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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Press Release :

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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Bardy Diagnostics™ Selected as One of Six Disruptive MedTech Startups For the HealthTech Arkansas Accelerator Program

SEATTLE, Aug. 9, 2019 /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced that HealthTech Arkansas, a healthcare accelerator and investment fund that connects early-stage healthcare companies with disruptive technologies to Arkansas healthcare providers, has selected BardyDx to participate in the organization’s 2019 accelerator program. BardyDx was chosen for its innovative advancements in cardiac monitoring by delivering industry-leading diagnostic accuracy with the Carnation Ambulatory Monitor (“CAM™”), the industry’s only P-wave centric™ ambulatory cardiac patch monitor and arrhythmia detection device.

HealthTech Arkansas is a new and expanded iteration of two previous accelerator programs in the state, Health InnovatAR and HubX-LifeSciences. This year, with more provider partners and increased investment for participating companies, HealthTech Arkansas is focused on bringing the most innovative healthcare technologies to Arkansas. The 2019 cohort selection was announced this week at the Arkansas Heart Hospital with a welcome from CEO Dr. Bruce Murphy, followed by a message from Arkansas Governor Asa Hutchinson and presentations from each of the six chosen companies. Both Dr. Murphy and Governor Hutchinson focused on the importance of working together to bring innovative technologies to Arkansas.

“It’s an honor to be selected as part of the 2019 accelerator cohort,” said Ken Nelson, BardyDx Chief Commercial Officer. “HealthTech Arkansas presents an invaluable opportunity to perform clinical studies with highly-engaged and pioneering healthcare organizations that are eager to implement the newest innovative technologies, like the CAM patch, to advance their clinical care – a clear win for both BardyDx and each partnering institution.”

This year’s six companies were selected from hundreds of applicants across 18 different countries. The cohort will participate in a program that provides them the opportunity to partner with and build solutions specifically identified by Arkansas Heart Hospital, Arkansas Children’s, Arkansas Urology, Baptist Health, CHI St. Vincent, Conway Regional, Mercy, the University of Arkansas for Medical Sciences (UAMS), and Washington Regional Medical Center as areas of opportunity within their organizations. Each of the cohort companies will receive seed investment as well as complete and total access to clinicians and administrators at each partnering site.

“We’re delighted to have the participation of BardyDx as one of six companies in our cohort this year,” said Jeff Stinson, Director of HealthTech Arkansas. “Collectively, they’re among the most accomplished early stage healthcare companies in the country. BardyDx was specifically chosen because the leadership teams in our partner hospitals believe the company can significantly increase the quality of care through its innovative devices. We can’t wait to begin our work with BardyDx.”

This distinction adds to the growing market recognition of the innovative P-wave centric CAM patch. Recently, BardyDx was named both 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 was 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 HealthTech Arkansas:

HealthTech Arkansas is a healthcare accelerator and investment fund that connects early stage healthcare companies bringing disruptive technologies to the market with Arkansas healthcare providers for the purpose of conducting pilot projects. We target the intersection of technology and healthcare in three categories: digital health (software), connected medical devices and diagnostic platforms. Our program is by providers and for providers, so we seek technologies that can improve our providers’ quality of care and increase their efficiency. Additional information can be found at www.healthtecharkansas.com.

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, the female-friendly, hourglass-shaped CAM patch is placed on the center of the chest, directly over the heart. 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 and the determination of appropriate medical or procedural intervention. 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

Press Release :

Bardy Diagnostics™ Selected as One of 50 Leading Startups in the 2019 MedTech Innovator Showcase Program

SEATTLE, June 19, 2019 /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced that MedTech Innovator, the premier nonprofit startup accelerator in the medical technology industry, has selected BardyDx to participate in the organization’s 2019 Showcase program, featuring the most promising medical technologies from around the globe. BardyDx was chosen for its innovative advancements in cardiac monitoring by delivering industry-leading diagnostic accuracy with the Carnation Ambulatory Monitor (“CAM™”), the industry’s only P-wave centric™ ambulatory cardiac patch monitor and arrhythmia detection device.

