edge, disruptive start-up medical device companies, to further elevate Bardy Diagnostics in its goals to revolutionize ECG technology.”

Most recently, Dr. Levy served as the Chief Executive Officer and Chairman of the Board at Chrono Therapeutics. In addition, he was a Senior Advisor and Venture Partner of Frazier Healthcare Partners focusing on the Life Science sector. Dr. Levy’s notable previous leadership experiences include serving as the founding Chief Executive Officer at Incline Therapeutics that was acquired by The Medicines Company for $390 million, Chief Executive Officer and President at Northstar Neuroscience that went public and raised $112 million in their IPO, Chief Executive Officer and President at Heartstream that was acquired by Hewlett-Packard for $140 million, and President at Heart Technology that was acquired by Boston Scientific for $500 million. In addition, he held several leadership positions at Ethicon, a division of Johnson & Johnson, including serving as the Vice President of Research and New Business Development and Director.

Dr. Levy serves as a board member of several public and private companies including Intuitive Surgical, Proteus Digital Health and Seattle BioMed. He received his PhD in Organic Chemistry from Purdue University, a BS in Chemistry from City University of New York, and holds an Honorary Doctor of Science from Purdue University.

“It is with great pleasure and excitement that I accept this position alongside the other high-caliber members of the board,” said Dr. Levy. “I have been a part of various medical device companies and have had the opportunity to evaluate many investment opportunities in the space; the potential of Bardy Diagnostics is outstanding and I am eager to support the company through its next phase of growth in becoming the industry leader in cardiac monitoring.”  

About Bardy Diagnostics:

Bardy Diagnostics, Inc. is an innovator in digital health and remote patient monitoring, with a focus on providing diagnostically-accurate and patient-friendly cardiac and vital signs 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 men, women, and children through its lifestyle-enabling patch design. Designed to be worn comfortably and discreetly by both men and women, 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 innovative and broadly-patented technology of the CAM patch provides optimal detection and clear recording of the often difficult-to-detect P-wave, the part of the ECG waveform that is essential for accurate arrhythmia diagnosis.

For more information please visit www.bardydx.com

MEDIA CONTACT:
Jonathan Wu
Director, Marketing
Bardy Diagnostics, Inc.
1-844-422-7393
jwu@bardydx.com

SOURCE Bardy Diagnostics, Inc.

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http://www.bardydx.com

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SEATTLE, April 19, 2018 /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced today it has been recognized as one of the Top 10 Cardio Vascular Device Companies of 2018 by MedTech Outlook Magazine, an industry periodical committed to covering the trends, challenges, and solutions impacting the healthcare and medical device sectors. BardyDx was selected among its peers for pioneering P-wave focused ECG monitoring with the introduction of the Carnation Ambulatory Monitor (“CAM™”), the world’s only P-wave centric™ ambulatory cardiac patch monitor and arrhythmia detection device.

MedTech Outlook’s distinguished selection panel, comprised of physicians, healthcare executives, and the magazine’s editorial board, chose from a list of hundreds of candidates submitted through nominations and consultations with industry leaders to decide upon 10 companies that stood out in the cardiovascular market for delivering today’s most innovative advancements in diagnostic and therapeutic medical devices.

BardyDx’s CAM Patch Monitoring System was chosen due to its market-leading advances in ECG diagnostic accuracy, patient-friendly design, and workflow versatility. Gust Bardy, MD, BardyDx Founder and Chief Executive Officer, explains, “Clinicians harnessing CAM’s P-wave focused technology have enthusiastically noted an improved ability to confidently diagnose heart rhythms, including rare arrhythmias not typically detected or recorded by other devices.”

Chief Commercial Officer Ken Nelson added, “BardyDx aims to work within, rather than around, our customers’ various workflows and clinical settings, which includes permitting them to perform their own ECG scanning analyses, enabling them to download CAM and other data on-site for expedient processing, or allowing their patients the convenience of sending the CAM patch directly to BardyDx for subsequent analysis. As a result, we’re seeing strong interest and adoption outside of the traditional cardiology practice, including the Emergency Department and post-stroke monitoring settings.”

Commenting on the recognition, Dr. Bardy said, “It is a great honor to be recognized for our continuing efforts to provide a clinically-valuable and versatile ambulatory cardiac diagnostic tool.” He continued, “The CAM is the first step in our mission to make P-wave centric monitoring the standard of care in ECG monitoring and we look forward to deploying AI-based tools to enable consistent, objective, accurate and timely diagnostic data to physicians and their patients.”

The cardiovascular device companies selected for the Top 10 list, along with a detailed feature on Bardy Diagnostics, can be found here in the April edition of MedTech Outlook.

