Jon Hunt is the President and CEO of Bardy Diagnostics (https://www.bardydx.com/). Prior to Bardy, Jon spent 11 years as the Vice President of Clinical & Regulatory Affairs with Cameron Health, Inc. (acquired by Boston Scientific Corporation in 2012). He spent the 10 years prior with Cardiac Pacemakers, Inc., St. Jude Medical and Cardiac Pathways Corporation. Jon began his career with Cardiac Pacemakers, Inc. (now Boston Scientific Corporation) as the Director of Clinical Programs; he subsequently held positions at St. Jude Medical in Clinical Affairs and as the Business Unit Director for the Cardiac Rhythm Management division for Europe, the Middle East, and Africa. Jon has extensive experience providing key support to cardiac electrophysiologists around the world to ensure that they, and their patients, implement new technologies safely and effectively.
How did you and Dr. Gust Bardy, the founder of Bardy Diagnostics, initially connect?
Gust and I first worked together at Cameron Health, a medical device start-up company developing the world’s first totally subcutaneous implantable defibrillator (S-ICD®). Gust was the Founder of Cameron Health, Inc. and I was hired as the VP of Clinical and Regulatory Affairs in early 2002. Gust and I worked closely together on evaluating the clinical feasibility of the S-ICD and I was responsible for running the clinical trials to gain regulatory approvals in Europe in 2009 and the US in 2012. Cameron Health was acquired by Boston Scientific Corporation in 2012. Gust had been thinking about developing an ambulatory cardiac ECG monitor and shortly after the acquisition of Cameron Health asked me to join Bardy Diagnostics, Inc. once I exited Boston Scientific. I left Boston Scientific in September 2013 and became the CEO of Bardy Diagnostics in October 2013.
Explain how the CAM monitor works. What are its improvements on traditional ECG monitors?
The CAM is a single-lead, patch-based ambulatory cardiac ECG monitor that is approved for use in the US & Europe and fits within existing reimbursement codes in each region. Traditional Holter and Event Monitors are typically multi-lead systems that are connected to recording hardware that is worn on the patient’s belt or a lanyard, while the low-profile CAM is simply placed on the patient’s sternum. Traditional monitoring systems are cumbersome for the patient and result in poor patient compliance which is reflected by the low diagnostic yield (<10%) for these systems.
The CAM is the world’s smallest and lightest P-wave centric ambulatory cardiac monitor and arrhythmia detector. It is specifically designed to detect the P-wave, which defines the heart’s atrial electrical activity. Arrhythmias are defined by P-wave morphology and its relationship to the QRS. Detecting the P-wave and understanding its relationship to the QRS is critical to accurate rhythm diagnosis. Location of the atria and their low-amplitude signal make P-waves difficult to see. We designed the CAM sensing architecture with these factors in mind and the result is that the device’s functionality is built into the hardware and is not dependent on a software algorithm to see the P-wave. In addition, the CAM’s recorder has an extremely low noise floor to enable it to detect the low amplitude P-wave signals. The combination of these patented design elements allows the CAM to reliably see the P-wave and improve the prospects for clinically actionable arrhythmia diagnoses and timely interventions. The earlier intervention and proper treatment of arrhythmias has the potential to drastically reduce the long-term complications and costs.
Which patients benefit most from this technology?
The CAM technology is beneficial for all patients undergoing cardiac monitoring. Its design is female friendly and allows all patients to go about their normal daily activities, including exercising and showering, while being continuously monitored. Bardy provides the monitor directly to hospital systems, cardiology groups and electrophysiologists, so patients interested in the CAM should consult their physician to see if system is right for them.
What are your greatest challenges in the cardiac monitoring space?
Cardiac monitoring is a very high volume market, there are approximately 4-4.5 million cardiac monitors prescribed per year in the US. There has been very little innovation since the first Holter monitors were introduced in the 1960s. Current technologies are viewed as outdated and clinicians have low expectations because historically the diagnostic yields are low (<10%) and patient compliance is low, resulting in delayed, poor and missed diagnoses. Given the size of the market, the other big challenge we face is scaling the back-end infrastructure to accommodate data handling for centers around the world. We’ve developed the BDx web portal hosted on Microsft’s Azure Cloud to allow us to upload patient data, analyze it either locally at a hospital or clinic, or with a third-party ECG reading site, and provide patient ECG reports. The web portal allows us to host clinical data on the cloud in different geographic regions around the world to comply with patient information confidentiality legislation.
What is next on the horizon for Bardy?
We are in the process of scaling our US and European commercial operations. Our recent funding allowed us to hire a full direct sales team in the US to accelerate our US sales efforts. We have signed a distributor in the UK who is responsible for leading our sales efforts in Europe. We have developed a BDx web portal to allow customers to upload patient data, analyze the data, and access patient ECG reports. Our engineering resources are currently dedicated to supporting the BDx web portal development and to complete a multi-use recorder project for the CAM. The two-part design of the CAM allows us to provide a cost-effective solution for cardiac monitoring worldwide by providing a disposable patch (the Battrode) and a reusable recorder. This, in turn, allows us to launch the CAM globally, even in typically low-cost markets.
What occupies your time outside of the office?
My wife and I spend time at home with our two dogs, we entertain frequently and we are actively involved with several philanthropic endeavors in the Charlotte area. We enjoy traveling and take at least one trip a year to a location on our must do list.