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Interview with Dr. Dov Rubin, CEO of Lev-El Diagnostics on HeartTrends

MDNM: What is HeartTrends and how can it be used in the early detection of myocardial ischemia?

Dr. Dov Rubin: HeartTrends® is a stress test alternative, offering early detection of myocardial ischemia in relatively healthy individuals without physical stress. The clinically proven test analyzes 20 minutes of heart rate data obtained by wearing a standard heart rate recorder such as a strap, smartwatch or bracelet, without the need for stressful maneuvers or heart strain. This is a true differentiator for those populations for which not having to undertake a stressful test has a meaningful impact – particularly the elderly, impaired and over-weight. HeartTrends’ technology represents the next step in digital heart health monitoring for wearable smart devices – an easy to take, timely and affordable option we would like to see become the newest cardiac risk factor and part of a standard annual health checkup and the normal standard of care.

MDNM: You say HeartTrends is a stress test alternative but without the stress. How easy is HeartTrends really to use?

Dr. Dov Rubin:: There is no physical stress involved in a HeartTrends test. In fact, a user can sit down and record his/her heart rate and HeartTrends will analyse the heart rate variability (HRV) of a normal, non-stressed heart. Sitting, talking, eating, strolling, and even shopping are all acceptable activities that will produce reliable test results. Importantly, this process removes the fear-factor that comes with taking a traditional treadmill stress test and represents an accurate, low-cost, easy-to-use and time-efficient alternative.

MDNM: How does this differ from traditional stress testing?

Dr. Dov Rubin: Both HeartTrends and traditional treadmill stress testing are designed to detect ischemia, but use two different methods to reach a diagnosis. The famous Framingham Heart Study showed that HRV is a well-established marker of mortality and sudden death, which is accentuated in patients with coronary artery disease (CAD) even at rest. Based on this clinical evidence, HeartTrends was developed to provide an innovative analysis with a high sensitivity for early detection of myocardial ischemia at rest.

MDNM: Digital heart health monitoring has been a significant growth area for the wearable smart-device market. Some monitoring devices have failed and/or inefficient. How does HeartTrends differ from similar technology currently being used in the wearable smart devices?

Dr. Dov Rubin:: Today’s wearable smart devices record and calculate all sorts of different statistics, such as the counting of heartbeats in a certain period of time. However, not all of them can create a medically meaningful statement from these statistics. Health monitoring in the wearable smart-device market is moving beyond meaningless statistics and more towards substantial tests that allow individuals to take control of their personal health. HeartTrends is a clinically proven and medically meaningful test relevant to 80% of the world’s healthy population with no known cardiac disease. By comparison, the AFib-detecting technology used in current wearable smart-devices such as The Apple Watch, is only relevant to 2% of individuals. HeartTrends represents a significant upgrade to current technology and has the potential to usher in the next wave in digital heart monitoring for wearable smart device developers.

MDNM: Apple recently released a study in partnership with Stanford University & The American College of Cardiology. Hasn’t The Apple Watch’s AFib feature pre-empted HeartTrends?

Dr. Dov Rubin: Comparing Afib to HeartTrends is like comparing apples to oranges. Afib is not as prevalent in the general population as ischemia. The Apple study on 400,000 individuals, just released this month showed that Afib affected only 0.5% of their population. Comparatively, the Mayo Clinic study using HeartTrends, presented at the American Heart Association, showed the presence of ischemia in 6.3% of healthy individuals. That means HeartTrends is 1,200% more relevant for the general population than monitoring AFib! Notably, a smartwatch with the HeartTrends functionality installed would have the ability to detect ischemia in 80% of the world’s healthy population with no known cardiac disease. Of course, both features in the same smartwatch would create a true digital heart health monitoring powerhouse.

MDNM: What commercial opportunities does this represent for wearable smart-device developers?

