Q3 2022 Heartbeam Inc Earnings Call

Operator: Greetings, and welcome to the HeartBeam Third Quarter 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. As a reminder, this conference is being recorded.

Operator: Before we begin the formal presentation, I would like to remind everyone that statements made on the call and webcast may include predictions, estimates, or other information that might be considered forward-looking. While these forward-looking statements represent our current judgment on what the future holds, they are subject to risks and uncertainties that could cause actual results to differ materially.

Operator: You are cautioned not to place undue reliance on these forward-looking statements, which reflect our opinions only as of the date of this presentation. Please keep in mind that we are not obligating ourselves to revise or publicly release the results of any revision to these forward-looking statements in light of new information or future events.

Operator: Throughout today’s discussion, we will attempt to present some important factors relating to our business that may affect our predictions. You should also review our most recent Form 10-K and Form 10-Q for a more complete discussion of these factors and other risks, particularly under the heading Risk Factors. A press release detailing these results crossed the wires this afternoon at 4:01 p.m. Eastern Time and is available in the Investor Relations section of our company’s website, heartbeam.com.

I'd also review our most recent form <unk> and Form 10-Q for a more complete discussions of these factors and other risks, particularly under the heading risk factors a press release detailing these results crossed the wires. This afternoon at four O N P. M. Eastern time and is available in the Investor Relations section of our company's website hurt.

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Operator: Your host today Branislav Vajdic, Chief Executive Officer and Founder; Jon Hunt, Chief Business Officer; and Rick Brounstein, Chief Financial Officer, will present results of operations for the third quarter ended September 30, 2022. At this time, I will turn the call over to HeartBeam Chief Executive Officer, Branislav Vajdic. Please go ahead.

Brenna Suave Idec. Please go ahead.

Branislav Vajdic: Thank you, operator, and good afternoon, everyone. I’m pleased to welcome you to today’s third quarter 2022 financial results conference call. I could not be more enthusiastic about the future of HeartBeam, the rapid pace of our product timeline and our team’s ability to scale our commercialization path. 

I'm pleased to welcome you to todays third quarter 2022 financial results Conference call. I could not be more enthusiastic about the future. The rapid pace of auto product timeline, and our team's ability to scale our commercialization path.

I could not be more enthusiastic about the future. The rapid pace of auto product timeline, and our team's ability to scale our commercialization path.

The rapid pace of auto product timeline, and our team's ability to scale our commercialization path.

Those of you.

Branislav Vajdic: For those of you joining us for the first time, I’d like to take a moment to introduce HeartBeam and our opportunity in a short video introduction. The video explores the HeartBeam AIMIGo technology need market opportunity and use in heart attack detection. AIMIGo is the first and only credit card sized 12-lead ECG device for remote heart detection with a 510(k) regulatory pathway. While we’re playing the video for our dial-in participants unfortunately, it’ll be about three minutes of silence, but I’d like to remind you that the video is available on our website, heartbeam.com.

The video explores the heartbeat Amy go technology.

Need market opportunity and use in heart attack detection.

Amy go is the floor.

And all the credit card side that will lead ECG device for remote heart attack detection with a five.

Hi, Thank you I think it was 30 pathway.

While we are playing the BDO our dial in participants unfortunately.

It will be about three minutes of silence, but I'd like to remind you that the video is available on our web site <unk> Dot com.

Video presentation: Undiagnosed heart attacks can be lethal for individuals and costly to the health care system. Today, chest pain is the second most common reason for an ER visit in patients over 45. However, 82% of those visits are unnecessary and cost the health care system over $10 billion each year. Because of uncertainty, patients often delay seeking care for an average of three hours, causing a 40% increase in mortality rates. Currently available ECG monitoring solutions are indicated only for screening for arrhythmia, but not for heart attacks. Heartbeam's innovative technology, the Heartbeam AIMIGo device introduces a simple patient friendly solution designed specifically for heart attack detection. This credit card sized device paired with the smartphone application with patients in immediate contact with their care team. The patient places the wireless device on their chest for a 30 second signal recording. The patient's health care provider is then notified of the new ECG. To fully characterize the three dimensions of the heart, Heartbeam captures the heart's electrical activity in 3D by recording X, Y and Z projections into a simple user-friendly platform. The Heartbeam AIMI system provides a comparison of the patient's baseline ECG along with a symptomatic ECG with a marker and a diagnostic suggestion, indicating potential heart attack. The results are instantly shared with the patient's care team to the Heartbeam AIMI proprietary cloud-based platform. Physicians are aided by a fully autonomous diagnostic system to view the ECG, review diagnostic suggestions and direct to patient accordingly. Today, clinicians must rely on 12 lead ECG for heart attack detection performed solely within a hospital or clinic. Heartbeam's AIMI and AIMIGo technology has the potential to become the standard of care for cardiac patients with the potential to serve over 18 million patients in the U.S. alone. With a simplified 12 lead ECG process in a portable solution, Heartbeam is poised to revolutionize the healthcare industry by saving lives, reducing costs, improving the patient experience and provider outcomes, while advancing diagnoses with technology that can be used anytime, anywhere. Heartbeam, putting tomorrow's technology in patients hands today.

Today, chest pain is the second most common reason for an ER visit in patients over 45. However, 82% of those visits are unnecessary and cost the health care system over $10 billion each year.

However, 82% of those visits are unnecessary and cost the health care system over $10 billion each year.

Because of uncertainty, patients often delay seeking care for an average of three hours, causing a 40% increase in mortality rates. Currently available ECG monitoring solutions are indicated only for screening for arrhythmia, but not for heart attacks.

Currently available ECG monitoring solutions are indicated only for screening for arrhythmia, but not for heart attacks.

Heartbeam's innovative technology, the Heartbeam AIMIGo device introduces a simple patient friendly solution designed specifically for heart attack detection. This credit card sized device paired with the smartphone application with patients in immediate contact with their care team. The patient places the wireless device on their chest for a 30 second signal recording. The patient's health care provider is then notified of the new ECG.

This credit card sized device paired with the smartphone application with patients in immediate contact with their care team. The patient places the wireless device on their chest for a 30 second signal recording. The patient's health care provider is then notified of the new ECG.

The patient places the wireless device on their chest for a 30 second signal recording. The patient's health care provider is then notified of the new ECG.

The patient's health care provider is then notified of the new ECG.

To fully characterize the three dimensions of the heart, Heartbeam captures the heart's electrical activity in 3D by recording X, Y and Z projections into a simple user-friendly platform. The Heartbeam AIMI system provides a comparison of the patient's baseline ECG along with a symptomatic ECG with a marker and a diagnostic suggestion, indicating potential heart attack. The results are instantly shared with the patient's care team to the Heartbeam AIMI proprietary cloud-based platform. Physicians are aided by a fully autonomous diagnostic system to view the ECG, review diagnostic suggestions and direct to patient accordingly.

The Heartbeam AIMI system provides a comparison of the patient's baseline ECG along with a symptomatic ECG with a marker and a diagnostic suggestion, indicating potential heart attack. The results are instantly shared with the patient's care team to the Heartbeam AIMI proprietary cloud-based platform. Physicians are aided by a fully autonomous diagnostic system to view the ECG, review diagnostic suggestions and direct to patient accordingly.