The program commences today in San Francisco, where the leadership teams from its 50 startups will gather for the annual MedTech Innovator Summit. During this two-day exclusive event, innovators from early to later-stage startups will collaborate with MedTech Innovator’s corporate partners to find solutions to common challenges and mechanisms to accelerate their technologies. All 50 companies will then present in a Showcase and partnering meetings with executives and investors on June 21 at the Wilson Sonsini Goodrich & Rosati’s 27th Annual Medical Device Conference in San Francisco. The program culminates September 23-25 in Boston, where all companies will present in Showcase panels and gain access to exclusive partnering and roundtables at The MedTech Conference, powered by AdvaMed.

“We are thrilled to be included in this distinguished cohort of innovating companies developing cutting-edge and disruptive technologies in MedTech,” said Ken Nelson, BardyDx Chief Commercial Officer. “We look forward to working with MedTech Innovator and receiving unparalleled visibility and invaluable access to its network of investors, providers, payers, and industry stakeholders through this highly selective program.”

From an initial applicant pool of over 800 applicants spanning 34 countries, BardyDx was chosen among 150 best-in-class medical device, diagnostic, and digital health companies to participate at one of the six regional qualifying MedTech Innovator Pitch Events held in March. BardyDx was selected as part of the 50 advancing innovators from the qualifying round to the Showcase program. 

“We take great pride in bringing the world’s best medtech ecosystem together with standout entrepreneurs to provide them with the resources and connections needed to bring their transformative technologies to patients,” said Paul Grand, CEO of MedTech Innovator.

This distinction adds to the growing market recognition of the innovative P-wave centric CAM patch. Recently, BardyDx was named both 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 was 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.

The full list of the 2019 MedTech Innovator Top 50 Showcase & Accelerator Companies can be found here

About MedTech Innovator:

MedTech Innovator is the medical technology industry’s nonprofit global competition and accelerator for innovative medical device, digital health, and diagnostic companies. Its mission is to improve the lives of patients by accelerating the growth of companies that are transforming the healthcare system. MedTech Innovator is the largest platform of its kind, providing participants with broad exposure and mentorship from the leading players in the MedTech industry. Additional information can be found at https://medtechinnovator.org/.

About Wilson Sonsini Goodrich & Rosati’s Medical Device Conference:

Wilson Sonsini Goodrich & Rosati, the premier provider of legal services to technology, life sciences, medical and growth enterprises worldwide, will host its 27th Annual Medical Device Conference on June 21. This year’s Conference will focus on understanding the challenges facing the MedTech start-up today, and the strategies that are emerging to respond to these challenges, presented by industry CEOs, venture capitalists, industry strategists, investment bankers, and market analysts. For more information, please visit https://mdc.wsgrevents.com.

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, the female-friendly, hourglass-shaped CAM patch is placed on the center of the chest, directly over the heart. 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 and the determination of appropriate medical or procedural intervention. 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

Press Release :

Bardy Diagnostics™ Selected as Winner of the MedTech Breakthrough Award For Best New Diagnostic Technology

SEATTLE, June 6, 2019 /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced that MedTech Breakthrough, an independent organization that recognizes the top companies and solutions in the global health and medical technology market, has recognized the Carnation Ambulatory Monitor (CAM™) with the “Best New Diagnostic Technology” award in the 2019 MedTech Breakthrough Awards program. BardyDx earned the distinction for its innovative P-wave centric™ ambulatory cardiac patch monitoring and arrhythmia detection technology.

Reliably detecting and recording the P-wave, a small amplitude signal of the ECG originating in the atrium, is essential to accurate arrhythmia diagnosis and the determination of appropriate medical or procedural intervention. By focusing on the detection and recording of the P-wave, BardyDx advances cardiac monitoring by delivering industry leading diagnostic accuracy.

“It is an honor to be recognized by the MedTech community as one of the innovating companies and technologies paving the way for the future of cardiac monitoring,” said Gust H. Bardy, MD, Founder and Chief Executive Officer of Bardy Diagnostics. “This award recognizes our collective drive at BardyDx towards transforming clinical care and developing an efficient, effective, and accurate healthcare solution that finally addresses the limitations and challenges of current cardiac monitors faced by clinical decision-makers day-in and day-out.”

The MedTech Breakthrough Awards program is the premier awards and recognition platform founded to recognize the medical and health technology innovators, leaders and visionaries from around the world. The program evaluates and recognizes break through solutions and companies in a range of categories, including Medical Devices, mHealth, Robotics, TeleHealth, Patient Engagement, Electronic Health Records (EHR), Healthcare Security, Medical Data and more. This year’s program attracted more than 3,500 nominations from over 15 different countries throughout the world that were evaluated by an independent panel of experts within the MedTech industry, with the winning products and companies selected based on a variety of considerations, including innovation, design and user-experience.

