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| Statement |
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| The 3D VECG approach is an excellent platform for AI algorithms |
| And finally, in the longer run, we believe that applying deep learning algorithms on top of the rich VECG data that we obtained from our AIMIGo device, especially with the longitudinal data set from patients taking repeated recordings, could result in an unparalleled predictive and diagnostic capability |
| And adding a baseline reading for comparison, which is a crucial part of our system, resulted in significantly better accuracy than a single 12-Lead ECG |
| patents, enhancing our already strong IP portfolio |
| We anticipate that our strong cash position provides runway to early 2025 |
| To that end, our internal teams, in conjunction with working with cybersecurity experts in the field, we feel confident that we are able to meet all regulatory expectations, both from the FDA and the SEC side |
| And finally, as we will discuss in more detail, combining deep learning algorithms with a large number of longitudinally-created ECGs has the potential to create an unparalleled predictive and diagnostic algorithm |
| We will continue to advance our robust product pipeline that includes AI-enabled advances to expand indications as well as patient-friendly four factors such as the on-demand 12-Lead patch and the 12-Lead HeartBeam watch |
| So, having 30-second recordings will make a positive impact on the accuracy as well |
| We believe that, when combined with our credit card-sided AIMIGo 3D VECG technology, HeartBeam's AI will provide additional value to patients and physicians in a number of ways, including providing automated classification of cardiac conditions, including common arrhythmias, the potential to further enhance the user experience and simplify the onboarding process |
| So, in conclusion, this is an exciting time for HeartBeam and 2024 is a pivotal year in our company's evolution |
| It will also serve as a robust and IP protected foundation for many future developments |
| We're encouraged about the progress and the initial results we presented at scientific meetings in Q2 |
| So why do we think that an easy-to-use 12-lead ECG with patients is transformational? Well, first, having the ability for patients to take frequent 12-lead readings over time and in a variety of real-life situations potentially has huge diagnostic value |
| The leadership has deep AI expertise experience, including positions at Apple, Microsoft, and Google |
| As we continue to navigate the progress towards clearance, we have taken advantage of all available regulatory tools and opportunities to work interactively with FDA, gaining valuable official communication and feedback on our proposed response approach, including our testing protocol |
| As Debbie noted, we have made significant progress on the AIMIGo clearance, having successfully passed the acceptance of the filings and have completed the initial review phase |
| We remain confident that we have sufficient funds to deliver on our limited launch of AIMIGo that is currently anticipated to occur by the end of this year |
| We are very much encouraged by the progress and early results and we look forward to presenting the initial clinical data on AI at scientific meetings in Q2 of this year |
| We remain confident that we have sufficient funds to deliver on our milestones and get prepared to move into commercialization phase of HeartBeam AIMIGo |
| Unidentified Company Representative Excellent |
| So, all in all, that's the key why we are following what's happening in the field, but our unique situation is that we have even more data-rich set of signals, and that's why we like to take full advantage of those sets of signals that come out of AIMIGo device |
| In addition, there is significant clinical research over several decades that demonstrates the diagnostic value of a VECG approach |
| An effective triage tool in the hands of the patient would reduce the number of unnecessary emergency room visits and reduce costs to the healthcare system |
| The AIMIGo device, coupled with a smartphone app and cloud-based diagnostic software, enables a remote evaluation of cardiac symptoms by physicians, and we believe it could reduce the critical time to intervention for heart attack patients |
| And secondly, in some of the areas of prediction, they might be well ahead of everybody else |
| We have taken advantage of all available regulatory tools and opportunities to work interactively and intensely with the FDA |
| Secondly, trending a 12-lead ECG, both symptomatic and asymptomatic over time, will allow physicians to gain insight to help guide cardiac care |
| Shortening that time from symptoms to the door or a medical institution would reduce complications and save many lives |
| So, that's the key differentiation |
| Statement |
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| Our cash spending is actually down in fiscal 2023 compared to fiscal 2022 |
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