The results are instantly shared with the patient's care team to the Heartbeam AIMI proprietary cloud-based platform. Physicians are aided by a fully autonomous diagnostic system to view the ECG, review diagnostic suggestions and direct to patient accordingly.

Physicians are aided by a fully autonomous diagnostic system to view the ECG, review diagnostic suggestions and direct to patient accordingly.

Today, clinicians must rely on 12 lead ECG for heart attack detection performed solely within a hospital or clinic. Heartbeam's AIMI and AIMIGo technology has the potential to become the standard of care for cardiac patients with the potential to serve over 18 million patients in the U.S. alone. With a simplified 12 lead ECG process in a portable solution, Heartbeam is poised to revolutionize the healthcare industry by saving lives, reducing costs, improving the patient experience and provider outcomes, while advancing diagnoses with technology that can be used anytime, anywhere. Heartbeam, putting tomorrow's technology in patients hands today.

Heartbeam's AIMI and AIMIGo technology has the potential to become the standard of care for cardiac patients with the potential to serve over 18 million patients in the U.S. alone. With a simplified 12 lead ECG process in a portable solution, Heartbeam is poised to revolutionize the healthcare industry by saving lives, reducing costs, improving the patient experience and provider outcomes, while advancing diagnoses with technology that can be used anytime, anywhere. Heartbeam, putting tomorrow's technology in patients hands today.

With a simplified 12 lead ECG process in a portable solution, Heartbeam is poised to revolutionize the healthcare industry by saving lives, reducing costs, improving the patient experience and provider outcomes, while advancing diagnoses with technology that can be used anytime, anywhere. Heartbeam, putting tomorrow's technology in patients hands today.

improving the patient experience and provider outcomes, while advancing diagnoses with technology that can be used anytime, anywhere. Heartbeam, putting tomorrow's technology in patients hands today.

Heartbeam, putting tomorrow's technology in patients hands today.

Branislav Vajdic: Today, there are many ECG technologies offered to consumers and patients outside of a medical facility. What they all have in common is that they do not offer a standard of care 12-lead ECG. That means that they are not capable of detecting a heart attack. In the great majority of cases, it is a single lead ECG that may be adequate for some arrhythmias but is certainly not capable of detecting a heart attack.

What they all have in common is that they do not offer a standards of care that will lead to ECG.

That means that they're not capable of detecting a heart attack.

The great majority of cases, it is a single ECG it may be adequate for summary, but you're certainly not capable of detecting a heart attack.

Branislav Vajdic: So shown in this slide is the actual message from Apple Watch warning the user of its inability to detect the heart attack. Similarly, a live core with their cardiac products prominently feature on their website the same disclaimer about the inability to detect the heart attack. Our technology we believe has solved the problem of heart attack detection outside of a medical institution.

The user, albeit in ability to detect the heart attack.

A light quarter, you Darren cardiac products.

Entity feature on that site the same disclaimer about the ability to detect the heart attack.

Our technology, we believe has solved the problem heart attack detection outside the medical institutions.

Branislav Vajdic: The HeartBeam technology is intended to quickly and accurately help clinicians identify a heart attack. This could reduce the critical time to intervention for heart attack patients, saving lives and reducing healthcare costs by ruling out a heart attack and reducing the number of emergency room visits. 

This could reduce the critical time to intervention for us.

So tech patients saving lives and reducing healthcare costs by rolling out a heart attack.

And reducing the number of emergency room visits.

Okay.

Branislav Vajdic: Our third quarter was highlighted by progression on our commercialization pathway toward the series of important milestones including the 510(k) application submitted for HeartBeam AIMI product. As we look forward, FDA clearance for HeartBeam AIMI, we are also making significant progress with our core product, the AIMIGo 3D VECG collection device as we prepare for FDA submission in late Q4 of this year.

Submitted for Heartbeat AAV product.

As we look forward, but FDA clearness four have been Amy we are also making significant progress with our core product. The Amy go three the ECB collection device.

There for FDA submission in late Q4 of this year.

Branislav Vajdic: During this quarter, we broadened the product portfolio to enable smart watch connectivity to HeartBeam’s platform in future products as an option of monitoring solution for the clinician and their patient. We further advanced intellectual property protection during this quarter with two new patents, a patent for a 12-lead ECG patch monitor intended to – for detection of heart attacks and complex cardiac arrhythmias opens a pathway to offering ischemia and arrhythmia detection via an ECG patch.

Okay.

We further advanced intellectual property protection during this quarter.

<unk> patents.

And for <unk> patch monitor intended for the detection of heart attacks and complex garlic cardiac arrhythmias.

There is a pathway to offer an eighth EMEA and <unk>.

Section and.

ECG patch.

Branislav Vajdic: This innovation builds on our growing intellectual property portfolio enabling 12-lead ECG diagnostics outside of a medical setting. The technology offers the potential to bring a level of agnostic accuracy consistent with the current 12-lead ECG standard of care and could have a disruptive effect on the established multi-billion dollar ECG patch market with its ischemia detection capability.

The technology offers the potential to bring a level of a diagnostic accuracy consistent with the current <unk> standard of care and could have a disruptive effect on <unk>.

We established multibillion dollar ECG patch market.

Ischemia detection capabilities.

Branislav Vajdic: A second patent that enabled generation of a synthesized 12-lead ECG by our AIMIGo credit card size device opens a pathway for a patient to record a set of signals using AIMIGo outside of a medical setting with the agnostic synthesized 12-lead ECG immediately transmitted to a clinician for review and diagnosis.

Our Amy go cut size device Opus a pathway.

Ah patient to record the set of signals yielded Amy go outside of a medical setting.

Agnostic synthesized lead ECG immediately transmitted to a clinician for review and diagnosis.

Branislav Vajdic: This ECG format is one that clinicians are trained to interpret with the added benefit that by including a second recording of a patient’s baseline ECG, it is personalized to that individual and we expect that we’ll provide added data to assist a clinician in the diagnosis. We expanded the availability of patient population for our HeartBeam AIMI software platform to include unstable angina -- it's a diagnosis actually, for analysis and provide access to a broader patient population for technology once cleared by the FDA.

With the added benefit by including the second recording or patient base slide ECG. It is personalized to that individual and we expect that the bill provides added data to assist a clinician in the diagnosis.

We expanded the ability of patient population for our Heartbeat, Amy software platform to include unstable angina.

As a diagnosis actually four.

Analysis and provides access to a broader patient population core technology was cleared by the FDA.

Branislav Vajdic: Most recently, we announced the appointment of Dr. Peter Fitzgerald, a Chief Medical Officer. Peter is a renowned Stanford University Cardiologist who brings deep clinical research and industry experience to our executive team and is one of the most preeminent opinion leaders in cardiology and digital health. We expect that he will play a major role in defining best paths to adoption, clinical strategies and partnerships to advance our products and markets.

Peter is.

Stanford University cardiologist, who brings deep clinical research and industry experience to our executive team and is one of the most premium preeminent opinion leaders in cardiology and digital health, we expect that he will play a major role in defining best paths to it.

The option clinical strategies and partnerships to advance our products and markets.

Branislav Vajdic: We are also privileged to welcome Ken Persen to the role of Chief Technology Officer to lead overall Technology Strategy and Development of the HeartBeam AIMI and AIMIGo platforms. Ken has over 25 years experience in the Digital Health Care and Cardiac Devices Industries. Most recently, he founded the Digital Health Company a little more where he served as Chief Technology Officer. I would now like to turn the call over to Jon Hunt, our Chief Business Officer to further discuss our products and commercialization paths. Jon?

