HeartBeam: Expects HeartBeam AIMI System Approval in Near Future

 Developed by our pioneering team, our HeartBeam AIMI and HeartBeam AIMIGo solutions will transform the way patients and doctors detect heart attacks. By providing remote, 12-lead 3D vector ECG (VECG™) capability, the HeartBeam platform intends to offer fast, accurate detection of heart attacks and complex cardiac arrhythmias for the first time outside of a medical setting.

We expect the HeartBeam AIMI system for use in acute care settings to receive regulatory approval in the near future. We are in discussions with the FDA and plan to meet with them soon and expect HeartBeam AIMI to be cleared in the Q1 2023 time frame. The HeartBeam algorithm used in an emergency department setting leverages existing 12-lead ECG hardware and provides the attending physician with an instant comparison of the patient’s baseline and symptomatic ECG with a diagnostic suggestion for their consideration in the patient’s diagnosis. This will allow physicians to quickly determine if a patient needs intervention or can be discharged which helps manage ED capacity.

Our HeartBeam AIMIGo solution is the first and only credit card-sized device with 12-lead 3D vector ECG capability coupled with a smartphone app and diagnostic software for remote heart attack detection. FDA submission for HeartBeam AIMIGo Version 1 is projected for Q1 2023. In preparation for commercial launch, we recently signed an agreement with Evolve Manufacturing Technologies, a contract medical device manufacturing company, to build the credit card-sized HeartBeam AIMIGo device. We will leverage Evolve’s manufacturing and packaging expertise to support commercialization of the HeartBeam AIMIGo Version 1 device in anticipation of early market testing in Q2 2023. We anticipate the HeartBeam AIMIGo Version 2 device with synthesized 12L capability to be ready for FDA submission at the end of Q2 2023.

We plan to focus in 2023 and 2024 on the expansion of our core technology features, the 3D VECG data and clinical studies that we believe will establish our platform as the standard of care for ambulatory-based cardiology and taking advantage of the comprehensiveness of our technology.

Novel technologies that solve real healthcare problems are the bedrock of HeartBeam. During the year we strengthened the intellectual property (IP) around our technologies by receiving several seminal patents. Among these patents, one has particular importance. This is the patent for a 12-lead 3D vector ECG patch monitor intended for detection of heart attacks, a limitation of current patch technology, along with the ability to detect complex cardiac arrhythmias. Our 12-lead ECG patch technology will open the door to the global ECG patch monitor market which is estimated to reach $4.8B by 2030 and bring a level of diagnostic accuracy consistent with current 12-lead ECG standard of care. Additionally, we broadened our future product portfolio with a patent for a 12-lead ECG smartwatch-based monitor for detection of heart attacks and complex cardiac arrhythmias. With the global wearables medical device market estimated to reach $196B by 2030, incorporating our cutting edge 12-lead 3D vector ECG technology into a smartwatch could make all current single lead smart watch products obsolete for detecting cardiac conditions. We believe that for the first time, and based on our technology, a smartwatch will provide enough data to a physician to be able to detect a heart attack and other complex cardiac conditions.

Currently, available smartwatches are limited to detecting only irregular heart rhythms and recent studies show they generate a high rate of false positives and inconclusive results. The combination of a current generation single lead smartwatch with the HeartBeam AIMIGo 3D VECG technology provides the patient and clinician the benefit of a 12-lead ECG to interpret the cardiac event. We believe the integration of these platforms will transform the clinical accuracy of mobile technologies for monitoring at-risk cardiac patients.

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