Dr. Dov Rubin: Smartwatches can be the hub of true personalized digital health monitoring. To date, some facetiously refer to smartwatches as “solutions seeking real problems to solve.” The first wave of watches measured signals and reported them without interpretation or relevance, such as rudimentary step counting, calorie consumption guesstimates, cumulative heartbeats per day, quality of sleep and more, but fail to provide any meaningful data interpretation behind it. HeartTrends is the new wave of digital health tailor-made for a smartwatch offering the ability to perform an early detection stress test on demand.

MDNM: As a cost-effective, time-efficient and easy to use stress test alternative, what benefits does HeartTrends present to the medical community, particularly for insurers

Dr. Dov Rubin: By offering an early window into the existence of ischemia, insurance companies benefit immediately from improved underwriting via early warning detection of coronary artery disease. The test is both simple and cost effective, allowing more people to be tested than before and radically improving pass through rates of applicants. Just the cost-savings of avoiding a single life insurance policy due to imminent ischemia onset could more than cover the cost of testing the entire population of insurance applicants! “We look forward to recommending HeartTrends to our clients enabling the insurance industry to improve actuarial risk assessment and increase production in the years ahead,” says Hillel Damelin, CEO Swiss Re Israel.

MDNM: HeartTrends received attention when results of the world’s largest prospective multi-center clinical study in collaboration with the Mayo Clinic were announced and presented at The American Heart Association’s (AHA) 2019 Annual Scientific Late Breaking Sessions on November 17th. What was the focus of the study and are future studies planned?

Dr. Dov Rubin: The Mayo Clinic study focused on early detection of ischemia in healthy individuals. This study now introduces the first new cardiac risk factor, HRV, since diabetes was introduced in 1979. People around the world will now have access to take an easy-to-use, and convenient early detection stress test without the fear and apprehension of running on a treadmill to the point of dizziness and fainting. Remember, stress testing is usually reserved only for people who are already suspected of having advanced heart disease. Deploying artificial intelligence and machine learning, as the quantity of tests increase, will enable HeartTrends to grow drastically and refine its ischemia categorizations in the future.

MDNM: How do the findings of the study impact the way we look at traditional cardiac risk factors and what has been the medical community’s reaction?

Dr. Dov Rubin: The medical community has already expressed interest about this new, easy-to-use, and cost-effective analysis as it offers a unique window into the individual’s heart health. University of Rochester Professor and Director of Cardiology, Ilan Goldenberg MD, said it best, “In the era of wearable digital monitoring devices and increased interest in personalized approaches to risk assessment, HRV will provide useful information to direct lifestyle change, and to monitor general health status.”

Dr. Dov Rubin:: This is an exciting time – in the evolution of wearable technologies – and, equally, for people to now have the access to the information necessary to take control over their personal health. The challenge is finding a way to scale such advancements in medical technology so that people worldwide have access to, and can benefit from, them. With heart rate monitoring now a ubiquitous measurement, HeartTrends offers the ability to elevate these measurements and obtain insights to heart-health at a globally affordable price point – the democratization of health monitoring.

MDNM: What are the next steps for Lev El Diagnostics and HeartTrends in this space?

Lev-EL Diagnostics – the developers of HeartTrends – is continuing its research into other diseases that affect the autonomic nervous system reflected by measuring HRV. We are currently undertaking advanced international research into early detection of diabetes – a world epidemic – as well as contemplating early detection of Parkinson’s disease.

MDNM: How easy is it for consumers to access HeartTrends technology?

Dr. Dov Rubin:: HeartTrends is currently a B2B product administered by health clinics and labs around the world. The test is medically CE-certified across Europe and has performed over 24,000 tests. The app is available by simple download from the Google Play Store outside the US. It will soon be available in the US and for Apple users as well. We are seeking discussions with smartwatch manufacturers to make HeartTrends available to the general public as a B2C feature adding significant value to each device. This has the real potential to be a smartwatch game-changer.

MDNM: Lastly, how can people learn more about HeartTrends?

Dr. Dov Rubin: More information can be found on the HeartTrends’ website (www.heartrends.com) or by contacting info@Levhm.com.

 

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Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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