The role of Chief Technology Officer to lead overall technology strategy and development of the Harvey of Amy and Amy go platforms.

Kevin has over 25 years' experience in the digital health care and cardiac device industries. Most recently he founded the digital health company leave more where he served as Chief Technology Officer.

I would now like to turn the call over to John Hanna, Our Chief business officer to further discuss our products and commercialization paths.

John .

Jon Hunt: Thank you, Branislav. Turning to our product timelines and updates, we had several key developments related to our HeartBeam AIMI and AIMIGo platforms. As Branislav mentioned, we announced the 510(k) submission of our HeartBeam AIMI platform to the FDA, we received questions from the FDA within the statutory 30-day review deadline, discuss the questions by a teleconference with the FDA review team and provided written responses addressing the questions to the primary reviewer.

<unk> mentioned.

The five 10-K submission of our Heartbeat, Amy platform to the FDA.

We received questions from the FDA within the statutory 30 day review deadline.

The questions by a teleconference with the FDA review team and provided written responses addressing the questions to the primary reviewer.

Jon Hunt: The substantive review is in progress and we expect to receive FDA clearance in the fourth quarter followed by a limited market release in Q1 of 2023 and full commercial rollout in Q2 of 2023. We expanded the addressable patient population for the HeartBeam AIMI software platform to include unstable angina as a diagnosis for analysis and provide access to a broader patient population for technology once cleared by the FDA.

We expanded the addressable patient population for the Heartbeat, Amy software platform to include unstable angina, a diagnosis for analysis and provide access to a broader patient population.

The technology once cleared by the FDA.

Jon Hunt: It is important to include unstable angina as a diagnosis for analysis, as it is a frequent occurrence in patients presenting with chest pain. Patients with unstable angina may have subtle electrical changes brought on by ischemia without definitive injury to the cardiac tissue. We engage multiple partner health systems and they provided the needed ECG data to complete our clinical trial that was part of the FDA submission of our HeartBeam AIMI software product.

Diagnosis for analysis.

Is it is a frequent occurrence in patients presenting with chest pain.

Patients with unstable angina may have subtle electrical changes brought on by ischemia without definitive injury to the cardiac tissue.

We engaged multiple partner health systems, and they provided the needed ECG data to complete our clinical trial.

As part of the FDA submission of our beam Amy software product.

Jon Hunt: After this, we have plans for additional pilot studies for our end-to-end prescription only AIMIGo system for remote heart attack detection in at risk patients, as well as other future scientific and commercial collaborations with these health systems.

Jon Hunt: HeartBeam AIMI is software as a medical device solution for use in acute care settings with market clearance via the 510(k) regulatory pathway and our first target will be emergency departments, where this will be a software licensing business model on a subscription basis of an average cost of $100,000 per year per emergency department.

This will be a software licensing business model on a subscription basis.

Of an average cost of one hand $100000 per year for emergency Department.

Jon Hunt: In high volume emergency departments, we’ve discussed this with this turns out to be about 85 patients per day that go through the emergency department requiring a 12-lead ECG, so it works out at an amortized cost of between $3 to $4 per use. There are 5,000 emergency departments in the U.S. with a total addressable market of about $500 million.

Discussed this with this turns out to be about 85 patients per day. It go through the emergency department, requiring a 12 maintenance in June so it.

Worksite had an amortized cost of between three to $4 per use.

There are 5000 emergency departments in the U S with a total addressable market of about $500 million.

Jon Hunt: The HeartBeam AIMI solution is a web browser that slots into the existing workflow of an emergency department leverages existing 12-lead ECG hardware and provides the attending physician a diagnostic suggestion with an instant comparison of the patient’s baseline and symptomatic ECGs for their consideration in the patient’s diagnosis.

But the patients baseline in symptomatic <unk> for their consideration in the patient's diagnosis.

Jon Hunt: Quickly determining if a patient needs intervention or needs to be held in the ER for further observation or can be discharged helps the EDs manage throughput. To-date, HeartBeam has completed three key Harvard design studies in Europe. The study shown in this slide demonstrates the accuracy of the HeartBeam algorithm. It outperformed the panel of cardiologists in detecting a heart attack. The data showed the HeartBeam algorithm was agnostic to the physical location of the occluded vessel compared to cardiologist whose performance declined in occlusions in both lateral and posterior vessels. Briefly, the total addressable market for the AIMI software solution, as I just said, is approximately $500 million and compare that to the AIMIGo Technology platform we anticipate this to be about a $10 billion market and these are estimated numbers for the U.S. market alone.

Or needs to be held in the ER for further observation or can be discharged help ceb's manage throughput.

To date <unk> completed three key Harvard design studies in Europe .

As shown in this slide demonstrates the accuracy at the Heartbeat algorithm.

It outperformed the panel of cardiologists and detecting a heart attack.

The data showed the heart beam algorithm was agnostic to the physical location of the occluded vessel compared to cardiologists, whose performance declined in occlusions and both lateral posterior vessels.

Jon Hunt: Briefly, the total addressable market for the AIMI software solution, as I just said, is approximately $500 million and compare that to the AIMIGo Technology platform we anticipate this to be about a $10 billion market and these are estimated numbers for the U.S. market alone.

The total addressable market for the Amey software solution as I, just said is approximately $500 million.

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Compare that to the Amy go.

Technology platform, we anticipate this to be about a $10 billion market and these are estimated numbers for the U S market alone.

Jon Hunt: Turning to our AIMIGo product, we expanded our product portfolio pipeline to serve the growing cardiac device wearable technology market by bringing clinically relevant diagnostic information to patients and clinicians with smart watch connectivity enablement supporting a daily multi-hour heart monitoring solution.

<unk> multi hour monitoring solution.

Jon Hunt: In September, we were granted a patent that provides additional intellectual property protection for our AIMIGo Technology offering, 12-lead ECG capability in the form of a credit card size device with the same footprint as the single lead products currently in the market today.

<unk> ECG capability in the form of a credit card sized device with the same footprint as the single layer products currently in the market today.

Jon Hunt: This was quickly followed by the granting of a patent for a 12-lead electrogram patch monitor intended for detection of heart attacks and complex cardiac arrhythmias, building upon HeartBeam’s intellectual property portfolio, enabling 12-lead ECG diagnostics outside of a medical setting. We engage Silicon Valley based Triple Ring Technologies, a co-development engineering company to assist in the design and development of our AIMIGo complete solution 3D vector ECG collection device for remote heart attack monitoring. Triple Ring has a long history of successfully designing a wide variety of innovative medical devices and underlying technologies and we’re now working closely with its medical device team to rapidly build and test our 3D ECG device. This joint partnership is a five phase expedited device development project scheduled to be completed in the fourth quarter of 2022 in time for our 510(k) submission to the FDA.

Building upon heartbeats intellectual property portfolio, enabling 12 lead ECG diagnostics outside of a medical setting. We engaged Silicon Valley based Triple Ring technologies Co development Engineering company to assist in the design and development of our Amy go complete solution Treaty vector ECG collection device for remote heart attack monitoring. Triple Ring has a long history of successfully designing a wide variety of innovative medical devices and the underlying technologies. Now working closely with its medical device team to rapidly build and test our <unk> device. This joint partnership is a five phase expedited device development project scheduled to be completed in the fourth quarter of 2022 and time for our five 10-K submission to the FDA.

