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Monitoring a patient’s heart condition is an extensive undertaking considering the current standard of care practices. Up until a few years ago, heart patients seeking to have their condition monitored outside of a clinical environment were tasked with wearing a monitoring device called a Holter monitor.
Holter monitors and records electrocardiographic signals from an individual as they go through their regular daily activities. Think of having an old "Walkman" with wires sticking out and strapped to you as you go through your daily life. Furthermore, the Holter monitor was developed in 1957 by Dr. Norman Holter. Given the incredible technology available today versus 1957, it is hard to believe the mobile ECG has not seen any major hardware updates in decades.
HeartBeam (NASDAQ: BEAT) is one company that is working on a 21st-century upgrade to the outdated wearable ECG market, using a convenient patch to help patients monitor their heart condition using a 12-lead ECG.
What is the Importance of a 12-Lead ECG and Why Existing Patch Options Fall Short
Wearable medical technologies continue to permeate into mainstream consumer electronics, as individuals look for ways to help monitor their health and wellness. Among the most popular wearables available right now is the Apple (NASDAQ: AAPL) Watch. Consumers have been told they can monitor several different health and wellness metrics, including being able to take an ECG on the go.
Unfortunately, what is not immediately known to those consumers is the fact the Apple Watch only uses a single-lead ECG. In the context of obtaining useful medical information, a single-lead ECG does not tell the patient or medical professionals very much at all. Single-lead ECGs only record one dimension of the heart's activity and do not provide the needed medical data to determine if an individual is having a heart attack or cardiac episode.
The 12-lead ECG, on the other hand, provides a complete, standard of medical care, information for a patient’s heart. Rather than just monitoring rhythm, the 12-lead ECG provides diagnostic information needed for the detection of all heart diseases. For example, single-lead ECGs cannot detect ischemia, a condition that restricts blood flow to the heart and eventually results in a heart attack.
Currently, there are a few patch products available on the market for heart patients. However, these products are largely single-lead and are only focused on diagnosing arrhythmias. These existing patch products are not capable of diagnosing any condition related to Coronary Artery Disease (CAD), which occurs when plaque builds along the heart's walls and can cause a life-threatening heart attack. Zio Patch by iRhythm Technologies (NASDAQ: IRTC) is considered to be the current market-leading patch option available today. However, the product again only has single-lead capabilities.
Overall, the wearable ECG device market is estimated to be valued at a total addressable market of $2 billion in the United States alone, according to iRhythm. According to ResearchAndMarkets.com, the global ECG patch and Holter monitor market are estimated to reach $4.8 billion by 2030. This represents a compound annual growth rate (CAGR) of 19.16% between 2022 and 2030.
With a CAGR of just under 20%, the patch and wearable ECG market is forecast to grow substantially faster than most other industries. HeartBeam’s disruptive technology could help them obtain a huge advantage over the existing products available today.
HeartBeam’s Patch and AIMIGo ECG Technologies
Through HeartBeam’s credit-card-sized AIMIGo 12-lead ECG device, patients at a high risk of heart attack can carry this ECG device in their purses or wallets without any major inconveniences to ensure anytime, anyplace monitoring. The company’s patch product is designed to be used by patients who are experiencing cardiac symptoms but do not have an existing underlying diagnosis.
Despite HeartBeam’s high patient convenience factors the 12-lead data that is obtained is not reduced in value in any way. This ensures that patients and medical professionals are obtaining accurate health data to ensure a proper diagnosis and treatment plan. Furthermore, combining the convenience of a credit card-sized device with a more powerful 12-lead ECG, means that medical professionals would not likely prescribe a single-lead option when a better option is available. Not only that HeartBeam solutions offer critical remotely collected highly relevant medical data for use in a treatment plan, but these devices have potentially more favorable economics to that medical practice as well.
HeartBeam’s disruptive ECG products are protected by U.S. patents. In fact, the company’s patent portfolio accounts for six granted patents that serve as vital protection for its technology against competitors. These patents continue to help HeartBeam position itself as a major player in the high-growth industry of cardiac telehealth.
Specifically for the 12-lead patch product, HeartBeam was granted a U.S. patent in September 2022. The patent (No. 11,419,538 B2) expanded on the company's previously granted patent (No. 11,071,490 B1) for a 12-lead ECG patch monitoring technology. These two issued patch patents serve as a major foundation for the company's intellectual footprint as the company looks to expand its technology to make cardiac patients and their medical professionals' treatment options more effective.
Overall, HeartBeam’s planned 12-lead ECG patch product is reportedly the first-of-its-kind and only such technology in existence. The U.S. patents granted for this disruptive technology help to ensure HeartBeam is protected from competitors and can potentially commercialize the products once approved by the FDA. HeartBeam looks to be at the forefront of the mobile, wearable ECG market, which gives freedom to patients while also ensuring regular monitoring of their conditions. For investors, patients, and medical professionals, HeartBeam’s technologies look to be a major game-changer.
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