HeartBeam, Inc. (NASDAQ:BEAT) Q4 2023 Earnings Call Transcript

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Secondly, based on the fact that this technology will be with the patient 24-7, and very many ECGs will be taken by the patient and users over time, this longitudinal data is normally not available in the hospital ECG environment is an extremely important source of differential signals that AI, we believe, can comprehend and shed additional light on the cardiac condition of that patient. And lastly, we have 30-second recordings, right? And all these tools that you see published in the results given are for 10-second recordings. So, having 30-second recordings will make a positive impact on the accuracy as well. So, all in all, in summary, we are following, but our unique situation is that we have a set of signals, a set of features that go beyond what everybody else has.

So, that’s the main reason why we are developing the internally, which, on the other hand, we plan, actually, to engage some of these academic institutions in the future for some of the predictive algorithms, perhaps. And so, I wouldn’t be surprised if we actually engage one of them because they have many, many more signals. And secondly, in some of the areas of prediction, they might be well ahead of everybody else.

Unidentified Company Representative: Thank you. The next question is, where will the AIMIGo device be manufactured?

Rick Brounstein: Yeah, this is Rick. I’m happy to take care of that. Do you want to do that?

Branislav Vajdic: No, go ahead.

Rick Brounstein: All right, sure. So, thank you. So, we’ve been working in Silicon Valley with Triple Ring, who’s been helping us with the development of the hardware, and they link in with a group called Evolve Manufacturing. All of those are discussed in the 10-K. And Evolve will do the initial manufacturing, the quality systems interlink. We’re looking forward to an easy transition. Ultimately, when we get into higher volumes, we’ll likely be moving off-site. But in the initial, we can probably make $10,000 a month or so. So, I think it’ll get us going for some period of time.

Unidentified Company Representative: Great. Thank you. Our next question, are you able to deal with cybersecurity aspects? I hear that the FDA and the SEC are very much focused on that.

Branislav Vajdic: Debbie, please.

Deborah Castillo: Sure, I can take that. So, certainly, cybersecurity is clearly an important area for FDA, but also for our team, as we strive to keep our systems secure. 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. I’ll also point out that we’ve included our cybersecurity policy, which is disclosed in the 10-K, for additional information.

Unidentified Company Representative: Great. Thank you. Next question, medical studies are usually very expensive. Did you fully account for the cost of your valid ECG study within your final financial projections? Can you speak to the cost of the study?

Rick Brounstein: Yeah. It actually is not so expensive, as people might believe. There is no intervention required. There’s no follow-up required. So, it is much less expensive. We’ve actually signed contracts with a clinical research organization, and the first of our expected five sites. In the footnotes in the financials, if you go to the very end and the subsequent events, we quantified it, and you can see that the commitment to the CRO is about a half a million, and the cost of the enrolling the approximate 200 patients, 198 we’re predicting, is going to be about 200,000.So, the full cost of the study is going to be about 700,000.

Unidentified Company Representative: Thank you. There are no more questions at this time, so I’d like to now turn the call back over to Dr. Vajdic for his closing remarks.

Branislav Vajdic: Thank you, operator. I would like to thank each of you for joining our earnings conference today, and look forward to continuing to update you on our ongoing progress and growth. If you were unable to answer any of your questions, please reach out to our IR firm, MZ Group, who will be more than happy to assist. Again, thank you very much for your participation today.

Operator: And this concludes today’s conference, and you may disconnect your line at this time. Thank you for your participation.

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