We engaged Silicon Valley based Triple Ring technologies Co development Engineering company to assist in the design and development of our Amy go complete solution Treaty vector ECG collection device for remote heart attack monitoring.

Triple Ring has a long history of successfully designing a wide variety of innovative medical devices and the underlying technologies.

Now working closely with its medical device team to rapidly build and test our <unk> device. This joint partnership is a five phase expedited device development project scheduled to be completed in the fourth quarter of 2022 and time for our five 10-K submission to the FDA.

Jon Hunt: The AIMIGo product incorporates the hardware design and development efforts of Triple Ring and our software firmware and remote patient monitoring platform development efforts. Engaging Triple Ring for the hardware development of the AIMIGo 3D ECG device to plug into our RPM platform, allows the company to provide an end-to-end telehealth solution for patients and physicians.

Gauging Triple ring, the hardware development of the Amy go <unk> device to plug into our RPM platform allows the company to provide an end to end telehealth solution for patients and physicians.

Jon Hunt: An added benefit of the partnership with Triple Ring is that they have an established relationship with an OEM manufacturer who is able to manufacture the AIMIGo 3D ECG device at scale. In addition, the OEM manufacturer is capable of handling logistics and distribution for their customers. By engaging experience development partners like Triple Ring HeartBeam management is confident, we’ll meet our project timelines for late Q4 2022 FDA submission and are in active discussions with Triple Ring’s manufacturing partner to support a limited market release of the AIMIGo product in Q2 of 2023.

<unk> relationship with an OEM manufacturer, who is able to manufacture the Amy go <unk> device at scale. In addition, the OEM manufacturers capable of handling logistics and distribution for their customers.

By engaging experience development partners like Triple Ring RP management is confident we will meet our project timelines for late Q4, 2022 FDA submission.

Uh-huh and are in active discussions with triple range manufacturing partner to support a limited market release of the Amy go product in Q2 2023.

Jon Hunt: HeartBeam’s AIMIGo product is a 510(k) regulatory pathway. We have already identified a predicate device to demonstrate substantial equivalence with a simple validation study. Importantly, the clearance of the Gen 1 device allows HeartBeam to collect 3D vector cardiogram data and use these data for developing advanced features for a Gen 2 product.

<unk> already identified a predicate device to demonstrate substantial equivalents with a simple validation study.

Certainly the clearance of the Gen. One device allows heartbeat collect trading vectorcardiogram data and use these data for developing advanced features for our Gen two product.

Jon Hunt: HeartBeam AIMIGo has a clear reimbursement pathway with existing CPT Codes and these are highlighted on this slide. We’re planning on using a subscription model, where HeartBeam builds a practice on a per patient per month basis. And the discussions my commercial team have had with the cardiology practices indicate this is an attractive business model, because they can use existing codes and it provides an enhanced level of care for high risk patients that they currently do not monitor.

Planning on using a subscription model, where heartbeat builds a practice on a per patient per month basis.

And the discussions my commercial team have had with the cardiology practices indicate this is an attractive business model because they can use existing codes.

And it provides an enhanced level of care for high risk patients that they currently do not monitor.

Jon Hunt: Looking at the average monthly reimbursement per practice per patient is approximately $1,300 per year per patient or about $110 per month based on average reimbursement cost in the U.S. And HeartBeam will build a practice a technical fee of $50 per month per patient or $600 per year. Again, this is to monitor a currently underserved high risk patient population that until now we’re not able to be easily monitored outside of a medical facility. This is also expected to provide a new revenue stream for a cardiology practice. We estimate that our share of this revenue stream, i.e., the technical fee is about $10 billion a year in the U.S. market alone.

This is approximately <unk> hundred dollars per year per patient for about $110 per month based on average reimbursement cost in the U S and hopping, we will build a practice of technical fee of $50 per month per patient or $600 per year.

Again. This is to monitor are currently underserved high risk patient population that until now were not able to be easily monitored outside of a medical facility.

This is also expected to provide a new revenue stream for our cardiology practice.

We estimate that our share of this revenue stream I E. The technical fee is about $10 billion a year in the U S market alone.

Jon Hunt: This slide shows several companies in the cardiac monitoring market that you are very familiar with. While each product offers some of the capabilities of the HeartBeam telehealth product, the 12-lead ECG capability, integration of patient history and symptoms, and the presentation of comparative ECGs, providing a baseline and symptomatic ECG to the physician, differentiate the AIMIGo device significantly from other products in the market.

While each product offers some of the capabilities of the heart being telehealth product the 12 week ECG capability.

Integration of patient history, and symptoms and the presentation of comparative ECG.

Providing a baseline and symptomatic ECG to the position differentiate the Amy go device significantly from other products in the market.

Jon Hunt: We believe HeartBeam AIMI and HeartBeam AIMIGo by leveraging our patented 3D vector ECG technology offer substantial capabilities beyond existing offerings and we continue to engage with potential customers and partners in anticipation of FDA clearance and commercial launch for our products.

Jon Hunt: It is important to note while a live course credit card sized cardio mobile product recently introduced and shown on this slide is only a single lead ECG recording and does not contain the vector information recorded by the AIMIGo device. I will now turn the call over to Rick Brounstein, Chief Financial Officer to discuss operational updates and financials.

Is only a single lead ECG recording and does not contain the vector information recorded by the anchor of the device.

I will now turn the call over to Rick Bryan <unk>, Chief financial officer to discuss operational updates and financials.

Rick Brounstein: Thank you, Jon. I would like to briefly discuss our sample financial model at scale for our HeartBeam AIMI and AIMIGo solutions, which shows that capturing even a modest percent of our total addressable market results in the significant reoccurring revenue base. The existing insurance codes that Jon just reviewed previously are going to drive the AIMIGo revenue.

I would like to briefly discuss our sample financial model at scale for our gaming and our Amy go solutions.

We chose that capturing even a modest percentage of our total addressable market. <unk> and a significant reoccurring revenue base. The existing insurance codes that Jon just reviewed previously are going to drive the Amy go revenue.

<unk> and a significant reoccurring revenue base.

The existing insurance codes that Jon just reviewed previously are going to drive the Amy go revenue.

Rick Brounstein: This telehealth is a much larger market, probably about 20 times or so our market opportunity compared to this side of the ED market and over time we expect that it will be the primary source of revenue.

Rick Brounstein: I would also like to highlight that our solutions also generate high gross margins under either base case assumptions with gross margins above 80%. And finally as the company scales, operating margins can be in excess of 30% even as we increase investments in R&D. As R&D opportunity is most evident by taking a look at our platform technology and what we’re doing with it today.

With gross margins above 80%.

And finally as the company scales operating margins can be in excess of 30%, even as we increase investments in R&D.

This R&D opportunity is most evident.

Taking a look at our platform technology, and what we're doing with it today.

Rick Brounstein: Turning to our financials. I will now give us a sync review of our financial results. A full breakdown is available in our regulatory filings we just issued the 10-Q for the quarter and in the press release that just cross the wire after market closed today. Our third quarter 2022 financials are the last comparing HeartBeam’s results as a private company in 2021 to now a public company working on the commercialization of our first two products.

Breakdown is available in our regulatory filings, we just issued the 10-Q for the quarter.

And in the press release that crossed the wire after market close today.