“BardyDx’s non-invasive P-wave centric CAM patch is disrupting decades of old practice and technology for cardiac diagnostics and monitoring,” said James Johnson, managing director, MedTech Breakthrough. “CAM represents a true digital health breakthrough and we are thrilled to recognize the Company with a 2019 MedTech Breakthrough Award in recognition of their outstanding success and innovation in the digital health space.”

This award adds to the growing market recognition of the innovative P-wave centric CAM patch. Last month, BardyDx was named both the winner of the 2019 Frost & Sullivan Award for Technology Innovation in Remote Cardiac Monitoring and the winner of the 2019 GeekWire Award in the Hardware of the Year category. Also, BardyDx was 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.

The full list of the 2019 MedTech Breakthrough Award winners can be found here

About MedTech Breakthrough:

Part of Tech Breakthrough, a leading market intelligence and recognition platform for global technology innovation and leadership, the MedTech Breakthrough Awards program is an independent program devoted to honoring excellence in medical and health related technology companies, products, services and people. The MedTech Breakthrough Awards provide a platform for public recognition around the achievements of breakthrough health and medical companies and products in categories that include Patient Engagement, mHealth, Health & Fitness, Clinical Administration, Healthcare IoT, Medical Data, Healthcare Cybersecurity and more. For more information visit MedTechBreakthrough.com.  

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.

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

Press Release :

Bardy Diagnostics Earns Acclaim from Frost & Sullivan for Its Groundbreaking Carnation Ambulatory Monitor™ Patch for Arrhythmia Monitoring

CAM™’s unique P-wave-centric ECG monitor offers unmatched signal clarity and superior arrhythmia detection

SANTA CLARA, Calif., May 6, 2019 /PRNewswire/ — Based on its recent analysis of the North American remote cardiac monitoring market, Frost & Sullivan recognizes Bardy Diagnostics, Inc. (BardyDx) with the 2019 North America Technology Innovation Award for its Carnation Ambulatory Monitor™ (CAM™) patch. The CAM™ patch is a first-of-its-kind P-wave-centric surface electrocardiograph (ECG) arrhythmia detection device that leverages state-of-the-art engineering and design to deliver groundbreaking monitoring.

2019 North American Remote Cardiac Monitoring Technology Innovation Award
2019 North American Remote Cardiac Monitoring Technology Innovation Award

“The patch’s use of advanced engineering and design allows it to detect different arrhythmias occurring at the same time, positively impacting patient management, especially when the arrhythmias may require different treatment decisions. For example, the CAM™ patch can accurately detect classic atrial flutter (AFL) and paroxysmal atrial fibrillation (PAF) occurrences. With a typical monitor, AFL may be obscured by AF presence, resulting in inadequate treatments and increased costs and risks to the patient,” said Kamaljit Behera, Industry Analyst at Frost & Sullivan. “BardyDX developed the CAM™ patch to provide 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 and subsequent patient management.”

The CAM™ patch’s novel circuit design and signal capture technologies result in accurate and clear P-wave detection and recording. As a result, the CAM™ patch delivers improved ECG resolution and diagnostic accuracy while simultaneously providing continuous data on the heart’s rhythm.

In addition, CAM™ patch’s ease-of-use promotes patient compliance and streamlines clinical workflows. To simplify diagnostics and reporting further, BDxCONNECT, a companion patient management portal, provides healthcare professionals with a single system for creating, accessing, and managing patient CAM™ reports. Finally, BardyDx’s augmented intelligence and visualization technologies will accelerate information delivery and clinically meaningful insights to clinicians while enhancing operational efficiencies.

“These product benefits have earned the company a wide interest from investors, including some of the largest healthcare venture capital firms, and many of the top US health systems are already using the CAM™ patch. Furthermore, the device is one of only a few monitors suitable for pediatric applications,” noted Behera. “Overall, BardyDx’s thought leadership, unparalleled innovation, and disruptive potential have positioned it for greater adoption in the cardiac monitoring market.”

Each year, Frost & Sullivan presents this award to the company that develops a product with innovative features and functionality that is gaining rapid acceptance in the market. The award recognizes the quality of the solution and the customer value enhancements it enables.