About Bardy Diagnostics:

Bardy Diagnostics, Inc. is an innovator in digital health and remote patient monitoring, with a focus on providing diagnostically-accurate and patient-friendly cardiac and vital signs 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 men, women, and children through its lifestyle-enabling patch design. Designed to be worn comfortably and discreetly by both men and women, 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 innovative and broadly-patented technology of the CAM patch provides optimal detection and clear recording of the often difficult-to-detect P-wave, the part of the ECG waveform that is essential for accurate arrhythmia diagnosis.

For more information please visit www.bardydx.com

MEDIA CONTACT:
Jonathan Wu
Director, Marketing
Bardy Diagnostics, Inc.
1-844-422-7393
jwu@bardydx.com

SOURCE Bardy Diagnostics, Inc.

Related Links
http://www.bardydx.com

SEATTLE, April 2, 2018 /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, including the Carnation Ambulatory Monitor (“CAM™”), the world’s smallest and lightest P-wave centric™ ambulatory cardiac monitor and arrhythmia detection device, announced today the appointment of Kenneth W. Nelson III as Chief Commercial Officer effective April 2, 2018. He will serve on the company’s Executive Committee and be responsible for leading Bardy Diagnostics’ Global Sales, Marketing, Business Development, and Customer Experience functions.

“We are pleased to name Ken Nelson as the head of the Commercial team,” said Gust Bardy, MD, Bardy Diagnostics Founder and Chief Executive Officer. “Nelson brings a strong record of successful domestic and international sales, marketing, and business development leadership experiences ranging from start-ups with disruptive technologies to Fortune 500 companies. We look forward to leveraging his proven track record in leading medical device, diagnostics services, and digital health industry sales and strategic partnerships to successfully help the company achieve new levels of growth, performance, and innovation.”

Nelson joined Bardy Diagnostics in September 2017 and currently serves as Senior Vice President of Corporate Development. His extensive experience in the cardiac monitoring and cardiac rhythm management market includes most recently leading the sales and strategic partnership activities as the US Vice President of Sales and Director of Business Development for BioTelemetry (formerly CardioNet), where he helped transform declining sales to 19 consecutive quarters of revenue and share growth, drastically reduced sales team turnover, and led several high-value strategic partnerships and acquisitions in the cardiac monitoring space.

Previously, Nelson was national Vice President of Sales and Marketing for iRhythm Technologies, where he built the entire foundational sales and marketing team for the US and substantially grew product sales ten-fold. In addition, he also served at Boston Scientific (formerly Guidant) in their Cardiac Rhythm Management Division for 8 years in various sales leadership roles.

“I am excited for this opportunity to take an even greater role in Bardy Diagnostics at this pivotal time of corporate expansion,” said Nelson. “In my years in this space, never have I encountered a product that I feel could make such a widespread impactful difference in patient care. I am pleased to join such a dedicated team and do my part in furthering the mission of the company to make our products the global standard of care in monitoring.”

Robert Cockrill Named Vice President of Sales

Bardy Diagnostics also announced today that Robert (Bobby) Cockrill, MBA has been named Vice President of Sales, effective immediately. With over 17 years in the medical device industry, he will be responsible for leading all of Bardy Diagnostics’ US Sales and Business Development functions.

“We are fortunate to bring on Bobby Cockrill to direct our domestic sales initiatives,” says Bardy. “Cockrill brings extensive experience in structuring, optimizing, and deploying sales assets from companies of varying sizes from early and late stage start-ups to large-scale businesses. His reputation and commitment for creating a strong sales culture of collaboration and individual success will prove invaluable as Bardy Diagnostics continues to grow and makes greater strides into the cardiac monitoring market.”

Prior to joining in November 2017, Cockrill served as Vice President of Sales at SonoSim, Inc., where he was tasked with reengineering and growing the sales team. In addition, he possesses strong experience in the cardiac device space with various sales leadership positions at Boston Scientific, Cardionet (now BioTelemetry), and Eli Lilly and Company.

About Bardy Diagnostics:

Bardy Diagnostics, Inc. is an innovator in digital health and remote patient monitoring, with a focus on providing diagnostically-accurate and patient-friendly cardiac and vital signs 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 men, women, and children through its lifestyle-enabling patch design. Designed to be worn comfortably and discreetly by both men and women, the female-friendly CAM patch is placed on the center of the chest, directly over the heart for optimum ECG signal collection. Distinguished from other products by its innovative, broadly-patented technology, the CAM patch provides optimal detection and clear recording of the often difficult-to-detect P-wave, the part of the ECG waveform that is essential for accurate arrhythmia diagnosis.

For more information please visit www.bardydx.com

MEDIA CONTACT:
Jonathan Wu
Director, Marketing
Bardy Diagnostics, Inc.
1-844-422-7393
jwu@bardydx.com

SOURCE Bardy Diagnostics, Inc.