Our third quarter 2022 financials.

And the last comparing <unk> results as a private company.

In 2021 to now a public company working on the commercialization of our first two products.

Rick Brounstein: Research and development expenses for the third quarter of 2022 were $1.6 million compared to $105,000 for the third quarter of 2021. Our focus on R&D consisted largely of product development costs for HeartBeam AIMI, which is now essentially done and also HeartBeam AIMIGo. This includes both software and hardware, the latter with our professional service agreement with Triple Ring Technologies to assist in the hardware for AIMIGo. Additionally, there are clinical costs and support of our FDA submissions for both our products this year as well as research costs and support of future product pipeline coming from our patented vector 3D ECG platform technology.

Compared to 105000 for the third quarter.

Of 2021, our focus on R&D consisted largely of product development costs for Hurricane Amy which is now essentially done.

And also heart beaming amigo.

This includes both software and hardware.

Later with our professional service agreement, a triple ring technologies to assist in the hardware for Amigo.

Additionally, there are clinical costs in support of our FDA submissions for both our products this year as well as research costs in support of future product pipeline coming in from our patented sector <unk>.

<unk> platform technology.

Rick Brounstein: General and administrative expenses for the third quarter of 2022 were $2.0 million, so 2 million even, compared to $341,000 for the third quarter of 2021, reflecting the growth in our team and other costs in support of being a public company. Interest income during the three months ended September of 2022 of $28,000 is related to the cash balances from the last November IPO. In 2021, we had $608,000 of expense tied to the 2015 convertible notes that converted into and added to the common stock as of December 31 of 2021.

General and administrative expenses for the third quarter of 2022 or $2 million, so $2 million even.

Compared to 341000.

For the third quarter of 2021.

Reflecting the growth in our team and other costs in support of being a public company.

Interest income during the three months ended September of 2022 of $28000 is related to the cash balances from the last November IPO.

In 2021, we had 608000 of expense tied to the 2015 convertible notes.

That converted into an attitude of the common stock as of December 31.

'twenty one.

Rick Brounstein: Net loss for the quarter – third quarter was $3.6 million compared to a net loss of $1.2 million for the third quarter of 2021. We ended the third quarter of 2022 with $6.5 million in cash and cash equivalents compared to $13.2 million as of the end of December 31, 2021. We expect our cash position to provide a runway into 2023 and the expected FDA submission in Q4 of this year as well as the clearance of HeartBeam AIMIGo next year. I'll now turn the call back over to Branislav for his closing thoughts.

Third quarter was $3 6 million compared to a net loss of $1 2 million for the third quarter 2021.

We ended the third quarter of 2022 with $6 5 million in cash and cash equivalents compared to $13 2 million as of the end of December 31 2021.

We expect our cash position to provide a runway into 2023 and.

And the expected FDA submission in Q4 of this year as well as the clearance of RP, mainly go next year.

I'll now turn the call back over to Branislav for his closing thoughts.

Branislav Vajdic: Thank you, Rick. Indeed, our technology is a true platform technology. So far, we have developed two products that are going to the process of either already submitted to the FDA in the case of HeartBeam AIMI or soon to be submitted to the FDA for the HeartBeam AIMIGo product. During the third quarter, we continued to operate from a position of strength, equipped with strategic partnerships to advance product development, near-term milestones and cash runway into 2023.

Branislav Vajdic: Thank you, Rick. Indeed, our technology is a true platform technology. So far, we have developed two products that are going to the process of either already submitted to the FDA in the case of HeartBeam AIMI or soon to be submitted to the FDA for the HeartBeam AIMIGo product. During the third quarter, we continued to operate from a position of strength, equipped with strategic partnerships to advance product development, near-term milestones and cash runway into 2023.

<unk> Amy go product.

During the third quarter, we continued to operate from a position of strength.

With strategic partnerships to advance product development near term milestones and cash runway into 2023.

Branislav Vajdic: Looking ahead, we are accelerating our commercialization path in remain confident in our anticipated upcoming product milestones. By the end of this year, we expect to receive FDA clearance for our HeartBeam AIMI platform and we expect to have our HeartBeam AIMIGo solution submitted to the FDA for clearance. 

By the end of this year, we expect to receive FDA clearance for our Heartbeat Amy platform.

And we expect to have our Harbin Amy go solution submitted to the FDA for clearance.

Branislav Vajdic: We approach these milestones from a position of strength with an experienced team bolstered by recent appointment of Dr. Peter Fitzgerald as Chief Medical Officer, and Ken Persen is our Chief Technology Officer to support these goals.

Branislav Vajdic: Beyond that, looking at the product pipeline, we think that the application of our artificial intelligence will be of great value to us. We will have very unique dataset of patients with actually have recorded ECG on a daily, weekly or monthly basis. That longitudinal data for our patient population will be of tremendous value. Applying artificial intelligence to these data sets will be extremely valuable. It is an extremely data rich set, much richer than the standards 12-lead ECG.

Will be of great value to us.

We will have very unique data set of patients with actually.

We have recorded ECG on a daily weekly or monthly basis.

That's longitudinal data for our patient population will be of tremendous value.

Applying artificial intelligence with these.

<unk>.

Be extremely valuable.

These are extremely data at each set much richer.

Then the standards Velveeta ECG.

Branislav Vajdic: Additionally, insight that we will gain by applying artificial intelligence will help cardiovascular population with predictive and preventive value we believe. On the lower right portion of this slide, it shows the 12-lead patch. We have recently received a patent for that essential tool for the physicians and it is a unique patch in this category of a market that’s growing and is projected to be at $4.8 billion by 2030. This is a disruptive technology that has the potential to have a significant influence on the patch industry as a whole.

Insight.

We'll gain.

By applying artificial intelligence will help cardiovascular population.

With predictive preventive value we believe.

On the lower right portion of this slide it shows the 12 liter batch.

We have recently received a patent for that essential.

Two for the physicians.

And it is a unique.

Batch in the category of.

A market that's growing and is projected to be at $4 8 billion.

Dollars by 2030.

This is a disruptive technology that has the potential to have a significant influence on the patch industry as a whole.

Branislav Vajdic: I’d like to share one final thought. We are all very excited about the prospect of helping millions and millions of cardiovascular patients, initially heart attack patients, but we believe our technology will essentially address all cardiac patients and all disease, cardiac disease that are detectable by a 12-lead ECG. So that’s very exciting prospect for all of us and a great motivator to be helping many, many millions of patients throughout the world. I look forward to providing our shareholders with further updates in the near-term as we move forward towards commercialization.

One final thought.

We are all very excited about the prospects of helping millions and millions of cardiovascular patients.

Initially heart attack patients, but we believe our technology Bill essentially addressed all cardiac patients.

And all disease cardiac disease detectable by its above the BCG.

So thats very exciting prospect for all of us and a great motivator to be helping many many millions of patients throughout the world.

I look forward to providing our shareholders with further updates in the near term is the move forward.

Towards commercialization.

Branislav Vajdic: I thank you all for attending and now the HeartBeam team would like to answer any questions. Operator?

Operator.

Operator: Thank you. If you'd like to ask a question, please signal by pressing star one on your telephone keypad. If you're using a speaker phone, please make sure your mute function is turned off to allow your signal to reach our equipment. A voice prompt from the line will indicate when your line is open. Once again, that's press star one to ask a question and we will pause for a moment to allow everyone an opportunity to signal. We’ll take our first question from the line of Jason Kolbert with Dawson James. Please go ahead. Your line is now open.