Frost & Sullivan Best Practices awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research to identify best practices in the industry.

About Bardy Diagnostics, Inc.
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 weighing more than 10kg (22lbs) 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. For more information, please visit www.bardydx.com.

About Frost & Sullivan
Frost & Sullivan, the Growth Partnership Company, works in collaboration with clients to leverage visionary innovation that addresses the global challenges and related growth opportunities that will make or break today’s market participants. For more than 50 years, we have been developing growth strategies for the global 1000, emerging businesses, the public sector, and the investment community. Contact us: Start the discussion.

Contact:
Bianca Torres
P: 1.210.477.8418
E: bianca.torres@frost.com

SOURCE Frost & Sullivan

Related Links
http://www.frost.com

Press Release :

Bardy Diagnostics™ Announces $35.5M in Series B Funding Round

SEATTLE, April 16, 2019 /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced today it has raised $35.5 million in Series B funding, led by River Cities Capital Funds with participation from new investors HealthQuest Capital, Aperture Venture Partners, Aphelion CapitalLumira Ventures, and Rex Health Ventures. Existing equity investors, SV Health Investors, Health Enterprise Partners, and Ascension Ventures also joined the round. The funds will be used to further accelerate growth of its innovative P-wave focused cardiac monitoring platform through expansion of BardyDx’s sales force and monitoring services, and to support advanced development programs, including augmented intelligence and visualization technologies.

“The caliber of our new investors in addition to our exceptional existing syndicate of financiers underscores the exciting opportunity before us,” said Gust H. Bardy, MD, Founder and Chief Executive Officer of BardyDx. “With these funds, we will grow our business by refining and expanding our primary goal of revealing to patients, and their physicians, the full complexity and meaning of their cardiac rhythm.” 

BardyDx’s Carnation Ambulatory Monitor (“CAM™”) is the industry’s only P-wave centric™ ambulatory cardiac patch monitor and arrhythmia detection device. The genesis of the CAM is a result of Dr. Bardy’s frustrations with the fundamental flaws rooted in the development and evolution of cardiac monitoring.

“For nearly 60 years, standard ECG engineering practices have over-processed the heart’s electrical message to make machines’ ‘lives’ easier at the expense of losing details in the ECG,” added Dr. Bardy. “In essence, such legacy engineering doesn’t listen to what the heart is trying to tell us but rather tells the heart what we are willing to hear. At BardyDx, our pioneering technology focuses on revealing the cardiac rhythm message fully, and in so doing, allows for precise and meaningful patient management predicated on cardiac truth.” 

BardyDx’s footprint within the cardiac monitoring industry continues to expand with growing recognition of the innovative P-wave centric technology. The company was recently selected winner of the Impact Pediatric Health Competition at SXSW, Children’s National Health System Pediatric Medical Device Innovation Competition, and 2018 Fierce Innovation Life Sciences Award for Medical Device Innovation. “Our Series B capital will continue to fuel the technological innovation that Dr. Bardy has always insisted on and for which BardyDx has come to be known,” said Mark Handfelt, BardyDx’s Chief Operating Officer.

BardyDx also announced that Rik Vandevenne, Managing Director of River Cities Capital Funds, and Garheng Kong, Managing Director of HealthQuest Capital, will join the company’s board of directors.

“It’s not every day you have the opportunity to partner with such a groundbreaking serial entrepreneur and innovator as Dr. Gust Bardy and the team at BardyDx,” said Vandevenne. “The company has a clear focus on putting the patient first and they have developed a clinically-superior ECG platform that is revolutionizing heart monitoring. We are excited for the opportunity to help further drive growth for the company while positively impacting the lives of thousands of people every week.”

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 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 weighing more than 10kg (22lbs) 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.

About River Cities Capital Funds:

River Cities is a growth equity firm investing in high-potential healthcare and information technology companies. A consistent, cohesive team has honed its strategy over six funds with compelling performance. River Cities seeks to be a business partner first and a capital provider second, investing significant human capital to leverage its domain expertise and a network of thought leaders assembled over the last 25 years. With $750 million of capital raised and a consistent track record of success, River Cities has established itself as a preferred source of growth capital. The firm, located in Cincinnati, OH and Raleigh, NC, is actively seeking new investments for its Fund VI. For more information, please visit www.rccf.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