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CHARLOTTE, N.C., Nov. 16, 2017 /PRNewswire/ — Bardy Diagnostics, Inc., a leading provider of ambulatory cardiac technologies and custom data solutions, including the Carnation Ambulatory Monitor™ (“CAM™”), announced it has been recognized as one of the 10 Most Promising Patient Monitoring Solution Providers of 2017 by CIOReview Magazine, a notable technology publication aimed at C-level executives and decision-makers. Bardy Diagnostics was recognized for its innovative development and commercialization of CAM, the world’s smallest and lightest P-wave centric™ ambulatory cardiac patch monitor and arrhythmia detection device.

Bardy Diagnostics’ CAM device was nominated and ultimately selected following CIOReview’s annual comprehensive review of cutting edge technologies and solutions that shape the patient monitoring landscape. CIOReview’s editorial team analyzed hundreds of companies that provide patient monitoring solutions and are at the forefront of solving patient and provider challenges. From that pool, 50 companies were shortlisted and reviewed by a distinguished panel comprised of CEOs, CIOs, VCs, and analysts, including the CIOReview editorial board, to further narrow the list to the final ten.

CAM distinguished itself from others in the nomination pool through its novel, state-of-the-art sensing architecture that incorporates ultra-low power, low-noise circuitry designed for the optimal detection and clear recording of the P-wave, the small amplitude ECG signal originating in the right atrium essential for accurate arrhythmia diagnosis and the determination of appropriate medical or procedural intervention. Other monitoring technologies may not reliably detect or record the P-wave, resulting in inaccurate, vague, or missed diagnoses. In addition, CAM’s discreet shape and lifestyle-enabling design increase patient compliance, resulting in uninterrupted data collection over longer periods of time when compared to traditional Holter monitors.

Commenting on the award, BDx Founder and Chief Executive Officer, Gust H. Bardy, MD, who in 2014 received the Pioneer in Cardiac Pacing and Electrophysiology Award, stated, “My passion is to bring innovative medical devices and products to the market for the benefit of the patient. All elements of the design and engineering processes we used in the development of the CAM were driven by the primary purpose of easy patient use and deployment to improve public health. I’m honored that CAM has captured those purposes and that it has been recognized as the innovative product that it is.”

BDx Chief Operating Officer, Mark Handfelt, added, “CAM’s innovative design permits us to offer our customers choices that aren’t otherwise available to them with competitive technologies. For instance, the CAM recorder can be used for both short-term monitoring up to 48 hours and extended-term monitoring up to seven days. In addition, unlike competitive offerings, CAM users can elect to perform their own ECG analysis and report generation or have us provide the analysis and Carnation ECG Report to them. The CAM platform was designed with future innovation in mind as it will also permit us to add additional sensor types to meet the evolving needs of our customers and their patients. We look forward to bringing the benefits of this innovative monitor technology to clinicians and patients around the world.”

The top 10 patient monitoring solution providers being recognized, along with a detailed feature on Bardy Diagnostics, can be found here in the November edition of CIOReview.

About Bardy Diagnostics
Bardy Diagnostics, Inc. (“BDx”) develops and markets the Carnation Ambulatory Monitor, a non-invasive, P-wave centric™ ambulatory cardiac monitor and arrhythmia detection device that is designed to be worn comfortably and discreetly by both men and women. Thoughtfully designed with the female anatomy in mind, CAM is placed on the center of the chest, directly over the heart for optimal ECG P-wave signal collection. Its state-of-the-art engineering enables optimal detection and clear recording of the P-waves.

Contact:  
Bardy Diagnostics, Inc.  
Jonathan Wu 
Director, Strategic Marketing
206-259-2876
jwu@bardydx.com

www.bardydx.com

SOURCE Bardy Diagnostics, Inc.

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CHARLOTTE, N.C., Jan. 5, 2017 /PRNewswire/ — Bardy Diagnostics, Inc. (“BardyDx” or “the Company”), which has developed and is commercializing the Carnation Ambulatory Monitor (“CAM™”), the world’s smallest and lightest P-wave centric™ ambulatory cardiac monitor and arrhythmia detection device, today announced that it has raised a significant round of growth capital from experienced healthcare investors SV Life Sciences Advisers (“SVLS”), Health Enterprise Partners (“HEP”), Ascension Ventures (“AV”) and Square 1 Bank, a division of Pacific Western Bank (“Square 1”).  The capital will be used to support continued development as well as sales and marketing of CAM™ in the U.S. and Europe.