A voice prompt from the line will indicate when your line is open. Once again, that's press star one to ask a question and we will pause for a moment to allow everyone an opportunity to signal. We’ll take our first question from the line of Jason Kolbert with Dawson James. Please go ahead. Your line is now open.

Once again, that's press star one to ask a question and we will pause for a moment to allow everyone an opportunity to signal. We’ll take our first question from the line of Jason Kolbert with Dawson James. Please go ahead. Your line is now open.

Operator: We’ll take our first question from the line of Jason Kolbert with Dawson James. Please go ahead. Your line is now open.

Jason Kolbert: Hi guys. Congratulations on all the progress. I’d like to hear you talk a little bit more about the overall commercialization plans as approval becomes a reality and you start getting into raising physician awareness and really driving this product, both AIMIGo and the entire platform. Thanks.

Raising physician awareness and really driving this product both Amy go and the entire platform. Thanks.

Branislav Vajdic: Jon, please.

Jon Hunt: Hey, Jason. Yes, thank you. Well, obviously we’re already in the discussions now with some pilot sites for anticipating HeartBeam AIMI. One of the things the commercial team wants to do with a few pilot sites we’ve already identified is to evaluate the product in terms of how it slots into the clinical workflow and gets some early feedback from those users.

One of the things that commercial team wants to do with a few.

Pilot sites, we've already identified.

Is to evaluate the product in terms of.

How it slots into the clinical workflow.

And get some early feedback from from those.

Users.

Jon Hunt: We’ve identified some very prominent physicians in the emergency medicine space to help us in that effort. And once we’ve characterized that, then we’ll expand the commercial footprint. But as I’ve said previously, initially with a small commercial team, we’re going to focus on accounts that are regionally based to the – where the folks are located in the HeartBeam team. And that’s in these following metropolitan area, Charlotte, North Carolina; Atlanta, Georgia; Minneapolis, St. Paul; Denver, Colorado; and Seattle, Washington. So it’ll be a small footprint initially to gain traction. And then as we get traction with the product, we’ll expand the commercial team footprint.

The medicine space.

Help us in that effort and once we.

Is that then we'll expand.

The commercial footprint.

As I've said previously.

Initially with.

Small commercial team.

Focus on accounts that are.

Regionally base to the where folks are located in the heart being team.

These following metropolitan area, Charlotte, North Carolina, Atlanta, Georgia.

Minneapolis, St Paul Denver, Colorado, and Seattle, Washington, So it'll be a small footprint initially to gain traction and then as we get traction with the product.

We'll expand the.

Commercial team footprint.

Jon Hunt: With AIMIGo, we’ve already got a lot of interest from some of those same centers, because we’re finding -- in fact, I know one of my staff just had a discussion today with a major academic center in the Seattle region, where we’re bringing cardiology and emergency medicine together, because we think long-term there’s a possibility that AIMIGo will get prescribed not just by cardiologists who follow these high risk patients, but also out of emergency departments by physicians that are often discharging up to 80% of patients that present with chest pain. They get diagnosed for a non-cardiac reason, and then they’re cycled back into cardiology, because obviously it was chest pain that brought them into the center.

Already got a lot of interest from some of those same centers because we're finding.

And in fact, I know one of my staff just had a discussion today with a major academic center.

That whole region.

There were.

Bringing cardiology emergency medicine, together, because we think.

Long term there is a possibility that Amy go will get prescribed not just by cardiologists, who follow these high risk patients but also.

Out of the emergency departments by physicians that are often discharging up to 80% of patients that present with chest pain.

Get diagnosed non cardiac region reason and then there theyre cycled back into cardiology, because obviously the chest pain that brought them into the center.

Jon Hunt: And a lot of emergency physicians we’ve spoken to, like, the idea of actually giving a device to a patient as they discharge them, because currently they’re just discharge them with the promise that they’re going to get a cardiology follow up call, which as you know based on scheduling can take anywhere from on average six to eight weeks. So doesn’t necessarily make the patient feel well.

Promise that theyre going to get.

Cardiology call up.

<unk>, which as you know.

Based on schedule and can take anywhere from on average six to eight weeks. So it doesn't necessarily make the patient sale.

Jason Kolbert: Yes, it makes sense. Sounds like a very --

So it sounds like a very good Friday in court.

Jon Hunt: That’s important, right.

Jason Kolbert: Right. Sounds like a very pragmatic paced launch and a lot of planning sounds like it’s gone into it. Can you also Branislav talk a little bit about what the interaction was like with the FDA? You turned around the written response pretty quickly, did – were there questions kind of just – were there any real big surprises there or was it pretty routine and what’s your confidence level given that interaction on where you stand now? It sounds like it’s pretty high.

<unk> shed a lot of planning sounds like its gone into it.

Can you also let us off talk a little bit about what the interaction with like with the FDA you turned around the written response pretty quickly.

What did that.

Where there are questions kind of chest.

Were there any real big surprises, there or was it pretty routine and what's your confidence level given that interaction on where you stand now it sounds like it's pretty high.

Branislav Vajdic: Yes. Thanks Jason for the question. I have a comment and also I ask for Jon who has been very close to that process to comment as well. So far we have not seen any surprises. We have received a set of questions, we responded and actually spent half an hour with the FDA team, basically putting a bit more detail around our response and that went well as far as we can tell. At this point, we are waiting for the next step here. We really don’t know what the next step will be, but at this point, we are confident that the clearance will come this year. Exact timing is impossible to say, right. And the FDA has been under a lot of stress, in terms of tail end of COVID, et cetera. So we really don’t know exact action – final action by the FDA, but the optimistic and we believe that that’s going to be for sure this year. But Jon maybe additional light from you.

So far we have not seen any surprises we have received a set of questions. We responded and actually spent half an hour.

It would be the FDA team.

Basically putting a bit more detail about our response.

And that went well as far as we can tell.

At this point.

<unk> for the next step here, we really don't know what the next steps will be but at this point.

We are.

Confident that the.

The clearance will come this year exact timing is impossible to say right.

He has been under a lot of stress.

In terms of.

Atlanta, Colby et cetera, So we really don't know exact.

Action of final action by the FDA, but we are optimistic and we believe that that's going to be.

For sure this year, but John maybe additional light from you.

Jon Hunt: Yes. Well, one, I think Jason was the – we got questions back from the FDA. I think some of them is typically in the experience I’ve had previously. Sometimes it’s just a misunderstanding on the reviewer's part of the – review team’s part, right. And I think we had a couple of those questions, which we dispositioned on the phone call. But then we wanted to provide written responses, which we turned around quickly, because that’s just my preference in dealing with the FDA. You never sort of show indifference to responding to their question. I think the promising thing from my standpoint was that they were very responsive in hosting a conference call with us, and the reviewer pulled the entire team together.

One I think Jason was that.

We've got questions back from the FDA I think some of them as is typically the experience I've had.

Previously is that sometimes is just a misunderstanding on the review as part of the review teams part right and I think we had a couple of those questions, which we we dispositions on the phone call. But then we wanted to provide written responses, which we turned around quickly because.

That's just my preference and dealing with the FDA you never.

So the show indifference to responding to their questions I think the promising thing from my standpoint was that they were very responsive and hosting a conference call with us and the reviewer put the entire team together.

