Founder Profile: The Future Of Cardiac Monitoring

My father was a well known surgeon. I clearly remember one Saturday afternoon, in spite of chest pain that he was feeling and that was  typical for a heart attack, he did not react in time. He was simply in denial that it could happen to him. He waited for hours thinking it was indigestion that will go away. He waited too long. It did not end well for him and us, his family. 20+ years later, while working for Intel as a Senior Manager responsible for Pentium 4 design,  I invested as an angel investor in a company in the cardiovascular space. I started reading about how heart performs as “an electrical device”. I got deeply interested in it and the scenes of my father not having any tools at home to help him decide if indeed that chest pain was a heart attack was a deciding factor in me starting HeartBeam. I wanted to provide that timely and competent advice to chest pain patients on how to react to it: is it a heart attack or indigestion?

1. HeartBeam collects ECG information that describes heart’s activity in 3D space of electrical signals. The diagnostic value of these signals is as high as the standard 12-lead ECG. This is in stark contrast to the single lead ECG technologies such as AppleWatch and Kardia that can diagnose only some arrhythmias. Single lead ECG is only sufficient for (some) arrhythmia detection and is not enough to diagnose a heart attack. 3D signals that we collect from the heart are as good as, or more valuable than the standard 12- lead ECG that is part of the standard of care for heart attack diagnoses. 
2. Our device fits easily in a wallet and has no wires and external electrodes that need to be attached to the body. Devices that offer heart attack detection that are in the market do require a set of wires and special electrodes that patient needs to carry at all times and self attach to their body at the time they experience chest pain. Contrast that with our credit card sized device with integrated electrodes. 
3. Our iCardiologist system provides an instant advice generated by our cloud based expert system. It goes well beyond collecting cardiovascular signals. There is no product that offers this value to the chest pain i.e. potential heart attack patients. Cardiologists are welcome to be part of that diagnostic decision for the patient that is outside of a medical facility but they are not required. 

To clarify, a Harvard cardiology Professor has designed all our studies, but they were executed in Europe. These studies have shown that if you subscribe to our iCardiologist service that is with you 24/7 you have an advisor on how to react to your cardiovascular symptoms that is equivalent to a panel of 3 world class cardiologists  and a standard 12 lead ECG. Again, all that in your wallet 24/7. We have also shown that the false positive rate for non symptomatic patients was zero. This is hugely important as these non symptomatic patient recordings will be a very important part of our big data and enable deep learning and AI applications.

We expect that we will have to repeat our chest pain study under FDA rules in the US. We have developed a plan for FDA clearance path and we believe that we will finish the submission within 18 months. It is a brand new technology, a new category of solutions that did not exist in the form of a combined hardware and software solution for heart attack patients. Our biggest challenge is, based on that fact, finding a combination of predicate devices for our FDA submission. We have a proposal in place and we will be, in the near future, seeking FDA’s feedback.

At this time we have our technology fully developed for detection of heart attack and Afib. We plan to continue our development so that we can help  patients with heart failure and other cardiovascular conditions. In order to achieve the goals of FDA clearance and commercial introduction we will soon be seeking the A round of financing.

We need to convince cardiologists and heart patients alike that our solution works and that it can make a big difference in saving lives and healthcare dollars. In order to achieve that we will be publishing scientific articles and papers. Acceptance by cardiologist who will be recommending the iCardiologist to their patients, leads through high quality studies and publications. There are about 80 million people in the US that have a heart condition. We believe that our easy to use technology that is always with the patient will bring much needed peace of mind and timely intervention to this large segment of the US population. Insurance companies stand to benefit as well as our technology will substantially reduce the number of unnecessary ER visits. Cost of unnecessary ER visits for chest pain is well over $10B!

The most common feedback we hear from the high risk heart patients is that  the key benefit of participating in our studies is that they felt a much reduced level of fear and anxiety as they had their iCardiologist with them 24/7. They really liked the fact that the hardware fits easily in a wallet and that the feedback they received from the iCardiologist was in the form of an instant and  clear instructions on how to proceed and react to their symptoms. Many felt that the iCardiologist was “an alarm” for the heart when they really needed it.

Our product has created a new category. That means that it created a new value and new market for an “electronic cardiologist” when no real physician  is available. The challenge for a novel product like our iCardiologist is always in the initial market acceptance. We need to educate both patients and physicians of the capabilities and the value we offer.

We have an exceptional mix of experiences and specialties in our executive team. Our team members have both big company, as well as startup experience. The team is a balanced mix of technology and life sciences experts. This type of team is required to create a new category that merges the best of high tech and life sciences. As we approach commercialization phase we will be focusing on attracting top notch marketing and sales talent. 

We have been focusing and will stay focused on increasing the value of our company. FDA clearance and commercial introductions are two key milestones that will increase our value. At the time we start getting traction in the marketplace we would not be surprised if a big tech or medical device player decides to approach us for a partnership or acquisition. Again, for us it is all about increasing the value by achieving the milestones and whether it is through an IPO or an MA event we are convinced that it will be satisfactory to our founders, employees and investors.