“Through its clinically superior P-wave centric™ data capture, ergonomic engineering and design, and its flexibility to fit within varied healthcare workflows and business models, we’re confident that CAM™ will be rapidly adopted as a standard of care and that it will further our mission of improving the clinical efficacy of ambulatory monitoring and patient health,” said Gust Bardy, M.D., founder of BardyDx. “We’re very excited to add the expertise and capital of SVLS, HEP, AHV and Square 1 to our team and look forward to their support and assistance in executing the next phase of growth for the Company.”

Paul LaViolette, Managing Partner at SVLS, added, “It’s a privilege to partner with Dr. Bardy on another of his compelling innovations in the diagnosis and treatment of cardiovascular disease.  The Carnation Ambulatory Monitor represents a significant improvement over current technologies in how physicians diagnose and manage arrhythmias of all types.”

Incorporating the extensive research, clinical expertise and intellectual property of Dr. Bardy, CAM™ is a non-invasive cardiac monitor worn by patients to record heart rhythms for extended periods of time.  Due to its novel engineering and design, unique data capture and presentation capabilities and improved patient compliance, CAM™ improves the prospects for clinically actionable arrhythmia diagnoses and timely interventions.  The earlier intervention and proper treatment of arrhythmias has the potential to drastically reduce their long-term complications and related costs.  The CAM™ data file can be quickly downloaded for analysis at a hospital or clinic or at a third-party reading site, whichever the customer prefers.  CAM™ is approved for use in the U.S. and Europe and fits within existing reimbursement codes in each region. 

“CAM™ addresses a true market need for a comfortable, clinically effective monitoring solution, and we look forward to working with our new investors to accelerate the Company’s market penetration and future development of CAM,” said BardyDx CEO, Jon Hunt, Ph.D.

About Bardy Diagnostics   
Bardy Diagnostics, Inc. (“BardyDx”) develops and markets the Carnation Ambulatory Monitor, a non-invasive P-wave centric™ ambulatory cardiac monitor and arrhythmia detection device that generates superior clinical data, improves patient compliance and fits within varied hospital and cardiology workflows and reimbursement concerns.

About SV Life Sciences Advisers  
SV Life Sciences Advisers, LLC (“SVLS”) is a global leader in healthcare and life sciences investing. SVLS affiliated funds have been investing in such companies since the early 1980s, forming its first dedicated healthcare fund in 1994. Today, SVLS manages five funds with approximately $2.0 billion of capital commitments under management. The firm has invested in over 175 companies through its venture funds, and employs a diversified investment strategy capitalizing on opportunities in the following subsectors; therapeutics, medical devices, healthcare information technology (HCIT) and healthcare services. SVLS employs a close symbiosis between operating and financial professionals which has led to significant success over five investment funds. SVLS has offices in Boston, London and San Francisco. For more information, please visit the company’s website at http://www.svlsa.com.

About Health Enterprise Partners  
Health Enterprise Partners invests primarily in privately held, profitable, middle market companies in the health care information technology and health care service sectors. HEP’s strategy is to leverage its unique and extensive hospital system and health plan network, 26 members of which are investors in HEP’s funds. HEP seeks to invest in companies that improve the quality of the patient experience, reduce the cost of health care, and improve operating margins for their customers, typically hospital systems and / or health plans. For more information, please visit http://www.hepfund.com.

About Ascension Ventures  
Ascension Ventures (www.ascensionventures.org) is a strategic healthcare venture firm with four funds and more than $800 million in capital under management. The firm is a wholly owned subsidiary of Ascension, the nation’s largest Catholic and non-profit health system. Ascension Ventures’ role is to construct and manage a strategic portfolio of investments that deliver venture-level investment returns, have the potential to transform the healthcare industry, and significantly enhance the experience for patients, their families and their caregivers. Its health system limited partners operate 474 hospitals, have 578,000 employees and generate $88 billion in annual revenue.

About Square 1 Bank  
Square 1 Bank is a division of Pacific Western Bank, a Los Angeles-based commercial bank with over $21 billion in assets. A full service financial services partner to entrepreneurs and their investors, Square 1 provides clients flexible resources and attentive service to help their companies grow. Square 1 offers a broad range of venture debt, treasury and cash management solutions through offices in top innovation centers: Atlanta, Austin, the Bay Area, Boston, Chicago, Denver, Durham, Los Angeles, Minneapolis, New York, San Diego, Seattle and Washington, DC. Pacific Western Bank is a wholly-owned subsidiary of PacWest Bancorp. For more information, visit www.square1bank.com.

Contact:  
Bardy Diagnostics, Inc.  
Jon Hunt, PhD  
President and CEO  
949-636-5835  
jhunt@bardydx.com

www.bardydx.com

SOURCE Bardy Diagnostics, Inc.

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http://www.bardydx.com