Jon Hunt: And we had an interactive dialogue with them, said we were going to provide both minutes to the meeting, which obviously FDA reviews along with responses, and now it’s under substantive review. I think as you’re all aware, FDA is still working remotely. It’s post COVID. They’ve been hammered during COVID, obviously, it’s the fact that they’ve kept up with this and met their statutory timeline on the initial review was promising from my perspective. But as Branislav said, very difficult to try and pin them down to when they’ll get done with the substantive review or those getting close to year end. And I know they have a tendency that they want to close out. Submissions that are already in the queue and under review and I’ve experienced that previously as well. So very positive from my perspective.

The fact that they've kept up with this met their statutory timeline on the initial review was promising from my perspective, but as Brian as I've said very difficult to try and bring them to when they will get done with the substantive review.

Although it is getting close to year end and I know they have a tendency that they want a closeout.

Submissions that are already in the Q and a number of you and I have experienced that previously as well so.

Very positive from my perspective.

Jason Kolbert: Yes, very helpful. I appreciate that color. And by the way, thank you for laying out the milestones so clearly as you did in the press release. It’s refreshing to see that. Thank you so much.

Branislav Vajdic: Thank you for your questions, Jason.

Operator: Once again, if you'd like to ask a question, that's press star one. We’ll take our next question from Bill Sutherland from The Benchmark Company. Please go ahead. Your line is now open.

Operator: We’ll take our next question from Bill Sutherland from The Benchmark Company. Please go ahead. Your line is now open.

Bill Sutherland: Thank you. Hello team. Great quarter. Branislav, I was curious on the intellectual property front, are you anticipating any additional patents that you believe could be issued here in the roughly near future? And if so, would they –- maybe the type of area that they would cover?

Hello team. Great quarter. Branislav, I was curious on the intellectual property front, are you anticipating any additional patents that you believe could be issued here in the roughly near future? And if so, would they – maybe the type of area that they would cover?

Great quarter.

Brandon swap I was curious on the intellectual property front.

Are you anticipating any additional patents that you believe.

Could be issued here in the relatively near future and if so would they.

Maybe the.

The type.

Type of.

The area that they would cover.

Branislav Vajdic: Yes. Apparently, intellectual property is sort of foundation of this company. Very rarely do you find in this device space, in this market cap if you want a range companies that have this strong of a IP portfolio and growing, right. So in general, I would say, this is – we are very proud of it. It’s not very common at all. Secondly, we have a couple of significant patents that are being reviewed. Especially, one of them in my own mind is extremely meaningful in terms of its commercial impact, potential commercial impact. And they’re under review and the FDA and the patent office are hard to predict in terms of exactly when they will act, but certainly a significant patent by the end of the year approval of a significant patent by the end of the year is very much possible. And secondly, we continue to generate new intellectual property filings, right. One is going out within a few days. And then we have two more in preparation as well. So the cadence of IP continues at a very rapid pace.

Do you find in the device space and this is.

Market cap, if you want a range.

The companies that have this strong.

IP portfolio and growing right. So that in general I would say this is we.

We are very proud of it is it's not very common at all.

Secondly, we have couple of.

Significant factors that are being reviewed.

The officially one of them.

In my own mind is.

Extremely.

Meaningful in terms of its core commercial impact potential commercial impact and they are under review and the the FDA and the patent office.

Hard to predict in terms of exactly when they will act.

But suddenly a significant pattern, but at the end of the year approval of a significant bad but the year is very much possible and.

Secondly, we continue to generate new intellectual.

Property filings right.

One is going out.

<unk> been in a few days.

And then we have two more in preparation as well so.

The cadence of IP.

<unk> continues at a very rapid pace.

Bill Sutherland: Great. And the – as you look at the commercialization process next year, have you – as you’ve expanded the two types of AIMIGos, in terms of the 12-lead. Do you expect to have that at all impact your – how you go-to-market? Or will it really be just two sets of solutions with the same real market focus?

Yeah.

As you look at the.

Commercialization.

<unk> process next year.

Have you.

As you know as you would.

Band it.

<unk>.

The two types of AMD goes.

In terms of <unk>.

Do you expect to have that at all impact your.

You know how your go to market or will it really be just.

<unk>.

Our solutions.

With the same the same real market focus.

Branislav Vajdic: Jon, please go ahead.

Jon Hunt: Yes. I think initially we will stick to our knitting as it were, and focus on the two products as we described them in this presentation HeartBeam AIMI and AIMIGo. I think one of the challenges always with commercial teams, especially sales people is keeping them focused. So I want to get the pilots established, get those running, see what the uptake is like the value we create for the clinicians, getting early feedback from those early adopters if you like making any tweaks if we see them getting input for the technical team, that sort of thing, or the user interface and all those things. And I think if we get too scattered, the message gets jumbled a little bit when you go-to-market if you have too many things in the hopper at once. So I want to get them established and I think then when we get them established also get some feedback from the market on what they think the key value points may be given, I’ve got an inventor who’s my boss and CEO that keeps coming up with more and more ideas of how to leverage this platform. So and I’m spoiled for choice, but I want to keep the commercial team focused out of the gate for sure.

The two products as we've described them in this presentation are being and Amy Amy go.

I think.

One of the challenges always with commercial teams, especially salespeople is keeping them focused so I want to get the pilots establish get those running let's see what the.

The uptake is like the value we create for the clinicians getting early feedback from those.

Early adopters if you like.

Making any tweaks, if we see them getting input from the technical clean that sort of thing all the user interface and all those things and I think if we get too scattered.

The message gets jumbled a little bit when you go to market. If you have too many things.

In the hopper at once so I want to get them established and I think then when we get them established also get some feedback from the market on what they think that key value points may be given.

Got an inventor who's my boss and CEO that keeps coming up with more and more ideas of how to leverage this platform.

Though.

And I am spoiled for choice, but I want to keep the commercial team focused out of it for sure.

Bill Sutherland: Got it. Well, look forward to seeing you all at our Discovery Conference, December 1 and great work. Thanks.

Well look forward to senior all that are so every conference December one.

Framework. Thanks.

Branislav Vajdic: Thank you, Bill.

Operator: Once again, if you'd like to ask a question, that's press star one. There are no further audio questions at this time. We will move over to the Webcast.

There are no further audio questions at this time. We will move over to the Webcast.

questions at this time. We will move over to the Webcast.

Multiple speakers: [Rick Brounstein] Our first webcast question asked, have you had discussions with insurance companies and can you comment on how easy or difficult it will be to get insurance companies to cover these devices? [Branislav Vajdic] Jon, please go ahead.

Our first webcast question asked have you had discussions with insurance companies.

And can you comment on how easy or difficult it will be to get insurance companies to cover these devices.

John Please go ahead.

Jon Hunt: Yes. We haven’t had specific discussions with insurance companies. We have had discussions with some people that are very well connected to the large payers and large payers that have lots of covered lives under their span of control, spend an awful lot of money on the care of cardiovascular patients. So I think once we get established in the market, having that discussion with large payers will be very attractive. I know of some technologies that also manage high risk patients like diabetic patients, for example, where the reimbursement for helping to manage those patients from payers is much higher than corresponding codes for managing those patients or reimbursement for those patients.

Very well connected.

To the large payers.

And <unk>.

A large payers that have lots of covered lives under there.

Span of control spend an awful lot of money.

On the care of cardiovascular patients. So I think once we get.

Established in the market, having that discussion with large payers will be very attractive I know of some technologies that also manage high risk patients like diabetic patients for example.

Where the reimbursement for helping to manage those patients from Payors is much higher than corresponding codes for managing those page until reimbursement for those patients.

Jon Hunt: So that’s a discussion we’re certainly got on the books to have. And I think in order to make a dent with an insurance company, one of my commercial team actually has been on the payer side and in a previous life has run the sorts of studies that will need to do a study to demonstrate to a payer the value that we provide in managing those patients. So that’s definitely on our books and something we plan on doing is, I think it actually from a revenue standpoint is a very attractive option for us. And it removes us from the standard CPT Code sort of reimbursement mill. But yes, it’s definitely our mind, so want to get the products approved and then have those discussions.

Within the insurance company.

One of my commercial team actually has been on.

The payer side.

And in a previous life has run the sorts of studies that will need to do a study to demonstrate to a payer.

The value that we provide in managing those patients. So that's definitely on our books and something we plan on doing great. So I think it actually from a revenue standpoint.

Very attractive option for us.

It removes us from the standard CPT code reimbursements mill.

Yes, it's definitely on our minds.

I wanted to get the products approved and then have those discussions.

Rick Brounstein: The next question asks, how many questions has the FDA asked regarding the current 510(k) submission? And are there any questions yet to be answered?

Branislav Vajdic: Well, we are not going to go into detail --

Jon Hunt: Yeah, I’ll take that Branislav.

Branislav Vajdic: Yeah, well let's just say that we are not going into details on how many questions we're asked. I’m not sure that we accurately remember the number of questions that they were all answered very thoroughly. And indeed at this point, we are not aware of any questions that are not answered by us. So the answer is, we have answered all questions and we are expecting action by the FDA by the end.

Going into detail many questions.

We're asked I have nothing further.

Accurately remember the number of questions. There did they are all answered very thoroughly and indeed it disappoints we are not aware of any questions that are not.

Not necessarily.

US so.

So.

The asset is we have answers to all questions and <unk>.

Expecting action by the FDA by the end of it.

Rick Brounstein: The next question asks, will you allow pharmacists in retail settings to use this technology to provide a life saving diagnosis?

Or will you allow pharmacist in retail settings to use this technology.

To provide a life saving diagnosis.

Branislav Vajdic: Jon, maybe you should answer this one.

Jon Hunt: Well, I’m assuming retail setting, you’re thinking of CVS and Walgreens and others Walmart that have these minute clinics or minute clinic equivalents. And certainly in the Charlotte region, I know CVS is our staff by a lot of mid-levels as well as pharmacists in their clinics. So it’s potential to have that discussion. And I think cardiologists may push back on as pharmacists are making a diagnosis regarding a cardiac condition. I’m not sure, I’d have to investigate that further. But clearly, one of the potential markets for us is interacting with the CVS’ of the world because of a lot of people in the country are closer to a CVS in many instances, than they are to a hospital.

Well im assuming retail setting youre thinking of Cvs and Walgreens.

Others Walmart.

Yes.

That clinics are a minute clinic equivalents.

And certainly in the Charlotte region, I know Cvs is our staff by a lot of mid levels as well as pharmacists then the clinics.

So its potential to have that discussion.

And I think.

Cardiologists.

They pushed back on.

Pharmacists are making a diagnosis regarding cardiac condition I'm not I'm not sure I'd have to investigate that further but one.

One of the potential markets for us is <unk>.

Interacting with the Cvs is of the world.

On the call.

<unk>.

A lot of people in the country.

Closer to a Cvs in many instances there than they are to a hospital so.

Jon Hunt: So I could see that being something of tremendous value. It’s a matter of how do we go about proving that that’s providing value one to the patient and also to the clinical community at large. So -- but it’s a very interesting question. Again, something that I think a CVS or Walmart or Walgreens would want to conduct a study to show that value before that even got into the realm of being allowing a pharmacist to make those diagnoses in the field. 

As a matter of how do we go about proving that that's providing value to the patient and also.

To the clinical community at large so that's.

Very interesting question again, something that I think CBS or Walmart or Walgreens would want to conduct a study to show that value.

Before.

That even got into the.

The realm.

<unk>. Allowing a pharmacist to make those diagnoses. So.

Allowing a pharmacist to make those diagnoses.

So.

Rick Brounstein: I think we have time for one more webcast question and that question is, the first release of AIMIGo version one next spring is a commercial release, and if not, why not?

Is it a commercial release and if not why not.

Multiple speakers: [Branislav Vajdic]  Again, I think Jon is the best equipped to answer that one. [Jon Hunt] Yes. So if you remember, we’d indicated previously that, that the version one of AIMIGo is sort of the stripped down basic version of AIMIGo’s recording a 3D orthogonal, 3D vector ECG at the heart.

So. If you remember.

If you remember.

We had indicated previously that the version one of AME go is sort of stripped down.

Basic version of anchors recording a three D orthogonal.

Three the vector ECG or the heart.

Jon Hunt: So it provides the core information for us to create a synthesized 12-lead. But version one has a very high cost structure at the moment. And at the moment, we’re building a limited number and we’re planning on -- because the cost of goods for version one, it’s not a scalable commercial product from our perspective, given the current reimbursement landscape.

Version, one has a very high cost structure at the moment.

And at the moment, we're building a limited number and we're planning on.

Uh huh.

Because the cost of goods for version one it's not a scalable commercial product from our perspective, given the current reimbursement landscape.

Jon Hunt: And so because we have V2 coming close behind, which is scalable, where we made a dramatic drop in the cost of goods for the entire packaged product labeled and everything and we’ve reduced it by some 80% from the version one. So we’re going to use V1 at these centers that we’ve identified to integrate it into a clinical practice and gather valuable clinical information from patients. Look at workflow, UI/UX, put BAS in place with those healthcare systems to facilitate the V2 launch, which will be a scalable product that we can then go after in a much more aggressive fashion and version one out of the gate from our perspective at the moment is going to sort of fill that very valuable role for us as this regulatory clinical work horse to set the stage for a full scale launch of the V2 product.

Is scalable where we.

Made a dramatic drop in the cost of goods for the entire packaged product labels and everything.

And we reduced it by some 80% from the version one.

So.

We're going to use the one at these <unk>.

Centers that we've identified to integrate it into clinical practice.

And.

Gather valuable clinical information from patients look at workflow UI UX.

Could be as in place with those health care systems.

To facilitate the <unk> to launch which will be a scalable product that we can.

Then.

No.

Go after a much more aggressive fashion version one out of the gate from our perspective at the moment is going to.

Sort of fill that very valuable.

Role for us as this regulatory clinical work horse.

Set the stage for them.

A full scale launch of the product.

Operator: I would now like to turn the conference over to -- back over to Mr. Vajdic for his closing remarks.

Back over to Mr. <unk> for his closing remarks.

Branislav Vajdic: Thank you, operator. I would like to thank each one of you who joined us today for our earnings conference call 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. Thank you, again and have a good day. 

I would like to thank each one of you. Joined us today for our earnings conference call.

Joined us today for our earnings conference call.

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 thank you again and have a good day.

Hi.

Operator: This concludes today’s call. Thank you for your participation. You may now disconnect.

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Yeah.

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